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Намерени 4,781 изпитвания Стр. 94 от 240
Набира участници
Aerobic Exercise Versus Digital Cognitive Behavioral Therapy for Insomnia
Insomnia Chronic

The purpose of this study is to compare the effects of aerobic exercise versus digital CBT-I in university students with insomnia complaints. This is a clinical trial. Participants will be randomized into two groups: aerobic exercise (n=25) and digital CBT-I (n=25). The severity of insomnia, sleep quality, pre-sleep cognitive and somatic arousal, and participants' complaints of depression, anxiety, and stress will be assessed using self-administered questionnaires. Based on previous studies describing the effects of physical exercise on chronic insomnia, the hypothesis of this study is that aerobic exercise promotes similar results compared to digital CBT-I in insomnia severity and sleep quality, in addition to improving the complaints of depression, anxiety and stress of the participants.

Начало: 10.10.2024 Край: 30.12.2027 Възраст: от 18 г.
Brazil Universidade Federal de Goias NCT06636006
Набира участници
Contrast-Enhanced Photon-Counting Detector CT (PCD-CT) for the Local Staging of Rectal Cancer
Rectal Carcinoma

This study evaluates whether images taken using a photon counting detector CT scanner (PCD-CT) can determine the growth of rectal cancer as well as, or better than, MRI for the management of patients with rectal cancer.

Начало: 07.10.2024 Край: 31.12.2026 Възраст: 18–99 г.
United States Mayo Clinic NCT06965166
Набира участници
BASIS Optimization
Mental Health Health Services Evidence Based Programs in Schools

The objective of the BASIS R34 pilot study is to test the impact of eBASIS in a randomized controlled trial (RCT). Consistent with IMPACT's IQM, the study tests effects of eBASIS on treatment fidelity and youth outcomes, compared to a digitally delivered control (N=32 clinicians; 96 clients). A well-established EBP (Cognitive Behavioral Therapy Plus), will be a focus of the investigation, which eligible participants will already be signed up to receive.

Начало: 05.10.2024 Край: 30.07.2026 Възраст: от 18 г.
United States University of Washington NCT06672835
Набира участници
Effects of Processed Foods on Brain Reward Circuitry and Food Cue Learning
Ultra-processed Foods (UP)

Examine if ultra-processed (UP) foods are more effective in activating reward, attention, and memory brain regions and in promoting food cue learning than minimally-processed foods. Assess individual differences in neurobehavioral responses to UP foods.

Начало: 04.10.2024 Край: 28.02.2029 Възраст: 13–15 г.
United States Stanford University NCT06165952
Набира участници
Evaluation of a Haptic Glove for Assessing Tactile Perception in Post-Stroke Patients
Stroke

The aim of the SCORES Haptic Glove Study is to assess the technical features, safety, and reliability of a sensor-equipped glove designed to evaluate tactile perception. This will help guide further technical and functional improvements to finalize the device. The secondary goal is to validate a new tactile sensitivity index based on data collected using the glove. This will be done in a randomized controlled multicenter study (ClinicalTrials.gov ID NCT06109324) aimed to compare the effectiveness of robotic upper limb rehabilitation to conventional treatment in improving cognitive and sensory deficits, as well as evaluating the impact of these deficits on motor recovery.

Начало: 04.10.2024 Край: 01.04.2027 Възраст: 18–85 г.
Italy Fondazione Don Carlo Gnocchi Onlus NCT06643273
Набира участници Фаза 1
A Study of BG-C477 in Participants With Advanced Solid Tumors
Advanced Solid Tumors

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity of BG-C477 alone and in combination with anticancer agents in participants with selected advanced solid tumors.

Начало: 03.10.2024 Край: 31.12.2027 Възраст: от 18 г. Лечение
Australia, China, Japan +2 BeOne Medicines NCT06596473
Набира участници Фаза 2/3
Can PLIA Reduce Early Post-operative Pain After PAO Surgery?
Hip Dysplasia

The goal of this clinical trial is to compare different peri-incisional local infiltrative anesthesia (PLIA) methods in patients ages 13 to 50 undergoing a periacetabular osteotomy (PAO). The main questions to answer here are: 1. Does PLIA impact post-operative pain after PAO? 2. Does PLIA impact pain medication usage as measured by morphine equivalent dosing (MED) after PAO? 3. Does the timing of PLIA administration impact post-operative pain and MED after PAO? Participants will be asked to complete some surveys; demographics survey, General Self-Efficacy Scale (GSE) and the Pain Resilience Scale. All other information will be gathered from the patients medical chart. Researchers will compare three groups. 1.) Patients who do not receive PLIA. 2.) Patients who receive PLIA after their incision is closed. 3.) Patients who receive PLIA throughout PAO.

Начало: 03.10.2024 Край: 01.09.2026 Възраст: 13–50 г.
United States Michael C Willey NCT06519955
Набира участници
The Prevalence of the Aortic to Radial Pressure Gradient in States of Shock, Outside the Context of Cardiac Surgery, a Prospective Study
Shock

First described in cardiac surgery, the aortic to radial pressure gradient (ATRAP) is the cause of an underestimation of the aortic pressure with a measure assumed with a radial catheter, and he can concert 1 of 3rd patients. The risks factor well known are small height, previous hypertension, long and difficult surgery, radial artery diameter less than 1.8mm. The ATRAP definition is a pressure difference between radial and femoral (same of the aortic pressure) pressure of 25mmHg on the systolic pressure, or a pressure difference on the mean pressure of 10mmHg, both measures realised by arterial canulation, and with a duration superior than 5 minutes. If this gradient appears in pathophysiological specifics situations, there is a risk of inappropriate administration of vasopressors, with more hospitalisation days, more side effect of vasopressors like an augmentation of myocardial work. The ATRAP is documented in septic shock with a prevalence between 21% and 27%. The ATRAP can appear in shocks, moreover with doses of equivalent norepinephrine of 0.5 µg/kg/min who is use for the definition of refractive shock, the difference between the two pressure is higher if the dose of equivalent norepinephrine is higher than 1µg/kg/min. But the prevalence and risks factors are barely unknowns in this situation. Most of the time, a radial arterial catheter is used for hemodynamic monitoring for his simplicity of utilisation and the lows complications associated. Some medical teams in cardiac surgeries, or in intensive care unit (ICU) for the management of shocks used often radial and femoral arterial catheter. It seems there is no at risk for the utilisation of a radial and femoral arterial canulation. Out of the situation of cardiac surgery, there is a lack of information of the ATRAP, the objective of the study is to evaluate the prevalence of the ATRAP in shock, out of the situation of cardiac surgery.

Начало: 03.10.2024 Край: 03.11.2027 Възраст: 18–99 г.
France Hospices Civils de Lyon NCT06460519
Набира участници
Ketogenic Diet and Brain Response in Anorexia Nervosa
Anorexia Nervosa

This is a longitudinal study with an open design in weight recovered anorexia nervosa (wrAN) individuals. Healthy controls (HC) will also be assessed. Study participants will be carefully assessed and will have 18F-fluorodeoxyglucose (\[18F\]FDG) positron emission tomography (PET) scans for assessment of regional brain glucose uptake. The wrAN group will be compared to healthy controls. Participants in the wrAN group will then complete 14 weeks of therapeutic ketogenic diet (TKD). At the end of the TKD study, participants will have assessments and a second \[18F\]FDG and TMS/EEG scan. Study participants will be followed over six months after the intervention. This follow-up procedure will help determine whether symptom improvement will be stable or worsen in individuals who choose to continue or discontinue the TKD intervention. This will be a naturalistic follow-up.

Начало: 02.10.2024 Край: 01.01.2030 Възраст: 18–45 г.
United States University of California, San Diego NCT06540703
Набира участници
NIMH Clinical Pathway in Rural Appalachian School-based Health Clinics
Suicide Prevention Suicide

This study will adapt and evaluate an evidence-based suicide risk screening and follow-up program in two school-based health centers in West Virginia. The suicide screening program is titled the "NIMH Clinical Pathway" and provides tools and procedures for routinely screening adolescents for suicide risk, completing risk assessments, safety planning, lethal means restriction, follow-up referrals, and other disposition planning as appropriate. Investigators aim to do the following: 1. Gather formative data from providers, parents, and youth to inform ways to adapt and implement the NIMH Clinical Pathway so that it can be effectively implemented in rural, Appalachian School-Based Health Centers (SBHCs). 2. Gather preliminary data regarding the feasibility, acceptability, and effectiveness of the adapted intervention.

Начало: 02.10.2024 Край: 01.05.2027 Възраст: 12–17 г.
United States West Virginia University NCT06808503
Набира участници Фаза 2
A Trial to Test if TEV-56286 is Effective for Treatment of Participants With Multiple System Atrophy
Multiple System Atrophy

The primary objective of the study is to evaluate the efficacy of TEV-56286 administered orally for the treatment of adult participants with Multiple System Atrophy (MSA). A secondary objective of the study is to evaluate specific efficacy parameters of TEV-56286. Another secondary objective is to evaluate the safety and tolerability of TEV-56286. The planned study period per participant is 56 weeks including a screening period (up to 4 weeks), a 48-week double-blind treatment period, and a follow-up visit (approximately 4 weeks after the end of the double-blind treatment period). The study duration will be approximately 27 months.

Начало: 02.10.2024 Край: 15.09.2027 Възраст: 30–75 г.
France, Germany, Israel +4 Teva Branded Pharmaceutical Products R&D LLC NCT06568237
Набира участници Фаза 3
A Trial to Evaluate Intravesical Nadofaragene Firadenovec Alone or in Combination With Chemotherapy or Immunotherapy in Participants With High-grade BCG Unresponsive Non-muscle Invasive Bladder Cancer
Non-muscle Invasive Bladder Cancer With Carcinoma in Situ

The pivotal phase 3 trial (rAd-IFN-CS 003) evaluating the efficacy of nadofaragene firadenovec showed that 55 (53.4%) of 103 subjects with CIS ± high-grade Ta/T1 achieved a complete response (CR) at 3 months. In this trial, the safety and efficacy of intravesical instillation of nadofaragene firadenovec alone or in combination with chemotherapy or immunotherapy will be evaluated in participants with NMIBC CIS (± high-grade Ta/T1).

Начало: 01.10.2024 Край: 31.12.2030 Възраст: от 18 г.
Canada, Czechia, France +4 Ferring Pharmaceuticals NCT06545955
Набира участници
DISCOVERY of Risk Factors for Type 2 Diabetes in Youth
Diabetes Mellitus Type 2, Childhood-Onset

The goal of the DISCOVERY study is to provide innovative critical information regarding the unique natural history of glycemic control, insulin sensitivity, and β-cell function, and their mechanistic determinates, in obese adolescents at risk for developing type 2 diabetes.

Начало: 01.10.2024 Край: 31.01.2028 Възраст: 8–15 г.
United States George Washington University NCT06525259
Набира участници
A Multifocal tDCS-EEG Protocol for Improving Symptoms of Mild Cognitive Impairment and Early Dementia
Mild Cognitive Impairment (MCI) Dementia Alzheimer Disease, Early Onset Alzheimer Disease +2

The goal of this clinical trial is to learn if an integrated protocol using multifocal non invasive brain stimulation and brain recording combined with cognitive training is effective in treating cognitive and affective symptomatology in patients with mild cognitive impairment and early stages of dementia. The main questions it aims to answer are: * Does multifocal non-invasive brain stimulation reduce cognitive and affective symptoms in patients with mild cognitive impairment and early stages of dementia? * Do some specific factors, such as education and cognitive reserve, affect the extent of the possible outcomes achievable from the intervention? * Do electrophysiological measures contribute identifying responders and non-responders to the treatment? Researchers will compare real non-invasive brain stimulation to a placebo stimulation (reproducing the same feeling of stimulation without actually stimulating the brain) combined with cognitive rehabilitation on general cognition measures and depression symptoms. Participants will * Undergo two treatment cycles (real stimulation or placebo over frontal and temporal ares of the left hemisphere) combined with cognitive training twice a week for two months. * Complete neuropsychological evaluations before the first rehabilitation cycle and at the end of each rehabilitation cycle. Caregivers will provide information on functional daily living activities for their relatives.

Начало: 01.10.2024 Край: 01.10.2026 Възраст: 55–85 г.
Italy University of Campania Luigi Vanvitelli NCT06668610
Набира участници
Potential of Interface Care Models to Deliver More Appropriate Care to Patients With Acute Medical Illness
Falls Injury Falls Hospitalization in Acute Care Chronic Obstructive Pulmonary Disease (COPD) +5

Every country in the world is experiencing growth in both the size and the proportion of older persons. As a result of the changes, the profile and needs of people with medical illnesses have evolved. How care is delivered to patients has to keep pace with these changes, or patients will experience poor care at high cost and not have their needs met. A new model of care has emerged to meet these challenges: Acute Medical Unit. Despite considerable investment and popularity of this model, questions remain: (i) Who benefits most from this care model? (ii) How may these models be most effectively implemented for the best results? (iii) How effective are these models? Singapore is well-placed to answer these questions with its national healthcare system and excellent research institutions. The investigators plan to study how effective the model is by comparing patients with similar profiles exposed to both these care models compared to how hospital care is usually provided, looking for four differences: (i) how long patients stay in hospital, (ii) how often they use the emergency department (iii) quality of health (iv) cost. Additionally, the investigators seek to characterise patterns of health needs for this group of patients.

Начало: 30.09.2024 Край: 31.05.2026 Възраст: от 21 г.
Singapore National University Hospital, Singapore NCT07536035
Набира участници Фаза 2
Efficacy and Safety of Envafolimab Plus Doxorubicin and Ifosfamide for Advanced Soft Tissue Sarcoma
Soft Tissue Sarcoma

Soft tissue sarcoma (STS) is a rare, highly heterogeneous malignancy with a poor prognosis. The standard first-line treatment for advanced patients is anthracyclines (doxorubicin, A) combined with ifosfamide (I, AI regimen), but the efficacy is limited, and some subtypes do not respond well. Immune checkpoint inhibitors (ICI) have shown potential in specific STS subtypes. Anthracyclines can induce immunogenic cell death and upregulate PD-L1, providing a theoretical basis for combined immunotherapy. Previous studies have shown that ICI combined with chemotherapy (such as pembrolizumab + doxorubicin) is more effective than chemotherapy alone. Envolizumab is the world's first subcutaneously injected PD-L1 single-domain antibody-Fc fusion protein, with significant advantages: (1) small molecular weight (\~80kDa) and strong tissue penetration; (2) high stability and can be stored at room temperature; (3) convenient subcutaneous injection and good tolerability (Phase II study of MSI-H/dMMR solid tumors ORR 42.7%, grade 3-4 TEAE 15.5%). In 2022, the FDA granted orphan drug designation for the treatment of STS. This study aims to evaluate the efficacy (ORR, PFS, OS, etc.) and safety of Envolizumab combined with an AI regimen (doxorubicin + ifosfamide) as a first-line treatment for advanced STS.

Начало: 30.09.2024 Край: 01.06.2027 Възраст: от 18 г.
China Second Affiliated Hospital, School of Medicine, Zhejian NCT07243626
Набира участници Фаза 2
Venetoclax and HMA Treatment of Older and Unfit Adults With FLT3 Mutated Acute Myeloid Leukemia (AML) (A MyeloMATCH Treatment Trial)
Acute Myeloid Leukemia

This phase II MyeloMATCH treatment trial compares the usual treatment of azacitidine and venetoclax to the combination treatment of azacitidine, venetoclax and gilteritinib in treating older and unfit patients with acute myeloid leukemia and FLT3 mutations. Azacitidine is a drug that is absorbed into DNA and leads to the activation of cancer suppressor genes, which are genes that help control cell growth. Venetoclax is in a class of medications called B-cell lymphoma-2 (BCL-2) inhibitors. It may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. Gilteritinib is in a class of medications called kinase inhibitors. It works by blocking the action of a certain naturally occurring substance that may be needed to help cancer cells multiply. This study may help doctors find out if these different approaches are better than the usual approaches. To decide if they are better, the study doctors are looking to see if the study drugs lead to a higher percentage of patients achieving a deeper remission compared to the usual approach.

Начало: 27.09.2024 Край: 15.05.2029 Възраст: от 18 г.
Puerto Rico, United States National Cancer Institute (NCI) NCT06317649
Набира участници Фаза 3
A Study of Elacestrant Versus Standard Endocrine Therapy in Women and Men With ER+,HER2-, Early Breast Cancer With High Risk of Recurrence
Breast Cancer

The primary goal of this study is to evaluate the effectiveness of elacestrant versus standard endocrine therapy in participants with node-positive, Estrogen Receptor-positive (ER+), Human Epidermal Growth Factor-2 negative (HER2-) early breast cancer with high risk of recurrence.

Начало: 27.09.2024 Край: 01.10.2032 Възраст: от 18 г. Лечение
Argentina, Australia, Austria +24 Stemline Therapeutics, Inc. NCT06492616
Набира участници
The Feasibility of Pulmonary Perfusion Assessment Using Sodium Bicarbonate Contrast With Electrical Impedance Tomography: A Prospective Pilot Study
Acute Respiratory Failure Acute Respiratory Distress Syndrome (ARDS) Pneumonia Critical Illness +1

The goal of this observational pilot study is to learn if sodium bicarbonate can be used safely and effectively as a contrast agent to map lung blood flow using electrical impedance tomography (EIT) in adults on mechanical ventilation. Electrical impedance tomography (EIT) is a bedside imaging method that uses a soft belt with small sensors around the chest to track changes in electrical signals related to breathing and blood flow. The main questions are: Does sodium bicarbonate create clear, readable lung blood flow images with EIT? Are these images similar in quality and pattern to images made with hypertonic saline (10% sodium chloride)? Is the short-term safety profile acceptable, including effects on blood pressure, heart rhythm, and blood tests? Researchers will compare two contrast agents within the same participant to see if image quality and lung blood flow patterns match: Hypertonic saline (10% sodium chloride) Sodium bicarbonate (5%) Participants will: Have an EIT belt placed around the chest during routine ICU care Pause the ventilator briefly during image capture to reduce motion Receive two small intravenous boluses through an existing central line, one of hypertonic saline and one of sodium bicarbonate, with time between doses Have routine monitoring of vital signs; blood gases and electrolytes may be checked per clinical care Be observed for any short-term side effects Findings from this study will show whether sodium bicarbonate is a practical and safe option for EIT-based lung blood flow assessment and will guide larger future studies.

Начало: 26.09.2024 Край: 25.09.2026 Възраст: от 18 г.
China First Affiliated Hospital of Wannan Medical College NCT07542366
Набира участници Фаза 2
High vs.Standard Dose Influenza Vaccine in Pediatric Solid Organ Transplant (SOT) Recipients
Immunization; Infection Transplantation Infection Influenza

Influenza virus is a significant pathogen in pediatric solid organ transplant (SOT) recipients. However, these individuals respond poorly to standard-dose (SD) inactivated influenza vaccine (IIV). Recent studies have investigated two strategies to overcome poor immune responses in SOT recipients: (1) administration of high-dose (HD)-IIV compared to SD-IIV and (2) two doses of SD-IIV compared to one dose of SD-IIV in the same influenza season. One study compared HD-IIV vs. SD-IIV in adult SOT recipients and noted that HD-IIV was safe and more immunogenic; however, the median post-transplant period was 38 months. A phase I pediatric study comparing a single dose of HD-IIV vs. SD-IIV was safe with higher immunogenicity, but the study was limited by small sample size and median post-transplant vaccine administration was 26 months. In another phase II trial of adult SOT recipients, two doses of SD-IIV one month apart compared to one-dose of SD-IIV revealed modestly increased immunogenicity when given at a median of 18 months post-transplant. Therefore, these studies lack both evaluation in the early post-transplant period and substantive pediatric populations. Additionally, the administration of two-doses of HD-IIV in the same influenza season has not been evaluated in pediatric SOT recipients. Thus, the optimal immunization strategy for pediatric SOT recipients less than 24 months post-transplant is unknown. In addition, immunologic predictors and correlates of influenza vaccine immunogenicity in pediatric SOT recipients have not been well-defined. The central hypothesis of our proposal is that pediatric SOT recipients 1-23 months post-transplant who receive two doses of HD-quadrivalent inactivated influenza vaccine (QIV) will have similar safety but higher Hemagglutination Inhibition (HAI) geometric mean titers (GMTs) to influenza antigens compared to pediatric SOT recipients receiving two doses of SD-QIV.

Начало: 26.09.2024 Край: 01.09.2027 Възраст: 3–17 г.
United States National Institute of Allergy and Infectious Diseases ( NCT05947071
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