data
stringlengths 358
232k
|
|---|
protocolSection identificationModule nctId: NCT06302946, orgStudyIdInfo id: P.T.REC/012/005024, briefTitle: Effect of Neuromuscular Stimulation and Mindfulness Breathing in Patients With Stroke, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-15, primaryCompletionDateStruct date: 2025-05-30, completionDateStruct date: 2025-12-30, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: Cairo University, class: OTHER, descriptionModule briefSummary: It is an interventional study in which 60 stroke patients estimated to enroll according to random allocation and divided into two groups. The experimental group will receive neuromuscular stimulation, mindfulness breathing and traditional physiotherapy while the control group will stick to traditional physiotherapy only., conditionsModule conditions: Stroke, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: neuromuscular stimulation ,mindfulness breathing and traditional physiotherapy program, interventions name: traditional physiotherapy program, outcomesModule primaryOutcomes measure: level of physical function, secondaryOutcomes measure: ventilatory function, secondaryOutcomes measure: level of stress, eligibilityModule sex: ALL, minimumAge: 50 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Faculty of Physical Therapy, status: RECRUITING, city: Cairo, state: Dokki, zip: 11432, country: Egypt, contacts name: marwa M elsayed, phd, role: CONTACT, phone: 01156033818, phoneExt: 02, email: marwadd999@gmail.com, contacts name: marwa M elsayed, ph.d, role: CONTACT, phone: 01156033818, phoneExt: 02, email: marwadd999@gmail.com, geoPoint lat: 30.06263, lon: 31.24967, hasResults: False
|
protocolSection identificationModule nctId: NCT06302933, orgStudyIdInfo id: ANRS 12414 PediacamNEG, briefTitle: Negative Serology by Immunoenzymatic Test (EIA) in HIV-infected Children Treated Early With Antiretroviral in the ANRS-Pediacam Study: Pathophysiological Mechanisms, acronym: PediacamNEG, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2025-08-30, completionDateStruct date: 2025-08-30, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: ANRS, Emerging Infectious Diseases, class: OTHER_GOV, collaborators name: Centre Pasteur du Cameroun, collaborators name: Centre Mère et Enfant de la Fondation Chantal Biya, collaborators name: Centre Hospitalier D'essos, collaborators name: Hospital General De Douala, collaborators name: Centre Hospitalier Universitaire d'Orléans, collaborators name: Institut Pasteur, collaborators name: Hopital Universitaire Robert-Debre, collaborators name: Université Paris-Sud, descriptionModule briefSummary: The objective of the study is to identify the pathophysiological mechanisms responsible for the induction and maintenance of negative serologies by EIA tests in HIV-infected children treated early with HAART in the ANRS 12225-Pediacam III cohort in CameroonThe hypothesis of better control of HIV infection through interactions between immunological, viral, and genetic factors was made to build the following objectives:* Immunological aspect: lack of humoral response or immune activation* Virological aspect: Reduced HIV reservoir size* Determine the HLA phenotype in the different groups of children included and the KIR genotypes., conditionsModule conditions: HIV Infections, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: Study type: a study nested in the ANRS 12225 - Pediacam III cohort, comprising two phases* A retrospective phase: case-control study The analyzed data are those collected previously or measured from the already available bio bank, within the framework of the Pediacam III cohort during the primary infection phase before the initiation of HAART, at 6 months after the end of the first series of EPI vaccines, and at 2 years.* A prospective phase: cross-sectional study Based on an ad hoc bio bank created for parameters we couldn't measure on the existing bio bank, primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: NONE, enrollmentInfo count: 451, type: ESTIMATED, armsInterventionsModule interventions name: Blood sampling, outcomesModule primaryOutcomes measure: Level of pro-inflammatory and anti-inflammatory cytokines, chimiokines in the plasma, primaryOutcomes measure: Level of pro-inflammatory and anti-inflammatory cytokines, chimiokines in the plasma, primaryOutcomes measure: Level of pro-inflammatory and anti-inflammatory cytokines, chimiokines in the plasma, primaryOutcomes measure: Level of pro-inflammatory and anti-inflammatory cytokines, chimiokines in the plasma, primaryOutcomes measure: Level of pro-inflammatory and anti-inflammatory cytokines, chimiokines in the plasma, primaryOutcomes measure: Level of pro-inflammatory and anti-inflammatory cytokines, chimiokines in the plasma, primaryOutcomes measure: Level of pro-inflammatory and anti-inflammatory cytokines, chimiokines in the plasma, secondaryOutcomes measure: - Humoral response to vaccines against tetanus, pertussis, and viral hepatitis B, secondaryOutcomes measure: - Functional and phenotypic characterization of B and T lymphocytes, secondaryOutcomes measure: - Size of the HIV reservoir, secondaryOutcomes measure: - Residual viremia in perinatally HIV-infected adolescent, secondaryOutcomes measure: - Level of HIV plasma p24, secondaryOutcomes measure: - HLA phenotype and the KIR genotypes, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Centre Pasteur Cameroun, city: Yaounde, zip: 1274, country: Cameroon, contacts name: Mathurin C Tejiokem, role: CONTACT, phone: +237222231803, email: tejiokem@pasteur-yaounde.org, geoPoint lat: 3.86667, lon: 11.51667, hasResults: False
|
protocolSection identificationModule nctId: NCT06302920, orgStudyIdInfo id: 0001, briefTitle: Effect of Kinesiotaping on Pain,Edema and Kinesiophobia in Patients With Complex Regional Pain Syndrome, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-20, primaryCompletionDateStruct date: 2024-06-20, completionDateStruct date: 2024-12-20, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: Alanya Alaaddin Keykubat University, class: OTHER, descriptionModule briefSummary: Patients will be divided into 2 groups according to the random numbers table, and both groups will receive a conventional physical therapy and rehabilitation program and nutritional support. Afterwards, edema-reducing kinesiotaping will be applied to one group. The applied kinesio tape will remain on the patient for 5 days and will be taped again after 2 days without tape. In this way, taping will be done 3 times in total, once a week for 3 weeks. During this period, patients will continue their routine physical therapy program and measurements will be taken by the same researcher in the 1st week of treatment and 3 weeks later., conditionsModule conditions: Complex Regional Pain Syndrome Type I, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Kinesiotape, outcomesModule primaryOutcomes measure: Resting pain, primaryOutcomes measure: Edema, primaryOutcomes measure: Kinesiophobia, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Alanya Alaaddin Keykubat University, city: Antalya, country: Turkey, contacts name: Deniz Bulut, role: CONTACT, phone: +90 05059445604, email: denizhava1988@gmail.com, contacts name: Deniz Bulut, role: PRINCIPAL_INVESTIGATOR, contacts name: İsmet Aslı Topcuoğlu, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 36.90812, lon: 30.69556, hasResults: False
|
protocolSection identificationModule nctId: NCT06302907, orgStudyIdInfo id: M/45- 14.1.2023, briefTitle: The Effect of Adding Sodium Bicarbonate 8.4% to Local Anesthesia on Pain During Upper Canine Infiltration, statusModule overallStatus: ENROLLING_BY_INVITATION, startDateStruct date: 2023-01-14, primaryCompletionDateStruct date: 2023-09-10, completionDateStruct date: 2024-06-30, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: Al-Wataniya University, class: OTHER, descriptionModule briefSummary: The aim of the present study was to evaluate the pain during local anesthetic buccal infiltration for the maxillary canines after adding Sodium Bicarbonate 8.4% during local anesthesia., conditionsModule conditions: Local Anesthetic Complication, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Buffered Local anaesthesia, interventions name: Unbuffered Local anaesthesia, outcomesModule primaryOutcomes measure: Pain on injection, eligibilityModule sex: ALL, minimumAge: 15 Years, maximumAge: 50 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: Al Wataniya Private University, city: Hama, state: Hama Government, zip: 00000, country: Syrian Arab Republic, geoPoint lat: 35.13179, lon: 36.75783, hasResults: False
|
protocolSection identificationModule nctId: NCT06302894, orgStudyIdInfo id: BAIBU-SBF-EC-01, briefTitle: The Effect of the Nursing Intervention Program on Adolescent Problematic Internet Users, statusModule overallStatus: ENROLLING_BY_INVITATION, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2024-10-01, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: Abant Izzet Baysal University, class: OTHER, descriptionModule briefSummary: In this study; The effect of the nursing intervention program (education enriched with web 2.0 tools based on the Health Belief Model) on problematic internet use, loneliness and family harmony in adolescents who use the internet with problems will be determined., conditionsModule conditions: Internet Addiction Disorder, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 1000, type: ESTIMATED, armsInterventionsModule interventions name: Self-sufficiency, outcomesModule primaryOutcomes measure: Internet Addiction Scale, eligibilityModule sex: ALL, minimumAge: 12 Years, maximumAge: 18 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: Bolu Abant İzzet Baysal University Faculty of Health Sciences, city: Bolu, zip: 14300, country: Turkey, geoPoint lat: 40.73583, lon: 31.60611, hasResults: False
|
protocolSection identificationModule nctId: NCT06302881, orgStudyIdInfo id: liaohongfan, briefTitle: Differentiating Tumor-stroma Ratio in Pancreatic Ductal Adenocarcinoma, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2013-01, primaryCompletionDateStruct date: 2022-07, completionDateStruct date: 2024-03, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: First Affiliated Hospital of Chongqing Medical University, class: OTHER, descriptionModule briefSummary: This study introduces a novel transfer learning-based contrastive language-image pretraining adapter (CLIP-adapter) model for predicting the tumor-stroma ratio (TSR) in pancreatic ductal adenocarcinoma (PDAC) using preoperative dual-phase CT images. The primary aim is to develop an efficient and accessible tool for risk stratification and personalized treatment planning., conditionsModule conditions: Pancreatic Ductal Adenocarcinoma, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 207, type: ACTUAL, armsInterventionsModule, outcomesModule primaryOutcomes measure: The diagnostic AUC value of pancreatic ductal adenocarcinoma with deep learning algorithm., secondaryOutcomes measure: The diagnostic accuracy of pancreatic ductal adenocarcinoma with deep learning algorithm., secondaryOutcomes measure: The diagnostic sensitivity of pancreatic ductal adenocarcinoma with deep learning algorithm., secondaryOutcomes measure: The diagnostic specificity of pancreatic ductal adenocarcinoma with deep learning algorithm., secondaryOutcomes measure: The diagnostic positive predictive value of pancreatic ductal adenocarcinoma with deep learning algorithm., secondaryOutcomes measure: The diagnostic negative predictive value of pancreatic ductal adenocarcinoma with deep learning algorithm., eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False
|
protocolSection identificationModule nctId: NCT06302868, orgStudyIdInfo id: 006215, secondaryIdInfos id: R43MH129065, type: NIH, link: https://reporter.nih.gov/quickSearch/R43MH129065, briefTitle: Telemedicine-Based Virtual Reality Clinic for the Treatment of Phobias, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-10-03, primaryCompletionDateStruct date: 2024-08-01, completionDateStruct date: 2024-08-01, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: University of South Florida, class: OTHER, collaborators name: National Institute of Mental Health (NIMH), descriptionModule briefSummary: The purpose of this study is to assess the feasibility of conducting a randomized controlled efficacy trial comparing the delivery of exposure therapy via a telemedicine-based virtual reality clinic (Doxy.me VR) vs. standard telemental health (TMH) to adults with intense fear of dogs, snakes, and/or spiders. The secondary purpose is to preliminarily examine the efficacy of using Doxy.me VR vs. TMH in reducing phobia severity., conditionsModule conditions: Arachnophobia, conditions: Cynophobia, conditions: Ophidiophobia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Telemedicine Exposure Therapy Using Photos and Videos, interventions name: Telemedicine-Based Virtual Reality Exposure Therapy, outcomesModule primaryOutcomes measure: Phobia symptom severity, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of South Florida, status: RECRUITING, city: Tampa, state: Florida, zip: 33613, country: United States, contacts name: Brian Bunnell, PhD, role: CONTACT, contacts name: Brian Bunnell, PhD, role: PRINCIPAL_INVESTIGATOR, contacts name: Triton Ong, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 27.94752, lon: -82.45843, documentSection largeDocumentModule largeDocs typeAbbrev: Prot, hasProtocol: True, hasSap: False, hasIcf: False, label: Study Protocol, date: 2023-11-21, uploadDate: 2024-01-23T13:01, filename: Prot_000.pdf, size: 451422, largeDocs typeAbbrev: ICF, hasProtocol: False, hasSap: False, hasIcf: True, label: Informed Consent Form, date: 2023-12-11, uploadDate: 2024-01-23T12:22, filename: ICF_001.pdf, size: 14053932, hasResults: False
|
protocolSection identificationModule nctId: NCT06302855, orgStudyIdInfo id: 2024-00124, briefTitle: Exploring Adherence and Knowledge Among Diabetic Individuals in Periodontal Care, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2026-03-01, completionDateStruct date: 2026-09-01, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: Karim Gariani, class: OTHER, descriptionModule briefSummary: Objective(s) The primary objective is to evaluate the adherence of diabetic patients to periodontal care, accomplished either through oral communication (group A, control) or through a photograph of their smile, and focusing on their gum health evaluated by a periodontist (group B, test).Secondary objectives include assessing the prevalence of periodontal disease (PD) in this diabetic sample population and evaluating the presence of specific biomarkers related to it.The final objective is to assess the agreement between the diagnosis of periodontitis based on the photographs and the diagnosis given after the dental visit, based on the clinical examination. The aim is to determine if the photos could potentially serve as a reliable indicator for periodontal risk assessment., conditionsModule conditions: Periodontitis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: DIAGNOSTIC, maskingInfo masking: NONE, enrollmentInfo count: 180, type: ESTIMATED, armsInterventionsModule interventions name: dental expertise, outcomesModule primaryOutcomes measure: adherence of diabetic patients to periodontal, secondaryOutcomes measure: calculate the prevalence of periodontitis, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False
|
protocolSection identificationModule nctId: NCT06302842, orgStudyIdInfo id: 20J201, briefTitle: Pilot Open Label Study With Commercial Supplementation in Healthy Subjects, acronym: AUXNUTRIMMUN, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2023-07-01, primaryCompletionDateStruct date: 2023-10-15, completionDateStruct date: 2024-04-30, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-19, sponsorCollaboratorsModule leadSponsor name: Istituto Auxologico Italiano, class: OTHER, descriptionModule briefSummary: A bidirectional relationship among nutrition, infection and immunity exists: changes in one component affect the others. Various micronutrients are essential for immunocompetence, particularly vitamins A, C, D, E, B2, B6, and B12, folic acid, iron, selenium, and zinc. Micronutrient deficiencies are a recognized global public health issue, and poor nutritional status predisposes to certain infections. Immune function may be improved by restoring deficient micronutrients to recommended levels, thereby increasing resistance to infection and supporting faster recovery when infected. Diet alone may be insufficient and tailored micronutrient supplementation based on specific age-related needs is necessary.Aim of the study is to investigate whether nutrient supplementation may affect different functional parameters of the innate and adaptive immunity., conditionsModule conditions: Supportive Care, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 15, type: ACTUAL, armsInterventionsModule interventions name: Bioritmon Immuno Defend, outcomesModule primaryOutcomes measure: Change in neutrophil chemotaxis, primaryOutcomes measure: Change in neutrophil phagocytosis, primaryOutcomes measure: Change in neutrophil oxidative burst, primaryOutcomes measure: Change in mononuclear CD4pos69pos, primaryOutcomes measure: Change in mononuclear CD56pos69pos granzymepos, primaryOutcomes measure: Change in plasma cytokine levels, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Istituto Auxologico Italiano IRCCS, city: Milan, zip: 20145, country: Italy, geoPoint lat: 45.46427, lon: 9.18951, hasResults: False
|
protocolSection identificationModule nctId: NCT06302829, orgStudyIdInfo id: RiphahIU Shafia Anjum, briefTitle: Comparison of IMES Versus DN on ATrPs of AC, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-21, primaryCompletionDateStruct date: 2024-06-30, completionDateStruct date: 2024-07-30, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: Riphah International University, class: OTHER, descriptionModule briefSummary: The aim of our study to compare DN and IMES for pressure pain threshold, ROM and the shoulder function in active trigger points with adhesive capsulitis. This study will add to the growing body of knowledge that if these two techniques yield comparable outcomes and if one technique is superior to the other, which should be the alternative of therapy. Moreover, it would add to the society as there are very limited researches done in Pakistan using needling for trigger points in adhesive capsulitis., conditionsModule conditions: Shoulder Pain, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: randomized, whoMasked: PARTICIPANT, enrollmentInfo count: 44, type: ESTIMATED, armsInterventionsModule interventions name: Dry needling, interventions name: intramusuar electrical stimulation, outcomesModule primaryOutcomes measure: Algometer (pressure pain threshold), secondaryOutcomes measure: ROM Shoulder (Flexion), secondaryOutcomes measure: ROM Shoulder (Abduction), secondaryOutcomes measure: ROM Shoulder (External rotation), secondaryOutcomes measure: ROM Shoulder (Internal Rotation), secondaryOutcomes measure: ASES Questionnaire; (American shoulder and elbow surgeons scale), eligibilityModule sex: ALL, minimumAge: 30 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule locations facility: Railway general hopsital, status: RECRUITING, city: Rawalpindi, state: Punjab, zip: 46000, country: Pakistan, contacts name: Aneela zia, MS-OMPT, role: CONTACT, phone: +923365869031, email: aneela.zia@riphah.edu.pk, contacts name: Shafia Anjum, MS-OMPT, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 33.6007, lon: 73.0679, hasResults: False
|
protocolSection identificationModule nctId: NCT06302816, orgStudyIdInfo id: REC/RCR&AHS/23/0580, briefTitle: Effects of Tupler and Scoop Exercises in Diastasis Recti, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-02-23, primaryCompletionDateStruct date: 2024-08-01, completionDateStruct date: 2024-09-01, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: Riphah International University, class: OTHER, descriptionModule briefSummary: To compare the effects of tupler and scoop exercises on inter recti distance, low back pain, abdominal strength and urogynecological symptoms in diastasis., conditionsModule conditions: Diastasis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: TUPLER exercises, interventions name: SCOOP EXERCISES, outcomesModule primaryOutcomes measure: Digital nylon calipers for inter recti distance (IRD), primaryOutcomes measure: NPRS for low back pain, primaryOutcomes measure: Manual muscle testing for intra-abdominal strength, primaryOutcomes measure: Short form Pelvic Floor Distress Inventory for Urogynaecological symptoms, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 40 Years, stdAges: ADULT, contactsLocationsModule locations facility: Innovative Health Concepts, status: RECRUITING, city: Lahore, zip: 05499, country: Pakistan, contacts name: hina gul gul, role: CONTACT, phone: 03214979172, email: hina.gul@riphah.edu.pk, contacts name: Rutaba Hussain, MSPT(WH), role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 31.558, lon: 74.35071, hasResults: False
|
protocolSection identificationModule nctId: NCT06302803, orgStudyIdInfo id: NFEC-2024-033, briefTitle: Modified Intermittent Eating on Weight Loss (INTEREST-3 Trial), acronym: INTEREST-3, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2026-12-31, completionDateStruct date: 2027-07-01, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-04-02, sponsorCollaboratorsModule leadSponsor name: Nanfang Hospital, Southern Medical University, class: OTHER, descriptionModule briefSummary: Calorie restriction (CR) is the most important treatment for weighting loss. In recent years, two novel types of intermittent fasting recently have gained more attention: the 5:2 diet and time-restricted eating (TRE). TRE requires individuals to eat in a specified number of hours per day (typically 4 to 10 hours) without energy intake restriction. The 5:2 diet involves 5 feast days and 2 fast days per week; participants eat ad libitum without restriction on feast days while 25% of energy needs (approximately 500-800 kcal per day) are consumed on fast days. However, the effects of dietary strategy of intermittent fasting plus time-restricted eating (modified time-restricted eating: TRE 5 days and fasting 2days per week) on weight loss and cardiometabolic risk factors in obese adults have not been proved. This randomized controlled trial aimed to evaluate the effect of modified time-restricted eating (mTRE) and CR on weight loss and cardiometabolic risk factors in obese adults compared to usual health care over 12 months., conditionsModule conditions: Obesity, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 225, type: ESTIMATED, armsInterventionsModule interventions name: Intermittent fasting plus time-restricted eating, interventions name: Calorie restriction, outcomesModule primaryOutcomes measure: Change in body weight over 12 months, secondaryOutcomes measure: Change in body mass index （BMI）, secondaryOutcomes measure: Change in waist circumference, secondaryOutcomes measure: Change in body fat composition meassured by DEXA, secondaryOutcomes measure: Change in liver fat, secondaryOutcomes measure: Change in systolic blood pressure, secondaryOutcomes measure: Change in diastolic blood pressure, secondaryOutcomes measure: Change in concentration of serum triglyceride, secondaryOutcomes measure: Change in concentration of serum total cholesterol, secondaryOutcomes measure: Change in concentration of serum LDL-c, secondaryOutcomes measure: Change in concentration of HbA1c, secondaryOutcomes measure: Change in insulin sensitivity, secondaryOutcomes measure: Change in β cell function, secondaryOutcomes measure: Change in arterial stiffness measured by pulse wave velocity, secondaryOutcomes measure: Change in depression score measured by the Patient Health Questionnaire-9, secondaryOutcomes measure: Change in quality of sleep score measured by the Pittsburgh sleep quality index, secondaryOutcomes measure: Change in quality of life score measured by the 12-item Short-Form Health Survey Questionnaire, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Nanfang Hospital of Southern Medical University, city: Guangzhou, state: Guangdong, zip: 510515, country: China, geoPoint lat: 23.11667, lon: 113.25, hasResults: False
|
protocolSection identificationModule nctId: NCT06302790, orgStudyIdInfo id: AcuteMolliiSuitEffects, briefTitle: Examination of the Acute Effect of Mollii Suit in Children With Cerebral Palsy, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2025-03-01, completionDateStruct date: 2025-05-01, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: Kırıkkale University, class: OTHER, collaborators name: Gazi University, descriptionModule briefSummary: The aim of our study is to examine the acute effect of Mollii Suit application on balance and muscle tone problems in children with spastic cerebral palsy., conditionsModule conditions: Mollii Suit, conditions: Cerebral Palsy, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, maskingDescription: The statistician in the study and the physiotherapist performing the evaluation will be blinded., whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Molli Suit Apply, outcomesModule primaryOutcomes measure: Gross Motor Function Classification System (GMFCS), primaryOutcomes measure: Modified Tardiue Scale (MTS), primaryOutcomes measure: Modifiye Modified Ashworth Scale (MAS), primaryOutcomes measure: NMC Tests with Seansamove Sensbalance, eligibilityModule sex: ALL, minimumAge: 4 Years, maximumAge: 18 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: Gazi University, status: RECRUITING, city: Ankara, country: Turkey, contacts name: Kübra Uğurlu, role: CONTACT, phone: +905077295353, email: kubra.ozdamar06@gmail.com, geoPoint lat: 39.91987, lon: 32.85427, hasResults: False
|
protocolSection identificationModule nctId: NCT06302777, orgStudyIdInfo id: 2023-1184, briefTitle: MAIN-IMAGE Registry, acronym: MAIN-IMAGE, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-09-26, primaryCompletionDateStruct date: 2028-09-26, completionDateStruct date: 2031-09-26, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: Goethe University, class: OTHER, descriptionModule briefSummary: All comers registry with patients with chronic coronary syndrome or acute coronary syndrome who underwent intracoronary imaging during cardiac catherization. The aim is to identify plaque characteristics on OCT or IVUS that are associated with adverse cardiac events including myocardial infarction and atherosclerotic progression., conditionsModule conditions: Coronary Artery Disease, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: PROSPECTIVE, enrollmentInfo count: 500, type: ESTIMATED, outcomesModule primaryOutcomes measure: Major adverse cardiovascular Events (MACE), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Frankfurt University Hospital, status: RECRUITING, city: Frankfurt, state: Hesse, zip: 60590, country: Germany, contacts name: Lena Seegers, role: CONTACT, phone: +496963016666, geoPoint lat: 50.11552, lon: 8.68417, locations facility: Frankfurt University Hospital, status: RECRUITING, city: Frankfurt, country: Germany, contacts name: Lena Seegers, role: CONTACT, geoPoint lat: 50.11552, lon: 8.68417, hasResults: False
|
protocolSection identificationModule nctId: NCT06302764, orgStudyIdInfo id: WZiKS.4.1.2023.2, secondaryIdInfos id: WZiKS.4.1.2023, type: OTHER_GRANT, domain: Jagiellonian University in Kraków, briefTitle: Emergency Medical Staff Workload Analysis, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-10-01, primaryCompletionDateStruct date: 2024-04-20, completionDateStruct date: 2024-06-30, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: Jagiellonian University, class: OTHER, descriptionModule briefSummary: The aim of this study is to identify trauma determinants and leverage this understanding to develop solutions applicable to the prevention and treatment of PTSD among emergency medical personnel. By categorizing stimuli associated with traumatic professional experiences, the study aims to enhance existing therapeutic protocols through exposure therapy. The specific objectives are as follows:1. Analysis and characterization of occupational workloads among doctors and emergency medical personnel, focusing on the scale of burdens associated with PTSD symptoms.2. Development of categories for aggravating and potentially traumatizing stimuli within the medical staff of rescue teams.3. Examination of the feasibility of incorporating the obtained results into cognitive-behavioral therapy protocols.4. Assessment of the potential for implementing the results in solutions utilizing virtual reality technology.5. Formation of an interdisciplinary international research team., conditionsModule conditions: Stress, conditions: Work Related Stress, conditions: PTSD, conditions: Mental Stress, conditions: Medical Emergencies, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 400, type: ESTIMATED, armsInterventionsModule interventions name: Qualitative & Quantitative Research, outcomesModule primaryOutcomes measure: Focused Interview, primaryOutcomes measure: Posttraumatic Stress Disorder Checklist (PCL-5), primaryOutcomes measure: Patient Health Questionnaire (PHQ-9), primaryOutcomes measure: Depersonalization Mechanism Scale (DMS), eligibilityModule sex: ALL, minimumAge: 21 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Institute of Applied Psychology, Jagiellonian University in Krakow, Poland, status: RECRUITING, city: Krakow, state: Małopolska, zip: 30-348, country: Poland, contacts name: Krystyna Golonka, Prof, role: CONTACT, email: krystyna.golonka@uj.edu.pl, contacts name: Katarzyna Sitnik-Warchulska, PhD, role: CONTACT, email: katarzyna.sitnik-warchulska@uj.edu.pl, contacts name: Krystyna Golonka, Prof, role: PRINCIPAL_INVESTIGATOR, contacts name: Katarzyna Sitnik-Warchulska, PhD, role: SUB_INVESTIGATOR, contacts name: Dominika Fortuna, MS, role: SUB_INVESTIGATOR, geoPoint lat: 50.06143, lon: 19.93658, locations facility: University of Coimbra, status: RECRUITING, city: Coimbra, country: Portugal, contacts name: João Ferreira, PhD, role: CONTACT, email: naquelepordosol@gmail.com, contacts name: João Ferreira, PhD, role: SUB_INVESTIGATOR, geoPoint lat: 40.20564, lon: -8.41955, locations facility: Bogomolets National Medical University, status: RECRUITING, city: Kyiv, country: Ukraine, contacts name: Sergii Tukaiev, PhD, role: CONTACT, email: tsv.serg.69@gmail.com, contacts name: Borys Palamar, Prof, role: CONTACT, email: palamar.bi@ukr.net, contacts name: Borys Palamar, Prof, role: SUB_INVESTIGATOR, contacts name: Sergii Tukaiev, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 50.45466, lon: 30.5238, hasResults: False
|
protocolSection identificationModule nctId: NCT06302751, orgStudyIdInfo id: 3647, briefTitle: A Mobile Application to Improve Postoperative Outcomes in Colorectal Cancer, acronym: RAISe-Care, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-26, primaryCompletionDateStruct date: 2026-02-26, completionDateStruct date: 2026-08-31, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: Istituto Clinico Humanitas, class: OTHER, descriptionModule briefSummary: The unplanned readmission rate after colorectal cancer surgery is still high, despite the implementation of enhanced recovery programs. The use of a mobile-based application for perioperative remote monitoring may improve the postoperative outcomes and reduce the unplanned postoperative readmissions., conditionsModule conditions: Colorectal Cancer, conditions: Surgery, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Single-center, prospective, interventional case-series study with a historical cohort of comparison, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 600, type: ESTIMATED, armsInterventionsModule interventions name: Care 4 Today ® (Johnson and Johnson) mobile app, outcomesModule primaryOutcomes measure: Unplanned hospital readmissions, secondaryOutcomes measure: Severity of postoperative complications, secondaryOutcomes measure: Length of hospital stay, secondaryOutcomes measure: Time from symptoms onset to diagnosis, secondaryOutcomes measure: Healthcare costs, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: IRCCS Humanitas Research Hospital, status: RECRUITING, city: Rozzano, state: MI, zip: 20089, country: Italy, contacts name: Annalisa Maroli, PhD, role: CONTACT, phone: 02 8224 7776, phoneExt: 0039, email: colorapp@humanitas.it, contacts name: Stefano De Zanet, MS, role: CONTACT, phone: 02 8224 4623, phoneExt: 0039, email: colorapp@humanitas.it, geoPoint lat: 45.38193, lon: 9.1559, hasResults: False
|
protocolSection identificationModule nctId: NCT06302738, orgStudyIdInfo id: 09C221, briefTitle: Phenotypisation of Sleep Pattern in Hypertensive Patients With Non Dipper Pattern, acronym: INTO-DIP, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-05-04, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: Istituto Auxologico Italiano, class: OTHER, descriptionModule briefSummary: High blood pressure is the most common modifiable risk factor for cardiovascular diseases (CV). The large interindividual variability in clinical expression of the disease and response to treatment, however, makes the management of the hypertensive patient complex.Therefore, identifying phenotypes of hypertensive patients associated with a specific CV outcome or who tend to respond/not respond to treatment is of paramount importance for improving CV prevention.It has been shown that the phenotype of hypertensive patient with poor control of nighttime blood pressure values, especially when associated with a "non-dipper" profile, was associated with an increased risk of developing CV and cerebrovascular complications.The non-dipper profile and nocturnal hypertension are caused by several factors including excessive salt intake and dysautonomia. However, they are also inevitably influenced by sleep duration and the presence of sleep disorders: obstructive sleep apnea (OSA), but also insomnia and periodic movements of the lower limbs,such as those frequently seen in restless legs syndrome, are among the the main determinants related to altered nighttime pressure pattern. However, such disturbances are not systematically assessed during the performance of monitoring 24h pressor and their impact in the outcome of the hypertensive patient is unknown.The primary objective of this study is to phenotype non-dipper patients with or without nocturnal hypertension to determine the prevalence of sleep disorders such as sleep apnea syndrome, insomnia, and restless legs syndrome (RLS) (OSA diagnosed considering AHI\>5 events/hour, insomnia and RLS according to ICSD 3 criteria) and correlate the presence of various sleep disorders with cardiac organ damage, vascular, and renal damage mediated by hypertension., conditionsModule conditions: Hypertension, conditions: Sleep Disorder, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 143, type: ESTIMATED, armsInterventionsModule interventions name: polysomnography, outcomesModule primaryOutcomes measure: Prevalence of sleep disorders, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: UOSD Ipertensione Arteriosa "A.M. Pirrelli" - AUOC Policlinico di Bari, University of Bari,, status: RECRUITING, city: Bari, state: Italy, Bari, zip: 70120, country: Italy, contacts name: Sebastiano Cicco, MD, role: CONTACT, email: sebastiano.cicco@uniba.it, geoPoint lat: 41.11148, lon: 16.8554, locations facility: Azienda Sanitaria Locale della provincia di Brindisi, status: RECRUITING, city: Brindisi, state: Italy, Brindisi, zip: 72100, country: Italy, contacts name: Luigi Vernaglione, MD, role: CONTACT, phone: 003908311882006, geoPoint lat: 40.63215, lon: 17.93607, locations facility: Medicina Interna 1, Ambulatorio Ipertensione e Malattie Metaboliche AOU "Maggiore della carità"- Novara, status: RECRUITING, city: Novara, state: Italy, Novara, zip: 28100, country: Italy, geoPoint lat: 45.44694, lon: 8.62118, locations facility: Padova 1- Clinica Medica 3 · Dipartimento di Medicina · Azienda Ospedaliera di Padova, Italy, status: RECRUITING, city: Padova, state: Italy, Padova, zip: 35128, country: Italy, contacts name: Maria Teresa Seccia, MD, PhD, role: CONTACT, phone: 00390498212263, email: teresamaria.seccia@unipd.it, geoPoint lat: 45.40797, lon: 11.88586, locations facility: Padova 2 - UOC Medicina d'urgenza, Centro Regionale Specializzato per l'ipertensione arteriosa OSA - Azienda ospedaliera Università di Padova, Italy, status: RECRUITING, city: Padova, state: Italy, Padova, zip: 35128, country: Italy, contacts name: Giuseppe Maiolino, MD, role: CONTACT, phone: 00390498212872, email: giuseppe.maiolino@gmail.com, geoPoint lat: 45.40797, lon: 11.88586, locations facility: UO Cardiologia, UO Pneumologia, Presidio Ospedaliero Cittadella, Azienda ULSS 6 Euganea, Cittadella, Italy., status: NOT_YET_RECRUITING, city: Cittadella, state: Italy, PD, zip: 35013, country: Italy, contacts name: Francesca Saladini, MD, role: CONTACT, phone: 00390499424531, email: francesca.saladini@alss6.veneto.it, geoPoint lat: 45.64523, lon: 11.78453, locations facility: Azienda Unità Sanitaria Locale-IRCCS di Reggio Emilia- S.O.S Centro per la Cura dell'Ipertensione Arteriosa- Medicina II Cardiovascolare, status: NOT_YET_RECRUITING, city: Reggio Emilia, state: Italy, RE, zip: 42122, country: Italy, contacts name: Chiara Grasselli, MD, role: CONTACT, email: chiara.grasselli@ausl.re.it, geoPoint lat: 44.69825, lon: 10.63125, locations facility: Azienda Provinciale per i Servizi Sanitari, Provincia Autonoma di Trento- UO Medicina interna - Rovereto, status: NOT_YET_RECRUITING, city: Rovereto, state: Italy, Trento, zip: 38068, country: Italy, contacts name: Francesco Dalle Vedove, MD, role: CONTACT, geoPoint lat: 45.8904, lon: 11.04053, locations facility: Azienda sanitaria universitaria Giuliano-Isontina (ASU-GI)- SC (UCO) Medicina Clinica, status: NOT_YET_RECRUITING, city: Trieste, state: Italy, Trieste, zip: 34128, country: Italy, contacts name: Andrea Grillo, MD, PhD, role: CONTACT, phone: 00390403994619, email: andrea.grillo@asugi.sanita.fvg.it, geoPoint lat: 45.64953, lon: 13.77679, locations facility: Department of Medicine, University of Verona, Verona, Italy, status: RECRUITING, city: Verona, state: Italy, Verona, zip: 37126, country: Italy, contacts name: Cristiano Fava, MD, PhD, role: CONTACT, phone: 00390458124732, email: cristiano.fava@univr.it, geoPoint lat: 45.4299, lon: 10.98444, locations facility: Istituto Auxologico Italiano IRCCS, status: RECRUITING, city: Milano, state: MI, zip: 20149, country: Italy, contacts name: Martino Pengo, MD, PhD, role: CONTACT, phone: 00390261911, email: m.pengo@auxologico.it, contacts name: Elisa Nardin, role: CONTACT, phone: 00390261911, email: e.nardin@auxologico.it, contacts name: Gianfranco Parati, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 45.46427, lon: 9.18951, hasResults: False
|
protocolSection identificationModule nctId: NCT06302725, orgStudyIdInfo id: APHP231514, secondaryIdInfos id: 2023-A02623-42, type: OTHER, domain: IDRCB, briefTitle: Vaginal Self-sampling for Detecting High-risk Human Papillomavirus Cervical Infection in Patients With Immune-mediated Inflammatory Diseases, acronym: APOSY, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2026-03, completionDateStruct date: 2027-03, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: Assistance Publique - Hôpitaux de Paris, class: OTHER, descriptionModule briefSummary: Main objective: -To determine Human Papilloma Virus (HPV) prevalence in patients with immune-mediated inflammatory diseases (IMID) using vaginal self-sampling (VSS), one year after VSS was proposed Primary endpoint: - To determine the prevalence of HPV infection (yes/no) after VSS proposal Secondary objectives: - To describe the HPV typology and the rate of co-infection (with several high-risk HPV (HR-HPV)) in this population - To describe the factors associated with the presence of HPV infection - To determine the rate of HPV clearance after one year, during the second screening at 12 months- To determine the percentage of pre-cancerous cervical lesions and cervical cancer in the event of subsequent cervical smear - To determine the factors associated with persistence (or non-clearance ) of HPV infection - To determine the factors associated with the presence of pre-cancerous and cancerous cervical lesions - To determine the characteristics, tolerance and acceptability of VSS - To determine the rate of cervical cancer screening carried out following French Health Authorities guidelines -To determine the HPV vaccination coverage Secondary endpoints: 1/ HPV typology and presence of co-infection (Yes/No, type) or HPV multi-infection (more than 2 HPV, Yes/No) identified on samples at inclusion and at 1 year. 2/ Explanatory variables: demographic, clinical, biological factors and treatments (corticoids, immunosuppressive treatments); variable to be explained: presence of HPV infection during follow-up. 3/ Characteristics, acceptability, obstacles and tolerance of VPA reported by self-questionnaire (including procedure failures, bleeding and pain). 4/ Up-to-date cervical cancer screening rate in accordance with HAS recommendations at 12 months post-procedure. 5/ Proportion of cervical cytological abnormalities and cervical cancer authenticated on cervico-vaginal smear, if performed (histological confirmation if available) during follow-up. 6/ Explanatory variables: demographic, clinical, biological factors and treatments (corticoids, immunosuppressants; variable to be explained: presence of cervical precancerous lesions and cervical cancer, authenticated on cervico-vaginal smear, if performed (histological confirmation if available) during follow-up. 7/ HPV vaccination coverage rate (measured on initial self-questionnaire) 8/ Prevalence of HR-HPV(s) at second screening at one year, in the case of initial positivity (Persistence of HPV infection (Yes/No). 9/ Explanatory variables: demographic, clinical, biological factors and treatments (corticoids, immunosuppressive treatments); variable to be explained: persistence of cervical HPV infection at one year (in the case of initial positivity)., conditionsModule conditions: HPV Infection, conditions: Systemic Disease, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 300, type: ESTIMATED, armsInterventionsModule interventions name: Vaginal self sampling detecting HPV, outcomesModule primaryOutcomes measure: prevalence of HPV infection (yes/no) after VSS proposal, secondaryOutcomes measure: the HPV typology of co-infection (with several high-risk HPV (HR-HPV)) in this population, secondaryOutcomes measure: The rate of co-infection (with several high-risk HPV (HR-HPV)) in this population, otherOutcomes measure: Presence of HPV infection during follow-up (yes/no), otherOutcomes measure: description of demographic factor, otherOutcomes measure: description of clinical factor, otherOutcomes measure: description of biological factor, otherOutcomes measure: description of treatment (corticoids, immunosuppressive treatments), otherOutcomes measure: description of characteristics of VPA reported by self-questionnaire (including procedure failures, bleeding and pain)., otherOutcomes measure: description of acceptability of VPA reported by self-questionnaire (including procedure failures, bleeding and pain)., otherOutcomes measure: description of tolerance of VPA reported by self-questionnaire (including procedure failures, bleeding and pain)., otherOutcomes measure: description obstacles of VPA reported by self-questionnaire (including procedure failures, bleeding and pain)., otherOutcomes measure: Up-to-date cervical cancer screening rate in accordance with HAS recommendations, otherOutcomes measure: Proportion of cervical cytological abnormalities if performed (histological confirmation if available), otherOutcomes measure: proportion of cervical cancer authenticated on cervico-vaginal smear, if performed (histological confirmation if available), otherOutcomes measure: presence of cervical precancerous lesions and cervical cancer, otherOutcomes measure: HPV vaccination coverage rate, otherOutcomes measure: Persistence of HPV infection, eligibilityModule sex: FEMALE, minimumAge: 30 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Service de Médecine Interne - Hôpital Bichat Claude Bernard, city: Paris, zip: 75018, country: France, contacts name: Tiphaine Goulenok, MD, role: CONTACT, phone: 00 33 1 40 25 72 89, email: tiphaine.goulenok@aphp.fr, geoPoint lat: 48.85341, lon: 2.3488, hasResults: False
|
protocolSection identificationModule nctId: NCT06302712, orgStudyIdInfo id: TIIP, briefTitle: Traditional Islamically Integrated Psychotherapy for Muslims With OCD in Pakistan, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2024-10-01, completionDateStruct date: 2024-11-30, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-18, sponsorCollaboratorsModule leadSponsor name: International Islamic University Malaysia, class: OTHER, collaborators name: Foundation University Islamabad, descriptionModule briefSummary: The current study aims to determine the effectiveness of the first culturally adapted Traditional Islamically Integrated Psychotherapy (TIIP) for Muslims with OCD in Pakistan along with the module effectiveness in reducing OCD symptoms with comorbidities like anxiety, depression, stress, thought control, thought-action fusion, and enhancing the spiritual quality of life of participants., conditionsModule conditions: Obsessive-Compulsive Disorder, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Traditional Islamically Integrated Psychotherapy, outcomesModule primaryOutcomes measure: Yale Brown Obsessive Compulsive Scale, secondaryOutcomes measure: Depression, Stress, Anxiety, secondaryOutcomes measure: Thought Action Fusion, secondaryOutcomes measure: Thought Control, secondaryOutcomes measure: Spiritual Quality, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 40 Years, stdAges: ADULT, hasResults: False
|
protocolSection identificationModule nctId: NCT06302699, orgStudyIdInfo id: UCAD-MM-001, briefTitle: Detecting Minimal Residual Diseases (MRD) and Monitoring Clonal Evolution Using Ultrasensitive Chromosomal Aberrations Detection (UCAD) in Multiple Myeloma, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-05-01, primaryCompletionDateStruct date: 2024-05-01, completionDateStruct date: 2026-03-01, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: Institute of Hematology & Blood Diseases Hospital, China, class: OTHER, descriptionModule briefSummary: The presence of minimal residual disease (MRD) is an important prognostic factor for multiple myeloma, while copy number variation (CNV) is a widely accepted biomarker used for multiple myeloma (MM). Detecting MRD and monitoring clonal evolution by monitoring CNV using low-pass whole genome sequencing is promising due to its high analytical sensitivity. To evaluate the correlation between MRD detected by flow cytometry and low-pass whole genome sequencing, nearly 200 samples were collected for this study. We applied ultrasensitive chromosomal aberrations detection to detect CNV for each patient. The follow-up samples were then collected and sequencing used the same method., conditionsModule conditions: Multiple Myeloma, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: RETROSPECTIVE, enrollmentInfo count: 80, type: ESTIMATED, outcomesModule primaryOutcomes measure: Detection of copy number variation, secondaryOutcomes measure: Serial monitoring of treatment response, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
|
protocolSection identificationModule nctId: NCT06302686, orgStudyIdInfo id: INRCA_004_2023, briefTitle: engAGE: Managing cognitivE decliNe throuGh Theatre Therapy, Artificial Intelligence and Social Robots drivEn Interventions, acronym: engAGE, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-10-09, primaryCompletionDateStruct date: 2024-06-24, completionDateStruct date: 2024-06-24, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: Istituto Nazionale di Ricovero e Cura per Anziani, class: OTHER, collaborators name: European Union, descriptionModule briefSummary: The objectives of the engAGE project are to counteract and slow down cognitive decline progression, to enhance the intrinsic capacity of the users, and to support the wellbeing of older persons with mild cognitive impairment (MCI) by providing an ecosystem of services based on an innovative system that integrates social robots., conditionsModule conditions: Mild Cognitive Impairment, conditions: Older Adults, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 78, type: ESTIMATED, armsInterventionsModule interventions name: engAGE system, interventions name: Group practicing with only the support of a booklet, outcomesModule primaryOutcomes measure: Change in perceived stability of cognitive status by the older adults, secondaryOutcomes measure: Change in cognitive impairment in older adults, secondaryOutcomes measure: Change in depression in older adults, secondaryOutcomes measure: Change in frailty status in older adults, secondaryOutcomes measure: Change in mental well being in older adults, secondaryOutcomes measure: Change in quality of life in older adults, secondaryOutcomes measure: Change in acceptability of the engAGE system in older adults, secondaryOutcomes measure: Change in quality of life in informal caregivers, secondaryOutcomes measure: Change in mental well being in informal caregivers, secondaryOutcomes measure: Change in caregiver burden, eligibilityModule sex: ALL, minimumAge: 65 Years, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: IRCCS INRCA Hospital, status: RECRUITING, city: Ancona, zip: 60127, country: Italy, contacts name: Elvira Maranesi, role: CONTACT, contacts name: Roberta Bevilacqua, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 43.5942, lon: 13.50337, locations facility: Karde A/S, status: RECRUITING, city: Oslo, country: Norway, contacts name: Terje Grimstad, role: CONTACT, contacts name: Terje Grimstad, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 59.91273, lon: 10.74609, locations facility: HUG, status: RECRUITING, city: Geneva, country: Switzerland, contacts name: Christian Lovis, role: CONTACT, contacts name: Christian Lovis, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 46.20222, lon: 6.14569, hasResults: False
|
protocolSection identificationModule nctId: NCT06302673, orgStudyIdInfo id: 23081229, briefTitle: The Role Of Laserpuncture For Prevention Of Nausea And Vomiting Post Strabismus Surgery With General Anesthesia In Adult Patients, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-10-09, primaryCompletionDateStruct date: 2024-10, completionDateStruct date: 2024-10, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: Indonesia University, class: OTHER, descriptionModule briefSummary: This study to determine the effectiveness of a combination of pre-surgical laserpuncture with standard anti-emetic therapy for PONV symptoms in adult patients after strabismus surgery under general anesthesia compared to a combination of pre-surgical placebo laserpuncture with standard anti-emetic therapy. Research design using a double blinded randomized controlled trial (RCT) where research subjects and data takers who will be disguised. The research will be carried out in the Operation and Inpatient Room, Kirana Building, RSUPN Dr. Cipto Mangunkusumo (RSCM) with research subjects as adult patients undergoing strabismus surgery under general anesthesia. Assessment of nausea and vomiting using AVS ( Analog Visual Scale) consists of scoring using a score from 1-5 which indicates the severity of nausea and vomiting., conditionsModule conditions: Nausea and Vomiting, Postoperative, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Double blinded randomized controlled trial (RCT), primaryPurpose: PREVENTION, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 32, type: ESTIMATED, armsInterventionsModule interventions name: Laserpuncture and anti emetic standar therapy, interventions name: Sham Laserpuncture and anti emetic standar therapy, outcomesModule primaryOutcomes measure: Analog Visual Scale for nausea vomitting, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 59 Years, stdAges: ADULT, contactsLocationsModule locations facility: RSUPN Dr. Cipto Mangunkusumo, status: RECRUITING, city: Jakarta Pusat, state: Jakarta, country: Indonesia, contacts name: Yossie Faudina Putri, MD, role: CONTACT, phone: 6281290371481, email: yossie.dina2@gmail.com, geoPoint lat: -6.1818, lon: 106.8223, hasResults: False
|
protocolSection identificationModule nctId: NCT06302660, orgStudyIdInfo id: 22/LO/0169, briefTitle: Profiling Microbiome Associated Metabolic Pathways in Oesophageal Cancer Survivors, acronym: MAPLES, statusModule overallStatus: RECRUITING, startDateStruct date: 2022-03-09, primaryCompletionDateStruct date: 2024-06-01, completionDateStruct date: 2025-06-01, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: Imperial College London, class: OTHER, collaborators name: Imperial College Healthcare NHS Trust, collaborators name: West Hertfordshire Teaching Hospitals NHS Trust, collaborators name: Barking, Havering and Redbridge University Hospitals NHS Trust, descriptionModule briefSummary: The goal of this observational study is to learn about long term symptoms in oesophageal cancer survivors. The main question it aims to answer is are:* Study the changes in gut bacteria by examining saliva, stool and blood.* Investigate the products of bacteria in breath to develop a non-invasive breath test to detect the changes in gut bacteria.* Develop new strategies to treat this change and trial new treatments to improve quality- of-life in oesophageal cancer survivors.Participants will attend an outpatient clinic, fasted for at least 4 hours for collection of breath, saliva, blood, urine, stool and complete validated healthy-related quality-of-life questionnaires.Researchers will compare symptomatic and asymptomatic participants to detect the changes stated above., conditionsModule conditions: Oesophageal Cancer, conditions: Quality of Life, conditions: Bacterial Overgrowth, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Breath test, interventions name: Saliva sample, interventions name: Blood sample, interventions name: Urine sample, interventions name: Stool sample, interventions name: Health-related Quality of life questionnaires, outcomesModule primaryOutcomes measure: Identify microbiome dysbiosis in saliva associated with long-term functional symptoms., primaryOutcomes measure: Identify microbiome dysbiosis in stool associated with long-term functional symptoms., secondaryOutcomes measure: Identify underlying metabolic pathways associated with microbiome derived metabolites., secondaryOutcomes measure: Develop a breath test to detect volatile biomarkers associated with microbiome dysbiosis., secondaryOutcomes measure: Propose a strategy for treatment of long-term symptoms in oesophageal adenocarcinoma survivors., eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 90 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Barking, Havering and Redbridge University Hospitals NHS Trust, status: RECRUITING, city: London, country: United Kingdom, contacts name: Munir Tarazi, MB BCh BAO MRCS MCh, role: CONTACT, phone: +44 (0)20 7594 8197, email: m.tarazi@imperial.ac.uk, geoPoint lat: 51.50853, lon: -0.12574, locations facility: Imperial College Healthcare NHS Trust, status: RECRUITING, city: London, country: United Kingdom, contacts name: Munir Tarazi, MB BCh BAO MRCS MCh, role: CONTACT, phone: +44 (0)20 7594 8197, email: m.tarazi@imperial.ac.uk, geoPoint lat: 51.50853, lon: -0.12574, locations facility: West Hertfordshire NHS Teaching Hospitals, status: RECRUITING, city: London, country: United Kingdom, contacts name: Munir Tarazi, MB BCh BAO MRCS MCh, role: CONTACT, phone: +44 (0)20 7594 8197, email: m.tarazi@imperial.ac.uk, geoPoint lat: 51.50853, lon: -0.12574, hasResults: False
|
protocolSection identificationModule nctId: NCT06302647, orgStudyIdInfo id: PI-6022, briefTitle: Assessing Interest in Web/App Platforms for Early Phase Clinical Trial Recruitment, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-14, primaryCompletionDateStruct date: 2024-06-15, completionDateStruct date: 2024-06-30, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: Instituto de Investigación Hospital Universitario La Paz, class: OTHER, descriptionModule briefSummary: Study objective:To assess whether the different stakeholders (volunteers, patients, doctors and industry) involved in early phase trials would be interested in using a platform to facilitate recruitment and engagement in this type of trials. In addition, we will also evaluate the degree of awareness existing in society about clinical trials.Study subjects: General population, patient, physicians, pharmaceutical-biotechnological industry.Keywords: healthy volunteer, patient, pharma industry, patient associaiton, questionnaire, clinical trial, platform, recruitment, engagement., conditionsModule conditions: Assessing Interest in a Platform for Early Phase Clinical Trial Recruitment, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: PROSPECTIVE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Questionnaires, outcomesModule primaryOutcomes measure: percentage of each of the three groups that would find the platform useful, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 100 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
|
protocolSection identificationModule nctId: NCT06302634, orgStudyIdInfo id: ReCO, secondaryIdInfos id: 2022/137, type: OTHER, domain: Comité de Ética de la Investigación de Santiago-Lugo, briefTitle: Cardio-Oncology Rehabilitation Care Process, acronym: ReCO, statusModule overallStatus: RECRUITING, startDateStruct date: 2022-06-22, primaryCompletionDateStruct date: 2027-06-22, completionDateStruct date: 2027-06-22, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: Hospital Clinico Universitario de Santiago, class: OTHER, descriptionModule briefSummary: The objective of this observational study is to assess the outcomes of a hospital-based Cardio-Oncology Rehabilitation (CORe) program focused on exercise in cancer patients undergoing cardiotoxic treatment. This evaluation will be conducted by analyzing disease-related health indicators, functional capacity, and quality of life. Patients at risk of cardiotoxicity attending the Cardio-Onco-Hematology Unit will be offered the exercise program, which includes two modalities: in-person (center-based) and remote (home-based) options. The assignment to either modality is non randomized, based on the functional assessment conducted in the Rehabilitation Unit and the agreement between healthcare professional and patient. All participants will perform a 3-month supervised exercise intervention. There are 3 time points for assessment: at baseline (T0), 3-month after the exercise program (T1) and follow-up at 9 months from baseline (T2)., conditionsModule conditions: Cardio-Oncology, conditions: Rehabilitation, conditions: Cardiovascular Diseases, conditions: Exercise, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 300, type: ESTIMATED, armsInterventionsModule interventions name: Exercise-based cardio-oncology rehabilitation, outcomesModule primaryOutcomes measure: Change in left ventricular systolic function quantified by left ventricular ejection fraction and global longitudinal strain by transthoracic echocardiography, primaryOutcomes measure: Increased cardiac biomarkers (Troponin I and BNP/NT-proBNP), primaryOutcomes measure: Decrease in functional capacity assessed by estimated VO2peak, primaryOutcomes measure: Change in cardiovascular risk profile as assessed by the presence or absence of classic cardiovascular risk factors., primaryOutcomes measure: Changes in fasting blood glucose, primaryOutcomes measure: Changes in total low-density lipoprotein (LDL) and total cholesterol (TC) levels, primaryOutcomes measure: Change in haemoglobin, primaryOutcomes measure: Significant cardiovascular and non-cardiovascular adverse effects during treatment., secondaryOutcomes measure: Change in health-related quality of life assessed by the Functional Assessment of Cancer Therapy - Breast plus Arm Morbidity (FACT-B+4) questionnaire., secondaryOutcomes measure: Change in localized lower limb functional capacity assessed by number of repetitions performed within 30 seconds in the sit-to-stand test., secondaryOutcomes measure: Change in lower limb strength measured by squat dynamometry (kg)., secondaryOutcomes measure: Change in biceps strength by dynamometry (kg)., secondaryOutcomes measure: Change in perimeter (cm) of the right thigh 5cm above the upper edge of the patella, secondaryOutcomes measure: Changes in peak expiratory flow, secondaryOutcomes measure: Change in upper limb strength measured by dynamometry (kg)., secondaryOutcomes measure: Change in anthropometric parameters: weight in kg., secondaryOutcomes measure: Change in anthropometric parameters: Body mass index (BMI) in kg/m^2, secondaryOutcomes measure: Change in anthropometric parameters: abdominal circumference in cm., secondaryOutcomes measure: Change in resting heart rate measured by pulse oximetry (beats per min)., secondaryOutcomes measure: Change in resting blood pressure (mmHg) measured by a blood pressure monitor., secondaryOutcomes measure: Change in physical activity assessed by the score in the Godin Leisure Test Exercise Questionnaire (GLTEQ)., secondaryOutcomes measure: Change in cardiovascular treatment by its presence or absence., otherOutcomes measure: Adherence and compliance to cardiac rehabilitation program (CBCORe) assessed by number of training sessions attended/number of sessions planned., otherOutcomes measure: Compliance to home-based cardiac rehabilitation program (HBCORe) assessed by the total number of telephone calls during the Physiotherapy follow-up and the total time of telephone calls., otherOutcomes measure: Security of the cardiac rehabilitation program assessed by number of adverse events during training (CBCORe)., otherOutcomes measure: Satisfaction with the CORe program, otherOutcomes measure: Follow-up of the exercise performed after participation in the CORe program, otherOutcomes measure: Presence or absence of lymphoedema., eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Hospital Clínico Universitario de Santiago, status: RECRUITING, city: Santiago de Compostela, state: A Coruña, zip: 15706, country: Spain, contacts name: Carlos Peña-Gil, MD, PhD, role: CONTACT, phone: +34 981 950 778, email: carlos.pena.gil@sergas.es, contacts name: Estíbaliz Díaz-Balboa, role: CONTACT, phone: +34 981950747, email: estibaliz.diaz.balboa@sergas.es, geoPoint lat: 42.88052, lon: -8.54569, hasResults: False
|
protocolSection identificationModule nctId: NCT06302621, orgStudyIdInfo id: 21-725, briefTitle: Pemigatinib + Afatinib in Advanced Refractory Solid Tumors, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-07-01, primaryCompletionDateStruct date: 2024-12-01, completionDateStruct date: 2025-12-01, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: Massachusetts General Hospital, class: OTHER, collaborators name: Boehringer Ingelheim, collaborators name: Incyte Corporation, descriptionModule briefSummary: This study is researching whether the combination of Afatinib and Pemigatinib is safe and effective in FGFR altered unresectable or metastatic advanced solid tumors.The study is also trying to discover the highest doses of the study drugs that can be administered without causing any intolerable side effects.This research study involves the study drugs Afatinib and Pemigatinib., conditionsModule conditions: Advanced Solid Tumor, conditions: Unresectable Solid Tumor, conditions: Metastatic Solid Tumor, conditions: Cholangiocarcinoma, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 70, type: ESTIMATED, armsInterventionsModule interventions name: Afatinib, interventions name: Pemigatinib, outcomesModule primaryOutcomes measure: Maximum tolerated dose (MTD), primaryOutcomes measure: Objective response rate (ORR), secondaryOutcomes measure: Disease Control Rate, secondaryOutcomes measure: Duration of Response, secondaryOutcomes measure: Overall Survival, secondaryOutcomes measure: Progression-free Survival, secondaryOutcomes measure: Best Overall Response, secondaryOutcomes measure: Time to response, secondaryOutcomes measure: Treatment Related Adverse Events, secondaryOutcomes measure: Maximum Plasma Concentration [Cmax]) and C trough of pemigatinib and afatinib, secondaryOutcomes measure: Molecular correlates of response, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Massachusetts General Hospital, status: RECRUITING, city: Boston, state: Massachusetts, zip: 02115, country: United States, contacts name: Andreas Varkaris, MD, role: CONTACT, phone: 617-724-4000, email: AVARKARIS@MGH.HARVARD.EDU, contacts name: Andreas Varkaris, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 42.35843, lon: -71.05977, hasResults: False
|
protocolSection identificationModule nctId: NCT06302608, orgStudyIdInfo id: NGGT-BCD-P-2203, briefTitle: Safety and Efficacy Study of NGGT001 in Bietti Crystalline Corneoretinal Dystrophy, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2023-02-08, primaryCompletionDateStruct date: 2024-05-29, completionDateStruct date: 2028-05-29, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: Xiamen Ophthalmology Center Affiliated to Xiamen University, class: OTHER, descriptionModule briefSummary: Evaluate the safety and tolerability of NGGT001 subretinal injection for the treatment of crystalline retinal degeneration (BCD), conditionsModule conditions: Bietti's Crystalline Dystrophy, designModule studyType: INTERVENTIONAL, phases: EARLY_PHASE1, designInfo allocation: NON_RANDOMIZED, interventionModel: SEQUENTIAL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 6, type: ESTIMATED, armsInterventionsModule interventions name: NGGT001, outcomesModule primaryOutcomes measure: BCVA, primaryOutcomes measure: Incidence and severity of adverse events (AEs) and serious adverse events (SAEs), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Xiuju Chen, city: Xiamen, state: Fujian, zip: 361000, country: China, geoPoint lat: 24.47979, lon: 118.08187, hasResults: False
|
protocolSection identificationModule nctId: NCT06302595, orgStudyIdInfo id: 2022P001093, secondaryIdInfos id: 5R44CA224853, type: NIH, link: https://reporter.nih.gov/quickSearch/5R44CA224853, briefTitle: MRI Guided Prostate Biopsy, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-08-24, primaryCompletionDateStruct date: 2024-05-31, completionDateStruct date: 2024-08-31, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: Brigham and Women's Hospital, class: OTHER, collaborators name: National Cancer Institute (NCI), collaborators name: Physical Sciences Inc., descriptionModule briefSummary: This study aims to assess the feasibility of magnetic resonance (MR) guided prostate biopsy using a needle holder frame. This frame is used to help position the needle used for the biopsy. The feasibility in this study is defined as whether the needle holder frame enables accurate tissue sampling from a suspicious region in the prostate found on an MR image. If it does, a biopsy can be carried out with the needle holder frame safely in a clinical routine. The study will be conducted during a routine MR-guided prostate biopsy procedure with an investigational needle holder frame instead of a conventional needle-guiding template., conditionsModule conditions: Suspected Prostate Cancer, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: DEVICE_FEASIBILITY, maskingInfo masking: NONE, enrollmentInfo count: 15, type: ESTIMATED, armsInterventionsModule interventions name: MRI-guided prostate biopsy using the needle holder frame., outcomesModule primaryOutcomes measure: Accuracy of needle placement, eligibilityModule sex: MALE, minimumAge: 30 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Brigham and Women's Hospital, status: RECRUITING, city: Boston, state: Massachusetts, zip: 02115, country: United States, contacts name: Kemal Tuncali, MD, role: CONTACT, phone: 617-732-7631, email: ktuncali@bwh.harvard.edu, geoPoint lat: 42.35843, lon: -71.05977, hasResults: False
|
protocolSection identificationModule nctId: NCT06302582, orgStudyIdInfo id: stress injury, briefTitle: Platelet Rich Plasma Combined With Human Umbilical Cord Mesenchymal Stem Cells for Stage 3 and 4 Stress Injury, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-29, primaryCompletionDateStruct date: 2024-11-25, completionDateStruct date: 2024-11-25, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: Liaocheng People's Hospital, class: OTHER, descriptionModule briefSummary: This study is an open-label, single-center trial which aim to evaluate of efficacy and safety of human umbilical cord-derived mesenchymal stem cells (hUC-MSCs) combined with platelet-rich plasma (PRP) in stage 3 and 4 stress injury., conditionsModule conditions: Pressure Injuries - Stage 3, conditions: Pressure Injuries - Stage 4, designModule studyType: INTERVENTIONAL, phases: PHASE1, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: Platelet-rich plasma (PRP) combined with human umbilical cord mesenchymal stem cells (huMSCs), interventions name: Control group, outcomesModule primaryOutcomes measure: Change From Baseline in Pressure Ulcer Scale for Healing (PUSH), primaryOutcomes measure: Change from baseline in Determination of growth factor content, secondaryOutcomes measure: Wound healing time, secondaryOutcomes measure: Positive rate of bacterial culture, otherOutcomes measure: Safety evaluation, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Central laboratory, status: RECRUITING, city: Liaocheng, state: Shandong, zip: 252000, country: China, contacts name: changhui Zhou, postgraduate, role: CONTACT, phone: 13562078772, email: zhouchanghui008@163.com, geoPoint lat: 36.45596, lon: 115.97766, hasResults: False
|
protocolSection identificationModule nctId: NCT06302569, orgStudyIdInfo id: Bellini INT 2024-511587-93-00, briefTitle: Pembrolizumab Plus Enfortumab Vedotin in Collecting Duct and Renal Medullary Carcinoma, acronym: REPRINT, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2026-10, completionDateStruct date: 2028-05, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-08, sponsorCollaboratorsModule leadSponsor name: Giuseppe Procopio, class: OTHER, descriptionModule briefSummary: This is a single-arm, monocentric, phase II trial, enrolling patients with histological diagnosis of collecting duct carcinoma and renal medullary carcinoma with locally advanced or metastatic disease who will be treated with Pembrolizumab plus Enfortumab Vedotin.Approximately, 23 patients will be enrolled. At screening, pre-existing archival primary and metastatic FFPE tumor specimen will be collected and submitted for central pathology review and translational analysis. All participants will undergo baseline screening imaging for clinical staging. Patients will be treated with Pembrolizumab q21 plus Enfortumab Vedotin 1,8q21 for 3 cycles (3 infusion of Pembrolizumab and 6 infusion of Enfortumab Vedotin) then radiological imaging will be repeated and patients with SD, PR or CR will continue pembrolizumab until disease progression, unacceptable toxicities or completion of treatment (17 cycles). Patients with progressive disease after 3 cycles of study intervention will be treated as per clinical practice.Patients who will experience progressive disease during pembrolizumab monotherapy treatment could restart Enfortumab Vedotin.The study will also involve collection of a blood sample taken at the commencement of treatment, at the first cycle, after cycle 3 and at the end of treatment or progression of disease, to be used for research purposes., conditionsModule conditions: Bellini Carcinoma, conditions: Collecting Duct Carcinoma, conditions: Renal Medullary Carcinoma, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 23, type: ESTIMATED, armsInterventionsModule interventions name: Pembrolizumab + Enfortumab Vedotin, outcomesModule primaryOutcomes measure: ORR in patients treated with Pembrolizumab plus Enfortumab Vedotin, secondaryOutcomes measure: Progression-free survival (PFS) in patients treated with Pembrolizumab plus Enfortumab Vedotin, secondaryOutcomes measure: Overall-survival (OS) in patients treated with Pembrolizumab plus Enfortumab Vedotin, secondaryOutcomes measure: Number of Participants treated with Pembrolizumab + Enfortumab Vedotin who experience AEs/SAEs, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Fondazione Irccs Istituto Dei Tumori Di Milano, city: Milan, zip: 20133, country: Italy, geoPoint lat: 45.46427, lon: 9.18951, hasResults: False
|
protocolSection identificationModule nctId: NCT06302556, orgStudyIdInfo id: 2022XJ9W4F, secondaryIdInfos id: G53D2300526 0006, type: OTHER_GRANT, domain: Ministry of University and Research. NextGenetationUE, briefTitle: The Role of Immune Checkpoints in Lung Transplant (ILTRA), acronym: ILTRA, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2026-01, completionDateStruct date: 2026-02, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-08, sponsorCollaboratorsModule leadSponsor name: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico, class: OTHER, collaborators name: University of Milan, collaborators name: University of Padova, collaborators name: University of Turin, Italy, descriptionModule briefSummary: The goal of this observational study is to learn about rejection in lung transplantation.The main question it aims to answer is:• what is the role of immune checkpoints in lung transplantation? Participants will describe pathways of rejection in lung transplantation analyzing the immune checkpoints on explanted lungs as well as trans-bronchial biopsies., conditionsModule conditions: Lung Transplant Rejection, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: OTHER, enrollmentInfo count: 280, type: ESTIMATED, armsInterventionsModule interventions name: Immune checkpoints analysis, interventions name: Gene expression analysis, outcomesModule primaryOutcomes measure: Lung-tissue immune-checkpoint profile and bronchoalveolar immune-cells mRNA signature in acute rejection after lung transplantation., primaryOutcomes measure: Lung-tissue immune-checkpoint profile in chronic rejection after lung transplantation., eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Fondazione IRCCS Cà Granda, Ospedale Maggiore Policlinico, city: Milan, zip: 20122, country: Italy, contacts name: Mario Nosotti, Medicine, role: CONTACT, phone: 3393924679, email: mario.nosotti@unimi.it, contacts name: Ilaria Righi, Medicine, role: CONTACT, phone: +393470556707, email: ilaria.righi78@gmail.com, contacts name: Mario Nosotti, Medicine, role: PRINCIPAL_INVESTIGATOR, contacts name: Ilaria Righi, Medicine, role: SUB_INVESTIGATOR, contacts name: Lorenzo Rosso, Medicine, role: SUB_INVESTIGATOR, contacts name: Valentina Vaira, Biology, role: SUB_INVESTIGATOR, contacts name: Mario Clerici, Medicine, role: SUB_INVESTIGATOR, contacts name: Daria Trabattoni, Biology, role: SUB_INVESTIGATOR, geoPoint lat: 45.46427, lon: 9.18951, locations facility: University of Modena and Reggio Emilia, city: Modena, zip: 41121, country: Italy, contacts name: Marcello Pinti, Biology, role: CONTACT, phone: +390592055386, email: marcello.pinti@unimore.it, geoPoint lat: 44.64783, lon: 10.92539, locations facility: University of Padua, city: Padova, zip: 35131, country: Italy, contacts name: Marco Schiavon, Medicine, role: CONTACT, phone: +39 3475642901, email: marco.schiavon@unipd.it, geoPoint lat: 45.40797, lon: 11.88586, locations facility: University of Turin, city: Torino, zip: 10124, country: Italy, contacts name: Massimo Boffini, Medicine, role: CONTACT, phone: +39 3474267034, email: massimo.boffini@unito.it, geoPoint lat: 45.07049, lon: 7.68682, hasResults: False
|
protocolSection identificationModule nctId: NCT06302543, orgStudyIdInfo id: POI bone marrow, briefTitle: Treatment of Premature Ovarian Insufficiency Using Bone Marrow Cells, acronym: alfarah, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2024-09-10, completionDateStruct date: 2024-10-24, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-08, sponsorCollaboratorsModule leadSponsor name: abdulmajeed hammadi, class: INDUSTRY, descriptionModule briefSummary: investigator is doing single armed clinical interventional study to treat premature ovarian insufficiency with autologous bone marrow derived mononuclear cells to be given systematically and locally to the ovaries under ultrasound guidance with experienced gynecologist and to look for the results including: laboratory evidence through hormonal study ultrasound proof of ovarian follicle development. premature ovarian insufficiency is characterized by early loss of ovarian function (less than 40 years of age) manifested by menstrual irregularity or amenorrhea with elevated levels of gonadotropin hormones and low estrogen and anti-Mullerian hormone.Autologous use of stem cells from bone marrow are alternative safe minimal manipulative products that can provide a solution to this clinical problem without the need for oocyte donation program., conditionsModule conditions: Premature Ovarian Insufficiency, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: single armed interventional study, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 10, type: ESTIMATED, armsInterventionsModule interventions name: autologous bone marrow cells injection, outcomesModule primaryOutcomes measure: change in gonadotropin levels, eligibilityModule sex: FEMALE, minimumAge: 30 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule locations facility: Ministry of Health, status: RECRUITING, city: Baghdad, zip: 964, country: Iraq, contacts name: abdulmajeed Hammadi, MD, role: CONTACT, phone: +9647902268105, email: alzaitounhospital@gmail.com, geoPoint lat: 33.34058, lon: 44.40088, hasResults: False
|
protocolSection identificationModule nctId: NCT06302530, orgStudyIdInfo id: UCV/2022-2023/155, briefTitle: "Effectiveness of the Ultrasound - Guided Lengthening of the Gastrocsoleus Complex", acronym: EUGLGC, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-15, primaryCompletionDateStruct date: 2024-08-30, completionDateStruct date: 2025-03-15, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-04-23, sponsorCollaboratorsModule leadSponsor name: Fundación Universidad Católica de Valencia San Vicente Mártir, class: OTHER, descriptionModule briefSummary: This research project compares the effectiveness of different surgical techniques for lengthening the gastrocnemius-soleus system in patients with equinus deformity. The study will compare 2 techniques: gastrocnemius tendon recession (Strayer) and plantaris resection. Increased ankle range of motion, complications, operative time, recovery time, pain scales and function will be measured. The results will help determine which technique is most effective and safe for correcting equinus deformity., conditionsModule conditions: Gastrocnemius Equinus, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, maskingDescription: To reduce bias, the study will use double-blind blinding. Patients will not know the group to which they have been assigned. In addition, the assessors performing the ankle range of motion measurements by goniometry will be blinded to each patient's treatment group.Randomization to each group will be performed using opaque sealed envelopes that will be opened in the operating room just prior to surgery. Neither the surgeon nor the patient will know the assignment until that time.The statistical analysis will also be performed in a blinded manner, without the statistician knowing the intervention received by each group. Only after the analysis will the groups be unblinded.In this way, the aim is to reduce the possibility of knowledge of the assigned treatment influencing the evaluation of the results, both on the part of the patients and of the evaluators and analysts., whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 48, type: ESTIMATED, armsInterventionsModule interventions name: Stayer, interventions name: Plantar transection, outcomesModule primaryOutcomes measure: Ankle range of motion, secondaryOutcomes measure: Visual Analog Scale., secondaryOutcomes measure: American Orthopedic Foot and Ankle Score, secondaryOutcomes measure: Complications, eligibilityModule sex: ALL, minimumAge: 10 Years, maximumAge: 90 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Podologia Avançada, status: RECRUITING, city: Granollers, state: Barcelona, zip: 08401, country: Spain, contacts name: Lluis Castillo-Sanchez, Dr, role: CONTACT, phone: 610143173, email: info@podologiaavanzadabcn.com, contacts name: Lluis Castillo, Dr, role: SUB_INVESTIGATOR, contacts name: Cristina Razzano, role: PRINCIPAL_INVESTIGATOR, contacts name: Simone Moroni, role: SUB_INVESTIGATOR, geoPoint lat: 41.60797, lon: 2.28773, locations facility: Clinica Mayral foot center, status: RECRUITING, city: Barcelona, state: Barcelon, zip: 08029, country: Spain, contacts name: Jordi Mayral, role: CONTACT, phone: (+34) 93 339 78 41, email: barcelona@clinicamayral.com, contacts name: Jordi Mayral, role: SUB_INVESTIGATOR, contacts name: Cristina Razzano, role: PRINCIPAL_INVESTIGATOR, contacts name: Simone Moroni, role: SUB_INVESTIGATOR, geoPoint lat: 41.38879, lon: 2.15899, locations facility: Clinica Pasito a pasito, status: RECRUITING, city: Valencia, zip: 46008, country: Spain, contacts name: Javier Ferrer-Torregrosa, Dr, role: CONTACT, phone: 963855535, email: clinicaspasitoapasito@gmail.com, contacts name: Javier Ferrer-Torregrosa, Dr, role: CONTACT, phone: 644733882, email: javier.ferrer@ucv.es, contacts name: JAVIER Ferrer- TORREGROSA, Dr, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.46975, lon: -0.37739, hasResults: False
|
protocolSection identificationModule nctId: NCT06302517, orgStudyIdInfo id: K2020097, briefTitle: Bis Monitoring Effect on Delirium Occurrence and Nursing Quality Improvement Recovering From General Anesthesia, statusModule overallStatus: COMPLETED, startDateStruct date: 2020-09-01, primaryCompletionDateStruct date: 2022-05-31, completionDateStruct date: 2022-08-29, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-08, sponsorCollaboratorsModule leadSponsor name: The Fourth Affiliated Hospital of Zhejiang University School of Medicine, class: OTHER, descriptionModule briefSummary: ①Effects of BIS Index (BIS) monitoring on delirium incidence in Post-anesthesia care unit (PACU) in patients undergoing general anesthesia②Effects of BIS BIS Index (BIS) monitoring on the quality of nursing care in the Post-anesthesia care unit (PACU), conditionsModule conditions: Delirium, Postoperative, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: OTHER, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, enrollmentInfo count: 134, type: ACTUAL, armsInterventionsModule interventions name: BIS-guided, outcomesModule primaryOutcomes measure: Ricker sedation-agitation scale, primaryOutcomes measure: The nursing activity score (NAS), primaryOutcomes measure: vital signs （Mean arterial pressure, heart rate, pulse oxygen saturation ）, primaryOutcomes measure: Comparison of complications during the PACU period, primaryOutcomes measure: The comprehensive satisfaction score, eligibilityModule sex: ALL, minimumAge: 20 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: The Fourth Affiliated Hospital, School of Medicine, Zhejiang University, city: Jinhua, state: Zhejiang, zip: 322000, country: China, geoPoint lat: 29.10678, lon: 119.64421, hasResults: False
|
protocolSection identificationModule nctId: NCT06302504, orgStudyIdInfo id: Nature, briefTitle: Nature-based Mindfulness Intervention Program for Family Carers, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-04-15, primaryCompletionDateStruct date: 2024-03-31, completionDateStruct date: 2024-03-31, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-08, sponsorCollaboratorsModule leadSponsor name: The Hong Kong Polytechnic University, class: OTHER, descriptionModule briefSummary: The program integrates ordinary mindfulness exercise with nature environment. Participants will be able to practice mindfulness in a natural environment in some of the program sessions. The study will study the effects of nature-based mindfulness program in reducing caregiving stress. The program will last for 4 session, 8 hours in total., conditionsModule conditions: Mental Health Issue, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Nature-based mindfulness program, outcomesModule primaryOutcomes measure: depression, primaryOutcomes measure: anxiety, primaryOutcomes measure: stress, primaryOutcomes measure: family functioning, primaryOutcomes measure: family conflict, primaryOutcomes measure: well-being, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: The Hong Kong Polytechnic University, status: RECRUITING, city: Hong Kong, zip: 852, country: Hong Kong, contacts name: Hay-ming Herman Lo, PhD, role: CONTACT, phone: +852-27665769, email: herman.lo@polyu.edu.hk, geoPoint lat: 22.27832, lon: 114.17469, hasResults: False
|
protocolSection identificationModule nctId: NCT06302491, orgStudyIdInfo id: AND017-BTH-205, briefTitle: A Study of Safety and Efficiency of AND017 in Patients With Transfusion Dependent and Non-transfusion Dependent β-thalassemia, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2025-12, completionDateStruct date: 2026-07, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-08, sponsorCollaboratorsModule leadSponsor name: Kind Pharmaceuticals LLC, class: INDUSTRY, descriptionModule briefSummary: This is a phase II, randomized, double-blinded, placebo-controlled study to treat patients with transfusion-dependent and non-transfusion dependent β -thalassemia with AND017 and optimal supportive care, including blood transfusion and iron removal, based on the clinician's judgment and practice., conditionsModule conditions: β -Thalassemia, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 64, type: ESTIMATED, armsInterventionsModule interventions name: AND017 capsules, interventions name: AND017 Placebo, outcomesModule primaryOutcomes measure: Evaluate the safety and tolerability of different oral doses of AND017 in the treatment of β-thalassemia subjects, secondaryOutcomes measure: Change in mean Hb levels relative to baseline at weeks 8-12 and week 20-24 post-treatment compared to baseline (mean Hb values during the 4 weeks prior to the first dose)., secondaryOutcomes measure: The level of Hb and the change from baseline at each visit throughout the treatment period., secondaryOutcomes measure: Proportion of patients with mean Hb elevation ≥1.0 g/dL from baseline to weeks 8-12 after dosing., secondaryOutcomes measure: Levels of and changes from baseline in red blood cell count throughout the treatment period, secondaryOutcomes measure: Levels of and changes from baseline in reticulocyte count throughout the treatment period, secondaryOutcomes measure: Levels of and changes from baseline in mean corpuscular volume (MCV) throughout the treatment period, secondaryOutcomes measure: Levels of and changes from baseline in mean corpuscular hemoglobin (MCH) throughout the treatment period, secondaryOutcomes measure: Levels of and changes from baseline in mean corpuscular hemoglobin concentration (MCHC) throughout the treatment period, secondaryOutcomes measure: Throughout the treatment period, changes in the levels and relative baseline of transferrin will be assessed., secondaryOutcomes measure: Throughout the treatment period, changes in the levels and relative baseline of transferrin saturation (TSAT) will be assessed., secondaryOutcomes measure: Throughout the treatment period, changes in the levels and relative baseline of ferritin will be assessed., secondaryOutcomes measure: Throughout the treatment period, changes in the levels and relative baseline of serum iron level will be assessed., secondaryOutcomes measure: Throughout the treatment period, changes in the levels and relative baseline of total iron binding capacity (TIBC) will be assessed., secondaryOutcomes measure: Change in transfusion load (units transfused) at 12-24 weeks post-dose compared to baseline (12 weeks to W0 before first dose)., secondaryOutcomes measure: Change in number of transfusions at 12-24 weeks post-dose compared to baseline (12 weeks to W0 before first dose)., secondaryOutcomes measure: Proportion of subjects with ≥33% reduction in transfusion load (transfusion units) relative to baseline (12 weeks prior to first dose to W0) from baseline to any consecutive 12-week period after dosing., secondaryOutcomes measure: Duration (days) of maintenance below this transfusion dose after a 33% reduction in transfusion load from baseline has been achieved., eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
|
protocolSection identificationModule nctId: NCT06302478, orgStudyIdInfo id: KhonKaenU001, briefTitle: 5E Program for Preventing Venous Thromboembolism in Patients With Spinal Cord Disorders, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-12, primaryCompletionDateStruct date: 2024-05-30, completionDateStruct date: 2024-10-31, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-13, sponsorCollaboratorsModule leadSponsor name: Khon Kaen University, class: OTHER, descriptionModule briefSummary: The goal of this quasi-experimental study is to examine the effects of a venous thromboembolism prevention program, or "5E" program, on the rates of venous thromboembolism in patients with spinal cord disorders. The main questions it aims to answer are:* Will participants receiving the 5E program have lower rates of venous thromboembolism compared to those receiving the usual care?* Will participants receiving the 5E program have lower scores of venous thromboembolism signs and symptoms compared to those receiving the usual care?* Will the average thigh and calf circumferences of participants before and after receiving the 5E program be different?Participants in the intervention group will receive the 5E program, including* Education: health education regarding venous thromboembolism prevention* Elevation: leg elevation of 10-20 degrees* Exercise: ankle exercises* Enough fluid: adequate fluid uptake* Early application of intermittent pneumatic compression (IPC): IPC use within 48 hours after admission, conditionsModule conditions: Venous Thromboembolism, conditions: Spinal Cord Diseases, conditions: Spinal Cord Injuries, conditions: Nurse's Role, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: SEQUENTIAL, interventionModelDescription: A quasi-experimental research (two group pretest-posttest design), primaryPurpose: PREVENTION, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 42, type: ESTIMATED, armsInterventionsModule interventions name: 5E program, outcomesModule primaryOutcomes measure: The rate of venous thromboembolism, secondaryOutcomes measure: Signs and symptoms of deep venous thrombosis and pulmonary embolism, secondaryOutcomes measure: Thigh and calf circumference, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Chaiyaphum Hospital, status: RECRUITING, city: Chaiyaphum, zip: 36000, country: Thailand, contacts name: Suchada Chindamart, BNS, role: CONTACT, phone: +66619411828, email: suchada.chi@kkumail.com, geoPoint lat: 15.81047, lon: 102.02881, hasResults: False
|
protocolSection identificationModule nctId: NCT06302465, orgStudyIdInfo id: PKUPH-sarcoma 18, briefTitle: Narlumosbartmab Combined With Neoadjuvant Chemotherapy in Bone-derived Malignancies With Osteolytic Lesions and Multinucleated Giant Cells, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2026-11-01, completionDateStruct date: 2026-12-31, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-29, sponsorCollaboratorsModule leadSponsor name: Peking University People's Hospital, class: OTHER, descriptionModule briefSummary: Malignant tumor of bone is rare with poor prognosis. Surgery is the main treatment for non- metastatic bone tumor. Although neoadjuvant chemotherapy for non-metastatic bone tumor cannot improve survival rate based on adjuvant chemotherapy, it can reduce and clarify tumor boundary. Control of local recurrence rate is the core objective of oncotherapy. Surgery way and boundary have a significant effect on prognosis of non- metastatic bone tumor. Narlumosbartmab, a RANKL inhibitor, can make tumor boundary clear and reduce surgical difficulty by inhibiting osteoclast. This is a prospective, randomized, controlled, two-arm, open, single-center clinical trial to compare the efficacy and safety of narlumosbartmab combined with neoadjuvant chemotherapy and neoadjuvant chemotherapy alone in bone-derived malignancies with bone lytic lesions and multinucleated giant cells. Investigators mainly observe the local recurrence rate to evaluate the survival benefit for patients with poor prognosis., conditionsModule conditions: Malignant Bone Tumor, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: narlumosbartmab plus doxorubicin、cisplatin、methotrexate、ifosfamide, interventions name: doxorubicin、cisplatin、methotrexate、ifosfamide, outcomesModule primaryOutcomes measure: local recurrence rate, secondaryOutcomes measure: tumor necrosis rate, secondaryOutcomes measure: R0 removal rate, secondaryOutcomes measure: Event-free survival, secondaryOutcomes measure: Overall survival, eligibilityModule sex: ALL, minimumAge: 8 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Peking University People's Hospital, status: RECRUITING, city: Beijing, state: Beijing, zip: 100044, country: China, contacts name: Lu Xie, M.D., role: CONTACT, phone: +8613401044719, email: xie.lu@hotmail.com, geoPoint lat: 39.9075, lon: 116.39723, hasResults: False
|
protocolSection identificationModule nctId: NCT06302452, orgStudyIdInfo id: IRB00433605, secondaryIdInfos id: R01MD019173, type: NIH, link: https://reporter.nih.gov/quickSearch/R01MD019173, briefTitle: Adult Trauma Centers RE-AIM at Gun Safety (ACTFAST) Prevention, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2028-02, completionDateStruct date: 2028-02, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-08, sponsorCollaboratorsModule leadSponsor name: Johns Hopkins University, class: OTHER, collaborators name: National Institute on Minority Health and Health Disparities (NIMHD), collaborators name: Rhode Island Hospital, descriptionModule briefSummary: The goal of this interventional study is to evaluate the implementation and effectiveness of a comprehensive a universal firearm injury prevention program, ACTFAST (Adopting Comprehensive Training for FireArm Safety in Trauma centers), in level 1 trauma centers. The main aims of the study are:1. (Primary Aim 1) Increase the adoption, implementation, and maintenance of a universal firearm injury prevention intervention at three participating trauma centers in the mid-Atlantic states;2. (Primary Aim 2) Assess firearm injury prevention knowledge, attitudes, and safe storage practices among trauma patients treated within participating trauma centers., conditionsModule conditions: Firearm Injury, conditions: Safety Issues, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: SEQUENTIAL, interventionModelDescription: The trial uses a unidirectional crossover stepped wedge design with a sequential roll-out of the intervention, ACTFAST, RE-AIM implementation framework, over several discrete time points or "steps." Each of the three trauma centers will be randomly assigned to one step that will determine when they crossover from control to implementation.Data are collected over multiple wedges, each 4-6 months in length. During the first wedge, none of the participating trauma centers will receive ACTFAST. During the second wedge, the first trauma center completes the Adoption and Implementation period. Over the third wedge, the first center shifts to the Maintenance period, the second trauma center enters the Adoption and Implementation period, and the remaining cohort stays in the control condition. This pattern continues until all trauma centers have progressed from control condition through the active implementation period., primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 1776, type: ESTIMATED, armsInterventionsModule interventions name: Adopting Comprehensive Training for FireArm Safety in Trauma Centers, outcomesModule primaryOutcomes measure: Proportion of admitted injured patients receiving each element of the ACTFAST Program, primaryOutcomes measure: Percentage of admitted injured patients receiving elements of the ACTFAST Program, primaryOutcomes measure: Patient firearm safety attitudes and behaviors as assessed by survey, secondaryOutcomes measure: Clinician firearm safety knowledge and confidence as assessed by survey, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Johns Hopkins Bayview Medical Center, city: Baltimore, state: Maryland, zip: 21224, country: United States, geoPoint lat: 39.29038, lon: -76.61219, locations facility: Johns Hopkins Hospital, city: Baltimore, state: Maryland, zip: 21287, country: United States, geoPoint lat: 39.29038, lon: -76.61219, hasResults: False
|
protocolSection identificationModule nctId: NCT06302439, orgStudyIdInfo id: INZ701-007, briefTitle: PROPEL - A Prospective Observational Patient Registry to Evaluate ENPP1 and ABCC6 Deficiency, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2034-05, completionDateStruct date: 2034-05, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-18, sponsorCollaboratorsModule leadSponsor name: Inozyme Pharma, class: INDUSTRY, collaborators name: GACI Global, descriptionModule briefSummary: The purpose of this prospective registry is to characterize the natural history of ectonucleotide pyrophosphatase/phosphodiesterase1(ENPP1) Deficiency and the infantile-onset form of adenosine triphosphate (ATP) binding cassette transporter protein subfamily C member 6 (ABCC6) Deficiency longitudinally. The registry will prospectively gather information about the genetic, biochemical, physiological, anatomic, radiographic, and functional manifestations (including patient reported outcomes \[PROs\]) of each disease during routine, standard-of-care visits, with the aim of developing a comprehensive understanding of the burden of illness and progressive nature of the disease., conditionsModule conditions: Ectonucleotide Pyrophosphatase/Phosphodiesterase 1 Deficiency, conditions: ATP-Binding Cassette Subfamily C Member 6 Deficiency, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: PROSPECTIVE, enrollmentInfo count: 1000, type: ESTIMATED, armsInterventionsModule interventions name: No Intervention for this observational study, outcomesModule primaryOutcomes measure: Characterization of the natural history of ENPP1 Deficiency and the infantile-onset form of ABCC6 Deficiency longitudinally, primaryOutcomes measure: Assessment of Patient Functional changes through a validated Patient Reported Outcomes (PROs) tool, primaryOutcomes measure: Assessment of Health-Related Quality-of-Life (HRQoL) changes through validated Patient Reported Outcomes (PROs) tools, primaryOutcomes measure: Measurement of inorganic phosphate (PPi) levels in patients' venous blood, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
|
protocolSection identificationModule nctId: NCT06302426, orgStudyIdInfo id: INI-4001-101, briefTitle: Trial of INI-4001 in Patients With Advanced Solid Tumours, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-29, primaryCompletionDateStruct date: 2024-08-01, completionDateStruct date: 2026-04-30, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-08, sponsorCollaboratorsModule leadSponsor name: Inimmune Corporation, class: INDUSTRY, collaborators name: Avance Clinical Pty Ltd., descriptionModule briefSummary: Phase 1 open-label, dose-escalation and dose-expansion study of INI-4001 as a single agent and in combination with approved checkpoint inhibitors in subjects with advanced solid tumors., conditionsModule conditions: Advanced Solid Tumor, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NON_RANDOMIZED, interventionModel: SEQUENTIAL, interventionModelDescription: This is a Phase Ia/Ib, open-label, dose-escalation and dose expansion study. This study will be conducted in two parts: Phase Ia (dose escalation) and Phase Ib (dose expansion)., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: INI-4001, interventions name: Nivolumab, interventions name: Pembrolizumab, interventions name: Cemiplimab, interventions name: Avelumab, interventions name: Atezolizumab, interventions name: Durvalumab, outcomesModule primaryOutcomes measure: Incidence of dose-limiting toxicities (DLTs) during Cycle 1 to determine the maximum tolerated dose of INI-4001 Monotherapy, secondaryOutcomes measure: Incidence, type, and severity of treatment-emergent adverse events (TEAEs) leading to discontinuation of study treatment after multiple ascending doses, secondaryOutcomes measure: Incidence and nature of dose-limiting toxicities (DLTs) and regimen-limiting toxicities (RLTs) leading to discontinuation of study treatment after multiple ascending doses, secondaryOutcomes measure: Number of Participants with a Change from baseline in Vital signs measurements after multiple ascending doses, secondaryOutcomes measure: Number of Participants with a Change from baseline in body weight after multiple ascending doses, secondaryOutcomes measure: Number of Participants with a Change from baseline in clinical laboratory parameters (haematology) after multiple ascending doses, secondaryOutcomes measure: Number of Participants with a Change from baseline in clinical laboratory parameters (serum chemistry) after multiple ascending doses, secondaryOutcomes measure: Number of Participants with a Change from baseline in clinical laboratory parameters (urinalysis) after multiple ascending doses, secondaryOutcomes measure: Change from baseline in measurements of HR in beats per minute after multiple ascending doses, secondaryOutcomes measure: Change from baseline in measurements of PR interval via 12-lead electrocardiogram after multiple ascending doses, secondaryOutcomes measure: Change from baseline in measurements of QT interval via 12-lead electrocardiogram after multiple ascending doses, secondaryOutcomes measure: Change from baseline in measurements of RR interval in breaths per minute via 12-lead electrocardiogram after multiple ascending doses, secondaryOutcomes measure: Change from baseline in measurements of QRS duration via 12-lead electrocardiogram after multiple ascending doses, secondaryOutcomes measure: Change from baseline in measurements of QTcF via 12-lead electrocardiogram after multiple ascending doses, secondaryOutcomes measure: Change from baseline in Eastern Cooperative Oncology Group (ECOG) score after multiple ascending doses, secondaryOutcomes measure: Single dose PK Parameters - maximum observed concentration (Cmax), secondaryOutcomes measure: Multiple dose PK Parameters - maximum observed concentration (Cmax), secondaryOutcomes measure: Single dose PK Parameters - Time to Cmax (Tmax), secondaryOutcomes measure: Multiple dose PK Parameters - Time to Cmax (Tmax), secondaryOutcomes measure: Single dose PK Parameters - Area under the concentration-time curve from time 0 to 24 hours post-dose (AUC0-24), secondaryOutcomes measure: Single dose PK Parameters - Total amount excreted in urine (Ae), secondaryOutcomes measure: Single dose PK Parameters - Fraction excreted in the urine (Fe), secondaryOutcomes measure: Single dose PK Parameters - Renal clearance (CLr), secondaryOutcomes measure: Multiple dose PK Parameters - Area under the concentration-time curve from time 0 to 24 hours post-dose (AUC0-24), secondaryOutcomes measure: Single dose PK Parameters - Area under the concentration-time curve (AUC0-t), secondaryOutcomes measure: Multiple dose PK Parameters - Area under the concentration-time curve (AUC0-t), secondaryOutcomes measure: Single dose PK Parameters - Half-life (t1/2), secondaryOutcomes measure: Multiple dose PK Parameters - Half-life (t1/2), secondaryOutcomes measure: Single dose PK Parameters - Clearance (Cl), secondaryOutcomes measure: Multiple dose PK Parameters - Clearance (Cl), secondaryOutcomes measure: Single dose PK Parameters - Volume of distribution (Vz), secondaryOutcomes measure: Multiple dose PK Parameters - Volume of distribution (Vz), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: The Border Cancer Hospital, city: Albury, state: New South Wales, zip: 2640, country: Australia, contacts name: Reenu Arora, role: CONTACT, email: AroraReenu@ramsayhealth.com.au, contacts name: Kay Xu, Dr, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: -36.07482, lon: 146.92401, locations facility: Cabrini Hospital, city: Malvern, state: Victoria, zip: 3144, country: Australia, contacts name: Prachi Bhave, role: CONTACT, email: PBhave@cabrini.com.au, contacts name: Prachi Bhave, Dr, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: -32.02849, lon: 151.32225, hasResults: False
|
protocolSection identificationModule nctId: NCT06302413, orgStudyIdInfo id: 1805574553; Aims 9-10, secondaryIdInfos id: 1R01AA029396-01, type: NIH, link: https://reporter.nih.gov/quickSearch/1R01AA029396-01, briefTitle: Enhancing Prospective Thinking in Early Recovery, acronym: HOME, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-15, primaryCompletionDateStruct date: 2027-07-31, completionDateStruct date: 2027-07-31, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-08, sponsorCollaboratorsModule leadSponsor name: Indiana University, class: OTHER, collaborators name: National Institute on Alcohol Abuse and Alcoholism (NIAAA), descriptionModule briefSummary: The goal of this clinical trial is to use a novel virtual reality intervention to test for efficacy in reducing alcohol use and increasing abstinence, with concomitant increases in future self-identification, future time perspective, and delay-of-reward, in early recovering alcohol use disorder (AUD) persons. The main question\[s\] this trial aims to answer are:Will the Virtual Reality (VR) intervention decrease the number of stimulant use days? Will the VR intervention produce longer abstinence periods during follow-up visits? Will the VR intervention increase alcohol abstinence rates? Will the VR intervention increase future self-identification? Will the VR intervention increase self-reported future time perspective? Will the VR intervention increase preference for delayed rewards in a laboratory delay discounting task on the study day? Will the VR intervention produce gains in the behavioral effects of future self-identification, future time perspective, and delayed rewards at the 30-day and 6-month follow-ups? Researchers will compare the experimental and control groups to see if there are differences in the results for the questions outlined above., conditionsModule conditions: Alcohol Use Disorder, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: SINGLE, maskingDescription: All study participants are randomly assigned to a group prior to study enrollment. Participants will not be made aware of their group assignment., whoMasked: PARTICIPANT, enrollmentInfo count: 500, type: ESTIMATED, armsInterventionsModule interventions name: Virtual Reality, interventions name: Virtual Reality, outcomesModule primaryOutcomes measure: Reduced Use of Drug Using Days, primaryOutcomes measure: Increased Length of Abstinence, primaryOutcomes measure: Increased (overall) Abstinence, primaryOutcomes measure: Future Self-identification with Future Self Continuity Questionnaire, primaryOutcomes measure: Future Time Perspective with the Delayed Discounting Behavioral Task and Future Self Continuity Questionnaire, primaryOutcomes measure: Delayed Reward Preference with the Delayed Discounting Behavioral Task, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule locations facility: Indiana University School of Medicine - Goodman Hal, status: RECRUITING, city: Indianapolis, state: Indiana, zip: 46202, country: United States, contacts name: Sarah Turo, BA, role: CONTACT, phone: 317-963-7220, email: sturo@iu.edu, contacts name: Brandon G Oberlin, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.76838, lon: -86.15804, hasResults: False
|
protocolSection identificationModule nctId: NCT06302400, orgStudyIdInfo id: RS-IC04, briefTitle: Individualized Dosimetry for Holmium-166 Radioembolization in Patients With Unresectable Hepatocellular Carcinoma, acronym: RHEPaiR, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-22, primaryCompletionDateStruct date: 2027-02, completionDateStruct date: 2027-02, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-08, sponsorCollaboratorsModule leadSponsor name: Imperial College London, class: OTHER, collaborators name: Terumo Europe N.V., descriptionModule briefSummary: The goal of this clinical trial is to test the safety and effectiveness of a medical device called 166-Holmium microspheres (QuiremSpheres®) in patients with hepatocellular carcinoma (HCC) . The main questions it aims to answer are:* What is the safety and toxicity profile of the 166-Holmium microspheres?* Is the device effective in treating HCC?Participants will undergo a range of screening procedures to confirm they are eligible and to record their baseline results, including:* A Computed Tomography (CT) scan* A Magnetic Resonance Imaging (MRI) scan* Blood tests* Quality of life questionnairesBefore receiving treatment with QuiremSpheres® the participant will receive a 'scout' dose of the microspheres, to check whether there is distribution of the radioactivity to other non-target areas of the body. This is measured using Single-Photon Emission Computed Tomography-CT imaging. If the distribution to non-target areas is deemed to not be too high, the participant will go on to receive the individualised therapeutic dose of QuiremSpheres®. Follow-up visits will occur 3 and 6 weeks post-treatment dose, and then at 3 and 6 months., conditionsModule conditions: Carcinoma, Hepatocellular, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 15, type: ESTIMATED, armsInterventionsModule interventions name: 166Holmium microspheres (QuiremSpheres®), outcomesModule primaryOutcomes measure: The incidence of adverse and serious adverse events in patients receiving individualized treatment with 166Ho- microspheres, using National Cancer Institute CTCAE v5.0., secondaryOutcomes measure: The rate of efficacy as defined as overall response rate (ORR) in patients receiving individualized treatment with 166Ho- microspheres, using modified RECIST (mRECIST) response evaluation criteria., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Imperial College Healthcare NHS Trust, status: RECRUITING, city: London, zip: W12 0HS, country: United Kingdom, contacts name: Rohini Sharma, Professor, role: CONTACT, phone: 02033133720, email: r.sharma@imperial.ac.uk, geoPoint lat: 51.50853, lon: -0.12574, hasResults: False
|
protocolSection identificationModule nctId: NCT06302387, orgStudyIdInfo id: BEC-LSMU(R)-27, briefTitle: Acellular Dermal Matrix Versus Tenting Technique in Peri-implant Soft Tissue Augmentation and Crestal Bone Stability, statusModule overallStatus: COMPLETED, startDateStruct date: 2018-01-01, primaryCompletionDateStruct date: 2020-04-01, completionDateStruct date: 2023-02-01, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-08, sponsorCollaboratorsModule leadSponsor name: Harvard Medical School (HMS and HSDM), class: OTHER, descriptionModule briefSummary: This study looks at two ways to make gums thicker and bones stable around dental implants for people with thin gums. It compares two methods in 40 people: one method uses a special graft, and the other uses a technique called tenting. The goal is to see which method might work better for making the gums and bones around implants healthier. The check-ups are planned when the implant is put in and again after one year. The study focuses on how these methods are done without talking about what the results are., conditionsModule conditions: Soft Tissue Augmentation, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: The interventional study model for this trial is a two-arm, double-blind, randomized, prospective controlled clinical trial., primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, maskingDescription: double-blind, where neither the patients nor the clinicians responsible for treatment know the specific treatment modality, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, enrollmentInfo count: 40, type: ACTUAL, armsInterventionsModule interventions name: Acellular Dermal Matrix, interventions name: Soft Tissue Expansion using Tenting Technique, outcomesModule primaryOutcomes measure: Crestal Bone Levels, secondaryOutcomes measure: Vertical soft tissue thickness, secondaryOutcomes measure: PPD, secondaryOutcomes measure: BOP, secondaryOutcomes measure: PI, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: VIC Clinic, city: Vilnius, zip: 01362, country: Lithuania, geoPoint lat: 54.68916, lon: 25.2798, hasResults: False
|
protocolSection identificationModule nctId: NCT06302374, orgStudyIdInfo id: GR2001-001, briefTitle: Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Immunogenicity of GR2001 in Chinese Healthy Adults, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-03-04, primaryCompletionDateStruct date: 2023-11-01, completionDateStruct date: 2024-02-19, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-08, sponsorCollaboratorsModule leadSponsor name: Genrix (Shanghai) Biopharmaceutical Co., Ltd., class: INDUSTRY, descriptionModule briefSummary: The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and Immunogenicity characteristics of GR2001 and compare the anti-tetanus neutralizing antibody titers of GR2001 with human tetanus immunoglobulin (HTIG)in healthy adult subjects., conditionsModule conditions: Tetanus, designModule studyType: INTERVENTIONAL, phases: PHASE1, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: In the phase I part of the study, a total of 94 healthy subjects will be enrolled. The 94 healthy adult subjects will be enrolled into 7 cohorts sequentially. Each participant will receive a single IM dose of GR2001 or placebo or HTIG according to the cohort in which they were enrolled. After injection (Day 0), participants will remain in the study site for observation up to Day 1. The phase I part will last for 105 days following the assessments of safety, PK, PD and ADA.In the phase II part of the study, a total of 108 healthy subjects will be enrolled. The 108 healthy subjects will be randomly assigned to the experimental group and the control group based on a ratio of 1:1:1:2:2:2.The phase II part will last for 105 days following the assessments of safety, PK, PD and ADA., primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, maskingDescription: Double Blind, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 202, type: ACTUAL, armsInterventionsModule interventions name: GR2001, interventions name: Placebo, interventions name: HTIG, interventions name: Tetanus Toxoid, outcomesModule primaryOutcomes measure: Incidence of AEs(Phase I), primaryOutcomes measure: Tetanus-antibody titer(Phase II), secondaryOutcomes measure: Tetanus-antibody titer(Phase I/II), secondaryOutcomes measure: Incidence of ADA(Phase I/II), secondaryOutcomes measure: Incidence of AEs(Phase II), secondaryOutcomes measure: Peak plasma concentration(Cmax), secondaryOutcomes measure: Area under the plasma concentration versus time curve (AUC), secondaryOutcomes measure: Time of maximum plasma concentration (Tmax), secondaryOutcomes measure: Terminal half-life (T1/2), secondaryOutcomes measure: Apparent total body clearance (CL/F), secondaryOutcomes measure: Apparent volume of distribution (Vd/F), secondaryOutcomes measure: The elimination rate constant (Kel), secondaryOutcomes measure: Mean Residence Time (MRT), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule locations facility: Huashan Hospital affiliated of Fudan University, city: Shanghai, state: Shanghai, zip: 200040, country: China, geoPoint lat: 31.22222, lon: 121.45806, hasResults: False
|
protocolSection identificationModule nctId: NCT06302361, orgStudyIdInfo id: 23/54225, briefTitle: Lymphovenous Anastomosis for Breast Cancer Lymphedema, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2026-06-30, completionDateStruct date: 2026-06-30, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-08, sponsorCollaboratorsModule leadSponsor name: Odense University Hospital, class: OTHER, collaborators name: Vejle Hospital, collaborators name: Zealand University Hospital, collaborators name: Herlev and Gentofte Hospital, descriptionModule briefSummary: This multi-center cohort study focuses on evaluating the efficacy of lymphovenous anastomosis (LVA) for treating pitting lymphedema in female breast cancer survivors. Conducted across multiple centers in Denmark, including Odense University Hospital, Herlev Hospital, Lillebaelt Hospital Vejle, and Zealand University Hospital, it aims to assess LVA's impact on reducing arm volume and improving quality of life in patients with upper extremity lymphedema secondary to breast cancer treatment.Eligible participants are adult women with unilateral arm lymphedema who show active pitting and identifiable lymphatic vessels via indocyanine green lymphography. Inclusion involves informed consent and the ability to complete Danish questionnaires.Patients are recruited from the outpatient clinics of the participating hospitals and will undergo LVA surgery under either local or general anesthesia. Following the intervention, patients are seen for data collection up to twelve months.The study measures outcomes like arm volume changes through water displacement volumetry and arm circumferential measurements, body composition via bioimpedance, health-related quality of life through LYMPH-Q, general quality of life through SF-36, arm function via DASH, and anastomosis patency via ICG lymphography. Additionally, changes in ICG lymphography images, arm fibrosis via SkinFibroMeter, and surgery duration are evaluated.The study adheres to ethical guidelines, ensuring patient safety and the integrity of the research., conditionsModule conditions: Lymphedema, conditions: Lymphedema Arm, conditions: Breast Cancer Lymphedema, conditions: Lymphedema, Secondary, conditions: Lymphedema; Surgical, conditions: Lymphedema of Upper Limb, conditions: Lymphedema, Breast Cancer, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: Multi-center cohort study, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 47, type: ESTIMATED, armsInterventionsModule interventions name: Lymphovenous anastomosis (LVA), outcomesModule primaryOutcomes measure: Arm volume (Water Displacement), primaryOutcomes measure: Arm volume (Arm Circumferences), secondaryOutcomes measure: Health-related quality of life (LYMPH-Q), secondaryOutcomes measure: General quality of life (SF-36), secondaryOutcomes measure: Arm and shoulder function (DASH), secondaryOutcomes measure: L-Dex, secondaryOutcomes measure: LVA patency, secondaryOutcomes measure: Skin Fibrosis, secondaryOutcomes measure: Surgery duration, secondaryOutcomes measure: Body composition, eligibilityModule sex: FEMALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Department of Plastic Surgery, Odense University Hospital, status: RECRUITING, city: Odense, state: Region Of Southern Denmark, zip: 5000, country: Denmark, contacts name: Caroline Lilja, MD, role: CONTACT, phone: +4560555340, email: caroline.lilja@rsyd.dk, geoPoint lat: 55.39594, lon: 10.38831, documentSection largeDocumentModule largeDocs typeAbbrev: Prot_SAP, hasProtocol: True, hasSap: True, hasIcf: False, label: Study Protocol and Statistical Analysis Plan, date: 2024-02-07, uploadDate: 2024-03-04T05:57, filename: Prot_SAP_000.pdf, size: 934504, hasResults: False
|
protocolSection identificationModule nctId: NCT06302348, orgStudyIdInfo id: PTC923-PKU-401, briefTitle: A Study of Sepiapterin in Participants With Phenylketonuria (PKU), acronym: EPIPHENY, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-02-29, primaryCompletionDateStruct date: 2031-02-28, completionDateStruct date: 2031-02-28, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-08, sponsorCollaboratorsModule leadSponsor name: PTC Therapeutics, class: INDUSTRY, descriptionModule briefSummary: The main purpose of this trial is to evaluate the long-term efficacy of sepiapterin on preserving neurocognitive functioning in children with PKU when treatment is initiated in early childhood., conditionsModule conditions: Phenylketonuria, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 56, type: ESTIMATED, armsInterventionsModule interventions name: Sepiapterin, outcomesModule primaryOutcomes measure: Mean Change From Baseline in Full-scale Intelligence Quotient (FSIQ) Weschler Preschool and Primary Scale of Intelligence - Fourth Edition (WPPSI-IV) Score, primaryOutcomes measure: Mean Change From Baseline in FSIQ Weschler Intelligence Scale for Children - Fifth Edition (WISC-V) Score, secondaryOutcomes measure: Change From Baseline in Phenylketonuria-Quality of Life (PKU-QOL) Questionnaire Score, secondaryOutcomes measure: Change From Baseline in the European Quality of Life - 5 Dimensions (EQ-5D) Score, secondaryOutcomes measure: Mean Change From Baseline in FSIQ (WPPSI-IV) Score, secondaryOutcomes measure: Mean Change From Baseline in FSIQ (WISC-V) Score, secondaryOutcomes measure: Change From Baseline in Mean Blood Phe Levels, eligibilityModule sex: ALL, maximumAge: 12 Years, stdAges: CHILD, contactsLocationsModule locations facility: Indiana University, city: Indianapolis, state: Indiana, zip: 46202, country: United States, contacts name: Susan Romie, role: CONTACT, contacts name: Melissa Lah, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.76838, lon: -86.15804, hasResults: False
|
protocolSection identificationModule nctId: NCT06302335, orgStudyIdInfo id: 2022-0442, briefTitle: Povidone-iodine vs Saline Solution in Colorectal Surgeries and Its Effects on the Surgical Site Infection, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-01-02, primaryCompletionDateStruct date: 2027-12-31, completionDateStruct date: 2027-12-31, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-08, sponsorCollaboratorsModule leadSponsor name: Hospital de Clinicas de Porto Alegre, class: OTHER, descriptionModule briefSummary: Considering the relatively high incidence of surgical site infection (SSI) in colorectal surgery, this trial will compare rates of SSI in patients undergoing colorectal resections followed by surgical wound irrigation with povidone-iodine versus the group of patients undergoing surgical wound irrigation with saline solution. The trial will be conducted in a large university hospital in Southern Brazil., conditionsModule conditions: Surgical Site Infection, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: This a randomized clinical trial involving patients undergoing colorectal surgeries who will submitted to the application of povidone-iodine versus saline solution in their surgical sites., primaryPurpose: PREVENTION, maskingInfo masking: SINGLE, maskingDescription: Participants will not know what kind of substance will be used during the surgery., whoMasked: PARTICIPANT, enrollmentInfo count: 228, type: ESTIMATED, armsInterventionsModule interventions name: Povidone-iodine, interventions name: Saline solution, outcomesModule primaryOutcomes measure: Surgical site infection, secondaryOutcomes measure: Intracavitary surgical infection, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Hospital de Clinicas de Porto Alegre, status: RECRUITING, city: Porto Alegre, state: RS, zip: 90.035-903, country: Brazil, contacts name: Daniel C Damin, role: CONTACT, phone: +5551996020442, email: damin@terra.com.br, geoPoint lat: -30.03306, lon: -51.23, hasResults: False
|
protocolSection identificationModule nctId: NCT06302322, orgStudyIdInfo id: 158200-07-512-149, briefTitle: Long-term Follow up of Mucosal Tissue Height Influence on Peri-implant Bone Levels., statusModule overallStatus: COMPLETED, startDateStruct date: 2021-01-07, primaryCompletionDateStruct date: 2022-08-15, completionDateStruct date: 2022-10-01, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-08, sponsorCollaboratorsModule leadSponsor name: Harvard Medical School (HMS and HSDM), class: OTHER, descriptionModule briefSummary: Our study looks into how the thickness of the gum tissue affects the health of the bone around dental implants over ten years. We include 59 people and divide them into three groups based on their gum tissue thickness. Some have naturally thin gums, some have thin gums that were made thicker with a special procedure, and some already had thick gums. We try to find out if having thicker gums, whether naturally or through enhancement, can help keep the bone around dental implants healthy in the long run., conditionsModule conditions: Edentulous Alveolar Ridge, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SCREENING, maskingInfo masking: NONE, enrollmentInfo count: 59, type: ACTUAL, armsInterventionsModule interventions name: Thin Tissues, interventions name: Thick Tissues, interventions name: Surgically augmented thin tissues, outcomesModule primaryOutcomes measure: Crestal Bone Levels, secondaryOutcomes measure: PPD, secondaryOutcomes measure: BOP, secondaryOutcomes measure: PI, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: VIC Clinic, city: Vilnius, zip: 01362, country: Lithuania, geoPoint lat: 54.68916, lon: 25.2798, hasResults: False
|
protocolSection identificationModule nctId: NCT06302309, orgStudyIdInfo id: NL85217.091.23, briefTitle: Tackling Anxiety-related Freezing of Gait in People With Parkinson's Disease, acronym: TACKLING-FOG, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2025-09, completionDateStruct date: 2025-09, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-08, sponsorCollaboratorsModule leadSponsor name: Radboud University Medical Center, class: OTHER, descriptionModule briefSummary: The purpose of this study is to investigate whether personalized strategies that target anxiety and stress surrounding freezing of gait can alleviate freezing of gait in people with Parkinson's Disease., conditionsModule conditions: Freezing of Gait, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: TREATMENT, maskingInfo masking: NONE, maskingDescription: Randomization will be performed in CastorEDC, a web-based data management system for academic studies (www.castoredc.com). Breaking of the randomization code is not applicable, since researchers and trainers cannot be blinded., enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: Psychological intervention, outcomesModule primaryOutcomes measure: % time frozen during a personalized gait trajectory, secondaryOutcomes measure: subjective impact of anxiety and stress on FOG, as measured with a Visual Analogue Scale, secondaryOutcomes measure: Heart Rate Variability, secondaryOutcomes measure: The Parkinson Anxiety Scale (PAS), secondaryOutcomes measure: Gait-Specific Attention Profile, secondaryOutcomes measure: he Updated Perceived Control over Falling Scale (UP-COF), secondaryOutcomes measure: New Freezing of Gait Questionnaire, secondaryOutcomes measure: The Parkinson's Disease Questionnaire, secondaryOutcomes measure: The Rosenberg self-esteem score, secondaryOutcomes measure: Perceived Stress Scale, otherOutcomes measure: Montreal Cognitive Assessment, otherOutcomes measure: Unified Parkinson's Disease Rating Scale Part III, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
|
protocolSection identificationModule nctId: NCT06302296, orgStudyIdInfo id: Hama University/, briefTitle: Evaluating the Effect of Injectable Platelet-rich Fibrin on Accelerating Orthodontic Tooth Movement, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-20, primaryCompletionDateStruct date: 2024-05-15, completionDateStruct date: 2025-07-15, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-08, sponsorCollaboratorsModule leadSponsor name: Hama University, class: OTHER, descriptionModule briefSummary: One of the main goals of orthodontic treatment is the reduction of treatment time through faster tooth movement. The previous studies evaluating platelet-rich fibrin (PRF) and orthodontic tooth movement (OTM) are limited, which makes the results difficult to generalize., conditionsModule conditions: Tooth Mobility, conditions: Injectable Platelet-rich Fibrin, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 14, type: ESTIMATED, armsInterventionsModule interventions name: injectable form of PRF, interventions name: Placebo injection, outcomesModule primaryOutcomes measure: Leveling and alignment maxillary incisors, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 26 Years, stdAges: ADULT, contactsLocationsModule locations facility: Fadi Jnaid, status: RECRUITING, city: Hama, country: Syrian Arab Republic, contacts name: Fadi Jnaid, Associate Professor, role: CONTACT, email: Drfadijnaid@gmail.com, contacts name: PhD, role: CONTACT, phone: 0988499015, geoPoint lat: 35.13179, lon: 36.75783, hasResults: False
|
protocolSection identificationModule nctId: NCT06302283, orgStudyIdInfo id: 114/23-EP, briefTitle: Collateral Effects of Pandemics - Care for Informal Caregivers, acronym: COLLPAN-3A, statusModule overallStatus: ENROLLING_BY_INVITATION, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2024-12, completionDateStruct date: 2024-12, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-08, sponsorCollaboratorsModule leadSponsor name: University of Bonn, class: OTHER, collaborators name: Wuerzburg University Hospital, collaborators name: Johannes Gutenberg University Mainz, collaborators name: Universitätsklinikum Hamburg-Eppendorf, descriptionModule briefSummary: The study is a workpackage in the German research consortium COLLPAN. The study will map collateral effects in terms of psychosocial and spiritual burden of informal caregivers during after the pandemic and identification/mapping of risk factors.It will also map available therapeutic and preventive interventions and relief of this burden for the present situation and for future pandemics., conditionsModule conditions: Bereavement, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: RETROSPECTIVE, enrollmentInfo count: 400, type: ESTIMATED, armsInterventionsModule interventions name: Survey, outcomesModule primaryOutcomes measure: Bereavement burden, primaryOutcomes measure: Anxiety, primaryOutcomes measure: Depression, primaryOutcomes measure: Caregiving burden, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University Hospital Bonn, city: Bonn, zip: 53127, country: Germany, geoPoint lat: 50.73438, lon: 7.09549, hasResults: False
|
protocolSection identificationModule nctId: NCT06302270, orgStudyIdInfo id: K2024-0507, briefTitle: CFTR Modulators in Pregnancy and Postpartum, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-15, primaryCompletionDateStruct date: 2034-01-31, completionDateStruct date: 2039-01-31, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-08, sponsorCollaboratorsModule leadSponsor name: Region Stockholm, class: OTHER_GOV, collaborators name: Karolinska Institutet, descriptionModule briefSummary: Observational study on women with Cystic Fibrosis treated with CFTR modulators during pregnancy and postpartum and their children. Registration on maternal health parameters and effects of CFTR-modulators in the newborn infant as well as effects of exposure through mother's own milk., conditionsModule conditions: Cystic Fibrosis, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 75, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Health effects in the newborn infant, eligibilityModule sex: ALL, maximumAge: 50 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: Stockholm CF center, status: RECRUITING, city: Stockholm, country: Sweden, contacts name: Terezia Pinzikova, MD, PhD, role: CONTACT, phone: +46 8 123 80000, email: jenny.svedenkrans@regionstockholm.se, geoPoint lat: 59.33258, lon: 18.0649, hasResults: False
|
protocolSection identificationModule nctId: NCT06302257, orgStudyIdInfo id: 0532-23-HMO, briefTitle: Randomized Controlled Trial of Combined Lidocaine - Chlorprocaine in Labor Epidural Analgesia., statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2025-03-01, completionDateStruct date: 2025-03-01, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: Hadassah Medical Organization, class: OTHER, descriptionModule briefSummary: Abstract: Background: The current "gold standard" epidural analgesia involves some undesirable side effects such as motor and sympathetic blockade. Here, the investigators suggest a new approach for inducing prolonged differential pain blockade during labor by selectively targeting local anesthetic chloroprocaine to the pain-related peripheral (nociceptive) fibers. The investigators approach involves nociceptor-selective anesthesia by selective targeting of ionized local anesthetics into nociceptive fibers via activation of nociceptor-specific TRPV1 channels. The authors demonstrated that activation of these channels by specific TRPV1-agonists (capsaicin or the local anesthetic lidocaine), allows entry of a polarized, membrane-impermeable lidocaine derivative (QX-314) specifically into nociceptive neurons, inhibiting their activity and pain blockade, without causing other neural effects. Capsaicin and QX-314 are not suitable for clinical use, as capsaicin causes severe injection pain and QX-314 is neurotoxic. Here, the investigators use lidocaine as the TRPV1 agonist, and use the high pKa chloroprocaine as the ionized local anesthetic instead of the toxic QX-314. Both drugs are in routine clinical use, but have not been described in co-administration before. The investigators preclinical results show that co-administration of chloroprocaine with TRPV1 agonists, leads to prolonged nociceptor-specific analgesia. KKK Hypothesis: The investigators hypothesize that co-administration of epidural lidocaine (to activate TRPV1 channels) and chloroprocaine (as a polarized local anesthetic which can gain preferential access to nociceptors via opened TRPV1 pores) will elicit selective nociceptive-anesthesia. Methodology: This study assess epidural local analgesia in nulliparous labor. There are 2 stages: Stage 1: Prior to direct comparison of lidocaine (Group L), chloroprocaine (Group C), and a lidocaine-chloroprocaine combination (Group L-C), the investigators first determine equipotential doses of epidural chloroprocaine and lidocaine using double-blinded up-down sequential analysis using the well-established minimum local anesthetic concentration (MLAC or ED50) design. ED50 is estimated using Dixon-Massey analysis and Wilcoxon and Litchfield probit regression. Stage 2: The main phase of the study involves a randomized double-blinded comparison between Groups L, C and L-C where all drug concentrations are based on the ED50/MLAC from the Stage 1. The primary endpoint is a composite measure of selective nociceptive analgesia (VAS pain score / modified Bromage motor score). Secondary outcomes are: 1. pain (VAS 0-100), 2. modified Bromage motor score, 3. thermal imaging of feet and hands, 4. sensory assessment to cold sensation using ice, 5. anesthesia requirement from the PCEA pump, 6. maternal blood pressure. 7. ambulation, and pushing ability in labor. Primary endpoint is assessed using repeated measures ANOVA (first 30-min) and mixed models ANOVA until first analgesic request. Implications: Positive findings will be the first evidence in humans of nociceptor-specific local anesthesia; will provide a more effective neuraxial analgesia protocol for labor, and will lead to future studies of systemic nociceptor-specific local anesthesia., conditionsModule conditions: Labor Pain, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: RANDOMIZED, interventionModel: SINGLE_GROUP, primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Chlorprocaine, interventions name: Lidocaine, interventions name: Lidocaine-chlorprocaine combination, outcomesModule primaryOutcomes measure: VAS pain score / modified Bromage motor block score, secondaryOutcomes measure: Segmental sympathectomy, secondaryOutcomes measure: Sensory assessment to cold sensation, secondaryOutcomes measure: Anesthesia requirement., secondaryOutcomes measure: Pushing ability in labor., secondaryOutcomes measure: Maternal Blood pressure, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 40 Years, stdAges: ADULT, contactsLocationsModule locations facility: Hadassah Hebrew University Medical Center, POB 12000, city: Jerusalem, zip: 91120, country: Israel, geoPoint lat: 31.76904, lon: 35.21633, hasResults: False
|
protocolSection identificationModule nctId: NCT06302244, orgStudyIdInfo id: R-21075263, briefTitle: Multimodal Neuromonitoring in Acute Brain Injury, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2017-03-27, primaryCompletionDateStruct date: 2023-06-01, completionDateStruct date: 2024-11-01, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: Rigshospitalet, Denmark, class: OTHER, descriptionModule briefSummary: Acute brain injury due to aneurysmal subarachnoid haemorrhage (SAH) or traumatic brain injury (TBI) is a condition with a high mortality, and surviving patients often have permanent disabilities. Multimodal neuromonitoring of intracranial pressure, brain tissue oxygen tension (PbtO2), and brain energy metabolism (measured with microdialysis (MD)) may help individualise the treatment of this patient group to protect the brain and potentially improve outcomes. However, there is still a significant lack of knowledge regarding the advantages and disadvantages of this type of monitoring.The present study consists of four substudies with the overall aim of examining which factors are most influential for regulating commonly measured intracerebral parameters such as oxygenation, glucose, and lactate. Additionally, the influence of these of parameters on functional outcome and mortality will be explored.The individual studies are detailed below:, conditionsModule conditions: Acute Brain Injury, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 200, type: ACTUAL, outcomesModule primaryOutcomes measure: Correlation between systemic glucose and microdialysis glucose, primaryOutcomes measure: Median goodness of fit (Pearsons R2) of the relationship between PaO2 (kPa) and PbtO2 (mmHg)., primaryOutcomes measure: Correlation between systemic lactate and microdialysis lactate when corrected for PbtO2 and cerebral perfusion pressure., primaryOutcomes measure: The predictive value of glutamate measured by intracerebral microdialysis for episodes of neuroworsening, primaryOutcomes measure: The predictive value of glutamate measured by intracerebral microdialysis for 6-month functional outcome, secondaryOutcomes measure: Length of hospital stay, secondaryOutcomes measure: Mixed effects linear regression of the relationship betwen PaO2 (kPa) and PbtO2 (mmHg)., secondaryOutcomes measure: Functional outcome at six months, secondaryOutcomes measure: Mortality at six months, secondaryOutcomes measure: Length of stay in the ICU, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Rigshospitalet, city: Copenhagen, zip: 2100, country: Denmark, geoPoint lat: 55.67594, lon: 12.56553, hasResults: False
|
protocolSection identificationModule nctId: NCT06302231, orgStudyIdInfo id: 16690919.5.0000.5347, briefTitle: Effects of Time-restricted Eating and Aerobic Exercise Training in Women With Overweight and Obesity, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2024-12, completionDateStruct date: 2024-12, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-08, sponsorCollaboratorsModule leadSponsor name: Federal University of Rio Grande do Sul, class: OTHER, descriptionModule briefSummary: Time-restricted eating (TRE) is a dietary approach that aims to increase fasting time and decrease the eating window. Promising TRE effects on weight loss and improvements in some cardiometabolic risk factors have been reported in studies in animals and humans. However, the impacts of TRE combined with aerobic exercise training in individuals with overweight and obesity have been insufficiently investigated.Additionally, aerobic training performed in a fasted state appears to promote physiological adaptations that may improve the metabolic health in individuals with overweight and obesity.The present study investigates the effects of 8 weeks of TRE associated with aerobic training in a fasted state versus a fed state on body composition and cardiometabolic parameters in women with overweight and grade 1 obesity., conditionsModule conditions: Time Restricted Eating, conditions: Obesity, conditions: Intermittent Fasting, conditions: Overweight and Obesity, conditions: Time Restricted Feeding, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Dietary and Exercise Approaches, interventions name: Dietary and Exercise Approaches, interventions name: Dietary Approach, outcomesModule primaryOutcomes measure: Insulin sensitivity (indices), secondaryOutcomes measure: Insulin resistance (indices), secondaryOutcomes measure: Fasting insulin levels (µIU/mL), secondaryOutcomes measure: Fasting glucose levels (mg/dL), secondaryOutcomes measure: Glucose tolerance, secondaryOutcomes measure: Fasting lipid profile levels, secondaryOutcomes measure: β cell function (indices), secondaryOutcomes measure: Fat Mass (kg), secondaryOutcomes measure: Fat Percentage (%), secondaryOutcomes measure: Fat Free Mass (kg), secondaryOutcomes measure: Body Weight (kg), secondaryOutcomes measure: Body Weight (kg), secondaryOutcomes measure: Bone Mineral Content (kg), secondaryOutcomes measure: Body Mass Index (kg/m^2), secondaryOutcomes measure: Fasting ketones (β-hydroxybutyrate) levels (mmol/L), secondaryOutcomes measure: Resting metabolic rate (Kcal/day), secondaryOutcomes measure: Substrate Oxidation (respiratory exchange ratio), secondaryOutcomes measure: Absolute Peak oxygen consumption, secondaryOutcomes measure: Relative Peak oxygen consumption, secondaryOutcomes measure: Fasting Leptin Levels, secondaryOutcomes measure: Fasting Adiponectin Levels, secondaryOutcomes measure: Inflammatory Markers Levels, secondaryOutcomes measure: LDL-cholesterol levels, secondaryOutcomes measure: Non-HDL-cholesterol levels, eligibilityModule sex: FEMALE, minimumAge: 20 Years, maximumAge: 40 Years, stdAges: ADULT, hasResults: False
|
protocolSection identificationModule nctId: NCT06302218, orgStudyIdInfo id: 5/2024, briefTitle: ESPB vs iPACK+ACB in Total Knee Arthroplasty, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2024-09-30, completionDateStruct date: 2025-10-30, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-08, sponsorCollaboratorsModule leadSponsor name: Poznan University of Medical Sciences, class: OTHER, descriptionModule briefSummary: Effect of iPACK block with Adductor Canal Block and ESPB on pain management, and NLR and PLR following knee arthroplasty, conditionsModule conditions: Knee Arthritis, conditions: Knee Arthropathy, conditions: Knee Osteoarthritis, conditions: Knee Pain Chronic, conditions: Knee Disease, conditions: Knee Rheumatism, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Ropivacaine 0.2% Injectable Solution, interventions name: Ropivacaine 0.2% Injectable Solution, interventions name: control group, outcomesModule primaryOutcomes measure: Opioid consumption, secondaryOutcomes measure: Time to first rescue opiate analgesia, secondaryOutcomes measure: Numerical Rating Scale [range 0:10], secondaryOutcomes measure: Numerical Rating Scale [range 0:10], secondaryOutcomes measure: Numerical Rating Scale [range 0:10], secondaryOutcomes measure: Numerical Rating Scale [range 0:10], secondaryOutcomes measure: Numerical Rating Scale [range 0:10], secondaryOutcomes measure: Numerical Rating Scale [range 0:10], secondaryOutcomes measure: Numerical Rating Scale [range 0:10], secondaryOutcomes measure: Numerical Rating Scale [range 0:10], secondaryOutcomes measure: Neutrophil-to-lymphocyte ratio, secondaryOutcomes measure: Neutrophil-to-lymphocyte ratio, secondaryOutcomes measure: Platelet-to-lymphocyte ratio, secondaryOutcomes measure: Platelet-to-lymphocyte ratio, secondaryOutcomes measure: Quadriceps muscle strength assessed using medical research council scale [range 0:5], eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 100 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Poznan University of Medical Sciences, city: Poznan, state: Poznań, zip: 61-701, country: Poland, geoPoint lat: 52.40692, lon: 16.92993, hasResults: False
|
protocolSection identificationModule nctId: NCT06302205, orgStudyIdInfo id: S66232, briefTitle: A Home-based Exercise and Physical Activity Intervention After Liver Transplantation: Impact of Exercise Intensity, acronym: PHOENIX-L, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-03-01, primaryCompletionDateStruct date: 2026-01, completionDateStruct date: 2026-12, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-04-01, sponsorCollaboratorsModule leadSponsor name: Universitaire Ziekenhuizen KU Leuven, class: OTHER, collaborators name: KU Leuven, descriptionModule briefSummary: Research demonstrated that transplant recipients benefit from physical activity, but there is a gap in knowledge regarding the required intensity. In the PHOENIX-Liver study, researchers aim to investigate the adequate intensity of rehabilitation programs after liver transplantation. Patients will be randomized into one of the three PHOENIX-Liver training groups (low, moderate, moderate to high). The six months rehabilitation program is conducted from the patient's home but supervised by a PHOENIX-investigator.At baseline, after three months of rehabilitation and after six months of rehabilitation, a test moment takes place at which physical fitness, cardiovascular health, liver function, and body composition will be assessed. Questionnaires are taken monthly to survey well-being, safety, quality of life, physical activity, and cost-effectiveness.To gather information on the potential for implementation in a real-world setting, a 15-month-long physical activity phase will start after the intervention phase. This entails a maintenance physical activity program tailored to the patients' preferences. A follow-up at UZ Leuven is planned at three and at 15 months where the same clinical evaluations will be conducted as during the test moments of the intervention phase., conditionsModule conditions: Liver Transplantation, conditions: Physical Fitness, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Two interventional groups and one control group, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: The nature of the intervention does not allow blinding of study participants. However, outcome assessors and data investigators will be blinded to the participants' group allocation., whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 147, type: ESTIMATED, armsInterventionsModule interventions name: Physical activity, interventions name: Sham intervention, outcomesModule primaryOutcomes measure: Cardiorespiratory fitness, secondaryOutcomes measure: Functional exercise capacitiy, secondaryOutcomes measure: Hand grip strength, secondaryOutcomes measure: Knee-extensor strength, secondaryOutcomes measure: Endothelial function, secondaryOutcomes measure: Arterial stiffness, secondaryOutcomes measure: Graft function, secondaryOutcomes measure: Occurence of adverse events, secondaryOutcomes measure: Motor fitness, secondaryOutcomes measure: Blood pressure, secondaryOutcomes measure: Blood profile, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: UZ Leuven, status: RECRUITING, city: Leuven, state: Vlaams-Brabant, zip: 3000, country: Belgium, contacts name: Hanne Van Criekinge, role: CONTACT, phone: +3216343162, email: hanne.vancriekinge@kuleuven.be, contacts name: Diethard Monbaliu, MD PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 50.87959, lon: 4.70093, hasResults: False
|
protocolSection identificationModule nctId: NCT06302192, orgStudyIdInfo id: 4302, briefTitle: Renal Doppler to Predict Acute Kidney Injury (AKI) in ARDS Patients. (RED-AKI Study), acronym: RED-AKI, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2026-01-31, completionDateStruct date: 2026-06-30, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-08, sponsorCollaboratorsModule leadSponsor name: Policlinico Hospital, class: OTHER, descriptionModule briefSummary: This is a multicenter international observational prospective cohort study. The main questions it aims to answer are:* PRIMARY AIM: To describe the capability of IRVF demodulation at diagnosis of ARDS to predict development of AKI within 7 days from the ARDS onset* SECONDARY AIMS: A)Describe the capability of IRVF demodulation or pattern of IRVF (continuous, pulsatility, biphasic, monophasic) to predict development of AKI within 14 days from the ARDS onset. B) To describe the RD parameters and VexUS in the AKI and no AKI patients over time. C) Describe the impact of invasive mechanical ventilation (IMV) on the intrarenal venous congestion and VexUS., D) Evaluation of effect of CRRT on IRVF pattern, VexUS and parameters. E) Describe the feasibility of renal doppler to assess IRVF in critically ill respiratory patients. F) Evaluate the incidence of AKD and CKD Participants will Adult patients with diagnosis of ARDS admitted to intensive care unit and undergoing invasive mechanical ventilation, conditionsModule conditions: Acute Kidney Injury, conditions: ARDS, Human, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 164, type: ESTIMATED, armsInterventionsModule interventions name: ARDS+AKI, outcomesModule primaryOutcomes measure: cumulative incidence, secondaryOutcomes measure: AKI14, secondaryOutcomes measure: AKIstage, secondaryOutcomes measure: cross talk lung-kidney, secondaryOutcomes measure: CRRT, secondaryOutcomes measure: incidence of failed exam, secondaryOutcomes measure: CKD progression, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False
|
protocolSection identificationModule nctId: NCT06302179, orgStudyIdInfo id: 140-14/24, briefTitle: Risk Factors of Venous Thromboembolism After Colorectal Cancer Surgery, statusModule overallStatus: COMPLETED, startDateStruct date: 2015-01, primaryCompletionDateStruct date: 2017-12, completionDateStruct date: 2023-05, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-08, sponsorCollaboratorsModule leadSponsor name: Pirogov Russian National Research Medical University, class: OTHER, descriptionModule briefSummary: Aim of our study is to find frequency and identify risk factors for venous thromboembolism development in patients who underwent surgery for colorectal cancer. There were 137 patients enrolled in our retrospective observational cohort study. Included patients were operated for incisional hernia in Saveljev University Surgery Clinic from January 2016 to December 2017. Compression duplex ultrasound of lower legs veins was performed in 2-14 days after surgery for all participants. The primary endpoint was the occurrence of the venous thromboembolism event, including pulmonary embolism., conditionsModule conditions: Colorectal Cancer, conditions: Venous Thromboembolism, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 137, type: ACTUAL, outcomesModule primaryOutcomes measure: Venous Thromboembolism, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Pirogov Russian National Research Medical University, city: Moscow, zip: 117997, country: Russian Federation, geoPoint lat: 55.75222, lon: 37.61556, hasResults: False
|
protocolSection identificationModule nctId: NCT06302166, orgStudyIdInfo id: HafsaJaved, briefTitle: Effects of HICT and Intermittent Fasting on PCOS, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-15, primaryCompletionDateStruct date: 2024-07-01, completionDateStruct date: 2024-07-01, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-08, sponsorCollaboratorsModule leadSponsor name: Riphah International University, class: OTHER, descriptionModule briefSummary: The goal of this randomized controlled trial is to compare the effects of High intensity circuit training, Intermittent Fasting, and their combination on PCOS morphology, Anthropometrics, clinical hyperandrogenism and body image concerns in females with PCOS.Participants will be divided into three groups who will receive High intensity circuit training, Intermittent fasting and their combination. The outcomes will be PCOS morphology, anthropometrics', clinical hyperandrogenism and body image concerns., conditionsModule conditions: Polycystic Ovary Syndrome, conditions: PCO, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 33, type: ESTIMATED, armsInterventionsModule interventions name: High Intensity Circuit training (HICT), interventions name: Intermittent Fasting (IF), interventions name: Combination of HICT and IF, outcomesModule primaryOutcomes measure: PCOS Morphology, secondaryOutcomes measure: Anthropometrics, secondaryOutcomes measure: Clinical Hyperandrogenism, secondaryOutcomes measure: Body Image concerns, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 35 Years, stdAges: ADULT, contactsLocationsModule locations facility: AlMuratza Hospital, city: Rawalpindi, state: Punjab, zip: 44000, country: Pakistan, contacts name: Sarah Ehsan, PP-DPT, role: CONTACT, phone: 03217770829, email: sarah.ehsaan@riphah.edu.pk, contacts name: Hafsa Javed, DPT, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 33.6007, lon: 73.0679, hasResults: False
|
protocolSection identificationModule nctId: NCT06302153, orgStudyIdInfo id: amnashahid, briefTitle: Progressive Loading Exercises and Conditioning Exercises on Calf Strain, acronym: runners, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-06-01, primaryCompletionDateStruct date: 2024-02-10, completionDateStruct date: 2024-02-10, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-08, sponsorCollaboratorsModule leadSponsor name: Riphah International University, class: OTHER, descriptionModule briefSummary: Calf pain is a common complaint among runners of all ages but is most frequent in masters athletes. The most common calf injury is a tear of the medial gastrocnemius muscle (Tennis Leg) but other structures including the lateral gastrocnemius, plantaris and soleus also may be the cause of muscular pain.There are multiple techniques for the management that involves loading the strained calf musculature through rest, taping techniques, and appropriate soft tissue massage techniques, modalities such as dry needling or western acupuncture can be popular amongst runners and may also be useful. Progressive loading is a principle of resistance training exercise program design that typically relies on increasing load to increase neuromuscular demand to facilitate further adaptations whereas Athletic performance is based on a number of skills that can be developed through a sports conditioning program. This particular program focuses on improving both muscular strength and power using a technique called post-activation potentiation (PAP), also commonly referred to as complex training., conditionsModule conditions: Range of Motion, Pain, Sports Injuries, Stretching, Triceps Surae, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 40, type: ACTUAL, armsInterventionsModule interventions name: Progressive Loading Exercises, outcomesModule primaryOutcomes measure: pain, range of motion, functions, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Jawad club, Alfatah sports complex, city: Faisalābad, state: Punjab, zip: 38000, country: Pakistan, geoPoint lat: 31.41554, lon: 73.08969, locations facility: Riphah International University, Raiwind Campus, city: Faisalābad, state: Punjab, zip: 5400, country: Pakistan, geoPoint lat: 31.41554, lon: 73.08969, hasResults: False
|
protocolSection identificationModule nctId: NCT06302140, orgStudyIdInfo id: VT3996-102, briefTitle: A Mass Balance Study of [14C]-Nanatinostat and Relative Bioavailability Study of Nanatinostat in Patients With Advanced Cancers, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-28, primaryCompletionDateStruct date: 2025-02, completionDateStruct date: 2025-10, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-29, sponsorCollaboratorsModule leadSponsor name: Viracta Therapeutics, Inc., class: INDUSTRY, descriptionModule briefSummary: This study will determine how nanatinostat is absorbed, modified, and removed from the body (Part A), the amount of nanatinostat that becomes available to the body (Part B), and will evaluate the safety and tolerability of nanatinostat (Part C) in patients with advanced cancers., conditionsModule conditions: Advanced Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, interventionModelDescription: This clinical trial is divided into 3 parts (Part A, Part B, and Part C).Patients may begin their study participation in Part A or Part B. Part B (for patients who participate in Part A) and Part C (for patients who participate in Part A and/or Part B) are optional for patients who meet certain conditions for crossover.In Part A, patients will be given a single dose of radiolabeled nanatinostat by mouth on Day 1. Patients may stay in the hospital up to 8 days.In Part B, patients will receive both nanatinostat in a salt form and a non-salt form, coadministered with valganciclovir in different order across 2 treatment days. Patients will be randomly assigned to either receive the salt or the non-salt form of nanatinostat first. Patients may stay in the hospital up to 4 days.Part C will allow patients to continue receiving nanatinostat treatment as long as they are deriving clinical benefit. This part will not require a hospital stay., primaryPurpose: BASIC_SCIENCE, maskingInfo masking: NONE, enrollmentInfo count: 14, type: ESTIMATED, armsInterventionsModule interventions name: [14C]-Nanatinostat, interventions name: Nanatinostat (free base) tablets in combination with Valganciclovir, interventions name: Nanatinostat mesylate tablets in combination with Valganciclovir, interventions name: Single-agent Nanatinostat (free base) tablets, outcomesModule primaryOutcomes measure: The amount of radioactivity in excreta [Part A], primaryOutcomes measure: Pharmacokinetic Parameter: area under the plasma concentration versus time curve (AUC) [Part B], primaryOutcomes measure: Pharmacokinetic Parameter: maximum plasma concentration (Cmax) [Part B], primaryOutcomes measure: Pharmacokinetic Parameter: time to maximum observed plasma concentration (Tmax) [Part B], primaryOutcomes measure: Pharmacokinetic Parameter: Fraction of the administered dose in comparison with a standard (Frel) [Part B], primaryOutcomes measure: Incidence of adverse events and serious adverse events [Part C], secondaryOutcomes measure: Incidence of adverse events and serious adverse events [Parts A and B], secondaryOutcomes measure: Incidence of clinically significant changes in selected safety assessments [Parts A and B], secondaryOutcomes measure: Pharmacokinetic Parameter: area under the plasma concentration versus time curve (AUC) [Part A], secondaryOutcomes measure: Pharmacokinetic Parameter: maximum plasma concentration (Cmax) [Part A], secondaryOutcomes measure: Pharmacokinetic Parameter: time to maximum observed plasma concentration (Tmax) [Part A], secondaryOutcomes measure: Pharmacokinetic Parameter: elimination half-life (t1/2) [Part A], secondaryOutcomes measure: Pharmacokinetic Parameter: apparent total clearance (CL/F) [Part A], secondaryOutcomes measure: Pharmacokinetic Parameter: apparent volume of distribution during terminal phase (Vz/F) [Part A], secondaryOutcomes measure: Pharmacokinetic Parameter: elimination rate constant from the central compartment (Kel) [Part A], secondaryOutcomes measure: The ratio of total radioactivity in blood relative to plasma [Part A], secondaryOutcomes measure: [14C]-metabolic profile and identification of metabolites in plasma [Part A], secondaryOutcomes measure: Major radioactive peak/metabolites in urine and fecal radiochromatograms as a percentage of the radioactive dose [Part A], secondaryOutcomes measure: Pharmacokinetic Parameter: elimination half-life (t1/2) [Part B], secondaryOutcomes measure: Pharmacokinetic Parameter: metabolite-to-parent ratio [Part B], secondaryOutcomes measure: Objective Response Rate (ORR) [Part C], secondaryOutcomes measure: Time to Response (TTR) [Part C], secondaryOutcomes measure: Duration of Response (DOR) [Part C], secondaryOutcomes measure: Disease Control Rate (DCR) [Part C], eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: START Madrid - CIOCC - Hospital Universitario HM Sanchinarro, status: RECRUITING, city: Madrid, zip: 28050, country: Spain, contacts role: CONTACT, email: ClinicalTrials@Viracta.com, geoPoint lat: 40.4165, lon: -3.70256, hasResults: False
|
protocolSection identificationModule nctId: NCT06302127, orgStudyIdInfo id: CCHDS, briefTitle: County Medical Community-based, Cardiovascular Risk Stratified Integrated Care Model: a Pragmatic Cluster Randomised Control Trial, acronym: RISIMA, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-20, primaryCompletionDateStruct date: 2025-04-20, completionDateStruct date: 2025-05-20, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-08, sponsorCollaboratorsModule leadSponsor name: Peking University, class: OTHER, descriptionModule briefSummary: The goal of this cluster randomized trial is to evaluate the effectiveness of the RISIMA model based on an integrated county healthcare consortium implemented by multi-level family health teams (FHTs)on patients with diabetes and/or hypertension, including CVD risk assessment, treatment, and management., conditionsModule conditions: Hypertension, conditions: Diabetes Mellitus Type 2, conditions: Cardiovascular Diseases, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: SINGLE, maskingDescription: The follow-up data collection, data entry, and data quality checks will be conducted by researchers unaware of the group assignments. The analysis of results will also be performed by statisticians unaware of the allocation., whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 2560, type: ESTIMATED, armsInterventionsModule interventions name: Team-based care, interventions name: Risk-stratified care pathway, interventions name: Strengthened health education, interventions name: Financial incentives for integration of care, interventions name: Supporting health information system, outcomesModule primaryOutcomes measure: CVD 10-year risk, secondaryOutcomes measure: CVD incidence rate, secondaryOutcomes measure: systolic blood pressure, secondaryOutcomes measure: total cholesterol, eligibilityModule sex: ALL, minimumAge: 40 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
|
protocolSection identificationModule nctId: NCT06302114, orgStudyIdInfo id: Tubitak, briefTitle: Upper Extremity Asymmetries in Overhead Athletes, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-12-01, primaryCompletionDateStruct date: 2024-03-27, completionDateStruct date: 2024-03-30, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-26, sponsorCollaboratorsModule leadSponsor name: Pamukkale University, class: OTHER, collaborators name: Tübitak, descriptionModule briefSummary: Although overhead sports have different characteristics, the movements in the shoulder and upper extremity are similar. These sports may involve a combination of symmetrical, asymmetrical, bilateral and unilateral movements. In sports involving asymmetric movements, biomechanical changes are observed in that area due to the use of the dominant extremity. One of the reliable methods to reveal the stress effects caused by biomechanical stresses is to determine limb asymmetries. Considering the literature, limb asymmetries may be related to injury and performance., conditionsModule conditions: Extremity Asymmetries, conditions: Injury;Sports, conditions: Performance, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 58, type: ESTIMATED, armsInterventionsModule interventions name: Assessment of overhead athletes, outcomesModule primaryOutcomes measure: Medicine ball forward throw, primaryOutcomes measure: Y balanced test, primaryOutcomes measure: Range of motion of internal and external rotation, primaryOutcomes measure: Strength of Internal and External Rotator Muscles, eligibilityModule sex: ALL, minimumAge: 15 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Pamukkale University, status: RECRUITING, city: Pamukkale, state: Denizli, zip: 20000, country: Turkey, contacts name: Fatma Ünver, role: CONTACT, email: funver@pau.edu.tr, contacts name: Erhan Kızmaz, role: CONTACT, phone: +905418966676, email: erhankizmaz@hotmail.com, geoPoint lat: 37.91644, lon: 29.11729, hasResults: False
|
protocolSection identificationModule nctId: NCT06302101, orgStudyIdInfo id: Exercise in older adults, briefTitle: Telerehabilitation Exercise in Older Adults, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-21, primaryCompletionDateStruct date: 2024-04-18, completionDateStruct date: 2024-04-30, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-08, sponsorCollaboratorsModule leadSponsor name: Pamukkale University, class: OTHER, descriptionModule briefSummary: The aim of this study was to investigate the effectiveness of chair-based exercises and cognitive exercises through synchronous telerehabilitation in older adults.Older adults will be divided into two groups (intervention group n=16; control group n=16) ., conditionsModule conditions: Pain, conditions: Elderly, conditions: Balance, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 32, type: ESTIMATED, armsInterventionsModule interventions name: chair-based exercises, interventions name: cognitive exercises, outcomesModule primaryOutcomes measure: Berg Balance Scale, primaryOutcomes measure: Timed Up and Go Test During Dual Tasking, primaryOutcomes measure: Geriatric Pain Measure, primaryOutcomes measure: Older people's quality of life-brief (OPQOL-brief), secondaryOutcomes measure: Hodkinson Mental Test, secondaryOutcomes measure: Dominant Side One Leg Stand Test, secondaryOutcomes measure: Timed Up and Go Test, secondaryOutcomes measure: chair sit and stand test, secondaryOutcomes measure: Geriatric Depression Scale, secondaryOutcomes measure: Successful Aging Scale, eligibilityModule sex: ALL, minimumAge: 65 Years, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Elif Gur Kabul, status: RECRUITING, city: Usak, state: Center, zip: 64200, country: Turkey, contacts name: Elif Gur Kabul, role: CONTACT, geoPoint lat: 38.67351, lon: 29.4058, hasResults: False
|
protocolSection identificationModule nctId: NCT06302088, orgStudyIdInfo id: STUDY00026205, briefTitle: The Safety Integration Stakeholders (SAINTS) Program to Integrate Worker and Patient Safety in Oregon Rural Hospitals, acronym: SAINTS, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-10-01, primaryCompletionDateStruct date: 2027-10, completionDateStruct date: 2027-12, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-22, sponsorCollaboratorsModule leadSponsor name: Oregon Health and Science University, class: OTHER, descriptionModule briefSummary: The safety integration stakeholders (saints) program to integrate worker and patient safety in Oregon rural hospitals. The rationale is that the saints program will positively impact outcomes by identifying and training peer leaders on strategies to optimize environmental, administrative, and educational components to become a saint and regularly collaborate with safety stakeholders/administrative leaders at each site through continuous improvement cycles (e.g. plan-do-study-act)., conditionsModule conditions: Accidental Falls, conditions: Injuries, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: All participating clinics will take part in baseline surveys of unit staff (n=240-360) and safety stakeholders will be identified. Following surveys, hospitals will be randomized to the control arm (n=3) or the intervention arm (n=3). Both groups will engage in key informant interviews on safety culture (n=30-60). Control group hospitals will continue standard operating procedures. Intervention group hospitals will engage in social network analysis of surveys, have peer leaders identified, and engage in safety leadership training and quality improvement cycles. All hospitals regardless of arm will take part in 6-and-12-month surveys and 24-month interviews., primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: NONE, enrollmentInfo count: 240, type: ESTIMATED, armsInterventionsModule interventions name: SAINTS program, outcomesModule primaryOutcomes measure: Safety participation, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
|
protocolSection identificationModule nctId: NCT06302075, orgStudyIdInfo id: UKA-L2086, briefTitle: Functional Recovery After Medial Monocompartmental Knee Prosthesis: One Day Protocol Versus Fast Protocol, acronym: UKA-L2086, statusModule overallStatus: RECRUITING, startDateStruct date: 2021-11-16, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2025-12-01, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio, class: OTHER, descriptionModule briefSummary: The study is defined as prospective, randomized, interventional single-center; the general aim is to evaluate the post-operative recovery of the patient who carries out rehabilitation with the one day protocol (Group A), compared to the patient who carries out rehabilitation during the hospital stay with the fast protocol (group B)., conditionsModule conditions: Gonarthrosis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: One Day Rehabilitation, interventions name: Fast Rehabilitation, outcomesModule primaryOutcomes measure: Knee Society Score (KSS) from 0 to 100 (whether higher scores mean a better outcome), eligibilityModule sex: ALL, minimumAge: 40 Years, maximumAge: 85 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Istituto Clinico San Siro, status: RECRUITING, city: Milan, state: Italia, country: Italy, contacts name: Elena Cittera, role: CONTACT, phone: 0283502224, email: direzionescientifica.iog@grupposandonato.it, contacts name: Andrea Parente, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 45.46427, lon: 9.18951, hasResults: False
|
protocolSection identificationModule nctId: NCT06302062, orgStudyIdInfo id: FIT003-001, briefTitle: Phase I Clinical Study of Tumor-associated Lymph Node T Cell Therapy for Advanced Solid Tumors, acronym: TAL-T, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-06-06, primaryCompletionDateStruct date: 2025-12-30, completionDateStruct date: 2026-06-30, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-08, sponsorCollaboratorsModule leadSponsor name: Guangzhou FineImmune Biotechnology Co., LTD., class: INDUSTRY, descriptionModule briefSummary: A total of 17 to 23 participants are anticipated to be enrolled in the Phase I clinical trial, which is further divided into two distinct parts: one part involves single-agent cell therapy, while the other entails a combination of cell therapy and Serplulimab Injection.To be more precise, the study aims to include patients who have been diagnosed with metastatic or locally advanced refractory/recurrent malignant solid tumors and have shown resistance to standard therapeutic interventions. These tumor types may encompass head and neck cancer, ovarian cancer, lung cancer, melanoma, and others., conditionsModule conditions: Advanced Solid Tumor, conditions: Tumor Associated Lymph Node T Cell, conditions: Immunotherapy, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 23, type: ESTIMATED, armsInterventionsModule interventions name: Tumor Associated Lymph node T cell, interventions name: cyclophosphamide, interventions name: IL-2, interventions name: Serplulimab Injection, outcomesModule primaryOutcomes measure: DLT, primaryOutcomes measure: MDT, primaryOutcomes measure: Number of participants with treatment-related adverse events as assessed by CTCAE V4.03, secondaryOutcomes measure: ORR, secondaryOutcomes measure: PFS, secondaryOutcomes measure: life quality score, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Sun Yat-sen University Cancer Center, status: RECRUITING, city: Guangzhou, state: Gaungdong, zip: 510700, country: China, contacts name: Xuzhi Pan, role: CONTACT, phone: 86-020-87343135, email: panxzh@sysucc.org.cn, contacts name: Xiaoshi Zhang, professor, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 23.11667, lon: 113.25, hasResults: False
|
protocolSection identificationModule nctId: NCT06302049, orgStudyIdInfo id: 12345, briefTitle: Clinical Study Evaluating the Safety and Efficacy of Esomeprazole in Treatment of Non-alcoholic Steatohepatitis, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2025-05-01, completionDateStruct date: 2026-05-01, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-08, sponsorCollaboratorsModule leadSponsor name: Sadat City University, class: OTHER, descriptionModule briefSummary: The aim of the study is to test the implication of esomeprazole as a possible potential therapy for patients with NASH through evaluating its effect on ultrasound and fibrosis risk scores, serum levels of liver fibrosis biomarkers (fibronectin 1), insulin resistance, metabolic and inflammatory parameters., conditionsModule conditions: Fatty Liver Disease, conditions: Steatohepatitis, Nonalcoholic, designModule studyType: INTERVENTIONAL, phases: PHASE1, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 46, type: ESTIMATED, armsInterventionsModule interventions name: Esomeprazole, interventions name: Placebo, outcomesModule primaryOutcomes measure: Change in non-alcoholic fatty liver disease (NAFLD) fibrosis score (NFS), secondaryOutcomes measure: Liver function improvement, secondaryOutcomes measure: Reduction of oxidative stress, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
|
protocolSection identificationModule nctId: NCT06302036, orgStudyIdInfo id: 7777777, briefTitle: Emotional Freedom Techniques (EFT) on Stress, Anxiety and Depression in University Students Experiencing Earthquakes, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-30, primaryCompletionDateStruct date: 2024-04-05, completionDateStruct date: 2024-04-28, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-08, sponsorCollaboratorsModule leadSponsor name: Emine Yıldırım, class: OTHER, descriptionModule briefSummary: After two earthquakes in Kahramanmaraş Pazarcık in our country, the continuation of long-term aftershocks caused repetition of psychological problems and difficulties in recovery. Social and spiritual support plays a key role in the post-traumatic recovery period. It is necessary to use psychological support methods that can be applied in a short time and whose effect can be observed in a short time in the spiritual healing and healing of traumas. The emotional freedom technique (EFT) is One of the short-term psychotherapeutic techniques and ıt can also be applied online. EFT, which can be easily applied by individuals or professionals after receiving the necessary training; Cognitive therapy, acceptance and commitment therapy combine elements of acupuncture point stimulation, relying on manual stimulation of acupuncture points rather than using acupuncture needles. When we look at the literature, many scientific studies have been found in which the effectiveness of EFT on anxiety, stress and depression has been evaluated, but there has been no randomized controlled study evaluating the effectiveness of EFT online on individuals who have experienced earthquakes. With this project, it is aimed to determine the effect of online Emotional Freedom Techniques (EFT) on stress, anxiety and depression in university students who experienced earthquakes.This study, which will be carried out as a randomized controlled experimental study, will be carried out between 16.12.2023 and 20.12.2023 by online with university students who score 17 or higher on the Beck Depression Scale. Total of 60 students with depressive symptoms will be recruited to the intervention and control groups, EFT sessions will be applied to the intervention group, and the control group will only be followed. At the beginning of the application, pre-tests (Information Form, Beck Depression Inventory, State Trait Anxiety Inventory, Perceived Stress Inventory) and at the end of the last session, post-tests will be applied for both groups.With this study, a randomized controlled study will be brought to the literature on the effectiveness of a therapeutic method such as EFT, which is a method that can be used after an earthquake, which is easy to apply, has no cost, and can be accessed online in hard-to-reach areas. Our project will both contribute to the literature and provide short and long-term benefits in practice, in terms of raising awareness of students about important mental problems such as anxiety and depression, which are likely to be experienced after the earthquake, and enabling them to continue their education in a healthy way. It is aimed to present the work planned within the project as a paper in at least one national / international congress. It is aimed to publish in journals within the scope of SCI, SCI-Expanded related to the research area. The results and outputs of the research will be shared in various media (Kırklareli University and Osmaniye Korkut Ata University website and social media accounts).By determining the stress, anxiety and depression status of university students who have experienced an earthquake, it will be possible to reduce their stress, anxiety and depression with EFT application. The fact that the application used is a short-term, effective and easy psychotherapy method will prevent the disruption of the normal education processes of the students. It will make an economic contribution by reducing the need for psychological drugs that may be needed to reduce the effects of the earthquake., conditionsModule conditions: Emotional Problem, conditions: University Students Who Experienced an Earthquake, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: EFT will be applied and surveys will be administered to the intervention group. No application will be made to the control group and surveys will be asked., primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: EFT, outcomesModule primaryOutcomes measure: depression, secondaryOutcomes measure: stress, anxiety, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 45 Years, stdAges: ADULT, hasResults: False
|
protocolSection identificationModule nctId: NCT06302023, orgStudyIdInfo id: HE661462, briefTitle: Docosahexaenoic Acid (DHA) Supplementation During Pregnancy Reduces the Risk of Preterm Birth in Threatened Preterm Labor, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2025-05-31, completionDateStruct date: 2025-05-31, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-08, sponsorCollaboratorsModule leadSponsor name: Khon Kaen University, class: OTHER, descriptionModule briefSummary: The goal of this clinical trial is to learn about the effects of Docosahexaenoic acid (DHA) in reducing the incidence of premature birth in threatened preterm laborThe main questions it aims to answer are:* Can DHA supplementation reduce the incidence of premature birth in threatened preterm labor?* How does DHA supplementation affect pregnancy outcomes? Participants were organized into two groups* Group 1 (Intervention) Participants will be asked to take a DHA 1000mg per day* Group 2 (control) Participant will not need to take a DHA, conditionsModule conditions: Pregnant Women Diagnosed With Threatened Preterm Labor, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Docosahexaenoic acid (DHA) 1000 mg, outcomesModule primaryOutcomes measure: Number of Participants with preterm birth, secondaryOutcomes measure: Rate of low birth weight neonate, secondaryOutcomes measure: Rate of Neonatal Intensive care unit admission, eligibilityModule sex: FEMALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
|
protocolSection identificationModule nctId: NCT06302010, orgStudyIdInfo id: KafkasU3636, briefTitle: The Effect of Stress Ball Intervention During Non-Stress Test on Anxiety and Fetal Well-Being in High-Risk Pregnancy, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2024-08-31, completionDateStruct date: 2024-08-31, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-08, sponsorCollaboratorsModule leadSponsor name: Hümeyra TÜLEK DENİZ, class: OTHER, descriptionModule briefSummary: This research will be conducted to determine the effect of stress ball intervention during NST on anxiety and fetal well-being in high-risk pregnant women. Women with high-risk pregnancies randomly assigned to intervention (n=43) and control (n=43) groups at a state and a faculty hospital in Turkey will be included in the study. Pregnant women in the intervention group will be told to squeeze and release the ball once after counting to three, to inhale each time they press the ball, to exhale when they relax their grip and to focus only on the ball. Pregnant women will be instructed to continue this practice throughout the NST procedure (approximately 20 minutes). Pregnant women in the control group will not receive any intervention other than routine hospital care during the NST procedure. Data on anxiety and fetal well-being outcomes will be collected before and after NST., conditionsModule conditions: Anxiety, conditions: Fetal Conditions, conditions: Pregnancy Related, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: The research will be conducted as a two-group, parallel, randomized, controlled experimental study with a pretest-posttest design., primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 86, type: ESTIMATED, armsInterventionsModule interventions name: Stress Ball Intervention, outcomesModule primaryOutcomes measure: Anxiety, secondaryOutcomes measure: Fetal well-being, secondaryOutcomes measure: Fetal well-being, secondaryOutcomes measure: Fetal well-being, secondaryOutcomes measure: Fetal well-being, secondaryOutcomes measure: Fetal well-being, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 45 Years, stdAges: ADULT, contactsLocationsModule, hasResults: False
|
protocolSection identificationModule nctId: NCT06301997, orgStudyIdInfo id: IRCT20210218050404N5, secondaryIdInfos id: IR.FUMS.REC.1400.125, type: OTHER, domain: Fasaums, briefTitle: A Herbal Compound for Psoriasis, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2023-02-01, primaryCompletionDateStruct date: 2024-03-30, completionDateStruct date: 2024-12-30, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-08, sponsorCollaboratorsModule leadSponsor name: Fasa University of Medical Sciences, class: OTHER, collaborators name: Zarrin Avaye Kowsar Salamat (ZAX company), descriptionModule briefSummary: The goal of this interventional clinical trial study is to compare ZAX.1400.P03 and placebo in Psoriasis patients. The main question it aims to answer is:• Can treatment with ZAX.1400.P03 for 3 weeks improve clinical signs of skin in psoriasis patients? Participants will be divided into two groups of 52 people. One group will use ZAX.1400.P03 topically twice daily for 3 weeks and the other group will use placebo topically twice daily for 3 weeks.Researchers will compare treatment and placebo groups to see if there is any improvement in the clinical signs of skin caused by psoriasis after treatment with ZAX.1400.P03 for 3 weeks., conditionsModule conditions: Psoriasis, conditions: Inflammation, conditions: Skin Diseases, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 104, type: ACTUAL, armsInterventionsModule interventions name: ZAX.1400.P03, interventions name: Placebo, outcomesModule primaryOutcomes measure: Change from Baseline in Dermatology Life Quality Index (DLQI) score at Day0 (Baseline), Day7, Day14, Day21, Day28, Day35, and Day42, secondaryOutcomes measure: Change From Baseline in Percent Body Surface Area (%BSA) at Day0 (Baseline), Day7, Day14, Day21, Day28, Day35, and Day42, secondaryOutcomes measure: Change From Baseline in erythema score at Day0 (Baseline), Day7, Day14, Day21, Day28, Day35, and Day42, secondaryOutcomes measure: Change From Baseline in Swelling score at Day0 (Baseline), Day7, Day14, Day21, Day28, Day35, and Day42, secondaryOutcomes measure: Change From Baseline in pruritus score at Day0 (Baseline), Day7, Day14, Day21, Day28, Day35, and Day42, secondaryOutcomes measure: Change From Baseline in flake score at Day0 (Baseline), Day7, Day14, Day21, Day28, Day35, and Day42, secondaryOutcomes measure: Change From Baseline in skin dryness score at Day0 (Baseline), Day7, Day14, Day21, Day28, Day35, and Day42, secondaryOutcomes measure: Change From Baseline in skin irritation score at Day0 (Baseline), Day7, Day14, Day21, Day28, Day35, and Day42, secondaryOutcomes measure: Change From Baseline in pain score at Day0 (Baseline), Day7, Day14, Day21, Day28, Day35, and Day42, secondaryOutcomes measure: Change From Baseline in skin scratch score at Day0 (Baseline), Day7, Day14, Day21, Day28, Day35, and Day42, secondaryOutcomes measure: Change From Baseline in skin scar score at Day0 (Baseline), Day7, Day14, Day21, Day28, Day35, and Day42, secondaryOutcomes measure: Change From Baseline in skin thickness score at Day0 (Baseline), Day7, Day14, Day21, Day28, Day35, and Day42, secondaryOutcomes measure: Change From Baseline in skin rashes score at Day0 (Baseline), Day7, Day14, Day21, Day28, Day35, and Day42, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule locations facility: Fasa university of medical sciences, city: Fasa, state: Fars, zip: 7461686688, country: Iran, Islamic Republic of, geoPoint lat: 28.9383, lon: 53.6482, hasResults: False
|
protocolSection identificationModule nctId: NCT06301984, orgStudyIdInfo id: ANDROMEDA_01_2023_V1, briefTitle: Safety and Efficacy Evaluation of Insight GS Growing System, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-07, primaryCompletionDateStruct date: 2027-06, completionDateStruct date: 2027-08, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-08, sponsorCollaboratorsModule leadSponsor name: EVEREST PESQUISA E DESENVOLVIMENTO LTDA, class: OTHER, descriptionModule briefSummary: Premarket, interventional, single-arm clinical study, to evaluate the safety and efficacy of Insight GS Growing System in the surgical treatment of Early Onset Scoliosis (EOS). Also, to evaluate the difference in height of the spine and trunk, the success rate of the procedure, monitor adverse events and evaluate the satisfaction of the patient and care providers. The Andromeda Insight Growing System (Insight GS) is intended to treat severe, progressive multi-planar spinal deformities such as early-onset scoliosis while allowing for skeletal growth.The Andromeda Insight Growing System consists of blades, clamps and pedicle screws used to form a distinct spinal construct in growing children. The implanted blade is used to brace the spine during growth and minimize the progression of scoliosis. The components are implanted from a posterior approach and are made from Titanium alloy (Ti6AL-4V-ELI), and High Density Polyethylene (HDPE).Patients from 3 to 10 years of age, or who are still skeletally immature, who present early-onset scoliosis and who are considered as able to receive the surgical procedure with the Insight GS system, will be included in the study.Patients will be screened in the outpatient setting of the study site. All participants who meet the eligibility criteria will be invited to participate in the study, which includes screening/pre-op, surgery to install the Insight GS system, and follow-up visits at 6 weeks, 2, 4, 6, 8, 10, 12,. 18 and 24 months for data collection, clinical evaluation, imaging, and monitoring of adverse events., conditionsModule conditions: Early Onset Scoliosis (EOS), designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 26, type: ESTIMATED, armsInterventionsModule interventions name: Insight GS, outcomesModule primaryOutcomes measure: Cobb Angle, secondaryOutcomes measure: Adverse event, secondaryOutcomes measure: Trunk height, secondaryOutcomes measure: Pain, secondaryOutcomes measure: Satisfaction, eligibilityModule sex: ALL, minimumAge: 3 Years, maximumAge: 10 Years, stdAges: CHILD, contactsLocationsModule locations facility: Hospital Ortopédico AACD, city: São Paulo, state: SP, zip: 04027-000, country: Brazil, contacts name: Mariana F Goncalves, role: CONTACT, email: mfgoncalves@aacd.org.br, contacts name: Alexandre F Cristante, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: -23.5475, lon: -46.63611, hasResults: False
|
protocolSection identificationModule nctId: NCT06301971, orgStudyIdInfo id: CVL-231-HV-1011, briefTitle: A Study to Assess Mass Balance, Pharmacokinetics, Metabolism, and Excretion of Emraclidine in Healthy Adult Male Participants, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2024-04, completionDateStruct date: 2024-04, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-08, sponsorCollaboratorsModule leadSponsor name: Cerevel Therapeutics, LLC, class: INDUSTRY, descriptionModule briefSummary: The primary purpose of this study is to determine the mass balance, routes, and rates of elimination of total radioactivity and characterize the pharmacokinetics (PK) of emraclidine, metabolite CV-0000364, and total radioactivity in plasma and whole blood following a single oral dose of \[14C\]-emraclidine in healthy adult male participants., conditionsModule conditions: Healthy Participants, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 8, type: ESTIMATED, armsInterventionsModule interventions name: Emraclidine, outcomesModule primaryOutcomes measure: Area Under the Concentration Time Curve (AUC) from Zero to Infinity (AUCinf) of Emraclidine, its Metabolite CV-0000364 and Total Radioactivity in Plasma and Whole Blood, primaryOutcomes measure: AUC from Time 0 to last Quantifiable Concentration (AUClast) of Emraclidine, its Metabolite CV-0000364 and Total Radioactivity in Plasma and Whole Blood, primaryOutcomes measure: Maximum Plasma Concentration (Cmax) of Emraclidine, its Metabolite CV-0000364 and Total Radioactivity in Plasma and Whole Blood, primaryOutcomes measure: Time to Last Measurable Concentration (Tlast) of Emraclidine, its Metabolite CV-0000364 and Total Radioactivity in Plasma and Whole Blood, primaryOutcomes measure: Time to Maximum Observed Concentration (Tmax) of Emraclidine, its Metabolite CV-0000364 and Total Radioactivity in Plasma and Whole Blood, primaryOutcomes measure: Apparent Terminal Elimination Half-life (t½) of Emraclidine, its Metabolite CV-0000364 and Total Radioactivity in Plasma and Whole Blood, primaryOutcomes measure: Terminal Rate Constant (λz) of Emraclidine, its Metabolite CV-0000364 and Total Radioactivity in Plasma and Whole Blood, primaryOutcomes measure: Total Plasma Clearance After Oral Administration (CL/F) of Emraclidine, primaryOutcomes measure: Apparent Volume of Distribution During the Terminal Phase (Vz/F) of Emraclidine, primaryOutcomes measure: Ratio of Plasma AUCinf for Emraclidine to Plasma AUCinf for Total Radioactivity, primaryOutcomes measure: Ratio of Plasma AUCinf for Metabolite CV-0000364 to Plasma AUCinf for Total Radioactivity, primaryOutcomes measure: Ratio of Plasma AUCinf for Metabolite CV-0000364 to Plasma AUCinf for Emraclidine, primaryOutcomes measure: Ratio of Whole Blood AUCinf for Total Radioactivity to Plasma AUCinf for Total Radioactivity, primaryOutcomes measure: Amount Excreted in Urine (Aeu) of Total Radioactivity, primaryOutcomes measure: Cumulative Aeu of Total Radioactivity, primaryOutcomes measure: Percentage Excreted in Urine (feu) of Total Radioactivity, primaryOutcomes measure: Cumulative feu of Total Radioactivity, primaryOutcomes measure: Amount Excreted in Feces (Aef) of Total Radioactivity, primaryOutcomes measure: Cumulative Aef of Total Radioactivity, primaryOutcomes measure: Percentage Excreted in Feces (fef) of Total Radioactivity, primaryOutcomes measure: Cumulative fef of Total Radioactivity, primaryOutcomes measure: Percentage Dose (%Dose) of Total Radioactivity Excreted in Urine Plus Feces Combined, primaryOutcomes measure: Cumulative Percentage Dose of Total Radioactivity Excreted in Urine Plus Feces Combined, secondaryOutcomes measure: Metabolite Profile of Emraclidine in Plasma, Urine and Feces, secondaryOutcomes measure: Structural Identification of Emraclidine Metabolites Found in Plasma, Urine and Feces, secondaryOutcomes measure: Number of Participants with Treatment Emergent Adverse Events (TEAEs), secondaryOutcomes measure: Number of Participants with Clinically Significant Changes in Electrocardiogram (ECG) Values, secondaryOutcomes measure: Number of Participants with Clinically Significant Changes in Vital Signs, secondaryOutcomes measure: Number of Participants with Clinically Significant Changes in Laboratory Assessments, secondaryOutcomes measure: Number of Participants with Clinically Significant Changes in Physical and Neurological Examination Results, secondaryOutcomes measure: Change from Baseline in Columbia Suicide Severity Rating Scale (C-SSRS) Score, eligibilityModule sex: MALE, minimumAge: 18 Years, maximumAge: 55 Years, stdAges: ADULT, contactsLocationsModule locations facility: Austin, Texas, status: RECRUITING, city: Austin, state: Texas, zip: 78744, country: United States, geoPoint lat: 30.26715, lon: -97.74306, hasResults: False
|
protocolSection identificationModule nctId: NCT06301958, orgStudyIdInfo id: 202102567A3, briefTitle: Dextrose Prolotherapy on Articular Cartilage, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-01-21, primaryCompletionDateStruct date: 2024-08-31, completionDateStruct date: 2024-08-31, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-08, sponsorCollaboratorsModule leadSponsor name: Chang Gung Memorial Hospital, class: OTHER, descriptionModule briefSummary: Dextrose prolotherapy is a controversial injection therapy in sports medicine. Currently, 25% hypertonic glucose solution is commonly used in clinical practice. Although this method has a certain therapeutic effect, there is still some controversy about the molecular mechanism of dextrose prolotherapy. In the past, it was thought that local stimulation would increase inflammatory reactions such as local leukocyte and macrophage infiltration and restart the "self-healing mechanism." However, some studies have pointed out that this treatment can cause cell apoptosis. In my clinical work, I often perform dextrose prolotherapy. I deeply feel the importance of exploring the detailed mechanism of action of this therapy in order to apply this therapy more appropriately to patients. We believe that the concentration of 25% hypertonic glucose solution should show a stepwise decrease in the joint cavity. Our preliminary cell experiment results using 2-fold serial dilutions of 25% glucose solution showed that 25%, 12% and 6% glucose solution will trigger the apoptosis of chondrocytes, vascular endothelial cells and immune cells, and will also inhibit the expression of the pro-inflammatory factor IL-6. Glucose solution below 3% will not have the effect of inducing apoptosis on cells. We believe that the therapeutic effect of 25% hypertonic glucose solution in the joint cavity may have cell-specific effects as the concentration changes dynamically. Therefore, in this study, we will clarify the therapeutic mechanism of dextrose prolotherapy for arthritis through basic research and clinical specimen analysis. The clinical research part will use clinical synovial fluid specimens to verify the therapeutic mechanism of hypertonic glucose dissolution. The joint pain level assessment of different types of patients (OA and RA) before dextrose prolotherapy (preliminary period), 1 month after treatment (midterm period) and 3 months after treatment (late period) will be collected, and joint effusion will be measured. Further analyze the cell apoptosis and concentration changes of inflammatory response factors in the liquid.We hope that through this study, we will have a clear understanding of the molecular mechanism of dextrose prolotherapy on joint component cells. This result will have reference value for the more appropriate application of dextrose prolotherapy in the treatment of human cartilage-related lesions., conditionsModule conditions: Arthritis Knee, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: NONE, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Dextrose prolotherapy, outcomesModule primaryOutcomes measure: Visual Analogue Scale (VAS), secondaryOutcomes measure: Western Ontario and McMaster Universities Arthritis Index (WOMAC), secondaryOutcomes measure: Interleukin 6 (IL-6), eligibilityModule sex: ALL, minimumAge: 20 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Chang Gung Memorial Hospital, Chiayi, status: RECRUITING, city: Chiayi City, state: 嘉義市, zip: 600, country: Taiwan, contacts name: HUNG-CHIH HSU, PhD, role: CONTACT, phone: +886-3-3621000, phoneExt: 2601, email: dr.tonyhsu@gmail.com, geoPoint lat: 23.47917, lon: 120.44889, hasResults: False
|
protocolSection identificationModule nctId: NCT06301945, orgStudyIdInfo id: Maastro Clinic, secondaryIdInfos id: 72725524, type: OTHER_GRANT, domain: Hanarth Fonds, briefTitle: Artificial Intelligence Prediction Tool in Thymic Epithelial Tumors, acronym: INTHYM, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-08-01, primaryCompletionDateStruct date: 2027-08-01, completionDateStruct date: 2027-08-01, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-27, sponsorCollaboratorsModule leadSponsor name: Erasmus Medical Center, class: OTHER, collaborators name: Maastro Clinic, The Netherlands, collaborators name: Hospices Civils de Lyon, descriptionModule briefSummary: Thymic epithelial tumors are rare neoplasms in the anterior mediastinum. The cornerstone of the treatment is surgical resection. Administration of postoperative radiotherapy is usually indicated in patients with more extensive local disease, incomplete resection and/or more aggressive subtypes, defined by the WHO histopathological classification.In this classification thymoma types A, AB, B1, B2, B3, and thymic carcinoma are distinguished. Studies have shown large discordances between pathologists in subtyping these tumors. Moreover, the WHO classification alone does not accurately predict the risk of recurrence, as within subtypes patients have divergent prognoses.The investigators will develop AI models using digital pathology and relevant clinical variables to improve the accuracy of histopathological classification of thymic epithelial tumors, and to better predict the risk of recurrence.In this multicentric and international project three existing databases will be used from Rotterdam, Maastricht and Lyon. For all models one database will be used to build AI models, and the other two for external validation.The ultimate goal of this project is to develop AI models that support the pathologist in correctly subtyping thymic epithelial tumors, in order to prevent patients from under- or overtreatment with adjuvant radiotherapy., conditionsModule conditions: Thymic Epithelial Tumor, conditions: Thymic Carcinoma, conditions: Thymoma, conditions: Thymoma and Thymic Carcinoma, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 1020, type: ESTIMATED, armsInterventionsModule interventions name: Artificial Intelligence Diagnostics, interventions name: Recurrence Prediction Tool, outcomesModule primaryOutcomes measure: WP1 - Databases/Data Pre-processing, secondaryOutcomes measure: WP2 - Deep Learning-Model for TET Classification and Recurrence Prediction, otherOutcomes measure: WP3: Clinical Evaluation, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Erasmus MC, status: RECRUITING, city: Rotterdam, state: South Holland, zip: 3015 GD, country: Netherlands, contacts name: Anna Salut Esteve Domínguez, role: CONTACT, email: a.estevedominguez@erasmusmc.nl, geoPoint lat: 51.9225, lon: 4.47917, hasResults: False
|
protocolSection identificationModule nctId: NCT06301932, orgStudyIdInfo id: ANE-2562-06771, briefTitle: The Effectiveness and Outcomes of Epidural Analgesia in Patients Undergoing Open Hepatectomy, statusModule overallStatus: COMPLETED, startDateStruct date: 2006-01-01, primaryCompletionDateStruct date: 2018-12-31, completionDateStruct date: 2023-12-31, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: Chiang Mai University, class: OTHER, descriptionModule briefSummary: This observational study is to compare the effectiveness and outcomes of epidural analgesia in patients undergoing open hepatectomy: A propensity score matching analysis.The main question is: What is the superior method of pain control in open hepatectomy: epidural analgesia or intravenous PCA?, conditionsModule conditions: Epidural Analgesia, conditions: Patient Controlled Analgesia, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 654, type: ACTUAL, armsInterventionsModule interventions name: Open liver resection, outcomesModule primaryOutcomes measure: Post-operative opioid consumption, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False
|
protocolSection identificationModule nctId: NCT06301919, orgStudyIdInfo id: IRBN042024/CHUSTE, briefTitle: Use of N-Butyl Cyanoacrylate in Transarterial Emergency Embolization, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2024-05-01, completionDateStruct date: 2024-05-01, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: Centre Hospitalier Universitaire de Saint Etienne, class: OTHER, descriptionModule briefSummary: NBCA is a synthetic biodegradable cyanoacrylate basis glue, modified by the addition of a monomer with adhesive, hemostatic, and antiseptic properties.Its use requires a steep learning curve to control emulsification of the NBCA/lipiodol mixture, and injection, to avoid non-target embolization.The aim of this retrospective monocentric study was to evaluate safety and efficacy of use of NBCA as embolic agent in emergency setting., conditionsModule conditions: Haemostasis Embolisation, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Clinical data, interventions name: Imaging data, interventions name: Biological data, outcomesModule primaryOutcomes measure: Evaluation of technical success, secondaryOutcomes measure: Assessment of clinical success, secondaryOutcomes measure: Assessment of clinical success, secondaryOutcomes measure: Assessment of clinical success, secondaryOutcomes measure: Assessment of clinical success, secondaryOutcomes measure: Assessment of clinical success, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: CHU de Saint-Etienne, status: RECRUITING, city: Saint-Priest-en-Jarez, zip: 42270, country: France, contacts name: Rémi Grange, MD, role: CONTACT, phone: (0)477828963, phoneExt: +33, email: remi.grange@chu-st-etienne.fr, contacts name: Sylvain Grange, MD, role: SUB_INVESTIGATOR, contacts name: Rémi Grange, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 45.47501, lon: 4.37614, hasResults: False
|
protocolSection identificationModule nctId: NCT06301906, orgStudyIdInfo id: 202301060A3, briefTitle: Red Yeast Rice for Primary Prevention of Hypercholesterolemia, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-26, primaryCompletionDateStruct date: 2025-12-31, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-08, sponsorCollaboratorsModule leadSponsor name: Chang Gung Memorial Hospital, class: OTHER, descriptionModule briefSummary: This two-year observational study will be conducted at the outpatient clinic of the Department of Traditional Chinese Medicine of Taoyuan Chang Gung Hospital from February 26, 2024 to December 31, 2025. This study will enroll 35\~55 year-old male patients who are expected to take LipoCol Forte Capsules for primary prevention of hypercholesterolemia. The investigators will collect the TCM constitution questionnaires from patients before taking LipoCol Forte Capsules and every three months after taking the medicine. At the same time, blood will be drawn to detect glycated hemoglobin, fasting blood sugar, insulin, lipids profile, liver and kidney function, creatine kinase, predictive parameters of atherosclerotic cardiovascular disease, and plasma bile acids, etc. Fecal samples will also be collected to analyze the intestinal microbiota and fecal bile acid composition. This study will evaluate the efficacy, durability and safety of LipoCol Forte capsules in the primary prevention of hypercholesterolemia in patients with different constitutions, as well as whether it can reduce the risk of cardiovascular disease, and its influence on bile acid metabolism and intestinal microbiota., conditionsModule conditions: Hypercholesterolemia, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: LipoCol Forte Capsule 600mg bid, outcomesModule primaryOutcomes measure: Low Density Lipoprotein-Cholesterol (LDL-C), secondaryOutcomes measure: 10-Year ASCVD Risk, eligibilityModule sex: MALE, minimumAge: 35 Years, maximumAge: 55 Years, stdAges: ADULT, contactsLocationsModule locations facility: Taoyuan branch of Chang Gung Memorial Hospital, status: RECRUITING, city: Taoyuan, zip: 333, country: Taiwan, contacts name: Yueh Hsiang Huang, PhD, role: CONTACT, phone: 886-975360240, email: igighuang@gmail.com, geoPoint lat: 24.95233, lon: 121.20193, hasResults: False
|
protocolSection identificationModule nctId: NCT06301893, orgStudyIdInfo id: US-3_Uganda (IRB#2013-4576), briefTitle: Uganda Sickle Surveillance Study (US-3), statusModule overallStatus: RECRUITING, startDateStruct date: 2013-09-07, primaryCompletionDateStruct date: 2030-12-31, completionDateStruct date: 2032-12-31, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: Children's Hospital Medical Center, Cincinnati, class: OTHER, collaborators name: Makerere University, collaborators name: Ministry of Health, Uganda, collaborators name: Mulago Hospital, Uganda, descriptionModule briefSummary: It is estimated that over 250,000 babies are born with sickle cell disease (SCD) annually in sub-Saharan Africa, and only 10% - 50% of them survive beyond five years of age. Data describing the magnitude of the sickle cell problem are lacking in most African countries. The available data on prevalence were mainly from older studies and small numbers of hospitalized patients. In Uganda, approximately 25,000 children are born with SCD but 70-80% die before their 5th birthday. Lehmann and Raper found 'sicklaemia' prevalence of 0.8% and 45% in the Sebei and Bambaa ethnic groups, respectively. A recent study found a SCT and SCD prevalence of 3% - 19% and 0% - 3%, respectively but this study addressed only 5 of Uganda's 111 districts and used a small convenience sample of children aged 6 - 60 months. The objective of this study is to determine the prevalence and map out the burden of SCT and SCD in Uganda., conditionsModule conditions: Sickle Cell Disease, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 1000000, type: ESTIMATED, outcomesModule primaryOutcomes measure: Incidence of HbSS and HbA, secondaryOutcomes measure: Incidence of HbSS and HbA, eligibilityModule sex: ALL, maximumAge: 12 Months, stdAges: CHILD, contactsLocationsModule locations facility: Makerere University, status: RECRUITING, city: Kampala, country: Uganda, contacts name: Grace Ndeezi, MBChB, MMed, PhD, role: CONTACT, geoPoint lat: 0.31628, lon: 32.58219, locations facility: Minister of Health, status: RECRUITING, city: Kampala, country: Uganda, contacts name: Jane R. Aceng, MD, role: CONTACT, geoPoint lat: 0.31628, lon: 32.58219, locations facility: National Coordinator EID Program, status: RECRUITING, city: Kampala, country: Uganda, contacts name: Charles Kiyaga, MBLSM, role: CONTACT, contacts name: Charles Kiyaga, PhD, role: SUB_INVESTIGATOR, geoPoint lat: 0.31628, lon: 32.58219, locations facility: Sickle Cell Clinic Department of Pediatrics & Child Health Mulago Hospital, status: RECRUITING, city: Kampala, country: Uganda, contacts name: Deogratias Manube, MBChB, MMed, role: CONTACT, geoPoint lat: 0.31628, lon: 32.58219, hasResults: False
|
protocolSection identificationModule nctId: NCT06301880, orgStudyIdInfo id: 3200, briefTitle: Effect of Topically-applied Milrinone or Nitroglycerin on Internal Mammary Artery Free Flow, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-01-01, primaryCompletionDateStruct date: 2023-01-31, completionDateStruct date: 2023-01-31, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-08, sponsorCollaboratorsModule leadSponsor name: Damascus University, class: OTHER, descriptionModule briefSummary: Forty-six consecutive patients undergoing elective primary coronary artery bypass grafting were enrolled. After the left IMA was harvested, free flow was measured under controlled hemodynamic conditions before any intervention (flow 1) and at a mean of 12.5 minutes after the topical application of one of three agents (milrinone, nitroglycerin or normal saline) on the IMA (flow 2)., conditionsModule conditions: Internal Mammary Artery Syndrome, conditions: Vasodilation, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, maskingDescription: All surgical procedures and measurements were carried out by a single surgeon (MBI) who was blinded to the topical agent which was applied., whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 46, type: ACTUAL, armsInterventionsModule interventions name: The topical application of a vasodilator on the LIMA graft, outcomesModule primaryOutcomes measure: LIMA free flow, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Damascus University Cardiac Surgery Hospital, city: Damascus, country: Syrian Arab Republic, geoPoint lat: 33.5102, lon: 36.29128, hasResults: False
|
protocolSection identificationModule nctId: NCT06301867, orgStudyIdInfo id: Pro00113877, briefTitle: Preventing Failed Extubations, acronym: PreFIX, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2024-07-31, completionDateStruct date: 2024-08-31, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-21, sponsorCollaboratorsModule leadSponsor name: Duke University, class: OTHER, descriptionModule briefSummary: More than 300,00 people in the United States experience acute respiratory failure and require mechanical ventilation every year. Of those that recover and are extubated, the most common reason for reintubation is recurrent respiratory failure. Our study proposes a novel methodology for identifying those patients most at risk for recurrent respiratory failure., conditionsModule conditions: Mechanical Ventilation Complication, conditions: Weaning Failure, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 250, type: ESTIMATED, armsInterventionsModule interventions name: Plateau Pressure, outcomesModule primaryOutcomes measure: Percentage of patients who had a plateau pressure measured prior to extubation as a measure of feasibility, secondaryOutcomes measure: Percentage of patients who were reintubated prior to hospital discharge, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 120 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Duke University Medical Center, status: RECRUITING, city: Durham, state: North Carolina, zip: 27710, country: United States, contacts name: Elias H Pratt, MD, role: CONTACT, email: elias.pratt@duke.edu, geoPoint lat: 35.99403, lon: -78.89862, hasResults: False
|
protocolSection identificationModule nctId: NCT06301854, orgStudyIdInfo id: TPN171H-E302, briefTitle: Long-term Safety of TPN171H Tablet in Erectile Dysfunction., statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-12, primaryCompletionDateStruct date: 2025-04-30, completionDateStruct date: 2025-04-30, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: Vigonvita Life Sciences, class: INDUSTRY, descriptionModule briefSummary: This is a multicenter, open study to evaluate the long-term safety and efficacy of TPN171H in men with erectile dysfunction., conditionsModule conditions: Erectile Dysfunction, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 400, type: ESTIMATED, armsInterventionsModule interventions name: TPN171H, outcomesModule primaryOutcomes measure: Incidence of adverse events (AE) and adverse drug reactions (ADRs) during treatment observation., secondaryOutcomes measure: Change From Baseline in the International Index of Erectile Function - Erectile Function., secondaryOutcomes measure: Change From Baseline in Question 2 of the Patient Sexual Encounter Profile (SEP) Diary at the 3rd and 6th month in Percentage of Yes Responses., secondaryOutcomes measure: Change From Baseline in Question 3 of the Patient Sexual Encounter Profile (SEP) Diary at the 3rd and 6th month in Percentage of Yes Responsesat Week 12 in Percentage of Yes Responses., secondaryOutcomes measure: Percentage of subjects whose IIEF-EF scores returned to normal (≥26) at the 3rd and 6th month of medication., secondaryOutcomes measure: Change From Baseline to the 3rd months and 6th months Endpoint in International Index of Erectile Function (IIEF),Orgasmic Functions,Sexual Desire,Intercourse Satisfaction, Overall Satisfaction., secondaryOutcomes measure: Percentage of respondents who answered "yes" to questions 1 and 2 of the Comprehensive Evaluation Questionnaire (GAQ) at 3 Erectile Function (IIEF),Orgasmicand at the 3rd and 6th month., secondaryOutcomes measure: Change From Baseline in the International Index of Erectile Function - Erectile Function., secondaryOutcomes measure: Change From Baseline in Question 2 of the Patient Sexual Encounter Profile (SEP) Diary at the 3rd，6th，9th，12th month in Percentage of Yes Responses., secondaryOutcomes measure: Change From Baseline in Question 3 of the Patient Sexual Encounter Profile (SEP) Diary at the 3rd，6th，9th，12th month in Percentage of Yes Responsesat Week 12 in Percentage of Yes Responses., secondaryOutcomes measure: Percentage of subjects whose IIEF-EF scores returned to normal (≥26) at the the 3rd，6th，9th，12th month of medication., secondaryOutcomes measure: Change From Baseline to the 3rd，6th，9th，12th month Endpoint in International Index of Erectile Function (IIEF),Orgasmic Functions,Sexual Desire,Intercourse Satisfaction, Overall Satisfaction., secondaryOutcomes measure: Percentage of respondents who answered "yes" to questions 1 and 2 of the Comprehensive Evaluation Questionnaire (GAQ) at 3 Erectile Function (IIEF),Orgasmicand at the 3rd，6th，9th，12th month ., eligibilityModule sex: MALE, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: The First Affiliated Hospital of Anhui Medical University, status: RECRUITING, city: Hefei, state: Anhui, zip: 230000, country: China, contacts name: Xiansheng Zhang, role: CONTACT, geoPoint lat: 31.86389, lon: 117.28083, locations facility: Peking University First Hospital, status: NOT_YET_RECRUITING, city: Beijing, state: Beijing, zip: 100032, country: China, contacts name: Hui Jiang, role: CONTACT, geoPoint lat: 39.9075, lon: 116.39723, locations facility: Peking University Third Hospital, status: RECRUITING, city: Beijing, state: Beijing, zip: 100191, country: China, contacts name: Kai Hong, role: CONTACT, geoPoint lat: 39.9075, lon: 116.39723, locations facility: Guangzhou First People's Hospital, status: RECRUITING, city: Guangzhou, state: Guangdong, zip: 510000, country: China, contacts name: Junhong Deng, role: CONTACT, geoPoint lat: 23.11667, lon: 113.25, locations facility: The Fifth Affiliated Hospital of Guangzhou Medical University, status: RECRUITING, city: Guangzhou, state: Guangdong, zip: 510700, country: China, contacts name: Xianhan Jiang, role: CONTACT, geoPoint lat: 23.11667, lon: 113.25, locations facility: The Third Affiliated Hospital of Guangzhou Medical University, status: RECRUITING, city: Guangzhou, state: Guangdong, country: China, contacts name: Geng An, role: CONTACT, geoPoint lat: 23.11667, lon: 113.25, locations facility: Shantou Central Hospital, status: RECRUITING, city: Shantou, state: Guangdong, country: China, contacts name: hong huang, role: CONTACT, geoPoint lat: 23.36814, lon: 116.71479, locations facility: The Second Affiliated Hospital of Shantou University Medical College, status: RECRUITING, city: Shantou, state: Guangdong, country: China, contacts name: Junhong Zheng, role: CONTACT, geoPoint lat: 23.36814, lon: 116.71479, locations facility: Shenzhen Songgang People's Hospital, status: RECRUITING, city: Shenzhen, state: Guangdong, zip: 518105, country: China, contacts name: Qin Xiang, role: CONTACT, geoPoint lat: 22.54554, lon: 114.0683, locations facility: The 2nd Affiliated Hospital of Guilin Medical University, status: RECRUITING, city: Guilin, state: Guangxi, country: China, contacts name: Li Gao, role: CONTACT, geoPoint lat: 25.28194, lon: 110.28639, locations facility: The Affiliated Hospital of Guizhou Medical University, status: RECRUITING, city: Guiyang, state: Guizhou, country: China, contacts name: Qiang Wang, role: CONTACT, geoPoint lat: 26.58333, lon: 106.71667, locations facility: Qingyuan People's Hospital, status: RECRUITING, city: Qingyuan, state: G, country: China, contacts name: Jianwen Zeng, role: CONTACT, geoPoint lat: 23.7, lon: 113.03333, locations facility: The Second Hospital of Hebei Medical Uniyersity, status: RECRUITING, city: Shijiazhuang, state: Hebei, country: China, contacts name: Yaxuan Wang, role: CONTACT, geoPoint lat: 38.04139, lon: 114.47861, locations facility: Xingtai People's Hospital, status: RECRUITING, city: Xingtai, state: Hebei, country: China, contacts name: Junli Wei, role: CONTACT, geoPoint lat: 37.06306, lon: 114.49417, locations facility: Henan Provincial People's Hospital, status: RECRUITING, city: Zhengzhou, state: Henan, zip: 450100, country: China, contacts name: Xiangsheng Zhang, role: CONTACT, geoPoint lat: 34.75778, lon: 113.64861, locations facility: The First Affiliated Hospital of Henan University, status: RECRUITING, city: Zhengzhou, state: Henan, country: China, contacts name: Guoliang Xu, role: CONTACT, geoPoint lat: 34.75778, lon: 113.64861, locations facility: The Central Hospital of Wuhan, status: NOT_YET_RECRUITING, city: Wuhan, state: Hubei, zip: 430014, country: China, contacts name: Yonglian Guo, role: CONTACT, geoPoint lat: 30.58333, lon: 114.26667, locations facility: Wuhan Union Hospital, status: NOT_YET_RECRUITING, city: Wuhan, state: Hubei, zip: 430022, country: China, contacts name: Zhaohui Zhu, role: CONTACT, geoPoint lat: 30.58333, lon: 114.26667, locations facility: The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine, status: RECRUITING, city: Changsha, state: Hunan, country: China, contacts name: Yifeng Yuan, role: CONTACT, geoPoint lat: 28.19874, lon: 112.97087, locations facility: Loudi Central Hospital, status: RECRUITING, city: Loudi, state: Hunan, country: China, contacts name: Liang Peng, role: CONTACT, geoPoint lat: 27.73444, lon: 111.99444, locations facility: Yueyang People's Hospital, status: RECRUITING, city: Yueyang, state: Hunan, country: China, contacts name: Zeping Li, role: CONTACT, geoPoint lat: 29.37455, lon: 113.09481, locations facility: Second Affiliated Hospital of Suzhou University, status: RECRUITING, city: Suzhou, state: Jiangsu, zip: 215000, country: China, contacts name: Boxin Xue, role: CONTACT, geoPoint lat: 31.30408, lon: 120.59538, locations facility: Nanchang reproductive hospital, status: RECRUITING, city: Nanchang, state: Jiangxi, zip: 330001, country: China, contacts name: Wenliang Yao, role: CONTACT, geoPoint lat: 28.68396, lon: 115.85306, locations facility: Yichang Central People's Hospital (Xiling Campus), status: RECRUITING, city: Yichang, state: Jiangxi, country: China, contacts name: Junfeng Yu, role: CONTACT, geoPoint lat: 30.71444, lon: 111.28472, locations facility: The First Hospital of Jilin University, status: NOT_YET_RECRUITING, city: Changchun, state: Jilin, zip: 130021, country: China, contacts name: Fubiao Li, role: CONTACT, geoPoint lat: 43.88, lon: 125.32278, locations facility: The Second Hospital of Dalian Medical University, status: NOT_YET_RECRUITING, city: Dalian, state: Liaoning, zip: 116011, country: China, contacts name: Tao Jiang, role: CONTACT, geoPoint lat: 38.91222, lon: 121.60222, locations facility: Chifeng Municipal Hospital, status: RECRUITING, city: Chifeng, state: Neimenggu, country: China, contacts name: Xin Chen, role: CONTACT, geoPoint lat: 42.26833, lon: 118.96361, locations facility: The Affiliated Hospital of Qinghai University, status: RECRUITING, city: Xining, state: Qinghai, country: China, contacts name: Guoliang Chen, role: CONTACT, geoPoint lat: 36.62554, lon: 101.75739, locations facility: Xianyang Central Hospital, status: RECRUITING, city: Xianyang, state: Shanxi, country: China, contacts name: Nan Li, role: CONTACT, geoPoint lat: 34.33778, lon: 108.70261, locations facility: The Second Affiliated Hospital of Shaanxi University of Chinese Medicine, status: RECRUITING, city: Xian, state: Shanxi, country: China, contacts name: Wei Zheng, role: CONTACT, geoPoint lat: 34.25833, lon: 108.92861, locations facility: Nuclear Industry 416 Hospital, status: RECRUITING, city: Chengdu, state: Sichuang, country: China, contacts name: Jichun Shao, role: CONTACT, geoPoint lat: 30.66667, lon: 104.06667, locations facility: The Affiliated Hospital of Chengdu University, status: RECRUITING, city: Chengdu, state: Sichuang, country: China, contacts name: Jin Yang, role: CONTACT, geoPoint lat: 30.66667, lon: 104.06667, locations facility: Suining Central Hospital, status: RECRUITING, city: Suining, state: Sichuang, country: China, contacts name: Yougang Feng, role: CONTACT, geoPoint lat: 30.50802, lon: 105.57332, locations facility: Xinjiang Uygur Autonomous Region Hospital of Traditional Chinese Medicine, status: RECRUITING, city: Urumqi, state: Xinjiang, country: China, contacts name: Feng Wang, role: CONTACT, geoPoint lat: 43.80096, lon: 87.60046, hasResults: False
|
protocolSection identificationModule nctId: NCT06301841, orgStudyIdInfo id: 2023-A00903-42, briefTitle: An Antibiotic Protocol Guided by a Multimodal Approach in AECOPD With Pneumonia in Intensive Care, acronym: BPCTréa2, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-15, primaryCompletionDateStruct date: 2026-04-15, completionDateStruct date: 2026-07-15, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-08, sponsorCollaboratorsModule leadSponsor name: University Hospital, Caen, class: OTHER, descriptionModule briefSummary: Investigators propose to conduct a multicenter, prospective, randomized, controlled, assessing the interests of an antibiotic protocol guided by the combined use of serum procalcitonin (PCT) and a broad-panel respiratory multiplex PCR (mPCR) to reduce duration of antibiotics exposure in patients with chronic obstructive pulmonary disease (COPD) hospitalized in intensive care unit (ICU) with pneumonia. The primary endpoint is the number of antibiotic-days for the treatment of pneumonia., conditionsModule conditions: To Reduce Duration of Antibiotics Exposure in Patients With COPD Hospitalized in Intensive Care Unit With Pneumonia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 64, type: ESTIMATED, armsInterventionsModule interventions name: experimental, outcomesModule primaryOutcomes measure: Duration of antibiotic therapy, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Medical Intensive Care Unit, CHU Caen, city: Caen, zip: 14000, country: France, geoPoint lat: 49.18585, lon: -0.35912, hasResults: False
|
protocolSection identificationModule nctId: NCT06301828, orgStudyIdInfo id: KY202401, briefTitle: Endostar Combined With SBRT and Envafolimab in the Treatment of Advanced Gastrointestinal Tumors, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-21, primaryCompletionDateStruct date: 2025-06-21, completionDateStruct date: 2026-02-21, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-08, sponsorCollaboratorsModule leadSponsor name: Nanjing First Hospital, Nanjing Medical University, class: OTHER, descriptionModule briefSummary: This is a single-arm, prospective, exploratory clinical study to evaluate the efficacy and safety of endostar combined with stereotactic body radiation therapy (SBRT) and Envafolimab in patients with advanced gastrointestinal cancer after multi-line treatment., conditionsModule conditions: Gastrointestinal Neoplasms, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: Gastrointestinal neoplasms, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 16, type: ESTIMATED, armsInterventionsModule interventions name: Envafolimab Injection, interventions name: Endostar, outcomesModule primaryOutcomes measure: DCR, primaryOutcomes measure: ORR, secondaryOutcomes measure: PFS, secondaryOutcomes measure: Incidence of Treatment-Emergent Adverse Events, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Nanjing First Hospital, status: RECRUITING, city: Nanjing, state: Jiangsu, zip: 210006, country: China, contacts name: wei x wei, M.D., role: CONTACT, phone: 52271000, phoneExt: 025, geoPoint lat: 32.06167, lon: 118.77778, hasResults: False
|
protocolSection identificationModule nctId: NCT06301815, orgStudyIdInfo id: Shaw_Stroke_REC24/YH/0010_2024, briefTitle: Feasibility of Measuring Vertical Perception in Acute Stroke, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2024-10-31, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-08, sponsorCollaboratorsModule leadSponsor name: University of Winchester, class: OTHER, collaborators name: Hampshire Hospitals NHS Foundation Trust, collaborators name: University Hospitals Dorset NHS Foundation Trust, descriptionModule briefSummary: The goal of this observational study is to establish if it is feasible to identify vertical perception deficits in people with acute stroke. The primary purpose to the study is:• To establish the feasibility of completing the Catherine Bergego Scale, Scale for Contraversive Pushing (SCP) and bucket test in a clinical environment with acute stroke patients to assist with identification of vertical perception loss.Participants will be asked to complete the assessments with a therapist 48 hours after admission. If they are not completed for any reason attempts will be made to complete them at one, two and four weeks after admission. Some participants will have them completed again on discharge. The Catherine Bergego Scale and SCP are observational and will involve a therapist watching the participant undertake daily activities. The bucket test involves a therapist placing a bucket in front of the face of the participant and asking them to identify when a line on the bottom of the bucket is vertical. Acceptabiliy and feasibility will be further investigated using a survey of participants who complete the assessments and through focus groups with the rehabilitation professionals admininstering the assessments.If it is feasible and acceptable to complete these assessments then further research can use them as an acceptable measure of vertical alignment in the clinical setting., conditionsModule conditions: Stroke, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Scale for Contraversive Pushing, interventions name: Catherine Bergego Scale, interventions name: Bucket Test, outcomesModule primaryOutcomes measure: Bucket Test to measure subjective visual vertical (SVV)., primaryOutcomes measure: Catherine Bergego Scale to measure neglect., primaryOutcomes measure: Scale for Contraversive Pushing to measure lateropulsion, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Royal Hampshire County Hospital, city: Winchester, zip: SO22 5DG, country: United Kingdom, contacts name: Amelia Shaw, MSc, role: CONTACT, phone: 01962 824940, email: amelia.shaw@hhft.nhs.uk, geoPoint lat: 51.06513, lon: -1.3187, hasResults: False
|
protocolSection identificationModule nctId: NCT06301802, orgStudyIdInfo id: myelomeningocele management, briefTitle: Outcomes of Proactive Management of Children With Myelomeningocele, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-04, primaryCompletionDateStruct date: 2026-03-10, completionDateStruct date: 2026-03-15, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-08, sponsorCollaboratorsModule leadSponsor name: Assiut University, class: OTHER, descriptionModule briefSummary: Spina bifida birth prevalence in Africa is 0.13%. Myelomeningocele (MMC) represents the most frequent and most severe cause of NB in children. Treatment of neuropathic bladder secondary to spina bifida is an ongoing challenge. Damage of the renal parenchyma in children with NB is preventable given adequate evaluation, follow-up and proactive management. Proactive management was defined as use of clean intermittent catheterization (CIC), and/or anticholinergics at presentation, or based on initial high-risk urodynamic findings by 1 year of age. The proactive approach to treat SB (CIC and pharmacotherapy) has contributed to decreasing chronic kidney disease (CKD). Myelomeningocele is considered a complex congenital disease. Hence, a multidisciplinary team is the best choice for management of spina bifida, involving neurosurgeons, orthopedic surgeons, urologists, physical medicine and rehabilitation specialists and pediatricians. Currently, children with spina bifida in Egypt must visit multiple different locations to access the complex care they need. Here, we review our experience with patients with spina bifida who will be followed with this team with an emphasis on patients' upper urinary tract protection and decreasing urinary incontinence., conditionsModule conditions: Urologic Diseases, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: PROSPECTIVE, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: CIC, interventions name: Anticholinergic, outcomesModule primaryOutcomes measure: upper tract affection, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Assiut university hospital, status: RECRUITING, city: Assiut, zip: 11571, country: Egypt, contacts name: Islam Mahmoud, DR, role: CONTACT, phone: 00201090088672, email: doctorislam672@gmail.com, geoPoint lat: 27.18096, lon: 31.18368, hasResults: False
|
protocolSection identificationModule nctId: NCT06301789, orgStudyIdInfo id: Quadratus lumborum block, briefTitle: Role of Magnesium Sulphate as an Adjuvant to Bupivacaine in U.S Guided Quadratus Lumborum Block in Lower Abdominal Cancer Surgeries, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2026-02, completionDateStruct date: 2026-03, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-08, sponsorCollaboratorsModule leadSponsor name: Assiut University, class: OTHER, descriptionModule briefSummary: The aim of this study is to assess the efficacy of Mg sulfate ( 10% ) as an adjuvant to Bupivacain ( 0.25 % ) in an U.S guided QLB for postoperative analgesia and postoperative Morphine consumption in lower abdominal cancer surgeries., conditionsModule conditions: QLB in Lower Abdominal Cancer Surgeries as a Post Operative Analgesia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Effect of adding Mg sulphate as an adjuvant to bupivacaine for postoperative analgesia in cases of lower abdominal cancer surgeries, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 52, type: ESTIMATED, armsInterventionsModule interventions name: Effect of adding Mg sulfate as an adjuvant to bupivacain in U/S guided QLB for postoperative analgesia in lower abdominal cancer surgeries, outcomesModule primaryOutcomes measure: Postoperative analgesia, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
|
protocolSection identificationModule nctId: NCT06301776, orgStudyIdInfo id: Bridge-2023-02-0A, briefTitle: A Prospective, Experimental, Multicenter, Open-label, Randomized, Controlled Trial of 3-month Dual Antiplatelet Therapy Followed by Ticagrelor Versus 6-month Dual Antiplatelet Therapy Followed by Ticagrelor After Implanting Bridge, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-12-05, primaryCompletionDateStruct date: 2025-12-31, completionDateStruct date: 2026-06-30, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-08, sponsorCollaboratorsModule leadSponsor name: The Fourth Affiliated Hospital of China Medical University, class: OTHER, descriptionModule briefSummary: To compare the incidence of the composite endpoints of non-fatal ischaemic stroke, transient ischaemia (TIA) and all-cause mortality at 12-month follow-up after implantation of Bridge for the treatment of symptomatic vertebral artery stenosis in subjects who had been taking different durations of dual-antiplatelet therapy (3 vs 6 months) and ticagrelor monotherapy., conditionsModule conditions: Brain Disease, conditions: Vertebral Artery Stenosis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 560, type: ESTIMATED, armsInterventionsModule interventions name: Ticagrelor, outcomesModule primaryOutcomes measure: Incidence of the composite endpoint of non-fatal ischaemic Stroke, TIA, and all-cause mortality at 12-months., secondaryOutcomes measure: Incidence of the composite endpoint of major bleeding and hemorrhagic stroke at 12-months., secondaryOutcomes measure: Incidence of target vessel-related stroke and neurological death at 1month, secondaryOutcomes measure: Incidence of stroke and neurological death at 12 month., secondaryOutcomes measure: Incidence of all-cause mortality at 12 month., secondaryOutcomes measure: Incidence of in-stent-stenosis at 12 month (subgroup of imaging follow-up)., eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: the Fourth Affiliated Hospital of China Medical University, status: RECRUITING, city: Shenyang, state: Liaoning, zip: 110032, country: China, contacts name: Lianbo Gao, role: CONTACT, email: gaolbdoc@163.com, geoPoint lat: 41.79222, lon: 123.43278, hasResults: False
|
protocolSection identificationModule nctId: NCT06301763, orgStudyIdInfo id: nosencekCancer-old, briefTitle: Oral Enteral Nutrition in Delayed Onset Radiotherapy-related Swallowing Disorder in Nasopharyngeal Carcinoma, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-06-01, primaryCompletionDateStruct date: 2022-12-25, completionDateStruct date: 2022-12-31, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: Muhammad, class: OTHER, descriptionModule briefSummary: This is a prospective multicenter study with patients with delayed dysphagia after radiotherapy for NPC. Patients enrolled are randomly divided equally into the observation group and the control group. All patients receive conventional care, and the observation group received IOE while the control group received NGT for enteral nutrition support. Baseline information (demographics, medical history, etc.), nutritional status at admission and after treatment, depression, dysphagia, and quality of life (QOL) after treatment as well as adverse events are compared., conditionsModule conditions: Dysphagia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 56, type: ACTUAL, armsInterventionsModule interventions name: Intermittent Oral-esophageal Tube Feeding, interventions name: nasogastric tube feeding, outcomesModule primaryOutcomes measure: Hemoglobin Level, primaryOutcomes measure: Serum albumin Level, primaryOutcomes measure: Total serum protein Level, primaryOutcomes measure: Serum prealbumin Level, primaryOutcomes measure: Body Mass Index Level, secondaryOutcomes measure: Depression, secondaryOutcomes measure: Swallowing-Quality of Life questionnaire, secondaryOutcomes measure: Functional Oral Intake Scale, secondaryOutcomes measure: Penetration-Aspiration Scale, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Ubonratchathani Hospital, city: Ubon Ratchathani, country: Thailand, geoPoint lat: 15.23844, lon: 104.84866, hasResults: False
|
protocolSection identificationModule nctId: NCT06301750, orgStudyIdInfo id: Tube-Alzheimer, briefTitle: Oral Enteral Nutrition Feeding in Alzheimer's Patients, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2024-06, completionDateStruct date: 2024-06, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: Muhammad, class: OTHER, descriptionModule briefSummary: This is a prospective multicenter study with Alzheimer's patients with dysphagia. Patients enrolled are randomly divided equally into the observation group and the control group. All patients receive conventional care, and the observation group received Intermittent Oral-esophageal Tube Feeding while the control group received Nasogastric Tube Feeding for enteral nutrition support. Baseline information (demographics, medical history, etc.), nutritional status at admission and after treatment, depression, dysphagia, and quality of life after treatment are compared., conditionsModule conditions: Alzheimer Disease, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: Conventional Care, interventions name: Intermittent Oral-esophageal Tube Feeding, interventions name: Nasogastric tube, outcomesModule primaryOutcomes measure: Level of Hemoglobin, primaryOutcomes measure: Level of Serum albumin, primaryOutcomes measure: Level of Total serum protein, primaryOutcomes measure: Level of Serum prealbumin, secondaryOutcomes measure: Body Mass Index, secondaryOutcomes measure: Pulmonary Infections, secondaryOutcomes measure: Mini Nutritional Assessment, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 85 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
|
protocolSection identificationModule nctId: NCT06301737, orgStudyIdInfo id: SGB-YanD, briefTitle: Lidocaine Injection: A Nove Block Therapy for Stroke-related Dysphagia, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-06-21, primaryCompletionDateStruct date: 2023-05-02, completionDateStruct date: 2023-05-17, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-25, sponsorCollaboratorsModule leadSponsor name: Muhammad, class: OTHER, descriptionModule briefSummary: This was a multicenter randomized controlled study. 66 post-stroke patients with pharyngeal dysphagia were randomly allocated to the observation group (n=33) or the control group (n=33). Both groups were provided with comprehensive rehabilitation including routine rehabilitation and swallowing function training. Besides, the observation group additionally underwent the stellate ganglion block (SGB). At admission and after 20-day treatment, Kubota water swallowing test, video fluoroscopic swallowing study (VFSS), and Rosenbek penetration-aspiration scale (PAS) were used to assess swallowing function., conditionsModule conditions: Dysphagia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 65, type: ACTUAL, armsInterventionsModule interventions name: Comprehensive rehabilitation, interventions name: Injection, interventions name: Lidocaine Hydrochloride, outcomesModule primaryOutcomes measure: Video fluoroscopic swallowing study, secondaryOutcomes measure: Rosenbek penetration-aspiration scale, secondaryOutcomes measure: Functional Oral Intake Scale, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Zhen No.1 Hos., city: Taiwan, country: China, geoPoint lat: 32.32812, lon: 118.76384, hasResults: False
|
protocolSection identificationModule nctId: NCT06301724, orgStudyIdInfo id: SGB-PKS, briefTitle: Effectiveness of Stellate Ganglion Block in Individuals With Parkinson's Disease, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2024-06, completionDateStruct date: 2024-06, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: Muhammad, class: OTHER, descriptionModule briefSummary: The goal of this or clinical trial is to explore efficacy of stellate ganglion block on dysphagia and activities of daily living in patients with Parkinson's disease. The main question it aims to answer are:• Can stellate ganglion block improve the dysphagia and activities of daily living in patients with Parkinson's disease.Participants will be divided into the the control group and observation group evenly. All the patients were provided with routine therapy, while the patients in the observation group were given stellate ganglion block. The swallowing function, and activities of daily living of the two groups of patients before and after treatment were evaluated., conditionsModule conditions: Parkinson Disease, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: Injection, interventions name: Lidocaine hydrochloride, outcomesModule primaryOutcomes measure: Penetration-Aspiration Scale, secondaryOutcomes measure: Modified Barthel Index, secondaryOutcomes measure: Functional Oral Intake Scale, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
|
protocolSection identificationModule nctId: NCT06301711, orgStudyIdInfo id: SGB-CVSD, briefTitle: Investigation of Potential Mechanisms in Stellate Ganglion Block in Individuals With Cerebral Small Vessel Disease, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2024-06, completionDateStruct date: 2024-06, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: Ahmadu Bello University Teaching Hospital, class: OTHER, descriptionModule briefSummary: This is a prospective study conducted on patients with Cerebral Small Vessel Disease, dysphagia and cognitive impairment. They were divided into the comparison group and observation group evenly. All the patients were provided with routine therapy, while the patients in the observation group were given Stellate Ganglion Block. The swallowing function, cognitive function and activities of daily living of the two groups of patients before and after treatment were evaluated by Penetration-Aspiration Scale, Mini-mental state examination and modified Barthel index., conditionsModule conditions: Cerebral Small Vessel Diseases, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: Rehabilitation therapy, interventions name: Stellate ganglion block, interventions name: Lidocaine Hydrochloride, outcomesModule primaryOutcomes measure: Penetration-Aspiration Scale, secondaryOutcomes measure: Modified Barthel Index, secondaryOutcomes measure: Mini-Mental State Examination, secondaryOutcomes measure: Swallowing duration, secondaryOutcomes measure: Functional Oral Intake Scale, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
|
protocolSection identificationModule nctId: NCT06301698, orgStudyIdInfo id: SGB-BP, briefTitle: The Effectiveness of Stellate Ganglion Block in Managing Dysphagia in Patients With Medullary Infarction, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2024-06, completionDateStruct date: 2024-06, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: Ahmadu Bello University Teaching Hospital, class: OTHER, descriptionModule briefSummary: This is a randomized controlled study, including dysphagic patients with bulbar palsy after ischemic stroke who were received in the department of rehabilitation medicine. All patients are randomly allocated to the observation group or the control group. Both groups are provided with comprehensive rehabilitation. Besides, the observation group additionally undergoes the stellate ganglion block. At admission and after 10-day treatment, video fluoroscopic swallowing study, and penetration-aspiration scale, Functional Oral Intake Scale, Flexible laryngoscope are used to assess swallowing function., conditionsModule conditions: Bulbar Palsy, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: Comprehensive rehabilitation, interventions name: Injection, interventions name: Lidocaine Hydrochloride, outcomesModule primaryOutcomes measure: Penetration-Aspiration Scale, secondaryOutcomes measure: Functional Oral Intake Scale, secondaryOutcomes measure: Murray secretion severity scale, secondaryOutcomes measure: Yale pharyngeal residue severity rating scale, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
|
protocolSection identificationModule nctId: NCT06301685, orgStudyIdInfo id: SGB-AST, briefTitle: Effectiveness of Lidocaine Injection on Stellate Ganglion in Pediatric Patients With Autism Spectrum Disorder, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2024-06, completionDateStruct date: 2024-06, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: Muhammad, class: OTHER, descriptionModule briefSummary: The goal of this clinical trial is to explore efficacy of stellate ganglion block Children with Autistic Disorder. The main question it aims to answer is:Can stellate ganglion block improve the Autistic Disorder in children? Children with Autistic Disorder will be divided into the control group and experimental group evenly. All the patients were provided with routine therapy, while the patients in the experimental group were given stellate ganglion block. The Childhood Autism Rating Scale of the two groups of patients before and after treatment are evaluated., conditionsModule conditions: Autistic Disorder, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: Routine therapy, interventions name: Injection, interventions name: Lidocaine Hydrochloride, outcomesModule primaryOutcomes measure: Childhood Autism Rating Scale, secondaryOutcomes measure: Children's Communication Checklist, secondaryOutcomes measure: Social Interaction Assessment Scale, secondaryOutcomes measure: Children's Depression Inventory, secondaryOutcomes measure: Childhood Anxiety Sensitivity Index, eligibilityModule sex: ALL, minimumAge: 3 Years, maximumAge: 6 Years, stdAges: CHILD, contactsLocationsModule, hasResults: False
|
protocolSection identificationModule nctId: NCT06301672, orgStudyIdInfo id: NecknoseCancer-Xin, briefTitle: Effect of Oral Enteral Nutrition in Nasopharyngeal Carcinoma Survivors With Swallowing Disorders, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2024-08, completionDateStruct date: 2024-08, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: Muhammad, class: OTHER, descriptionModule briefSummary: This is a prospective multicenter study with patients with delayed dysphagia after radiotherapy. Patients enrolled are randomly divided equally into the observation group and the control group. All patients receive conventional care, and the observation group received Intermittent Oro-esophageal Tube Feeding while the control group received Nasogastric Tube Feeding for enteral nutrition support. Baseline information (demographics, medical history, etc.), nutritional status at admission and after treatment, depression, dysphagia, and quality of life after treatment as well as adverse events are compared., conditionsModule conditions: Dysphagia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Nasogastric Tube Feeding, interventions name: Intermittent Oral-esophageal Tube Feeding, interventions name: comprehensive rehabilitation therapy, outcomesModule primaryOutcomes measure: concentration of Hemoglobin, primaryOutcomes measure: concentration of Serum albumin, primaryOutcomes measure: concentration of Serum prealbumin, primaryOutcomes measure: Body Mass Index, secondaryOutcomes measure: Depression, secondaryOutcomes measure: Functional Oral Intake Scale, secondaryOutcomes measure: Penetration-Aspiration Scale, secondaryOutcomes measure: Feeding amount, eligibilityModule sex: ALL, minimumAge: 30 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
|
protocolSection identificationModule nctId: NCT06301659, orgStudyIdInfo id: Jingxiang-Jiu, briefTitle: Impact of Adapted Mirror Therapy on Individuals With Hemiparesis of the Upper Limb Following a Stroke, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-08-01, primaryCompletionDateStruct date: 2023-07-12, completionDateStruct date: 2023-08-31, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-08, sponsorCollaboratorsModule leadSponsor name: Ahmadu Bello University Teaching Hospital, class: OTHER, descriptionModule briefSummary: Patients with upper limb hemiplegia after stroke, who were admitted in the Department of Rehabilitation Medicine, were enrolled. The study lasted 30 days for each participant. The patients enrolled were randomly divided into the experimental group and the control group, all under routine rehabilitation therapy. Additionally, the patients in the experimental group were given modified mirror therapy. On day 1 and day 30, patients' Upper Limb function were compared., conditionsModule conditions: Hemiparesis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 116, type: ACTUAL, armsInterventionsModule interventions name: routine rehabilitation therapy, interventions name: Modified mirror therapy, outcomesModule primaryOutcomes measure: Fugl-Meyer Assessment-Upper Extremity, secondaryOutcomes measure: coordinated contraction rate-Surface electromyography, secondaryOutcomes measure: Visual Analog Scale, secondaryOutcomes measure: Anxiety, secondaryOutcomes measure: Depression, eligibilityModule sex: ALL, minimumAge: 35 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Center Rehabilitation Hospital, city: Yangon, country: Myanmar, geoPoint lat: 16.80528, lon: 96.15611, hasResults: False
|
Subsets and Splits
No community queries yet
The top public SQL queries from the community will appear here once available.