text
stringlengths 0
197k
|
|---|
<|newrecord|> nctId: NCT06263699 id: S68225 briefTitle: Goniometry and Goniometric Measurement on Standardised Images in Dupuytren's Disease acronym: Goniometry overallStatus: RECRUITING date: 2024-01-29 date: 2025-01-01 date: 2025-01-01 date: 2024-02-16 date: 2024-02-21 name: Universitaire Ziekenhuizen KU Leuven class: OTHER briefSummary: Measuring range of motion (ROM) is essential in detecting musculoskeletal deficits, monitoring the effects of treatment and progression of the disease. In Dupuytren's disease the active and passive extension deficits (AED, PED) of digits 4 and 5 are usually clinically measured using a universal, short arm goniometer which is considered the standard of care. Using the goniometer can be time consuming. Measuring the extension deficit on a standardised picture could improve follow up, since it is a faster and easier process to take a picture and upload it to the patients files. Though this gives rise to the question whether this kind of measurement would be equally accurate and reliable in comparison to regular clinical measurement using a goniometer. conditions: Dupuytren's Disease studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 59 type: ESTIMATED name: ROM measurement of the MCP and PIP joints in digits 4 and 5 measure: Active Extension Deficits (AED) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Universitaire Ziekenhuizen KU Leuven status: RECRUITING city: Leuven state: Vlaams-Brabant zip: 3000 country: Belgium name: Ilse Degreef, Prof. Dr. role: CONTACT phone: +32 16 33 88 43 email: [email protected] name: Anna Tarasiuk role: CONTACT phone: +32 16 33 88 18 email: [email protected] name: Ilse Degreef, Prof. Dr. role: PRINCIPAL_INVESTIGATOR lat: 50.87959 lon: 4.70093 hasResults: False
|
<|newrecord|> nctId: NCT06263686 id: DAN056 briefTitle: Evaluation of the Effects of Routine Intake of Fresh vs- Pasteurized Yoghurt on the Immune System in Healthy Adults acronym: YASI-03 overallStatus: COMPLETED date: 2016-06-01 date: 2016-11-01 date: 2016-12-31 date: 2024-02-16 date: 2024-02-16 name: University of Valladolid class: OTHER name: Danone Institute International name: University of Seville briefSummary: In this study, the purpose was to describe and compare the modulator effects on the immune system of the routine ingestion of fresh vs. pasteurized yoghurt. A unicentral, prospective, randomized, double-blind, parallel group nutritional study for 8 weeks was carried out comparing the ingestion of 125 g (three times a day) of the products in healthy adults. A complete battery of in vitro tests on the activity of immune system, processes and phenomena was performed. conditions: Immune System conditions: Innate Inflammatory Response studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: BASIC_SCIENCE masking: SINGLE whoMasked: CARE_PROVIDER count: 125 type: ACTUAL name: Pasteurised yoghurt name: Fresh yoghurt name: Sterilised yoghurt measure: T-cells measure: IFN-gamma induction measure: IgG sex: ALL minimumAge: 20 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
|
<|newrecord|> nctId: NCT06263673 id: 23-008183 briefTitle: Anti-Diabetic Medications to Fight PD and LBD overallStatus: RECRUITING date: 2024-04-17 date: 2024-06-30 date: 2024-06-30 date: 2024-02-16 date: 2024-04-17 name: Mayo Clinic class: OTHER briefSummary: The purpose of this study is to test the hypothesis that DPP4 inhibitors and SGLT2 inhibitors are well tolerated and have beneficial neurological effects, specifically for Parkinson's disease and Lewy body dementia. conditions: Lewy Body Dementia conditions: Parkinson Disease studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 12 type: ESTIMATED name: Sitagliptin name: Dapagliflozin name: Placebo measure: Movement Disorder Society- Unified Parkinson's Disease Rating Scale (MDS-UPDRS) measure: Change in Mini Mental State Examination measure: Glucose measure: Supine blood pressure measure: Standing blood pressure sex: ALL minimumAge: 45 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Mayo Clinic Florida status: RECRUITING city: Jacksonville state: Florida zip: 32224 country: United States name: Zoe A Parrales, BS role: CONTACT phone: 904-953-3381 email: [email protected] lat: 30.33218 lon: -81.65565 hasResults: False
|
<|newrecord|> nctId: NCT06263660 id: 2022-007 briefTitle: Evaluation of a Keto-Like Supplement on Brain Responses to Emotional Stimuli in Depression overallStatus: RECRUITING date: 2024-01-09 date: 2026-01 date: 2026-01 date: 2024-02-16 date: 2024-02-20 name: Laureate Institute for Brain Research, Inc. class: OTHER briefSummary: This study aims to determine whether a keto-like supplement relative to placebo results in functional brain changes during fMRI tasks evaluating positive and negative valence in individuals with moderate to severe depression. In this double-blind randomized placebo-controlled trial, 75 individuals with a Patient Health Questionnaire (PHQ-9) scale score ≥ 10 (MDD) will be enrolled to participate in an 8-week treatment study to obtain 60 completers. Participants will be randomized with a 1-1 ratio to receive the keto-like supplement (n= 30 completers) or placebo (n=30 completers) taken orally three times per day for 8 weeks. Participants will undergo a 10.5-hour screening/baseline evaluation visit split over 2 days at week 0 including questionnaires, neuroimaging before and after supplement or placebo administration and blood draws, office visits at week 2 (1.5 hours), week 4 (3 hours), week 6 (0.5 hours), week 8 (6 hours), a follow-up visit at week 10 (1.5 hours) and two phone calls between visits (weeks 1 and 3) during which a brief clinical assessment will be obtained (10 minutes each). The total time involved in the study is approximately 23.5 hours. conditions: Depression studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: BASIC_SCIENCE masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 75 type: ESTIMATED name: Keto-like supplement name: Placebo measure: BOLD response during Monetary Incentive Delay Task measure: BOLD response during Adjective Task sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Laureate Institute for Brain Research status: RECRUITING city: Tulsa state: Oklahoma zip: 74136 country: United States name: Teresa Victor, PhD role: CONTACT phone: 918-502-5108 email: [email protected] name: Colleen McCallum role: CONTACT phone: 918-502-5180 lat: 36.15398 lon: -95.99277 hasResults: False
|
<|newrecord|> nctId: NCT06263647 id: HSC-MS-23-0904 id: UG3NR021232 type: NIH link: https://reporter.nih.gov/quickSearch/UG3NR021232 briefTitle: Incorporation of a Health Equity Approach to Hospital Violence Intervention Programs: The Integration of a Community and Hospital Based Initiatives to Reduce Gun Violence in a Large Metropolitan Area overallStatus: NOT_YET_RECRUITING date: 2025-06-01 date: 2028-02-01 date: 2028-05-01 date: 2024-02-16 date: 2024-02-16 name: The University of Texas Health Science Center, Houston class: OTHER name: National Institute of Nursing Research (NINR) briefSummary: The purpose of this study is to evaluate the effectiveness of Houston-Hospital Violence Intervention Programs (HVIP) in reducing the occurrence of repeat violent events among adults receiving care at Memorial Hermann Hospital in Houston, to determine the impact of the community-engaged Houston-HVIP program on violent re-injury and mental and behavioral health, assess the impact of the Houston-HVIP program on racial and ethnic disparities in those impacted by firearm violence injury and to identify the predictors of implementation success, including dosage, reach, fidelity, and acceptability from the perspective of gun violence victims, health care providers, and community violence intervention specialists conditions: Firearm Injury studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: DOUBLE maskingDescription: Participants will be partially blinded in that they will know some information about the intervention but will not be exposed to the details of the intervention or the intervention manual. whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 300 type: ESTIMATED name: Houston-HVIP treatment name: Enhanced Case Management measure: Repeat violent victimization as assessed by the number of participants who return to the hospital system for a violent injury measure: Repeat violent victimization as assessed by the number of participants who are exposed to repeat violence but not admitted to the hospital captured using the Computer-assisted self-interviewing (CASI) instrument measure: Change in post-traumatic stress as assessed by the post-Traumatic Stress Disorder Checklist Version 5(PCL-5) measure: Change in aggression as assessed by the Buss-Perry Aggression Questionnaire (BPAQ) measure: Change in general health as assessed by the 12-item Short Form Health Survey (SF-12) sex: ALL minimumAge: 18 Years maximumAge: 30 Years stdAges: ADULT facility: The University of Texas Health Science Center at Houston city: Houston state: Texas zip: 77030 country: United States name: Sandra McKay, MD role: CONTACT phone: 713-500-5666 email: [email protected] name: Alexander Testa, PhD role: CONTACT phone: (210) 276-9000 email: [email protected] lat: 29.76328 lon: -95.36327 hasResults: False
|
<|newrecord|> nctId: NCT06263634 id: 2022-206 briefTitle: Hand Exercises in Psoriatic Arthritis overallStatus: RECRUITING date: 2023-04-05 date: 2024-04-05 date: 2024-05-05 date: 2024-02-16 date: 2024-02-28 name: Akdeniz University class: OTHER briefSummary: This study is a randomized controlled study examining the effects of 8-week hand home exercises on grip strength, functionality, disease activity and quality of life in patients with PsA. Individuals participating in the study will be randomly divided into 2 groups. Individuals in the intervention group will perform home exercises consisting of stretching, mobility and strengthening, 4 days a week for 8 weeks, and the patients' compliance with the exercise will be monitored by phone call once a week. Individuals in the control group are on the waiting list and the same home exercise program will be taught to the patients at the end of the study. conditions: Psoriatic Arthritis conditions: Hand Rheumatism studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomized controlled trial primaryPurpose: TREATMENT masking: NONE count: 34 type: ESTIMATED name: Hand exercises measure: Psoriatic Arthritis Disease Activity Score (DAPSA) measure: Hand grip strength measurement measure: Hand fine grip strength measurement: measure: Nine-Hole Peg Test measure: Duruöz Hand Index measure: Michigan Hand Outcome Questionnaire (MHQ) measure: Hand Functional Index (HFI) measure: Psoriatic Arthritis Quality of Life Questionnaire (PsAQoL) sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Akdeniz University status: RECRUITING city: Antalya country: Turkey name: Ayse Ayan, MD role: CONTACT phone: +90 242 249 44 00 email: [email protected] lat: 36.90812 lon: 30.69556 hasResults: False
|
<|newrecord|> nctId: NCT06263621 id: 855090 briefTitle: Changing Portion Size Descriptions in a Cafeteria overallStatus: ACTIVE_NOT_RECRUITING date: 2024-01-11 date: 2024-05-29 date: 2024-05-29 date: 2024-02-16 date: 2024-02-26 name: University of Pennsylvania class: OTHER name: Restaurant Associates briefSummary: The goal of this this intervention is to test the degree to which a portion size labeling intervention influences consumer selection of smaller portions at two large cafés. The main question it aims to answer is: Do consumers order fewer calories when the portion size label for the smaller entree is called "standard" instead of "small"?
|
Participants will order lunch as usual in the two cafes (one intervention, one control) for 5.5 months, and all order items will be recorded in the check-out system. One cafe will receive the labeling intervention, while the other will not. Researchers will compare the average calories per order between the two cafes to see if there are differences. conditions: Food Selection conditions: Obesity conditions: Weight Gain conditions: Food Preferences studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Entrees are offered in two different portion sizes at two cafes. The cafes were randomized to either receive the "Standard" portion label for the smaller size (Intervention) or the "Small" portion label for the smaller size (Control). The larger portion was labeled "Large." Daily lunch transaction data will be provided by the cafes. primaryPurpose: PREVENTION masking: NONE count: 12000 type: ESTIMATED name: Intervention "Standard" measure: Average kcal per entree sold measure: Number of entrée units purchased measure: Total kcal per transaction measure: Weekly gross sales sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Courtyard Cafe city: Boston state: Massachusetts zip: 02115 country: United States lat: 42.35843 lon: -71.05977 facility: Elements Cafe city: Boston state: Massachusetts zip: 02115 country: United States lat: 42.35843 lon: -71.05977 hasResults: False
|
<|newrecord|> nctId: NCT06263608 id: BUN B3002023000204 briefTitle: Structured Testing and Treatment for Obstructive Sleep Apnea in Patients With Atrial Fibrillation acronym: STAROSA overallStatus: RECRUITING date: 2024-02-23 date: 2028-02 date: 2028-02 date: 2024-02-16 date: 2024-03-06 name: University Hospital, Antwerp class: OTHER name: Jessa Hospital name: Hasselt University name: Universiteit Antwerpen briefSummary: The main goal of this prospective pre-post implementation study is to investigate how a structured testing and treatment program for obstructive sleep apnea using the NOX T3s device and a Fitbit smartwatch with the FibriCheck algorithm impacts the proportion of atrial fibrillation (AF) in an AF population.
|
Participants will wear the NOX T3s respiratory polygraphy device for one night at home. In case of a positive obstructive sleep apnea diagnosis, patients will be referred to the sleep clinic for a polysomnography examination. Patients positively diagnosed with polygraph will be monitored semi-continuously with the Fitbit smartwatch for three months. After the polysomnography examination, the positively diagnosed patients will be monitored semi-continuously for another three months after initiation of treatment (mostly continuous positive airway pressure (CPAP) treatment). Additionally, patients will be administered satisfaction and symptom burden questionnaires twice: right after the polysomnography examination and after the 3-month treatment. conditions: Atrial Fibrillation conditions: Obstructive Sleep Apnea studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 209 type: ESTIMATED name: (Cardio)Respiratory polygraphy (NOX T3s) name: Polysomnography name: Devices to deliver Continuous Positive Airway Pressure (CPAP), Bilevel Positive Airway Pressure (BiPAP) or Adaptive support ventilation (ASV) name: Fitbit smartwatch measure: AF burden before and after CPAP treatment measure: Obstructive sleep apnea severity agreement between polygraphy and polysomnography measure: False positive rate of polygraphy measure: Total sleep apnea burden measure: CPAP/BiPAP/ASV compliance measure: Sleep score measure: Patients' AF-related symptom burden, assessed by the Leuven ARrhythmia Questionnaire (LARQ) measure: Patients' obstructive sleep apnea-related symptom burden, assessed by the Berlin Questionnaire (BQ) measure: Patients' obstructive sleep apnea-related symptom burden, assessed by the Epworth Sleepiness Scale (ESS) measure: Polygraphy negative patients measure: User-friendliness of the NOX T3s polygraphy device measure: User-friendliness of the Fitbit-based FibriCheck monitoring measure: Uptake rate of the advice to patients to undergo a polysomnography examination measure: Protocol adherence to smartphone heart rhythm measurements measure: The quality of the FibriCheck measurements measure: Number of technical issues sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University Hospital of Antwerp status: RECRUITING city: Edegem country: Belgium name: Lien Desteghe, MSc PhD role: CONTACT email: [email protected] lat: 51.15662 lon: 4.44504 facility: Jessa Hospital status: RECRUITING city: Hasselt country: Belgium name: Lien Desteghe, MSc PhD role: CONTACT email: [email protected] lat: 50.93106 lon: 5.33781 hasResults: False
|
<|newrecord|> nctId: NCT06263595 id: REB23-1754 briefTitle: Semaglutide and Preoperative Residual Gastric Volumes overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2024-12-31 date: 2024-12-31 date: 2024-02-16 date: 2024-02-16 name: University of Calgary class: OTHER name: Alberta Health services briefSummary: Given the pharmacodynamic and pharmacokinetic properties of glucagon-like peptide-1 (GLP-1) agonists, the Canadian Anesthesiologists' Society has recognized that patients on GLP-1 agonists may have an increased aspiration risk due to a 'full stomach,' even after following preoperative fasting guidelines. In other words, safe fasting timelines are not known in individuals taking GLP-1 agonists, as demonstrated by recent case reports of patients who either retained or regurgitated stomach contents despite being adequately fasted.
|
To address this gap, we plan to measure preoperative residual gastric volumes with point-of-care ultrasound (POCUS) in patients taking this medication. The priority is to first gather data to identify which patient populations need risk stratification and to then use this data to support the development of specific guidelines that reduce anesthetic complications, such as aspiration pneumonia.
|
Our primary objective is to use POCUS preoperatively to assess gastric volumes of fasted patients to demonstrate if there is a clinically significant increase in residual gastric volumes in patients on semaglutide. conditions: Pulmonary Aspiration studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 90 type: ESTIMATED name: gastric antral sonography measure: Number of participants presenting with a full stomach measure: Number of occurrences requiring change in anesthetic management plan measure: Relationship between dose, duration and timing of GLP-1 receptor agonist and gastric volume measure: Relationship between gastric emptying and purpose of GLP-1 receptor agonist administration sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: South Health Campus city: Calgary state: Alberta zip: T3M 1M4 country: Canada name: Joanna J Moser, MD, PhD role: CONTACT phone: 403-956-3883 email: [email protected] lat: 51.05011 lon: -114.08529 hasResults: False
|
<|newrecord|> nctId: NCT06263582 id: IGHID12333 briefTitle: Pharmacokinetics of Intravaginal, Self-administered Artesunate Vaginal Pessaries Among Women in Kenya overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2025-02 date: 2025-02 date: 2024-02-16 date: 2024-02-20 name: UNC Lineberger Comprehensive Cancer Center class: OTHER briefSummary: This study investigates the pharmacokinetics of Artesunate (AS) and dihydroartemisinin (DHA), the active metabolite of Artesunate, following intravaginal use at the dosing and frequency being studied for cervical precancer treatment. A secondary objective is to investigate safety among study participants. conditions: Cervix Cancer conditions: Cervix Intraepithelial Neoplasia Grade 3 conditions: Cervix; Intraepithelial Neoplasia, Grade I conditions: Cervix; Intraepithelial Neoplasia, Grade II studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 16 type: ESTIMATED name: Artesunate pessary name: blood draws for pharmacokinetics of the study drug measure: To determine the area under the plasma concentration versus time curve (AUC) of dihydroartemisinin measure: To determine the area under the plasma concentration versus time curve (AUC) of Artesunate (AS) measure: To determine the maximum concentration of Artesunate (AS) measure: To determine the maximum concentration of dihydroartemisinin (DHA) (Cmax) measure: To determine the time to maximum concentration (Tmax) of Artesunate (AS) following five consecutive days measure: To determine the time to maximum concentration (Tmax) of dihydroartemisinin (DHA measure: To determine the half-life (t1/2) of Artesunate (AS) measure: To determine the half-life (t1/2) of dihydroartemisinin (DHA) measure: To determine the apparent clearance (CL/F) of Artesunate (AS) measure: To determine the apparent clearance (CL/F) of dihydroartemisinin (DHA) measure: To determine the volume of distribution (V/F) of Artesunate (AS) measure: To determine the volume of distribution (V/F) of dihydroartemisinin (DHA) measure: Type, frequency, severity, and duration of adverse events sex: FEMALE minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Lumumba Sub-County Hospital city: Kisumu country: Kenya lat: -0.10221 lon: 34.76171 hasResults: False
|
<|newrecord|> nctId: NCT06263569 id: SDB 2023-002 briefTitle: Effectiveness of Total Hip Arthroplasty for Patients With Osteoarthritis, a Target Trial Emulation Study acronym: EAGLE overallStatus: COMPLETED date: 2023-05-24 date: 2023-05-24 date: 2023-05-24 date: 2024-02-16 date: 2024-02-16 name: JointResearch class: OTHER briefSummary: The aim of this study is to assess the effect of total hip arthroplasty on hip disability and pain compared to non-surgery in patients with hip osteoarthritis, using target trial emulation to emulate a randomized controlled trial. conditions: Hip Osteoarthritis studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: OTHER count: 156 type: ACTUAL name: Total hip arthroplasty measure: Hip disability and Osteoarthritis Outcome Score Physical function Short form (HOOS-PS), change score from baseline measure: Numerical Rating Scale (NRS) pain during weight bearing, change score from baseline sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: OLVG city: Amsterdam state: Noord Holland zip: 1090 HM country: Netherlands lat: 52.37403 lon: 4.88969 typeAbbrev: Prot_SAP hasProtocol: True hasSap: True hasIcf: False label: Study Protocol and Statistical Analysis Plan date: 2023-05-17 uploadDate: 2024-02-08T10:36 filename: Prot_SAP_000.pdf size: 949604 hasResults: False
|
<|newrecord|> nctId: NCT06263556 id: 2023/389 briefTitle: Effectiveness of TTNS in MS Patients With Lower Urinary Track Symptoms overallStatus: RECRUITING date: 2024-01-17 date: 2024-11-05 date: 2024-12-05 date: 2024-02-16 date: 2024-02-16 name: Bakirkoy Dr. Sadi Konuk Research and Training Hospital class: OTHER_GOV briefSummary: Multiple sclerosis (MS) is the most common inflammatory disease of the central nervous system. It is characterized with demyelinated plaques affecting subcortical, brain stem, and spinal cord nerve fibers. During the course of the disease, with the affection myelinated nerve tracks, lower urinary track symptoms may occur. 50-90% of the MS patients experience lower urinary track symptoms (LUTS) such as urinary incontinence, urgency, nocturia and/or urinary frequency during the at one point of their life.
|
Aim of this study is to determine the effects of transcutaneous tibial nerve stimulation (TTNS) on symptoms and quality of life in MS patients with LUTS. conditions: Multiple Sclerosis conditions: Lower Urinary Tract Symptoms studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Patients will be randomized and assigned to either group. primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 64 type: ESTIMATED name: Pelvic floor exercises name: Transcutaneous posterior tibial nerve stimulation name: Sham stimulation measure: Incontinence Quality of Life (I-QOL) measure: Post-void residue (PVR) measure: Bladder diary measure: International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF) sex: ALL minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT facility: Bakirkoy Dr. Sadi Konuk Research and Training Hospital status: RECRUITING city: Istanbul country: Turkey name: Sibel CAGLAR role: CONTACT phone: +905333365651 email: [email protected] name: Arda Can KASAP role: CONTACT phone: +905384590119 email: [email protected] lat: 41.01384 lon: 28.94966 hasResults: False
|
<|newrecord|> nctId: NCT06263543 id: 2023-MAH-001 briefTitle: Sequencing Antibody Drug Conjugates in ER+/HER2 LOW MBC acronym: SERIES overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2026-04 date: 2026-10 date: 2024-02-16 date: 2024-02-16 name: Reshma L. Mahtani, D.O. class: OTHER name: Gilead Sciences briefSummary: The purpose of this research study is to see if the medication sacituzumab govitecan (SG) is effective at the currently approved dose and schedule in people who have previously received trastuzumab deruxtecan (T-DXd) for the treatment of metastatic, hormone receptor positive (HR+)/human epidermal growth factor 2 low (HER2 low) breast cancer. Although SG is approved to treat metastatic HR+/HER2 negative breast cancer, the aim of this study is to determine if SG is still effective specifically in people who have already received T-DXd. conditions: Breast Cancer conditions: Metastatic Breast Cancer conditions: Advanced Breast Cancer conditions: Hormone-receptor-positive Breast Cancer conditions: Human Epidermal Growth Factor 2 Low Breast Cancer studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 75 type: ESTIMATED name: Sacituzumab govitecan measure: Overall response rate (ORR) measure: Clinical benefit rate (CBR) measure: Progression-free survival (PFS) measure: Overall survival (OS) measure: Duration of response (DOR) measure: Global Quality of Life measure: Treatment-related Adverse Events (AEs) and Serious Adverse Events (SAEs) measure: Laboratory and Vital Sign Abnormalities measure: Growth Factor Support sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: UCLA Jonsson Comprehensive Cancer Center city: Los Angeles state: California zip: 90404 country: United States name: Aditya Bardia, M.D. role: CONTACT phone: 310-586-2093 email: [email protected] lat: 34.05223 lon: -118.24368 facility: Miami Cancer Institute at Baptist Health, Inc. city: Miami state: Florida zip: 33176 country: United States name: Reshma L Mahtani, D.O. role: CONTACT phone: 786-596-2000 email: [email protected] name: Krystal Fernandez role: CONTACT phone: (786) 596-2000 email: [email protected] lat: 25.77427 lon: -80.19366 facility: Winship Cancer Institute at Emory University city: Atlanta state: Georgia zip: 30322 country: United States name: Kevin Kalinsky, M.D., M.S. role: CONTACT phone: 404-778-0519 email: [email protected] lat: 33.749 lon: -84.38798 hasResults: False
|
<|newrecord|> nctId: NCT06263530 id: NU22-03-00182 briefTitle: Prognostic Significance of ctDNA in HL overallStatus: RECRUITING date: 2022-01-02 date: 2023-12-31 date: 2027-12-31 date: 2024-02-16 date: 2024-02-16 name: Interni hematologicka klinika FNKV class: NETWORK name: Charles University, Czech Republic name: General University Hospital, Prague name: University Hospital Olomouc name: University Hospital Hradec Kralove name: University Hospital, Motol briefSummary: Specific somatic mutations using ctDNA will be analyzed in predefined subgroups of cHL (e.g., age \<60 and ≥ 60 years, EBV). These mutations will be correlated with response to the treatment in the first line, in the relapse, during brentuximab vedotin and/or nivolumab treatment. Circulating tumor DNA will be correlated with the extent of tumor mass and chemo/radiotherapy. conditions: Prognostic Cancer Model studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 500 type: ESTIMATED measure: Identification of tumor specific mutation profiles at dg. of HL based on ctDNA measure: Quantitative analysis of ctDNA level during the first-line chemotherapy measure: Identification of tumor specific mutation profiles at relapse of classical HL measure: In vitro functional characterization of identified DNA variants and/or mutations sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University Hospital Hradec Kralove status: RECRUITING city: Hradec Kralove zip: 50005 country: Czechia name: Alice Sykorova, M.D., Ph.D. role: CONTACT phone: +420495 832 866 email: [email protected] lat: 50.20923 lon: 15.83277 facility: University Hospital Olomouc status: RECRUITING city: Olomouc zip: 77520 country: Czechia name: Vit Prochazka, prof. M.D. role: CONTACT phone: +420588 442 878 email: [email protected] lat: 49.59552 lon: 17.25175 facility: University Hospital Kralovske Vinohrady status: RECRUITING city: Praha zip: 10034 country: Czechia name: Heidi Mocikova, M.D., Ph.D. role: CONTACT phone: +420267163554 email: [email protected] name: Katerina Klaskova, Ing. role: CONTACT phone: +420267162880 email: [email protected] lat: 50.08804 lon: 14.42076 facility: Charles University status: ACTIVE_NOT_RECRUITING city: Praha zip: 12108 country: Czechia lat: 50.08804 lon: 14.42076 facility: General University Hospital status: RECRUITING city: Praha zip: 12808 country: Czechia name: Jan Koren, M.D. role: CONTACT phone: +420224962541 email: [email protected] lat: 50.08804 lon: 14.42076 typeAbbrev: Prot_SAP hasProtocol: True hasSap: True hasIcf: False label: Study Protocol and Statistical Analysis Plan date: 2023-11-30 uploadDate: 2024-02-07T11:30 filename: Prot_SAP_000.pdf size: 329948 typeAbbrev: ICF hasProtocol: False hasSap: False hasIcf: True label: Informed Consent Form date: 2023-11-30 uploadDate: 2024-02-07T11:43 filename: ICF_001.pdf size: 82316 hasResults: False
|
<|newrecord|> nctId: NCT06263517 id: SPA-S-899-01-21 id: 2021-003124-33 type: EUDRACT_NUMBER briefTitle: Clinical Trial to Assess Efficacy, Tolerability of Rising Doses of Clodronate in Painful Knee Osteoarthritis Patients overallStatus: RECRUITING date: 2023-10-12 date: 2025-07 date: 2025-10 date: 2024-02-16 date: 2024-02-16 name: SPA Società Prodotti Antibiotici S.p.A. class: INDUSTRY name: Pharmaceutical Development and Services briefSummary: The goal of this clinical trial is to to clarify which is the best dose of administration, to select a dose and to confirm the therapeutic efficacy of clodronate in patients with painful knee osteoarthritis (OA). The clinical trial will be divided in two parts.
|
The main questions it aims to answer are:
|
* in Phase II, to assess the safety and tolerability of different escalating doses of intra articular (IA) clodronate
|
* in Phase II, to set a defined therapeutic dose (DTD) to be used in Phase III
|
* in Phase III, to assess the safety and tolerability of different escalating doses of IA clodronate to confirm and extensively evaluate the therapeutic efficacy and safety of the clodronate DTD in patients with knee OA conditions: Osteoarthritis of Knee studyType: INTERVENTIONAL phases: PHASE2 phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Adaptative, multicenter, randomized, double-blind, parallel-group, placebo controlled primaryPurpose: TREATMENT masking: QUADRUPLE maskingDescription: Randomization list will be performed with Proc Plan procedure by SAS ® Software (release 9.4 or later) software using the block randomization method with block size of 4.
|
Subjects eligible at Baseline will be randomly allocated to receive 2, 5, 10 /2ml or placebo according to the balanced randomization list. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 296 type: ESTIMATED name: Clodronate name: Clodronate name: Clodronate name: Placebo measure: Efficacy: VAS Reduction measure: VAS mean changes measure: VAS mean changes observed 120 minutes after IA measure: Lequesne Algofunctional Index mean changes measure: WOMAC mean changes measure: Range of motion mean changes measure: Paracetamol consumption measure: SAE Reporting measure: AE Reporting measure: Clinical signs of intolerance Recording sex: ALL minimumAge: 50 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: IRCCS Istituti Clinici Maugeri status: RECRUITING city: Castel Goffredo state: Mantova zip: 46042 country: Italy name: Lul Abdi-Ali role: CONTACT lat: 45.29403 lon: 10.473 facility: Ospedale San Pellegrino status: RECRUITING city: Castiglione delle Stiviere state: Mantova zip: 46043 country: Italy name: Paolo Roberto Ferrari role: CONTACT lat: 45.3902 lon: 10.48619 facility: Ospedale Civile Servizio di Riabilitazione Funzionale status: RECRUITING city: Volta Mantovana state: Mantova zip: 46049 country: Italy name: Luisa Selletti role: CONTACT lat: 45.32192 lon: 10.65891 facility: Azienda Ospedaliera Universitaria San Luigi Gonzaga status: NOT_YET_RECRUITING city: Orbassano state: Torino zip: 10043 country: Italy name: Filippo Castoldi role: CONTACT lat: 45.00547 lon: 7.53813 facility: Centro Riabilitativo Polifunzionale Teresio Borsalino status: RECRUITING city: Alessandria zip: 15122 country: Italy name: Marco Invernizzi role: CONTACT lat: 44.90924 lon: 8.61007 facility: IRCCS Ospedale Policlinico San Martino status: RECRUITING city: Genova zip: 16132 country: Italy name: Matteo Formica role: CONTACT lat: 44.40478 lon: 8.94438 facility: Ospedale Israelitico status: RECRUITING city: Roma zip: 00148 country: Italy name: Maria Chiara Meloni role: CONTACT lat: 41.89193 lon: 12.51133 facility: Ospedale San Pietro status: RECRUITING city: Rome zip: 00189 country: Italy name: Alberto Migliore role: CONTACT lat: 41.89193 lon: 12.51133 facility: Ospedale San Paolo status: NOT_YET_RECRUITING city: Savona zip: 17100 country: Italy name: Danilo Chiapale role: CONTACT lat: 44.30905 lon: 8.47715 facility: Azienda Ospedaliero Universitaria Senese status: RECRUITING city: Siena zip: 53100 country: Italy name: Bruno Frediani role: CONTACT lat: 43.31822 lon: 11.33064 facility: Ospedale Policlinico "G.B. Rossi" Borgo Roma status: RECRUITING city: Verona zip: 37134 country: Italy name: Luca Dalle Carbonare role: CONTACT lat: 45.4299 lon: 10.98444 hasResults: False
|
<|newrecord|> nctId: NCT06263504 id: DM001 briefTitle: The Influence of Complex Correction of Dental and Musculoskeletal Systems on the Frequency of Relapses of Functional Disorders in Patients With Dental Pathologies. overallStatus: NOT_YET_RECRUITING date: 2024-03-10 date: 2025-06-15 date: 2025-10-15 date: 2024-02-16 date: 2024-02-26 name: NMSI DENTMASTER class: OTHER briefSummary: In influence of complex correction of dental and musculoskeletal systems on the frequency of relapses of functional disorders in patients with somatic pathologies: a randomized pilot study there will be two groups: Group 1 (control group): Patients in this group will receive standard treatment aimed solely at correcting malocclusions or restoring the integrity of the dentition without interfering with the musculoskeletal system.
|
Group 2 (experimental group): Patients will receive comprehensive treatment, including not only dental correction of bite or restoration of the integrity of the dentition, but also correction of disorders of the musculoskeletal system.
|
The endpoints will be :
|
Primary endpoint:
|
• Frequency of relapses and repeated requests for correction of disorders bite or restoration of the integrity of the dentition within 12 months after treatment.
|
Secondary endpoints:
|
* Change in pain intensity measured by visual analog scale (VAS).
|
* Improvement of functional indicators of the temporomandibular joint, including range of motion.
|
* Improved quality of life, assessed using the OHRQoL (Oral Health Related Quality) scale All endpoints will be evaluated within 12 months. conditions: Malocclusion conditions: Musculoskeletal Disorder studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 40 type: ESTIMATED name: at correcting malocclusions or restoring the integrity of the dentition name: comprehensive treatment, including not only dental correction of bite or restoration of the integrity of the dentition, but also correction of disorders of the musculoskeletal system. measure: Frequency of relapses and repeated requests for correction of disorders bite or restoration of the integrity of the dentition. measure: Change in pain intensity measured by visual analog scale (VAS). measure: Changes in functional parameters of the temporomandibular joint, including range of motion. joint, including range of motion. measure: Improved quality of life, assessed using the OHRQoL (Oral Health Related Quality) scale sex: ALL minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT facility: Nmsi Dentmaster city: Novosibirsk state: Novosibirsk Region zip: 630090 country: Russian Federation name: Tatiana A Gatilova role: CONTACT phone: 952939919 phoneExt: +7 email: [email protected] name: Anastasia V Semivolova role: PRINCIPAL_INVESTIGATOR lat: 55.0415 lon: 82.9346 hasResults: False
|
<|newrecord|> nctId: NCT06263491 id: 2023-0413 id: NCI-2024-01325 type: OTHER domain: NCI-CTRP Clinical Registry briefTitle: Phase II Study of Pirtobrutinib, Rituximab (PR) in Previously Untreated Low and Intermediate Risk MCL (Mantle Cell Lymphoma) Patients overallStatus: NOT_YET_RECRUITING date: 2024-08-31 date: 2025-03-01 date: 2027-03-01 date: 2024-02-16 date: 2024-03-01 name: M.D. Anderson Cancer Center class: OTHER briefSummary: To learn if the chemotherapy-free combination of pirtobrutinib (also called LOXO-305) and rituximab can help provide long term remission in low and intermediate risk MCL. conditions: Mantle Cell Lymphoma studyType: INTERVENTIONAL phases: PHASE2 allocation: NON_RANDOMIZED interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 50 type: ESTIMATED name: Rituximab name: Pirtobrutinib measure: Safety and adverse events (AEs) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: MD Anderson Cancer Center city: Houston state: Texas zip: 77030 country: United States name: Preetesh Jain, MBBS, MD, DM, PhD role: CONTACT phone: (713) 563-8786 email: [email protected] name: Preetesh Jain, MBBS, MD, DM, PhD role: PRINCIPAL_INVESTIGATOR lat: 29.76328 lon: -95.36327 hasResults: False
|
<|newrecord|> nctId: NCT06263478 id: INCA34176-358 briefTitle: A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Axatilimab Monotherapy in Japanese Participants With Recurrent or Refractory Active Chronic Graft-Versus-Host Disease overallStatus: NOT_YET_RECRUITING date: 2024-06-30 date: 2025-12-31 date: 2025-12-31 date: 2024-02-16 date: 2024-02-16 name: Incyte Biosciences Japan GK class: INDUSTRY briefSummary: This study will be conducted to determine the clinical efficacy of axatilimab in Japanese participants with chronic graft-versus-host disease (cGVHD). conditions: Chronic Graft-versus-host-disease studyType: INTERVENTIONAL phases: PHASE3 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 20 type: ESTIMATED name: INCA034176 measure: Overall Response Rate in the First 6 Cycles measure: Proportion of participants with a ≥ 7-point improvement in modified Lee symptom scale (mLSS) score measure: Overall Response Rate measure: Duration of Response measure: Organ-specific Response Rate measure: Percent reduction in average daily dose (or equivalent) of corticosteroids measure: Proportion of participants who discontinue corticosteroid use measure: Number of participants with Treatment-emergent Adverse Events (TEAEs) measure: Change from baseline in Karnofsky/Lansky performance status measure: Axatilimab pharmacokinetic (PK) in Plasma measure: Number of Participants with Anti-Drug Antibody (ADA) sex: ALL minimumAge: 6 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
|
<|newrecord|> nctId: NCT06263465 id: CALM briefTitle: Precision Vaginal Microbiome Transplantation in Women With Bacterial Vaginosis overallStatus: RECRUITING date: 2024-03-11 date: 2025-07-01 date: 2025-12-31 date: 2024-02-16 date: 2024-03-13 name: Zhujiang Hospital class: OTHER name: ZhuHai Hospital briefSummary: The aim of this study was to explore the efficacy and safety of a new vaginal microbiome transplantation technique, using Lactobacillus cispatus from healthy donors as a treatment of bacterial vaginosis. conditions: Bacterial Vaginosis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 120 type: ESTIMATED name: Lactobacillus cispatus name: placebo measure: BV recurrence rate measure: vaginal secretions 16s rRNA gene sequencing measure: BV recurrence rate sex: FEMALE minimumAge: 18 Years maximumAge: 55 Years stdAges: ADULT facility: Zhuhai People'S Hospital status: RECRUITING city: Zhuhai state: Guangdong zip: 519050 country: China name: Jingya WU, Doctor role: CONTACT phone: +8615902057821 lat: 22.27694 lon: 113.56778 hasResults: False
|
<|newrecord|> nctId: NCT06263452 id: 23-2768 id: 1R01HL157422-01 type: NIH link: https://reporter.nih.gov/quickSearch/1R01HL157422-01 briefTitle: Beta-Blocker Influences on Inflammatory and Neural Responses to Stress overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2026-03 date: 2026-03 date: 2024-02-16 date: 2024-03-06 name: University of North Carolina, Chapel Hill class: OTHER name: National Heart, Lung, and Blood Institute (NHLBI) name: University of California, Los Angeles name: Dartmouth College briefSummary: The purpose of this study is to map the neural and molecular mechanisms underlying psychological stress-induced changes in inflammation which could reveal new targets for intervention to reduce the risk of cardiovascular disease. conditions: Cardiovascular Disease studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Subjects (n = 60 per condition, N = 120) will either take a one-time, 40mg dose of propranolol or an encapsulated placebo. primaryPurpose: BASIC_SCIENCE masking: TRIPLE maskingDescription: This is a double blind, randomized, placebo-controlled mechanistic clinical trial. The Investigational Drug Service will randomly assign patients to the experimental group (propranolol) or the placebo group. Research staff who have direct contact with the participant will be blind to their condition. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 120 type: ESTIMATED name: Propranolol name: Placebo measure: Change in levels of pro-inflammatory cytokine interleukin-6 in response to social stress measure: Change in levels of inflammatory gene expression in response to social stress sex: ALL minimumAge: 18 Years maximumAge: 30 Years stdAges: ADULT facility: Social Neuroscience and Health Laboratory city: Chapel Hill state: North Carolina zip: 27514 country: United States name: Keely A Muscatell, PhD role: CONTACT phone: 916-495-7661 email: [email protected] name: Jessica R Cohen, PhD role: SUB_INVESTIGATOR name: Kristen A Lindquist, PhD role: SUB_INVESTIGATOR name: Samantha E Meltzer-Brody, MD, MPH role: SUB_INVESTIGATOR lat: 35.9132 lon: -79.05584 hasResults: False
|
<|newrecord|> nctId: NCT06263439 id: RNI 2023 MIRAND id: 2023-A00585-40 type: OTHER domain: ANSM briefTitle: Surveillance of HFMD in Pediatric Outpatients acronym: PMB overallStatus: RECRUITING date: 2023-06-20 date: 2028-06-20 date: 2028-06-20 date: 2024-02-16 date: 2024-02-16 name: University Hospital, Clermont-Ferrand class: OTHER briefSummary: The aims of this prospective multicentric study is to determine the types of enteroviruses (EVs) responsible for hand, foot and mouth disease (HFMD) or herpangina in children seen within an ambulatory setting :
|
* to detect an EV-A71 epidemic or another type associated with atypical forms of the disease at an early stage
|
* to describe and compare the epidemiological, demographic, clinical and virological characteristics of these infections between the different types of EV. conditions: Hand, Foot and Mouth Disease conditions: Herpangina conditions: Enterovirus Infections studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 3000 type: ESTIMATED name: Throat/buccal swab sample measure: Prevalence of different types of Enteroviruses measure: Clinical characteristics of HFMD/Herpangina according to the different types of enteroviruses sex: ALL maximumAge: 10 Years stdAges: CHILD facility: CHU de Clermont-Ferrand status: RECRUITING city: Clermont-Ferrand zip: 63000 country: France name: Lise Laclautre role: CONTACT email: [email protected] name: Audrey Mirand role: PRINCIPAL_INVESTIGATOR lat: 45.77966 lon: 3.08628 hasResults: False
|
<|newrecord|> nctId: NCT06263426 id: IRB00387066 id: U01AI177211 type: NIH link: https://reporter.nih.gov/quickSearch/U01AI177211 briefTitle: Kidney Transplantation From Donors With HIV: Impact on Rejection and Long-Term Outcomes (Expanding HOPE Kidney) overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2028-09 date: 2029-09 date: 2024-02-16 date: 2024-02-16 name: Johns Hopkins University class: OTHER name: National Institute of Allergy and Infectious Diseases (NIAID) briefSummary: This research is being done to better understand rejection in transplant recipients with HIV who receive kidneys from donors with vs without HIV. conditions: Hiv studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 200 type: ESTIMATED name: HIV D+/R+ name: HIV D-/R+ measure: Cumulative incidence of death and allograft rejection. measure: Participant survival measure: Graft survival measure: Type and severity of graft rejection measure: Time to first rejection measure: Rate of rejection events over time measure: Graft function over time measured by eGFR trajectory measure: Incidence of HIV viremia post-transplant measure: Incidence of new antiretroviral drug resistance and/or X4 tropic virus posttransplant measure: Incidence of bacterial, fungal, viral, and other opportunistic infections posttransplant measure: Incidence of surgical and vascular transplant complications post-transplant measure: Incidence and causes of chronic kidney disease post-transplant measure: Incidence of post-transplant malignancies measure: Incidence of de novo donor specific antibody (DSA) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Alabama at Birmingham city: Birmingham state: Alabama zip: 35294 country: United States name: Shikha Mehta, MD role: CONTACT email: [email protected] name: Shikha Mehta, MD role: PRINCIPAL_INVESTIGATOR lat: 33.52066 lon: -86.80249 facility: University of California, Los Angeles city: Los Angeles state: California zip: 90095 country: United States name: Joanna Schaenman, MD, PhD role: CONTACT email: [email protected] name: Joanna Schaenman, MD, PhD role: PRINCIPAL_INVESTIGATOR lat: 34.05223 lon: -118.24368 facility: University of California, San Diego city: San Diego state: California zip: 92037 country: United States name: Saima Aslam, MBBS role: CONTACT email: [email protected] name: Saima Aslam, MBBS role: PRINCIPAL_INVESTIGATOR lat: 32.71533 lon: -117.15726 facility: University of California, San Francisco city: San Francisco state: California zip: 94143 country: United States name: Garrett Roll, MD role: CONTACT email: [email protected] name: Garrett Roll, MD role: PRINCIPAL_INVESTIGATOR lat: 37.77493 lon: -122.41942 facility: Yale School of Medicine city: New Haven state: Connecticut zip: 06510 country: United States name: Maricar Malinis, MD role: CONTACT email: [email protected] name: Maricar Malinis, MD role: PRINCIPAL_INVESTIGATOR lat: 41.30815 lon: -72.92816 facility: Rush University Medical Center city: Chicago state: Illinois zip: 60612 country: United States name: Carlos Santos, MD role: CONTACT email: [email protected] name: Carlos Santos, MD role: PRINCIPAL_INVESTIGATOR lat: 41.85003 lon: -87.65005 facility: Ochsner Clinic Foundation city: New Orleans state: Louisiana zip: 70121 country: United States name: Jonathan Hand, MD role: CONTACT email: [email protected] name: Jonathan Hand, MD role: PRINCIPAL_INVESTIGATOR lat: 29.95465 lon: -90.07507 facility: Johns Hopkins University city: Baltimore state: Maryland zip: 21205 country: United States name: Christine Durand, MD role: CONTACT email: [email protected] name: Christine Durand, MD role: PRINCIPAL_INVESTIGATOR lat: 39.29038 lon: -76.61219 facility: Massachusetts General Hospital city: Boston state: Massachusetts zip: 02114 country: United States name: Nahel Elias, MD role: CONTACT email: [email protected] name: Nahel Elias, MD role: PRINCIPAL_INVESTIGATOR lat: 42.35843 lon: -71.05977 facility: New York University city: New York state: New York zip: 10016 country: United States name: Sapna Mehta, MD role: CONTACT email: [email protected] name: Sapna Mehta, MD role: PRINCIPAL_INVESTIGATOR lat: 40.71427 lon: -74.00597 facility: Icahn School of Medicine at Mt. Sinai city: New York state: New York zip: 10029 country: United States name: Sander Florman, MD role: CONTACT email: [email protected] name: Sander Florman, MD role: PRINCIPAL_INVESTIGATOR lat: 40.71427 lon: -74.00597 facility: Columbia University city: New York state: New York zip: 10032 country: United States name: Marcus Pereira, MD role: CONTACT name: Marcus Pereira, MD role: PRINCIPAL_INVESTIGATOR lat: 40.71427 lon: -74.00597 facility: Weill Cornell Medical Center city: New York state: New York zip: 10065 country: United States name: Catherine Small, MD role: CONTACT email: [email protected] name: Catherine Small, MD role: PRINCIPAL_INVESTIGATOR lat: 40.71427 lon: -74.00597 facility: University of Pittsburgh Medical Center city: Pittsburgh state: Pennsylvania zip: 15213 country: United States name: Ghady Haidar, MD role: CONTACT email: [email protected] name: Ghady Haidar, MD role: PRINCIPAL_INVESTIGATOR lat: 40.44062 lon: -79.99589 hasResults: False
|
<|newrecord|> nctId: NCT06263413 id: 24.12.2266-GHM briefTitle: Clinical Workflow Optimization Using Artificial Intelligence for Dermatological Conditions acronym: IDEI_2023 overallStatus: RECRUITING date: 2024-01-15 date: 2024-06-30 date: 2024-09-30 date: 2024-02-16 date: 2024-03-19 name: AI Labs Group S.L class: INDUSTRY name: Instituto de Dermatología Integral (IDEI) briefSummary: Artificial intelligence (AI) based on imaging holds tremendous potential to enhance visual diagnostic accuracy in the medical field. Amid the COVID-19 pandemic, limited access to in-person healthcare services drove shifts in medical care, hastening the adoption of telemedicine. In this context, AI usage for triage and decision support may be crucial for professionals to manage workload and improve performance. In dermatology, pigmented lesions, acne, and alopecia are three recurring pathology groups with high demand in dermatological centers. Both triage, clinical evaluation, and patient follow-up require in-person resources and specialist dedication. Employing tools like AI can benefit these professionals in reducing such processes and optimizing workload.
|
Advancements in image recognition and interpretation, as well as in artificial intelligence, have spurred innovations in diagnosing various pathologies, including skin conditions. Computer-Aided Diagnosis (CAD) systems and other algorithm-based technologies have demonstrated the ability to classify lesion images with a competency comparable to that of an expert physician.
|
In this study, the Legit.Health tool, developed by AI LABS GROUP S.L., which utilizes artificial intelligence to optimize clinical flow and patient care processes for skin conditions, will be evaluated. The purpose of this tool is to automatically prioritize patients with greater urgency, assign the type of consultation (dermatological or aesthetic), enhance diagnostic capability and detection of malignant pigmented lesions in auxiliary staff, and provide a visual record (photograph) of the condition for later review by external experts.
|
Thus, the main objective of this study is to validate that Legit.Health, based on Artificial Intelligence, improves efficiency in clinical flow and patient care processes, thereby reducing time and cost of patient care through enhanced diagnostic accuracy and severity determination.
|
The secondary objectives focus on measuring the diagnostic performance of Legit.Health:
|
Demonstrate that Legit.Health enhances healthcare professionals\' ability to detect malignant or suspicious pigmented lesions.
|
Demonstrate that Legit.Health improves healthcare professionals\' ability and precision in measuring the degree of involvement in patients with female androgenetic alopecia.
|
Demonstrate that Legit.Health improves healthcare professionals\' ability and precision in measuring the degree of involvement in patients with acne.
|
Additionally, the study aims to assess the utility of this tool:
|
Automate the triage/initial assessment process in patients presenting with pigmented lesions.
|
Evaluate the reduction in healthcare resources usage by the center by reducing the number of triage consultations and directing the patient directly to the appropriate consultation (esthetic or dermatological).
|
Evaluate Legit.Health\'s usability by the patient. Demonstrate that Legit.Health increases specialist satisfaction. Evaluate the reduction in healthcare resources usage by reducing the number of triage consultations and directing the patient directly to the appropriate consultation, whether in aesthetic or dermatological settings.
|
Methodology Study Design Type This is an observational study, both prospective with a longitudinal character and retrospective case series.
|
Study Period This study estimates a recruitment period of 3 months. The total study duration is estimated at 6 months, including the previous time for retrospective analysis and the necessary time after recruiting the last subject for database closure and editing, data analysis, and preparation of the final study report.
|
The total study duration for each participant with pigmented lesions will be 1-3 months. The duration for patients with acne and alopecia will be 1 day.
|
Study Population Adult patients (≥ 18 years) with skin pathologies treated at the Dermatology Unit of IDEI. conditions: Acne conditions: Acne Vulgaris conditions: Alopecia, Androgenetic conditions: Pigmented Lesions conditions: Pigmented Skin Lesion studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: OTHER count: 150 type: ESTIMATED measure: Concordance between the physician's diagnosis and that of the tool. measure: Agreement of detected malignancy between the dermatologist and Legit.Health tool measure: Acne severity measure: Severity of alopecia sex: ALL minimumAge: 16 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: IDEI Hospital status: RECRUITING city: Madrid zip: 28009 country: Spain name: Miguel Sánchez-Viera, PhD role: CONTACT phone: +34 915740990 email: [email protected] name: Miguel Sánchez-Viera, PhD role: PRINCIPAL_INVESTIGATOR name: Concetta Alessandro, MD role: SUB_INVESTIGATOR name: Alejandra Capote, MD role: SUB_INVESTIGATOR name: Pablo López-Andina, MD role: SUB_INVESTIGATOR name: Allison Marie Bell-Smythe Sorg, MD role: SUB_INVESTIGATOR name: Alejandra Vallejos, MD role: SUB_INVESTIGATOR name: Isabel del Campo, MD role: SUB_INVESTIGATOR name: Juliana Machado, MD role: SUB_INVESTIGATOR name: Raúl Lucas-Escobar, MD role: SUB_INVESTIGATOR name: Beatriz Torres role: SUB_INVESTIGATOR name: Alfonso Medela, MsC role: SUB_INVESTIGATOR name: Taig Mac Carthy, MsC role: SUB_INVESTIGATOR lat: 40.4165 lon: -3.70256 hasResults: False
|
<|newrecord|> nctId: NCT06263400 id: randomized trial briefTitle: Recovery Levels of Depression Patients and Caregiver Psychoeducation overallStatus: RECRUITING date: 2022-09-01 date: 2024-12-30 date: 2024-12-30 date: 2024-02-16 date: 2024-02-16 name: Aydin Adnan Menderes University class: OTHER briefSummary: To determine the effect of psychoeducation given to patients and caregivers on patients' depression and recovery levels, caregivers' emotional expression and family burden levels. conditions: Psychoeducation studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: In randomization, among the patients who volunteered to participate in the study, the odd number of patients and their caregivers in the list made according to the order of hospitalization constituted the study group, and the even number of patients and their caregivers formed the control group. primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 92 type: ESTIMATED name: psychoeducation and follow-up study measure: to patients before training measure: pre-training caregivers measure: after training measure: after training sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: AydınAdnan Menderes University, Faculy of Nursing, Division Public Health Nursing status: RECRUITING city: Aydın state: Aydın/Turkey zip: 09000 country: Turkey name: şerife öztaban, MsC role: CONTACT phone: +905557130105 email: [email protected] name: Filiz ADANA, Phd role: SUB_INVESTIGATOR lat: 37.84501 lon: 27.83963 hasResults: False
|
<|newrecord|> nctId: NCT06263387 id: FILObsLAM_VENAZA briefTitle: Results From a French Temporary Utilization Authorization of First-line Acute Myeloid Leukemia (AML) Patients Ineligible for Intensive Chemotherapy (IC), Treated With Venetoclax Azacitidine acronym: VENAZA overallStatus: NOT_YET_RECRUITING date: 2024-04-29 date: 2024-11-30 date: 2025-03-30 date: 2024-02-16 date: 2024-04-18 name: French Innovative Leukemia Organisation class: OTHER name: Acute Leukemia French Association briefSummary: Following the results of the phase 1b and the phase 3 studies, Venetoclax/Azacitidine (VEN/AZA) was available in France for newly diagnosed AML patients ineligible-IC patients through the early access program the so-called ATU program.
|
Venetoclax (VEN) has been available in France through the ATU since Feb 2021 and through the current post-ATU schema from the point of marketing authorization approval and up to the pending publication of reimbursement and price. Between February 15, 2021, and June 30, 2021, 285 requests for ATU were made to the pharmaceutical company (Abbvie) and led to the initiation of treatment of more than 230 patients. At the end of ATU period, all these 230 ATU patients continued to be treated by VEN/AZA as part of the current post-ATU period. Healthcare professionals and health care decision makers need real world data to better understand the benefit/risk profile of treatment. Early access to treatment in France is close to real-life setting condition. conditions: AML, Adult studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: CROSS_SECTIONAL count: 230 type: ESTIMATED measure: characterize the overall response rate, in patients treated by Venetoclax/Azacitidine (VEN/AZA), in real life cohort measure: characterize the overal survival (OS) in patients treated by Venetoclax/Azacitidine (VEN/AZA), in real life cohort measure: characterize the event free survival (EFS) in patients treated by Venetoclax/Azacitidine (VEN/AZA), in real life cohort measure: characterize the incidence and relatedness of serious adverse events (SAE), in patients treated by Venetoclax/Azacitidine (VEN/AZA), in real life measure: describe the management of Venetoclax/Azacitidine (VEN/AZA) in a real -life cohort of patient. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Amiens CHU city: Amiens country: France lat: 49.9 lon: 2.3 facility: Angers CHU city: Angers country: France lat: 47.46667 lon: -0.55 facility: Avignon CH city: Avignon country: France lat: 43.94834 lon: 4.80892 facility: Bayonne CH city: Bayonne country: France lat: 43.48333 lon: -1.48333 facility: Besançon CHU city: Besançon country: France lat: 47.24878 lon: 6.01815 facility: Brest CHU city: Brest country: France lat: 48.3903 lon: -4.48628 facility: Caen CHU city: Caen country: France lat: 49.18585 lon: -0.35912 facility: CERGY PONTOISE - CH René Dubos city: Cergy-Pontoise country: France lat: 49.03894 lon: 2.07805 facility: Hôpital d'Instruction des Armées PERCY city: Clamart country: France lat: 48.80299 lon: 2.26692 facility: CHU Estaing city: Clermont-Ferrand country: France lat: 45.77966 lon: 3.08628 facility: Corbeil-Essonnes - Ch Sud Francilien city: Corbeil-Essonnes country: France lat: 48.60603 lon: 2.48757 facility: Créteil CHU HENRI MONDOR city: Créteil country: France lat: 48.78333 lon: 2.46667 facility: Dijon CHU city: Dijon country: France lat: 47.31667 lon: 5.01667 facility: Grenoble CHU city: Grenoble country: France lat: 45.16667 lon: 5.71667 facility: Le Mans CH city: Le Mans country: France lat: 48.0 lon: 0.2 facility: CHU Lille city: Lille country: France lat: 50.63297 lon: 3.05858 facility: Limoges CHU city: Limoges country: France lat: 45.83153 lon: 1.25781 facility: Lyon sud CHU city: Lyon country: France lat: 45.74848 lon: 4.84669 facility: Marseille IPC city: Marseille country: France lat: 43.29551 lon: 5.38958 facility: Meaux CH de l'Est francilien city: Meaux country: France lat: 48.96014 lon: 2.87885 facility: METZ-THIONVILLE CHR- Hôpital de Mercy city: Metz country: France lat: 49.11911 lon: 6.17269 facility: Montpellier - Chu Saint Eloi city: Montpellier country: France lat: 43.61092 lon: 3.87723 facility: Nantes CHU city: Nantes country: France lat: 47.21725 lon: -1.55336 facility: Nice CHU city: Nice country: France lat: 43.70313 lon: 7.26608 facility: Nimes CHU city: Nîmes country: France lat: 43.83333 lon: 4.35 facility: Paris La Pitié salpetrière city: Paris country: France lat: 48.85341 lon: 2.3488 facility: Paris Necker city: Paris country: France lat: 48.85341 lon: 2.3488 facility: Paris Saint Louis city: Paris country: France lat: 48.85341 lon: 2.3488 facility: Bordeaux CHU city: Pessac country: France lat: 44.81011 lon: -0.64129 facility: Reims CHU city: Reims country: France lat: 49.25 lon: 4.03333 facility: Rennes CHU city: Rennes country: France lat: 48.11198 lon: -1.67429 facility: roubaix CH city: Roubaix country: France lat: 50.69421 lon: 3.17456 facility: Centre de Lutte Contre le Cancer H. Becquerel city: Rouen country: France lat: 49.44313 lon: 1.09932 facility: Institut de Cancérologie Lucien Neuwirth city: Saint-Priest-en-Jarez country: France lat: 45.47501 lon: 4.37614 facility: Saint Quentin CH city: Saint-Quentin country: France lat: 49.84889 lon: 3.28757 facility: ICANS - Institut de cancérologie de strasbourg europe city: Strasbourg country: France lat: 48.58392 lon: 7.74553 facility: Toulouse - IUCT Oncopole - Service d'Hématologie city: Toulouse country: France lat: 43.60426 lon: 1.44367 facility: Tours CHU city: Tours country: France lat: 47.38333 lon: 0.68333 facility: Troyes CH city: Troyes country: France lat: 48.3 lon: 4.08333 facility: Nancy CHU city: vandoeuvre les Nancy country: France lat: 48.65 lon: 6.18333 facility: Versailles CH city: Versailles country: France lat: 48.8 lon: 2.13333 facility: Villejuif IGR city: Villejuif country: France lat: 48.7939 lon: 2.35992 hasResults: False
|
<|newrecord|> nctId: NCT06263374 id: 69HCL21_0355 briefTitle: Maxillofacial Rehabilitation Using Motor Imagery vs Sham After Orthognathic Surgery acronym: MAXIMAND overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2027-09-30 date: 2028-03-31 date: 2024-02-16 date: 2024-02-16 name: Hospices Civils de Lyon class: OTHER briefSummary: Dento-maxillary dysmorphoses are defined as an anomaly in the relative growth of the maxilla and/or mandible. They lead to functional disorders (i.e., disturbances in chewing or oral communication) and aesthetic issues with psychological repercussions on self-esteem, affecting the quality of life of these patients. The multidisciplinary treatment involves orthodontics (duration = 18-24 months), orthognathic surgery involving the maxillary and/or mandibular bone (at 12 months), immediately followed by physiotherapy (duration = 3 months). One main goal after surgery is the recovery of month opening to restore an appropriate orofacial function. Motor imagery (mental rehearsal of a movement without actually moving) is effectively used in athletes and in rehabilitation mainly neurological but so far has not been investigated in maxillofacial rehabilitation. Considering that the effectiveness of rehabilitation is increased when physical and mental practices are combined, this leads to propose this study aiming to investigate whether the addition of motor imagery of the maxillofacial region to maxillofacial physiotherapy (based on a practice of physical therapeutic exercises) modifies the recovery of maximum mouth opening, other ranges of motion, jaw function, and quality of life in patients after orthognathic surgery compared to the addition of a control cognitive task \[watching a non-emotional content film or filling out a crossword or Sudoku grid\] to maxillofacial physiotherapy. conditions: Maxillofacial Abnormalities studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Multi-centric randomized controlled trial primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: A randomization list will be centrally generated by an independent methodologist for each center and integrated into the electronic case report form. The physiotherapist will disclose the allocation to the participant during the inclusion visit, following clear, transparent, and appropriate information, and obtaining the participant's consent to participate in the study. This disclosure occurs after all measurements have been completed. The inclusion visit is scheduled 30 days ± 8 before the surgery. whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 100 type: ESTIMATED name: Motor imagery of the jaw name: Control task (Sudoku or Crossword puzzle) measure: Maximal mouth opening measured in millimeters using a caliper measure: Active maximum mouth opening in millimeter using a vernier caliper measure: Active jaw range of motion (ROM) other than maximal opening measure: Maxillofacial pain measure: Body weight mass (kilograms) measure: Orthodontic associated treatment measure: Compliance with physiotherapy and intervention measure: Orofacial function measure: Maxillofacial quality of life measure: Level of achievement of the goals set by the patient before surgery measure: Motor imagery capability sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Cabinet Bataille city: Lyon zip: 69003 country: France name: Guillaume Nainani role: CONTACT phone: 0478011908 phoneExt: +33 email: [email protected] lat: 45.74848 lon: 4.84669 facility: Cabinet de kinésithérapie Saint Alexandre city: Lyon zip: 69005 country: France name: Caroline Alvarado-Faysse role: CONTACT phone: 0437410332 phoneExt: +33 email: [email protected] lat: 45.74848 lon: 4.84669 facility: Hôpital Henry Gabrielle city: Saint-Genis-Laval zip: 69230 country: France name: Sébastien Matéo role: CONTACT phone: 0478865066 phoneExt: +33 email: [email protected] lat: 45.69558 lon: 4.7934 hasResults: False
|
<|newrecord|> nctId: NCT06263361 id: NCH02-2021 briefTitle: Improving Safety and Accuracy of Stereotactic Brain Biopsies in Primary Central Nervous System Lymphoma. overallStatus: RECRUITING date: 2021-10-01 date: 2026-12-31 date: 2026-12-31 date: 2024-02-16 date: 2024-02-16 name: IRCCS San Raffaele class: OTHER briefSummary: Primary central nervous system lymphoma (PCNSL) is an aggressive extranodal non- Hodgkin lymphoma exclusively localized into the nervous system. The aim of this study is to evaluate the MRI imaging characteristics of the peritumoral area (PTA) and to correlate this information to pathological findings. conditions: Cerebral Lymphoma studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 15 type: ESTIMATED name: MRI imaging name: Cerebral biopsy measure: MRI imaging measure: MRI imaging measure: MRI imaging measure: MRI imaging measure: Define immunopathological features measure: Accuracy of fluoresceine guided stereotactic biopsy sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: IRCCS San Raffaele Scientific Institute status: RECRUITING city: Milan zip: 20132 country: Italy name: Laura Sincinelli role: CONTACT phone: 003926435568 email: [email protected] lat: 45.46427 lon: 9.18951 hasResults: False
|
<|newrecord|> nctId: NCT06263348 id: HMM0601 briefTitle: A Post-Marketing Safety Study of Dorzagliatin in Patients With Type 2 Diabetes overallStatus: RECRUITING date: 2023-12-20 date: 2026-04-30 date: 2026-04-30 date: 2024-02-16 date: 2024-02-16 name: Hua Medicine Limited class: INDUSTRY name: Shanghai Branch, KunTuo Medical Research and Development (Beijing) Co., Ltd. briefSummary: The primary objective of this study is to evaluate the long-term safety of Dorzagliatin in a larger population of type 2 diabetes mellitus patients by collecting the post-marketing clinical safety data of Dorzagliatin. conditions: Type2diabetes studyType: INTERVENTIONAL phases: PHASE4 allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: The marketed product - Dorzagliatin tablet (HuaTangNing®) is used as the study drug. During this study, the dosage and administration of Dorzagliatin tablets will be completely in accordance with the investigator's judgment based on the package insert and the patient's condition. primaryPurpose: TREATMENT masking: NONE count: 2000 type: ESTIMATED name: Dorzagliatin tablets measure: Incidences of ADRs and SAEs measure: Blood glucose indicators measure: Response rate sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: China-Japan Friendship Hospital status: RECRUITING city: Beijing state: Beijing zip: 100029 country: China name: Wenying Yang, MD,PhD role: CONTACT lat: 39.9075 lon: 116.39723 facility: China-Japan Friendship Hospital status: RECRUITING city: Beijing state: Beijing zip: 100029 country: China name: Bo Zhang, MD,PhD role: CONTACT lat: 39.9075 lon: 116.39723 hasResults: False
|
<|newrecord|> nctId: NCT06263335 id: Fatima Jinnah Women University briefTitle: MBI for Psychological Distress, SI and NSSI Among Young Adults overallStatus: COMPLETED date: 2022-02-28 date: 2022-05-28 date: 2022-05-28 date: 2024-02-16 date: 2024-02-16 name: Fatima Jinnah Women University class: OTHER briefSummary: Designed to measure the impact of Mindfulness Based Intervention on depression, anxiety, stress, psychological distress, Suicidal Ideation, Non-Suicidal Self Injury urge and Mindfulness in young adults. Those individuals who agree to participate in the trial and identified with high levels of psychological distress and Suicidal Ideation, randomly divided into interventional (n=30) and control (n=30) groups. The Mindfulness Based Stress Reduction intervention then administered to the interventional group for eight weeks and pre and post intervention assessment done for both the groups. conditions: Psychological Distress conditions: Suicidal Ideation conditions: Non-Suicidal Self Injury studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 60 type: ACTUAL name: Mindfulness Based Stress Reduction Intervention measure: Psychological Distress measure: Suicidal Ideation measure: Non-Suicidal Self-Injury (NSSI) sex: ALL minimumAge: 18 Years maximumAge: 24 Years stdAges: ADULT facility: Fatima Jinnah Women University city: Rawalpindi state: Punjab zip: 46000 country: Pakistan lat: 33.6007 lon: 73.0679 hasResults: False
|
<|newrecord|> nctId: NCT06263322 id: IRB202200419 id: R21AG073769 type: NIH link: https://reporter.nih.gov/quickSearch/R21AG073769 briefTitle: The ROAMM-EHR Study acronym: ROAMM-EHR overallStatus: RECRUITING date: 2023-11-16 date: 2026-10-17 date: 2026-10-17 date: 2024-02-16 date: 2024-02-16 name: University of Florida class: OTHER name: National Institute on Aging (NIA) briefSummary: In recent years, mobile health (mHealth) apps have promised improved monitoring of health conditions to improve clinical outcomes. The objective of this study is to conduct a pilot randomized clinical trial (RCT) to evaluate the impact of using remotely collected patient generated health data (PGHD) from older patients undergoing bypass surgery due to chronic limb threatening ischemia. The hypothesis is that integrating PGHD with an EHR system will help providers manage post-surgical symptoms and thus improve post-operative mobility and quality of life health outcomes. conditions: Peripheral Arterial Disease conditions: Chronic Limb-Threatening Ischemia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Parallel Randomized Clinical trial. Comparison study to test the feasibility of patient generated health data compared to standard of care post-surgical observation. primaryPurpose: SUPPORTIVE_CARE masking: QUADRUPLE maskingDescription: Participants are masked to whether their PGHD are being sent to their care provider. Care providers are masked to who receives standard of care. Investigators (except for one who will be the point person for randomization) will be masked to intervention assignments. Staff assessors will be masked to whether PGHD are being sent to their care provider. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 50 type: ESTIMATED name: Actionable remotely generated health data name: Non-Actionable remotely generated health data measure: 6-min walk distance measure: self-reported quality of life sex: ALL minimumAge: 60 Years maximumAge: 100 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Institute of Aging status: RECRUITING city: Gainesville state: Florida zip: 32611 country: United States name: Institute_of_Aging role: CONTACT phone: 352-273-5919 email: [email protected] name: HOBI_Department role: CONTACT phone: 352.627.9467 email: [email protected] lat: 29.65163 lon: -82.32483 hasResults: False
|
<|newrecord|> nctId: NCT06263309 id: Femoralneckfracture briefTitle: Mid-Term Radiological Outcomes of Femoral Neck Fractures Treated With Osteosynthesis: A Comparative Analysis overallStatus: COMPLETED date: 2022-06-01 date: 2023-06-01 date: 2023-09-01 date: 2024-02-16 date: 2024-02-16 name: Istanbul University class: OTHER briefSummary: OBJECTIVES: This study assesses the efficacy of dynamic hip screw (DHS) versus cannulated screws for femoral neck fractures, focusing on femoral neck shortening, avascular necrosis (AVN) incidence, and functional outcomes.
|
METHODS:
|
Subsets and Splits
No community queries yet
The top public SQL queries from the community will appear here once available.