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The contents of follow-up examinations are:
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History of other diseases, medications being used, eye diseases, surgeries, treatments, height, weight, and blood pressure.
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Best corrected vision, logarithmic visual acuity chart. Tupai OCTA, 24×20mm range, 6×6mm range scan. Optos fundus imaging, color and no red light images. Fundus fluorescence angiography (only preliminary examination for the first time found mild to moderate NPDR patients, who have been angiographed in the past, only at the 5th year, or as required by the condition).
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Glycosylated hemoglobin. Creatinine, urea, glomerular filtration rate. Total cholesterol, triglycerides, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol.
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Urinary microalbumin/urinary creatinine ACR. Microvisual field. conditions: Biomarkers of Diabetic Retinopathy studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 200 type: ESTIMATED measure: Observation and follow-up of biomarkers of diabetic retinopathy measure: Level of Glycosylated hemoglobin measure: Creatinine measure: Total cholesterol measure: Urinary microalbumin measure: Urea measure: Glomerular filtration rate measure: Triglycerides measure: Low-density lipoprotein cholesterol measure: High-density lipoprotein cholesterol measure: Urinary creatinine ACR sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Sichuan Academy of Medical Science Sichuan Provincial Hosptial status: RECRUITING city: Chendu state: Sichuan zip: 610014 country: China name: Jie Li, doctor role: CONTACT phone: +86 13908094675 email: lijieyk@med.uestc.edu.cn hasResults: False
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<|newrecord|> nctId: NCT06269406 id: SW008 briefTitle: A Combination of Ibuprofen With Curcumin Covered With Liquorice Root Supplementation in the Management of Postoperative Dental Pain in Adults acronym: ICLID overallStatus: NOT_YET_RECRUITING date: 2024-03-10 date: 2024-07-10 date: 2024-09-10 date: 2024-02-21 date: 2024-02-21 name: S.LAB (SOLOWAYS) class: OTHER name: NMSI DENTMASTER briefSummary: Dental pain, a common issue in stomatology, requires a multifaceted treatment approach. This study explores the efficacy of combining Ibuprofen with curcumin and liquorice root supplements for managing postoperative dental pain. Curcumin, known for its antioxidant and anti-inflammatory properties, along with liquorice root, may enhance pain relief beyond conventional NSAIDs like Ibuprofen. This randomized, double-blind, placebo-controlled trial aims to evaluate the safety and effectiveness of this combination therapy in adults undergoing the removal of impacted third molars. Participants, aged 18-85, were divided into groups receiving different doses of Ibuprofen and curcumin with liquorice root, compared to a control group receiving Ibuprofen and placebo. The primary outcome is the sum of pain intensity differences over 8 hours, with secondary outcomes including total pain relief and the occurrence of any adverse events. The anticipated sample size, considering a 20% dropout rate, is 264 participants, ensuring the study is powered to detect significant differences in pain management efficacy. conditions: Dental Pain studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: OUTCOMES_ASSESSOR count: 264 type: ESTIMATED name: ibuprofen 400 mg in combination with Curcumin covered with liquorice root 100 mg name: ibuprofen 200 mg in combination with Curcumin covered with liquorice root 100 mg name: The combination of ibuprofen 400 mg and placebo in patients after 2-4 molars procedure measure: Sum of pain intensity differences (SPID), SPID on the visual analog score VAS (points) measure: Total pain relief (TOTPAR) % measure: Time to pain half pain gone (in minutes) measure: Duration of pain half gone (in minutes) measure: Any adverse events (facial swelling, nausea, vomiting, headache) (%) sex: ALL minimumAge: 18 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Nmsi Dentmaster city: Novosibirsk state: Novosibirsk Region zip: 630090 country: Russian Federation name: Gatilova A Tatyana, MD role: CONTACT phone: 9529399919 phoneExt: +7 lat: 55.0415 lon: 82.9346 hasResults: False
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<|newrecord|> nctId: NCT06269393 id: CIBI311Y101 briefTitle: A Study of IBI311 in Subjects With Steroid-resistant, Thyroid Associated Ophthalmopathy overallStatus: ACTIVE_NOT_RECRUITING date: 2024-01-01 date: 2025-06-01 date: 2026-02-01 date: 2024-02-21 date: 2024-02-21 name: Peking University People's Hospital class: OTHER briefSummary: This is an exploratory study of the efficacy and safety of IBI311, a modified anti-IGF-1R antibody, in patients with steroid-resistant, thyroid associated ophthalmopathy (TAO). This study includes two stages. Stage I is a single-center, single-arm, open-label clinical study designed to evaluate the safety and tolerability of IBI311 in subjects with TAO. Approximately 10 subjects meeting the study eligibility criteria will be enrolled. Stage II is a single-center, randomized, double-masked, placebo-controlled clinical trial designed to evaluate the efficacy and safety of IBI311 in subjects with steroid-resistant TAO. Approximately 54 subjects meeting the study eligibility criteria will be randomly assigned to IBI311 or placebo on day 1 (D1) in a 2:1 ratio stratified by disease activity. conditions: Thyroid Associated Ophthalmopathy studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 54 type: ESTIMATED name: Placebo name: IBI311 measure: The proptosis responder rate (defined as percentage of subjects with a ≥ 2mm reduction from baseline in proptosis in the study eye, without deterioration [≥ 2 mm increase] of proptosis in the non-study eye) of the study eye. measure: Overall responder rate in proptosis of the study eye. measure: Percentage of subjects with a CAS value of 0 or 1 measure: Diplopia responder rate (defined as percentage of subjects with a ≥ 1-grade improvement in diplopia) measure: Safety and tolerability of intravenous IBI311 in subjects with TAO sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Peking University People's Hospital city: Beijing state: Beijing zip: 100034 country: China lat: 39.9075 lon: 116.39723 hasResults: False
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<|newrecord|> nctId: NCT06269380 id: 30.01.2024-4274 briefTitle: Evaluation of Antral Biopsies Obtained in Normal Esophagogastroduodenoscopy overallStatus: COMPLETED date: 2024-02-13 date: 2024-02-20 date: 2024-02-21 date: 2024-02-21 date: 2024-02-23 name: Sisli Hamidiye Etfal Training and Research Hospital class: OTHER briefSummary: Esophagogastroduodenoscopy (EGD) is commonly performed in patients presenting with abdominal pain and dyspeptic symptoms, serving as a valuable diagnostic and therapeutic tool. While various methods are available for biopsy sampling when mucosal pathology is observed during EGD, the practice of obtaining biopsies from endoscopically normal mucosa remains controversial. Although there is literature suggesting that routine biopsies from the antrum and duodenum for surveillance purposes increase costs, pathological findings can sometimes be detected in areas that appear normal on mucosal examination, leading to potential changes in treatment approach if biopsies are obtained.
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In this study, a retrospective evaluation of the prevalence of various pathologies detected in biopsies obtained from endoscopically normal mucosa in patients who underwent EGD was reported as normal. conditions: Gastritis H Pylori conditions: Gastritis Chronic conditions: Intestinal Metaplasia studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: The biopsies obtained from patients who underwent esophagogastroduodenoscopy and were found to have normal endoscopic findings will be evaluated. The histopathological findings and their frequencies in these biopsies will be examined to assess the necessity of routine biopsy during esophagogastroduodenoscopy. primaryPurpose: DIAGNOSTIC masking: NONE count: 671 type: ACTUAL name: Esophagogastroduodenoscopy name: Endoscopic biopsy sampling measure: Rate of abnormal histopathologic findings measure: Rate of intestinal metaplasia measure: Rates of gastritis severity and activity measure: Rate of Helicobacter Pylori positivity sex: ALL minimumAge: 18 Years maximumAge: 95 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Sisli Hamidiye Etfal Research and Training Hospital city: Istanbul country: Turkey lat: 41.01384 lon: 28.94966 hasResults: False
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<|newrecord|> nctId: NCT06269367 id: HUM00226149 id: 1R41HD111289-01 type: NIH link: https://reporter.nih.gov/quickSearch/1R41HD111289-01 briefTitle: NewGait: A Low-Cost Rehabilitation System to Improve Post-Stroke Gait (Biomechanical Adaptations) overallStatus: RECRUITING date: 2024-04-01 date: 2024-12 date: 2024-12 date: 2024-02-21 date: 2024-04-03 name: University of Michigan class: OTHER name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) briefSummary: An affordable and easy to use gait-assistive device for stroke survivors to use at home is yet to be developed. This study is intended to modify the current design of the NewGait device to specifically work for stroke survivors based on feedback from patients and clinicians. Consequently, conducting a short-term biomechanical gait study is planned to determine the usability and functionality of the NewGait device compared to other comparative devices. conditions: Stroke studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: Participants will be randomly assigned to the two device interventions but will receive both interventions. primaryPurpose: TREATMENT masking: NONE count: 18 type: ESTIMATED name: NewGait name: Control wearable limb orthotic device measure: Gait speed measure: Ankle Muscle Activation measure: Changes in paretic leg propulsive force measure: Changes in paretic leg loading (i.e., vertical ground reaction force) measure: Changes in other lower extremity muscle activation measure: Muscle Coordination sex: ALL minimumAge: 40 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Physical Medicine & Rehabilitation 325 E Eisenhower Pkwy Suite 3011 status: RECRUITING city: Ann Arbor state: Michigan zip: 48108 country: United States name: Chanramouli Krishnan, PT, PhD role: CONTACT phone: 734-936-4031 email: mouli@umich.edu lat: 42.27756 lon: -83.74088 hasResults: False
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<|newrecord|> nctId: NCT06269354 id: 20231121-71479 briefTitle: Multi-center Study on Comprehensive Diagnosis and Treatment of Lower Limb Bone Defect Based on Three-dimensional Printing Technology overallStatus: RECRUITING date: 2023-11-01 date: 2026-06-01 date: 2026-12-31 date: 2024-02-21 date: 2024-02-21 name: Peking University Third Hospital class: OTHER briefSummary: The clinical diagnosis and treatment of lower limb bone defect is a difficult problem in orthopedics. The traditional treatment has the shortcomings of long treatment period, no weight bearing in the early stage of the limb, weak mechanical strength, many complications, and difficulty in repairing deformed and large segment bone defects around the joint. The Orthopedics Department of Peking University Third Hospital, the lead unit of this study, developed the TCBridge system based on three-dimensional (3D) printing technology in the early stage, which is the first approved 3D printing lower limb long bone defect repair system in China. The system can achieve personalized and accurate repair of lower limb bone defects, and ensure patients to carry out limb weight and functional exercise safely in the early stage after surgery. On this basis, this study will establish a multi-center clinical case cohort to achieve accurate comprehensive diagnosis and treatment of lower limb bone defects, benefiting patients and contributing to society. conditions: Bone Defects studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 120 type: ESTIMATED name: 3D printed prostheses measure: Evaluation of implant stability, new bone growth- limb length measure: Evaluation of bone healing measure: Pain assessment measure: Evaluation of life quality and health status. measure: Evaluation of knee function measure: Evaluation of hip function measure: Evaluation of ankle function sex: ALL minimumAge: 18 Years maximumAge: 90 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Peking University Third Hospital status: RECRUITING city: Beijing state: Haidian country: China name: Bingchuan Liu role: CONTACT phone: +86 18310188678 email: liubc@bjmu.edu.cn lat: 39.9075 lon: 116.39723 hasResults: False
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<|newrecord|> nctId: NCT06269341 id: SCCH-TS2208 briefTitle: Outcomes of Smoker and Drinker With Esophageal Squamous Cell Carcinoma After Esophagectomy acronym: OSinEC overallStatus: RECRUITING date: 2010-02-01 date: 2024-07-30 date: 2024-08-30 date: 2024-02-21 date: 2024-02-21 name: Sichuan Cancer Hospital and Research Institute class: OTHER briefSummary: Our study demonstrates that patients who did not consume alcohol or smoke had a significant advantage in overall survival (OS) after undergoing esophagectomy. Furthermore, our findings indicate that there was no statistically significant difference in OS between patients with a history of both smoking and drinking, and those who only smoked or drank conditions: Outcomes of Smoker and Drinker After Esophagectomy studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 2957 type: ESTIMATED name: No intervention measure: Overall Survival sex: ALL minimumAge: 18 Years maximumAge: 90 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Sichuan Cancer Hospital and Research Institute status: RECRUITING city: Chengdu state: Sichuan zip: 610041 country: China name: Lin Peng, M.D. role: CONTACT phone: +8618908190013 email: penglinms@126.com name: Wenwu He, M.D. role: CONTACT phone: +8613350055340 email: wenwu_he@126.com lat: 30.66667 lon: 104.06667 hasResults: False
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<|newrecord|> nctId: NCT06269328 id: 2011-KAEK-26/463 briefTitle: Measuring Sleep Quality In Patients That Posterior Spinal Instrumentatıon Plannıng overallStatus: COMPLETED date: 2022-07-01 date: 2023-09-01 date: 2024-01-01 date: 2024-02-21 date: 2024-02-28 name: Uludag University class: OTHER briefSummary: Postoperative sleep disorders have serious problems with cognition, pain perception, sustained circadian rhythm, psychomotor function, metabolic function, catabolic responses, and continuity. The relationship between general anesthesia and sleep disturbances following surgery is still unclear. Since the risk of sleep disorders after surgery is high, it is important to determine the efficiency of the interval with automatic sleep disorders. By evaluating how major orthopedic surgery and general anesthesia applied to posterior spinal instrumentation divides sleep quality, risk management allows determining the factors involved in the peroperative period and thus facilitating surgical results and patient comfort. conditions: Sleep Disorder conditions: Sleep, Inadequate conditions: Total ıntravenous Anesthesia conditions: Inhalation Anesthesia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 39 type: ACTUAL name: Total ıntravenous anesthesia with propofol and remifentanil for anesthetic maintenance name: Inhalation anesthesia with sevoflurane for anesthetic maintenance measure: Subjective sleep quality (evaluated by PIRS-20 (Pitssburg Insomnia Rating Scale) measure: Subjective anxiety level measure: Subjective pain level sex: ALL minimumAge: 18 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Elifgül Ulutaş city: Bursa state: Nilüfer zip: 16240 country: Turkey lat: 40.19559 lon: 29.06013 hasResults: False
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<|newrecord|> nctId: NCT06269315 id: SBDDCP briefTitle: Assessment of Skin Barrier Disruption Due to Daily Use of Cleaning Products and Hand Disinfectants acronym: SBDDCP overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2024-12-31 date: 2025-04-01 date: 2024-02-21 date: 2024-02-21 name: Swiss Institute of Allergy and Asthma Research class: OTHER name: University Hospital, Zürich briefSummary: The goal of this clinical trial is to assess the effects of household detergents and hand disinfectants on human skin barrier integrity among healthy adult volunteers.
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The main questions it aims to answer are:
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* How does exposure to household detergents and hand disinfectants impact skin barrier function?
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* Are there differences in skin barrier disruption between various types of cleaning agents and disinfectants?
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Participants will:
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Undergo patch testing with controlled amounts of household detergents and hand disinfectants on a small area of their skin.
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Be monitored for adverse reactions during and after exposure. Have their skin barrier integrity assessed using electrical impedance spectroscopy at multiple time points post-exposure.
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If there is a comparison group:
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Researchers will compare the effects of different types of cleaning agents, hand disinfectants, and their ingredients on skin barrier integrity to determine variations in their impact. conditions: Control Condition (PBS) conditions: Household Detergent Exposure conditions: Hand Disinfectant Exposure conditions: Surfactant Exposure conditions: Other Ingredients Exposure studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: 1. Skin Cleansing and Testing Patch Preparation:
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Prepare a test set of patch testing tapes, each containing a small amount of a different household cleaner, hand disinfectant, their ingredients, and control with proper dilution. The safety dose of the tested products and agents will be defined beforehand.
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Before exposure, selected areas of forearm skin will be cleaned and moistened. Electrical impedance will be measured by electrical impedance spectroscopy (EIS) to assess skin barrier integrity.
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2. Patch Application:
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Apply the prepared patches on the skin of the forearm. Patches will be removed after 5 minutes of exposure.
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During the exposure period, subjects will be instructed not to touch, wash, or wet the exposed area to avoid interfering with the action of the testing reagents. 3. Patch Removal and Post-Exposure Monitoring:
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The patch will be gently removed from the skin. Exposed areas of skin will be evaluated by EIS at specific times up to 24 hours after the treatment. primaryPurpose: BASIC_SCIENCE masking: NONE count: 50 type: ESTIMATED name: Cleaning product exposure measure: Skin barrier evaluation sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Swiss Institute of Allergy and Asthma Research city: Davos state: Graubuenden zip: 7265 country: Switzerland name: Yasutaka Mitamura, MD PhD role: CONTACT phone: +41 (0) 81 410 08 48 email: yasutaka.mitamura@siaf.uzh.ch name: Cezmi A Akdis, MD professor role: CONTACT phone: +41 (0) 81 410 08 48 email: cezmi.akdis@siaf.uzh.ch name: Manru Li role: SUB_INVESTIGATOR name: Marie-Charlotte Brueggen, MD PhD professor role: SUB_INVESTIGATOR lat: 46.80429 lon: 9.83723 hasResults: False
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<|newrecord|> nctId: NCT06269302 id: 2 briefTitle: Comparison of the Effect of Warfarin and Direct Oral Anticoagulants overallStatus: COMPLETED date: 2022-01-01 date: 2022-12-31 date: 2022-12-31 date: 2024-02-21 date: 2024-02-21 name: Samsun Education and Research Hospital class: OTHER briefSummary: In this study, it was aimed to compare the frequency of new oral anticoagulants and warfarin usage, and to reveal the rates of recurrent upper gastrointestinal bleeding among patients who applied to our hospital with upper gastrointestinal bleeding conditions: Anticoagulants and Bleeding Disorders conditions: Gastrointestinal Hemorrhage studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: CROSS_SECTIONAL count: 346 type: ACTUAL measure: Change in the incidence of recurrent bleeding sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Samsun Education and Research Hospital city: Samsun state: İlkadım country: Turkey lat: 41.27976 lon: 36.3361 hasResults: False
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<|newrecord|> nctId: NCT06269289 id: SBU-KOMSERN-001 briefTitle: Effects of Web-Based Education on Patient Empowerment and Asthma Control in Asthma Patients overallStatus: NOT_YET_RECRUITING date: 2024-05-30 date: 2024-06-30 date: 2024-09-30 date: 2024-02-21 date: 2024-02-21 name: Saglik Bilimleri Universitesi class: OTHER briefSummary: Asthma is defined as a chronic inflammatory disorder of the airways associated with an extreme increase in airway hyperresponsiveness leading to recurrent wheezing, shortness of breath, chest tightness, and coughing attacks. The World Health Organization states that approximately 339 million individuals worldwide have asthma and more than 400 thousand deaths occur due to asthma every year.
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With effective and sustainable asthma management, it is possible to reduce disease-related complaints, admissions to emergency units and hospitalizations, limit the physiological and psychological effects of the disease, prevent dependence on healthcare professionals and caregivers, increase the quality of life and reduce the mortality of the disease. Patient education, which is within the educational role of professional nurses, is very important in asthma management. The research was planned in a single-center, randomized control group pretest-posttest design. The sample will consist of individuals who applied to the Allergy and Immunology clinic of Sureyyapasa Chest Diseases and Surgery Training and Research Hospital between May 2024 and January 2024, who have been diagnosed with asthma for at least one year and who accept the study \[25 intervention group - 25 control group\]. Groups will be determined using the random numbers table from the simple random sampling method. A web-based asthma education module will be created in line with the literature, and participants in the intervention group will be given synchronous training in 5 modules. After meeting the individuals in the intervention and control groups and obtaining verbal and written consent, they will be asked to fill out the Patient Information Form, Patient Empowerment Scale and Asthma Control Test prepared via Google Forms. A 30-minute training session will be given to the intervention group every week and there will be short evaluations after each training. When the 5th Module is completed, the intervention group will be asked to fill out the Patient Empowerment Scale and Asthma Control Test Scale. No intervention will be applied to the control group. 5. At the end of the module, the Patient Empowerment Scale and Asthma Control Test will be completed by individuals in the control group. It is thought that web-based asthma education that individuals will receive will positively affect their empowerment levels and increase their disease control. conditions: Asthma conditions: Patient Empowerment studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The research was designed as a randomized controlled experimental study with a pretest-posttest design. primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 50 type: ESTIMATED name: web based education name: Standard education brochure measure: patient empowerment scale (PES) measure: Asthma Control Test (ACT) sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Sureyyapasa Chest Diseases and Thoracic Surgery Training and Research Hospital city: Istanbul zip: 34854 country: Turkey lat: 41.01384 lon: 28.94966 hasResults: False
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<|newrecord|> nctId: NCT06269276 id: CAVCU briefTitle: Caregiver Contribution to Self-Care in Ostomy Patient Index: Turkish Validity and Reliability Study overallStatus: COMPLETED date: 2020-09-20 date: 2021-01-15 date: 2021-01-15 date: 2024-02-21 date: 2024-02-21 name: Namik Kemal University class: OTHER briefSummary: This study was conducted to evaluate the Turkish validity and reliability of the Caregiver Contribution to Self-Care in Ostomy Patient Index, to evaluate the relatives of patients with stoma who contribute to their self-care in Turkish society, and to contribute to the nursing literature of the measurement tool.
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This methodological type of research was carried out between September 2020 and January 2021 in a state and a university hospital in Tekirdağ. The research sample consisted of 223 individuals who contributed to the self-care of individuals with colostomy, ileostomy and urostomy who applied for outpatient control. In the analysis of the data, descriptive statistics, language and content validity, confirmatory factor analysis, item analysis, internal consistency and test-retest methods were used.
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At the end of the study, it was determined that the scale was suitable for Turkish society and was valid and reliable in Turkish. conditions: Stoma Colostomy conditions: Stoma Ileostomy conditions: Caregiver conditions: Self Care studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: CROSS_SECTIONAL count: 223 type: ACTUAL name: Caregiver Contribution to Self-Care in Ostomy Patient Index measure: Caregiver Contribution to Self-Care in Ostomy Patient Index sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Tekirdag Namık Kemal University city: Tekirdag state: Suleymanpasa zip: 59000 country: Turkey lat: 40.9781 lon: 27.51101 hasResults: False
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<|newrecord|> nctId: NCT06269263 id: 339/23-ek briefTitle: Pilot Study to Determine Feasibility of Home-based Cardiac Rehabilitation in Patients With Chronic Heart Failure (Pilot-CRHF) acronym: Pilot-CRHF overallStatus: NOT_YET_RECRUITING date: 2024-02-19 date: 2025-02 date: 2025-02 date: 2024-02-21 date: 2024-02-21 name: University of Leipzig class: OTHER briefSummary: The proposed study will determine the willingness of patients for participation. Furthermore, the assessment of tests to identify eligible patients and the type of exercise intervention that goes along with a high patient compliance is crucial. Also, more information about possible factors preventing patients from participating is required. Therefore, if the patient is willing to participate, we will assess patients' medical history, medication and QoL as well as parameters of routine diagnostics (i.e. echocardiography, laboratory testing, MRI). Following, while the in-patient stay due to cardiac decompensation, we will conduct several assessment-tests to determine the physical status, the exercise capacity and the cognitive function. Moreover, physiotherapists will instruct the patients in the exercise program. After discharge from the hospital, physiotherapist will visit the patient at home to instruct them again in the exercises. Then, the patients will conduct the program on their own for a period of 12 weeks. During the exercise period, a doctoral student will visit the patients at home every 3 weeks to check whether they are doing the exercises correctly and to determine whether there are any problems with the program. After the exercise period of 12 weeks, the baseline characteristics will be assessed again at the University Hospital Leipzig. conditions: Heart Failure studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Pilot study of home-based cardiac rehabilitation primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 30 type: ESTIMATED name: Home-based cardiac rehabilitation measure: Percentage of patients completing the program measure: Quality of life measure: Exercise capacity sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Universitätsklinikum Leipzig city: Leipzig state: Saxony zip: 04103 country: Germany lat: 51.33962 lon: 12.37129 hasResults: False
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<|newrecord|> nctId: NCT06269250 id: ANDI-MFA2023_10 briefTitle: Acceptance and Perceived Benefits of Digitalization by Medical Assistants acronym: ANDI-MFA overallStatus: RECRUITING date: 2023-11-01 date: 2024-12-31 date: 2024-12-31 date: 2024-02-21 date: 2024-02-21 name: Jacobs University Bremen gGmbH class: OTHER name: Mirjam Jansen; medmedia Academy briefSummary: The aim of this project is to improve the integration of digital processes, including e-prescriptions, within medical and dental practices for healthcare professionals. Through a better understanding of the obstacles healthcare workers encounter during the adoption of digital processes and their feedback post-implementation, this study will add to the current state of science, contributing to digital process optimization in healthcare. conditions: Health Care Providers conditions: Patient Safety conditions: eHealth studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 1000 type: ESTIMATED name: Policy Change measure: Adoption and acceptance of information technology (IT) measure: Requests by patients regarding IT measure: Perceived Benefits of IT measure: Knowledge and Digital health literacy measure: Preferred learning format sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Germany status: RECRUITING city: Bremen zip: 28759 country: Germany name: Sonia Lippke, Prof. Dr. role: CONTACT phone: +49 421 200 4730 email: slippke@constructor.university name: Keller Franziska, PhD role: CONTACT phone: +49 421 200 4730 email: fkeller@constructor.university lat: 53.07516 lon: 8.80777 hasResults: False
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<|newrecord|> nctId: NCT06269237 id: 2023LTA briefTitle: Point of Care Test of LTA Level in Tear Fluid, Measured With a POCT Test, in DE Patients Following IPL Treatment overallStatus: NOT_YET_RECRUITING date: 2024-02-22 date: 2024-06-01 date: 2024-07-01 date: 2024-02-21 date: 2024-02-21 name: He Eye Hospital class: OTHER briefSummary: To quantify and compare tear levels of Intense pulsed light (IPL) and traditional dry eye clinical tests in dry eye patients before and after Intense pulsed light (IPL) treatment. conditions: Dry Eye studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 30 type: ESTIMATED name: M22 name: sham M22 measure: LTA measure: Non-invasive tear break-up time (NITBUT) measure: Fluorescein and lissamine conjunctival and cornea staining (CFS) measure: Meibomian quality measure: Tear Film Lipid Layer Score(TFLL) measure: Tear meniscus height (TMH) measure: Conjunctival hyperemia (RS score) measure: Ocular Surface Disease Index (OSDI) sex: ALL minimumAge: 18 Years maximumAge: 90 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06269224 id: HU-FTR-KS-01 briefTitle: Examining Factors Influencing Thoracolumbar Mobility in Runners overallStatus: COMPLETED date: 2022-09-01 date: 2023-01-01 date: 2024-01-01 date: 2024-02-21 date: 2024-02-22 name: Hacettepe University class: OTHER briefSummary: The presence of to is thoracolumbar (TL) mobility a significant aspect in the context of running. Most of the factors may be related to certain kinematic parameters of the lumbopelvic-hip complex during running. conditions: Runners conditions: Mobility conditions: Fascia conditions: Range of Motion studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: CROSS_SECTIONAL count: 90 type: ACTUAL name: Participants were recreational runners who run between 20 to 50 km weekly; each one has 35 runners. measure: Myoton Assessment sex: ALL minimumAge: 30 Years maximumAge: 45 Years stdAges: ADULT facility: Hacettepe University city: Ankara state: Altındağ zip: 06100 country: Turkey lat: 39.91987 lon: 32.85427 hasResults: False
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<|newrecord|> nctId: NCT06269211 id: RTS-019 briefTitle: Neoadjuvant Toripalimab for Clinically Stage II-IIIB Resectable Non-small Cell Lung Cancer With EGFR Mutation and PD-L1 Positive Expression acronym: TOPLINE overallStatus: NOT_YET_RECRUITING date: 2024-03-30 date: 2027-01-31 date: 2030-01-31 date: 2024-02-21 date: 2024-02-21 name: Ruijin Hospital class: OTHER name: Guangdong Provincial People's Hospital briefSummary: The study is a prospective, open label, multicenter, single arm Phase II clinical trial, aiming to explore the use of neoadjuvant Toripalimab for clinically stage II-IIIB NSCLC patients with EGFR mutations and PD-L1 positive expression, providing a novel perspective for further improving the prognosis of NSCLC patients. This study will provide valuable information for further clinical trials of neoadjuvant Toripalimab and other immune checkpoint inhibitors in NSCLC patients with EGFR mutations and PD-L1 positive expression. conditions: Carcinoma, Non-Small-Cell Lung studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: This study has only one arm, neoadjuvant Toripalimab treatment arm. Primary endpoint is MPR. We apply the optimal design of Simon's two-stage model to calculate the sample size and set both sides α= 0.05 and power=0.8, resulting in a total sample size of 29. Among them, 10 patients will be enrolled in the first stage. If the number of MPR cases in the first stage is less than or equal to 1, the study will be terminated in the early stage; On the contrary, participants in the second stage will continue to be enrolled. If the total number of MPR cases is greater than or equal to 5 after the completion of the second stage, the study is considered positive. primaryPurpose: TREATMENT masking: NONE count: 29 type: ESTIMATED name: Toripalimab measure: Major Pathological Response (MPR) measure: Pathological Complete Response (pCR) measure: Objective Response Rate (ORR) measure: 2-year Event Free Survival (EFS) measure: 2-year Overall Survival (OS) measure: Safety (Number of Participants With Grade 3 and Higher-grade Treatment-related Adverse Events) measure: Feasibility (Number of Participants Who Finished Neoadjuvant therapy and Receive Surgery Within 3-6 Weeks After Neoadjuvant Therapies) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Guangdong Provincial People's Hospital city: Guangzhou state: Guangdong zip: 510180 country: China lat: 23.11667 lon: 113.25 facility: Ruijin Hospital, Shanghai Jiao Tong University School of Medicine city: Shanghai state: Shanghai zip: 200025 country: China lat: 31.22222 lon: 121.45806 hasResults: False
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<|newrecord|> nctId: NCT06269198 id: WARD - SX - RCT II briefTitle: Postoperative Complications in Cancer Patients Monitored With Intelligent Continuous Monitoring System acronym: WARD-SX-RCT-II overallStatus: RECRUITING date: 2023-10-31 date: 2025-04-01 date: 2027-04-01 date: 2024-02-21 date: 2024-03-25 name: Rigshospitalet, Denmark class: OTHER name: Bispebjerg Hospital name: Hvidovre University Hospital briefSummary: The primary objective of this study is to determine the effect on complication severity of using a clinical monitoring system with automatic vital sign alerts in addition to routine monitoring versus routine monitoring alone in high-risk postoperative cancer patients within 30 days after surgery.
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Other objectives include documentation of the severity of complications within seven days of surgery, frequency of serious adverse events, mortality, length of stay and delay of planned chemotherapy. conditions: Postoperative Complications conditions: Cancer, Treatment-Related studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomisation stratified by study site primaryPurpose: PREVENTION masking: DOUBLE maskingDescription: Participants will not be given information on group allocation. Care-providers will not be blinded, due to having to carry out the intervention.
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Investigator will not be blinded to carrie out roles such as safety surveillance, error-solving and quality assurance.
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Outcome assessor will be blinded to study allocation. whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 504 type: ESTIMATED name: WARD-CSS measure: Overall complication severity - 30 days measure: Overall complication severity - 7 days measure: Frequency of Serious adverse events measure: Days alive and out of hospital measure: Days alive and out of hospital measure: Time to initiation of post-operative adjuvant chemotherapy measure: Completion of post-operative adjuvant chemotherapy measure: Frequency of severe clinical complications measure: ICU admission measure: Surgical reintervention of any kind measure: Post-discharge readmission measure: Health-economic cost-effectiveness. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Copenhagen University hospital - Rigshospitalet status: RECRUITING city: Copenhagen state: Other (Non US) zip: 1665 country: Denmark name: Jesper Mølgaard, PhD role: CONTACT phone: +4535453545 email: jesper.moelgaard@regionh.dk name: Eske K Aasvang, DMSc role: CONTACT phone: +4535450802 email: eske.kvanner.aasvang.01@regionh.dk lat: 55.67594 lon: 12.56553 facility: Bispebjerg Hospital status: RECRUITING city: Copenhagen state: Other (Non US) zip: 2400 country: Denmark name: Christian S Meyhoff, PhD role: CONTACT phone: +4524910542 email: christian.sylvest.meyhoff@regionh.dk name: Christian S Meyhoff, PhD role: PRINCIPAL_INVESTIGATOR lat: 55.67594 lon: 12.56553 facility: Hvidovre Hospital status: NOT_YET_RECRUITING city: Hvidovre state: Other (Non US) zip: 2650 country: Denmark name: Katja B L Glud, RN role: CONTACT phone: +4538625713 email: katja.balle.levring.glud@regionh.dk name: Søren Kjær, MD role: PRINCIPAL_INVESTIGATOR lat: 55.65719 lon: 12.47364 hasResults: False
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<|newrecord|> nctId: NCT06269185 id: 2024_IFXvsADAinUC briefTitle: Comparison Between Infliximab and Adalimumab on Patients With Ulcerative Colitis overallStatus: RECRUITING date: 2024-03-06 date: 2025-03-01 date: 2025-03-01 date: 2024-02-21 date: 2024-03-15 name: Vastra Gotaland Region class: OTHER_GOV briefSummary: Anti-TNF (tumor necrosing factor) treatment with infliximab (IFX) and adalimumab (ADA) are established first-line biological therapies used in treatment of patients with ulcerative colitis (UC). There are no head-to-head comparative studies between these two drug but meta-analysis of randomized controlled trials states that IFX might be more effective than ADA for the induction of clinical remission. However, several observational studies conclude that ADA seem to have similar effect as IFX in treating patients with UC but these studies have limitations.
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The overall aim of this retrospective multicenter observational cohort study is to evaluate if there is a difference in efficacy between infliximab (IFX) and adalimumab (ADA) in treating bio-naive patients with UC in the short and long term during the modern era when therapeutic drug monitoring have been used to optimize anti-TNF treatment. conditions: Ulcerative Colitis conditions: Inflammatory Bowel Diseases studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 270 type: ESTIMATED name: Infliximab name: Adalimumab measure: Percentage of patients achieving steroid-free clinical remission measure: Percentage of patients achieving clinical response measure: Percentage of patients achieving clinical remission measure: Percentage of patients achieving biochemical remission measure: Percentage of patients achieving clinical remission measure: Percentage of patients achieving biochemical remission measure: Percentage of patients achieving endoscopic response measure: Percentage of patients achieving endoscopic remission measure: Remission rates in the subpopulations of UC-patients with severe, moderate and mild disease respectively sex: ALL minimumAge: 18 Years maximumAge: 100 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Västra Götalandsregionen status: RECRUITING city: Göteborg country: Sweden name: Börje Jonefjäll role: CONTACT phone: +46703753933 email: borje.jonefjall@vgregion.se lat: 57.70716 lon: 11.96679 hasResults: False
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<|newrecord|> nctId: NCT06269172 id: 162076 id: 322453 type: OTHER domain: HRA briefTitle: Perceptions Across Ethnicities to Develop an Adapted Intervention for Breathlessness acronym: Paint overallStatus: RECRUITING date: 2024-02-12 date: 2025-11-30 date: 2025-11-30 date: 2024-02-21 date: 2024-02-21 name: University Hospitals, Leicester class: OTHER briefSummary: An individual's experience of their breathlessness is influenced by multiple factors including their medical condition, psychology, sociological and situational circumstances which will include ethnicity. There is currently a lack of evidence exploring the impact of ethnicity in the experience and presentation of breathlessness.
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The non-medical management of breathlessness in respiratory diseases includes pulmonary rehabilitation (PR). PR is a highly evidenced exercise-based intervention to help manage breathlessness, improving health-related quality of life and improving survival. Recent audits in England and Wales showed 89% of patients attending PR were recorded as having a White British ethnicity which is in contrast to national ethnicity demographics. This may be because the cultural acceptability of PR components are not fully considered. Therefore, this study will explore how individuals with cardiorespiratory disease from different ethnicities from the Leicestershire population experience and manage their breathlessness through art workshops, focus groups and interviews. Informed by these results, the study team will work with individuals from under-represented ethnicities and key stakeholders to co-design adaptations of PR that may improve the management of breathlessness in underrepresented ethnicities that do not attend conventional PR programmes.
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The study is funded by the Wellcome Trust as part of the Leicestershire Health Inequalities Improvement Programme at the University of Leiceste conditions: Cardiovascular Diseases studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: PROSPECTIVE count: 45 type: ESTIMATED name: intereviews measure: Art Workshops, Focus Groups and Semi-Structured Interviews measure: : Experience Based Co-design The co-development of an intervention for breathlessness for under-represented ethnicities. sex: ALL minimumAge: 18 Years maximumAge: 100 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Glenfield Hospital status: RECRUITING city: Leicester state: Leicestershire zip: LE39QP country: United Kingdom name: Holly Ms Drover role: CONTACT email: hd225@leicester.ac.uk lat: 52.6386 lon: -1.13169 hasResults: False
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<|newrecord|> nctId: NCT06269159 id: ONZ-2023-0185 briefTitle: The Power of 24-hour: Co-designing Intervention Components overallStatus: RECRUITING date: 2023-09-05 date: 2025-03-31 date: 2025-03-31 date: 2024-02-21 date: 2024-02-21 name: University Hospital, Ghent class: OTHER briefSummary: Most of the existing lifestyle interventions in adults with overweight or obesity focus on one movement behavior in isolation (i.e. moderate to vigorous physical activity (MVPA)). However, recent research suggests to incorporate all movement behaviors performed in one day to explore the possible synergistic health effects of targeting more than one behavior. Moreover, more optimal 24-hour movement behavior compositions are related with better cardiometabolic health. Literature shows that adults with obesity have less optimal 24-hour compositions (8-9). Therefore it would be of interest to discover the needs related to an optimal 24-hour movement behavior intervention for a group of adults with overweight and obesity using co-design to develop an intervention.
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This study will conduct a concept mapping protocol to explore the needs to of people with overweight and obesity to change their sedentary behavior into more physical activity as well to include the opinion of health care providers (HCP are physiotherapists) on the needs of their patients. conditions: Overweight and Obesity studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: OTHER count: 210 type: ESTIMATED name: Concept mapping: brainstorm name: Concept mapping: clustering and rating measure: Themes measure: Score of effectiveness measure: Score of feasibility measure: Score of modifiability sex: ALL minimumAge: 25 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Ghent university Hospital status: RECRUITING city: Ghent zip: 9000 country: Belgium name: Bruno Lapauw role: CONTACT email: bruno.lapauw@uzgent.be lat: 51.05 lon: 3.71667 hasResults: False
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<|newrecord|> nctId: NCT06269146 id: 806035 id: 1R61MH129380-01 type: NIH link: https://reporter.nih.gov/quickSearch/1R61MH129380-01 briefTitle: Pramipexole to Enhance Social Connections overallStatus: NOT_YET_RECRUITING date: 2024-02 date: 2025-03 date: 2025-03 date: 2024-02-21 date: 2024-02-21 name: University of California, San Diego class: OTHER name: National Institute of Mental Health (NIMH) name: New York State Psychiatric Institute briefSummary: This study seeks to understand if the medication pramipexole improves social connectedness and functioning in adults (ages 18-50) who experience anxiety or depression. The study plans to enroll 108 participants total across two sites (University of California San Diego and New York State Psychiatric Institute). Pramipexole will be given in a 6-week randomized, double-blind, placebo-controlled trial. Social reward processing will be assessed using measures of brain function (fMRI), behavior, and self-report at baseline and week 6. Knowledge gained from this study will help determine the therapeutic potential of targeting the dopamine system to remediate social disconnection as an anxiety and depression intervention. conditions: Anxiety Disorders conditions: Anxiety conditions: Depression conditions: Social Disconnection studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE maskingDescription: The pharmacy will blind drug and placebo through identical encapsulation. Placebo will match the study drug in mode of administration, color, size, and taste. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 108 type: ESTIMATED name: Pramipexole Pill name: Placebo Pill measure: Neural activation during social reward anticipation measure: Neural activation during opportunities to disclose to others measure: Motivation to engage in shared experiences with others measure: Positive affect in response to the social affiliation task measure: Social approach goals during the social affiliation task measure: Social approach behavior during the social affiliation task measure: Future approach motivation measure: Blood plasma pramipexole concentrations measure: Negative affect in response to the social affiliation task measure: Neural activation during social punishment anticipation measure: Social avoidance goals during the social affiliation task measure: Anxious behavior during the social affiliation task sex: ALL minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT facility: University of California, San Diego city: San Diego state: California zip: 92093 country: United States name: Margaret K Satchwell, BS role: CONTACT phone: 858-822-4357 email: mksatchwell@health.ucsd.edu lat: 32.71533 lon: -117.15726 facility: New York State Psychiatric Institute city: New York state: New York zip: 10032 country: United States name: Liza Handler, BS role: CONTACT phone: 917-652-6355 email: liza.handler@nyspi.columbia.edu lat: 40.71427 lon: -74.00597 hasResults: False
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<|newrecord|> nctId: NCT06269133 id: R2810-ONC-22115 briefTitle: Evaluation of Cemiplimab in Combination With Platinum-Doublet Chemotherapy in First-Line (1L) Treatment of Advanced Non-Small Cell Lung Cancer (NSCLC) in Adult United States (US) Patients overallStatus: ACTIVE_NOT_RECRUITING date: 2024-02-21 date: 2027-03-31 date: 2027-06-23 date: 2024-02-21 date: 2024-03-13 name: Regeneron Pharmaceuticals class: INDUSTRY briefSummary: This multi-year cohort study will assess the real-world safety and effectiveness of 1L treatment with cemiplimab in combination with platinum-doublet chemotherapy across advanced NSCLC patient subgroups defined by age, sex, race, and ethnicity. Patients will be retrospectively identified from at least two US electronic health record (EHR)-based databases. conditions: Advanced Non-small Cell Lung Cancer studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: OTHER count: 1000 type: ESTIMATED name: REGN2810 name: Platinum-doublet chemotherapy measure: Real-world response rate (rwRR) measure: Any treatment-emergent immune-mediated adverse event (imAE) measure: Any treatment-emergent imAE resulting in hospitalization measure: Any treatment-emergent imAE resulting in death measure: Specific treatment-emergent imAEs measure: Real-world duration of response (rwDOR) measure: Real-world progression-free survival (rwPFS) measure: Real-world overall survival (rwOS) measure: Treatment-emergent immune-mediated adverse events (imAEs) measure: Infusion-related reaction (IRR) measure: IRR resulting in hospitalization measure: IRR resulting in death sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Regeneron Research Facility city: Tarrytown state: New York zip: 10591 country: United States lat: 41.07621 lon: -73.85875 hasResults: False
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<|newrecord|> nctId: NCT06269120 id: NN9924-7787 id: U1111-1290-8109 type: OTHER domain: World Health Organization (WHO) briefTitle: SEMA-CardioDiab HUNGARY: A Research Study to Understand the Effects of Oral Semaglutide on Blood Sugar Levels, Weight, and Cardiovascular Risk in People With Type 2 Diabetes Patients in Hungary overallStatus: NOT_YET_RECRUITING date: 2024-02-15 date: 2024-09-30 date: 2024-09-30 date: 2024-02-21 date: 2024-02-21 name: Novo Nordisk A/S class: INDUSTRY briefSummary: Participant will get oral semaglutde as prescribed by the study doctor. The study will last for about 26 ± 4 weeks (5 to 7 months). Participant will be asked to complete a questionnaire about how they take oral semaglutide tablets during normal scheduled visit with doctor. Participant will also be asked questions about health and their diabetes treatment and lab tests as part of normal doctor's appointment. conditions: Type 2 Diabetes studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 470 type: ESTIMATED name: Oral Semaglutide measure: Glycated haemoglobin (HbA1c ) reduction greater than or equal to (≥) 0.5%-point and body weight reduction ≥ 5% measure: Change in HbA1c measure: Change in fasting plasm glucose (FPG) measure: Absolute change in body weight (BW) measure: Relative change in BW measure: HbA1c less than (<) 7.0% measure: HbA1c <6.5% measure: Body weight reduction ≥5% measure: HbA1c reduction ≥1%-point and BW reduction ≥5% measure: HbA1c reduction ≥1%-point and BW reduction ≥3% measure: Change in waist circumference measure: Change in blood pressure (BP) (systolic and diastolic) measure: Change in lipid parameters (total cholesterol, low density lipoprotein cholesterol [LDL-C], high density lipoprotein cholesterol [HDL-C], triglycerides [TG]) measure: Change in high sensitive C-reactive protein (hsCRP) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06269107 id: NN1535-4988 id: U1111-1283-8648 type: OTHER domain: World Health Organization (WHO) id: 2022-502484-38-00 type: OTHER domain: European Medicines Agency (EMA) briefTitle: A Research Study to See How Well New Weekly Medicine IcoSema, Which is a Combination of Insulin Icodec and Semaglutide, Controls Blood Sugar Levels in People With Type 2 Diabetes (T2D), Compared to Daily Insulin Glargine (COMBINE 4) acronym: COMBINE 4 overallStatus: RECRUITING date: 2024-02-15 date: 2025-06-05 date: 2025-07-10 date: 2024-02-21 date: 2024-04-18 name: Novo Nordisk A/S class: INDUSTRY briefSummary: This study will compare the new medicine IcoSema, which is a combination of insulin icodec and semaglutide, taken once a week, to insulin glargine (mentioned as insulin glargine in this form) taken daily in people with type 2 diabetes. The study will look at how well IcoSema controls blood sugar levels as compared to insulin glargine in people with type 2 diabetes who do not have their blood sugar properly controlled with other oral diabetes medicines. Participant will either get IcoSema or insulin glargine. Which treatment participants get is decided by chance. IcoSema is a new medicine that doctors cannot prescribe. Doctors can already prescribe insulin glargine in many countries. The study will last for about 11 months (47 weeks). conditions: Type 2 Diabetes studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 474 type: ESTIMATED name: IcoSema name: Insulin glargine measure: Change in glycated haemoglobin (HbA1c) measure: Change in body weight measure: Time in range 3.9-10.0 millimoles per liter (mmol/L) (70-180 milligram per deciliter [mg/dL]) measure: Time spent less than (<) 3.0 mmol/L (54 mg/dL) measure: Time spent greater than (>) 10.0 mmol/L (180 mg/dL) measure: Weekly basal insulin dose measure: Change in fasting plasma glucose (FPG) measure: Change in Diabetes Treatment Satisfaction Questionnaire (DTSQs) in total treatment satisfaction measure: Number of clinically significant hypoglycaemic episodes (level 2) (<3.0 mmol/L (54 mg/dL), confirmed by blood glucose meter) or severe hypoglycaemic episodes (level 3) measure: Number of clinically significant hypoglycaemic episodes (level 2) (<3.0 mmol/L (54 mg/dL), confirmed by BG meter) measure: Number of severe hypoglycaemic episodes (level 3) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Scripps Whittier Diabetes Inst status: RECRUITING city: La Jolla state: California zip: 92037 country: United States lat: 32.84727 lon: -117.2742 facility: First Valley Med Grp Lancaster status: RECRUITING city: Lancaster state: California zip: 93534 country: United States lat: 34.69804 lon: -118.13674 facility: Clinical Trials Research_Sacramento status: RECRUITING city: Lincoln state: California zip: 95648 country: United States lat: 38.89156 lon: -121.29301 facility: Desert Oasis Hlthcr Med Group status: RECRUITING city: Palm Springs state: California zip: 92262 country: United States lat: 33.8303 lon: -116.54529 facility: Northeast Research Institute status: RECRUITING city: Fleming Island state: Florida zip: 32003 country: United States lat: 30.0933 lon: -81.71898 facility: Clinical Research of Central Florida_Winter Haven status: RECRUITING city: Winter Haven state: Florida zip: 33880 country: United States lat: 28.02224 lon: -81.73286 facility: Atlanta Diabetes Associates status: RECRUITING city: Atlanta state: Georgia zip: 30318 country: United States lat: 33.749 lon: -84.38798 facility: Endo Res Solutions Inc status: RECRUITING city: Roswell state: Georgia zip: 30076 country: United States lat: 34.02316 lon: -84.36159 facility: Elite Clinical Trials status: RECRUITING city: Blackfoot state: Idaho zip: 83221 country: United States lat: 43.19047 lon: -112.34498 facility: Cedar-Crosse Research Center status: RECRUITING city: Chicago state: Illinois zip: 60607 country: United States lat: 41.85003 lon: -87.65005 facility: NorthShore Univ Hlth Sys status: RECRUITING city: Skokie state: Illinois zip: 60077 country: United States lat: 42.03336 lon: -87.73339 facility: Cotton-O'Neil Diab & Endo Ctr status: RECRUITING city: Topeka state: Kansas zip: 66606 country: United States lat: 39.04833 lon: -95.67804 facility: Methodist Phys. Clinic status: RECRUITING city: Omaha state: Nebraska zip: 68114 country: United States lat: 41.25626 lon: -95.94043 facility: Albuquerque Clin Trials, Inc. status: RECRUITING city: Albuquerque state: New Mexico zip: 87102 country: United States lat: 35.08449 lon: -106.65114 facility: Albany Medical College - Endo status: RECRUITING city: Albany state: New York zip: 12206 country: United States lat: 42.65258 lon: -73.75623 facility: Southgate Medical Group, LLP status: RECRUITING city: West Seneca state: New York zip: 14224 country: United States lat: 42.85006 lon: -78.79975 facility: Physician's East Endocrinology status: RECRUITING city: Greenville state: North Carolina zip: 27834 country: United States lat: 35.61266 lon: -77.36635 facility: Diab & Endo Assoc of Stark Co status: RECRUITING city: Canton state: Ohio zip: 44718 country: United States lat: 40.79895 lon: -81.37845 facility: Advanced Medical Research status: RECRUITING city: Maumee state: Ohio zip: 43537 country: United States lat: 41.56283 lon: -83.65382 facility: New Venture Medical Research status: RECRUITING city: Wadsworth state: Ohio zip: 44281-9236 country: United States lat: 41.02561 lon: -81.72985 facility: Holston Medical Group status: RECRUITING city: Kingsport state: Tennessee zip: 37660 country: United States lat: 36.54843 lon: -82.56182 facility: Amarillo Med Spec LLP status: RECRUITING city: Amarillo state: Texas zip: 79106 country: United States lat: 35.222 lon: -101.8313 facility: Velocity Clinical Research- Cedar Park status: RECRUITING city: Cedar Park state: Texas zip: 78613 country: United States lat: 30.5052 lon: -97.82029 facility: Velocity Clinical Res-Dallas status: RECRUITING city: Dallas state: Texas zip: 75230 country: United States lat: 32.78306 lon: -96.80667 facility: North Texas Endocrine Center status: RECRUITING city: Dallas state: Texas zip: 75231 country: United States lat: 32.78306 lon: -96.80667 facility: Diabetes and Thyroid Ctr of FW status: RECRUITING city: Fort Worth state: Texas zip: 76132 country: United States lat: 32.72541 lon: -97.32085 facility: Fmc Science, Llc status: RECRUITING city: Lampasas state: Texas zip: 76550 country: United States lat: 31.06378 lon: -98.1817 facility: Consano Clinical Research, LLC status: RECRUITING city: Shavano Park state: Texas zip: 78231 country: United States lat: 29.58495 lon: -98.55252 facility: Wade Family Medicine status: RECRUITING city: Bountiful state: Utah zip: 84010 country: United States lat: 40.88939 lon: -111.88077 facility: Peking University People's Hospital status: RECRUITING city: Beijing state: Beijing zip: 100044 country: China lat: 39.9075 lon: 116.39723 facility: Beijing Friendship Hospital, Capital Medical University status: RECRUITING city: Beijing state: Beijing zip: 100050 country: China lat: 39.9075 lon: 116.39723 facility: Chongqing University Three Gorges Hospital status: RECRUITING city: Chongqing state: Chongqing zip: 404000 country: China lat: 29.56278 lon: 106.55278 facility: Huizhou Central People's Hospital status: RECRUITING city: Huizhou state: Guangdong zip: 516001 country: China lat: 23.11147 lon: 114.41523 facility: The Second Affiliated Hospital of Nanjing Medical University status: RECRUITING city: Nanjing state: Jiangsu zip: 210011 country: China lat: 32.06167 lon: 118.77778 facility: The Second Affiliated Hospital of Nanjing Medical University status: NOT_YET_RECRUITING city: Nanjing state: Jiangsu zip: 210011 country: China lat: 32.06167 lon: 118.77778 facility: The Affiliated Hospital of Jiangsu University status: RECRUITING city: Zhenjiang state: Jiangsu zip: 212001 country: China lat: 32.21086 lon: 119.45508 facility: Jinan Central Hospital status: RECRUITING city: Jinan state: Shandong zip: 250013 country: China lat: 36.66833 lon: 116.99722 facility: Jinan Central Hospital status: NOT_YET_RECRUITING city: Jinan state: Shandong zip: 250013 country: China lat: 36.66833 lon: 116.99722 facility: Shanghai Pudong New Area People's Hospital status: RECRUITING city: Shanghai state: Shanghai zip: 201200 country: China lat: 31.22222 lon: 121.45806 facility: Harrison International Peace Hospital status: WITHDRAWN city: Hengshui zip: 053000 country: China lat: 37.73222 lon: 115.70111 facility: Evangelismos Hospital status: RECRUITING city: Athens zip: GR-10676 country: Greece lat: 37.97945 lon: 23.71622 facility: 'G. Gennimatas' General Hospital of Athens status: RECRUITING city: Athens zip: GR-115 27 country: Greece lat: 37.97945 lon: 23.71622 facility: "Laiko" General Hospital of Athens status: RECRUITING city: Athens zip: GR-11527 country: Greece lat: 37.97945 lon: 23.71622 facility: General Hospital of Kalamata status: RECRUITING city: Kalamata zip: 24100 country: Greece lat: 37.03913 lon: 22.11265 facility: Univ Gen Hospital Larisa, Endocrinology & Metabolic Disease status: RECRUITING city: Larissa zip: GR-41110 country: Greece lat: 39.63689 lon: 22.41761 facility: "Thermi" Private Hosital status: RECRUITING city: Thessaloniki zip: GR-57001 country: Greece lat: 40.64361 lon: 22.93086 facility: Ramaiah Memorial Hospital status: RECRUITING city: Bangalore state: Karnataka zip: 560054 country: India lat: 12.97194 lon: 77.59369 facility: Ramaiah Memorial Hospital status: NOT_YET_RECRUITING city: Bangalore state: Karnataka zip: 560054 country: India lat: 12.97194 lon: 77.59369 facility: Mysore Medical College and Research Institute status: NOT_YET_RECRUITING city: Mysore state: Karnataka zip: 570001 country: India lat: 12.29791 lon: 76.63925 facility: BYL Nair Hospital and T N Medical College Department of endo status: RECRUITING city: Mumbai state: Maharashtra zip: 400008 country: India lat: 19.07283 lon: 72.88261 facility: BYL Nair Hospital and T N Medical College Department of endo status: NOT_YET_RECRUITING city: Mumbai state: Maharashtra zip: 400008 country: India lat: 19.07283 lon: 72.88261 facility: Seth GS Medical College & KEM Hospital status: RECRUITING city: Mumbai state: Maharashtra zip: 400012 country: India lat: 19.07283 lon: 72.88261 facility: Seth GS Medical College & KEM Hospital status: NOT_YET_RECRUITING city: Mumbai state: Maharashtra zip: 400012 country: India lat: 19.07283 lon: 72.88261 facility: BSES MG hospital status: RECRUITING city: Mumbai state: Maharashtra zip: 400058 country: India lat: 19.07283 lon: 72.88261 facility: BSES MG hospital status: NOT_YET_RECRUITING city: Mumbai state: Maharashtra zip: 400058 country: India lat: 19.07283 lon: 72.88261 facility: Chellaram Diabetes Institute status: RECRUITING city: Pune state: Maharashtra zip: 411021 country: India lat: 18.51957 lon: 73.85535 facility: SMS Medical College & Hospital status: NOT_YET_RECRUITING city: Jaipur state: Rajasthan zip: 302004 country: India lat: 26.91962 lon: 75.78781 facility: Diabetes, Thyroid and Endocrine Centre status: RECRUITING city: Jaipur state: Rajasthan zip: 302006 country: India lat: 26.91962 lon: 75.78781 facility: Madras Diabetes Research Foundation status: RECRUITING city: Chennai state: Tamil Nadu zip: 600086 country: India lat: 13.08784 lon: 80.27847 facility: Madras Diabetes Research Foundation status: NOT_YET_RECRUITING city: Chennai state: Tamil Nadu zip: 600086 country: India lat: 13.08784 lon: 80.27847 facility: Udyaan Health Care status: RECRUITING city: Lucknow state: Uttar Pradesh zip: 226002 country: India lat: 26.83928 lon: 80.92313 facility: Post Graduate Institute of Medical Education & Research status: NOT_YET_RECRUITING city: Chandigarh zip: 160012 country: India lat: 30.73629 lon: 76.7884 facility: IPGME&R and SSKM Hospital status: NOT_YET_RECRUITING city: Kolkata zip: 700020 country: India lat: 22.56263 lon: 88.36304 facility: Ospedale San Salvatore, Dipartimento Medico ASL1 Abruzzo, UOC Diabetologia status: RECRUITING city: L'Aquila state: Abbruzzo zip: 67100 country: Italy lat: 42.35055 lon: 13.39954 facility: Casa Sollievo della Sofferenza reparto endocrinologia status: RECRUITING city: San Giovanni Rotondo state: FG zip: 71013 country: Italy lat: 41.70643 lon: 15.7277 facility: I.N.R.C.A. Istituto Nazionale di Riposo E Cura Per Gli Anziani status: NOT_YET_RECRUITING city: Ancona zip: 60127 country: Italy lat: 43.5942 lon: 13.50337 facility: Casa della Salute di Ceccano (FR) status: RECRUITING city: Ceccano (Frosinone) zip: 03023 country: Italy facility: ASL 4 Chiavarese status: NOT_YET_RECRUITING city: Chiavari (genova) zip: 16034 country: Italy facility: ASST Grande Ospedale Metropolitano Niguarda status: RECRUITING city: Milano zip: 20162 country: Italy lat: 45.46427 lon: 9.18951 facility: Azienda Ospedaliera di Perugia;Ospedale S. Maria della Miser status: RECRUITING city: Perugia zip: 06129 country: Italy lat: 43.1122 lon: 12.38878 facility: A.O.U. Policlinico Umberto I status: RECRUITING city: Rome zip: 00161 country: Italy lat: 41.89193 lon: 12.51133 facility: Heiwadai Hospital status: RECRUITING city: Miyazaki-shi state: Miyazaki zip: 880-0034 country: Japan lat: 31.91667 lon: 131.41667 facility: Tokuyama clinic status: RECRUITING city: Chiba zip: 261-0004 country: Japan lat: 35.6 lon: 140.11667 facility: Oodouri Diabetes, Internal medicine Clinic status: RECRUITING city: Hokkaido zip: 060-0001 country: Japan lat: 43.41104 lon: 142.88878 facility: Oyama East Clinic status: RECRUITING city: Tochigi zip: 323-0022 country: Japan lat: 36.38333 lon: 139.73333 facility: Tokyo-Eki Center-building Clinic status: RECRUITING city: Tokyo zip: 103-0027 country: Japan lat: 35.6895 lon: 139.69171 facility: Fukuwa Clinic status: RECRUITING city: Tokyo zip: 104-0031 country: Japan lat: 35.6895 lon: 139.69171 facility: Juntendo University Hospital status: RECRUITING city: Tokyo zip: 113-8431 country: Japan lat: 35.6895 lon: 139.69171 facility: NZOZ Specjalistyczny Osrodek Internistyczno-Diabetologiczny Małgorzata Arciszewska status: RECRUITING city: Bialystok state: Podlaskie zip: 15-435 country: Poland lat: 53.13333 lon: 23.16433 facility: SNZOZ Lege Artis status: RECRUITING city: Bialystok zip: 15-404 country: Poland lat: 53.13333 lon: 23.16433 facility: Uniwersyteckie Centrum Kliniczne Regionalne Centrum Diabetologii status: RECRUITING city: Gdansk zip: 80-214 country: Poland lat: 54.35205 lon: 18.64637 facility: Grazyna Pulka Specjalistyczny Osrodek "All-Med" status: RECRUITING city: Krakow zip: 30-033 country: Poland lat: 50.06143 lon: 19.93658 facility: Gabinet Lekarski Malgorzata Saryusz-Wolska status: RECRUITING city: Lodz zip: 90-132 country: Poland lat: 51.75 lon: 19.46667 facility: Centrum Terapii Wspolczesnej status: RECRUITING city: Lodz zip: 90-338 country: Poland lat: 51.75 lon: 19.46667 facility: Ko-Med Nova Sp.zo.o. Lublin II status: RECRUITING city: Lublin zip: 20-362 country: Poland lat: 51.25 lon: 22.56667 facility: Ko-Med Nova Sp.zo.o. STASZOW status: RECRUITING city: Staszow zip: 28-200 country: Poland lat: 50.56307 lon: 21.16593 facility: NBR Polska Tomasz Klodawski status: RECRUITING city: Warszawa zip: 00-710 country: Poland lat: 52.22977 lon: 21.01178 facility: PANSTWOWY INSTYTUT MEDYCZNY MSWiA status: RECRUITING city: Warszawa zip: 02-507 country: Poland lat: 52.22977 lon: 21.01178 facility: Clinhouse Centrum Medyczne status: RECRUITING city: Zabrze zip: 41-807 country: Poland lat: 50.32492 lon: 18.78576 facility: Advanced Clinical Research LLC status: RECRUITING city: Bayamon zip: 00959 country: Puerto Rico lat: 18.39856 lon: -66.15572 facility: Dr R Dulabh status: RECRUITING city: Johannesburg state: Gauteng zip: 1812 country: South Africa lat: -26.20227 lon: 28.04363 facility: Dr R Dulabh status: NOT_YET_RECRUITING city: Johannesburg state: Gauteng zip: 1812 country: South Africa lat: -26.20227 lon: 28.04363 facility: Newtown Clinical Research status: RECRUITING city: Johannesburg state: Gauteng zip: 2001 country: South Africa lat: -26.20227 lon: 28.04363 facility: Roodepoort Medicross Clinical Research Centre status: RECRUITING city: Roodepoort state: Gauteng zip: 1724 country: South Africa lat: -26.1625 lon: 27.8725 facility: Clinical Research Institute of South Africa status: RECRUITING city: KwaDukuza state: KwaZulu Natal zip: 4449 country: South Africa lat: -29.32816 lon: 31.28954 facility: Dr Pillay's Rooms status: RECRUITING city: Durban state: KwaZulu-Natal zip: 4450 country: South Africa lat: -29.8579 lon: 31.0292 facility: Dr Pillay's Rooms status: NOT_YET_RECRUITING city: Durban state: KwaZulu-Natal zip: 4450 country: South Africa lat: -29.8579 lon: 31.0292 facility: Langeberg Clinical Trials status: RECRUITING city: Cape Town state: Western Cape zip: 7572 country: South Africa lat: -33.92584 lon: 18.42322 facility: Akdeniz University Tip Fakultesi Hastanesi status: RECRUITING city: Antalya zip: 07058 country: Turkey lat: 36.90812 lon: 30.69556 facility: Seyrantepe Hamidiye Etfal Egitim ve Arastirma Hastanesi status: RECRUITING city: Istanbul zip: 34371 country: Turkey lat: 41.01384 lon: 28.94966 facility: Istanbul Universitesi Istanbul Tip Fakultesi - Endokrinoloji status: RECRUITING city: Istanbul zip: 34390 country: Turkey lat: 41.01384 lon: 28.94966 facility: T.C. Saglik Bakanligi Pendik Egitim ve Arastirma Hastanesi status: RECRUITING city: Istanbul zip: 34899 country: Turkey lat: 41.01384 lon: 28.94966 facility: Tekirdag Namık Kemal UTF status: RECRUITING city: Tekirdag zip: 59030 country: Turkey lat: 40.9781 lon: 27.51101 hasResults: False
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<|newrecord|> nctId: NCT06269094 id: MB-2312 briefTitle: A Study to Understand How Continuous Glucose Monitors Impact Eating Behavior overallStatus: RECRUITING date: 2024-02-14 date: 2024-05 date: 2024-05 date: 2024-02-21 date: 2024-03-13 name: Midwest Center for Metabolic and Cardiovascular Research class: OTHER briefSummary: The purpose of this study is to evaluate if and how continuous glucose monitors (CGMs) impact food consumption, choice, and purchasing in individuals attempting to lose weight using their own weight management approach. conditions: Weight Loss studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: OTHER masking: NONE count: 20 type: ESTIMATED name: CGM measure: Qualitative insights on consumer behavior sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: Biofortis, Inc. status: RECRUITING city: Addison state: Illinois zip: 60101 country: United States name: Grace Mooney, MS role: CONTACT phone: 630-617-2000 email: grace.mooney@mxns.com name: Gina Castiglione, RD role: CONTACT phone: 6306172000 email: gina.castiglione@mxns.com name: Aditi M Shah, MD role: PRINCIPAL_INVESTIGATOR lat: 41.9317 lon: -87.98896 hasResults: False
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<|newrecord|> nctId: NCT06269081 id: R01NR020770 type: NIH link: https://reporter.nih.gov/quickSearch/R01NR020770 id: R01NR020770 type: NIH link: https://reporter.nih.gov/quickSearch/R01NR020770 briefTitle: Testing Two Interventions to Improve Health Outcomes and Quality of Life Among Rural Older Adults Living With HIV overallStatus: RECRUITING date: 2024-04-08 date: 2027-01-31 date: 2027-01-31 date: 2024-02-21 date: 2024-04-03 name: Medical College of Wisconsin class: OTHER name: National Institute of Nursing Research (NINR) briefSummary: Engagement in HIV medical care and adherence to HIV medications are both essential in improving health outcomes among people living with HIV (PLH), but PLH living in rural areas-who suffer higher mortality rates than their urban counterparts-can confront multiple barriers to care engagement and adherence, especially as they face the logistical, medical, and social challenges associated with aging. This project will test the efficacy of two interventions to determine their impact on HIV health outcomes and quality of life among rural, older PLH living in the Southern U.S. The two interventions, adapted from evidence-based interventions and delivered remotely, are: (1) supportive-expressive peer social support groups and (2) strengths-based case management. We hypothesize that both interventions will increase viral suppression, antiretroviral therapy adherence, and health-related quality of life and decrease depressive symptoms. Results from this study will provide us with tools to improve health outcomes for rural older people living with HIV. conditions: HIV studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: FACTORIAL primaryPurpose: TREATMENT masking: NONE count: 352 type: ESTIMATED name: Supportive-Expressive Peer Social Support Group Intervention name: Individual Strengths-Based Case Management Intervention measure: Viral Suppression measure: Antiretroviral Treatment Medication Adherence measure: Health-Related Quality of Life measure: Depressive Symptoms measure: Social Support measure: Loneliness measure: Internalized HIV Stigma measure: General Self-Efficacy measure: HIV Treatment Adherence Self-Efficacy measure: Accessing Needed Social and Medical Services measure: Structural Barriers sex: ALL minimumAge: 50 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Center for AIDS Intervention Research, Medical College of Wisconsin status: RECRUITING city: Milwaukee state: Wisconsin zip: 53202 country: United States name: Jennifer Walsh role: CONTACT phone: 414-955-7710 email: jwalsh@mcw.edu lat: 43.0389 lon: -87.90647 hasResults: False
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<|newrecord|> nctId: NCT06269068 id: 12.01.2024.10 briefTitle: Investigation of the Relationship Between Central Sensitization and Neuropathic Pain in Lumbar Disc Herniation overallStatus: RECRUITING date: 2024-01-16 date: 2024-04-10 date: 2024-06-01 date: 2024-02-21 date: 2024-02-21 name: Marmara University class: OTHER briefSummary: Central sensitization (CS) is as increased response to normal or sub-threshold stimuli of central nervous system and its close relationship with in many musculoskeletal diseases with chronic pain has been demonstrated in several studies. CS is also one of the main mechanisms proposed in the generation of neuropathic pain, and the relationship between pain sensitization and neuropathic complaints has been shown in different diseases.In this study, it was aimed to investigate the effect of central sensitization on the distribution pattern and neuropathic character of pain in patients with lumbar disc herniation who applied to the physical medicine and rehabilitation outpatient clinic. conditions: Central Sensitisation studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: CROSS_SECTIONAL count: 180 type: ESTIMATED name: Central sensitization inventory name: Short form-36 name: Oswestry Low Back Pain Disability Questionnaire name: Douleur Neuropathique 4 name: Visual analogue scale measure: Central Sensitization Inventory (CSI) measure: DN4 measure: VAS pain measure: SF-36 measure: ODI sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Marmara University School of Medicine status: RECRUITING city: Istanbul state: Fevzi Çakmak Mah, Muhsin Yazıcıoğlu Cd, Pendik zip: 34899 country: Turkey name: Feyza Nur Yücel role: CONTACT phone: 5385577059 email: dr.fny28@gmail.com lat: 41.01384 lon: 28.94966 hasResults: False
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<|newrecord|> nctId: NCT06269055 id: 73151 briefTitle: Long-term Result of DTPA (Diethylenetriamine Pentaacetate) Chelation for Gadolinium Deposition Disease overallStatus: NOT_YET_RECRUITING date: 2024-05-15 date: 2025-09 date: 2025-12-31 date: 2024-02-21 date: 2024-04-18 name: Stanford University class: OTHER briefSummary: This study is aimed at describing the degree of benefit, if any, and the adverse effects, if any, from receiving 5 or more treatment sessions of Gadolinium Deposition Disease using two-day chelation treatment with the chelating agents Calcium Diethylenetriamine pentaacetate (Ca-DTPA) and Zinc Diethylenetriamine pentaacetate (Zn-DTPA). conditions: Gadolinium Deposition Disease conditions: Ca-DTPA studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: RETROSPECTIVE count: 50 type: ESTIMATED name: Interview measure: Rating of Gadolinium Deposition Disease Symptoms at start of GDD and currently measure: PROMIS Item Bank v2.0 - Cognitive Function- Short Form 8a measure: Sheehan Disability Scale sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Stanford University Medical Center city: Stanford state: California zip: 94305 country: United States name: Lorrin Koran, M.D. role: CONTACT phone: 650-799-1647 email: lkoran@stanford.edu lat: 37.42411 lon: -122.16608 hasResults: False
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<|newrecord|> nctId: NCT06269042 id: 0010 briefTitle: Influence of an Inspiratory Muscle Fatigue Protocol on Older Adults on Respiratory Muscle Strength and Heart Rate Variability overallStatus: NOT_YET_RECRUITING date: 2024-03-02 date: 2024-03-07 date: 2024-03-15 date: 2024-02-21 date: 2024-02-21 name: Sierra Varona SL class: OTHER name: Universidad Europea de Madrid briefSummary: Respiratory muscle training represents an effective method increasingly utilized in both sports and healthcare domains, employing various devices, among which threshold devices are prominent. The aim of this study is to determine the relationship between inspiratory muscle fatigue and maximal inspiratory pressure, diaphragmatic strength (guided by ultrasound image) and heart rate variability.
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According to our hypothesis, the execution of a protocol inducing inspiratory muscle fatigue in older adults could influence cardiorespiratory function.
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In this study, subjects will be divided into three groups: the experimental group , the activation group and the control group.
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Measurements of variables, such as maximal inspiratory pressure, heart rate variability and diaphragmatic strength (ultrasound image), will be conducted. conditions: Healthy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: the outcome assessor will not know in which group is each participant, and the investigator will receive the data without knowing which data is from which group whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 18 type: ESTIMATED name: Inspiratory muscle training measure: Respiratory muscle strength measure: Diaphragmatic thickness and thickening fraction measure: Diaphragm movement curve measure: Heart rate variability sex: ALL minimumAge: 60 Years maximumAge: 99 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06269029 id: P.T.Rec/012/004297 briefTitle: Chest Mobility Exercises Versus Proprioceptive Neuromuscular Facilitation in Patients With COPD overallStatus: RECRUITING date: 2024-02-17 date: 2024-05-30 date: 2024-06-30 date: 2024-02-21 date: 2024-04-18 name: Cairo University class: OTHER briefSummary: Chest mobility exercise versus proprioceptive neuromuscular facilitation in patients with chronic obstructive pulmonary disease conditions: Chronic Obstructive Pulmonary Disease Moderate studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 60 type: ESTIMATED name: Chest mobility exercises name: proprioceptive neuromuscular facilitation measure: Pulmonary function test sex: MALE minimumAge: 50 Years maximumAge: 60 Years stdAges: ADULT facility: Cairo university- faculty of physical therapy status: RECRUITING city: Cairo state: Dokki zip: 12556 country: Egypt name: Zahraa Serry, PHD role: CONTACT phone: 012854566880 phoneExt: 02 email: Isaaczakaria5@gmail.com lat: 30.06263 lon: 31.24967 hasResults: False
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<|newrecord|> nctId: NCT06269016 id: P.T.REC/012/003888 briefTitle: Effect of Hip Strengthening Exercises and Pelvic Floor Exercises on Stress Urinary Incontinence in Postnatal Women overallStatus: ACTIVE_NOT_RECRUITING date: 2023-02-20 date: 2023-08-25 date: 2024-04-20 date: 2024-02-21 date: 2024-02-21 name: Cairo University class: OTHER briefSummary: this study will investigate effect of hip strengthening exercises and pelvic floor exercises on stress urinary incontinence in postnatal women. Clinical practice guidelines recommend PFMT as the first-line treatment for female SUI . Also, it has been speculated that the hip muscles are involved in the continence mechanism and that their deficiency could destabilize the normal function of the system. The addition of hip muscle exercises, regardless of PFM contractions, aimed to improve muscular condition for the motor or synergic strategies in PFM contraction. Secondary effects of these techniques, such as the influence of passive lumbar rotational mobilization in improving hip flexor strength, have been of high interest in physiotherapy in general conditions: Stress Urinary Incontinence studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 120 type: ACTUAL name: expremental pre and post test measure: hip muscles strengthening exercise. sex: FEMALE minimumAge: 30 Years maximumAge: 35 Years stdAges: ADULT facility: Mai Mohamed Sherif Mohamed Hassan city: Cairo country: Egypt lat: 30.06263 lon: 31.24967 hasResults: False
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<|newrecord|> nctId: NCT06269003 id: STUDY00001223 id: 1K99CA281094-01A1 type: NIH link: https://reporter.nih.gov/quickSearch/1K99CA281094-01A1 briefTitle: Responses to Message Source and Presentation Using Psychophysiology overallStatus: ENROLLING_BY_INVITATION date: 2024-02-08 date: 2024-12-31 date: 2024-12-31 date: 2024-02-21 date: 2024-02-21 name: University of Massachusetts, Worcester class: OTHER name: National Cancer Institute (NCI) briefSummary: The goal of this clinical trial is to use psychophysiological methods to test the effects of a message source (expert and peer) and message presentation types (one-sided and two-sided) to identify the optimal message type for young adults who vape and do not vape. conditions: Vaping studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: FACTORIAL primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 112 type: ESTIMATED name: Expert name: Peer name: 1 Sided name: 2 Sided measure: Visual attention measure: Orienting response measure: Arousal measure: Attitudes measure: Behavioral intentions sex: ALL minimumAge: 18 Years maximumAge: 24 Years stdAges: ADULT facility: UMass Chan Medical School Shaw Building city: Worcester state: Massachusetts zip: 01605 country: United States lat: 42.26259 lon: -71.80229 typeAbbrev: SAP hasProtocol: False hasSap: True hasIcf: False label: Statistical Analysis Plan date: 2024-01-17 uploadDate: 2024-01-31T10:39 filename: SAP_000.pdf size: 176628 hasResults: False
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<|newrecord|> nctId: NCT06268990 id: FE 1159/6-1 briefTitle: FMT in Obesity: RYGB vs. LEAN vs. Autologous FMT acronym: DACH overallStatus: RECRUITING date: 2023-01-01 date: 2024-12-31 date: 2024-12-31 date: 2024-02-21 date: 2024-02-21 name: Wiebke Kristin Fenske class: OTHER name: Medical University of Graz briefSummary: This double-blinded proof-of-concept study is proposed to explore the effects of fecal microbiota transfer (FMT) in human subjects. Here we perform FMTs into obese recipients using stool from lean unoperated donors and from previously obese patients after successfull treatment with bariatric Roux-en-Y Gastric Bypass (RYGB) surgery. Obese patients treated with their own material (autologous FMT) serve as controls. After FMT treatment the functional impact of post-surgery microbiome changes on host energy consumption and regulation of blood glucose levels will be analysed. Additionally the variations on the microbiota and metabolite composition will be profiled using extensive sequencing analyses. The major aim of the study is to explore the scientific rationale for targeted gut microbiota modulation in management of obesity and related metabolic diseases.We estimate the transfer of microbiota from RYGB donors is superior to the transfer of lean microbiota at inducing reduced adiposity and improving high blood glucose levels in obese recipients. Each is better than a sham procedure (autologous FMT), which itself can also induce considerable short-term effects. conditions: Morbid Obesity conditions: Metabolic Syndrome conditions: Diabetes conditions: PreDiabetes conditions: Insulin Resistance studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 30 type: ESTIMATED name: Fecal microbiota transplantation measure: Insulin sensitivity measure: Insulin sensitivity measure: Glucose homeostasis measure: Body weight measure: Blood pressure measure: Fasting lipid profile measure: Fasting blood liver enzyme levels measure: Dietary intake levels measure: Metabolic inflammation measure: Gut hormones measure: Hunger and Satiety Scores measure: Fecal microbiota composition measure: Health-related quality of life measure: Tolerability of repeated FMT sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: Department of Internal Medicine, Medical University Graz status: RECRUITING city: Graz zip: 8010 country: Austria name: Julia K Mader, Assoc. Prof. role: CONTACT phone: +43 316 38582383 email: julia.mader@medunigraz.at name: Julia K Mader, Assoc. Prof. role: PRINCIPAL_INVESTIGATOR name: Patrizia Kump, PD Dr role: SUB_INVESTIGATOR lat: 47.06667 lon: 15.45 typeAbbrev: Prot_SAP hasProtocol: True hasSap: True hasIcf: False label: Study Protocol and Statistical Analysis Plan date: 2021-05-14 uploadDate: 2024-01-29T10:24 filename: Prot_SAP_000.pdf size: 651727 typeAbbrev: ICF hasProtocol: False hasSap: False hasIcf: True label: Informed Consent Form date: 2023-09-15 uploadDate: 2024-02-16T08:19 filename: ICF_001.pdf size: 276426 hasResults: False
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<|newrecord|> nctId: NCT06268977 id: SGLt2i in diabetic type 2 briefTitle: Using of SGLt2 Inhibitors in Patients With Type 2 DM overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2025-03-01 date: 2025-03-30 date: 2024-02-21 date: 2024-02-21 name: Assiut University class: OTHER briefSummary: To detect the efficacy of SGLT2i in improving the metabolic parameters in patients with type 2 diabetes.
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- To detect the side-effects of SGLT2i conditions: Type 2 Diabetes studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: PROSPECTIVE count: 400 type: ESTIMATED name: SGLT2 inhibitor measure: Effect of adding SGLTi on BP measure: Effect of adding SGLTi on BMI sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06268964 id: 2023-5 briefTitle: Exploring Treatments for Children's Abdominal Pain: Comparing Trimebutine and Probiotics acronym: FAPD_RCT overallStatus: RECRUITING date: 2024-03-01 date: 2024-12-31 date: 2025-06-30 date: 2024-02-21 date: 2024-02-21 name: Universidad de Colima class: OTHER briefSummary: The goal of this clinical trial is to test the effectiveness of trimebutine and probiotics in treating Functional Abdominal Pain Disorders (FAPD) in a pediatric population. The main questions it aims to answer are: Is trimebutine effective in reducing the symptoms of FAPD in children? Are probiotics effective in reducing the symptoms of FAPD in children? Participants will be randomly assigned to one of three treatment groups (trimebutine/probiotics, probiotics/placebo, or trimebutine/placebo). Undergo measurements for pain and other relevant metrics at the start of the study, after 4 weeks, and after 8 weeks.
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