Record
stringlengths 1
197k
|
|---|
<|newrecord|> nctId: NCT06286670 id: IRB00108312 id: HT94252311075 type: OTHER domain: Department of Defense briefTitle: Single Versus Dual Implant Fixation of Distal Femur Fractures acronym: PRORP overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2026-12 date: 2027-12 date: 2024-02-29 date: 2024-04-16 name: Wake Forest University Health Sciences class: OTHER name: United States Department of Defense briefSummary: The goal of this clinical trial is to compare two types of surgical fixation in patients with specific kinds of distal femur fractures. The main questions it aims to answer is which operation for distal femur fractures is better for efficient return to work and everyday activities. conditions: Articular Fractures studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: adult patients with extra-articular or complete articular distal femur fractures that will be operatively treated recruited from one of the participating sites during the index hospitalization primaryPurpose: TREATMENT masking: NONE count: 144 type: ESTIMATED name: Single Implant Fixation name: Dual Implant Fixation measure: Return to Work - International Physical Activity Questionnaire (IPAQ) Scores measure: Return to Work - International Physical Activity Questionnaire (IPAQ) Scores measure: Return to Work - International Physical Activity Questionnaire (IPAQ) Scores measure: Return to Work - International Physical Activity Questionnaire (IPAQ) Scores measure: Number of Unions measure: Number of Resource Utilizations measure: Number of Reoperations measure: Number of Complications measure: Time to Walking Without an Assistive Device measure: Prescribed Weight Bearing Status measure: Fear of Movement - Change in Tampa Scale for Kinesiophobia (TSK) Scores measure: Health Related Quality of Life - Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Scores measure: Global Health Status - Change in Veterans RAND 12 Item Health Survey (VR12) Scores measure: Change in the Work Productivity and Activity Impairment Questionnaire Scores measure: Change in Numeric Pain Rating measure: Change in Pain Inventory (BPI) measure: Change in Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Subscale--Pain Interference measure: Presence of Post-Traumatic Arthritis (PTOA) - Kellgren Lawrence (KL) classification measure: Presence of Post-Traumatic Arthritis (PTOA) - Paley Grading System (PGS measure: Isokinetic Knee Flexion/Extension Strength Testing measure: Counter-Movement Jump measurement measure: Single Leg Static and Dynamic Postural Stability Index measure: Triple Hop Performance Assessment sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Atrium Health Musculoskeletal Institute city: Charlotte state: North Carolina zip: 28204 country: United States name: Erica Grochowski role: CONTACT email: Erica.Grochowski@atriumhealth.org name: Laurence Kempton, MD role: PRINCIPAL_INVESTIGATOR lat: 35.22709 lon: -80.84313 hasResults: False
|
<|newrecord|> nctId: NCT06286657 id: UVienna23a briefTitle: Xanthohumol and Viral Infections (XL) overallStatus: RECRUITING date: 2023-08-01 date: 2024-04-30 date: 2024-12-30 date: 2024-02-29 date: 2024-02-29 name: University of Vienna class: OTHER briefSummary: The aim of the present study is to determine if a regular oral supplementation of xanthohumol attenuate the severity of symptoms and duration of´viral infections. conditions: Infection Viral studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: BASIC_SCIENCE masking: SINGLE whoMasked: PARTICIPANT count: 100 type: ESTIMATED name: Xanthohumol name: Placebo measure: Changes in severity and duration of viral infections measure: Changes in blood lipid levels measure: Changes in cognitive skills sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Vienna status: RECRUITING city: Vienna zip: 1090 country: Austria name: Ina Bergheim, Prof. Dr. role: CONTACT phone: +43-1-4277-54981 email: ina.bergheim@univie.ac.at lat: 48.20849 lon: 16.37208 hasResults: False
|
<|newrecord|> nctId: NCT06286644 id: UVienna23 briefTitle: Hop Compounds on the Immune System (VH) overallStatus: RECRUITING date: 2022-05-30 date: 2024-05-30 date: 2024-12-30 date: 2024-02-29 date: 2024-02-29 name: University of Vienna class: OTHER briefSummary: The aim of the present study is to determine the effect of Iso-alpha-Acids and Xanthohumol from hops on the immune response of healthy participants over a timeframe of 6 hours. conditions: Inflammatory Response studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: BASIC_SCIENCE masking: SINGLE whoMasked: PARTICIPANT count: 14 type: ESTIMATED name: Xanthohumol name: Iso-alpha-Acids name: Xanthohumol + Iso-alpha-Acids measure: Changes in parameters of immune response measure: Changes in parameters of immune response sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Vienna status: RECRUITING city: Vienna zip: 1090 country: Austria name: Ina Bergheim, Prof. Dr. role: CONTACT phone: +431427754981 email: ina.bergheim@univie.ac.at lat: 48.20849 lon: 16.37208 hasResults: False
|
<|newrecord|> nctId: NCT06286631 id: Rating scale-202402 briefTitle: Prediction of Lymph Node Metastasis in Patients With Thyroid Malignancy by a New Scale overallStatus: RECRUITING date: 2023-05-01 date: 2025-10-01 date: 2026-10-01 date: 2024-02-29 date: 2024-02-29 name: Second Affiliated Hospital of Xi'an Jiaotong University class: OTHER briefSummary: The incidence of papillary thyroid cancer (PTC) has been on the rise in recent years, and 20%-50% of PTC patients will have lymph node metastasis. Lymph node involvement in PTC patients is usually related to the recurrence of PTC after surgery, and 30% of patients recur without lymph node dissection, with the risk of central cervical lymph node metastasis being the greatest, so it seems to be a good choice to perform lymph node dissection on patients after thyroidectomy, but in fact, there are controversies at home and abroad as to whether to perform lymph node dissection or not. The 2021 Chinese Society of Clinical Oncology (CSCO) guidelines for the diagnosis and treatment of differentiated thyroid cancer state that prophylactic central lymph node dissection (PCND) may increase the incidence of postoperative complications, but due to the high metastatic rate of PTC and the ability of PCND to effectively prevent recurrence and reoperation, countries in the East Asian region perform prophylactic lymph node dissection on almost all patients with PTC. However, for more countries in Europe and the United States, performing PCND has become a non-essential, individualized option. The aim of this study is to collect multifactorial data from more than 1,000 patients who have undergone previous thyroidectomy from 2021 to 2023, and to develop a novel scoring scale that can be used to individualize patients' scores based on a variety of factors prior to surgery, so that patients can be more accurately predicted to have lymph node metastasis and need prophylactic lymph node dissection prior to surgery, and patients who do not need dissection can avoid surgery. For patients who do not need lymph node dissection, complications caused by surgery can be avoided, while for patients who do have lymph node metastasis, recurrence of their cancer can be prevented. This will change the status quo of not being able to accurately determine the actual situation through simple preoperative examination or performing prophylactic lymph node dissection for all PTC patients. conditions: Papillary Thyroid Cancer studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: OTHER count: 800 type: ESTIMATED measure: Height measure: Weight measure: Age measure: Genders measure: BMI measure: Whether lymph node dissection was performed during previous surgery measure: Tumor Diameter Size measure: Tumor limitation of the primary focus measure: Extratumoral invasion measure: Pathologic lymph node metastasis measure: Tumor cystic solidity on preoperative ultrasound measure: Preoperative ultrasound tumor echo intensity measure: Preoperative ultrasound tumor boundaries measure: Preoperative ultrasound tumor for the presence of calcifications measure: Preoperative ultrasound tumor aspect ratios measure: Preoperative ultrasound for enlarged cervical lymph nodes measure: TSH measure: TPOAb measure: TgAb measure: Calcium measure: B-raf gene mutation sex: ALL minimumAge: 16 Years maximumAge: 80 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: The Second Affiliated Hospital of Xi'an Jiaotong University status: RECRUITING city: Xi'an state: Shaanxi zip: 710000 country: China name: Yang Liu, doctor role: CONTACT phone: 0086+029-13384986500 email: individualliu@163.com lat: 34.25833 lon: 108.92861 typeAbbrev: Prot hasProtocol: True hasSap: False hasIcf: False label: Study Protocol date: 2023-10-29 uploadDate: 2024-02-22T03:07 filename: Prot_000.pdf size: 79490 typeAbbrev: ICF hasProtocol: False hasSap: False hasIcf: True label: Informed Consent Form date: 2023-10-29 uploadDate: 2024-02-22T03:08 filename: ICF_001.pdf size: 132491 hasResults: False
|
<|newrecord|> nctId: NCT06286618 id: HHSN268201800015I briefTitle: Nutrition360: Moving to Integrated and Holistic Disease Prevention Among Underserved Mississippians overallStatus: ACTIVE_NOT_RECRUITING date: 2022-09-01 date: 2024-08-31 date: 2024-08-31 date: 2024-02-29 date: 2024-02-29 name: University of Southern Mississippi class: OTHER name: My Brother's Keeper briefSummary: The objective for the study is to implement a pilot study to establish essential components to address diet quality in healthcare settings and examine what value an integrated service model delivery has for the primary prevention of cardiometabolic diseases with an initial focus on dietary behaviors. This objective will be met by 1: Utilizing a multiphase optimization study design to select and optimize essential components to address diet behaviors and 2: Comparing an integrated and referral-based delivery model for healthcare-based strategies that address structural and psychosocial barriers to a healthy diet for racial/ethnic minority, marginalized and disadvantaged background young to middle aged adult populations in Mississippi. conditions: Cardiovascular Diseases studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: HEALTH_SERVICES_RESEARCH masking: DOUBLE whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 24 type: ACTUAL name: Psychosocial Intervention name: Structural Intervention name: Traditional Psychosocial+Structural name: Integrated Psychosocial+Structural measure: Participant Burden measure: Diet Quality measure: cost effectiveness sex: ALL minimumAge: 25 Years maximumAge: 50 Years stdAges: ADULT facility: The University of Southern Mississippi city: Hattiesburg state: Mississippi zip: 39406-0001 country: United States lat: 31.32712 lon: -89.29034 hasResults: False
|
<|newrecord|> nctId: NCT06286605 id: UNISS_PHD_Osstem_4 briefTitle: RCT GBR One Stages Comparing A-Oss and Autogenous Bone Versus A-Oss and LCR-A overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2024-12-30 date: 2028-12-30 date: 2024-02-29 date: 2024-02-29 name: Università degli Studi di Sassari class: OTHER name: Dr. Dario Melodia name: Dr. Milena Pisano name: Dr. Aurea Lumbau name: Prof. Silvio Mario Meloni name: Prof. Edoardo Baldoni briefSummary: The aim of this randomized controlled trial is to evaluate the tridimensional bone stability after horizontal one-stage GBR using collagene membrane (OssMem) with a mix of Bovine Bone Substitute (A-Oss) and autogenous bone (test group) versus A-Oss and LCR-A, a synthetic bone (control group). conditions: Guided Bone Regeneration conditions: Dental Implant studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Multicenter, randomized controlled trial of parallel-group design. primaryPurpose: TREATMENT masking: NONE count: 42 type: ESTIMATED name: A-oss and autogenous bone name: A-oss an LCR-A measure: Rate of Implants survival measure: Number of Participants with prosthesis failure measure: Number of complications measure: Horizontal and volumetric dimensional changes measure: Rate of peri-implant marginal bone level measure: Plaque Index and bleeping on probing measure: Valuation of patient satisfaction measure: Valuation of soft tissue thickness and amount of keratinized tissue measure: Rate of pes score sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Marco Tallarico city: Sassari zip: 07100 country: Italy name: Dario Melodia, Dr role: CONTACT phone: 3331226618 email: dariomld1@gmail.com name: Marco Tallarico, Prof role: CONTACT phone: 3280758769 email: me@studiomarcotallarico.it lat: 40.72586 lon: 8.55552 hasResults: False
|
<|newrecord|> nctId: NCT06286592 id: Pro2023002053 briefTitle: LUNGevity: Lung Cancer Stigma Community Based Participatory Research overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2025-11 date: 2025-11 date: 2024-02-29 date: 2024-03-29 name: Rutgers, The State University of New Jersey class: OTHER briefSummary: Lung cancer survival rates are low for intersectional underserved groups. Lung cancer stigma and intersectional stigma related to minoritized group status leads to increased morbidity and mortality and health disparities. Mindfulness interventions have been shown to decrease stigma and the negative impacts of stigma, however, these interventions have never been tested to decrease lung cancer stigma specifically. In this study, the investigators will use Community Based Participatory Research framework and MOST methodology to build and optimize a brief virtual mindfulness intervention to decrease lung cancer stigma, through first building a diverse coalition of lung cancer patients on a participatory action council. conditions: Lung Cancer studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: FACTORIAL interventionModelDescription: Details of the specific interventions will be selected in collaboration with the Community Advisory Board.
|
Then, in a Phase IB trial, we will use a MOST design to assign patients to promising intervention components, combining them and altering exposure time, measuring preliminary effects of possible components of interventions. Details of the specific interventions will be selected in collaboration with the Community Advisory Board. primaryPurpose: TREATMENT masking: NONE count: 100 type: ESTIMATED name: Ultra-brief mindfulness intervention video name: Forgiveness video name: ACT values video measure: Lung Cancer Stigma Inventory (LCSI) measure: Tobacco use quit likelihood sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
|
<|newrecord|> nctId: NCT06286579 id: UNISS_PHD_Osstem_3 briefTitle: SOI Immediately vs Delayed overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2024-12-31 date: 2028-01-31 date: 2024-02-29 date: 2024-02-29 name: Università degli Studi di Sassari class: OTHER name: Dr. Dario Melodia name: Dr. Milena Pisano name: Dr. Aurea M. I. Lumbau name: Prof. Silvio Mario Meloni name: Prof. Edoardo Baldoni briefSummary: The aim of this randomized controlled trial is to compare the clinical and radiographic of immediately loaded, immediate (post-extractive, test group) versus delayed (control group) implants with new SOI surface conditions: Dental Implant conditions: Dental Implant-Abutment Design studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomised controlled trial of parallel group design. primaryPurpose: TREATMENT masking: SINGLE maskingDescription: One "blinded (when possible)" independent assessor whoMasked: OUTCOMES_ASSESSOR count: 70 type: ESTIMATED name: Immediately implant placement name: Delayed measure: Number of prosthesis failure measure: Number of implant failure measure: Number of complications measure: Rate of peri-implant marginal bone level changes measure: Valuation of patient satisfaction measure: Rate of implant stability quotient (ISQ) measure: Valuation of soft tissue thickness and amount of keratinized tissue measure: Number of PES score sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Marco Tallarico city: Sassari zip: 07100 country: Italy lat: 40.72586 lon: 8.55552 hasResults: False
|
<|newrecord|> nctId: NCT06286566 id: UNISS_PHD_Osstem_2 briefTitle: Soi TS3 Surface in Patients With and Without Type 2 Diabetes overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2024-12-31 date: 2028-01-31 date: 2024-02-29 date: 2024-02-29 name: Università degli Studi di Sassari class: OTHER name: Dr. Dario Melodia name: Dr. Milena Pisano name: Dr. Aurea M. I. Lumbau name: Prof. Silvio Mario Meloni name: Prof. Edoardo Baldoni briefSummary: The aim of this prospective cohort study is to compare clinical and radiographic data of Osstem implants with SOI surface placed in patients with or without diabetes. conditions: Dental Implant conditions: Dental Implant-Abutment Design studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Multicenter prospective cohort study primaryPurpose: TREATMENT masking: SINGLE maskingDescription: centralized radiographic assessor, outcome assessors(when possible), and the statistical advisors will be blind to the used implants whoMasked: OUTCOMES_ASSESSOR count: 84 type: ESTIMATED name: Implant placement with soi surface in diabetic subjects name: Implant placement with soi surface in healthy subjects measure: Number of prosthesis failure: measure: Number of implant failure measure: Number of complication measure: Rate of peri-implant marginal bone level changes measure: Valuation of patient satisfaction sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Marco Tallarico city: Rome state: Sassari zip: 07100 country: Italy lat: 41.89193 lon: 12.51133 hasResults: False
|
<|newrecord|> nctId: NCT06286553 id: DRA Rehab TEG & IMT briefTitle: Rehabilitation of Abdominal Diastasis After Childbirth: Trunk and Inspiratory Muscle Training acronym: DR-TIME overallStatus: RECRUITING date: 2024-03-11 date: 2025-05-30 date: 2025-08-30 date: 2024-02-29 date: 2024-03-13 name: University of Patras class: OTHER briefSummary: Diastasis Recti Abdominis (DRA) is the separation of the rectus muscles caused by stretching and thinning of the linea alba during pregnancy and childbirth. It's a common condition, affecting 66-100% of women post-birth and can persist for many years, leading to abdominal protrusion, discomfort, and aesthetic concerns. It might also contribute to back pain, urinary issues, and reduced abdominal strength, impacting quality of life. Recent guidelines propose that conservative management, such as rehabilitation interventions, should be prioritized for DRA. However, there is a lack of consensus among researchers regarding the most effective exercise regimen, resulting in diverse rehabilitation programs. Recent evidence advocates not only for closing the gap but also for achieving optimal function. Current studies often neglect to address functional rehabilitation, underscoring the necessity for robust clinical trials, which is the primary focus of this study.
|
Additionally, although breathing exercises are commonly prescribed for DRA, the precise role of the diaphragm, the primary respiratory muscle, in rehabilitation hasn't been fully examined. The diaphragm forms the upper boundary of the abdominal cavity and plays a key role in the stability of the trunk, working together with the abdominal and pelvic floor muscles. A recent study found reduced diaphragm excursion in postpartum women with lumbopelvic pain during a low postural demanding task, while previous studies suggest that diaphragm training could alleviate such symptoms influencing factors such as diaphragm thickness and excursion, which may be linked to improved trunk stability. Hence, training the diaphragm and accessory inspiratory muscles through Inspiratory Muscle Training (IMT) could potentially play a crucial role in managing DRA.
|
In summary, the goal of this study is to develop and assess a comprehensive rehabilitation program aimed at effectively reducing DRA and addressing associated dysfunctions. The program will integrate evidence-based rehabilitation interventions, such as trunk stabilization exercises and IMT, targeting all related dysfunctions caused by DRA, and introducing a novel therapeutic protocol not previously implemented. The study will take the form of a prospective, randomized controlled trial (RCT). conditions: Diastasis Recti And Weakness Of The Linea Alba conditions: Diastasis, Muscle studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: In this interventional study, three distinct groups are included. The Trunk Exercise Group (TEG) will partake in a comprehensive 12-week therapeutic exercise program that involves progressive strengthening exercises specifically targeting the trunk and pelvic floor muscles, alongside functional retraining exercises. The Trunk Exercise and Inspiratory Muscle Training Group (IMT+TEG) will adhere to the same 12-week therapeutic exercise program as TEG, with additional exercises focusing on strengthening the inspiratory muscles using inspiratory resistance (IMT). The control group (CG) will not participate in the 12-week exercise program but will receive a single exercise session and general management information (oral and written) for DRA. primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 48 type: ESTIMATED name: Trunk exercise name: Inspiratory Muscle Training (IMT) name: Control Group measure: Inter-recti distance (IRD) measure: Diaphragmatic Thickness measure: Diaphragmatic Excursion measure: Maximum Inspiratory Pressure (MIP) measure: Strength Index (S-Index) measure: Peak Inspiratory Flow (PIF) measure: Trunk flexion test measure: Plank test measure: Side plank test measure: McGill's trunk flexor endurance test measure: Body Image States Scale (BISS) measure: Activities Assessment Scale (AAS) measure: Hernia-Related Quality-of-Life Survey (HerQLes) sex: FEMALE minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT facility: Laboratory of Clinical Rehabilitation and Research (CPRlab), University of Patras status: RECRUITING city: Patras state: Achaia, Greece zip: 26504 country: Greece name: Evdokia Billis, PhD role: CONTACT phone: 00306973047170 email: billis@upatras.gr name: Anastasia Skoura, MSc role: CONTACT phone: 00306947784948 email: a.skoura@upatras.gr lat: 38.24444 lon: 21.73444 hasResults: False
|
<|newrecord|> nctId: NCT06286540 id: 26031993 briefTitle: Evaluation of the Efficacy and Safety of Surgical Device "Lymphoblock" for Prevention of Lymphorrhea in Patients With Thoracoabdominal Aorta Repair. overallStatus: RECRUITING date: 2023-02-22 date: 2026-02 date: 2026-05 date: 2024-02-29 date: 2024-03-15 name: Petrovsky National Research Centre of Surgery class: OTHER briefSummary: Randomized, double-blind, placebo-controlled study will determine the clinical efficacy and safety of Lymphoblock in the prevention of postoperative retroperitoneal chylo-/lymphorrhoea in patients with open surgical treatment of the thoracoabdominal aorta. It is planned to recruit 138 clinical observations. Efficacy will be evaluated based on clinical and laboratory data. conditions: Aorta Abdominalis; Aneurysm conditions: Aorta Thoracic; Aneurysm studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 138 type: ESTIMATED name: Lymphoblock name: Placebo measure: Number of Participants with Chylous Effusion (Сhilo-/lymphorrhea) measure: Number of Participants with Lymphocele measure: The amount of drainage discharge 1 measure: The amount of drainage discharge 2 measure: The amount of drainage discharge 3 measure: Concentration of triglycerides in the drainage discharge measure: Concentration of triglycerides in blood plasma measure: Concentration of cholesterol in the drainage discharge measure: Concentration of cholesterol in the blood plasma measure: Concentration of protein in the drainage discharge measure: Concentration of protein in the blood plasma measure: Concentration of albumin in the drainage discharge measure: Concentration of albumin in the blood plasma measure: Concentration of lactate dehydrogenase in the drainage discharge measure: Concentration of lactate dehydrogenase in the blood plasma measure: Concentration of glucose in the drainage discharge measure: Concentration of glucose in the blood plasma measure: Number of Participants with Pleural effusion within 10 days measure: Number of Participants with Lymphocele 3 months after the surgery measure: Number of Participants with Pleural effusion 3 months after the surgery sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Petrovsky NRCS status: RECRUITING city: Moscow zip: 119991 country: Russian Federation name: Denis Breshenkov, Phd role: CONTACT phone: +79773439041 email: denisbreshenkov@gmail.com name: Boris Tivelev role: CONTACT phone: +79044244886 email: boristivelev@gmail.com name: Omar Mutaev role: SUB_INVESTIGATOR lat: 55.75222 lon: 37.61556 hasResults: False
|
<|newrecord|> nctId: NCT06286527 id: EssaiClinique_PREP-QUAL-VS briefTitle: Quality of Sexual Life of PrEP Users acronym: PREP-QUAL-VS overallStatus: NOT_YET_RECRUITING date: 2024-03-06 date: 2024-09-06 date: 2024-09-06 date: 2024-02-29 date: 2024-03-01 name: University Hospital, Grenoble class: OTHER briefSummary: The study will recruit participants on the occasion of their visit in a sexual health center or another HIV pre-exposure prophylaxis (PrEP) facility in France.
|
PrEP users will be proposed to fill a self-administered, online, anonymous questionnaire regarding how they perceive different fields of their sexual life, and how they perceive that PrEP has an impact on the quality of sexual life. conditions: HIV Pre-exposure Prophylaxis Use conditions: Adult studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: OTHER count: 1000 type: ESTIMATED name: anonymous self-administered online questionnaire measure: quality of sexual life as assessed by a set of questions measure: perceived influence of PrEP use on the quality of sexual life sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Olivier EPAULARD city: Grenoble state: Is zip: 38043 country: France name: Olivier EPAULARD, MD, PhD role: CONTACT phone: +33476765291 email: oepaulard@chu-grenoble.fr lat: 45.16667 lon: 5.71667 hasResults: False
|
<|newrecord|> nctId: NCT06286514 id: STUDY00019996 briefTitle: Food at Home Study overallStatus: RECRUITING date: 2024-03-01 date: 2026-03-30 date: 2026-03-30 date: 2024-02-29 date: 2024-04-16 name: University of Minnesota class: OTHER briefSummary: The study objective is to develop an accessible home food environment assessment toolkit that includes valid and reliable paper and electronic tools targeting foods known to impact diet-related health that can be user-administered across literacy levels in English and Spanish. conditions: Obesity conditions: Diet, Healthy studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: CROSS_SECTIONAL count: 350 type: ESTIMATED name: No intervention measure: Usability of HFI core measure: Acceptability of HFI core measure: Concurrent criterion validity of HFI core measure: Concurrent criterion validity of HFI core measure: Convergent construct validity of HFI core measure: Convergent construct validity of HFI core measure: Test-retest reliability of HFI core measure: Usability of eHFI measure: Acceptability of eHFI measure: Concurrent criterion validity of eHFI measure: Concurrent criterion validity of eHFI measure: Convergent construct validity of eHFI measure: Convergent construct validity of eHFI sex: ALL minimumAge: 18 Years maximumAge: 99 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Minnesota status: RECRUITING city: Minneapolis state: Minnesota zip: 55414 country: United States name: Sarah Friend role: CONTACT lat: 44.97997 lon: -93.26384 hasResults: False
|
<|newrecord|> nctId: NCT06286501 id: R23060L briefTitle: Targeting of Preventive Treatment for Adolescents at Risk of Oral Diseases acronym: LumoPrevent overallStatus: NOT_YET_RECRUITING date: 2024-04-18 date: 2025-09-30 date: 2025-12-31 date: 2024-02-29 date: 2024-04-17 name: Wellbeing Services County of Pirkanmaa class: OTHER name: Tampere University name: University of Helsinki name: Metropolia University of Applied Sciences briefSummary: The aim of the study is to identify adolescent patients that are at risk of developing oral diseases, and to assess if targeted preventive oral treatment with antibacterial dual-light therapy as an adjunctive treatment method can have a positive impact in preventing oral diseases from emerging. conditions: Dental Caries in Children conditions: Dental Plaque conditions: Tooth Decay conditions: Periodontitis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomized clinical study on a CE-approved medical device primaryPurpose: PREVENTION masking: SINGLE maskingDescription: Data will be collected using individual study codes for participants. Study codes do not reveal which group the participant has belonged to. whoMasked: OUTCOMES_ASSESSOR count: 120 type: ESTIMATED name: Lumoral Treatment name: Standard, personalized oral health care measure: Bleeding on probing (BOP) measure: Bleeding on probing (BOP) measure: Active matrix metalloproteinase 8 (aMMP-8) measure: Probing Pocket Depth (PPD) measure: Probing Pocket Depth (PPD) measure: Visible plaque index (VPI) measure: Visible plaque index (VPI) measure: Decayed tooth assessment (DT) measure: Clinical attachment level (CAL) measure: Clinical attachment level (CAL) measure: Microbiological evaluation/16S rRNA analysis measure: Microbiological evaluation/16S rRNA analysis measure: Oral-related quality of life measurement (OHIP-14) measure: Absence of adverse effects sex: ALL minimumAge: 14 Years maximumAge: 16 Years stdAges: CHILD facility: Wellbeing Services of County Pirkanmaa city: Tampere state: Pirkanmaa zip: 33520 country: Finland name: Milla Sarja, dentist role: CONTACT phone: +358405337979 email: milla.sarja@pirha.fi name: Mikko Kylmänen role: CONTACT email: mikko.kylmanen@metropolia.fi name: Anna Maria Heikkinen, Professor role: PRINCIPAL_INVESTIGATOR lat: 61.49911 lon: 23.78712 hasResults: False
|
<|newrecord|> nctId: NCT06286488 id: KB/96/2020 briefTitle: Effectiveness and Tolerability of Influenza Vaccine in Patients at Risk for Severe and Complicated Influenza overallStatus: ACTIVE_NOT_RECRUITING date: 2020-09-15 date: 2023-08-23 date: 2026-05-01 date: 2024-02-29 date: 2024-03-01 name: Medical University of Warsaw class: OTHER briefSummary: The aim of the study is to evaluate simultaneously the immunological and clinical efficacy and tolerability of an influenza vaccine, inactivated, quadrivalent, with cleaved virus, in patients at risk for severe and complicated influenza routinely vaccinated against influenza in family medicine clinics or specialty clinics (pediatric, internal medicine, cardiology, gynecological diabetes, pregnant women, transplant). conditions: Influenza conditions: Obesity conditions: Pregnancy; Infection conditions: Elderly Infection conditions: Vaccine Reaction conditions: Vaccine Adverse Reaction conditions: Tolerance studyType: INTERVENTIONAL phases: PHASE4 allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: NONE count: 1500 type: ACTUAL name: Vaxigrip measure: influenza vaccine immunogenicity, seroconversion and seroprotection measure: assessment of vaccination tolerance sex: ALL minimumAge: 18 Years maximumAge: 99 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Department of Social Medicine and Public Health, Medical University of Warsaw city: Warsaw zip: 02-077 country: Poland lat: 52.22977 lon: 21.01178 hasResults: False
|
<|newrecord|> nctId: NCT06286475 id: VGCS-50635-003 briefTitle: A Study of VRG50635 in Healthy Volunteers overallStatus: RECRUITING date: 2024-02-29 date: 2024-05 date: 2024-05 date: 2024-02-29 date: 2024-03-27 name: Verge Genomics class: INDUSTRY briefSummary: The primary objectives of this study are to investigate the safety and tolerability of VRG50635 and to determine how VRG50635 is absorbed by the body. conditions: Healthy Volunteers studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: SEQUENTIAL interventionModelDescription: This is a 2-part study that includes both an open-label (Part 1) and a double-blind, placebo-controlled (Part 2) design. In Part 1, participants will be randomly assigned to receive open-label VRG50635 in 1 of 2 treatment sequences. In Part 2, participants will receive VRG50635 or placebo in a double-blind manner. primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 30 type: ESTIMATED name: VRG50635 name: Placebo measure: Number of Participants with Adverse Events measure: Area Under the Concentration-time Curve from Time 0 Extrapolated to Infinity (AUCinf) measure: Area Under the Concentration-time Curve from Time 0 to the Last Measurable Concentration (AUClast) measure: Area Under the Concentration-time Curve from Time 0 to 24 Hours Post-dose (AUC0-24) measure: Area Under the Concentration-time Curve Between Consecutive Doses (AUCtau) measure: Maximum Observed Concentration (Cmax) measure: Half-life (t1/2) measure: Time of Maximal Plasma Concentration (tmax) sex: ALL minimumAge: 19 Years maximumAge: 55 Years stdAges: ADULT facility: Site 001 status: RECRUITING city: Lincoln state: Nebraska zip: 68502 country: United States lat: 40.8 lon: -96.66696 hasResults: False
|
<|newrecord|> nctId: NCT06286462 id: R01CA278617 type: NIH link: https://reporter.nih.gov/quickSearch/R01CA278617 briefTitle: Evaluation of the Cancer Tracking System (CATSystem) acronym: CATSystem overallStatus: RECRUITING date: 2024-02-05 date: 2026-08-31 date: 2028-01-31 date: 2024-02-29 date: 2024-03-05 name: University of Kansas Medical Center class: OTHER name: Global Health Innovations name: DARTNet Institute name: San Diego State University name: University of Michigan briefSummary: Cervical cancer contributes to significant preventable mortality in Kenya where less than 20% of women are screened. The Cancer Tracking System (CATSystem) is a web-based, algorithm generated tool to promote guideline adherent cervical cancer screening and retention through treatment. The goal of this project is to rigorously evaluate the efficacy, implementation, and cost-effectiveness of the CATSystem to improve rates of screening, treatment, referral, and follow-up care in a matched, cluster randomized controlled trial in 10 Kenyan government hospitals (5 intervention, 5 standard of care). conditions: Cervical Cancer studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Matched, cluster randomized controlled design primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 6600 type: ESTIMATED name: Cancer Tracking System (CATSystem) measure: Guideline adherent treatment for a positive screen measure: Cost-effectiveness of the CATSystem Intervention on screening and treatment outcomes measure: Cervical cancer screening sex: FEMALE minimumAge: 16 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Akala Health Center status: RECRUITING city: Akala country: Kenya name: May H Maloba, MCH role: CONTACT phone: +254720254069 email: maymcurtis@gmail.com name: John Ochieng, BA role: CONTACT phone: +254735870242 email: johnchng5@gmail.com lat: -0.06003 lon: 34.42693 facility: Bondo Referral Hospital status: RECRUITING city: Bondo country: Kenya name: May H Maloba, MCH role: CONTACT phone: +254720254069 email: maymcurtis@gmail.com name: John Ochieng, BA role: CONTACT phone: +254735870242 email: johnchng5@gmail.com lat: 0.23861 lon: 34.26944 facility: Alupe Sub-County Hospital status: RECRUITING city: Busia country: Kenya name: May H Maloba role: CONTACT phone: +254720254069 email: maymcurtis@gmail.com name: John Ochieng role: CONTACT phone: +254735870242 email: johnchng5@gmail.com lat: 0.46005 lon: 34.11169 facility: Busia County Referral Hospital status: RECRUITING city: Busia country: Kenya name: May H Maloba, MCH role: CONTACT phone: +254720254069 email: maymcurtis@gmail.com name: John Ochieng, BA role: CONTACT phone: +254735870242 email: johnchng5@gmail.com lat: 0.46005 lon: 34.11169 facility: Khunyangu Sub-County Hospital status: RECRUITING city: Busia country: Kenya name: May H Maloba role: CONTACT phone: +254720254069 email: maymcurtis@gmail.com name: John Ochieng role: CONTACT phone: +254735870242 email: johnchng5@gmail.com lat: 0.46005 lon: 34.11169 facility: Matayos Health Center status: RECRUITING city: Busia country: Kenya name: May H Maloba role: CONTACT phone: +254720254069 email: maymcurtis@gmail.com name: John Ochieng role: CONTACT phone: +254735870242 email: johnchng5@gmail.com lat: 0.46005 lon: 34.11169 facility: Port Victoria Sub-County Hospital status: RECRUITING city: Busia country: Kenya name: May H Maloba, MCH role: CONTACT phone: +254720254069 email: maymcurtis@gmail.com name: John Ochieng, BA role: CONTACT phone: +254735870242 email: johnchng5@gmail.com lat: 0.46005 lon: 34.11169 facility: Nambale Sub-County Hospital status: RECRUITING city: Siaya country: Kenya name: May H Maloba role: CONTACT phone: +254720254069 email: maymcurtis@gmail.com name: John Ochieng role: CONTACT phone: +254735870242 email: johnchng5@gmail.com lat: 0.06116 lon: 34.28823 facility: Yala Sub-County Hospital status: RECRUITING city: Siaya country: Kenya name: May H Maloba role: CONTACT phone: +254720254069 email: maymcurtis@gmail.com name: John Ochieng role: CONTACT phone: +254735870242 email: johnchng5@gmail.com lat: 0.06116 lon: 34.28823 facility: Ukwala Sub-County Hospital status: RECRUITING city: Ukwala country: Kenya name: May H Maloba role: CONTACT phone: +254720254069 email: maymcurtis@gmail.com name: John Ochieng role: CONTACT phone: +254735870242 email: johnchng5@gmail.com lat: 0.19039 lon: 34.18908 hasResults: False
|
<|newrecord|> nctId: NCT06286449 id: CSV_AUD briefTitle: Identification of Cellular and Molecular Mechanisms Involved in the Pathophysiology of Alcohol Use Disorder by Examination of Cerebrospinal Fluid overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2026-12-31 date: 2026-12-31 date: 2024-02-29 date: 2024-02-29 name: Vastra Gotaland Region class: OTHER_GOV briefSummary: BACKGROUND
|
The brain and spinal cord are enveloped by cerebrospinal fluid (CSF), which extends down to the base of the spine, a few centimeters below the termination of the spinal cord. Here, it can be collected through a minor needle puncture. This procedure enables the gathering of information about otherwise concealed molecular and cellular processes in the brain. Analyzing various specific molecules in the CSF has yielded crucial insights into the underlying mechanisms of many neurological and psychiatric disorders, such as multiple sclerosis (MS) and dementia, significantly enhancing the prospects for its treatment. However, for several brain disorders, including Alcohol Use Disorder (AUD) and substance use disorders, CSF studies are absent. AUD, a brain disease affecting the reward system, is characterized by an inability to limit alcohol consumption. High levels of alcohol intake, as seen in AUD, are a leading cause of morbidity and premature mortality. Yet, there is a lack of effective medications for its treatment. Analyzing molecules in CSF, believed to be significant for the development and maintenance of AUD, could enhance the development of effective pharmacological treatments. At present, there are no CSF studies on individuals with AUD, that explore the underlying mechanisms of the disease. Additionally, several CSF studies lack a representative control group of truly healthy controls (i.e. have not presented any neurological or psychiatric symptoms), which is crucial for drawing accurate conclusions.
|
OBJECTIVE
|
Sub-study 1 aims to collect CSF from individuals with AUD across various ages to analyze brain molecules that contribute to the development and maintenance of the disease.
|
Sub-study 2 aims to gather CSF from healthy controls across various ages to study molecules involved in neurological and psychiatric conditions, including AUD, substance dependency, brain inflammation, and narcolepsy. The goal is to create a reference group of CSF from healthy controls for comparison with CSF collected from individuals with the aforementioned conditions.
|
We hypothesize that levels of certain molecules, such as dopamine, differ between healthy controls and those with e.g. AUD. This study may provide insights into cellular and molecular mechanisms underlying brain disorders, which is in turn crucial for developing new, effective treatments.
|
Sub-study 3 will examine how the incubation of nerve cells in CSF collected in sub-study 1 and 2 affects their excitability and ability to form new synapses, essential for communication in the brain.
|
We hypothesize that the excitability and synaptogenesis of nerve cells will vary depending on whether they are incubated in CSF from neurologically and psychiatrically healthy individuals versus those with AUD, substance use disorders, brain inflammation, and narcolepsy. Understanding how CSF composition influences brain function in these conditions could be instrumental in creating new therapeutic drugs.
|
METHODS
|
Individuals with AUD, as well as psychiatrically and neurologically healthy volunteers, will be successively recruited for CSF collection and analyses. Recruitment will be performed through media advertisements and posters within healthcare facilities (The Sahlgrenska University Hospital) and the University of Gothenburg. Additional participants will be recruited from parallel research projects performed within the group (IV-ASA BO10 dnr: 2019-04120, COMB BO8 dnr 431-18, GlycinA BO5 dnr 806-14, PI Bo Söderpalm and NordAlc BO9 dnr: 430-18, PI Andrea de Bejczy) CSF will be obtained through lumbar puncture (spinal tap), a procedure where a thin needle is inserted below the end of the spinal cord. Local anesthesia will be administered in order to mitigate potential discomfort. The lumbar puncture will be performed by an experienced physician, minimizing the risk of injury. Blood samples will also be collected to correlate molecule levels in CSF with those in the blood. Participants will be interviewed about their medical history including their alcohol consumption, and a comprehensive medical examination will be performed.
|
SIGNIFICANCE
|
CSF studies offers unique insights into the cellular and molecular processes within the brain. This approach has been utilized for exploring the mechanisms behind several psychiatric and neurological disorders, but not for certain brain diseases like AUD. AUD inflicts significant suffering for affected individuals, contributes to high mortality rates, and imposes considerable burdens on the society. Moreover, a deeper understanding of the cellular and molecular underpinnings of brain diseases such as AUD, can facilitate the development of novel, more effective medications for its treatment. conditions: Alcohol Use Disorder studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: The intervention in this study consists of a spinal tap that all study participants undergo. We are comparing biomarkers in cerebrospinal fluid collected from either participants with Alcohol Use Disorder or from healthy controls. primaryPurpose: BASIC_SCIENCE masking: NONE count: 50 type: ESTIMATED name: Spinal tap measure: CSF-DA levels sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
|
<|newrecord|> nctId: NCT06286436 id: IR.SBMU.RETECH.REC.1401.842 briefTitle: Effect of Dual-task Training on the Number of EEG Band in Stroke Patients overallStatus: NOT_YET_RECRUITING date: 2024-02-25 date: 2024-04-29 date: 2024-05-29 date: 2024-02-29 date: 2024-03-01 name: Universidad de Zaragoza class: OTHER briefSummary: Stroke is a prevalent global health concern, causing widespread disability as it disrupts blood supply to the brain, leading to functional impairments. Upper limb dysfunction affects over 80% of stroke survivors acutely and becomes permanent in approximately 60%, hindering daily activities and autonomy. Dual-task training (DTT), involving simultaneous cognitive and motor tasks resembling daily activities, is proposed as an effective intervention.
|
The study suggests using electroencephalogram (EEG) analysis, particularly the Fast Fourier Transform (FFT), to assess changes in brain signals pre- and post-DTT intervention. EEG provides real-time insights into brain function, and FFT analyzes signal frequencies. The intervention involves three tasks performed concurrently with mental calculations, such as sorting blocks and manipulating objects. This 12-session, four-week intervention aims to improve upper limb function. The study explores EEG's role in evaluating DTT effects on stroke patients, particularly using FFT to analyze brain signal frequencies. conditions: Stroke conditions: Electroencephalography studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 5 type: ESTIMATED name: Dual-task training measure: EEG Data measure: Upper limb function measure: Elbow flexor muscle tone measure: Wrist extension range of motion measure: ADLs sex: FEMALE minimumAge: 35 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Shahid Beheshti University of Medical Sciences city: Tehran state: Velenjak country: Iran, Islamic Republic of name: Borhan Asadi, Eng role: CONTACT lat: 35.69439 lon: 51.42151 hasResults: False
|
<|newrecord|> nctId: NCT06286423 id: HSR220446 briefTitle: Colchicine in Acutely Decompensated HFREF overallStatus: RECRUITING date: 2024-03 date: 2026-02 date: 2028-02 date: 2024-02-29 date: 2024-03-20 name: University of Virginia class: OTHER briefSummary: This is a double blind, placebo-controlled pilot trial randomizing patients admitted to the hospital with acutely decompensated heart failure (ADHF) and inflammation to receive either colchicine or matching placebo.
|
Upon enrollment, patients will be randomized 1:1 to receive either the experimental drug (Colchicine) or matching placebo. The regimen in the active arm will consist of 14 days of Colchicine 0.6 mg bid followed by 76±14 days of Colchicine 0.6 mg once per day. Placebo regimen will be analogous, with one pill bid for 14 days followed by one pill once per day for 76 days. Dose reduction for patients with Stage III chronic kidney disease is allowed as detailed in the protocol. At the same time, dose reduction can also be elected in case of GI symptoms. The study team will transiently stop the experimental medication in case of acute kidney injury (AKI), defined per Kidney Disease Improving Global Outcomes (KDIGO) Stage I, as specified in the protocol.
|
These patients will continue with their standard of care for the management of heart failure which consists of a combination of medications that relieve congestion, normalize blood pressure and heart rate, and block the effects of hormones on the heart. The proposed treatment will be in addition to standard of care. No standard of care medications will be withheld. While inflammation is a known risk factor in heart failure, there are no standard anti-inflammatory drugs used in patients with heart failure, as the benefit is not established. The study team will study colchicine, an anti-inflammatory drug, as compares with placebo.
|
Blood will be obtained from the patients in order to measure hsCRP and IL-6. Blood samples will be collected at baseline, 24±6h, 48±6h and 72±6h after treatment initiation, and subsequently at 14±7 days and at study closure. The first four blood samples will be obtained while the subject is still admitted to the hospital. The blood sample at 14±7 days will be obtained during an outpatient encounter. A study closure visit with clinical assessment and experimental drug collection for capsule counting to assess compliance will be conducted at 90±14; the final blood sample will be collected at that time. conditions: Heart Failure conditions: Decompensated Heart Failure conditions: Heart Failure With Reduced Ejection Fraction studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The study team is planning to use controls in the present study. Controls will be patients from the target population, i.e. acutely decompensated heart failure with reduced ejection fraction. primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 30 type: ESTIMATED name: Colchicine 0.6 mg name: Control/Placebo group measure: Difference in the change in high sensitivity C-reactive protein (hsCRP) between colchicine arm and placebo arm in the first 72 hours of treatment measure: Difference in hsCRP area under curve between colchicine and placebo arm at 14 days measure: Difference in change in plasma IL-6 concentration between colchicine arm and placebo arm in the first 72 hours of treatment measure: Difference in the incidence of a composite of all-cause mortality or hospitalizations for heart failure at 90 days sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: UVA Health status: RECRUITING city: Charlottesville state: Virginia zip: 22908 country: United States name: Austin Hogwood role: CONTACT email: ach2jb@virginia.edu name: Francesco Moroni, MD role: CONTACT email: nmf7mm@uvahealth.org name: Antonio Abbate, MD role: PRINCIPAL_INVESTIGATOR lat: 38.02931 lon: -78.47668 hasResults: False
|
<|newrecord|> nctId: NCT06286410 id: 184950 briefTitle: Accommodation Response in Hypermetropic Anisometropia (ARIHA Study) acronym: ARIHA overallStatus: NOT_YET_RECRUITING date: 2024-02 date: 2024-12 date: 2024-12 date: 2024-02-29 date: 2024-03-01 name: University of Sheffield class: OTHER name: Sheffield Children's NHS Foundation Trust briefSummary: Anisometropic amblyopia is when one eye has a much stronger glasses prescription than the other, causing poor vision in one eye, even with glasses, because the brain favours the better-seeing eye.
|
With standard care treatment (glasses plus either patching or atropine drops given to the better seeing eye), 35% of children with anisometropic amblyopia do not have any significant visual improvements, and will have reduced vision in one eye for life. There is no consensus for the reasons why some children do not respond as well as others.
|
Recent research using the Plusoptix PowerRefractor (PR3), which quickly measures eye focusing (accommodation), suggested that in children with anisometropic amblyopia, the focusing of the amblyopic eye might influence treatment success. However, such measurements weren't previously common due to equipment limitations in clinics.
|
The investigators aim to use the non-invasive PR3 to assess accommodation in hypermetropic anisometropic amblyopia, at the University of Sheffield. This will be a two-phase study of children aged 4-10 years who have hypermetropic anisometropia. The investigators will recruit participants attending the Ophthalmology Department at Sheffield Children's NHS Foundation Trust (SCH). The investigators will take repeated measurements of accommodation at points during standard care treatment (phase 1) and conduct a pilot intervention study (phase 2) to determine whether adjusting glasses prescriptions based on accommodation responses with amblyopia treatment can improve vision in the weaker eye. The goal is to gather evidence to inform a future larger multicentre RCT to improve the visual outcomes for anisometropic amblyopic children in the future. conditions: Anisometropic Amblyopia conditions: Accommodation Disorder studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL interventionModelDescription: During Phase 2 of the study:
|
The participants found to have residual amblyopia following standard care treatment (completed treatment but still have unequal vision) and asymmetrical accommodation (following their PR3 measurements and data interpretation), will be offered an intervention dependent upon their type of asymmetrical accommodation. There will not be any cross over in the treatment arms, and no randomisation during this pilot study, as the interventions differ and are bespoke to each patient.
|
Asymmetrical accommodation can be one of two things: Aniso-A and Anti-A. primaryPurpose: TREATMENT masking: NONE count: 22 type: ESTIMATED name: Bespoke glasses prescription worn during amblyopia treatment. measure: Change in visual acuity measure: Change in PR3 accommodation measurements sex: ALL minimumAge: 4 Years maximumAge: 10 Years stdAges: CHILD facility: Division of Ophthalmology & Orthoptics, School of Allied Health Professions, Nursing and Midwifery, The University of Sheffield city: Sheffield state: South Yorkshire zip: S10 2RX country: United Kingdom name: Holly Geraghty role: CONTACT phone: 0114 215 9005 email: hgeraghty@sheffield.ac.uk name: Gemma Arblaster role: CONTACT phone: 0114 215 9005 email: g.arblaster@sheffield.ac.uk name: Holly Geraghty role: PRINCIPAL_INVESTIGATOR lat: 53.38297 lon: -1.4659 hasResults: False
|
<|newrecord|> nctId: NCT06286397 id: 855173 briefTitle: Topical Anti-Androgens in Pilonidal Sinus Disease overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2027-05-01 date: 2027-12-01 date: 2024-02-29 date: 2024-03-04 name: University of Pennsylvania class: OTHER briefSummary: The goal of this randomized clinical trial is to test the topical drug clascoterone in patients with pilonidal disease, which is a common, benign skin condition of the gluteal cleft. The main questions it aims to answer are:
|
* Does clascoterone improve the severity of pilonidal disease as scored by a physician?
|
* Does clascoterone improve patient symptoms due to pilonidal disease?
|
* Does clascoterone improve the inflammation seen under the microscope in pilonidal disease removed at surgery Participants will apply clascoterone or a placebo cream to the diseased area for 3 months. They will be assessed every 4 weeks for disease severity assessed by a physician viewing patient photos and a symptom-based survey.
|
Researchers will compare participants who received clascoterone treatment to those who received placebo. conditions: Pilonidal Disease conditions: Pilonidal Disease of Natal Cleft conditions: Pilonidal Sinus conditions: Pilonidal Cyst studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomized, Double-Blinded, Placebo-Controlled Trial primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 75 type: ESTIMATED name: 1% Clascoterone name: Vehicle Cream measure: Physician-Assessed Disease Severity Assessment measure: Dermatology Life Quality Index measure: Subcutaneous Inflammation sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Pennsylvania city: Philadelphia state: Pennsylvania zip: 19103 country: United States name: Lillias Maguire, MD role: CONTACT phone: 215-662-2078 email: lillias.maguire@pennmedicine.upenn.edu name: Lillias Maguire, MD role: PRINCIPAL_INVESTIGATOR lat: 39.95233 lon: -75.16379 hasResults: False
|
<|newrecord|> nctId: NCT06286384 id: LEMU47 briefTitle: Evaluating the Long-term Effects of Microfocused Ultrasound on Facial Tightening Using Quantitative Instruments overallStatus: RECRUITING date: 2023-07-03 date: 2024-09-15 date: 2025-03-15 date: 2024-02-29 date: 2024-02-29 name: First Affiliated Hospital of Jinan University class: OTHER briefSummary: By utilizing standardized photographs in conjunction with quantification detection instruments, data analysis before and after treatment is conducted, along with long-term efficacy observations. This approach aims to provide more comprehensive scientific evidence for the clinical application of ultrasound treatment in anti-aging therapy. conditions: Facial Aging studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: PROSPECTIVE count: 32 type: ESTIMATED measure: Total Volume Change of Nasolabial Folds measure: Change in Maximum Depth of Nasolabial Folds measure: Vertical Elevation Value of Nasolabial Fold Curve Projection Curve measure: Elevation Value of Nasolabial Fold Curve Projection Curve (Along the Nasal Wing Method measure: Change in Mid-Facial Volume measure: Brow Lift Height sex: FEMALE minimumAge: 25 Years maximumAge: 60 Years stdAges: ADULT facility: First Affiliated Hospital of Jinan University status: RECRUITING city: Guangzhou state: Guangdong zip: 510000 country: China name: Xuangu LI role: CONTACT phone: +8613825136477 email: 443747565@qq.com lat: 23.11667 lon: 113.25 hasResults: False
|
<|newrecord|> nctId: NCT06286371 id: 2023-13/37 briefTitle: Pelvic Neuro-Angiogenesis in Deep Endometriosis overallStatus: RECRUITING date: 2023-12-01 date: 2024-09 date: 2025-04 date: 2024-02-29 date: 2024-03-04 name: Uludag University class: OTHER briefSummary: Endometriosis is observed in one out of every ten women in society, causing endometrial cells to be found outside their normal location in the body and proliferate in other locations, leading to fibrosis in the tissue due to the secretion of various factors from the cells. Additionally, the substances secreted by the cells can cause various other changes in the tissue besides fibrosis. Increased neurogenesis and neovascularization are among the primary changes, which occur as a result of the secretion of substances from the cells. Increased neovascularization, neurogenesis, and fibrosis in the tissue lead to the formation of nodular structures in the pelvic region, resulting in pain development in women.
|
Nodular formations in the pelvic region due to endometriosis are especially observed in the rectovaginal space. Despite being small in size, they can induce increased neovascularization and neurogenesis even in healthy peritoneal tissue due to the microenvironment they create, leading to different clinical symptoms clinically. However, it is not known how far these changes occur around the endometriotic nodule in the presence of endometriosis.
|
In this project, in patients operated on due to endometriosis, the density of nerve and vascular structures in the surgical margins of the peritoneal tissue excised along with the nodule, and the synthesis and release of chemical mediators causing pain (e.g., Bradykinin, Substance-P) are evaluated. The aim is to determine the minimum surgical margin where excision should be applied in surgery and to demonstrate any endometriotic changes that may exist in the tissues, even though they may appear macroscopically healthy. conditions: Endometriosis-related Pain conditions: Endometriosis conditions: Deep Endometriosis conditions: Endometriosis; Peritoneum studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 15 type: ESTIMATED name: Laparoscopic Endometriosis Surgery measure: Density of Neuro-Angiogenesis measure: Density of Pain Mediators in Pelvic Peritoneum measure: Relationship between Neuro-Angiogenesis Density and Pelvic Pain Scores sex: FEMALE minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: Uludag University Faculty Hospital status: RECRUITING city: Bursa state: Gorukle zip: 16285 country: Turkey name: Kiper Aslan, Assoc. Prof. role: CONTACT phone: +905548127272 email: kiperaslan@uludag.edu.tr name: Erberk Cimer, M.D. role: CONTACT phone: +905316770596 name: Kiper Aslan, Assoc. Prof. role: PRINCIPAL_INVESTIGATOR name: Erberk Cimer, M.D. role: PRINCIPAL_INVESTIGATOR name: Isil Kasapoglu, Assoc. Prof. role: SUB_INVESTIGATOR name: Cihan Cakir, M.D. role: SUB_INVESTIGATOR name: Berrin Avci, Prof. role: SUB_INVESTIGATOR name: Gurkan Uncu, Prof. role: SUB_INVESTIGATOR lat: 40.19559 lon: 29.06013 hasResults: False
|
<|newrecord|> nctId: NCT06286358 id: P2023/346 / CCB : B40620230001 briefTitle: Aortopathy Relationship To Imagery and Kinocardiography Features (ARTIK) acronym: ARTIK overallStatus: RECRUITING date: 2024-03-07 date: 2025-03-30 date: 2025-09-30 date: 2024-02-29 date: 2024-03-12 name: Université Libre de Bruxelles class: OTHER name: Erasme University Hospital briefSummary: Kinocardiography (KCG) is a portable measurement technique developed to estimate cardiac mechanical performance by studying the vibrations produced by myocardial contraction during each heartbeat and transmitted to the body surface.
|
The goal of this observational study is to learn about kinocardiography in patients with aortic valve disease (AVD) or thoracic aortic aneurysm (TAA). The investigators believe that this technology will enable us to diagnose aortic valve disease and aortic aneurysm.
|
In patients with AVD of different severities or TAA, the investigators will collect informations from echocardiography and/or cardiac magnetic resonance imaging and KCG recordings. Researchers will also compare subjects without any AVD nor TAA to better understand these effects on KCG. conditions: Aortic Valve Disease conditions: Aortic Aneurysm studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 180 type: ESTIMATED name: Kinocardiography measure: Understand and assess the complex mechanisms underlying the modifications of KCG signals in patients with AVD and/or TAA measure: Comparing KCG to clinical assessment measure: Asses the clinical application of KCG to diagnose AVD and TAA sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Erasme hospital status: RECRUITING city: Brussels zip: 1070 country: Belgium name: Philippe van de Borne, MD, PhD role: CONTACT phone: 2 555 39 60 phoneExt: +32 email: philippe.vandeborne@hubruxelles.be name: Philippe van de Borne, MD, PhD role: PRINCIPAL_INVESTIGATOR name: Elza Abdessater, MD role: SUB_INVESTIGATOR lat: 50.85045 lon: 4.34878 hasResults: False
|
<|newrecord|> nctId: NCT06286345 id: 17644 briefTitle: Lifestyle InterVEntion Study in General Practice: LIVES - GP acronym: LIVES-GP overallStatus: RECRUITING date: 2023-08-01 date: 2025-03-01 date: 2025-07-01 date: 2024-02-29 date: 2024-03-04 name: University Medical Center Groningen class: OTHER name: GGZ Drenthe Mental Health Institution briefSummary: Patients with depression are at a substantially increased risk of chronic physical disease including cardiovascular disease. This may be attributed primarily to an unhealthy lifestyle related to their disorder. Interestingly, the unhealthy lifestyle feeds back to decreased quality of life and increased depressive symptoms, thus creating a hazardous vicious circle. Consequently, there is a great potential for 'Lifestyle Medicine' for depression. Yet, it is known that patients with depression often have motivational and self-management problems. Therefore an 18 session multimodal lifestyle intervention (MLI) specifically tailored to the needs of depressed patients was developed and piloted in mental health care, with promising results. This research aims to investigate using a process evaluation the feasibility of this MLI in general practice because this is the setting where the majority of patients with depression are treated and results from mental health care are unlikely to apply. conditions: Depression, Unipolar conditions: Cardiovascular Diseases studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Uncontrolled cohort study primaryPurpose: TREATMENT masking: NONE count: 50 type: ESTIMATED name: GLI-LEEF measure: Reach of GLI-LEEF measure: General practice adoption of GLI-LEEF measure: General practitioner adoption of GLI-LEEF measure: Lifestyle coach adoption of GLI-LEEF measure: Adherence to GLI-LEEF measure: Drop-out from GLI-LEEF measure: Barriers and facilitators of the GLI-LEEF implementation measure: Body weight of the participant as assessed by a medical weight scale measure: Body height of the participant as assessed by a stadiometer measure: Waist circumference of the participant as assessed using a tape meter line measure: Diastolic and systolic blood pressure as assessed using a sphygmomanometer measure: Treatment success on several domains by according to the Outcome Questionnaire-45 (OQ-=45) measure: Recovery of the participant according to the Individual Recovery Outcomes - Counter (I.ROC) measure: Wellbeing as assessed by the Mental Health Continuum Short Form (MHC-SF) measure: Self esteem according to the Rosenberg Self-Esteem Scale (RSES) measure: Insomnia according to the Insomnia Severity Index (ISI) measure: Quality of life according to the Recovering Quality of Life (ReQol) measure: Health care consumption and productivity loss according to the Treatment Inventory of Costs in Patients with psychiatric disorders (TIC-P) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University Medical Center Groningen status: RECRUITING city: Groningen zip: 9700 AD country: Netherlands name: Huibert Burger, MD PhD role: CONTACT phone: +31(0)50 361 6722 phoneExt: 6722 email: h.burger@umcg.nl name: Patrick Brink role: CONTACT phone: +31(0)50 361 6724 phoneExt: 6724 email: p.brink@umcg.nl lat: 53.21917 lon: 6.56667 hasResults: False
|
<|newrecord|> nctId: NCT06286332 id: Interventional briefTitle: Music Therapy in Acute Leukemia Patients With Fatigue overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2026-03-01 date: 2026-03-01 date: 2024-02-29 date: 2024-03-06 name: Chang Gung University class: OTHER briefSummary: The objective of this study is to assess the efficacy of employing music therapy in alleviating fatigue and medical laboratory values among patients with acute myeloid leukemia. conditions: Acute Myeloid Leukemia conditions: Fatigue studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: DOUBLE whoMasked: CARE_PROVIDER whoMasked: OUTCOMES_ASSESSOR count: 60 type: ESTIMATED name: Music Therapy measure: Change from baseline in fatigue on the Tang Fatigue Rating Scale (TFRS) and 11-point Numeric Rating Scale (NRS-11) at day 21. measure: Change from baseline in neutrophil, hemoglobin, abumin at day 21. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
|
<|newrecord|> nctId: NCT06286319 id: 23-00726 briefTitle: Cold Oxygen Lung Preservation and Ventilation With the "Angel Cooler" overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2026-04 date: 2026-04 date: 2024-02-29 date: 2024-02-29 name: NYU Langone Health class: OTHER briefSummary: The objective of this feasibility study is to evaluate continuous temperature monitoring, oxygen (O2) concentration and ventilation with positive end expiratory pressure (PEEP) to keep lungs cooled at 4-8 degrees Celsius, with continuous O2 concentration of 100% and inflated with a PEEP of 8-10 during the entire cold ischemic period. conditions: Lung Diseases studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: DEVICE_FEASIBILITY masking: NONE count: 20 type: ESTIMATED name: Angel Cooler measure: Proportion of Devices Deemed "Functional" sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: NYU Langone Health city: New York state: New York zip: 10016 country: United States lat: 40.71427 lon: -74.00597 hasResults: False
|
<|newrecord|> nctId: NCT06286306 id: 2022_0232 id: 2022-A02813-40 type: OTHER domain: ID-RCB number, ANSM briefTitle: Pronostic Value of Fluid Responsiveness Evaluated by Inferior Vena Cava Collapsibility Index in Patients Admitted in ICU With Acute Respiratory Failure acronym: PRIVACY overallStatus: RECRUITING date: 2023-02-24 date: 2025-05-25 date: 2025-05-25 date: 2024-02-29 date: 2024-02-29 name: University Hospital, Lille class: OTHER briefSummary: Acute respiratory failure represents a frequent cause of admission to intensive care units (ICUs). In the absence of tailored interventions, it poses an imminent threat to patients' lives. Most patients admitted in ICU undergo fluid expansion to enhance oxygen delivery and preserve cellular function.
|
This practice is grounded in the concept of " preload responsiveness ". However, the accrual of positive fluid balance resulting from fluid administration is now acknowledged as an autonomous risk factor for mortality.
|
Consequently, preload unresponsiveness assumes a pathological character, potentially indicative of fluid overload or right ventricular dysfunction, both deleterious conditions linked to unfavorable outcomes.
|
Maintaining patients in a preload-responsive state may be interesting to limit fluid expansion and the need of invasive mechanical ventilation.
|
The objective of this prospective observational study is to evaluate the prognostic significance of preload responsiveness in patients admitted to the ICU with hypoxemic, non-hypercapnic respiratory failure.
|
* Main objective: To evaluate the association between fluid responsiveness, assessed by the inferior vena cava collapsibility index (cIVC) with trans-thoracic echocardiography within the initial 48 hours post-ICU admission, and mortality or the need for invasive mechanical ventilation by day 28 in patients admitted to the ICU for hypoxemic, non-hypercapnic acute respiratory failure.
|
* Secondary objectives: To evaluate the association between fluid responsiveness and mortality at day 28 and day 90, the need of invasive mechanical ventilation, and the number of days free from organ support (vasopressors, mechanical ventilation and renal replacement therapy) by day 28.
|
Upon receipt of both oral and written information, patients will provide non-objection to participate in the study. This prospective single-center study has obtained approval from the Regional Ethics Committee of Ile de France III approval (No. 2022-A02813-40). conditions: Hypoxemic Without Hypercapnia Acute Respiratory Failure studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 50 type: ESTIMATED measure: Association between fluid responsiveness and death or the need of invasive mechanical ventilation measure: All cause mortality measure: Need of invasive mechanical ventilation measure: Days alive without vasopressor agents measure: Days alive without mechanical ventilation or oxygen support measure: Days alive without renal replacement therapy measure: Days alive without vasopressor agents, mechanical ventilation, oxygen support, and renal replacement therapy sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hopital Roger Salengro status: RECRUITING city: Lille zip: 59037 country: France name: PREAU Sebastien, Md PHd role: CONTACT phone: 03 20 44 64 45 email: sebastien.preau@chu-lille.fr name: Delforge Quentin, Md role: CONTACT phone: 0320446445 email: quentin.delforge@chu-lille.fr lat: 50.63297 lon: 3.05858 hasResults: False
|
<|newrecord|> nctId: NCT06286293 id: 18171 briefTitle: YOD-RiSoCo: Social Cognition and Risky Decision-making in Patients With Young-onset Dementia acronym: YOD-RiSoCo overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2026-06-30 date: 2027-03-31 date: 2024-02-29 date: 2024-03-04 name: University Medical Center Groningen class: OTHER name: ZonMw: The Netherlands Organisation for Health Research and Development briefSummary: The goal of this observational study is to learn about social cognition and risky behaviour in patients with young-onset dementia (YOD). The investigators want to
|
* Examine differences in performance on social cognition test and measures of risky behaviour between behavioural variant YOD patients, patients with frontal brain injury, non-behavioural YOD patients and healthy controls.
|
* Examine if there is a relation between social cognition tests and measures of risky behaviour.
|
Participants will be administered a neuropsychological assessment including social cognition measures and patients will complete a driving simulator task in which risky behaviour will be elicited. conditions: Young-onset Dementia studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: CROSS_SECTIONAL count: 140 type: ESTIMATED name: Neuropsychological assessment, driving simulator task measure: Social cognitive performance measure: Association between social cognition and risky decision-making sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
|
<|newrecord|> nctId: NCT06286280 id: AZ221/21 id: F/23/22 type: OTHER_GRANT domain: German Foundation of Heart Research briefTitle: Removal Of CytoKines With cytoSorbenTs After Inflammatory Response Reaction During Cardiac Surgery acronym: ROCKSTAR overallStatus: RECRUITING date: 2023-05-01 date: 2024-12-01 date: 2025-05-01 date: 2024-02-29 date: 2024-03-18 name: University of Giessen class: OTHER name: Deutsche Stiftung für Herzforschung briefSummary: Detailed knowledge about the association between systemic inflammation and endothelial progenitor cell (EPCs) activation during extracorporeal circulation (ECC) is lacking.
|
This pilot study aims to clarify the relationship between CD34-positive EPCs and cytokine release during ECC using the cytokine adsorber to make a predictive statement regarding the clinical expression of inflammation. conditions: Inflammatory Response studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: single-center, two-arm randomized-controlled prospective study primaryPurpose: BASIC_SCIENCE masking: SINGLE maskingDescription: Participant will not be informed about group allocation whoMasked: PARTICIPANT count: 50 type: ESTIMATED name: cytokine adsorber (CytoSorb®) measure: correlation of endothelial progenitor cells with cytokine levels with and without adsorber use measure: Overall mortality rate measure: Days on ventilator, vasopressor and renal replacement therapy measure: incidence of stroke measure: length of ICU and in-hospital stay measure: Echocardiographic changes measure: Influence of Cytokine on endothelial progenitor cells sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Universityhospital Giessen, Department of Cardiovascular Surgery status: RECRUITING city: Giessen zip: 35392 country: Germany name: Zulfugar T Taghiyev, MD, MBA role: CONTACT phone: 80064198556743 email: gk5019@uni-giessen.de name: Zulfugar T Taghiyev, MD, MBA role: PRINCIPAL_INVESTIGATOR lat: 50.58727 lon: 8.67554 hasResults: False
|
<|newrecord|> nctId: NCT06286267 id: SYSKY-2023-351-02 briefTitle: AI-Assisted System for Accurate Diagnosis and Prognosis of Breast Phyllodes Tumors overallStatus: RECRUITING date: 2023-03-01 date: 2027-12-31 date: 2027-12-31 date: 2024-02-29 date: 2024-02-29 name: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University class: OTHER name: Sun Yat-sen University name: Peking University Shenzhen Hospital name: Guangdong Provincial Maternal and Child Health Hospital name: The Third Affiliated Hospital of Guangzhou Medical University briefSummary: Breast phyllodes tumor (PT) is a rare fibroepithelial tumor, accounting for 1% to 3% of all breast tumors, categorized by the WHO into benign, borderline, and malignant, based on histopathology features such as tumor border, stromal cellularity, stromal atypia, mitotic activity and stromal overgrowth. Malignant PTs account for 18%-25%, with high local recurrence (up to 65%) and distant metastasis rates (16%-25%). Benign PT could progress to malignancy after multiple recurrences. Therefore, Early, accurate diagnosis and identification of therapeutic targets are crucial for improving outcomes and survival rates.
|
In recent years, there has been growing interest in the application of artificial intelligence (AI) in medical diagnostics. AI can integrate clinical information, histopathological images, and multi-omics data to assist in pathological and clinical diagnosis, prognosis prediction, and molecular profiling.AI has shown promising results in various areas, including the diagnosis of different cancers such as colorectal cancer, breast cancer, and prostate cancer. However, PT differs from breast cancer in diagnosis and treatment approach. Therefore, establishing an AI-based system for the precise diagnosis and prognosis assessment of PT is crucial for personalized medicine.
|
The research team, led by Dr. Nie Yan, is one of the few in Guangdong Province and even nationally, specializing in PT research. Their team has been conducting research on the malignant progression, metastasis mechanisms, and molecular markers for PT. The team has identified key mechanisms, such as fibroblast-to-myofibroblast differentiation, and the role of tumor-associated macrophages in promoting this differentiation. They have also identified molecular markers, including miR-21, α-SMA, CCL18, and CCL5, which are more accurate in predicting tumor recurrence risk compared to traditional histopathological grading.
|
The project has collected high-quality data from nearly a thousand breast PT patients, including imaging, histopathology, and survival data, and has performed transcriptome gene sequencing on tissue samples. They aim to build a comprehensive multi-omics database for breast PT and create an AI-based model for early diagnosis and prognosis prediction. This research has the potential to improve the diagnosis and treatment of breast PT, address the disparities in breast PT care across different regions in China, and contribute to the development of new therapeutic targets. conditions: Phyllodes Breast Tumor conditions: Artificial Intelligence conditions: Multiomics conditions: Prognostic Cancer Model conditions: Diagnosis studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: OTHER count: 4000 type: ESTIMATED name: imaging measure: Sensitivity measure: False-negative Rate measure: Specificity measure: False-positive Rate measure: Receiver Operating Characteristic Curve measure: Area under roc Curve sex: FEMALE stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Sun Yat-sen University Cancer Center status: RECRUITING city: Guangzhou state: Guangdong zip: 510050 country: China name: Feng Ye, Prof.Dr. role: CONTACT phone: 15914388994 lat: 23.11667 lon: 113.25 facility: Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University status: RECRUITING city: Guangzhou state: Guangdong zip: 510120 country: China name: Yan Nie, Prof.Dr. role: CONTACT phone: +86 020-81332587 email: nieyan7@mail.sysu.edu.cn lat: 23.11667 lon: 113.25 facility: The Third Affiliated Hospital of Guangzhou Medical University status: RECRUITING city: Guangzhou state: Guangdong zip: 510145 country: China name: Hui Mai, Prof.Dr. role: CONTACT phone: 13925129112 lat: 23.11667 lon: 113.25 facility: Guangdong Maternal and Child Health Hospital status: RECRUITING city: Guangzhou state: Guangdong zip: 511400 country: China name: Yu Tan, Prof.Dr. role: CONTACT phone: 13632356526 lat: 23.11667 lon: 113.25 hasResults: False
|
<|newrecord|> nctId: NCT06286254 id: CYCL-NTTF-2023 briefTitle: Study of Safety and Efficacy of the Drug Cycloferone in Patients With Acute Respiratory Viral Infection overallStatus: ACTIVE_NOT_RECRUITING date: 2023-09-20 date: 2024-02-20 date: 2024-07-30 date: 2024-02-29 date: 2024-02-29 name: POLYSAN Scientific & Technological Pharmaceutical Company class: INDUSTRY briefSummary: The study will collect the information on clinical effects and safety of the basic therapy of acute respiratory viral infection (ARVI) + Cycloferone® and basic therapy of ARVI1 + Arbidol® in real-life clinical settings. conditions: Acute Respiratory Viral Infection studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 742 type: ACTUAL name: Cycloferone measure: Average fever duration according to the data of the Patient's Diary measure: Dynamics of symptom severity parameter according to WURSS-21* questionnaire by visit 2, 3 and 4 (AUC value of change in symptom severity according to WURSS-21 questionnaire)** measure: Dynamics of symptom severity parameter according to CCQ scale by visit 2, 3 and 4 measure: Time (days) till disappearance of disease symptoms according to WURSS-21 scale. measure: Number of patients with symptoms of disease and everyday activity disturbance of different severity degree according to WURSS-21 scale. measure: Number of patients with symptoms of disease of different severity degree according to CCQ scale. measure: Number of patients with complete disappearance of symptoms according to WURSS-21 questionnaire per each day of the therapy. measure: Frequency of the need to administer the systemic antibacterial therapy measure: Percentage of patients who needed hospitalization measure: Average duration of the temporary incapacity period. measure: Frequency of revealing ARVI pathogen before beginning of the therapy (at visit 1) for each pathogen among those patients who underwent the qualitative investigation for ARVI pathogen. measure: Percentage of patients with negative result of the qualitative investigation for ARVI pathogen by visits 3 and 4 among those patients in whom the pathogen was revealed at visit 1. sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Clinic Zvezdnaya city: Saint Petersburg country: Russian Federation lat: 59.93863 lon: 30.31413 facility: Medical center Astarta city: Saint Petersburg country: Russian Federation lat: 59.93863 lon: 30.31413 facility: Medical Center Energiya Zdoroviy city: Saint Petersburg country: Russian Federation lat: 59.93863 lon: 30.31413 facility: Medical Center Meily city: Saint Petersburg country: Russian Federation lat: 59.93863 lon: 30.31413 facility: Medical Center Oris city: Saint Petersburg country: Russian Federation lat: 59.93863 lon: 30.31413 facility: Medical Center PiterClinica city: Saint Petersburg country: Russian Federation lat: 59.93863 lon: 30.31413 facility: Medical Center Reavita Med city: Saint Petersburg country: Russian Federation lat: 59.93863 lon: 30.31413 facility: Medical Center SOGAZ city: Saint Petersburg country: Russian Federation lat: 59.93863 lon: 30.31413 facility: Research Center Eco-Safety city: Saint Petersburg country: Russian Federation lat: 59.93863 lon: 30.31413 facility: Сity clinic No. 117 city: Saint Petersburg country: Russian Federation lat: 59.93863 lon: 30.31413 facility: Сity clinic No. 44 city: Saint Petersburg country: Russian Federation lat: 59.93863 lon: 30.31413 facility: Сity clinic No.109 city: Saint Petersburg country: Russian Federation lat: 59.93863 lon: 30.31413 facility: Сity hospital No. 40 city: Sestroretsk country: Russian Federation lat: 60.09801 lon: 29.96378 hasResults: False
|
<|newrecord|> nctId: NCT06286241 id: 877/2564(IRB2) briefTitle: Comparison of the Complications in Multiple Myeloma Patients Who Received Autologous Stem Cell Transplantation Between in HEPA-filtered Room and Non-HEPA-filtered Room acronym: Step down ward overallStatus: NOT_YET_RECRUITING date: 2024-03-25 date: 2024-06-30 date: 2024-07-30 date: 2024-02-29 date: 2024-03-15 name: Siriraj Hospital class: OTHER name: Faculty of Medicine Siriraj Hospital briefSummary: The goal of this observational study is to comparison of the complications in multiple myeloma patients who received autologous stem cell transplantation between in HEPA-filtered room and non-HEPA-filtered room. The main questions it aims to answer are:
|
* The incidence of febrile neutropenia, infection, and duration of hospital stay
|
* 2-year progression free survival Participants will be collected the data of baseline diagnosis, treatment, treatment results and complications during admission and follow-up visits from hospital medical record. conditions: Multiple Myeloma studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: OTHER count: 344 type: ESTIMATED measure: febrile neutropenia measure: Infection measure: duration of admission measure: progression free survival sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
|
<|newrecord|> nctId: NCT06286228 id: 751/2563(IRB4) briefTitle: Registry of Haploidentical Hematopoietic Stem Cell Transplantation in Adult With Hematologic Disease acronym: Haplo overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2029-04-01 date: 2030-04-01 date: 2024-02-29 date: 2024-03-01 name: Siriraj Hospital class: OTHER name: Faculty of Medicine Siriraj Hospital briefSummary: The goal of this observational study is to register hematologic patients with haploidentical hematopoietic stem cell transplantation (haploHSCT). The main questions it aims to answer are:
|
* 1-year progression free survival rate
|
* 1-year overall survival rate
|
* Graft-versus-host free relapsed free survival at 30-day, 100-day, 180-day and 1-year
|
* Chronic Graft-versus-host free relapsed free survival at 180-day and 1-year
|
* Rate of Neutrophil and platelet engraftment
|
* Efficacy of donor specific antibody desensitization
|
* Relapsed rate
|
* Primary and late graft failure
|
* Safety and complication of haploHSCT
|
* Complication of viral, bacterial, and fungal infection
|
* Viral reactivation
|
* Comparison outcomes between matched sibling donor (MSD) HSCT and matched unrelated donor (MUD) HSCT
|
* Comparison cost-effectiveness of treatment between matched sibling donor (MSD) HSCT and matched unrelated donor (MUD) HSCT Participants will be collected the data of baseline diagnosis, treatment, treatment results of all admission and follow-up visits from hospital medical record. conditions: Multiple Myeloma studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 43 type: ESTIMATED measure: register hematologic patients with haploidentical hematopoietic stem cell transplantation measure: progression free survival rate measure: overall survival rate measure: Chronic Graft-versus-host free relapsed free survival measure: Relapsed rate measure: Primary and late graft failure measure: Rate of Neutrophil and platelet engraftment measure: Efficacy of donor specific antibody desensitization measure: Safety and complication of haploHSCT measure: Complication of viral, bacterial, and fungal infection measure: Viral reactivation measure: outcomes between matched sibling donor (MSD) HSCT and matched unrelated donor (MUD) HSCT measure: cost-effectiveness of treatment between matched sibling donor (MSD) HSCT and matched unrelated donor (MUD) HSCT sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
|
<|newrecord|> nctId: NCT06286215 id: 586/2564(IRB2) briefTitle: Registry of Patients With Plasma Cell Disorders acronym: Registry PCD overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2034-04-01 date: 2035-04-01 date: 2024-02-29 date: 2024-02-29 name: Siriraj Hospital class: OTHER name: Faculty of Medicine Siriraj Hospital briefSummary: The goal of this observational study is to register patients with plasma cell disorders. The main questions it aims to answer are:
|
* The incidence of plasma cell disorders both before and after malignancy
|
* Time to progression of monoclonal gammopathy of undetermined significant (MGUS) or smoldering multiple myeloma (SMM) to light chain amyloidosis or multiple myeloma (MM)
|
* Progression free survival (PFS)
|
Subsets and Splits
No community queries yet
The top public SQL queries from the community will appear here once available.