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6. Inform patient and family for further intervention
Polytrauma patients in the control group will receive the usual/standard intervention.
Response time, early warning score, and arterial blood gas of polytrauma patients from both groups will be obtained and documented before and after the intervention. conditions: Polytrauma studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: INVESTIGATOR count: 48 type: ESTIMATED name: ELLASI name: Standard measure: Response time measure: Deterioration score measure: Acidic Level (pH) measure: Base Excess (BE) measure: Bicarbonate level (HCO3) sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: RSCM status: RECRUITING city: Jakarta Pusat state: Jawa Barat zip: 10430 country: Indonesia name: RSCM role: CONTACT phone: 062211500135 email: [email protected] lat: -6.1818 lon: 106.8223 hasResults: False
<|newrecord|> nctId: NCT06351813 id: B2024-029R briefTitle: Predicting Adverse Kidney Events of Cardiac Surgery-Associated Acute Kidney Injury Using Novel Biomarkers overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2026-12-31 date: 2027-12-31 date: 2024-04-08 date: 2024-04-08 name: Shanghai Zhongshan Hospital class: OTHER name: Zhongshan Hospital (Xiamen), Fudan University name: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University briefSummary: The aim of this study was to identify and validate novel biomarkers for predict acute kidney injury (AKI) subphenotype, major adverse kidney events and other poor outcomes. conditions: Acute Kidney Injury conditions: Critical Illness conditions: Kidney Failure studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 358 type: ESTIMATED measure: AKI nonresolving subphenotype measure: Major adverse kidney events at 30 days measure: Major adverse kidney events at 90 days measure: Major adverse kidney events at 365 days measure: Mortality measure: Receipt of renal replacement treatment measure: Moderate and severe AKI measure: AKI progression measure: Composite Outcome sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Shanghai Zhongshan Hospital city: Shanghai state: Shanghai zip: 200032 country: China lat: 31.22222 lon: 121.45806 hasResults: False
<|newrecord|> nctId: NCT06351800 id: PE-0280-2018 briefTitle: The PredictPlusPrevent Study overallStatus: NOT_YET_RECRUITING date: 2024-09-15 date: 2025-12-31 date: 2026-04-30 date: 2024-04-08 date: 2024-04-08 name: The Mediterranean Institute for the Advance of Biotechnology and Health Research class: OTHER briefSummary: Objective: To design, develop, and evaluate a personalized intervention for the universal prevention of depression and anxiety in the general population based on risk algorithms, ICTs, and decision support systems (DSS).
Methods: A double-blind, parallel-group, randomized controlled trial with a twelve-month follow-up. The entire process of recruitment, random allocation, intervention, and follow-up will be conducted through the 'PredictPlusPrevent' platform and its associated apps. Following a media campaign, at least 9,000 Spanish participants aged 18 to 55 years without depression and/or anxiety at baseline will be randomly assigned to the intervention or active control group "PredictPlusPrevent". The "PredictPlusPrevent" intervention will be self-guided and implemented through participants' smartphones via an app; it will have a biopsychosocial and multi-component approach (8 modules: physical exercise, improving sleep, expanding relationships, problem-solving, improving communication, assertiveness, decision-making, and managing thoughts). The "PredictPlusPrevent" intervention is based on validated risk algorithms for depression and anxiety and a DSS that will help participants develop their own personalized depression prevention plans, which they will implement themselves while the platform monitors and provides feedback. The active control "PredictPlusPrevent" will include information from the risk algorithms and 24 self-help booklets. The primary outcome will be the incidence of new cases of depression and/or anxiety assessed using the PRIME-MD questionnaire, and secondary outcomes will include reductions in depression (PHQ-9) and anxiety symptoms (GAD-7), probability of depression and anxiety risk (predictD and predictA algorithms), and physical and mental quality of life (SF-12). conditions: Depression conditions: Anxiety Disorders studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 9000 type: ESTIMATED name: Predictplusprevent intervention name: Psychoeducational intervention measure: Incidence of depression and/or anxiety disorders. measure: Depressive symptoms measured by the Patient Health Questionnaire-9 (PHQ-9). measure: Anxious symptoms measured by the General Anxiety Questionnaire (GAD-7). measure: Probability of depression measured by the Spanish predictD risk algorithm. measure: Probability of anxiety measured by the Spanish predictA risk algorithm. measure: Quality of life measured by the 12-item Short Form (SF-12). sex: ALL minimumAge: 18 Years maximumAge: 55 Years stdAges: ADULT hasResults: False
<|newrecord|> nctId: NCT06351787 id: 22-X-97 briefTitle: Project Soma: Cortical Activity of a Body Scan Meditation and Yoga Practice in Healthy Yogis overallStatus: COMPLETED date: 2022-10-31 date: 2023-06-28 date: 2023-06-28 date: 2024-04-08 date: 2024-04-08 name: Ohio University class: OTHER briefSummary: In this 2-armed randomized cross-sectional experimental study of healthy participants with yoga experience, we will examine the relationship between 4 self-reported enhancing psychological factors, cortical activity captured with functional near-infrared spectroscopy (fNIRS), and pain sensitivity (mechanical pressure pain tolerance) captured with algometry.
Specifically, we will examine the correlates of interoceptive awareness and mindful awareness with cortical activity (Aim 1a) and pain tolerance (Aim 1b); determine cortical activity responsiveness of two brief awareness-focused meditations - a resting-based body scan practice and yoga practice (Aim 2a); characterize cortical activity profiles with sequentially delivered body scan and yoga practices (Aim 2b); and elucidate the relationship between interoceptive awareness with healthy emotionality and psychological wellbeing (Aim 3).
Our central hypotheses are that (Aim 1a) higher interoceptive awareness and mindful awareness will moderately correlate with higher cortical activity for both awareness-focused meditation practices; (Aim 1b) individuals sub-grouped into the 'acceptance in action cluster' based on 2 self-report measures will exhibit higher pain tolerance; (Aim 2a) cortical activity will be higher in the yoga practice compared to the body scan practice; and (Aim 2b) higher cortical activity will be observed in the body scan-\>yoga intervention sequence compared to the yoga-\>body scan intervention sequence. Furthermore, (Aim 3) we predict that interoceptive awareness will moderately correlate with healthy emotionality and psychological well-being. conditions: Well-Being, Psychological studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: A 2-armed randomized cross-sectional experimental study with 20 healthy participants who hold yoga experience. primaryPurpose: TREATMENT masking: NONE count: 14 type: ACTUAL name: Resting and movement-based focused awareness meditations measure: Cortical activity measure: Interoceptive awareness measure: Mindful awareness measure: Pressure pain threshold and tolerance measure: Healthy emotionality measure: Well-being sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Ohio University city: Athens state: Ohio zip: 45701 country: United States lat: 39.32924 lon: -82.10126 hasResults: False
<|newrecord|> nctId: NCT06351774 id: 21-F-45 briefTitle: Project AdaPT: An Adaptive Physiotherapy Intervention Augmented With a Healthy Mind Training Program for People With Chronic Low Back Pain acronym: AdaPT overallStatus: COMPLETED date: 2022-05-24 date: 2024-02-08 date: 2024-03-25 date: 2024-04-08 date: 2024-04-08 name: Ohio University class: OTHER name: University of Wisconsin, Madison briefSummary: In the proposed research, we will elucidate the comparative effectiveness of standalone physiotherapy (PT) vs. PT augmented with a self-guided, app-based Healthy Minds Innovation wellbeing program (PT+HMI) aimed at cultivating awareness, connection, insight, and purpose for people with chronic low back pain (CLBP). conditions: Back Pain Lower Back Chronic conditions: Disability Physical studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: SEQUENTIAL interventionModelDescription: A 2 armed sequential, multiple-assignment randomized trial design primaryPurpose: TREATMENT masking: SINGLE maskingDescription: The investigator was masked to the initial treatment assignment. The outcome assessor was not masked to treatment assignment and monitored treatment response at the mid-intervention in order to recommend continuation of current treatment or to augment treatment with the Healthy Mind Innovations training program for individuals who did not favorably respond to standalone PT. whoMasked: INVESTIGATOR count: 13 type: ACTUAL name: Physical therapy measure: Oswestry Disability Index measure: PROMIS Pain Interference measure: Actigraphy measure: 3D Motion Capture measure: Pain acceptance measure: Committed action measure: Healthy emotionality measure: Exercise behavior measure: Back pain screening tool 1 measure: Back pain screening tool 1 measure: Kinesiophobia measure: Attitudes towards complementary and alternative medicine measure: Treatment expectancy measure: Lumbar pressure pain threshold measure: Thermal method of limits sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Ohio University city: Athens state: Ohio zip: 45701 country: United States lat: 39.32924 lon: -82.10126 hasResults: False
<|newrecord|> nctId: NCT06351761 id: SCT02-ECG briefTitle: WIBOFA - Validation of SCT02 With ECG-App for Detection of AF acronym: WIBOFA overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-01 date: 2025-03 date: 2024-04-08 date: 2024-04-08 name: Withings class: INDUSTRY briefSummary: The aim of the study is to evaluate the performance of Withings SCT02 with embedded Withings ECG-app in the automatic detection of atrial fibrillation conditions: Atrial Fibrillation studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: BASIC_SCIENCE masking: NONE count: 270 type: ESTIMATED name: Investigational Device (Withings SCT02) 30 second Electrocardiogram recording name: Reference Device (Schiller Cardiovit FT-1) 30 second Electrocardiogram recording measure: Co-primary outcome 1 - Sensitivity of Investigational Device measure: Co-primary outcome 2 - Specificity of Investigational Device measure: Rhythm classification by ranges of heart rate measure: Quality of plots measured by the IMD - ECG Waveform Visibility measure: Quality of plots measured by the IMD - ECG Waveforms Polarity measure: Quality of plots measured by the IMD - ECG Waveforms Intervals measure: Quality of plots measured by the IMD - Heart Rate calculation sex: ALL minimumAge: 22 Years stdAges: ADULT stdAges: OLDER_ADULT facility: FWD Clinical Research city: Boca Raton state: Florida zip: 33486 country: United States lat: 26.3669 lon: -80.13033 facility: Diverse Clinical Research city: Miami state: Florida zip: 33175 country: United States lat: 25.77427 lon: -80.19366 facility: Henri Mondor University Hospital city: Créteil state: Val De Marne zip: 94000 country: France lat: 48.78333 lon: 2.46667 hasResults: False
<|newrecord|> nctId: NCT06351748 id: NN9535-7877 id: U1111-1296-3151 type: OTHER domain: World Health Organization (WHO) briefTitle: Real-world Study of CHina Ozempic cLinicAl pRactice in Patients With Type 2 Diabetes (SCHOLAR) acronym: SCHOLAR overallStatus: ENROLLING_BY_INVITATION date: 2024-04-05 date: 2024-06-30 date: 2024-06-30 date: 2024-04-08 date: 2024-04-08 name: Novo Nordisk A/S class: INDUSTRY briefSummary: This study is to describe the real-world use and impact of semaglutide once-weekly (OW) among participants with type 2 diabetes mellitus (T2DM) in China. Participants diagnosed with T2DM who initiated semaglutide OW for the first time between 1 Jan 2022 (the date when semaglutide OW was listed in the National Reimbursement Drug List \[NRDL\] in China\] and 28 Feb 2023 (9 months prior to the data extraction cut-off date of 30 Nov 2023) will be included in this study. The study period will be 36 months prior to the first date of participants identification period. conditions: Diabetes Mellitus, Type 2 studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 27000 type: ESTIMATED name: Semaglutide measure: Change in Haemoglobin A1c (HbA1c) level measure: Change in HbA1c level measure: Proportion of participants achieving HbA1c less than (<) 7.0% measure: Change in HbA1c level measure: Change in HbA1c level measure: Proportion of participants achieving HbA1c <7.0% measure: Change in body weight measure: Change in body weight measure: Description of participants with different demographic characteristics measure: Description of participants with different clinical characteristics measure: Proportion of participants with different antidiabetic medications measure: Proportion of participants with different non-antidiabetic medications sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Tianjin Medical University Chu Hsien-I Memorial Hospital city: Tianjin country: China lat: 39.14222 lon: 117.17667 hasResults: False
<|newrecord|> nctId: NCT06351735 id: 2024-0336 briefTitle: Efficacy and Safety of Deep Cervical Lymph Node-vein Bypass Surgery in ALS Amyotrophic Lateral Sclerosis overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2026-05-01 date: 2027-05-01 date: 2024-04-08 date: 2024-04-08 name: Second Affiliated Hospital, School of Medicine, Zhejiang University class: OTHER briefSummary: Amyotrophic lateral sclerosis (ALS), a fatal neurodegenerative disease, affects motor neurons, causing progressive muscle atrophy and weakness. Current treatments are ineffective, with most patients dying within 3-5 years of diagnosis. The disease's exact cause is unclear, but factors such as oxidative stress and protein abnormalities are implicated. Abnormal protein deposits and neurotoxic factors in the brain and spinal cord contribute to ALS pathology. Recent research on the brain's glymphatic-lymphatic system suggests impaired waste clearance may exacerbate ALS. Restoring drainage connections between cervical lymphatic vessels and veins could potentially alleviate neurodegenerative disease progression. conditions: Evaluation of the Efficacy and Safety of Deep Cervical Lymph Node-vein Bypass Surgery in Patients With Amyotrophic Lateral Sclerosis studyType: OBSERVATIONAL observationalModel: CASE_CROSSOVER timePerspective: PROSPECTIVE count: 3 type: ESTIMATED name: Deep cervical lymph node-vein bypass surgery measure: ALSFRS-R scale measure: Cognitive and Behavioral Scale (CAS) measure: Baseline of slow vital capacity (SVC) measure: Evaluation of glymphatic and meningeal lymphatic drainage measure: Amyotrophic Lateral Sclerosis Assessment Questionnaire (ALSAQ-5) sex: ALL minimumAge: 20 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<|newrecord|> nctId: NCT06351722 id: smokingnlrp3inflasome briefTitle: Non-surgical Periodontal Treatment in Smokers on SIRT-1, NLRP3 Inflammasome and LncRNAs overallStatus: NOT_YET_RECRUITING date: 2024-05-15 date: 2024-12-15 date: 2025-03-15 date: 2024-04-08 date: 2024-04-08 name: Necmettin Erbakan University class: OTHER briefSummary: The goal of this observational is to analyze the relationship between levels of interleukin-18 (IL-18), interleukin (IL-1β), Tumor Necrosis Factor-alpha (TNF-α), interleukin-10 (IL-10), transforming growth factor beta (TGF-β), Nucleotide-binding oligomerization domain -like receptor protein 3 (NLRP3), apoptosis-associated speck-like protein (ASC), caspase-1, Sirtuin 1 (SIRT-1), Long noncoding RNA (lncRNA) small nucleolar RNA host gene 5 (SNHG5), and maternally expressed gene 3 (MEG3) in saliva, serum, and peripheral mononuclear blood cell (PMBC)in patients with periodontitis and smokers, to examine the changes in these biomarkers after non surgical periodontal treatment (NSPT), and to evaluate potential confounders that may mediate this relationship.
The main questions it aims to answer are:
question 1: Is there a relationship between the biomarkers mentioned above and periodontitis and smoking? question 2:How do the above-mentioned biomarkers change after NSPT in smokers and non-smokers? conditions: Periodontitis, Adult studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 100 type: ESTIMATED name: Before non-surgical periodontal treatment name: non-surgical periodontal treatment name: 3rd month after non-surgical periodontal treatment measure: Pre-treatment clinical and laboratory evaluation measure: Comparison of clinical measurements and laboratory measurements at 3 months post-treatment sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<|newrecord|> nctId: NCT06351709 id: UmutPaksoy briefTitle: Acute Effects of Heat, Cold and Stretching on Knee Proprioception and Vertical Jump overallStatus: COMPLETED date: 2020-11-02 date: 2021-02-20 date: 2021-02-20 date: 2024-04-08 date: 2024-04-08 name: Istanbul Bilgi University class: OTHER briefSummary: The aim of our study is to investigate the effects of heat, cold and stretching on knee proprioception and vertical jump. 60 healthy individuals were randomized into hot, cold, stretching and control groups of 15 each. Pre-test and post-test measurements were made immediately after the application. Knee proprioception was measured with a digital goniometer using the EPD (joint position sense) test. Vertical jump heights were measured with contact mat by countermovement (CMJ) and squat splash (SQS) tests. conditions: Healthy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 60 type: ACTUAL name: Stretching name: Hot pack application name: Cold pack application measure: Vertical Jump Distance Measurement measure: Joint Position Sense Measurement sex: ALL minimumAge: 18 Years maximumAge: 30 Years stdAges: ADULT facility: İstanbul Medipan Tıp Merkezi city: Istanbul zip: 34218 country: Turkey lat: 41.01384 lon: 28.94966 hasResults: False
<|newrecord|> nctId: NCT06351696 id: 43008563 briefTitle: The Effects of Bromelain Supplement in Patients With Ulcerative Colitis overallStatus: RECRUITING date: 2024-04-20 date: 2024-07-20 date: 2024-08-10 date: 2024-04-08 date: 2024-04-09 name: National Nutrition and Food Technology Institute class: OTHER briefSummary: In this study, patients with active mild to moderate UC with or without PSC will be randomized to receive either bromlein or placebo along with low FODMAP diet for 8 weeks.
IBDQ, SCCAIQ, CRP, TAC, TNF-a will be measured before and after the intervention. conditions: Ulcerative Colitis conditions: Primary Sclerosing Cholangitis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 84 type: ESTIMATED name: Bromlein name: Placebo measure: SCCAIQ measure: IBDQ measure: Serum TAC measure: Serum hsCRP measure: Serum TNF-a sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Azita Hekmatdoost status: RECRUITING city: Tehran state: Middle East zip: 19835 country: Iran, Islamic Republic of name: Azita Hekmatdoost, MD, PhD role: CONTACT phone: +989123065084 email: [email protected] lat: 35.69439 lon: 51.42151 hasResults: False
<|newrecord|> nctId: NCT06351683 id: 24-066-2 id: P30AG067988 type: NIH link: https://reporter.nih.gov/quickSearch/P30AG067988 briefTitle: Testing MitoQ on Lower Urinary Tract Symptoms in Older Women With Metabolic Syndrome acronym: Mito-LUTS overallStatus: RECRUITING date: 2024-04-03 date: 2025-12 date: 2025-12 date: 2024-04-08 date: 2024-04-25 name: Iman Al-Naggar, PhD class: OTHER name: National Institute on Aging (NIA) name: American Urological Association name: Urology Care Foundation name: Claude D. Pepper Older Americans Independence Center (OAIC) briefSummary: The goal of this clinical trial is to test the effect of a supplement called MitoQ (mitoquinol mesylate) on bladder symptoms such as urgency and frequency in women aged 50-75 years old who have the metabolic syndrome. The main questions it aims to answer are:
* Is the study design feasible and acceptable to participants?
* Do participants taking the study drug get any improvement to their bladder symptoms compared to participants taking a placebo (a look-alike substance that contains no drug)?
Participants will take 2 capsules of the study drug every morning for 4 months, answer many questions about their health including questions about their bladder health, perform physical and cognitive testing, give blood and urine samples, collect urine over 24 hour periods 3 times over the 4 months of the study, complete 3 day bladder diaries about how much they drink and void, undergo electrocardiograms, have their vitals and measurements (weight, height, waist circumference) taken, participate in 4 visits to the clinical research area and participate in many phone calls of varying length. Researchers will compare participants who were taking capsules containing MitoQ and participants taking capsules not containing MitoQ to see if MitoQ improves their bladder symptoms (urgency, frequency, nocturia, incontinence, etc.) conditions: Lower Urinary Tract Symptoms conditions: Overactive Bladder Syndrome studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE maskingDescription: Double-blinded. Pharmacy will randomize and dispense capsules. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 50 type: ESTIMATED name: MitoQ (mitoquinol mesylate) name: Placebo measure: Overactive Bladder Symptom Score (OABSS) measure: Three-day bladder voiding diary sex: FEMALE minimumAge: 50 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: UConn Health status: RECRUITING city: Farmington state: Connecticut zip: 06030 country: United States name: Lisa Kenyon-Pesce role: CONTACT phone: 860-679-2305 email: [email protected] name: Peter C Albertsen, MD role: SUB_INVESTIGATOR name: George A Kuchel, MD role: SUB_INVESTIGATOR name: Jenna M Bartley, PhD role: SUB_INVESTIGATOR name: Oh Sung Kwon, PhD role: SUB_INVESTIGATOR lat: 41.71982 lon: -72.83204 hasResults: False
<|newrecord|> nctId: NCT06351670 id: 1109/2024 briefTitle: Personalised Monitoring of Early and Intermediate Age-related Macular Degeneration With Artificial Intelligence and Identification of Disease Progression acronym: SUDETES overallStatus: NOT_YET_RECRUITING date: 2024-07 date: 2027-07 date: 2027-07 date: 2024-04-08 date: 2024-04-09 name: Medical University of Vienna class: OTHER name: University Medical Centre Ljubljana name: Centre Hospitalier Universitaire Dijon name: Queen's University, Belfast name: University of Zurich name: Vista Klinik name: Fundacion Clinic per a la Recerca Biomédica briefSummary: The goal of this prospective, multinational, multicenter observational study is to to predict conversion of early and intermediate AMD with functional vision to advanced AMD with irreversible loss of vision on an individual-based level over 2 years. The main objectives of this study are:
* Identify and quantify focal and global alterations in the retina in regard to disease progression.
* Assess the individual risk of disease progression in intermediate AMD patients converting to advanced AMD based on imaging.
* Specify the course of disease in regard to the sequence of events that lead to the conversion to advanced AMD
* Enhance the ability to classify AMD using artificial intelligence in addition to traditional models.
All patients will be followed for 24 months with 6 month intervals to assess clinical changes. Monitoring of disease progression will be performed using the following routine in-vivo imaging procedures:
* Scanning Laser Fundus Photography
* Color Fundus Photography (CFP)
* Optical Coherence Tomography (OCT)
* Optical Coherence Tomography Angiography (OCTA) Patients will be asked for their medical history. Standard ophthalmic examination, as well as a questionnaire on visual function will be carried out.
No intervention will be performed during the study since no treatment is yet available within Europe. As soon as treatment is approved in the EU, patients in this cohort might receive treatment according to availability in their respective country and standard of care. If treatment will be performed, it will be as standard of care outside the study according to each country's standard of care and by EMA label. conditions: Age-Related Macular Degeneration studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 500 type: ESTIMATED measure: To characterise and quantify focal and global changes of the retina by retinal imaging to identify patients at risk for conversion to advanced AMD. measure: To identify and quantify disease progression-related biomarkers measure: To evaluate monitoring of AMD progression assisted by AI algorithms sex: ALL minimumAge: 55 Years maximumAge: 99 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<|newrecord|> nctId: NCT06351657 id: 1088/2024 briefTitle: Personalized Monitoring of Non-foveal, Non-vision Compromising Atrophic Age-related Macular Degeneration With Artificial Intelligence and Identification of Disease Progression acronym: APENNINES overallStatus: NOT_YET_RECRUITING date: 2024-07 date: 2027-07 date: 2027-07 date: 2024-04-08 date: 2024-04-09 name: Medical University of Vienna class: OTHER name: University Medical Centre Ljubljana name: Centre Hospitalier Universitaire Dijon name: University of Zurich name: Vista Klinik name: Queen's University, Belfast name: Fundacion Clinic per a la Recerca Biomédica briefSummary: The goal of this prospective, multinational, multicenter observational study is to assess and predict progression in non-foveal, non-vision compromising atrophic AMD on an individual-based level over two years. The main objectives of this study are:
* Assess the individual progression rate of a patient in non-foveal, non-vision compromising atrophic AMD and assess personalized risk of progression based on imaging.
* Identify and quantify focal and global alterations in the retina in regard to disease progression.
* Evaluate the monitoring of AMD progression using approved AI algorithms.
All patients will be followed for 24 months with 6 month intervals to assess clinical changes. Monitoring of disease progression will be performed using the following routine in-vivo imaging procedures:
* Scanning Laser Fundus Photography
* Color Fundus Photography (CFP)
* Optical Coherence Tomography (OCT)
* Optical Coherence Tomography Angiography (OCTA)
Patients will be asked for their medical history. Standard ophthalmic examination, as well as a questionnaire on visual function will be carried out.
No intervention will be performed during the study since no treatment is yet available within Europe. As soon as treatment is approved in the EU, patients in this cohort might receive treatment according to availability in their respective country and standard of care. If treatment will be performed, it will be as standard of care outside the study according to each country's standard of care and by EMA label. conditions: Age-Related Macular Degeneration conditions: Geographic Atrophy studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 200 type: ESTIMATED measure: To characterise and quantify focal and global changes of the retina by retinal imaging to identify patients at risk for fast geographic atrophy (GA) progression measure: To identify and quantify disease progression-related biomarkers measure: To evaluate monitoring AMD progression using approved AI algorithms. sex: ALL minimumAge: 55 Years maximumAge: 99 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<|newrecord|> nctId: NCT06351644 id: STUDY-24-00244 briefTitle: ON 123300 (Narazaciclib) and Dexamethasone in Patients With Relapsed and/or Refractory Multiple Myeloma overallStatus: NOT_YET_RECRUITING date: 2024-06-03 date: 2028-06-05 date: 2028-06-05 date: 2024-04-08 date: 2024-04-08 name: Adriana Rossi class: OTHER briefSummary: Multiple myeloma (MM) is a malignancy characterized by uncontrolled proliferation of plasma cells for which there is an urgent and unmet need to develop new, effective therapeutics. Onconova Therapeutics has developed a first-in-class oral inhibitor of CDK4 and ARK5 ON 123300 (NARAZACICLIB) which shows potent anti-myeloma activity in vitro and in vivo in preclinical models, and is undergoing evaluation in Phase 1-2 trials worldwide.
In this study, the researchers will test the safety and preliminary efficacy of inhibition of CDK4 and ARK5 by ON 123300 (NARAZACICLIB) in combination with dexamethasone in myeloma patients in a Phase I/II clinical trial. conditions: Relapsed and/or Refractory Multiple Myeloma studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: This is a single arm optimal biologic dose finding phase I/II clinical trial. primaryPurpose: TREATMENT masking: NONE count: 36 type: ESTIMATED name: ON 123300 name: Dexamethasone measure: Phase I: The optimal biological dose (OBD) of the combination of ON 123300 (NARAZACICLIB) and dexamethasone measure: Phase I: Dose-Limiting Toxicity (DLT) rate measure: Phase II: Overall response rates (ORR) measure: Number of Adverse events of Special Interest (AESI) measure: HbA1c measure: Fasting insulin levels measure: Lipid profiles measure: Free fatty acids measure: Best overall response (BOR) measure: Duration of Response (DOR) measure: Time to Progression (TTP) measure: Progression-Free Survival (PFS) measure: Disease Control Rate (DCR) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Mount Sinai Health System city: New York state: New York zip: 10029 country: United States name: Adriana Rossi, MD role: CONTACT name: Katherine Vandris role: CONTACT email: [email protected] name: Adriana Rossi role: PRINCIPAL_INVESTIGATOR lat: 40.71427 lon: -74.00597 hasResults: False
<|newrecord|> nctId: NCT06351631 id: 3543-017 id: 2023-506996-89 type: OTHER domain: EU CT id: U1111-1294-8621 type: OTHER domain: UTN id: MK-3543-017 type: OTHER domain: Merck ID briefTitle: A Study to Evaluate Safety and Efficacy of Bomedemstat (MK-3543-017) overallStatus: NOT_YET_RECRUITING date: 2024-05-21 date: 2034-12-04 date: 2034-12-04 date: 2024-04-08 date: 2024-04-08 name: Merck Sharp & Dohme LLC class: INDUSTRY briefSummary: The primary purpose of the study is to transition participants into an extension study to collect long-term safety and efficacy data. The study will include participants who are safely tolerating bomedemstat, receiving clinical benefit from its use in estimation of the investigator, and have shown the following criteria:
* Participants from the IMG-7289-202/MK-3543-005 (NCT05223920) study must have received at least 6 months of treatment with bomedemstat;
* Essential thrombocythemia (ET) and polycythemia vera (PV) participants from studies other than IMG-7289-202/MK-3543-005 must have achieved confirmed hematologic remission.
No hypothesis testing will be conducted in this study. conditions: Thrombocythemia, Essential conditions: Primary Myelofibrosis conditions: Myelofibrosis conditions: Post-polycythemia Vera Myelofibrosis conditions: Post-essential Thrombocythemia Myelofibrosis conditions: Polycythemia Vera studyType: INTERVENTIONAL phases: PHASE3 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 400 type: ESTIMATED name: Bomedemstat measure: Percentage of participants with one or more adverse events (AEs) measure: Percentage of participants who discontinued study treatment due to an AE measure: For participants with ET or PV: Duration of clinicohematologic response measure: For participants with ET or PV: Duration of hematologic remission measure: For participants with ET or PV: Percentage of participants with transformation to MF or MDS/AML measure: For participants with MF: Percentage of participants with worsening of splenomegaly or transformation to MDS/AML measure: For participants with MF, ET, or PV: Percentage of participants with thrombotic events measure: For participants with MF, ET, or PV: Percentage of participants with major hemorrhagic events measure: For participants with MF, ET, or PV: Event-Free Survival (EFS) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<|newrecord|> nctId: NCT06351618 id: 2023-06114-01 briefTitle: Epidemiology of Injuries in the Professional Women's Swedish National IceHockey League Permitted to Body-Checking overallStatus: RECRUITING date: 2023-12-01 date: 2024-03-26 date: 2028-01-01 date: 2024-04-08 date: 2024-04-08 name: Lund University class: OTHER briefSummary: This research project can contribute to a deeper understanding of injury patterns among professional female ice-hockey players allowed to body check. An understanding of common injury types and mechanisms aids the clinician in diagnosis and management. This information can guide preventative strategies in the areas of education, coaching, rule enforcement, rule modifications, equipment improvement, and sportsmanship. Today, ice hockey is a sport associated with many severe injuries that not only causes suffering and lower quality of life for the athlete, but also costs society a lot of money. Reducing the number and severity of sport-related injuries is therefore of importance. Knowledge of the injury epidemiology of women's hockey could also contribute to better preventive training programs and other injury preventive actions in the sport. Currently, only a minority of all sports medicine research is made on female study participants (26). This research project has the possibility to gain more knowledge about the female athlete, not only applicable for elite hockey-players, but also for female athletes in different disciplines and in youth teams. Knowledge of factors associated with injury could also contribute to better injury preventive actions and highlight subgroups in extra need of future preventive interventions. conditions: Sport Injury conditions: Ice-Skates Accident conditions: Sports Accident conditions: Female Athlete Triad conditions: Female studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 225 type: ESTIMATED name: No intervention will be conducted. measure: Injuries per 1000 training hours measure: Injuries per 1000 game hours sex: FEMALE minimumAge: 16 Years maximumAge: 110 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: The Faculty of Medicine at Lund University status: RECRUITING city: Malmö zip: 20213 country: Sweden name: Amanda Lahti role: CONTACT phone: 0704854798 email: [email protected] lat: 55.60587 lon: 13.00073 hasResults: False
<|newrecord|> nctId: NCT06351605 id: CSP006 briefTitle: A Registry Study to Assess Photobiomodulation in Dry Age-Related Macular Degeneration (EUROLIGHT) (EUROLIGHT) overallStatus: RECRUITING date: 2023-09-01 date: 2026-09 date: 2026-12 date: 2024-04-08 date: 2024-04-08 name: LumiThera, Inc. class: INDUSTRY briefSummary: The EUROLIGHT study is being conducted to collect real life data for the safety and effectiveness of PBM in dry AMD, in routine clinical practice both retrospectively and prospectively. conditions: Dry Age-related Macular Degeneration studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: OTHER count: 500 type: ESTIMATED name: Valeda Light Delivery System measure: Best-Corrected Visual Acuity (BCVA) measure: OCT Imaging measure: FAF Imaging sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Oslo University Hospital status: RECRUITING city: Oslo country: Norway name: Øygunn Utheim, MD role: CONTACT phone: +47 93692578 email: [email protected] lat: 59.91273 lon: 10.74609 hasResults: False
<|newrecord|> nctId: NCT06351592 id: ALN-SOD-ALS-2351 id: 2023-510344-20-00 type: REGISTRY domain: EU CT Number briefTitle: First in Human (FIH) Study of ALN-SOD in Adult Participants With Amyotrophic Lateral Sclerosis Associated With Mutation in the SOD1 Gene (SOD1-ALS) overallStatus: NOT_YET_RECRUITING date: 2024-06-28 date: 2029-04-28 date: 2029-04-28 date: 2024-04-08 date: 2024-04-08 name: Regeneron Pharmaceuticals class: INDUSTRY briefSummary: This study is researching an experimental drug called ALN-SOD (called "study drug"). This study is focused on people with amyotrophic lateral sclerosis (ALS) who have a mutation in a gene called the superoxide dismutase-1 (SOD1) gene. This type of ALS is known as "SOD1-ALS". This is the first time that ALN-SOD will be given to people. The aim of the study is to see how safe and tolerable the study drug is.
The study is looking at several other research questions, including:
* The effect the study drug has on specific biomarkers, which are molecules in the blood or in the fluid that surrounds the brain and spinal cord, known as cerebrospinal fluid (CSF)
* How much study drug is in the blood and in the CSF, at different times
* Whether the body makes antibodies against the study drug (which could make the drug less effective or could lead to side effects)
* What effects the study drug has on ALS symptoms conditions: Amyotrophic Lateral Sclerosis (ALS) conditions: Mutation in the Superoxide Dismutase-1 (SOD1) Gene studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: QUADRUPLE maskingDescription: No masking during Open-Label Treatment Period after 4-week Double-Blind Treatment Period. This part of the study consists of a crossover design. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 42 type: ESTIMATED name: ALN-SOD name: Diluent name: Placebo (PB) measure: Incidence of treatment-emergent adverse event (TEAEs) in participants treated with ALN-SOD measure: Severity of TEAEs in participants treated with ALN-SOD measure: Concentration of SOD1 protein in cerebrospinal fluid (CSF) over time measure: Change in concentration of SOD1 protein in CSF over time measure: Concentration of neurofilament light chain (NfL) in plasma over time measure: Change in concentration of NfL in plasma over time measure: Concentration of NfL in CSF over time measure: Change in concentration of NfL in CSF over time measure: Concentration of ALN-SOD in plasma over time measure: Concentration of ALN-SOD in CSF over time measure: Incidence of anti-drug antibodies (ADAs) to ALN-SOD in serum over time measure: Titer of ADAs to ALN-SOD in serum over time sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<|newrecord|> nctId: NCT06351579 id: 1010159 briefTitle: Data Collection Post Radical Prostatectomy acronym: ALTO overallStatus: NOT_YET_RECRUITING date: 2024-06-15 date: 2025-12-30 date: 2026-03-15 date: 2024-04-08 date: 2024-04-08 name: Levee Medical, Inc. class: INDUSTRY name: RQMplus briefSummary: The study is to collect information on patients undergoing radical prostatectomy (RP), with a primary focus on the occurrence, duration, and severity of post-prostatectomy incontinence. Data will be collected at multiple time points, allowing for a dynamic understanding of urinary incontinence patterns at post RP. conditions: Stress Urinary Incontinence conditions: Radical Prostatectomy conditions: BPH studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: PROSPECTIVE count: 30 type: ESTIMATED name: Control measure: The change in average 24-hour pad weight over time measure: Change in pad weight during a 1-hour provocative pad weight test measure: Expanded Prostate Index Composite (EPIC-26) score. sex: MALE minimumAge: 45 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<|newrecord|> nctId: NCT06351566 id: VD3, Prebiotics in Diabetes briefTitle: Effects of Vitamin D3 and Prebiotics Supplementation on Cardiovascular Risk Factors in Patients With Type 2 Diabetes overallStatus: NOT_YET_RECRUITING date: 2024-04-24 date: 2024-12-31 date: 2025-12-31 date: 2024-04-08 date: 2024-04-22 name: Huazhong University of Science and Technology class: OTHER briefSummary: The goal of this randomized, double-blind, placebo-controlled, 6-month supplementation study in individuals with type 2 diabetes is to investigate whether taking daily dietary supplements of vitamin D3 (1600 IU) or prebiotics (inulin, 10 gram) has beneficial effects on cardiovascular disease risk factors. conditions: Diabetes Mellitus, Type 2 studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: FACTORIAL primaryPurpose: PREVENTION masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 200 type: ESTIMATED name: Vitamin D3 name: Prebiotics name: Vitamin D3 placebo name: Prebiotics placebo measure: Glycated hemoglobin (HbA1c) measure: Concentration of blood lipids measure: Metagenomic analysis of the gut microbiota measure: Concentration of fasting glucose measure: Concentration of fasting insulin measure: Systolic and diastolic blood pressure measure: Estimated glomerular filtration rate (eGFR) measure: Concentration of C-reactive protein (CRP) measure: Concentration of procalcitonin measure: Concentration of interleukin-6 (IL-6) measure: Concentration of serum 25(OH)D measure: Body weight measure: Waist circumference measure: Hip circumference sex: ALL minimumAge: 40 Years maximumAge: 69 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<|newrecord|> nctId: NCT06351553 id: 2023-169 briefTitle: Effect of the Autonomic Nervous System on the Outcomes of PULSEd Field Ablation to Treat Atrial Fibrillation acronym: EASy-PULSE AF overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2026-06 date: 2026-06 date: 2024-04-08 date: 2024-04-08 name: Hospital General Universitario de Alicante class: OTHER briefSummary: Pulmonary vein (PV) isolation is considered the therapeutic strategy of choice to maintain sinus rhythm (SR) in symptomatic patients with atrial fibrillation (AF). The most commonly used energy modality is radiofrequency (RF). However, this type of energy presents notable challenges, such as its lack of selectivity for myocardial tissue, which increases the risk of serious complications such as atrioesophageal fistula, PV stenosis, and vagus nerve injuries. In this context, PV isolation using pulsed field ablation (PFA) emerges as a promising alternative due to its greater myocardial selectivity. However, this selectivity presents additional challenges. Preliminary studies indicate that PFA may not damage the autonomic nervous system (ANS) involved in the initiation and maintenance of AF in certain patients, although stronger evidence is needed to support this claim.
The investigators propose to carry out a single-center clinical trial, although with the possibility in the future of including other centers. Patients will be randomized to three research groups: PV isolation with RF, PV isolation with PFA, and PV isolation combining PFA and RF (using RF on the anterior wall and PFA on the posterior wall). This assignment will be open to the operator who performs the procedure, but blind for the researcher responsible for monitoring and for the data analyst. The objective is to compare the impact of different energy sources during PV isolation on the ability to produce a permanent alteration in the ANS. The hypothesis is that combined PF isolation will be capable of producing a permanent alteration of autonomic function parameters superior to ablation using exclusive PFA. conditions: Atrial Fibrillation studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 156 type: ESTIMATED name: Pulmonary vein isolation exclusively with radiofrequency name: Pulmonary vein isolation exclusively with pulsed field ablation name: Combined pulmonary vein isolation measure: Efficacy primary outcome: Alteration of autonomic function parameters measure: Efficacy secondary outcome: Alteration of autonomic function parameters measure: Efficacy secondary outcome: Alteration of autonomic function parameters measure: Efficacy secondary outcome: Alteration of autonomic function parameters measure: Efficacy secondary outcome: Procedure duration. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Laura García Cano city: Alicante zip: 03010 country: Spain lat: 38.34517 lon: -0.48149 hasResults: False
<|newrecord|> nctId: NCT06351540 id: IRB00332797 id: R21DA056687 type: NIH link: https://reporter.nih.gov/quickSearch/R21DA056687 briefTitle: Examining the Role of Tolerance on Dose-dependent Effects of Acute THC on Oculomotor and Cognitive Performance overallStatus: NOT_YET_RECRUITING date: 2024-08-01 date: 2025-08-01 date: 2025-12-01 date: 2024-04-08 date: 2024-04-08 name: Johns Hopkins University class: OTHER name: National Institute on Drug Abuse (NIDA) briefSummary: The purpose of this research is to determine the extent to which oculomotor function accurately detects THC-impairment, if cannabis use experience impacts this detection threshold, and to examine how the oculomotor index corresponds to a measure of sustained attention. A double-blind, placebo-controlled, within-subjects crossover design will be used to examine the dose-effects of THC (0, 5mg, 30mg) on oculomotor performance tasks and a sustained attention task in frequent and infrequent cannabis users. Results from the study will advance the investigators' understanding of the effect of THC and cannabis use frequency on oculomotor function and sustained attention, and will directly inform the validity of the investigators' oculomotor platform for identifying acute THC- induced impairment in frequent and infrequent users. conditions: Cannabis Use conditions: Impaired Driving conditions: Cognitive Impairment studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: double-blind, placebo-controlled, within-subjects crossover design primaryPurpose: BASIC_SCIENCE masking: DOUBLE maskingDescription: placebo controlled, double-blind whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 40 type: ESTIMATED name: Cannabis measure: Commission Errors measure: Omission Errors measure: Reaction Time measure: Reaction Time Standard Error measure: Visuomotor Index measure: Saccade Speed measure: Visually Guided Oculomotor Performance measure: Antisaccade measure: Memory-Guided sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: Johns Hopkins Behavioral Pharmacology Research Unit city: Baltimore state: Maryland zip: 21224 country: United States lat: 39.29038 lon: -76.61219 hasResults: False
<|newrecord|> nctId: NCT06351527 id: ICP-CL-01202 briefTitle: Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of ICP-248 in Mature B-cell Malignancies overallStatus: NOT_YET_RECRUITING date: 2024-04-25 date: 2027-06-25 date: 2027-10-25 date: 2024-04-08 date: 2024-04-08 name: InnoCare Pharma Inc. class: INDUSTRY briefSummary: Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of ICP-248 in Mature B-cell Malignancies conditions: Mature B-cell Malignancies studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 40 type: ESTIMATED name: ICP-248 measure: Maximum tolerated dose and/or recommended Phase 2 dose measure: To investigate the incidence, nature and severity of adverse events (AE) according to NCI-CTCAE V5.0 evaluation criteria. sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<|newrecord|> nctId: NCT06351514 id: 2023/00745 briefTitle: An Open-Label, Single Arm Study of the Efficacy of Accelerated Intermittent Theta Burst Stimulation in Schizophrenia Patients With Persistent Negative Symptoms acronym: NOBLE-TMS overallStatus: RECRUITING date: 2024-04-01 date: 2026-09 date: 2026-09 date: 2024-04-08 date: 2024-04-08 name: Institute of Mental Health, Singapore class: OTHER briefSummary: Schizophrenia patients commonly present with persistent negative symptoms which remain the main reason for dysfunction after recovery from an acute episode of psychotic symptoms. Negative symptoms in schizophrenia exact significant burden with no effective pharmacological or behavior treatment options thus far. Neuromodulatory modalities present a novel and alternative treatment approach and recent trials have shown preliminary evidence for the efficacy of intermittent Theta Burst Stimulation (iTBS) to treat negative symptoms in schizophrenia. In this study, we aim to examine the effectiveness of an accelerated iTBS treatment protocol as an augmentation treatment regime for patient in rehabilitation care with persistent negative symptoms.
We propose a pragmatic, open label and single arm clinical trial. Forty patients with diagnosis of schizophrenia, who had been stabilized from psychotic symptoms and currently suffering from dominant negative symptoms will be recruited and undergo accelerated iTBS treatment for 5 consecutive sessions each day for 5 working days. Participants will be followed up immediately, 1 month and 3 months after the end of treatment. Clinical assessment includes, BNSS, The Brief Negative Symptom Scale; SANS, Scale for the assessment of negative symptoms; SAPS, Scale for the assessment of positive symptoms; PANSS, Positive and Negative Symptoms Scale; MoCA, Montreal Cognitive Assessment scale; CDSS, Calgary Depression Scale for Schizophrenia: SDS, Sheehans' disability scale and EQ-5D. The primary endpoint of the trial is the change of negative symptoms as assessed by PANSS, negative symptoms subscale immediately after the treatment.
This study will determine whether accelerated iTBS is effective to be delivered as an augmentation therapy for patients with persistent negative symptoms. The optimal treatment system for this population can be immediately translated to clinical practice and benefit patients in need. conditions: Schizophrenia; Negative Type studyType: INTERVENTIONAL phases: PHASE3 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 40 type: ESTIMATED name: Accelerated iTBS measure: Change of Negative symptoms measure: Trend of Negative symptoms sex: ALL minimumAge: 21 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Institute of Mental Health status: RECRUITING city: Singapore zip: 539747 country: Singapore name: Jenny Tay role: CONTACT email: [email protected] lat: 1.28967 lon: 103.85007 hasResults: False
<|newrecord|> nctId: NCT06351501 id: P170923J id: 2019-000300-16 type: EUDRACT_NUMBER briefTitle: Evaluation of the Effectiveness of Hormonal Treatment in Adolescents Suffering From Gender Dysphoria acronym: TRANSADO overallStatus: NOT_YET_RECRUITING date: 2024-06-06 date: 2029-06-06 date: 2031-06-06 date: 2024-04-08 date: 2024-04-08 name: Assistance Publique - Hôpitaux de Paris class: OTHER briefSummary: Gender dysphoria (GD) is a significant suffering lasting more than 6 months in a subject, regarding the gap felt between gender identity of someone and birth sex. From the start of puberty, most of these adolescents who identify as transgender will persist in this sense and will engage in hormonal-surgical reassignment at some stage. For these adolescents, International recommendations for good practice recommend early treatment at the beginning of pubertal development (Tanner 2) to block pubertal progression, with the possibility of hormonal transition by administration of sex hormones of the desired sex at the age of 16. However, in order to reduce the psychosocial consequences of GD, more and more reference teams are practicing this hormonal transition from the age of 14 without any randomized study showing its benefit compared to a transition at the age of 16 years old. Indeed, in the absence of treatment, comorbidities among adolescents suffering from gender dysphoria is very high, with anxiety and depression, suicidal risk and school dropout.
Our hypothesis is that when hormonal transition is started at an age closer to what physiological puberty would be, it will reduce comorbidities and improve quality of life of these adolescents. This is the first therapeutic randomized study in France on this transgender adolescent population, a field where international recommendations based on "Evidence Based Medicine" principles are scared. We hope that results of this study will guide transgender youth health care allowing them, if the study is positive, to access hormonal treatments earlier and improve their overall functioning, their anxious and depressive symptoms, their quality of life. conditions: Cross Sex Hormonal Treatment in Adolescents With Gender Dysphoria studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: multicentric, controlled, randomized, open trial with blinded assessment of the primary outcome measure (Prospective Open Blinding Endpoint PROBE study) primaryPurpose: TREATMENT masking: SINGLE maskingDescription: The evaluation of the main criterion by the CGAS will be administered by a psychologist trained on this scale who will not have knowledge of the adolescent's attribution group and will not have participated in their care, based on elements keys to the patient's file which will be provided to him without any element that could indicate his group to which he belongs or his original sex, and a telephone interview with the adolescent and with his parents where they will have been previously informed not to not reveal the group to which they belong or the sex of origin. whoMasked: OUTCOMES_ASSESSOR count: 60 type: ESTIMATED name: hormonal treatment with cross sex hormones (testosterone or oestrogenes) started at 14 years old +/- 6 months name: Cross sex hormones ( œstrogenes or testosterone) started at 16 years old +/- 6 months measure: Global functionning using the Children's Global Assessment Scale (CGAS) measure: DEP-ADO measure: WISC-V (weschler Test) measure: UGDS (Utrecht Gender Dysphoria Scale ) measure: Beck Depression Inventory (BDI) measure: Body Image Scale (BIS) measure: State and Anxiety Inventory for Children (STAI-C) measure: CBCL (Youth Self Report YSR) Child Behaviour Chekcklist measure: World Health Organization Quality Of Life (WHO QOL) measure: Satisfaction With Life Scale (SWLS) measure: Adolescent Depression Rating Scale (ADRS) measure: Mini International Neuropsychiatric Interview (MINI) measure: Inventory of Parents and Peers Attachment (IPPA) sex: ALL minimumAge: 14 Years maximumAge: 14 Years stdAges: CHILD hasResults: False
<|newrecord|> nctId: NCT06351488 id: APHP231661 briefTitle: Detection of Circulating Kidney DNA in Kidney Transplant Patients Facing an Episode of Graft Rejection acronym: DART-RREGREF overallStatus: NOT_YET_RECRUITING date: 2024-06-10 date: 2026-02-11 date: 2026-02-11 date: 2024-04-08 date: 2024-04-08 name: Assistance Publique - Hôpitaux de Paris class: OTHER name: CGenetix name: Institut National de la Santé Et de la Recherche Médicale, France briefSummary: In France, 3,500 kidney transplants are carried out per year; and 40,000 people succeed in 2019 with a kidney transplant. Despite regular medical monitoring, nearly 30% of transplant patients will develop rejection. Currently, only solid biopsy of the graft makes it possible to establish the diagnosis of graft rejection, and to characterize its cellular origin based on the Banff classification.