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<\|newrecord\|> nctId: NCT06352112 id: 02.04.2024 - POP briefTitle: Effects of the Hypopressive Exercises in Women With Pelvic Organ Prolapse overallStatus: COMPLETED date: 2023-03-15 date: 2024-01-15 date: 2024-02-15 date: 2024-04-08 date: 2024-04-10 name: Hacettepe University class: OTHER name: Istanbul Training and Research Hospital briefSummary: The aim of this study was compare home-based pelvic floor muscle training (PFMT) alone and home-based PFMT combined with hypopressive exercise (HE) in terms of pelvic floor muscle (PFM) activation and severity of pelvic floor dysfunction (PFD) in women with pelvic organ prolapse (POP) for eight weeks. For this purpose, the participants were randomly divided into two groups: \[PFMT alone (n:15) and PFMT combined with HE(n:17)\]. DuoBravo EMG device for evaluation of PFM activation and "Pelvic Floor Distress Inventory-20" was used to evaluate the severity of PFD. All evaluations were performed twice in total, at baseline and at week 8. conditions: Pelvic Floor Disorders conditions: Prolapse; Female studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 32 type: ACTUAL name: Pelvic Floor Muscle Training name: Hypopressive Exercises measure: Pelvic Floor Muscle Activation measure: Severity of pelvic floor dysfunction sex: FEMALE minimumAge: 20 Years maximumAge: 50 Years stdAges: ADULT facility: Istanbul Research and Training Hospital city: Istanbul country: Turkey lat: 41.01384 lon: 28.94966 hasResults: False
<\|newrecord\|> nctId: NCT06352099 id: 6315 briefTitle: Dietary Supplementation and Cognitive Functions in the Elderly acronym: ESPINS overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2024-11 date: 2025-04 date: 2024-04-08 date: 2024-04-08 name: Fondazione Policlinico Universitario Agostino Gemelli IRCCS class: OTHER briefSummary: In recent years, globally, there has been a growth in both the size and the proportion of older adults in the world population. The World Health Organization (WHO) has estimated that by 2030, 1 in 6 people will be 60 years of age or older, and that by 2050, the population of older adults will reach 2.1 billion. The population of older adults (over 80 years) will triple to 426 million by 2050. In particular, Italy represents the second country with the oldest population in the world.
Age-related evolution is a gradual and continuous process involving a series of physical and cognitive changes, which, however, has no real 'onset' age. In fact, rather than chronological age, the concept of 'elderly' is based on the individual's degree of self-sufficiency and independence. From a biological point of view, ageing is the set of changes at the molecular and cellular level that occur over time and lead to multi-system functional impairment. It is a process directly related to frailty, falls, and disability.
An important factor in counteracting frailty is nutritional intake. Humans ingest approximately 500 g of chemical compounds daily through their diet, most of which are components of plants or vegetables in general. In addition to the well-known macronutrients (proteins, fats, and carbohydrates) and micronutrients (minerals and vitamins), the plant world provides other elements, such as phenols, terpenes, terpenoids, alkaloids, purines, pyrimidines, nucleic acids, and steroids, that exert powerful biological activities. These components are generically called phytochemicals. Epidemiological studies have established that diets rich in plant-based foods help prevent many diseases, such as cardiovascular, metabolic, neurovegetative, and inflammatory diseases.
Phytochemical compounds are an extremely diverse set of elements that, when taken at significant levels, have a protective effect on human health. These substances exert various biological functions, such as antioxidant activity, modulation of detoxifying enzymes, stimulation of the immune system, reduction of platelet aggregation, modulation of hormone metabolism, reduction of blood pressure, and antibacterial and antiviral activity.
Among the phytochemical compounds, flavonoids represent a category of polyfunctional substances with high bioactivity, comprising more than 5000 compounds. They possess biochemical properties of functional interest in the nutritional and therapeutic fields; for example, rutin, diosmin, and hesperidin are present in some pharmaceutical specialties; flavonoids from ginkgo biloba, hawthorn, and red vine are the main components of many phytotherapeutic extracts. Flavonoids have been shown to play an important role in cardioprotection. Furthermore, in neuroprotection, anthocyanin-rich fruits play a protective role against age-related decline in cognitive functions.
However, few studies have evaluated the effect of hesperidin and proanthocyanidins on motor, cognitive, and functional aspects in the elderly.
Altemor® is a food supplement based on micronized diosmin, hesperidin, and herbal extracts that has an important integrative supporting action in optimising blood microcirculation.
The aim of the study is to evaluate the contribution of dietary supplementation with Altemor® on cognitive function, balance, fatigue, and some domains of quality of life in elderly subjects. conditions: Cognitive Impairment conditions: Old Age; Debility studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 36 type: ESTIMATED name: Dietary supplement with micronised diosmin, hesperidin and herbal extracts measure: Trial Making Test (TMT) measure: Short Physical Performance Battery (SPPB) measure: HandGrip Strenght Test (HGST) measure: Silver Index (SI) measure: Mental Deterioration battery (MDB) measure: Hospital Anxiety and Depression Scale (HADS) measure: EuroQol- 5 Dimension (EQ-5D) measure: Modified Fatigue Impact Scale (MFIS) sex: ALL minimumAge: 50 Years maximumAge: 99 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Fondazione Policlinico Universitario A. Gemelli IRCCS city: Roma state: RM zip: 00168 country: Italy name: Silvia Giovannini, MD, PhD role: CONTACT phone: +390630154382 email: silvia.giovannini@policlinicogemelli.it name: Letizia Castelli, PhD role: CONTACT phone: +390630154382 email: letizia.castelli@policlinicogemelli.it lat: 41.89193 lon: 12.51133 hasResults: False
<\|newrecord\|> nctId: NCT06352086 id: STUDY00009227 briefTitle: Understanding Visual Processing After Occipital Stroke overallStatus: NOT_YET_RECRUITING date: 2024-09 date: 2028-09 date: 2029-09 date: 2024-04-08 date: 2024-04-08 name: University of Rochester class: OTHER briefSummary: The purpose of this study is to investigate how visual orientation discrimination and metacognition (i.e., perceptual confidence) are affected by occipital stroke that causes hemianopia and quadrantanopia in adults. This research will provide insight as to how the residual visual system, which not directly damaged by the occipital stroke, processes orientation (assayed in terms of orientation discrimination) and metacognition (by measuring perceptual confidence for orientation discrimination). These measures will be used to refine computational models that attempt to explain how the brain copes with loss of primary visual cortex (V1) as a result of stroke. This knowledge is essential to devise more effective visual rehabilitation therapies for patients suffering from occipital strokes. conditions: Vision Loss Partial conditions: Vision; Loss, Both Eyes conditions: Hemianopia, Homonymous conditions: Hemianopia conditions: Quadrantanopia conditions: Stroke, Ischemic conditions: Stroke - Occipital Infarction conditions: Cortical Blindness conditions: Occipital Lobe Infarct conditions: Peripheral Visual Field Defect of Both Eyes studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: CROSS_SECTIONAL count: 20 type: ESTIMATED measure: Orientation discrimination threshold measure: Perceptual Confidence in Orientation Discrimination sex: ALL minimumAge: 21 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06352073 id: 23-2625 id: R668-EE-2380 type: OTHER domain: Regeneron briefTitle: Dupilumab for Eosinophilic Esophagitis With Severe Strictures acronym: DESTRICT overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-11 date: 2026-04 date: 2024-04-08 date: 2024-04-08 name: University of North Carolina, Chapel Hill class: OTHER name: Regeneron Pharmaceuticals name: Sanofi briefSummary: The purpose of this research study is to determine how well an FDA-approved drug, dupilumab, works to treat patients with severe strictures and active Eosinophilic Esophagitis (EoE). This is an open-label study, meaning everyone in the study will receive dupilumab.
Participants will have a screening visit where they will complete surveys and undergo an endoscopy (EGD). Blood and biopsies (small tissue samples) will also be collected. If eligible and enrolled into the study, participants will receive weekly subcutaneous (under the skin) injections of dupilumab for 52 weeks (one year). The first dose of dupilumab will be administered at the week 1 visit by a clinician and participants will receive training on how to self-administer the remaining doses.
Participants will return for study visits every at weeks 4, 8, 12, 18, 24, 30, 36, 44, and 52. During these visits, vital signs (temperature, heart rate, etc.) will be collected and participants will complete surveys. During visits at week 12, 24, and 52, blood will be collected and an endoscopy with biopsy will be performed.
At 64 weeks (12 weeks after the last dose of dupilumab), participants assigned male at birth (AMAB) will be contacted about their / their partner's pregnancy status and participants assigned female at birth (AFAB) may be asked to come for an in-person visit to complete a urine pregnancy test. conditions: Eosinophilic Esophagitis conditions: EoE studyType: INTERVENTIONAL phases: PHASE4 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 30 type: ESTIMATED name: Dupilumab measure: Histologic Response to Dupilumab measure: Change in Minimum Esophageal Caliber measure: Decrease in Number of Dilations measure: Change in Endoscopic Severity measure: Change in Histologic Severity sex: ALL minimumAge: 16 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: University of North Carolina at Chapel Hill city: Chapel Hill state: North Carolina zip: 27599 country: United States name: Julia Phillips role: CONTACT phone: 919-843-4453 email: julia_phillips@med.unc.edu name: Hiwot Ekuban role: CONTACT email: hiwot_ekuban@med.unc.edu lat: 35.9132 lon: -79.05584 hasResults: False
<\|newrecord\|> nctId: NCT06352060 id: KCHRRF_MONITOR AF_030 briefTitle: Dynamic Data-Driven Management of Atrial Fibrillation Using Implantable Cardiac Monitors: The MONITOR-AF Study overallStatus: RECRUITING date: 2024-04 date: 2024-06 date: 2024-09 date: 2024-04-08 date: 2024-04-08 name: Kansas City Heart Rhythm Research Foundation class: OTHER briefSummary: Observational, multi-center, retrospective study to evaluate the use of ICM (implantable cardiac monitor) versus traditional, non-ICM (non-implantable cardiac monitor) methods such as ECGs (electrocardiogram), Holter, and mobile cardiac outpatient telemetry (MCOT) units. conditions: Atrial Fibrillation studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 2500 type: ESTIMATED name: No intervention or administration will be performed due to the observational nature of the study measure: No.of patients with arrhythmia recurrence measure: No.of patients with redo ablation sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Menorah Medical Center status: RECRUITING city: Overland Park state: Kansas zip: 66209 country: United States name: Donita Atkins role: CONTACT lat: 38.98223 lon: -94.67079 facility: Kansas City Heart Rhythm Institute - Roe Clinic status: RECRUITING city: Overland Park state: Kansas zip: 66211 country: United States name: Donita Atkins role: CONTACT phone: 816-651-1969 email: Datkins@kchrf.com name: Naga Venkata K. Pothineni, MD role: PRINCIPAL_INVESTIGATOR lat: 38.98223 lon: -94.67079 facility: Overland Park Regional Medical Center status: RECRUITING city: Overland Park state: Kansas zip: 66215 country: United States name: Donita Atkins role: CONTACT phone: 816-651-1969 email: datkins@kchrf.com name: Naga Venkata K. Pothineni role: PRINCIPAL_INVESTIGATOR lat: 38.98223 lon: -94.67079 facility: Centerpoint Medical Center Clinic status: RECRUITING city: Independence state: Missouri zip: 64057 country: United States name: Donita Atkins role: CONTACT lat: 39.09112 lon: -94.41551 facility: Centerpoint Medical Center status: RECRUITING city: Independence state: Missouri zip: 64057 country: United States name: Donita Atkins role: CONTACT lat: 39.09112 lon: -94.41551 facility: Research Medical Center Clinic status: RECRUITING city: Kansas City state: Missouri zip: 64032 country: United States name: Donita Atkins role: CONTACT phone: 816-651-1969 email: Datkins@kchrf.com name: Naga Venkata K. Pothineni, MD role: PRINCIPAL_INVESTIGATOR lat: 39.09973 lon: -94.57857 facility: Research Medical Center status: RECRUITING city: Kansas City state: Missouri zip: 64032 country: United States name: Donita Atkins role: CONTACT phone: 816-651-1969 email: Datkins@kchrf.com name: Naga Venkata K. Pothineni, MD role: PRINCIPAL_INVESTIGATOR lat: 39.09973 lon: -94.57857 hasResults: False
<\|newrecord\|> nctId: NCT06352047 id: Karadeniz Tech. University briefTitle: The Effects of Positioning After Extubation of Preterm Infants on the Respiratory Functions overallStatus: COMPLETED date: 2018-11-01 date: 2019-06-01 date: 2019-06-01 date: 2024-04-08 date: 2024-04-08 name: Karadeniz Technical University class: OTHER briefSummary: The aim of this study was to examine the effect of positioning on respiratory functions of preterm infants after extubation.
Hypothesis 0a (H0a): There is no difference between the oxygen saturation (SpO2) levels of preterm infants in supine and prone positions after extubation.
Hypothesis 0b (H0b): There is no difference between the respiratory rate of preterm infants in supine and prone positions after extubation.
Hypothesis 0c (H0c): There is no difference between the respiratory rhythms of preterm infants in supine and prone positions after extubation.
Hypothesis 0d (H0d): There is no difference between respiratory distress in preterm infants in supine and prone positions after extubation. conditions: Premature Infants studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Simple randomization method was used in the sample of the study. In previous studies, there were no published data on the effect of supine and prone positioning after extubation on the pulmonary functions of premature infants. Therefore, the sample size was calculated using the G-power 3.1.3 program according to the SpO2 level and standard deviation values of 4 infants who were mechanically ventilated in the neonatal intensive care unit. The study was conducted with a total of 42 premature babies, two groups of 21 premature babies, each of whom had the characteristics of the research groups. Premature infants were divided into two groups, the supine position and the prone group, by randomization using a computer-based random number generator (www.randomizer.org). primaryPurpose: SUPPORTIVE_CARE masking: DOUBLE whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 42 type: ACTUAL name: The effect of positioning on respiratory functions of preterm infants after extubation. measure: Newborn Evaluation Form sex: ALL minimumAge: 37 Weeks maximumAge: 37 Weeks stdAges: CHILD facility: İlknur Kahriman city: Trabzon zip: 61080 country: Turkey lat: 41.005 lon: 39.72694 facility: Karadeniz Technical University Health Application and Research Center Farabi Hospital city: Trabzon zip: 61080 country: Turkey lat: 41.005 lon: 39.72694 hasResults: False
<\|newrecord\|> nctId: NCT06352034 id: Empathy Training for Students briefTitle: Empathy Training for Future Mental Health Practitioners in University Students overallStatus: NOT_YET_RECRUITING date: 2024-03-30 date: 2024-04-30 date: 2024-10-01 date: 2024-04-08 date: 2024-04-08 name: Peking University class: OTHER briefSummary: This study aims to investigate the efficacy of empathy training for future psychological counselors in university students. The training contains 5 sessions of psychoeducation, three-role group exercises, and Q\&A. Self-reported, listener-reported, and observer-reported measurements will be applied for empathy assessment. conditions: Empathy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 50 type: ESTIMATED name: Empathy Training measure: Change from counseling duration measure: Change from Baseline of 12-Item Version of the Barrett-Lennard Relationship Inventory measure: Change from consultation willingness question inquiry measure: Change from morphed emotion perception task measure: Change from Baseline of the Measure of Empathy Scale measure: Change from Baseline of the Emotion Perception Scale measure: Change from Baseline of the Peking Alexithymia Scale measure: Change from Baseline of the Patient Health Questionnaire measure: Change from Baseline of the Generalized Anxiety Disorder Scale measure: Change from Baseline of the Peking Irritability Scale measure: Change from Baseline of the the Fatigue Assessment Scale measure: Change from Baseline of the the Patient Health Questionnaire measure: Change from Baseline of the Cognitive-Emotion Regulation Questionnaire measure: Change from Baseline of the Difficulties in Emotion Regulation Scale measure: Change from Baseline of the the Satisfaction with Life Scale measure: Change from Baseline of the the Subjective Happiness Scale measure: Change from Baseline of the Connor-Davidson Resilience Scale sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Peking University city: Peking state: Beijing zip: 100871 country: China lat: 39.9075 lon: 116.39723 hasResults: False
<\|newrecord\|> nctId: NCT06352021 id: KAHRİMAN İlknur briefTitle: The Effect of Distraction With a Kaleidoscope on the Level of Perceived Pain During Blood Sampling in Children overallStatus: COMPLETED date: 2019-05-30 date: 2019-06-30 date: 2019-06-30 date: 2024-04-08 date: 2024-04-08 name: İlknur KAHRİMAN class: OTHER briefSummary: This experimental study aimed to determine the effect of distracting children with a kaleidoscope during blood sampling on their perception of pain during the procedure and to increase and improve the quality of evidence for the effectiveness of these methods across different populations and cultures.
Hypothesis 0 (H0): There is no difference between the pain scores of the kaleidoscope group and the control group during blood sampling.
Hypothesis 1 (H1): There is a difference between the pain scores of the kaleidoscope group and the control group during blood sampling. conditions: Pain studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 60 type: ACTUAL name: kaleidoscope measure: The Wong-Baker Pain Scale sex: ALL minimumAge: 7 Years maximumAge: 12 Years stdAges: CHILD facility: Karadeniz Technical University Health Application and Research Center Farabi Hospital city: Trabzon zip: 61080 country: Turkey lat: 41.005 lon: 39.72694 hasResults: False
<\|newrecord\|> nctId: NCT06352008 id: Zhansheng Jiang briefTitle: To Evaluate the Efficacy and Safety of Anrotinib Hydrochloride Capsule in Postoperative Non-pCR Patients With Non-small Cell Lung Cancer overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2025-06-01 date: 2026-06-01 date: 2024-04-08 date: 2024-04-08 name: Tianjin Medical University Cancer Institute and Hospital class: OTHER briefSummary: To explore the effectiveness of anrotinib hydrochloride capsule in postoperative non-pCR non-small cell lung cancer patients with adjuvant intensive therapy conditions: Event-free Lifetime studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 64 type: ESTIMATED name: Anlotinib measure: EFS sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Tianiin Medical University Cancer Institute & Hospital city: Tianjin country: China role: CONTACT phone: +008618526812877 lat: 39.14222 lon: 117.17667 hasResults: False
<\|newrecord\|> nctId: NCT06351995 id: KOR-19-22 briefTitle: Neostigmine and Glycopyrrolate by Iontophoresis overallStatus: ACTIVE_NOT_RECRUITING date: 2020-11-06 date: 2022-10-25 date: 2025-01-01 date: 2024-04-08 date: 2024-04-08 name: James J. Peters Veterans Affairs Medical Center class: FED briefSummary: To determine a lower effective dose of neostigmine to induce bowel evacuation by transcutaneous administration by iontophoresis. conditions: Spinal Cord Injuries conditions: Constipation conditions: Fecal Incontinence conditions: Neurogenic Bowel studyType: INTERVENTIONAL phases: PHASE3 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 6 type: ACTUAL name: Combination of Neostigmine and Glycopyrrolate name: I-Box by Dynatronics measure: Presence or absence of bowel evacuation measure: Time to bowel evacuation measure: Stool Consistency measure: Stool Quantity measure: Presence or absence of headache, dry mouth, muscle twitching and abdominal cramps. sex: ALL minimumAge: 18 Years maximumAge: 89 Years stdAges: ADULT stdAges: OLDER_ADULT facility: James J. Peters Veterans Affairs Medical Center city: Bronx state: New York zip: 10468 country: United States lat: 40.84985 lon: -73.86641 hasResults: False
<\|newrecord\|> nctId: NCT06351982 id: 211123PER3-3-2 briefTitle: Treatment Of Shallow Periodontal Pockets 4-6mm Using AIRFLOW Prophylaxis Master Device With Erythritol vs Manual Scalers overallStatus: RECRUITING date: 2024-03-01 date: 2025-06-01 date: 2026-01-01 date: 2024-04-08 date: 2024-04-08 name: Cairo University class: OTHER briefSummary: Periodontitis is a chronic condition associated with the inflammatory destruction of the periodontal tissues ultimately leading to tooth loss. Clinically, it is identified by key features such as clinical attachment loss (CAL), bleeding upon probing (BOP), and an increase in probing pocket depth (PPD), and/or gingival recession. Periodontitis is mediated by polymicrobial dysbiosis with keystone pathogens affecting the virulence of the entire biofilm community. The removal of this biofilm and its retention factors is the ultimate goal of clinical treatment and oral measures applied. The elimination of the biofilm has traditionally been achieved with the use of either hand instruments or power driven devices. Promoting periodontal health or diminishing bacterial presence and calculus buildup on teeth can be accomplished with the same efficacy whether using manual scalers and curettes or ultrasonic scaling instruments.
Both hand and ultrasonic instruments are characterized by being time-consuming and requiring technical skill, often causing patient discomfort and post-treatment pain, including hypersensitivity resulting from the loss of hard tissue when scaling the tooth surface. Ultrasonic instruments tend to leave a rougher surface behind compared to hand instruments. While effective the current techniques all have their disadvantages.
The aim of this study is to evaluate changes in probing depth clinically, Bleeding on probing, Clinical attachment level, Plaque index, Calculus index, Patient pain/discomfort, Patient satisfaction, Cost effectiveness, Treatment time and Number of pockets closed after using AIRFLOW® Prophylaxis Master device with erythritol powder. conditions: Periodontal Pocket conditions: Periodontitis conditions: Gingival Diseases conditions: Gingival Bleeding studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 46 type: ESTIMATED name: Electro Medical Systems AIRFLOW® Prophylaxis Master Device name: Hand and ultrasonic scalers and curettes measure: Change in probing pocket depth measure: Bleeding On Probing measure: Clinical Attachment Level measure: Plaque index measure: Calculus index measure: Patient pain/discomfort measure: Patient satisfaction measure: Cost effectiveness measure: Treatment time measure: Number of healed pockets sex: ALL minimumAge: 16 Years maximumAge: 80 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Faculty of Dentistry, Cairo University status: RECRUITING city: Cairo country: Egypt lat: 30.06263 lon: 31.24967 hasResults: False
<\|newrecord\|> nctId: NCT06351969 id: Ms 9-12-2023 briefTitle: Evaluating Placental Thickness and Thickness of Uterine Muscle at Placenta Attachment in Prediction of Postpartum Blood Loss overallStatus: RECRUITING date: 2023-12-21 date: 2024-12 date: 2024-12 date: 2024-04-08 date: 2024-04-08 name: Benha University class: OTHER briefSummary: Aim of the Work is To determine the significance of the placental thickness and the thickness of the uterine muscle layer at placenta attachment in the prediction of postpartum hemorrhage and to evaluate both of them as as parameters for identifying high-risk patients. conditions: Post Partum Hemorrhage studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 150 type: ESTIMATED measure: Evaluating Placental Thickness in cm and Thickness of Uterine Muscle in cm at Placenta Attachment in Prediction of Postpartum Blood Loss sex: FEMALE minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT facility: Benha Univeristy status: RECRUITING city: Banhā country: Egypt name: Ashraf Ismail mohamed, professor role: CONTACT phone: +201119709696 lat: 30.45906 lon: 31.17858 hasResults: False
<\|newrecord\|> nctId: NCT06351956 id: Arrhythmias in Septic Patients briefTitle: New Onset Cardiac Arrhythmias in Septic Patients in Critical Care Setting, Predictors and Outcomes. overallStatus: NOT_YET_RECRUITING date: 2024-04-20 date: 2026-04-20 date: 2026-12-30 date: 2024-04-08 date: 2024-04-08 name: Assiut University class: OTHER briefSummary: New Onset Cardiac Arrhythmias in Septic Patients in Critical Care Setting, Predictors and Outcomes conditions: Cardiac Arrhythmia studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 72 type: ESTIMATED measure: Risk Factors of cardiac arrhythmias in septic patients in CU. measure: Fates of cardiac arrhythmia. measure: The frequent type of arrhythmias. measure: Mortality rate due to new onset arrhythmia. sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06351943 id: ImageDB pilot briefTitle: Proximal Femur Image Database Validation overallStatus: ACTIVE_NOT_RECRUITING date: 2021-05-01 date: 2024-10-01 date: 2025-06-30 date: 2024-04-08 date: 2024-04-08 name: AO Innovation Translation Center class: OTHER name: University of Turin, Italy briefSummary: The AO@AI Turin project is a collaborative project with a Turin group and the AO (Arbeitsgemeinschaft für Osteosynthesefragen, or in English, Association for the Study of Internal Fixation) foundation. An Image database (DB) has been built to host AP pelvic radiographs ready for artificial intelligence (AI) development.
The goal of this project is to determine the agreement between the Turin annotation of fracture status and the annotation from an external group of AO expert surgeons for a random subset of the Turin images. conditions: Proximal Femoral Fracture studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: CROSS_SECTIONAL count: 2932 type: ESTIMATED name: Fracture classification annotations provided by the Turin group name: Fracture classification annotations provided by the AO expert surgeon group measure: Annotations of fracture status of the image measure: In case of fracture, Arbeitsgemeinschaft für Osteosynthesefragen (AO, in English, Association for the Study of Internal Fixation)/Orthopedic Trauma Association (OTA) classification: Type measure: In case of fracture, AO/OTA classification: Group measure: In case of fracture, AO/OTA classification: Subgroup measure: In case of fracture, AO/OTA classification: Qualifier for 31A1.1 measure: In case of fracture, AO/OTA classification: Qualifier for 31B2 sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: AO Foundation city: Dübendorf zip: 8600 country: Switzerland lat: 47.39721 lon: 8.61871 hasResults: False
<\|newrecord\|> nctId: NCT06351930 id: EA210473 briefTitle: CBT for Insomnia in Adolescents With ADHD overallStatus: RECRUITING date: 2023-01-01 date: 2025-12-31 date: 2025-12-31 date: 2024-04-08 date: 2024-04-08 name: The University of Hong Kong class: OTHER name: Kwai Chung Hospital, Hong Kong briefSummary: Insomnia and attention deficit hyperactivity disorder (ADHD) are highly comorbid conditions with an intricate, bidirectional relationship. In particular, insomnia and ADHD often co-occur, with 22.9-34.6% of adolescents with insomnia having clinically significant ADHD, and 22-33.5% of adolescents with ADHD experiencing comorbid insomnia symptoms. Insomnia is not only associated with increased ADHD severity, but also linked to an increased risk for other mental health problems and poorer treatment response in young people with ADHD. Behavioural sleep interventions have shown promise in improving sleep in young children with comorbid ADHD and insomnia. Nonetheless, when treating adolescent insomnia, especially those with ADHD, there is a need to consider the unique sleep and circadian features as well as psychosocial factors associated with not only ADHD but also adolescence, a challenging developmental stage. To date, there is a paucity of research to test the efficacy of cognitive behavioural therapy for insomnia (CBT-I) in adolescents with comorbid ADHD and insomnia. To address the limitations in the existing literature, this study aims to conduct a randomised controlled trial (RCT) to examine the effects of CBT-I relative to a usual care (UC) condition in adolescents with ADHD, on improving sleep and ADHD symptoms, and other clinical and daytime symptoms as well as overall functional improvement. conditions: Insomnia conditions: ADHD studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: A randomised, assessor-blind, parallel group controlled trial primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 84 type: ESTIMATED name: CBT-I + UC group measure: Change in Insomnia Symptoms measure: Change in ADHD Symptoms (Self-report) measure: Change in Internalising and Externalising Symptoms (Parent-rated) measure: Change in depressive symptoms (Self-report) measure: Change in anxiety symptoms (Self-report) measure: Change in Sleep Diary Measure - Time in Bed (TIB) measure: Change in Sleep Diary Measure - Total Sleep Time (TST) measure: Change in Sleep Diary Measure - Sleep Onset Latency (SOL) measure: Change in Sleep Diary Measure - Wake After Sleep Onset (WASO) measure: Change in Sleep Diary Measure - Sleep Efficiency (SE) measure: Change in Objective Sleep Measures - Time in Bed (TIB) measure: Change in Objective Sleep Measures - Total Sleep Time (TST) measure: Change in Objective Sleep Measures - Sleep Onset Latency (SOL) measure: Change in Objective Sleep Measures - Wake After Sleep Onset (WASO) measure: Change in Objective Sleep Measures - Sleep Efficiency (SE) measure: Change in Individual Beliefs and Attitude about Sleep measure: Change in Adolescent Sleep Hygiene measure: Change in Quality of Life sex: ALL minimumAge: 12 Years maximumAge: 18 Years stdAges: CHILD stdAges: ADULT facility: Child and adolescent outpatient psychiatric clinic of Kwai Chung Hospital status: RECRUITING city: Hong Kong country: Hong Kong name: Waiyan Vivian CHIU, Clinical Psychologist role: CONTACT lat: 22.27832 lon: 114.17469 facility: Sleep Research Clinic and Laboratory, Department of Psychology, The University of Hong Kong status: RECRUITING city: Hong Kong country: Hong Kong name: Shirley X Li, PhD, DClinPsy role: CONTACT phone: 852-39177035 email: shirley.li@hku.hk lat: 22.27832 lon: 114.17469 hasResults: False
<\|newrecord\|> nctId: NCT06351917 id: LEVEXE briefTitle: Effect of Topical PlexoZome® Levagen® Spray on Relief of Post Exercise Knee Joint Pain overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2025-04-01 date: 2025-05-01 date: 2024-04-08 date: 2024-04-10 name: RDC Clinical Pty Ltd class: INDUSTRY briefSummary: This is a randomised, double-blind, placebo controlled, 2 arm parallel clinical trial to evaluate the effect of topical PlexoZome® Levagen® spray on relief of post exercise knee joint pain in healthy adults compared to placebo over 4 weeks duration. conditions: Knee Joint Pain studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 80 type: ESTIMATED name: PlexoZome® Levagen® topical spray solution name: Placebo topical spray solution measure: Joint pain measure: Time to pain relief measure: Number of Adverse Events measure: Severity of Adverse Events measure: Rescue medication use sex: ALL minimumAge: 20 Years stdAges: ADULT stdAges: OLDER_ADULT facility: RDC Clinical Pty Ltd city: Brisbane state: Queensland zip: 4006 country: Australia name: Amanda Rao, PhD role: CONTACT phone: +61 414 488 559 email: amanda@rdcglobal.com.au name: David Briskey, PhD role: CONTACT phone: +61 421 784 077 email: david@rdcglobal.com.au name: Amanda Rao, PhD role: PRINCIPAL_INVESTIGATOR lat: -27.46794 lon: 153.02809 hasResults: False
<\|newrecord\|> nctId: NCT06351904 id: RAG-01-01 briefTitle: A Study of RAG-01 in Patients With Non-muscle-invasive Bladder Cancer (NMIBC) Who Have Failed Bacillus Calmette Guérin (BCG) Therapy overallStatus: RECRUITING date: 2024-04-03 date: 2025-06-30 date: 2025-08-31 date: 2024-04-08 date: 2024-04-16 name: Ractigen Therapeutics. class: OTHER briefSummary: This is an open label, multi-center study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary efficacy of RAG-01 in patients with NMIBC who have failed BCG therapy. conditions: Non-Muscle-Invasive Bladder Cancer (NMIBC) studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 15 type: ESTIMATED name: RAG-01 measure: Safety and tolerability of RAG-01 in patients with non-muscle-invasive bladder cancer (NMIBC) measure: Maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D) of RAG-01 sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: GenesisCare North Shore status: RECRUITING city: St Leonards state: New South Wales zip: 2065 country: Australia name: Laurence Krieger, MBCHB role: CONTACT phone: +61 2 8037 4100 email: laurence_krieger@hotmail.com lat: -33.82344 lon: 151.19836 hasResults: False
<\|newrecord\|> nctId: NCT06351891 id: SHARE2402 briefTitle: Efficacy and Safety of Bismuth Quadruple Therapy Containing Cefuroxime and Tetracycline as First-line Therapy for Eradicating Helicobacter Pylori in Patients Allergic to Penicillin overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2024-12 date: 2024-12 date: 2024-04-08 date: 2024-04-08 name: Qilu Hospital of Shandong University class: OTHER briefSummary: The researchers collected untreated H. pylori positive patients from outpatient clinics. Subjects were randomly assigned to receive either 14 days of bismuth quadruple therapy with cefuroxime and tetracycline or 14 days of bismuth quadruple therapy with cefuroxime and levofloxacin for Helicobacter pylori eradication. After 6 weeks of treatment, subjects underwent another 13C urea breath test. Eradication rates, adverse reaction rates and patient compliance were calculated. conditions: Helicobacter Pylori Infection studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 248 type: ESTIMATED name: 14-day bismuth quadruple regimen containing cefuroxime and tetracycline name: 14-day bismuth quadruple regimen containing cefuroxime and levofloxacin measure: Eradication rate measure: Rate of adverse reactions measure: Patient compliance sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Qilu Hospital of Shandong University city: Jinan state: Shandong zip: 250012 country: China name: Yueyue Li, MD,PhD role: CONTACT phone: 86-18560089751 email: lyynqj@162.com lat: 36.66833 lon: 116.99722 hasResults: False
<\|newrecord\|> nctId: NCT06351878 id: Pro00113559 briefTitle: TipTraQ Home Sleep Test Validation Study overallStatus: RECRUITING date: 2024-02-28 date: 2024-08-23 date: 2024-08-23 date: 2024-04-08 date: 2024-04-08 name: PranaQ Pte. Ltd. class: INDUSTRY briefSummary: A validation study has been designed to assess the performance of a home sleep test device, TipTraQ, for screening sleep apnea. The study involves participants wearing the TipTraQ device on their fingertip during a traditional sleep test, known as polysomnography (PSG), conducted in a sleep center. The performance of the device will then be evaluated by comparing the results from the TipTraQ system with those from the traditional sleep test. conditions: Obstructive Sleep Apnea studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 125 type: ESTIMATED measure: Apnea Hypopnea Index(AHI) measure: Oxygen Desaturation Index(ODI) measure: Total Sleep Time(TST) sex: ALL minimumAge: 20 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Duke University status: RECRUITING city: Durham state: North Carolina zip: 27705 country: United States name: Alexis Schuettke role: CONTACT phone: 919-668-2842 email: alexis.schuettke@duke.edu lat: 35.99403 lon: -78.89862 hasResults: False
<\|newrecord\|> nctId: NCT06351865 id: PHU/2023/21 briefTitle: Feasibility Study to Evaluate the Use of Patient Reported Complications After Digital Consent acronym: PRC overallStatus: RECRUITING date: 2024-03-07 date: 2024-09-19 date: 2024-10-31 date: 2024-04-08 date: 2024-04-09 name: Portsmouth Hospitals NHS Trust class: OTHER_GOV name: University of East Anglia briefSummary: Patient report complication data to our best knowledge has not been studied yet in electronic consent. This study is a feasibility study to assess whether patients will reliably report their complications, the quality of this reporting and whether the information provided in the consent form matches up to their experience. This data will then be used to improve the consent process and evaluate whether the Patient Initiated Follow Up (PIFU) model is effective or if it leads to underreporting of problems. conditions: Breast Cancer conditions: Complication of Surgical Procedure studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 50 type: ESTIMATED measure: Proportion of patients who respond to the feedback questionnaire measure: Final attrition rate measure: Quoted risks in the consent to the incidence of complications measure: Frequency of PRC and CRCs (Consent Form Reported Complications) measure: Understanding of consent measure: Language used in patient reported complications measure: Accuracy of potential complications measure: Participant preparation for surgery sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Queen Alexandra Hospital status: RECRUITING city: Portsmouth state: Hampshire zip: PO6 3LY country: United Kingdom name: Edward St John role: CONTACT phone: 02392286000 email: edward.stjohn@porthosp.nhs.uk lat: 50.79899 lon: -1.09125 hasResults: False
<\|newrecord\|> nctId: NCT06351852 id: 1678243 briefTitle: Transdermal Administration by a Novel Wireless Iontophoresis Device overallStatus: RECRUITING date: 2022-03-22 date: 2025-02-15 date: 2025-02-15 date: 2024-04-08 date: 2024-04-08 name: James J. Peters Veterans Affairs Medical Center class: FED briefSummary: Persons with spinal cord injury (SCI) have neurogenic bowel disorders which is associated with significant morbidity. The negative impact of bowel complications is often at the top of the list of problems reported by persons with SCI. Despite the magnitude of the problem of bowel dysfunction in persons with SCI, and the associated reduction in quality of life, this condition has yet to be effectively treated. The investigators have developed a novel dual drug combination to elicit a safe and predictable bowel evacuation (BE).
The ability to move the bowel contents along to the rectum was severely impaired primary because of poor gut contractions on the left side of the colon, as shown by our team of investigators. To address this problem, a dual medication combination (neostigmine and glycopyrrolate) was developed that safely and predictably caused the bowel to empty after delivering these drugs into a vein (intravenously) or into the muscle bed (intramuscularly). Because no one likes needles, and because of the practical limits of administering medications on a routine basis by the use of needles, especially in persons with SCI because of their other health considerations, the investigators have devised a new approach: driving these medications across the skin and into the circulation of the body by applying an electrical current that is too small to feel (iontophoresis).
The proposed research project to determine the safety of positively charged compounds (e.g., vitamin B12, NEO, and GLY) administered transcutaneously by the prototype wireless ION device and to compare the pharmacokinetic profiles of transcutaneous administration of NEO and GLY by the wireless ION device to a commercially available wired ION device. The potential administration of any number of other positively charged agents by this wireless prototype may be a clinically relevant outcome of this work. The ability to use a wireless ION device is far more practical for patients to use, especially those with SCI, which will permit the self-administration of these agents in the home setting to induce a bowel evacuation. conditions: Spinal Cord Injuries conditions: Constipation conditions: Fecal Incontinence conditions: Neurogenic Bowel studyType: INTERVENTIONAL phases: EARLY_PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 6 type: ESTIMATED name: Combination of Neostigmine and Glycopyrrolate name: I-Box by Dynatronics measure: Presence or absence of bowel evacuation measure: Time to bowel evacuation measure: Stool Consistency measure: Stool Quantity measure: Presence or absence of headache, dry mouth, muscle twitching and abdominal cramps sex: ALL minimumAge: 18 Years maximumAge: 89 Years stdAges: ADULT stdAges: OLDER_ADULT facility: James J. Peters Veterans Affairs Medical Center status: RECRUITING city: Bronx state: New York zip: 10468 country: United States name: Christopher P Cardozo, MD role: CONTACT phone: 718-584-9000 phoneExt: 1828 email: christopher.cardozo@va.gov lat: 40.84985 lon: -73.86641 hasResults: False
<\|newrecord\|> nctId: NCT06351839 id: 2024/500457(REK) briefTitle: Sleep Well Despite Persistent Pain Symptoms acronym: Sleep-Well overallStatus: NOT_YET_RECRUITING date: 2024-10 date: 2026-12 date: 2027-12 date: 2024-04-08 date: 2024-04-08 name: University of Tromso class: OTHER name: University Hospital of North Norway name: Diakonhjemmet Hospital briefSummary: Background: The prevalence of comorbid insomnia is 8-10 times higher in patients with chronic pain than in the general population. Insomnia adds a considerable burden as it worsens the quality of life, restoration and repair, mental health and pain symptoms. Since pain and sleep problems are mutually reinforcing, improvements in sleep may have beneficial effects on pain. Unfortunately, the customary use of sleep medication (TAU: treatment-as-usual) often yields short-lived plus side effects. The "Sleep-Well" intervention examines if a group-based intervention program focusing on sleep literacy, sleep restriction, stimulus control and metacognitive therapy modules may perform better than TAU in improving patients' insomnia and sleep quality.
Eligible patients: Investigators target adult patients referred to the University Hospital of North Norway (Tromsø) for a diagnostic evaluation of their pain condition. Patients eligible for the Sleep-Well study are those who satisfy diagnostic criteria for a non-malign pain disorder plus a comorbid insomnia sleep disorder. Patients are not eligible if they use drugs or large doses of morphine (\>100 equivalents), are engaged in an insurance case due to their diagnosis, or participate in other ongoing group programs at the hospital.
Aims: This trial uses a randomized semi-crossover design to examine if the Sleep-Well group does better regarding insomnia and sleep quality than the control patients (TAU). The primary outcome measures are reductions in diagnostic criteria for insomnia, self-reported insomnia symptoms, quality of life, and actigraphy-measured insomnia indicators (long sleep onset latency, frequent nightly awakenings and early morning awakening). The secondary outcome measures include a simplified polysomnography measurement of brain activity during sleep to assess if proportions or durations of slow-wave versus light-wave sleep and EEG-based arousal indices improve. In addition, it is examined if the Sleep-Well intervention incurs benefits concerning pain complaints, dysfunctional sleep and pain cognitions, anxiety and depression.
The intervention: The Sleep-Well program schedules group sessions that cover four topics (sleep literacy, behavioural and mental strategies, maintenance and relapse prevention). All sessions are led by two therapists. Those randomized to the active control group (TAU) cross over to the Sleep-Well intervention three months later. conditions: Insomnia Chronic conditions: Insomnia Due to Medical Condition conditions: Pain, Chronic studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: We randomize patients to receive either the Sleep-Well intervention or to the TAU condition (active waiting-list group). After 3 months, the TAU patients cross over and receive the Sleep-Well intervention; hence, the design is semi-crossover. primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 106 type: ESTIMATED name: Sleep-Well despite persistent pain name: TAU (treatment-as-usual) measure: Insomnia symptoms measure: Insomnia diagnosis measure: Actigraphy insomnia indicators (SOL, WASO and EMA in minutes) measure: Actigraphy insomnia indicators (SE %) measure: Sleep diary insomnia indicators (SOL, WASO and EMA in minutes) measure: Sleep brain activity as measured by a simplified polysomnography device, i.e., a Home Sleep Test (HST) measure: Anxiety and depression (HADS) measure: Quality of Life (EQ-5Q-5L) measure: Fatigue (Chalder Fatigue Scale) measure: Pain intensity, interference and locations (BPI) measure: Tolerance and Acceptance of chronic pain (CPAQ-R) measure: Mediator: Sleep hygiene (SHI) measure: Hyperactivity (HAS) measure: Mediator: Dysfunctional beliefs and attitudes about sleep (DBAS) measure: Mediator: Metacognitions about insomnia (MCQ-i) measure: Mediator: Insomnia catastrophizing Scale (ISC) measure: Mediator: Pain Catastrophizing Scale (PCS) sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: UiT The Arctic University of Norway city: Tromsø state: Troms County zip: 9037 country: Norway name: Oddgeir Friborg, ph.d. role: CONTACT phone: 4777646772 email: oddgeir.friborg@uit.no name: Svein Bergvik, ph.d. role: CONTACT phone: 4777646323 email: svein.bergvik@uit.no name: Oddgeir Friborg, ph.d. role: PRINCIPAL_INVESTIGATOR name: Jan H Rosenvinge, ph.d. role: SUB_INVESTIGATOR name: Svein Bergvik, PhD role: SUB_INVESTIGATOR lat: 69.6489 lon: 18.95508 hasResults: False
<\|newrecord\|> nctId: NCT06351826 id: 22070876 briefTitle: Effectiveness of ELLASI Intervention Towards Polytrauma Patients in the Emergency Department overallStatus: RECRUITING date: 2024-01-03 date: 2024-04 date: 2024-05 date: 2024-04-08 date: 2024-04-08 name: Indonesia University class: OTHER briefSummary: This clinical trial aims to test the effectiveness of ELLASI intervention in response time, deterioration score, and metabolic status of polytrauma patients in the emergency department. The main questions it aims to answer are:
1. Is the response time of polytrauma patients who receive ELLASI in the intervention group faster than the control group?
2. Is the deterioration score of polytrauma patients who receive ELLASI in the intervention group better than the control group?
3. Is the metabolic status of polytrauma patients who receive ELLASI in the intervention group better than the control group?
Polytrauma patients in the intervention group will receive ELLASI, a structured intervention consisting of the six following:
1. Evaluation of airway and cervical control, remove the foreign body, fluid, etc., from the airway,
2. Patient positioning and giving oxygen, head-up,
3. Stabilisation, including IV insertion, applying pressure and bandage, place monitor, and haemodynamic monitoring
4. Assessment: re-assessment of pain and other main complaints
5. Make sure informed consents are documented
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: info@rscm.co.id 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: a_hekmat2000@yahoo.com 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: kenyon-pesce@uchc.edu 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.

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