Record
stringlengths 1
197k
|
|---|
3. Consolidation treatment: consists of six 28-day cycles of subcutaneous Epcoritamab, commencing 6 - 12 weeks post ASCT. conditions: DLBCL - Diffuse Large B Cell Lymphoma conditions: High-grade B-cell Lymphoma conditions: High Grade B-Cell Lymphoma With MYC and BCL2 or BCL6 Rearrangements conditions: DLBCL, Nos Genetic Subtypes conditions: High Grade B-Cell Lymphoma, Not Otherwise Specified conditions: Follicular Large Cell Lymphoma, Relapsed conditions: Follicular Large Cell Lymphoma studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 39 type: ESTIMATED name: Epcoritamab measure: Event-free survival (EFS) measure: Evaluate safety and tolerability of combination Epcoritamab with salvage-ASCT measure: Overall response rate (ORR) measure: Complete response rate (CRR) measure: Overall Survival (OS) measure: Progression free survival (PFS) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
|
<|newrecord|> nctId: NCT06287385 id: NELN202212A briefTitle: An Exploratory RWE Study Exploring Effects of a Goat Milk Based Young Child Formula on Health Benefits overallStatus: NOT_YET_RECRUITING date: 2024-05-15 date: 2025-05-15 date: 2025-12-15 date: 2024-03-01 date: 2024-03-01 name: Danone Nutricia class: INDUSTRY briefSummary: This is an exploratory real-world study designed to gain insight into the role of the product in terms of health benefits in toddlers, with the potential to generate hypotheses on key and other exploratory objectives. conditions: Healthy Children studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: OTHER masking: NONE count: 120 type: ESTIMATED name: Goat-milk Based Formula measure: Stool characteristics measure: Gastrointestinal symptoms measure: Quality of life of subjects measure: Lifestyle-related immune indicators measure: Safety parameters sex: ALL minimumAge: 1 Year maximumAge: 2 Years stdAges: CHILD facility: Peking University Third Hospital city: Beijing state: Beijing country: China lat: 39.9075 lon: 116.39723 hasResults: False
|
<|newrecord|> nctId: NCT06287372 id: 3261 briefTitle: Comparison of Changes in Intra-myocardial Amino Acids During Use of Calafiore and Modified Del Nido Cardioplegia overallStatus: COMPLETED date: 2022-07-04 date: 2023-07-04 date: 2023-07-04 date: 2024-03-01 date: 2024-03-07 name: Damascus University class: OTHER briefSummary: The aim of the present study was to investigate intra-operative changes in markers of myocardial injury and myocardial intracellular amino acids during ischemia and reperfusion, comparing two methods of myocardial protection; Calafiore intermittent antegrade warm blood cardioplegia or modified del Nido intermittent antegrade cold blood cardioplegia in routine coronary artery bypass grafting procedures. conditions: Myocardial Injury conditions: Cardiac Surgery conditions: Myocardial Protection studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 20 type: ACTUAL name: Cardioplegic solution measure: Changes in markers of myocardial injury measure: Changes in myocardial amino acid concentrations sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Damascus University Cardiac Surgery Hospital city: Damascus country: Syrian Arab Republic lat: 33.5102 lon: 36.29128 hasResults: False
|
<|newrecord|> nctId: NCT06287359 id: Local/2024/MP-01 briefTitle: Experience of Parents/Carers of Children With Severe Motor Disabilities Suffering From Spinal Pain? acronym: Vé-Quo-Pa-H-R overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2024-12 date: 2024-12 date: 2024-03-01 date: 2024-04-05 name: Centre Hospitalier Universitaire de Nīmes class: OTHER briefSummary: Parents of disabled children suffer from back pain more frequently than the general population. At present, the literature does not identify any specific factors responsible for this suffering.
|
For patients suffering from chronic back pain, there are specific treatment programmes in the Physical Medicine and Rehabilitation Department, with a focus on pain management.
|
The investigators would like to develop specific programmes for parents/carers of children/adolescents with severe motor disabilities.
|
To achieve this, it is important to gain a better understanding of the factors that contribute to the onset of pain.
|
With this in mind, the investigators are conducting a qualitative study to gain a better understanding of the day-to-day lives of these parents. conditions: Low Back Pain studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 15 type: ESTIMATED name: individual interviews measure: Individual interviews sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
|
<|newrecord|> nctId: NCT06287346 id: 240101 briefTitle: 5-Years PMCF Study of Ceramic Dental Implants One-piece Versus Two-piece. acronym: 240101 overallStatus: RECRUITING date: 2024-01-01 date: 2029-01-01 date: 2030-01-01 date: 2024-03-01 date: 2024-03-01 name: CeraRoot SL class: INDUSTRY briefSummary: The goal of this cohort observational study is to compare in the survival rate of ceramic dental implants placed in patients with missing or hopeless teeth . The main question\[s\] it aims to answer are:
|
* Are there any significant differences in survival rate between the use of one-piece ceramic implant versus the two-piece (TL) variant?
|
* What are the complications associated to the procedure and differences between the two groups. conditions: Edentulism conditions: Tooth Loss studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 652 type: ESTIMATED name: dental implant measure: Survival rate measure: Complications sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Family Holistic Dentistry status: RECRUITING city: Boulder state: Colorado zip: 80303 country: United States name: CARMEN BURKE, DDS role: CONTACT phone: 303-219-0499 email: carmen@carmenburke.com name: CARMEN BURKE, DDS role: PRINCIPAL_INVESTIGATOR lat: 40.01499 lon: -105.27055 facility: CeraRoot CLINIC status: RECRUITING city: Les Franqueses del Vallès state: Barcelona zip: 08520 country: Spain name: JOSEP OLIVA-OCHOA, DDS MSC role: CONTACT phone: 800-485-1613 email: josep.oliva@cerarootclinic.com name: Ekaterina Treatment coordinator role: CONTACT phone: +34 935 950 247 email: ekaterina@ceraroot.com name: JOSEP OLIVA-OCHOA, DDS MSC role: PRINCIPAL_INVESTIGATOR name: XAVIER OLIVA-OCHOA, DDS MSC role: SUB_INVESTIGATOR name: CARLA OLIVA-PORTA, STUDENT role: SUB_INVESTIGATOR name: ARNAU OLIVA-PORTA, STUDENT role: SUB_INVESTIGATOR lat: 41.61929 lon: 2.29829 hasResults: False
|
<|newrecord|> nctId: NCT06287333 id: 2023PI221 briefTitle: Video-respiratory Polygraphy in Children overallStatus: NOT_YET_RECRUITING date: 2024-02-22 date: 2024-02-22 date: 2024-02-28 date: 2024-03-01 date: 2024-03-01 name: Central Hospital, Nancy, France class: OTHER briefSummary: The diagnosis of obstructive sleep apnea-hypopnea syndrome in children (OSAS) requires a polysomnography (PSG) in a sleep lab with video surveillance and monitoring by a nurse. But PSG is a cumbersome exam, sometimes difficult to perform in children. Simplified exams as respiratory polygraphy (RP) which uses only respiratory signals can be used for the diagnosis of OSAS but studies show that it underestimates the obstructive apnea-hypopnea index (OAHI) because the total sleep time cannot be accurately estimated. The use of a video camera with software synchronous with the RP software could compensate for this disadvantage, by estimating when the child is sleeping or not. conditions: Sleep Apnea, Obstructive studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 66 type: ESTIMATED name: Polysomnography in routine care measure: OAHI in video-RP significantly correlated with OAHI in PSG measure: Diagnostic ability of video-RP to identify OSAS in children measure: Diagnostic ability of video-RP to identify moderate-severe OSAS in children sex: ALL minimumAge: 2 Years maximumAge: 19 Years stdAges: CHILD stdAges: ADULT hasResults: False
|
<|newrecord|> nctId: NCT06287320 id: Bioplc briefTitle: The Predictive Biomarkers in Patients With Locally Advanced Non-small Cell Lung Cancer overallStatus: RECRUITING date: 2024-03-01 date: 2025-12-31 date: 2026-02-28 date: 2024-03-01 date: 2024-03-01 name: Cancer Institute and Hospital, Chinese Academy of Medical Sciences class: OTHER briefSummary: This study is a prospective cohort study to evaluate the peripheral blood lymphocyte subsets as predicative biomarkers reflecting the efficacy and toxicity in patients with locally advanced non-small cell lung cancer (NSCLC) received chemoradiotherapy (CRT) with or without immune checkpoint inhibitors (ICIs). conditions: Locally Advanced Non-small Cell Lung Cancer studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 200 type: ESTIMATED name: concurrent or sequential chemoradiotherapy name: Immunotherapy measure: Adverse Event measure: Progression-free survival (PFS) measure: Overall survival (OS) measure: Objective Response Rate (ORR) measure: Disease control rate (DCR) sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Chinese Academy of Medical Science and Peking Union Medical College status: RECRUITING city: Beijing state: Beijing zip: 100021 country: China name: Nan Bi, MD, PhD role: CONTACT email: binan_email@163.com lat: 39.9075 lon: 116.39723 hasResults: False
|
<|newrecord|> nctId: NCT06287307 id: NOK000024 briefTitle: Semaglutide 2.4mg for Low Responders After Bariatric Surgery acronym: SEABAR overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2026-02 date: 2026-09 date: 2024-03-01 date: 2024-03-01 name: Zuyderland Medisch Centrum class: OTHER name: Nederlandse Obestias Kliniek (NOK) briefSummary: In 20 - 30% of the patients, the low responders, sufficient weight loss is not achieved after bariatric surgery. Secondary and/or tertiary bariatric procedures can lead to successful weight loss and resolution of comorbid conditions though, morbidity and mortality rates of these procedures are high. Therefore, additional pharmacotherapy has been suggested. Semaglutide is one of the medications that might improve outcome in the post-bariatric population. Semaglutide is a Glucagon-like peptide-1 (GLP-1) receptor analogue developed to treat type 2 diabetes. It causes glucose-dependent insulin secretion, promotes satiety and inhibits glucagon secretion. In obese (non-bariatric) patients, semaglutide has shown to improve glycemic control, decrease blood pressure, lower cardiovascular risk, and decrease body weight. conditions: Obesity conditions: Obesity, Morbid conditions: Weight Gain studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER count: 152 type: ESTIMATED name: Placebo name: Semaglutide 2.4 MG/0.75 ML Subcutaneous Solution [WEGOVY] measure: Weight change from start study at 3 months post operative until 15 months later measure: Difference between placebo group and treatment group in weight change measure: Weight loss 3 months after surgery measure: Weight loss 6 months after surgery measure: Weight loss 12 months after surgery measure: Weight loss 18 months after surgery measure: Metabolic health before surgery (bloodpressure) measure: Metabolic health before surgery (HbA1c) measure: Metabolic health before surgery (glucose) measure: Metabolic health before surgery (triglyceride) measure: Metabolic health before surgery (LDL) measure: Metabolic health before surgery (HDL) measure: Metabolic health before surgery (total cholesterol) measure: Metabolic health 3 months after surgery (Bloodpressure) measure: Metabolic health 3 months after surgery (HbA1c) measure: Metabolic health 3 months after surgery (glucose) measure: Metabolic health 3 months after surgery (triglyceride) measure: Metabolic health 3 months after surgery (LDL) measure: Metabolic health 3 months after surgery (HDL) measure: Metabolic health 3 months after surgery (total cholesterol) measure: Metabolic health at 6 months after surgery (bloodpressure) measure: Metabolic health at 6 months after surgery (HbA1c) measure: Metabolic health at 6 months after surgery (glucose) measure: Metabolic health at 6 months after surgery (triglyceride) measure: Metabolic health at 6 months after surgery (LDL) measure: Metabolic health at 6 months after surgery (HDL) measure: Metabolic health at 6 months after surgery (total cholesterol) measure: Metabolic health at 12 months after surgery (bloodpressure) measure: Metabolic health at 12 months after surgery (HbA1c) measure: Metabolic health at 12 months after surgery (glucose) measure: Metabolic health at 12 months after surgery (triglyceride) measure: Metabolic health at 12 months after surgery (LDL) measure: Metabolic health at 12 months after surgery (HDL) measure: Metabolic health at 12 months after surgery (total cholesterol) measure: Metabolic health at 18 months after surgery (bloodpressure) measure: Metabolic health at 18 months after surgery (HbA1c) measure: Metabolic health at 18 months after surgery (glucose) measure: Metabolic health at 18 months after surgery (triglyceride) measure: Metabolic health at 18 months after surgery (LDL) measure: Metabolic health at 18 months after surgery (HDL) measure: Metabolic health at 18 months after surgery (total cholesterol) measure: Health-related quality of life also related to gastro intestinal symptoms before surgery measure: Health-related quality of life also related to gastro intestinal symptoms 3 months after surgery measure: Health-related quality of life also related to gastro intestinal symptoms 6 months after surgery measure: Health-related quality of life also related to gastro intestinal symptoms measure: Health-related quality of life also related to gastro intestinal symptoms measure: Cardiorespiratory fitness level before surgery measure: Cardiorespiratory fitness level 3 months after surgery measure: Cardiorespiratory fitness level 6 months after surgery measure: Cardiorespiratory fitness level 12 months after surgery measure: Cardiorespiratory fitness level 18 months after surgery measure: Change in liver fat and liver stiffness at start of treatment measure: Change in liver fat and liver stiffness 15 months after semaglutide start measure: To describe the persistence of therapy measure: To describe the average weekly dose sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
|
<|newrecord|> nctId: NCT06287294 id: RS23-042 briefTitle: An Investigation Into Taste Problems Associated With Xerostomia in Patients With Advanced Cancer overallStatus: RECRUITING date: 2023-08-30 date: 2024-12-31 date: 2024-12-31 date: 2024-03-01 date: 2024-03-01 name: Our Lady's Hospice and Care Services class: OTHER briefSummary: Taste problems and xerostomia (dry mouth) are common among patients with advanced cancer. These symptoms can affect the pleasure of eating and drinking, reduce dietary intake, cause low mood, and a lower quality of life. This study will explore the relationship between dry mouth and taste problems in patients with advanced cancer. conditions: Taste, Altered conditions: Xerostomia conditions: Neoplasms studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 120 type: ESTIMATED measure: To measure the prevalence of taste problems in patients with advanced cancer with a dry mouth using the Oral Symptom Assessment Scale (questionnaire) measure: To identify an association of any other oral symptoms present in patients with taste problems and dry mouth who have advanced cancer using the Oral Symptom Assessment Scale (questionnaire) measure: To characterise the taste disturbances i.e. to identify reduced taste, heightened taste, altered taste or no taste using the Taste Questionnaire in Palliative Care (questionnaire) and Waterless Empirical Taste Test (objective taste test) measure: To identify what impact taste problems are having on patients dietary intake using the Taste Questionnaire in Palliative Care (questionnaire). measure: To identify what impact taste problems are having on patients quality of life using the Taste Questionnaire in Palliative Care (questionnaire). sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Our Lady's Hospice and Care Services status: RECRUITING city: Dublin zip: D6WRY72 country: Ireland name: Andrew Davies, FRCP role: CONTACT phone: 0035314986235 email: andavies@tcd.ie name: Marie Hannon, BSc role: CONTACT phone: 0035314912558 email: marie.hannon@ucdconnect.ie lat: 53.33306 lon: -6.24889 hasResults: False
|
<|newrecord|> nctId: NCT06287281 id: Heel01 briefTitle: High-heeled Shoes in a Sample of Young Women overallStatus: RECRUITING date: 2023-12-15 date: 2024-02-15 date: 2024-02-28 date: 2024-03-01 date: 2024-03-01 name: Manusapiens class: OTHER briefSummary: At a postural level, many doctors, physiotherapists and chiropractors are convinced that lower back pain induced by heels is due to an increase in lumbar lordosis associated with an anterior pelvic tilt; this thought is even shared by the American Chiropractic Association and the American Physical Therapy Association.
|
Furthermore, in most of the websites consulted, even by non-experts, the reason for the onset of spinal pain is attributed to hyperlordosis and pelvic anteversion. However, this thought is not entirely in agreement with other scientific publications. Therefore it is necessary to pay attention to online searches which often answer these questions without taking EBM into account.
|
None of the studies reported above take into consideration the time factor. In fact, all the studies have evaluated the immediate changes brought about by heel raising. Women who complain of lower back pain when wearing high-heeled shoes rarely experience pain as soon as they start wearing them.
|
The objective of the research arises from these considerations. The aim of this study (primary outcome) is to investigate whether wearing high-heeled shoes for at least 2 hours modifies the spinopelvic parameters compared to the barefoot condition and as soon as the shoes are worn.
|
The secondary outcome will be to verify in the sample analyzed whether there are different behaviors between the subgroups of those who have complained in their anamnesis and those who have never complained of lower back pain when using high-heeled shoes for a few hours. conditions: Low Back Pain conditions: Healthy studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: CROSS_SECTIONAL count: 34 type: ESTIMATED name: heel hight shoes measure: effect of high-heeled shoes on trunk inclination measure: effect of high-heeled shoes on pelvic inclination measure: effect of high-heeled shoes on lordotic angle measure: effect of high-heeled shoes on kyphotic angle measure: effect of high-heeled shoes on lumbar arrow measure: effect of high-heeled shoes on cervical arrow measure: different response on trunk inclination between the subgroups (suffering from back pain and asymptomatic) measure: different response on pelvic inclination between the subgroups (suffering from back pain and asymptomatic) measure: different response on lordotic angle between the subgroups (suffering from back pain and asymptomatic) measure: different response on kyphotic angle between the subgroups (suffering from back pain and asymptomatic) measure: different response on lumbar arrow between the subgroups (suffering from back pain and asymptomatic) measure: different response on cervical arrow between the subgroups (suffering from back pain and asymptomatic) sex: FEMALE minimumAge: 20 Years maximumAge: 40 Years stdAges: ADULT facility: Spine Center status: RECRUITING city: Bologna zip: 40128 country: Italy name: Saverio Colonna, MD role: CONTACT phone: +39 051 095 2375 email: direzione@spine-center.it lat: 44.49381 lon: 11.33875 typeAbbrev: Prot_SAP hasProtocol: True hasSap: True hasIcf: False label: Study Protocol and Statistical Analysis Plan date: 2024-02-10 uploadDate: 2024-02-10T21:29 filename: Prot_SAP_000.pdf size: 222277 hasResults: False
|
<|newrecord|> nctId: NCT06287268 id: CETB115G1401 briefTitle: Revolade Tablets Specified Drug-use Survey overallStatus: NOT_YET_RECRUITING date: 2024-04-30 date: 2028-10-31 date: 2028-10-31 date: 2024-03-01 date: 2024-03-01 name: Novartis Pharmaceuticals class: INDUSTRY briefSummary: This is a multicenter, single-arm, non-interventional study (NIS) to confirm the safety and efficacy of eltrombopag in Anti-Thymocyte Globulin (ATG) treatment naive pediatric patients with aplastic anemia (AA). conditions: Aplastic Anemia studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: OTHER count: 10 type: ESTIMATED name: eltrombopag measure: Occurrence of serious adverse events measure: Occurrence of adverse events and adverse drug reactions leading to treatment discontinuation measure: Occurrence of adverse events and adverse drug reactions applicable to safety specifications (hepatic dysfunction and hematopoietic malignancies) measure: Occurrence of clonal evolution measure: Hematologic response status measure: Change over time from baseline in platelet count measure: Change over time from baseline in hemoglobin measure: Change over time from baseline in neutrophil count measure: Change over time from baseline in reticulocyte count measure: Change over time from baseline in transfusion dependence measure: Change over time from baseline in transfusion volume sex: ALL minimumAge: 6 Years maximumAge: 17 Years stdAges: CHILD hasResults: False
|
<|newrecord|> nctId: NCT06287255 id: 2023H0314 briefTitle: Feasibility and Acceptability of Incorporating Smartwatches Into an Exercise is Medicine Program in Older Individuals acronym: EIM+ overallStatus: NOT_YET_RECRUITING date: 2024-03-15 date: 2025-09-30 date: 2025-09-30 date: 2024-03-01 date: 2024-03-01 name: Ohio State University class: OTHER briefSummary: The effects of exercise on prevention and improved control of chronic diseases, reduced mortality, and improved quality of life are well established. Exercise has been shown to prevent heart disease, stroke, type 2 diabetes, depression, and certain types of cancers. In addition to prevention, physical activity is included in the standard or care for many chronic diseases and used in treatment. For example, the American Diabetes Association has identified positive health behaviors like physical activity as foundational in the treatment and management of disease and improving overall quality of life.
|
The Ohio State University Wexner Medical Center Exercise is Medicine Program (EIM) is a physician referral program that aims to increase physical activity to prevent and reduce complications from chronic disease.
|
The integration of technology among a 65+ population of EIM participants provides a novel approach to improving individual's health. Thus, our study aims to provide EIM participants aged 65+ with smartwatches in the hopes of increasing their overall physical activity levels. conditions: Physical Inactivity conditions: Obesity studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: A single-arm trial primaryPurpose: PREVENTION masking: NONE count: 150 type: ESTIMATED name: EIM+ measure: Feasibility of EIM+ measure: Acceptability of EIM+ measure: Change in physical activity measure: Change in weight measure: Change in BMI measure: Change in hip circumference measure: Change in waist circumference measure: Change in blood pressure measure: Change in heart rate variability measure: Change in hemoglobin A1c measure: Change in perceived stress measure: Change in depressive symptoms measure: Change in diet measure: Change in activity minutes per week measure: Change in daily steps total measure: Change in measured steps per minute measure: Change in sleep quality measure: Change in sleep duration measure: Change in estimated energy expenditure measure: Change in heart rate measure: Change in distance moved measure: Change in minutes of vigorous activity measure: Change in minutes of moderate activity measure: Change in minutes of light activity measure: Change in minutes of sedentary time measure: Change in number of manually entered and automatically detected physical activities (walking, running, etc.) measure: Change in quality of life measures sex: ALL minimumAge: 65 Years stdAges: OLDER_ADULT facility: The Ohio State University city: Columbus state: Ohio zip: 43202 country: United States name: Toluwa C Nafiu, B.S. role: CONTACT phone: 614-293-2404 email: toluwaniose.nafiu@osumc.edu name: Joshua Joseph, MD role: PRINCIPAL_INVESTIGATOR lat: 39.96118 lon: -82.99879 hasResults: False
|
<|newrecord|> nctId: NCT06287242 id: 24-01-282 briefTitle: Validation of the Cervicothoracic Differentiation Test acronym: EMU overallStatus: RECRUITING date: 2024-02-20 date: 2025-02 date: 2025-02 date: 2024-03-01 date: 2024-03-01 name: University of Hartford class: OTHER briefSummary: The goal of this clinical trial is to compare the effects of two spinal manipulations in adults between the ages of 18-65 based on the results of a non-invasive clinical test. The main question it aims to answer is: • Does matched or unmatched region of manipulation based on the CTDT result in greater reduction of pain levels and improvement in range of motion in adults with neck pain compared to unmatched manipulations? Participants will be asked to:
|
* rate their pain with neck movement, complete brief questionnaires about their pain,
|
* have their neck range of motion measured,
|
* perform a test known as the cervico-thoracic differentiation test (CTDT),
|
* receive either a cervical or thoracic manipulation,
|
* repeat the range of motion measurements.
|
* A second session will occur 7-10 days later where questionnaires and range of motion measures will be repeated.
|
Researchers will compare the effects of manipulation matched to CTDT test result to individuals in the unmatched CTDT manipulation group to see if the CTDT may indicate which region will provide a greater treatment effect for individuals with neck pain. conditions: Neck Pain studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE maskingDescription: Blinded research assistants will perform all baseline and follow-up measures. Investigator providing manipulation is blinded to group allocation (matched/unmatched) Participants will not be told if the CTDT indicates that they would benefit from cervical or thoracic manipulation, and the investigator performing the CTDT will only indicate which region is to be manipulated. All investigators are blinded to the work of the others and submit their results to an additional research assistant who will enter the data in a spreadsheet not accessible to the remainder of the research team until the conclusion of the study. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 40 type: ESTIMATED name: spinal manipulation measure: pain with motion measure: pain at rest measure: range of motion measure: neck disability index sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Hartford status: RECRUITING city: West Hartford state: Connecticut zip: 06117 country: United States name: Brian Swanson, PT, DSc role: CONTACT phone: 860-768-5314 email: bswanson@hartford.edu lat: 41.76204 lon: -72.74204 hasResults: False
|
<|newrecord|> nctId: NCT06287229 id: 2023-0627 id: NCI-2024-01756 type: OTHER domain: NCI-CTRP Clinical Registry briefTitle: Phase Ib/II Study Assessing the Clinical Activity and Safety of Brexucabtagene Autoleucel as a Consolidation in Patients With Relapsed/Refractory (R/R) and Newly Diagnosed B-cell Acute Lymphocytic Leukemia (ALL) Post Cytoreduction With Mini-HCVD-inotuzumab-blinatumomab/HCVAD-inotuzumab-blinatumomab overallStatus: NOT_YET_RECRUITING date: 2024-08-31 date: 2028-12-31 date: 2030-12-31 date: 2024-03-01 date: 2024-04-12 name: M.D. Anderson Cancer Center class: OTHER briefSummary: To learn about the safety of giving the drug brexucabtagene autoleucel to participants with relapsed/refractory B-cell ALL after treatment with inotuzumab ozogamicin, blinatumomab, and either hyper-CVAD or mini-hyper-CVD. Also, to learn if giving brexucabtagene autoleucel to patients with relapsed/refractory or high-risk, newly diagnosed B-cell ALL after treatment with inotuzumab ozogamicin, blinatumomab, and either hyper-CVAD or mini-hyper-CVD can help to control the disease. conditions: Relapsed/Refractory conditions: B-cell Acute Lymphocytic Leukemia studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 40 type: ESTIMATED name: Blinatumomab name: Inotuzumab Ozogamicin name: Hyper-CVAD name: Mini-hyper-CVD measure: Safety and adverse events (AEs) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: MD Anderson Cancer Center city: Houston state: Texas zip: 77030 country: United States name: Elias Jabbour, MD role: CONTACT phone: 713-792-4764 email: ejabbour@mdanderson.org name: Elias Jabbour, MD role: PRINCIPAL_INVESTIGATOR lat: 29.76328 lon: -95.36327 hasResults: False
|
<|newrecord|> nctId: NCT06287216 id: 2024001 briefTitle: Preliminary Evaluation of a Mental Health Program: a Comparison Study overallStatus: NOT_YET_RECRUITING date: 2024-02-29 date: 2024-04-30 date: 2024-04-30 date: 2024-03-01 date: 2024-03-01 name: The Royal Ottawa Mental Health Centre class: OTHER briefSummary: The mental hygiene challenge is a Royal Ottawa Health Care Group led initiative to engage the staff, clients and community members to attend to their mental well-being by way of practicing mental hygiene activities for 10 min on a daily basis, throughout the month of March. Participants are encouraged to choose one or many of the practices recommended and do them for about 10 minutes a day. Participants are encouraged to make it their own, in that they can combine the practice or tailor them in a way that suits them best. When signing up for the challenge, participants receive free access to a toolkit with brief outlines and instructional videos on various mental hygiene practices.
|
We also encourage participants to divide the 10 minutes in whatever way best works for them, such as 10 minutes all at once, 5 minutes twice, or even 2 minutes five times. This study aims to expand on the work that was done in 2022 and 2023, when the World Health Organization - 5 Wellbeing Index (WHO-5) and the Warwick Edinburgh Mental Wellbeing Scale (WEMWBS) were collected from participants to ascertain the impact of mental hygiene, by way of including a control group. conditions: Mental Wellbeing studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: SINGLE_GROUP primaryPurpose: PREVENTION masking: SINGLE whoMasked: PARTICIPANT count: 200 type: ESTIMATED name: Mental Hygiene name: Self-Care measure: Change in level of mental wellbeing as measured by the WHO-5 index. measure: Change in level of mental wellbeing as measured by the WEMWBS. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
|
<|newrecord|> nctId: NCT06287203 id: Pro2023001498 id: 3R01DA050721-04S1 type: NIH link: https://reporter.nih.gov/quickSearch/3R01DA050721-04S1 briefTitle: Novel Prevention Intervention Program to Reduce Risky Patterns of Substance Use Among Emerging Adults acronym: ARFP overallStatus: NOT_YET_RECRUITING date: 2024-03-20 date: 2024-11-20 date: 2024-11-20 date: 2024-03-01 date: 2024-03-01 name: Rutgers, The State University of New Jersey class: OTHER name: National Institute on Drug Abuse (NIDA) briefSummary: The purpose of this research study is to test whether completion of a new personalized feedback program is associated with reductions in risky substance use among emerging adults (18-25 years of age). conditions: Substance Use studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: NONE maskingDescription: Participants will not be made aware of their condition at baseline; however, they will know their condition once they receives their estimates (or not, in the case of the control condition) and are taken to their follow-up resources. count: 450 type: ESTIMATED name: Addiction Risk Feedback Program measure: Alcohol Consumption measure: Alcohol Problems measure: Drug Use Problems measure: Readiness to change measure: Future substance use intentions measure: Worry About Substance Use Disorders measure: Perceived Susceptibility measure: Well-Being measure: Anxiety and Depressive Symptoms measure: Addiction Risk Program Satisfaction measure: Feelings About Results measure: Satisfaction with the Assigned Conditions sex: ALL minimumAge: 18 Years maximumAge: 25 Years stdAges: ADULT facility: Rutgers Robert Wood Johnson Medical School city: Piscataway state: New Jersey zip: 08854 country: United States name: Emily Balcke role: CONTACT email: dnadiscoverystudy@rutgers.edu name: Danielle Dick, PhD role: PRINCIPAL_INVESTIGATOR lat: 40.49927 lon: -74.39904 hasResults: False
|
<|newrecord|> nctId: NCT06287190 id: Self-confidence assessment briefTitle: Assessment of Self-Confidence of Dental Interns Regarding Provision of Different Pediatric Dentistry Procedures overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2024-09-30 date: 2024-11-30 date: 2024-03-01 date: 2024-03-05 name: Cairo University class: OTHER briefSummary: This study mainly about dental interns testing their knowledge before and after entering the pediatric rotation conditions: Self Confidence studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: PROSPECTIVE count: 383 type: ESTIMATED name: Dental interns measure: Self-confidence regarding treatment measure: difficulties in dental practice through this period sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Cairo University city: Cairo country: Egypt name: Sherine E Eldin, Prof role: CONTACT phone: +20 1009073142 lat: 30.06263 lon: 31.24967 hasResults: False
|
<|newrecord|> nctId: NCT06287177 id: Protocol 28/2023 briefTitle: Multicenter Study on the Evaluation of Adherence, Persistence and Efficacy of Treatment With Inclisiran in Italy acronym: CHOLINET overallStatus: RECRUITING date: 2022-11-01 date: 2024-02-29 date: 2024-11-01 date: 2024-02-29 date: 2024-03-19 name: Federico II University class: OTHER briefSummary: Evaluation of adherence, persistence and efficacy of treatment with Inclisiran in a real-life Italian population conditions: Hypercholesterolemia studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 1000 type: ESTIMATED name: Inclisiran measure: Description of adherence to treatment with Inclisiran in a real-life Italian population measure: Description of persistence to treatment with Inclisiran in a real-life Italian population measure: Description of efficacy of treatment with Inclisiran in a real-life Italian population sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Federico II University of Naples, Department of Advanced Biomedical Sciences status: RECRUITING city: Napoli zip: 80131 country: Italy name: Pasquale Perrone Filardi, MD role: CONTACT phone: 0817462224 email: fpperron@unina.it lat: 40.85216 lon: 14.26811 hasResults: False
|
<|newrecord|> nctId: NCT06287164 id: 101 briefTitle: Management of Heart Failure in Italian Outpatients Clinics: Observational Study acronym: OPTIMA-HF overallStatus: RECRUITING date: 2023-03-01 date: 2024-02-01 date: 2025-02-01 date: 2024-02-29 date: 2024-02-29 name: Federico II University class: OTHER briefSummary: OPTIMA-HF is an observational, cross-sectional, multicenter, real-life study conducted in two different clinical settings: HF outpatients' clinics of Italian University Hospitals and territorial Cardiology outpatients' services.
|
Aim of the Optimization of Therapy in the Italian Management of Heart Failure \[OpTIMa-HF\] Registry is to collect data on HF patients followed in different Italian outpatients' settings to describe the current Italian population of HF patients, in terms of demographic characteristics and disease features, with a specific focus on guideline-directed medical therapy (GDMT) prescription, assessing its improvement after educational activities. In the present analysis we report the baseline data on the general enrolled population with a specific focus on HFrEF treatment adherence and prescription rates, according to the most recent European Guidelines. conditions: Heart Failure studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 4000 type: ESTIMATED name: Data collection measure: HF treatment adherence according to the most recent European Guidelines sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Federico II University of Naples, Department of Advanced Biomedical Sciences status: RECRUITING city: Napoli zip: 80131 country: Italy name: Pasquale Perrone Filardi, MD role: CONTACT phone: 0817462224 email: fpperron@unina.it lat: 40.85216 lon: 14.26811 hasResults: False
|
<|newrecord|> nctId: NCT06287151 id: STUDY00002844 briefTitle: Regional Anesthesia EMG Study overallStatus: RECRUITING date: 2023-08-09 date: 2024-12 date: 2024-12 date: 2024-02-29 date: 2024-02-29 name: Nationwide Children's Hospital class: OTHER briefSummary: This study aims to investigate how non-invasive, non-significant risk EMG monitoring can be used intraoperatively to objectively characterize neuraxial anesthesia (i.e. spinal and caudal blockade) in pediatric patients undergoing surgery. The investigators will also attempt to measure the effect of adjunctive intrathecal clonidine on spinal and caudal blockade using EMG. This study also aims to quantify the impact of sevoflurane on basal muscle tone based on EMG changes. This study aims to generate pilot data on this subject to help design future studies. conditions: Surgery studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Choice of group will be made by attending anesthesiologist based on clinical judgement. primaryPurpose: OTHER masking: SINGLE maskingDescription: Only the individuals performing data analysis will be blinded to type of anesthetic technique performed. whoMasked: OUTCOMES_ASSESSOR count: 124 type: ESTIMATED name: BlockSynop surface electromyography device name: Clonidine name: Sevoflurane measure: Determine onset of spinal anesthesia and caudal + general anesthesia using surface EMG as measured by power of signal amplitude. measure: Determine duration of spinal anesthesia and caudal + general anesthesia using surface EMG as measured by power of signal amplitude. . measure: Determine density of spinal anesthesia and caudal + general anesthesia using surface EMG as measured by power of signal amplitude. measure: Determine dermatomal level of spinal anesthesia and caudal + general anesthesia using surface EMG as measured by power of signal amplitude. measure: Determine objective effect of clonidine, a common additive to neuraxial blockade in children on the measures described above when SA and CA are used as defined as the onset of SA or CA and measured by the power of signal amplitude. measure: Determine objective effect of clonidine, a common additive to neuraxial blockade in children on the measures described above when SA and CA are used as defined as the duration of SA or CA and measured by the power of signal amplitude. measure: Determine objective effect of clonidine, a common additive to neuraxial blockade in children on the measures described above when SA and CA are used as defined as the density of SA or CA and measured by the power of signal amplitude. measure: Determine objective effect of clonidine, a common additive to neuraxial blockade in children on the measures described above when SA and CA are used as defined as the dermatomal level of SA or CA and measured by the power of signal amplitude. measure: Quantify the impact of sevoflurane (%) on basal muscle tone based on EMG signal amplitudes. sex: ALL minimumAge: 0 Years maximumAge: 5 Years stdAges: CHILD facility: Nationwide Children's Hospital status: RECRUITING city: Columbus state: Ohio zip: 43205 country: United States name: Catherine Roth role: CONTACT phone: 614-722-2997 email: catherine.roth@nationwidechildrens.org name: Grant Heydinger, MD role: PRINCIPAL_INVESTIGATOR lat: 39.96118 lon: -82.99879 hasResults: False
|
<|newrecord|> nctId: NCT06287138 id: KY2023-182-03 briefTitle: The Effect of Ciprofol on Breathing Patterns, Respiratory Drive, and Inspiratory Effort in Mechanically Ventilated Patients overallStatus: RECRUITING date: 2023-05-10 date: 2024-12-31 date: 2025-03-31 date: 2024-02-29 date: 2024-02-29 name: Capital Medical University class: OTHER briefSummary: Sedatives and analgesics are usually given for analgesic, anxiolytic, or sedating purposes for patients with critical illness, while they inevitably inhibit respiratory and circulatory function. Sometimes, patients receive deep sedation to induce hypoventilation or suppress spontaneous respiratory effort. The sedation level in clinical practice is usually assessed with subjective sedation scoring systems, such as the Richmond Agitation Sedation Scale (RASS). However, studies have found that sedation depth based on RASS is not a reliable marker of respiratory drive during critical illness. In recent years, researchers have proposed to monitor the effects of sedatives and analgesics on respiratory indicators and to implement lung-protective sedation, such as P0.1, Pocc, Pmus, WOB, and PTP. However, different pharmacological characteristics, different depths of sedation, and different sedation regimens among different sedatives and analgesics make a great difference in their effects on respiration. Ciprofol is an analog of propofol, with increased stereoselective effects adding to its anesthetic properties, is increasingly used in the intensive care unit, but its effects on respiration are not well understood. Therefore, this study aims to investigate the effects of ciprofol on respiratory patterns, respiratory drive, and inspiratory effort in mechanically ventilated patients. conditions: Mechanical Ventilation conditions: Sedation and Analgesia studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 20 type: ESTIMATED name: ciprofol measure: Explore the effect of ciprofol on tidal volume measure: Explore the effect of ciprofol on respiratory rate measure: Explore the effect of ciprofol on minute ventilation measure: Explore the effect of ciprofol on P0.1 measure: Explore the effect of ciprofol on PMI measure: Explore the effect of ciprofol on ΔPocc measure: Explore the effect of ciprofol on tidal volume measure: Explore the effect of ciprofol on respiratory rate measure: Explore the effect of ciprofol on minute ventilation measure: Explore the effect of ciprofol on P0.1 measure: Explore the effect of ciprofol on PMI measure: Explore the effect of ciprofol on ΔPocc measure: Explore the effect of ciprofol on systolic blood pressure measure: Explore the effect of ciprofol on diastolic blood pressure measure: Explore the effect of ciprofol on mean arterial pressure measure: Explore the effect of ciprofol on heart rate measure: Explore the effect of ciprofol on saturation of pulse oxygen measure: Explore the effect of ciprofol on end-tidal carbon dioxide pressure measure: Explore the effect of ciprofol on RASS score sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Beijing Tiantan Hospital status: RECRUITING city: Beijing state: Beijing zip: 100071 country: China name: Jian-Xin Zhou, MD role: CONTACT phone: 8610 59978019 email: zhoujx.cn@icloud.com name: Rui Su role: CONTACT phone: +8618611993866 email: surui1969@163.com lat: 39.9075 lon: 116.39723 hasResults: False
|
<|newrecord|> nctId: NCT06287125 id: Renal assess in SSc and SLE briefTitle: Renal Assessment for Early Detection of Renal Impairment in Systemic Sclerosis and Systemic Lupus Erythematosus Patients overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2026-03-01 date: 2027-03-01 date: 2024-02-29 date: 2024-02-29 name: Assiut University class: OTHER briefSummary: * Evaluate renal resistive index in SSc and SLE patients for early detection of renal impairment.
|
* Evaluate renal multi-parametric MRI in SSc and SLE patients for early detection of renal impairment.
|
* Measure the serum levels of CD147 in SSc and SLE patients and its correlation with renal impairment.
|
* Correlation between detected markers and other assessment tools. conditions: Systemic Sclerosis and Systemic Lupus Erythematous studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 95 type: ESTIMATED name: Renal multi-parametric MRI, Renal doppler ultrasound, Serum CD147 measure: Evaluate serum levels of CD147 in SSc and SLE patients measure: Evaluate renal resistive index in SSC and SLE patients measure: Evaluate Multiparametric MRI in SSC and SLE measure: Utility of CD 147 in ssc and SLE patients measure: Utility of renal resistive index in SSC and SLE patients measure: Utility of Multiparametric MRI in SSC and SLE sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
|
<|newrecord|> nctId: NCT06287112 id: PAC-ETGBD briefTitle: Prevention of Acute Cholecystitis With ETGBD overallStatus: NOT_YET_RECRUITING date: 2024-03-02 date: 2025-02-20 date: 2025-03-30 date: 2024-02-29 date: 2024-02-29 name: Seoul National University Hospital class: OTHER briefSummary: The goal of this clinical trial is to learn about Efficacy of the ETGBD parallel insertion with fully covered self-expandable metal stent for preventing acute cholecystitis in patients with low cystic duct insertion.
|
In this study, we hypothesized that endoscopic transpapillary gallbladder drainage (ETGBD) with parallel insertion of a fully covered self-expanding metal stent(FCSEMS) through an endoscopic biliary drainage tunnel is superior in preventing complications such as cholecystitis when the gallbladder ducts confluence within the distal third of the common bile duct. And we aimed to confirm its efficacy by comparing the frequency, severity, and rate of invasive additional procedures due to cholecystitis complications to provide evidence of clinical utility. conditions: Biliary Obstruction conditions: Acute Cholecystitis studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: PREVENTION masking: NONE count: 35 type: ESTIMATED name: Endoscopic transpapillary gallbladder drainage (ETGBD) measure: Incidence rate of acute cholecystitis sex: ALL minimumAge: 19 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
|
<|newrecord|> nctId: NCT06287099 id: 2023-BRL-101-SCD briefTitle: Clinical Study of BRL-101 in the Treatment of Sickle Cell Disease overallStatus: NOT_YET_RECRUITING date: 2024-04-20 date: 2025-10-20 date: 2026-05-10 date: 2024-02-29 date: 2024-03-19 name: Bioray Laboratories class: INDUSTRY name: Nanfang Hospital, Southern Medical University briefSummary: This is a single center, non-randomized, open label, single-dose study in subjects with Sickle Cell Disease (SCD). The study will evaluate the safety and efficacy of autologous CRISPR-Cas9 modified CD34+ human hematopoietic stem and progenitor cells (hHSPCs) (BRL-101). conditions: Sickle Cell Disease studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 5 type: ESTIMATED name: BRL-101 measure: Proportion of stem cell engrafted subjects measure: Time to neutrophil engraftment measure: Frequency, severity, and relationship to BRL-101 of adverse events over 12 months following BRL-101 infusion. sex: ALL minimumAge: 3 Years maximumAge: 35 Years stdAges: CHILD stdAges: ADULT hasResults: False
|
<|newrecord|> nctId: NCT06287086 id: 2024-BRL-101-SCD briefTitle: Clinical Study on the Safety and Efficacy of BRL-101 in the Treatment of Sickle Cell Disease overallStatus: NOT_YET_RECRUITING date: 2024-05-14 date: 2025-08-20 date: 2026-06-10 date: 2024-02-29 date: 2024-03-12 name: Bioray Laboratories class: INDUSTRY name: Chinese Academy of Medical Sciences briefSummary: This is a single center, non-randomized, open label, single-dose study in subjects with Sickle Cell Disease (SCD). The study will evaluate the safety and efficacy of autologous CRISPR-Cas9 modified CD34+ human hematopoietic stem and progenitor cells (hHSPCs) (BRL-101) conditions: Sickle Cell Disease studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 1 type: ESTIMATED name: BRL-101 autologous hematopoietic stem and progenitor cells injection measure: Proportion of stem cell engrafted subjects measure: Time to neutrophil engraftment measure: Frequency, severity, and relationship to BRL-101 of adverse events over 12 months following BRL-101 infusion.. sex: ALL minimumAge: 3 Years maximumAge: 35 Years stdAges: CHILD stdAges: ADULT hasResults: False
|
<|newrecord|> nctId: NCT06287073 id: 1245-0323 id: EUPAS107293 type: REGISTRY domain: EU PAS Register briefTitle: JARDIANCE® Post Marketing Surveillance in Korean Patients With Chronic Kidney Disease (CKD) overallStatus: RECRUITING date: 2024-03-29 date: 2025-08-18 date: 2025-11-22 date: 2024-02-29 date: 2024-04-23 name: Boehringer Ingelheim class: INDUSTRY briefSummary: The primary objective is to monitor the safety profile of JARDIANCE® in Korean patient with chronic kidney disease (CKD) in routine clinical practice.
|
The secondary objective is to monitor the efficacy of JARDIANCE® by evaluating changes in urine albumin-creatinine ratio (UACR) after 12 and/or 24 weeks of treatment. conditions: Kidney Disease, Chronic studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 600 type: ESTIMATED name: JARDIANCE® measure: Number of subjects with adverse events measure: Number of subjects with serious adverse event measure: Number of subjects with non-serious adverse events measure: Number of subjects with adverse drug reaction measure: Number of subjects with serious adverse drug reactions measure: Number of subjects with unexpected adverse events measure: Number of subjects with adverse events of special interest measure: Number of subjects with specific adverse events measure: Number of subjects with adverse events leading to temporary or permanent discontinuation measure: Number of subjects with adverse events by intensity measure: Number of subjects with adverse events by outcome of the events measure: Number of subjects with adverse events by causality measure: Number of subjects with adverse events leading to death measure: Occurrence of change in urine albumin-creatinine ratio (UACR) from baseline after 12 weeks and/or 24 weeks of treatment sex: ALL minimumAge: 19 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Samsung Medical Center status: RECRUITING city: Seoul zip: 03181 country: Korea, Republic of name: Boehringer Ingelheim role: CONTACT phone: 0808802084 email: namhan@bitrialsupport.com lat: 37.566 lon: 126.9784 hasResults: False
|
<|newrecord|> nctId: NCT06287060 id: Strawberry extract briefTitle: Bleaching Effect of Strawberry Extract Versus Hydrogen Peroxide in Patients With Extrinsic Staining overallStatus: NOT_YET_RECRUITING date: 2024-07 date: 2024-12 date: 2024-12 date: 2024-02-29 date: 2024-02-29 name: Cairo University class: OTHER briefSummary: with limited evidence based information in literature about using Strawberry extract for teeth bleaching in patients with extrinsic staining , it is beneficial to evaluate this new material using a randomized controlled clinical trial to test the null hypothesis that this extract will have the same effect as Hydrogen peroxide regarding the bleaching effect and hypersensitivity. conditions: Bleaching Effect and Postoperative Sensitivity of Strawberry Extract studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 40 type: ESTIMATED name: strawberry extract. measure: Bleaching effect of strawberry extract versus Hydrogen peroxide. measure: post operative sensitivity. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
|
<|newrecord|> nctId: NCT06287047 id: spinal needle sizes and DPE briefTitle: The Impact of Using Different Spinal Needle Sizes on the Efficacy of the Dural Puncture Epidural Block overallStatus: ACTIVE_NOT_RECRUITING date: 2021-01-01 date: 2022-01-31 date: 2024-04-15 date: 2024-02-29 date: 2024-03-19 name: Cairo University class: OTHER briefSummary: The aim of this study is to compare the dural puncture epidural technique (DPET) with either 25-gauge spinal needle or 27-gauge spinal needle versus conventional epidural technique and evaluate whether DPET improves onset and spread of labor analgesia and if there is a role of the usage of different sized needles as regards block efficiency and complications. conditions: Dural Puncture Epidural Technique studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: 81 patients meeting the inclusion criteria will be randomly divided into three equal groups: Group A (n=27): Conventional epidural. Group B (n=27): Dural puncture epidural with 25-gauge spinal needle. Group C (n=27): Dural puncture epidural with 27-gauge spinal needle. primaryPurpose: OTHER masking: DOUBLE maskingDescription: The details of the series will be unknown to the investigators and the group assignment will be kept in asset of sealed envelopes each bearing only the case number on the outside. Prior to surgery the appropriate numbered envelope will be opened by the nurse, the card inside will determine the patient group. whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 81 type: ACTUAL name: Epidural analgesia measure: Onset of analgesia measure: Degree of analgesia sex: FEMALE minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: Faculty of Medidcne, Cairo Univerisity city: Cairo country: Egypt lat: 30.06263 lon: 31.24967 hasResults: False
|
<|newrecord|> nctId: NCT06287034 id: RS1833/23 briefTitle: The Role of the Free/Pedunculated Flap in Total Laryngectomy After (Chemo-)Radiotherapy Failure for Laryngeal Carcinoma: Impact on the Risk of Pharyngocutaneous Fistula (PCF) overallStatus: RECRUITING date: 2023-03-21 date: 2025-03-21 date: 2025-09-21 date: 2024-02-29 date: 2024-02-29 name: Regina Elena Cancer Institute class: OTHER briefSummary: Multicenter, prospective, randomized study aimed at evaluating the difference in risk of PCF after salvage laryngectomy in two groups of patients: one cohort treated with Total Laryngectomy (LT) with primary suture, a second group treated with LT and reinforcement by flap positioning with onlay technique (PMM, ALT) conditions: Larynx Carcinoma studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 102 type: ESTIMATED name: Primary suture measure: questionnaires for evaluation of the quality of life measure: Identification of risk factors measure: Evaluation of swallowing function measure: Evaluation of vocal rehabilitation sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: "Regina Elena" National Cancer Institute status: RECRUITING city: Rome zip: 00144 country: Italy name: Pellini Raul, Doctor role: CONTACT phone: 06-52664484 email: raul.pellini@ifo.it lat: 41.89193 lon: 12.51133 hasResults: False
|
<|newrecord|> nctId: NCT06287021 id: TRASERBMD2022 briefTitle: Bone Remodeling Around a Trabecular Titanium Cup in Total Hip Arthroplasty overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2027-02 date: 2027-02 date: 2024-02-29 date: 2024-04-03 name: Permedica spa class: INDUSTRY briefSummary: The goal of this randomized controlled trial is to measure the periprosthetic bone mineral density changes around a 3D-printed highly-porous titanium acetabular cup used in primary total hip arthroplasty compared to a standard hydroxyapatite/titanium plasma-sprayed acetabular cup up to 2-year follow-up. conditions: Total Hip Arthroplasty studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Controlled, randomized, unblinded, multicenter primaryPurpose: TREATMENT masking: NONE count: 50 type: ESTIMATED name: Jump System Traser® cup name: Jump System HAX-Pore® cup measure: BMD - ROI 1 measure: BMD - ROI 2,3,4 measure: Harris hip score measure: Moore's osseointegration signs sex: ALL minimumAge: 40 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT facility: IRCCS Istituto Clinico San Siro city: Milan zip: 20148 country: Italy name: Matteo Del Re, MD role: CONTACT email: matteodelre91@gmail.com lat: 45.46427 lon: 9.18951 facility: IRCCS Ospedale Galeazzi-Sant'Ambrogio city: Milan zip: 20161 country: Italy name: Ricardo Ciliberto, MD role: CONTACT email: rciliberto@gmail.com name: Laura role: CONTACT lat: 45.46427 lon: 9.18951 hasResults: False
|
<|newrecord|> nctId: NCT06287008 id: 2023-0085 briefTitle: ABO-Incompatible Kidney Transplants Between Robot-Assisted vs. Open Surgery overallStatus: COMPLETED date: 2020-10-01 date: 2023-09-30 date: 2024-01-31 date: 2024-02-29 date: 2024-03-01 name: Asan Medical Center class: OTHER briefSummary: While robot-assisted kidney transplantation (RAKT) offers potential benefits such as minimal postoperative pain, better cosmesis, fewer wound infections, and shorter hospital stay, its efficacy in ABO-incompatible (ABO-i) KT compared to open KT (OKT) remains understudied. This study aims to compare ABO-i KT outcomes between RAKT and OKT.
|
The study utilized data from 29 ABO-i RAKT and 210 ABO-i OKT cases performed at Asan Medical Center from October 2020 to February 2023. Univariate and multivariate analyses were performed to evaluate factors associated with a composite of biopsy-proven acute rejection (BPAR), de novo donor-specific antibodies (DSA), and overall graft failure. conditions: Kidney Transplantation studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 239 type: ACTUAL name: robot-assisted kidney transplantation measure: Graft survival measure: renal function measure: . A composite of biopsy-proven acute rejection, graft failure, and the development of de novo donor-specific antibodies sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Asan Medical Center city: Seoul zip: 05505 country: Korea, Republic of lat: 37.566 lon: 126.9784 hasResults: False
|
<|newrecord|> nctId: NCT06286995 id: 6280 briefTitle: Postoperative Pain Assessment After Canal Preparation by Different NiTi File Systems overallStatus: COMPLETED date: 2023-10-14 date: 2024-01-29 date: 2024-02-14 date: 2024-02-29 date: 2024-02-29 name: Ain Shams University class: OTHER briefSummary: The participants were divided into two groups : group one ( Trunatomy file group)(n=10) was mechanically prepared the canals by Trunatomy file and group two ( Edgeendo x7 file group) ( n=10) was prepared the canals by Edgeendo x7 file, the participants were assessed pain preoperatively and postoperatively by Visual Analog Scale(VAS) conditions: Post Operative Pain conditions: Inflammation studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: This study was designed to be randomized,single- blinded, single-center clinical trial primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: A) Sequence generation: was done using random sequence number generated by computer software B) Allocation concealment Mechanism:folded,numbered papers were placed in tightly sealed envelopes containing patients' coding whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 20 type: ACTUAL name: Chemomechanical preparation for root canals measure: Level of post operative pain using 10-cm visual analogue scale ( VAS) measure: Level of inflammatory mediators substance P in apical fluid samples sex: ALL minimumAge: 20 Years maximumAge: 50 Years stdAges: ADULT facility: Ain Shams university city: Cairo country: Egypt lat: 30.06263 lon: 31.24967 hasResults: False
|
<|newrecord|> nctId: NCT06286982 id: OASIS III briefTitle: The Oral Symptom Assessment Scale in Older Patients With Frailty overallStatus: RECRUITING date: 2023-06-06 date: 2024-07-06 date: 2024-07-06 date: 2024-02-29 date: 2024-03-07 name: Our Lady's Hospice and Care Services class: OTHER briefSummary: Oral (or mouth) symptoms are common in older patients who live with frailty. It is known that frailty describes someone's overall resilience and how this relates to the chances of recovery following a health problem. A questionnaire called the Oral Symptom Assessment Scale (or OSAS) was designed to look at mouth symptoms in patients who had an advanced cancer. These symptoms may overlap with patients who have frailty.
|
This research study is taking place to find out if the OSAS will be a suitable questionnaire that can be used in older patients with frailty.
|
This study will take place in Our Lady's Hospice \& Care Services, Harold's Cross and St James' Hospital over six months. conditions: Frailty conditions: Older Adults studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 250 type: ESTIMATED name: Oral Symptom Assessment Scale measure: To determine the prevalence of oral symptoms in older patients with frailty measure: To determine the clinical features of these oral symptoms in this group (i.e. frequency, severity and level of distress) measure: To determine the relationship between oral symptoms and Clinical Frailty Score / Cumulative Illness Rating Scale for Geriatrics/Medications measure: To provide initial validation of OSAS in older patients with frailty sex: ALL minimumAge: 65 Years stdAges: OLDER_ADULT facility: St James's Hospital status: RECRUITING city: Dublin zip: D8 country: Ireland name: Niamh Cleary, MB MICGP role: CONTACT phone: +353876603466 (Ireland) email: clearynm@tcd.ie name: Amanda Lavan, PhD MRCPI role: SUB_INVESTIGATOR name: Roman Romero Ortuno, MSc PhD MRCP role: SUB_INVESTIGATOR lat: 53.33306 lon: -6.24889 facility: Our Lady's Hospice and Care Services status: RECRUITING city: Dublin zip: Dublin 6W country: Ireland name: Niamh M Cleary, MB MICGP role: CONTACT phone: +353876603466 (Ireland) email: clearynm@tcd.ie name: Norah Fagan, RGN MSc role: SUB_INVESTIGATOR lat: 53.33306 lon: -6.24889 hasResults: False
|
<|newrecord|> nctId: NCT06286969 id: ZSLL-ZN-2024-007-01 briefTitle: Clinical Study on Intensive Multi-acupuncture in the Treatment of Lumbar Muscle Strain. overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2024-12-31 date: 2025-03-01 date: 2024-02-29 date: 2024-02-29 name: Xu Xinnan class: OTHER briefSummary: Acupuncture is widely used as a routine treatment for lumbar muscle strain. The aim of this randomized controlled trial is to evaluate the effectiveness of the intensive multi-acupuncture method. This trial will include 108 patients with lumbar muscle strain injury from two outpatient clinics. All participants will be randomized in a 1:1 ratio to the intensive multi-acupuncture method group and the normal needling group. Outcomes will be assessed before the intervention, after one treatment, after five treatments, and at follow-up 2 weeks after the end of treatment. The primary outcome indicator will be the clinical efficacy evaluation criteria, and the secondary outcome indicators will be the pain visual analog scale (VAS) score, the Japanese Orthopaedic Association Assessment Treatment Score (JOA) score, the lumbar joint mobility measurement scale, and the Modified Ashworth Grading Scale. This study will provide evidence as to whether the intensive multi-acupuncture method is safe and effective. conditions: Lumbar Muscle Strain studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 108 type: ESTIMATED name: acupuncture measure: clinical efficacy evaluation criteria measure: Pain visual analog scale (VAS) score measure: Japanese Orthopaedic Association Scores measure: Lumbar Joint Mobility Measurement Scale measure: Improvement of the Ashworth Rating Scale sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
|
<|newrecord|> nctId: NCT06286956 id: vec-pr-1901 briefTitle: Rectal Tumor Resection Using the UNI-VEC Multichannel Transanal Access Device acronym: UNI-VEC overallStatus: RECRUITING date: 2021-04-19 date: 2024-05-07 date: 2024-09-07 date: 2024-02-29 date: 2024-02-29 name: Vecmedical Spain, S.L. class: INDUSTRY briefSummary: The aim of the clinical trial is to investigate whether the use of a new multichannel endoscopic transanal access device (named UNI-VEC) is safe and effective in the resection of a rectal polyp or tumor that sits in the distal part of the colon (up to about 20 cm from the anal margin). This is the first study to test the device in humans, after proving its good performance in preclinical development (preclinical development has included functional laboratory tests and an animal trial). conditions: Rectal Polyp conditions: Rectal Polyps conditions: Rectal Lesion conditions: Sessile Colonic Polyp conditions: Pedunculated Colorectal Polyps studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 40 type: ESTIMATED name: Treatment of rectal lesions with UNI-VEC measure: Assess that the use of the device meet the established functional requiremnt of allowing the removal of polyps measure: Rate of anorectal hemorrhagic events measure: Rate of injuries to the anorectal canal and perianal region measure: Assessment of anorectal continence sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hospital Universitario de Cabueñes status: RECRUITING city: Gijón state: Asturias zip: 33394 country: Spain name: Carlos Álvarez, Medicine role: PRINCIPAL_INVESTIGATOR lat: 43.53573 lon: -5.66152 facility: Hospital Universitari Mútua de Terrassa status: RECRUITING city: Terrassa state: Bercelona zip: 08221 country: Spain name: Salvadora Delgado, Medicine role: PRINCIPAL_INVESTIGATOR lat: 41.56667 lon: 2.01667 facility: Complexo Hospitalario Universitario de A Coruña status: RECRUITING city: A Coruña state: Galicia zip: 15006 country: Spain name: José F Noguera, Medicin role: CONTACT phone: +34 981178049 email: jose.francisco.noguera.aguilar@sergas.es name: José F Noguera, Medicine role: PRINCIPAL_INVESTIGATOR lat: 43.37135 lon: -8.396 facility: Hospital Quirón-Salud A Coruña status: RECRUITING city: A Coruña state: Galicia zip: 15006 country: Spain name: Alba Gómez, Medicine role: PRINCIPAL_INVESTIGATOR lat: 43.37135 lon: -8.396 facility: Hospital Universitario Lucus Augusti status: RECRUITING city: Lugo state: Galicia zip: 27003 country: Spain name: Olga Maseda, Medicine role: PRINCIPAL_INVESTIGATOR lat: 43.00992 lon: -7.55602 facility: Complejo Hospitalario Universitario de Vigo status: RECRUITING city: Vigo state: Galicia zip: 36204 country: Spain name: Raquel Sánchez, Medicine role: PRINCIPAL_INVESTIGATOR lat: 42.23282 lon: -8.72264 facility: Hospital del Mar status: RECRUITING city: Barcelona zip: 08003 country: Spain name: Marta Jiménez, Medicine role: PRINCIPAL_INVESTIGATOR lat: 41.38879 lon: 2.15899 facility: Hospital La Paz status: RECRUITING city: Madrid zip: 28046 country: Spain name: Mario Álvarez, Medicine role: PRINCIPAL_INVESTIGATOR lat: 40.4165 lon: -3.70256 facility: Hospital Universitario Reina Sofía de Murcia status: RECRUITING city: Murcia zip: 30003 country: Spain name: Pedro Parra, Medicine role: PRINCIPAL_INVESTIGATOR lat: 37.98704 lon: -1.13004 facility: Hospital Universitario Río Hortega status: RECRUITING city: Valladolid zip: 47012 country: Spain name: Javier Sánchez, Medicine role: PRINCIPAL_INVESTIGATOR lat: 41.65518 lon: -4.72372 facility: Hospital Universitario La Fe status: RECRUITING city: València zip: 46026 country: Spain name: Blas Flor, Medicine role: PRINCIPAL_INVESTIGATOR lat: 39.46975 lon: -0.37739 hasResults: False
|
<|newrecord|> nctId: NCT06286943 id: S68124 briefTitle: The Effects of Short-Chain Fatty Acids in Psychosocial Stress-Induced Impairment on Core Executive Functions acronym: GUTSIE overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2025-03 date: 2025-05 date: 2024-02-29 date: 2024-02-29 name: Universitaire Ziekenhuizen KU Leuven class: OTHER name: United States Department of Defense briefSummary: The aim of the present trial is to examine core executive functions (EFs) as a functional outcome of attenuating the cortisol response to acute laboratory stress through colonic delivery of an Short Chain Fatty Acids (SCFAs) mix (acetate, propionate, butyrate).
|
A triple-blind randomized placebo-controlled parallel group trial will be conducted to compare the effects of SCFAs vs. placebo on core EFs (working memory \[WM\], cognitive flexibility \[CF\], response inhibition \[RI\]) under stress vs. no-stress conditions, after one week of SCFA vs. placebo treatment.
|
First, the effects of SCFAs on stress-induced changes in core executive functions, with WM as the primary outcome, and CF and RI as secondary outcomes will be tested. Second, interindividual differences in microbiota composition (particularly abundance of SCFA-producers), saliva cortisol and serum SCFA levels will be explored to assess whether they are associated with interindividual differences in core EFs at baseline or following acute stress.
|
Each participant will undergo 2 study visits: one will involve a stress condition and the other will involve a no-stress condition. Each study visit is preceded by a 1-week intervention or placebo period and separated by a 3-4 week washout period. To induce stress, participants will perform the Maastricht Acute Stress Task (MAST) or sham MAST as the control condition. To assess EF performance, three cognitive tasks will be performed 15 minutes after task offset: n-back task for WM; Stop Signal Task for RI; and Wisconsin Card Sorting Test for CF. Saliva samples will be collected before, during and after the (sham) MAST to assess the cortisol response. Blood samples will be collected throughout all study visits to quantify serum SCFAs, inflammatory markers and ACTH. Additionally, cardiovascular variables will be measured, and self-report questionnaires will be completed to evaluate autonomic response to the condition and subjective stress responses, respectively conditions: Executive Function studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 80 type: ESTIMATED name: Short Chain Fatty Acids (SCFAs). name: Placebo name: Maastricht Acute Stress Task name: No-stress control task measure: Working memory measure: Cognitive Flexibility measure: Response Inhibition sex: MALE minimumAge: 20 Years maximumAge: 40 Years stdAges: ADULT hasResults: False
|
<|newrecord|> nctId: NCT06286930 id: STU-2023-0470 briefTitle: Cerebellar tDCS Stimulation in Children and Adult Women With Anorexia Nervosa Disorder overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2025-01-02 date: 2026-01-02 date: 2024-02-29 date: 2024-02-29 name: University of Texas Southwestern Medical Center class: OTHER briefSummary: Hypothesis: Will the use of tDCS brain modulation in the cerebellum assist in restricted behaviors, social cognition and cognitive flexibility in women with anorexia nervosa in addition to other therapies?
|
Primary Outcomes:
|
1. To observe the impacts and outcomes of cerebellar transcranial direct current stimulation (tDCS) on social behaviors measured by Cyberball and Trust Game.
|
2. To observe the neuropsychological impacts of cerebellar tDCS through fMRI imaging as well as looking at the Region of Interest (ROI) of changes in the Default Mode Network and Cerebellum circuits and their activation levels in those networks.
|
Secondary Outcomes:
|
1.To observe the impacts and outcome of cerebellar transcranial direct current stimulation (tDCS) measuring the differences between anodal and cathodal stimulation. To observe potential increases in responses to social stimuli, decreases in eating disorder/depressive symptomology via cathodal stimulation. To also observe potential little to no changes in social stimuli and eating disorder/depressive symptomology via anodal stimulation. conditions: Anorexia Nervosa studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 15 type: ESTIMATED name: anodal trans cranial direct current stimulation (tDCS) name: cathodal trans cranial direct current stimulation (tDCS) measure: tDCS impact on social behaviors using Cyberball measure: tDCS impact on social behaviors using the Trust Game measure: neurological impacts of tDCS as measured by fMRI imaging measure: measure the differences of social stimuli and eating disorder/depressive symptomology measure: measure the differences of social stimuli and eating disorder/depressive symptomology measure: measuring the differences of social stimuli and eating disorder/depressive symptomology measuring using the Food Rating Task. measure: measure the differences of social stimuli and mental flexibility with Trail Making Task measure: measure the differences of social stimuli and eating disorder/depressive symptomology utilizing Patient Health Questionnaire-9. sex: FEMALE minimumAge: 15 Years maximumAge: 30 Years stdAges: CHILD stdAges: ADULT hasResults: False
|
<|newrecord|> nctId: NCT06286917 id: R24001 briefTitle: Initiation of Noninvasive Ventilation in ALS Patients With Chronic Respiratory Insufficiency acronym: InNIVALS overallStatus: RECRUITING date: 2024-03-05 date: 2028-12 date: 2029-12 date: 2024-02-29 date: 2024-03-22 name: Tampere University class: OTHER briefSummary: This research will study whether noninvasive ventilation (NIV) used to treat chronic respiratory insufficiency in patients with amyotrophic lateral sclerosis (ALS) can be initiated as successfully in the outpatient setting as in the conventional inpatient setting, and what the costs of these alternative initiation methods are. conditions: Ventilation Therapy conditions: ALS conditions: Chronic Respiratory Failure studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: BASIC_SCIENCE masking: SINGLE whoMasked: INVESTIGATOR count: 120 type: ESTIMATED name: NIV initiation in patients with ALS measure: NIV usage hours according to different initiation locations in patients with ALS measure: Compliance with NIV according to NIV initiation setting in patients with ALS measure: Decrease in blood carbon dioxide levels in patients with ALS depending on the place of NIV initiation. measure: Costs of initiation of NIV in outpatient setting compared with inpatient setting in patients with ALS sex: ALL minimumAge: 18 Years maximumAge: 99 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Tampere University Hospital status: RECRUITING city: Tampere zip: 33520 country: Finland name: Heidi A Rantala, MD, PhD role: CONTACT phone: +3583311611 email: heidi.rantala@tuni.fi name: Lauri Lehtimäki, MD, PhD role: CONTACT phone: +3583311611 email: lauri.lehtimaki@tuni.fi name: Hanna Korkeamäki, MD, MSc role: PRINCIPAL_INVESTIGATOR name: Hannele Hasala, MD, PhD role: SUB_INVESTIGATOR name: Sirpa Leivo-Korpela, MD, PhD role: SUB_INVESTIGATOR lat: 61.49911 lon: 23.78712 hasResults: False
|
<|newrecord|> nctId: NCT06286904 id: McMaster-Myant 16633 briefTitle: Sleep Position Pattern Recording overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2024-12-01 date: 2025-03-30 date: 2024-02-29 date: 2024-03-01 name: Myant Medical Corp. class: INDUSTRY name: McMaster University briefSummary: The main goal of this study is to validate the accuracy of the body position detection by non-invasive wearable monitors (Skiin garments, Myant Medical Corp) during sleep in pregnant participants. This is a first step towards examining the association between maternal sleep position and fetal growth. conditions: Pregnant Women studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 52 type: ESTIMATED name: Skiin Garment system measure: Accuracy of Skiin Garment system for detecting sleep position of pregnant women measure: Questionnaire on wearable device invasiveness and satisfaction measure: Participant recruitment rate measure: Participant retention rate sex: FEMALE stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: McMaster University city: Hamilton state: Ontario zip: L8S 4K1 country: Canada name: Kyle McGowan role: CONTACT phone: 905.521.2100 phoneExt: 21334 email: mcgowank@mcmaster.ca name: Eran Ashwal role: PRINCIPAL_INVESTIGATOR lat: 43.25011 lon: -79.84963 hasResults: False
|
<|newrecord|> nctId: NCT06286891 id: CAAE: 73520523.7.0000.0068 briefTitle: Frailty, Physical Capacity and Lung Function in Postoperative Pulmonary Endarterectomy Patients overallStatus: RECRUITING date: 2024-02-29 date: 2024-11-01 date: 2025-09-30 date: 2024-02-29 date: 2024-03-19 name: University of Sao Paulo General Hospital class: OTHER briefSummary: The goal of this observational and prospective study is to investigate changes in physical performance, lung function, respiratory and peripheral muscle strength in patients during the postoperative period following pulmonary endarterectomy (PET). conditions: Chronic Thromboembolic Pulmonary Hypertension conditions: Physical Disability conditions: Fragility studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 50 type: ESTIMATED measure: To investigate changes in physical performance measured by Six-Minute Walk Test. measure: To investigate changes in physical performance measured by Short Physical Performance Battery (SPPB). measure: To investigate changes in physical performance by 1-minute sit-to-stand test (1-MSTST). measure: To investigate changes in peripheral muscle strength. measure: To investigate changes in respiratory muscle strength: measure: To investigate changes in lung function test measure by spirometry: measure: To investigate frailty by Clinical Frailty Scale (CFS) measure: To explore potential preoperative and immediate postoperative risk factors as predictors of functional loss. measure: To investigate changes in hemodynamic and respiratory variables during the funcional tests. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Instituto do Coração - Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo status: RECRUITING city: São Paulo state: SP zip: 05403-000 country: Brazil name: Orival Freitas Filho, MD role: SUB_INVESTIGATOR name: Fabio B Jatene, MD,PhD role: SUB_INVESTIGATOR name: Kelly CO Abud, PT, PhD role: SUB_INVESTIGATOR lat: -23.5475 lon: -46.63611 hasResults: False
|
<|newrecord|> nctId: NCT06286878 id: SDC 4620/17/120 briefTitle: Pleiotropic Effects of Dapagliflozin in Patients With Acute Coronary Syndromes overallStatus: RECRUITING date: 2021-12-08 date: 2024-12-30 date: 2025-07-30 date: 2024-02-29 date: 2024-02-29 name: University of Sao Paulo class: OTHER briefSummary: Type 2 diabetes mellitus (T2DM) is one of the most important risk factors for atherosclerotic heart disease. Strategies focused solely on glycemic control have failed to demonstrate vascular events reduction in this population. On the other hand, new antidiabetic drugs recently have demonstrated significant decrease of cardiovascular mortality, raising the hypothesis that possible effects beyond glycemia control could explain this benefit. Aim: This study is intended to evaluate possible pleiothropic effects of dapaglifozin, a SGLT-2 (sodium glucose cotransporter 2) inhibitor, in individuals admitted with a diagnosis of Acute Myocardial Infarction (AMI). Methods: This is a prospective, randomized, double-blind, placebo controlled trial. Individuals presenting with AMI whithin the first seven days of evolution will be randomized to dapaglifozin or placebo. The investigators's goal is to analyze platelet aggregability 48 hours after randomization (primary endpoint), as well as glycemic control, cardiac biomarkers, corrected QT interval electrocardiographic analysis, autonomic modulation through spectral analysis of the RR interval and inflammatory biomarkers at inclusion and 30 days after starting study drug (secondary endpoints). Sample size calculation resulted in 80 individuals (40 per group). Expected results: This study will seek to aggregate new insights to the current knowledge about this new antidiabetic drug class. Previous randomized clinical trials have demonstrated that SGLT-2 inhibitors significantly reduced the composite endpoint of cardiovascular death, AMI or stroke, as well as Heart Failure (HF) hospitalization. Therefore, this study is supposed to clarify possible mechanisms that could explain these results aforementioned. conditions: Myocardial Infarction conditions: Acute Coronary Syndrome conditions: Diabetes conditions: Ventricular Dysfunction studyType: INTERVENTIONAL phases: PHASE2 phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Single-center, prospective, randomized, double-blind, placebo-controlled clinical study. primaryPurpose: BASIC_SCIENCE masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 80 type: ESTIMATED name: Placebo name: Dapagliflozin measure: Platelet aggregation using ADP measure: Platelet aggregation using ADP at 30 (± 5) days after study therapy measure: Platelet aggregation using ASPI at 30 (± 5) days after study therapy measure: Analyze the primary objective of the study in the following pre-specified subgroups: sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Instituto do Coracao (InCor), Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo status: RECRUITING city: Sao Paulo zip: 05403-900 country: Brazil name: José Carlos Nicolau role: CONTACT phone: 551126615058 email: josecarlosnicolau@gmail.com lat: -23.5475 lon: -46.63611 hasResults: False
|
<|newrecord|> nctId: NCT06286865 id: 260972(REK) briefTitle: Improving Quality of ICD-10 Coding Using AI: Protocol for a Crossover Randomized Controlled Trial acronym: ClinCode overallStatus: RECRUITING date: 2023-10-20 date: 2024-04 date: 2024-04 date: 2024-02-29 date: 2024-02-29 name: University Hospital of North Norway class: OTHER name: The Research Council of Norway briefSummary: The goal of this randomised trial is to learn about the role of AI in clinical coding practice. The main question it aims to answer is:
|
Can the AI-based CAC system reduce the burden of clinical coding and also improve the quality of such coding? Participants will be asked to code clinical texts both while they use our CAC system and while they do not. conditions: Gastrointestinal Diseases studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: DIAGNOSTIC masking: SINGLE whoMasked: PARTICIPANT count: 30 type: ESTIMATED name: Easy-ICD measure: Time measure: Accuracy sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Norwegian Centre for E-health Research status: RECRUITING city: Tromso state: Troms zip: 9019 country: Norway name: Taridzo F Chomutare, PhD role: CONTACT phone: +4747680032 email: taridzo.chomutare@ehealthresearch.no name: Hercules Dalianis, PhD role: CONTACT phone: +46705681359 email: hercules@dsv.su.se lat: 69.6489 lon: 18.95508 hasResults: False
|
<|newrecord|> nctId: NCT06286852 id: EDE BA briefTitle: Italian Language Validation of The Eating Disorder Examination (EDE) - Child Version overallStatus: ACTIVE_NOT_RECRUITING date: 2022-11-01 date: 2023-12-30 date: 2024-06-30 date: 2024-02-29 date: 2024-02-29 name: Meyer Children's Hospital IRCCS class: OTHER briefSummary: Although eating disorders often occur during or after puberty, it is likely that critical antecedent conditions can be established before adolescence. The Eating Disorder Examination has been adapted for children and is described by Bryant - Waugh, Cooper, Taylor and Lask (1996). The EDE is considered the gold standard of measures of eating disorder psychopathology (Wilson, 1993), and this adaptation, which allows its use with a younger age group, is a potentially important addition to the assessment of eating disorders in children. The latest version of EDE, the l7th edition, has now surpassed its predecessors.
|
The aim of the study is to evaluate the psychometric properties of the Child vers ion EDE (chEDE) translated into Italian, in a sample of patients with eating disorder conditions: Feeding and Eating Disorders of Childhood studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 250 type: ESTIMATED name: Administration of K-SADS-PL- Kiddie-Schedule for Affective Disorder and Schizophrenia-Present and Lifetime version (Kaufmann, 2002) name: Administration of ChEDE- Child Version of the EatingDisorder Examination measure: K-SADS-PL (Kiddie-Schedule for Affective Disorder and Schizophrenia-Present and Lifetime version) questionnaire measure: ChEDE (Child Version of the EatingDisorder Examination) sex: ALL minimumAge: 8 Years maximumAge: 17 Years stdAges: CHILD facility: Meyer Children's Hospital IRCCS city: Firenze country: Italy lat: 43.77925 lon: 11.24626 facility: USL Toscana Centro city: Firenze country: Italy lat: 43.77925 lon: 11.24626 facility: Ospedale Villa Garda city: Garda country: Italy lat: 45.57889 lon: 10.71763 hasResults: False
|
<|newrecord|> nctId: NCT06286839 id: AFCRO-150 briefTitle: Study of Cannabidiol (CBD) in Healthy Volunteers overallStatus: COMPLETED date: 2022-05-12 date: 2022-10-28 date: 2022-12-14 date: 2024-02-29 date: 2024-02-29 name: NextEvo Inc. class: INDUSTRY name: Atlantia Food Clinical Trials briefSummary: This was a prospective, single-centre, open label, randomized, two-arm, parallel design study to evaluate the effect of four-weeks consumption of active study product on primary endpoint in healthy adults conditions: Immune System and Related Disorders conditions: Immune System Diseases studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 26 type: ACTUAL name: Cannabidiol (CBD) measure: Plasma CBD pharmacokinetics of twice daily intake of 2 different doses of CBD over three days measure: Evaluate the safety of twice daily intake of 2 different doses of CBD over three 3 days measure: Plasma CBD maximal concentration (Cmax, ng/ml) measure: Plasma CBD time to peak (Tmax, minutes) measure: Percentage Change between groups on whole blood LPS stimulated cytokines (% change) sex: ALL minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: Altantia Clinical Trials city: Chicago state: Illinois zip: 60611 country: United States lat: 41.85003 lon: -87.65005 hasResults: False
|
<|newrecord|> nctId: NCT06286826 id: ATRESO briefTitle: A Study of Patients Undergoing Surgical Treatment for Oesophageal Atresia overallStatus: RECRUITING date: 2023-10-12 date: 2024-10-12 date: 2026-01-12 date: 2024-02-29 date: 2024-03-04 name: Meyer Children's Hospital IRCCS class: OTHER briefSummary: Oesophageal atresia (EA) is a rare congenital anomaly whose prevalence varies between 1 and 2 per 5000 live births in Europe. This condition is characterised by an interruption of the oesophagus often associated with the presence of a tracheo-oesophageal fistula (FTE).
|
Although considerable progress has been made in the treatment of AE in recent years, the aetiology of this defect is still not fully understood and several theories have been put forward to explain this phenomenon. What they have in common is an abnormal separation of the primary oesophagus and trachea. The main goal of AE treatment is the closure of the FTE using surgical techniques.
|
This is a non-profit, multicentre longitudinal observational cohort study. This study will enrol patients who underwent surgery for oesophageal atresia during the period 2011-2021 and are still in follow-up at participating clinical centres.
|
The primary objective is to assess the incidence of musculoskeletal abnormalities, of any type, in the long term (4 years after surgery) in patients with oesophageal atresia treated surgically by two different approaches: postero-lateral thoracotomy and mini-thoracotomy with muscle preservation conditions: Atresia Esophagus studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 50 type: ESTIMATED name: Postero-lateral thoracotomy name: Minithoracotomy measure: incidence of musculoskeletal abnormalities patients with oesophageal atresia treated surgically measure: incidence of musculoskeletal abnormalities in the short term measure: incidence of musculoskeletal abnormalities in the medium term measure: Evaluation of severity of outcomes in the medium, short and long term measure: Predective Facotrs evaluation sex: ALL minimumAge: 1 Day maximumAge: 13 Years stdAges: CHILD facility: Spedali Civili di Brescia status: RECRUITING city: Brescia zip: 25123 country: Italy name: Daniele Alberti role: CONTACT email: daniele.alberti@unibs.it lat: 45.53558 lon: 10.21472 facility: Meyer Children's Hospital IRCCS status: RECRUITING city: Florence zip: 50139 country: Italy name: Elisa Severi role: CONTACT phone: 0555662900 email: elisa.severi@meyer.it lat: 43.77925 lon: 11.24626 facility: Ospedale Bambino Gesù di Roma status: RECRUITING city: Roma zip: 00165 country: Italy name: Andrea Conforti, MD role: CONTACT email: andrea.conforti@opbg.net lat: 41.89193 lon: 12.51133 hasResults: False
|
<|newrecord|> nctId: NCT06286813 id: Akarakoc briefTitle: The Effect of Almond and Extra Virgin Olive Oils on Maintaining Skin Integrity in Neonates overallStatus: RECRUITING date: 2024-03-02 date: 2024-05-03 date: 2024-05-30 date: 2024-02-29 date: 2024-02-29 name: Marmara University class: OTHER briefSummary: This study aimed to evaluate the effects of extra virgin olive and almond oils on maintaining skin integrity in neonates admitted to the neonatal intensive care unit.
|
Interventional research with two parallel groups and no control group conditions: Skin Care studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Interventional research with two parallel groups (almond olive group and virgin olive oil group) and no control group. primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 120 type: ESTIMATED name: Plant (natural) oils measure: Neonatal skin condition score measure: Skin moisture meter(DMM): sex: ALL minimumAge: 1 Hour maximumAge: 72 Hours stdAges: CHILD facility: Bakırköy Dr. Sadi Konuk Training and Research Hospital status: RECRUITING city: Istanbul zip: 34854 country: Turkey name: AYŞE KARAKOÇ role: CONTACT phone: +905335695138 email: akarakoc@marmara.edu.tr name: Irem Zulal Topçuoglu Arslan role: SUB_INVESTIGATOR lat: 41.01384 lon: 28.94966 hasResults: False
|
<|newrecord|> nctId: NCT06286800 id: PRO00036824 briefTitle: Personalized Transcranial Direct Current Stimulation in Stroke Recovery overallStatus: NOT_YET_RECRUITING date: 2024-03-14 date: 2026-03-14 date: 2026-09-14 date: 2024-02-29 date: 2024-02-29 name: The Methodist Hospital Research Institute class: OTHER briefSummary: The central objective of this application is to explore the neural substrate of personalized tDCS (ptDCS) and to determine whether the paradigm for each stroke patient can predict the amount of sustained clinical improvement through increased connectivity as measured by a biomarker of plasticity. conditions: Stroke studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 80 type: ESTIMATED name: Transcranial direct current stimulation (tDCS) with OT name: Sham tDCS with OT measure: fMRI functional connectivity biomarker measure: Wolf Motor Function Test measure: Fugl-Meyer assessment sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
|
<|newrecord|> nctId: NCT06286787 id: HSEARS20221110002 briefTitle: Efficacy of Mountain Craft Training at Enhancing the Resilience and Physio-psychological Well-being of Children From Low-income Families overallStatus: RECRUITING date: 2023-11-16 date: 2024-11-01 date: 2024-11-01 date: 2024-02-29 date: 2024-02-29 name: The Hong Kong Polytechnic University class: OTHER briefSummary: It is imperative to offer adequate community resources and psychosocial support, with a particular focus on enhancing resilience for children from low-income families. This study aims to determine the feasibility, acceptability, and preliminary efficacy of mountain craft training in enhancing resilience and self-esteem, reducing depressive symptoms, and improving the physical health of children from low-income families. conditions: Resilience conditions: Well-being conditions: Children studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: NONE count: 40 type: ESTIMATED name: Intervention name: Placebo measure: Resilience Scale-14 (RS-14) measure: Chinese version of the Center for Epidemiologic Studies Depression Scale for Children (CES-DC) measure: Chinese version of Rosenberg's Self-Esteem Scale (RSES) measure: The children's peak expiratory flow rate sex: ALL minimumAge: 12 Years maximumAge: 14 Years stdAges: CHILD facility: The Asbury Methodist Social Service status: RECRUITING city: Hong Kong country: China name: Chung role: CONTACT email: okjoyce.chung@polyu.edu.hk lat: 22.39407 lon: 114.13737 hasResults: False
|
<|newrecord|> nctId: NCT06286774 id: 2096884 briefTitle: Sleep as a Mechanism of Change in Alcohol Use acronym: ReTRAIN overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2028-04-01 date: 2028-04-01 date: 2024-02-29 date: 2024-02-29 name: University of Missouri-Columbia class: OTHER briefSummary: This project aims to evaluate improvement of insomnia as a mechanism of improvement in alcohol use outcomes. conditions: Insomnia conditions: Alcohol; Harmful Use studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Subjects will be randomized to Cognitive Behavioral Therapy for Insomnia (CBT-I) or waitlist control. primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: PI Miller and study therapists will be blinded to assessment outcomes, and assessment RAs will be blinded to participant condition. whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 256 type: ESTIMATED name: Cognitive Behavioral Therapy for Insomnia measure: Insomnia Symptoms measure: Drinking quantity measure: Alcohol-related consequences measure: Treatment willingness (alcohol) measure: Alcohol craving measure: Negative emotionality measure: Response inhibition measure: Working memory measure: Delay discounting measure: Alcohol to help with sleep measure: Heartrate variability measure: Dysfunctional Beliefs and Attitudes about Sleep Scale sex: ALL minimumAge: 18 Years maximumAge: 49 Years stdAges: ADULT facility: University of Missouri-Columbia city: Columbia state: Missouri zip: 65212 country: United States lat: 38.95171 lon: -92.33407 hasResults: False
|
<|newrecord|> nctId: NCT06286761 id: 2100332 briefTitle: Routine Validation and Reproducibility Testing of Laboratory Measures and Research Techniques Used for Metabolism Research (VAL) acronym: VAL overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2028-03 date: 2028-03 date: 2024-02-29 date: 2024-02-29 name: Bettina Mittendorfer class: OTHER briefSummary: The purpose of this research study is to validate (check the accuracy of) laboratory assays, intravenous catheter insertion, and equipment or devices and their reproducibility, which is necessary to perform high quality research on chronic diseases (obesity, pre-diabetes and type-2 diabetes, dyslipidemia, non-alcoholic fatty liver disease, cardiovascular disease, etc.), nutrition, and metabolism (the process by which a substance is handled in your body) at the University of Missouri. As technology changes and we start to use new testing methods, it is necessary to compare results from old tests, equipment and devices and new tests, equipment, or devices and the reproducibility of these measurements to make sure we are getting accurate results. Reproducibility means performing the same test more than once to see if the same results can be achieved each time. conditions: Obesity studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 100 type: ESTIMATED name: endothelial cell collection measure: Validation and reproducibility testing for blood assays measure: Validation and reproducibility testing for endothelial cell collection measure: Validation and reproducibility testing for mixed meal ingestion measure: Validation and reproducibility testing for glucose tolerance testing measure: Validation and reproducibility testing for DEXA measure: Validation and reproducibility testing for MRI measure: Validation and reproducibility testing for MRS sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
|
<|newrecord|> nctId: NCT06286748 id: DeniseMafra19 briefTitle: Beetroot Extract Supplementation Associated With an Exercise Protocol for Chronic Kidney Disease Patients overallStatus: NOT_YET_RECRUITING date: 2024-04-10 date: 2024-12-10 date: 2024-12-10 date: 2024-02-29 date: 2024-02-29 name: Universidade Federal Fluminense class: OTHER briefSummary: Chronic kidney disease (CKD) patients often present systemic inflammation and oxidative stress, resulting in metabolic disorders and high rates of disease-associated cardiovascular death. The literature has indicated that dietary control, the use of bioactive compounds, and the practice of regular physical exercise are essential for the prevention and management of CKD and its complications. In this context, beetroot (Beta vulgaris rubra) deserves attention as it is a source of several bioactive compounds, such as nitrate, betaine, and betalain, with beneficial effects for CKD patients, including anti-inflammatory, antioxidant effects, reduction of blood pressure, and vasodilatory action. The antioxidant and anti-inflammatory properties, in addition to their vasodilatory and antihypertensive capacity, can make supplementation of beetroot an excellent nutritional strategy to help in the treatment of CKD patients. So, this research project will bring contributions to the scientific world, providing strategies for application in clinical practice and the care of patients with CKD, on the use of beetroot associated with an exercise protocol as a non-pharmacological strategy in modulating inflammation, oxidative stress, and improved functional capacity. Furthermore, when supplemented hours before physical training, has been identified as an important factor in improving performance in these activities. Therefore, this study aims to evaluate the effects of supplementation (acute and chronic) of beetroot extract associated with an exercise protocol on complications associated with CKD. conditions: Chronic Kidney Diseases studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: SUPPORTIVE_CARE masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 25 type: ESTIMATED name: Beetroot juice name: Placebo measure: Change individual quality of life measure: Change physical activity level sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
|
<|newrecord|> nctId: NCT06286735 id: DeniseMafra18 briefTitle: Effects of Cinnamomum Supplementation in Chronic Kidney Disease Patients overallStatus: NOT_YET_RECRUITING date: 2024-06-22 date: 2024-11-22 date: 2024-12-22 date: 2024-02-29 date: 2024-03-25 name: Universidade Federal Fluminense class: OTHER briefSummary: Patients with chronic kidney disease (CKD) experience many complications related to inflammation and oxidative stress that are closely related to the progression of kidney failure and increased mortality. Furthermore, these patients may have intestinal dysbiosis associated with persistent uremia, generating greater production of uremic toxins arising from the metabolism of intestinal bacteria and also helping to maintain the inflammatory process and oxidative stress. In this context, some nutritional strategies have been proposed as an adjuvant therapeutic alternative to modulate inflammation and improve the antioxidant response of patients with CKD, and even more so to modulate the intestinal microbiota. Based on the consolidated knowledge of the role of nutrients and bioactive compounds on the expression of genes related to inflammation, oxidative stress, and also the modulation of the intestinal microbiota, cinnamon, a member of the Lauraceae family, has been widely used as a spice and traditional herbal medicine for centuries and has indicated beneficial benefits in cardiovascular diseases, obesity, diabetes. The bioactive compounds in cinnamomum, such as cinnamaldehyde, cinnamic acid, and cinnamate, can attenuate oxidative stress, inflammation, hyperglycemia, intestinal dysbiosis, and dyslipidemia, which are common complications in CKD patients. Therefore, the present project proposes a longitudinal clinical trial study that aims to evaluate the effects of cinnamomum on transcription factors and inflammatory markers, oxidative stress and modulation of intestinal health in patients with CKD on hemodialysis. conditions: Chronic Kidney Diseases studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 30 type: ESTIMATED name: cinnamomum name: Placebo measure: Concentration of Nuclear factor kappa B (NF-KB) sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
|
<|newrecord|> nctId: NCT06286722 id: LollandCD briefTitle: Optimized Rehabilitation of Older Adults With Hip Fracture and Signs of Cognitive Impairment - Feasibility Study acronym: ENHANCE overallStatus: RECRUITING date: 2024-02-08 date: 2025-06-30 date: 2025-06-30 date: 2024-02-29 date: 2024-02-29 name: Lolland Community, Denmark class: OTHER name: Vordingborg Municipality name: Stevns Municipality name: Guldborgsund Municipality briefSummary: Older adults suffering from a hip fracture are a significant concern, with higher incidence rates among women. Mortality rates post-hip fracture are alarming, with up to 8-fold increased risk within 3 months and significant percentages within 30 days and 12 months. Older adults with hip fracture face challenges in regaining pre-fracture level of function, especially those with cognitive impairment, which affects 25% to 40% of cases and increases mortality risk. While interventions exist, such as progressive strength training and structured exercise programs, patients with hip fracture don't consistently restore pre-fracture function, particularly in cognitively impaired patients, who are often excluded from studies. Limited evidence exists on effective management for this subgroup, with a lack of clarity on community-based rehabilitation. Although guidelines suggest exercise interventions for patients with mild to moderate cognitive impairment, the specifics remain uncertain due to insufficient research focused solely on this population.
|
This feasibility study aims to assess the practicality and safety of implementing a 12-week individualized, progressive exercise program for older adults with hip fracture and cognitive impairment in an outpatient setting. Additionally, the investigators seek to gather qualitative insights through observations and interviews regarding participants' experiences and the perceived value of rehabilitation post-hip fracture, particularly focusing on the exercise intervention provided. conditions: Hip Fractures conditions: Cognitive Impairment studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Feasibility study primaryPurpose: TREATMENT masking: NONE count: 20 type: ESTIMATED name: Progressive, individualized and structured exercise program measure: The New Mobility Score measure: Mini Mental State Examination measure: Height measure: Weight measure: Tandem balance test measure: The Barthel-20 measure: 30 sec chair raise test measure: Brief Assessment of Impaired Cognition Questionaire measure: Handgrip strength measurement measure: The Cumulated Ambulation Score measure: Four meter walk test measure: Euroqol 5 dimensions measure: Clinical Frailty Scale measure: The Verbal Rating Scale measure: Activity accelerometers sex: ALL minimumAge: 65 Years stdAges: OLDER_ADULT facility: Stevns Healthcare Center, Stevns Municipality status: NOT_YET_RECRUITING city: Hårlev zip: 4652 country: Denmark name: Lotte Bylov role: CONTACT email: jover@lolland.dk lat: 55.34936 lon: 12.23382 facility: Maribo Health Center, Lolland Municipality status: RECRUITING city: Maribo zip: 4930 country: Denmark name: Jan Arnholtz Overgaard, MSc. role: CONTACT phone: +4554677700 email: jover@lolland.dk name: Gwen Tremmel role: CONTACT phone: +4554677700 email: gptr@lolland.dk name: Jan A Overgaard, MSc. role: PRINCIPAL_INVESTIGATOR lat: 54.77662 lon: 11.50017 facility: Guldborgsund Healthcare Center, Guldborgsund Municipality status: RECRUITING city: Nykøbing Falster zip: 4800 country: Denmark name: Cecilie Kristensen role: CONTACT email: jover@lolland.dk lat: 54.76906 lon: 11.87425 facility: Vordingborg Healthcare Center, Vordingborg Municipality status: RECRUITING city: Vordingborg zip: 4760 country: Denmark name: Line Flemmer, Bachelor role: CONTACT email: jover@lolland.dk lat: 55.00801 lon: 11.91057 hasResults: False
|
<|newrecord|> nctId: NCT06286709 id: RG_22-063 briefTitle: FAecal Microbiota Transplantation in primaRy sclerosinG chOlangitis acronym: FARGO overallStatus: NOT_YET_RECRUITING date: 2024-02-29 date: 2026-04-30 date: 2026-07-29 date: 2024-02-29 date: 2024-02-29 name: University of Birmingham class: OTHER name: PSC Support name: Life Arc briefSummary: FARGO is a randomised, phase IIa, multi-centre, placebo-controlled trial to compare Faecal Microbiota Transplant (FMT) with placebo in patients with primary sclerosing cholangitis (PSC) and concomitant inflammatory bowel disease. conditions: Primary Sclerosing Cholangitis conditions: Inflammatory Bowel Diseases studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Phase IIa, multi-centre, randomised, placebo-controlled, single-blinded, parallel group, clinical trial primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: Single-blind whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 58 type: ESTIMATED name: Faecal Microbiota Transplant name: FMT Placebo measure: Serum Alkaline Phosphatase (ALP) measure: Patient-reported outcome (PRO) measures measure: Patient-reported outcome (PRO) measures measure: Patient-reported outcome (PRO) measures measure: Patient-reported outcome (PRO) measures measure: Surrogate biomarkers of liver fibrosis measure: Surrogate biomarkers of liver fibrosis measure: Routine liver laboratory parameters measure: Routine liver laboratory parameters measure: Routine liver laboratory parameters measure: Routine liver laboratory parameters measure: Routine liver laboratory parameters measure: PSC specific prognostic scores measure: PSC specific prognostic scores measure: Quantitative assessment of Inflammatory Bowel Disease (IBD) activity measure: Quantitative assessment of IBD activity measure: Quantitative assessment of IBD activity measure: The incidence of clinical non-trial endpoint events measure: The incidence of trial endpoint events measure: Occurrence of adverse events sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Queen Elizabeth Hospital Birmingham, University Hospitals Birmingham NHS Foundation Trust city: Birmingham zip: B15 2TH country: United Kingdom name: Palak Trivedi role: PRINCIPAL_INVESTIGATOR lat: 52.48142 lon: -1.89983 facility: St Mark's Hospital, London North West University Healthcare NHS Trust city: London zip: NW10 7NS country: United Kingdom name: Ailsa Hart role: PRINCIPAL_INVESTIGATOR lat: 51.50853 lon: -0.12574 facility: Royal Free Hospital, Royal Free London NHS Foundation Trust city: London zip: NW3 2QG country: United Kingdom name: Douglas Thorburn role: PRINCIPAL_INVESTIGATOR lat: 51.50853 lon: -0.12574 facility: King's College Hospital, King's College Hospital NHS Foundation Trust city: London zip: SE5 9RS country: United Kingdom name: Deepak Joshi role: PRINCIPAL_INVESTIGATOR lat: 51.50853 lon: -0.12574 facility: Norfolk and Norwich University Hospital, Norfolk and Norwich University Hospitals NHS Foundation Trust city: Norwich zip: NR4 7UY country: United Kingdom name: Simon Rushbrook role: PRINCIPAL_INVESTIGATOR lat: 52.62783 lon: 1.29834 facility: John Radcliffe Hospital, Oxford University Hospitals NHS Foundation Trust city: Oxford zip: OX3 9DU country: United Kingdom name: Emma Culver role: PRINCIPAL_INVESTIGATOR lat: 51.75222 lon: -1.25596 hasResults: False
|
<|newrecord|> nctId: NCT06286696 id: NL84914.058.23 briefTitle: Optic Nerve Sheath Diameter in Hypertensive Emergency acronym: OpticUS overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2026-04-01 date: 2026-07-01 date: 2024-02-29 date: 2024-02-29 name: Leiden University Medical Center class: OTHER briefSummary: This prospective observational study investigates the potential of point-of-care ultrasonography of the optic nerve sheath diameter (ONSD) to rule out papilledema in patients with suspected hypertensive emergency. The primary focus is on assessing ONSD sensitivity in identifying papilledema (hypertensive retinopathy grade 4), while secondary endpoints include hypertensive retinopathy grade 3, hypertensive encephalopathy, and the need for intravenous rapid-acting medications to lower elevated blood pressure. This study aims to determine the diagnostic characteristics of this procedure for the diagnosis of hypertensive retinopathy, thus assessing its potential as a screening tool to rule out hypertensive retinopathy by the acute internal medicine doctor. conditions: Hypertensive Emergency conditions: Papilledema conditions: Hypertension studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 375 type: ESTIMATED name: Optic Nerve Sheath Diameter measure: Papilledema measure: Hypertensive retinopathy grade 3 & 4 combined measure: Hypertensive encephalopathy measure: Rapid acting medications administered intravenously to lower the elevated blood pressure measure: Presence of a bulging optic nerve disc and/or crescent sign found by ultrasonography of the optic nerve sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
|
<|newrecord|> nctId: NCT06286683 id: APHP231706 briefTitle: Impact of Early Mobilization on SAH Patients Physiological Parameters acronym: MOBALPAH overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2027-02 date: 2027-02 date: 2024-02-29 date: 2024-03-08 name: Assistance Publique - Hôpitaux de Paris class: OTHER briefSummary: The aim of the study is to evaluate the physiological response to out-of-bed mobilization in patients admitted to the intensive care unit for subarachnoid hemorrhage. More specifically, the aim is to measure the impact on cerebral perfusion, lung aeration, cardiovascular and respiratory parameters. conditions: Subarachnoid Hemorrhage studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 100 type: ESTIMATED name: lung ultrasound name: Transcranial Doppler name: near-infrared spectroscopy (NIRS) name: clinical examination measure: Impact on lung aeration measure: Impact on cerebral blood flow measure: Impact on cerebral tissue oxygenation measure: Impact on heart rate measure: Impact on arterial pressure measure: Impact on Saturation measure: Impact on neurological examination measure: Impact on patient comfort sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Adéla FOUDHAÏLI city: Paris zip: 75010 country: France lat: 48.85341 lon: 2.3488 hasResults: False
|
Subsets and Splits
No community queries yet
The top public SQL queries from the community will appear here once available.