Loading clinical trials...
Loading clinical trials...
Showing 1-20 of 204 trials
NCT07036406
The goal of this clinical trial is to compare the effectiveness of traditional Semantic Feature Analysis (SFA) treatment to a modified SFA protocol that includes Metacognitive Strategy Training (SFA+MST) for adults with acquired aphasia. The main questions it aims to answer are: * What are the comparative outcomes in picture naming accuracy and strategy use during picture naming following 2 months of traditional SFA versus SFA + MST in adults with acquired aphasia? * What are the comparative outcomes in percent of informative content and rate of informative content during spontaneous speech production following 2 months of traditional SFA versus SFA + MST in adults with acquired aphasia? Researchers will compare outcomes between these two treatments to see if SFA+MST yields larger effects in picture naming and spontaneous speech outcomes than traditional SFA. Participants will complete: * 5-7 pre-treatment assessment sessions where they will be asked to name pictures, tell stories/describe pictures, answer questions, and complete questionnaires, * 3 treatment sessions of SFA \*OR\* SFA+MST per week for 8 weeks, for a total of 24 sessions, * 7 weekly probes (i.e., short, intermittent assessments throughout the treatment phase), * 3 post-treatment assessment sessions immediately after treatment ends, where they will complete the same assessment tasks as they did pre-treatment (e.g., naming pictures, telling stories, etc.), * 2 retention assessment sessions, one 30 days and the other 60 days following the final treatment session, where they will be asked to name pictures, tell stories/describe pictures, and describe what they learned during the study.
NCT04983030
A multicenter, randomized, parallel-group, placebo-controlled, double-blind, Phase 1/2a clinical study to investigate the safety, tolerability, immunogenicity and exploratory efficacy of a vaccine regimen consisting of an Ad26.Mos4.HIV prime and a boost with Modified Vaccinia Ankara (MVA)-BN-HIV in combination with broadly neutralizing antibodies (bNAb) PGT121, PGDM1400, and VRC07-523LS in human immunodeficiency virus type 1 (HIV-1)-infected study participants on suppressive anti-retroviral therapy (ART).
NCT05218083
Multicenter, prospective, randomized controlled trial providing mobile health supported physical rehabilitation to 120 patients who have been critically ill with COVID-19 and who complete at least one exercise session.
NCT04875936
The overall goal of this project is to advance a biologically-based approach to treatment of reading disorders after stroke, which will expand the limits of cognitive rehabilitation. Using a novel brain imaging technique, called real-time functional magnetic resonance imaging (fMRI) neurofeedback combined with right hand motor imagery, this project will re-instate brain activity in the left language-dominant hemisphere. Stroke patients will practice modulating their own brain activity using fMRI neurofeedback signal and will select the most effective mental strategies that help them maintain brain activation patterns associated with better reading recovery.
NCT07569835
VARIABLES TO BE COLLECTED AND SOURCE The primary efficacy endpoint will be the maintenance of flatfoot correction over time, assessed both clinically (tip-toe test, Jack test, tip-toe walking test) and radiologically (evaluation of Meary's angle on the lateral foot view and the talocalcaneal angle). The secondary efficacy endpoint will be the absence of pain at follow-up, assessed using the VAS scale, and evaluation of the footprint using a podoscope. TIP-TOE TEST: The patient is observed under weight-bearing conditions and then while rising onto the toes. If the foot is flexible, the plantar arch-previously absent-reappears when standing on tip-toe. JACK TEST: This consists of passive dorsiflexion of the hallux under weight-bearing conditions. If the previously absent arch reappears, the flatfoot is considered flexible. TIP-TOE WALKING TEST: The patient walks for about ten steps on tip-toe. The examiner observes any varus alignment of the hindfoot and reconstruction of the plantar arch. MEARY'S ANGLE: Measured between the longitudinal axis of the talus and that of the first metatarsal on a weight-bearing lateral foot radiograph. TALOCALCANEAL ANGLE: Measured between the longitudinal axis of the talus and that of the calcaneus on a weight-bearing dorsoplantar foot radiograph. VAS: The Visual Analog Scale for pain is a tool used to measure the subjective characteristics of pain experienced by the patient, ranging from 0 (no pain) to 10 (worst imaginable pain). PODOSCOPE FOOTPRINT ASSESSMENT: Evaluation of the isthmus (the narrow portion of the footprint connecting the heel to the forefoot). The foot is considered normal when the width of the isthmus is between one-third and one-half of the maximum width of the forefoot. SAMPLE SIZE AND STATISTICS In Prof. Giannini's study, 30 patients were enrolled; approximately 30% were lost to follow-up over 12 years. Barring further losses, about 20 patients currently followed at Clinic I are expected to be available. ENROLLMENT PROCEDURE Eligible patients will be enrolled in the study only after providing written informed consent. No data collection, procedures, or analyses will be performed prior to obtaining consent. DATA COLLECTION Clinical data required for the study will be extracted from patients' medical records and source documents. A dedicated data collection form will be used to record clinical information and the results of the analyses by the study. For each enrolled patient, a Case Report Form (CRF) will be completed.
NCT07171138
Burn patients are especially vulnerable to developing hospital-acquired pressure sores. The goal of this study is to determine which positions and positioning devices exert the least amount of pressure on problem areas such as the heels, the tailbone, the elbow and the back of the head. With the use of a pressure mapping device, it will allow the investigators to: 1. Identify patients at the highest risk of developing pressure injuries related to positioning/devices. 2. Use the findings to create positioning/device guidelines By optimizing positioning strategies, the investigators aim to enhance patient comfort, prevent complications, and ultimately improve the overall quality of care for burn patients.
NCT06849765
Study Title Rehabilitation Program for Bedridden Patients Using Digital Devices Study Purpose This study aims to evaluate the effectiveness of a rehabilitation program using digital devices and apps for bedridden patients in a hospital setting. The goal is to determine if digital rehabilitation can help improve physical function and contribute to recovery for patients who are unable to move easily. Study Participants The study will involve 20 adult patients who are bedridden and hospitalized. Participants will use the provided app, which delivers a customized rehabilitation exercise program. Study Methodology Exercise Protocol: Patients will follow a personalized exercise program through the MORA app, performing the exercises twice daily for a period of 2 weeks. Each session will last approximately 30 minutes and will be tailored to the patient's physical condition to ensure safety. Safety and Effectiveness Monitoring: The study will track the patients' physical function (e.g., strength, mobility) and monitor for any discomfort or adverse effects that may arise during the exercise sessions. Study Duration The study will run from September 2024 to December 2025. During this period, participants will engage in rehabilitation exercises using the digital app. Expected Outcomes This study will demonstrate whether digital rehabilitation can be a safe and effective treatment option for bedridden patients in the hospital. The findings are expected to help improve physical recovery for these patients and contribute to enhancing rehabilitation practices within hospital settings. Safety Considerations The exercises in this study are designed with safety in mind and will be adjusted to a low intensity. Any discomfort or adverse effects will be monitored closely, and immediate action will be taken if necessary. All exercises will be conducted under the supervision of healthcare professionals.
NCT07529041
The goal of this Proof of Concept Feasibility Study is to improve the fixation stability in patients with fixation loss due to blindness or central vision loss using a patented acoustic real-time feedback device. The main questions it aims to answer are: 1. Fixation guidance - can real-time acoustic biofeedback improve the fixation in healthy patients as well as patients with fixation loss? 2. Optimization of fixation guidance - testing of different stimuli to optimize an acoustic training protocol. 3. Optimization of imaging acquisition - testing improvement of both imaging quality and acquisition time using the acoustic feedback tool. For the proof-of-concept-study, patients are asked to fixate on a target point in a darkened room and keep up the fixation. We record patients eye movements with near-infrared-lighting and a camera. Fixation is tested in three conditions - visual target only, auditory feedback only, and visual target followed by auditory feedback. In between each set of trials, patients are asked to rate their subjective exhaustion on a Likert scale. At the end of each recording session, patients are handed a questionnaire for feedback on our proof-of-concept study and device settings. An ethics-approved extension phase is planned to further optimize device parameters and assess performance in a clinical setting.
NCT07513948
Data about efficacy and safety of daratumumab in iTTP refractory or intolerant to standard immunosuppressive treatments are scarce. Therefore, the investigators aim at collecting evidence on a larger number of patients through a collaborative, international study.
NCT07496645
The use of transcranial direct current stimulation (tDCS) for the management of deficits developed in stroke is a relatively new type of management option. Many of the studies performed using tDCS have focused on improvements noted in hemiplegia as compared to aphasia, which is an equally disabling outcome of strokes. The results of these studies have not been conclusive and concordant with each other. In aphasia management, the majority of the studies have focused on chronic strokes. Since the use of tDCS is relatively new, the studies have not focused on a particular type of deficit or stroke. Very few studies have focused on the impact of solely using tDCS. Very few studies have focused on acute to subacute strokes. The results of the studies have, nevertheless, been encouraging. Improvements in aspects of language tested after a single session of tDCS are short-lived. There is an unmet need to probe the utility of repetitive tDCS on aspects of language function in patients who are aphasic due to acute stroke. There is also a paucity of data in the Indian scenario regarding the same.
NCT06928233
This study aims to investigate whether genetic variation in the TNFAIP3 locus is associated with immune-mediated thrombotic thrombocytopenic purpura (iTTP), and whether such association is mediated by decreased expression of A20 (TNFAIP3). The study includes a case-control design to assess genotype-expression association and a cohort study to evaluate clinical outcomes such as disease relapse.
NCT04479943
The MOVIN (Mobilizing Older adult patients Via a systems-based Intervention) randomized controlled trial is designed to evaluate the impact of the MOVIN intervention on improving the functional ability of older adult hospital patients and reducing their healthcare utilization post-hospitalization. MOVIN is a program to increase patient ambulation while hospitalized. The study's hypothesis is that MOVIN will improve functional outcomes for hospitalized older adult patients by producing a change in nursing practice and culture of ambulation on inpatient units. MOVIN is a unit-based intervention. Therefore all patients on this unit are exposed to the intervention once it is implemented regardless of whether or not they participate in the trial. The study will enroll 360-420 total hospitalized participants 65 years and older for the duration of their stay. It will also enroll any nurses 18 years and older who worked on the units during the study and are willing to fill out surveys.
NCT03087253
Genetic lipodystrophy syndromes are extremely rare, orphan diseases with overall estimated prevalence of less than 2,000 in the United States. These rare disorders characterized by selective loss of adipose tissue and predisposition to insulin resistance and its metabolic complications diabetes, dyslipidemia and hepatic steatosis. Due to these metabolic problems, atherosclerotic vascular disease, recurrent episodes of acute pancreatitis, cirrhosis and other morbidities complicate the lives of these patients. In the last few years, several genes for CGL (AGPAT2, BSCL2, CAV1 and PTRF); FPL (LMNA, PPARG, AKT2, CIDEC, LIPE, PLIN1, PCYT1A and ADRA2A); MAD (LMNA and ZMPSTE24); APS (LMNA); autoinflammatory (PSMB8); NPS (FBN1, CAV1); SHORT syndrome (PIK3R1); and MDP syndrome (POLD1) have been identified. However, there is paucity of information about the natural history of these rare syndromes, especially genotype-specific causes of morbidity and mortality. To overcome the problems outlined above, this multicenter, collaborative, prospective, observational natural history cohort study will be conducted on approximately 500 patients with genetic or acquired lipodystrophy syndromes. Patients will be assessed on a yearly basis for approximately 5 to 7 years to collect robust clinical, metabolic, morbidity and mortality data. Medical history and patient questionnaires will be completed on a yearly basis by patients registered in the study. Clinical data such as vitals, laboratory results and anthropometric measurements will also be collected from patients' medical records if available.
NCT05279547
Up to 60% of patients admitted to the Intensive Care Unit (ICU) with a prolonged stay in the ICU develop complications such as intensive care unit acquired weakness (ICUAW) characterized by limb and respiratory muscle weakness. ICUAW is associated with worse prognosis, longer ICU stay and increased morbidity and mortality. Physical therapy (PT) interventions in the intensive care unit (ICU), can improve patients' outcomes. However, improvements in muscle function achieved with standard physical activity interventions aiming at early mobilization are highly variable due to lack of consistency in definition of the interventions, lack of consideration for the complexity of exercise dose and/or insufficient stimulation of muscles during interventions. It has been suggested that modifying early mobilization and exercise protocols towards shorter intervals consisting of higher intensity exercises might result in more optimal stimulation of muscles. In the present study the researchers therefore aim to simultaneously assess (by non-invasive technologies) locomotor muscle oxygenation and activation along with the measurements of the load imposed on respiration and circulation during two different training modalities i.e., moderate intensity continuous bed-cycling (endurance training) vs high-intensity alternated by lower intensity periods of bed-cycling (interval training).
NCT03936829
This study evaluates the change of insulin resistance and glucose metabolism of patients with panniculitis associated acquired lipodystrophy syndrome and type 1 diabetes with the treatment of cyclophosphamide.
NCT07472114
This is a multicenter, randomized controlled trial designed to evaluate the impact of tNGS in patients with community-acquired pneumonia who experience initial treatment failure.
NCT07409727
Background Mechanical ventilation is an essential medical intervention in the context of critical illness. However, the intervention is associated with a risk of significant, potentially preventable complications. Among these are ventilator-associated pneumonia, sepsis, acute respiratory distress syndrome, atelectasis, and pulmonary edema. Ventilator-associated complications commonly increase morbidity and mortality. They may also prolong the duration of mechanical ventilation and the length of stay in the hospital or the intensive care unit, with increased health care costs; so safe, effective therapeutic and preventative strategies are essential to attenuate poor outcomes from ventilator-associated events. Secretion retention and ineffective cough play a significant role in failed extubation and weaning from ventilator; the presence of the artificial airway, poor humidification of inspired gases, and immobility are the major causes of pulmonary secretion retention in this population. Accumulated secretion in the airways, if extensive, starts a self-sustaining cycle of ventilation/perfusion mismatch, gas-exchange impairment, increased work of breathing. For decades N-acetyl-L-cysteine (NAC) has been used for its mucolytic properties orally in different respiratory diseases like chronic obstructive pulmonary disease (COPD), idiopathic pulmonary fibrosis (IPF) and cystic fibrosis (CF); but its effects are not known if given by nebulization through endotracheal tube (ETT), studies to date have provided inconclusive results. Despite this uncertainty, mucoactive agents are still used in adult ICUs. NAC is usually administered orally, with several formulations and dosage forms available for both short- and long-term treatment of respiratory diseases. The inhalation route might also be considered a practical option, with recent interest, as the therapeutic drug acts directly on the bronchial mucosa, promotes continuous local retention of the drug, prolongs anti-inflammatory effects, and avoids the liver first-pass effect, which can help quickly improve airway inflammation. Contrary to other mucoactive drugs, NAC has been found to exhibit antioxidant, anti-inflammatory, antibacterial, and antibiofilm activities. In the respiratory infection field, the available data indicate that NAC was associated with inhibition of oxidative stress and reduced the inflammatory factors in community acquired pneumonia, antibiofilm activity specially in pseudomonas aeruginosa infection in pre-clinical and clinical reports and has good antibacterial properties and suggested to interfere with biofilm formation and disruption. NAC has shown improvement in the respiratory index (PaO₂/FiO₂), with lower rates of mechanical ventilation in COVID-19. When studied in mechanically ventilated patients with acute respiratory distress syndrome (ARDS), which is associated with oxidative stress, increased levels of glutathione, and inflammation, NAC demonstrated improvements in positive end-expiratory pressure (PEEP) and PaO₂/FiO₂. N-Acetylcysteine contributed to delaying ventilator-associated pneumonia (VAP) in mechanically ventilated patients when administered orally as a preventive medication. It was also effective in attenuating the decline in forced vital capacity (FVC) in mild to moderate idiopathic pulmonary fibrosis (IPF), and it showed a lower rate of postoperative pulmonary complications when given pre-operatively in orthotopic liver transplantation. Since NAC is relatively low-cost, readily available, and has a favorable side effect profile, it is important to properly assess the clinical benefits of nebulized NAC as an adjunct to standard medical treatments in mechanically ventilated patients. Aim of the study This study will assess the role of preventive N-acetylcysteine inhalation on incidence and time to develop VAP in critically ill mechanically ventilated patients. Objectives * 1\) Assessment of N-acetylcysteine inhalation efficacy in mechanically ventilated patients through monitoring the following parameters: time to develop ventilator-associated pneumonia (VAP), incidence of VAP, PaO₂/FiO₂, pH, oxygen saturation (SaO₂), peak inspiratory pressure (PIP), positive end-expiratory pressure (PEEP), frequency of endotracheal tube (ETT) suction and tube exchange, and infection parameters (total leukocyte count, body temperature). In addition, hospital mortality, duration of mechanical ventilation (MV), ventilator-free days, and the length of hospital and ICU stay * 2\) Assessment of the safety of N-acetylcysteine inhalation in mechanically ventilated patients by monitoring the incidence of new-onset bronchospasm
NCT06700694
This single-blind, three-group parallel randomized controlled trial will involve 138 patients with critical illness, randomly assigned at a 1:1:1 ratio to the technology-assisted early mobilization group (46 patients), the systematic early mobilization group (46 patients), or the control group (46 patients). The technology-assisted early mobilization group will receive interventions within 72 hours of ventilator use. The interventions include protocol-oriented early mobilization program carried out by physiotherapist and researcher and technology-assisted in-bed activities primarily assisted by family members. The systematic early mobilization group will receive only the similar protocol-oriented early mobilization program within 72 hours of ventilator use. The control group will receive routine rehabilitation as usual. The primary outcomes include occurrence of intensive care unit-acquired weakness (ICUAW). Secondary outcomes include muscle strength, delirium, sleep status, clinical outcomes, activities of daily living, and quality of life. Measurements will be assessed on the day of enrollment, during the ICU stay, on the day of ICU discharge (or up to 28 days), on the day of hospital discharge, and six months after hospital discharge.
NCT06867458
This is a single-center, non-blinded, prospective, pilot study enrolling patients admitted to the critical care unit at Royal Columbian Hospital. This study investigates the effects of universal nasal decolonization using antimicrobial photodynamic therapy (aPDT) on the prevention of hospital-acquired pneumonia (HAP), ventilator-acquired pneumonia (VAP), and hospital-acquired bloodstream infection (BSI) in this patient population. Main Objectives include: * To determine whether a large, multi-center RCT of this protocol is feasible * To determine baseline rates of VAP, HAP, and ICU-acquired BSI * To gather preliminary efficacy data regarding VAP, HAP, and ICU-acquired BSI prevention using universal aPDT nasal decolonization * To gather preliminary microbiological data on the effect of universal aPDT procedures on nasal carriage of various microoganisms in ICU patients.
NCT05919940
Intensive Care Unit Acquired Weakness (ICUAW) describes muscle weakness that occurs in around 40% of patients during an intensive care stay. The morbidity and mortality of these patients is significantly increased over a 5-year period. The aim of this study is to investigate the combined effect of early enteral high-protein nutrition and early muscle activation on muscle atrophy in critically ill patients. The study will include 40 patients (20 intervention, 20 observation) with requirement for enteral nutrition at time of inclusion. In the intervention group the maximum possible level of mobilization is carried out and muscles are activated twice a day using neuromuscular electrical stimulation (NMES). The nutrition plan of the intervention group is based on the applicable guidelines for intensive care medicine with exception of increased protein intake. The control group receives therapy without deviating from the standard according of the DGEM guideline. The study aims to show that the decrease in muscle mass is significantly less than in the control group (primary hypothesis) via ultrasound of the rectus femoris muscle and in case of given consent muscle biopsy. As secondary hypothesis it is examined whether the combination of early high protein intake and muscle activation improves muscle strength and endurance.