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NCT06857981
Frailty is a multidimensional syndrome that predominantly affects older people and people with long-term treatments such as cancer and chronic pain. This results in an increased risk of disability, reduced resistance and greater vulnerability to stressors. These factors culminate in worse postoperative outcomes, including higher rates of complications and mortality. With the current demographic shift towards an aging population in Latin America and Chile, the prevalence of frailty among surgical patients is increasing. Despite the clear association between frailty and adverse postoperative effects, in Chile there are few centers that routinely perform objective preoperative frailty assessment before to surgery. This is due to logistical challenges, the need for specialized training, and assessment tools. As a result, frailty remains an underestimated syndrome in the perioperative setting. Various interventions have been proposed to improve the care of fragile surgical patients. Prehabilitation, a multidisciplinary program designed to prepare patients for surgery and improve their resilience to surgical stress, has emerged as a promising intervention. Recent studies indicate that prehabilitation may lead to shorter hospital length of stay (LOS) and fewer complications. Recognizing the vital role that frailty plays in surgical outcomes and the paucity of research on prehabilitation, a prehabilitation or timely presurgical conditioning program (Prepare for Your Surgery Program) has been implemented at our center. This proposal seeks to optimize the patient before a surgical intervention in order to reduce frailty and complications, thus improving recovery and medium-term results. The program consists of interventions 4 to 6 weeks before surgery focused on: nursing assessment, screening and follow-up, geriatric and/or internal medicine assessment and intervention, physiotherapy assessment and intervention, nutrition assessment and intervention, psychological assessment and intervention, and preoperative anesthesiology intervention. For this purpose, it has been proposed to create a prospective database of patients from the Prepare for Your Surgery Program, who undergo elective surgery at Hospital Clinico Red Salud UC-Christus.
NCT07012681
It was planned to provide education using verbal education or verbal and picture-text brochure method as a discharge education strategy for patients who underwent intracranial surgery. In this context, it was aimed to compare the effects of two discharge education strategies used in the discharge education of patients who underwent intracranial surgery on the quality of life and daily living activities of the patients.
NCT06542289
Prospective, single-arm, multicenter, single-masked, pivotal study to Evaluate the Safety and Effectiveness of the Blinker system in Participants with Facial Nerve Palsy.
NCT06193590
To evaluate patient-reported pain, bleeding, and device efficiency along with provider satisfaction and ease of use between intrauterine procedures employing a suction cervical stabilizer (new device, FDA approved, atraumatic) or single-tooth tenaculum (standard, traumatic). This device, cleared by the FDA in 2023, was studied in Europe and showed pain reduced by up to 73% and bleeding reduced by 78% compared to the single-tooth tenaculum for intrauterine contraceptive device insertion. The investigators seek to study this device in the United States, and trial it among all intrauterine procedures.
NCT07014228
Endodontic retreatment is performed to alleviate symptoms of recurring infection, post-treatment disease after primary endodontic therapy. Retreatment can be performed in either single or multiple visits. and have their own implications. it is important to compare the patient response and post-op pain after single vs multi-visit reendo treatment.
NCT07013370
Human cytomegalovirus (CMV) is a globally prevalent, human-specific herpesvirus characterised by a lifelong latency after primary infection, an often asymptomatic reactivation and affecting up to 100% of adults based on region and age. CMV reactivation has serious risks for immunocompromised patients, especially those undergoing allogeneic hematopoietic stem cell transplantation (HSCT). In these patients, CMV can lead to graft failure, multiorgan disease, increased risk of other infections, GVHD, post-transplant lymphoproliferative disorders, and higher transplant-related mortality (TRM). Although antiviral prophylaxis, CMV infection occurs in 38-80% of HSCT recipients, but current antiviral drugs are insufficiently effective and they are associated with adverse effects. Furthermore, treatment failure is due to the high genetic variability of CMV. The protective role of virus-specific antibodies remains under debate. Some studies suggest that high neutralizing antibody titers protect transplant recipients from CMV, while others highlight the importance of T-cell responses. However, recent animal studies showed that humoral immunity alone can prevent CMV reactivation, even without T or NK cells. In solid-organ transplant patients, antibody titers ≥480 have been linked to reduced infection, shorter treatment, and full protection from CMV disease. Although the use of anti-CMV immunoglobulin remains controversial, the IRCCS Burlo Garofolo has used it as post-transplant prophylaxis and second-line treatment for over a decade. The main objective of their study was to assess whether CMV-specific immunoglobulin prophylaxis reduces CMV incidence and severity in pediatric HSCT patients. Secondary goals included evaluating its effect on transplant outcomes and its efficacy across different ethnic groups. A population pharmacokinetic (POP/PK) study was also conducted to better understand the drug's distribution and elimination and to identify factors influencing its pharmacokinetics in patients.
NCT05971342
Distal bone loss of the second molar due to extraction of the third molar is one of the most common pathological conditions that results in tooth loss of second molar. However, regeneration of functional alveolar bone has proved difficult. Therefore, the investigators conduct a two-arm study to evaluate the efficacy and safety of alveolar bone regeneration induced by gelatin sponge-loaded apoptotic vesicle complex in patients with mandibular third molar extraction.
NCT07011784
Falls are one of the leading causes of hospitalization and mortality among older adults (aged 65+) in Canada. Falls result from postural instability following age-related declines in muscle strength which begin in the 5th decade of life. Older women have higher rates of injury from falls due to greater deterioration of bone mass density and lower levels of physical activity when compared to men. Participation in physical activity and exercise has been shown to slow these age-related declines in postural stability by improving muscle function as well as proprioceptive and sensory systems, however the majority of older women are inactive. Dance has been used to inspire physical activity uptake among older women, and is particularly good for balance due to its both sensory and motor aspects that focus on precise execution of movement. Dance interventions have been found to improve postural stability and balance confidence. Post-pandemic, online dance classes have provided greater accessibility to exercise interventions aimed at promoting balance. These help reach women facing transportation barriers, who have a fear of exercising with others, women with time-consuming caregiver roles at home etc. While beneficial, the intensity of online classes must be lower to ensure safety, thereby limiting physiological stimulus for adaptations. As typically higher intensity exercise is needed to promote muscle strength there may not be adequate stimulus for adaptations. Furthermore, there is little evidence of strength gains even from in-person dance classes. Blood flow restriction may offer an easy and cost-effective way to mimic higher intensity exercise and boost training benefits. Blood flow restriction has been found to boost strength during low-intensity resistance training, but there is little information on adaptations after balance training or potential transfer to reduce the risk of falls. This 12-week online exercise intervention investigates whether blood flow restriction during dance classes can augment strength, dynamic balance and postural stability of older women aged 65 years and above. Two groups of older women will participate in twice weekly 75 minute ballet and modern-dance classes over Zoom. One group will be randomized to wear 5 centimeter elasticised blood flow restriction bands on their proximal thighs during the classes. Bands will be tightened to a 7/10 of perceived tightness. Postural stability will be assessed using 9, 30-second trials of quiet standing on a force platform in conditions of eyes-open, eyes-closed and on a foam block - trials will be staggered to reduce fatigue effects. Trials will also be video recorded for kinematic analysis of shoulder and hip displacement using Kinovea. Dynamic balance will be assessed using the Star Excursion Balance Test. Participants will be asked to stand on one foot in the middle of the star and reach their other leg as far as they can above the line. The distance the participant reaches in each direction will be recorded and normalized by limb length. Strength will be assessed using the 30-second Sit-to-Stand test and Calf-Raise Senior test. Both tests involve participants doing the maximum number of repetitions possible within a 30-second time frame. Finally scales of fears of falling and overall perceptions of health will be collected. It is expected that this study will have great practical implications as the accessibility of this program can provide opportunities to older adults from various remote locations to increase their levels of physical activity in a safe manner. The affordability may also aid in adoption by community health and recreation centers as an easy-to-implement program that helps to reduce the risk of falls of older women, thereby promoting independence and quality of life.
NCT07003412
The PULSE PVC Registry is a European multicenter observational study designed to assess the safety and efficacy of focal pulsed field ablation (PFA) using the Centauri Generator system in patients with symptomatic premature ventricular contractions (PVCs). The registry collects standardized procedural and follow-up data across diverse PVC origins, enabling comparisons with historical radiofrequency (RF) ablation outcomes. Data will include baseline characteristics, procedural details, complications, and long-term PVC burden reduction. Each center will obtain local ethics approval, and only anonymized data will be analyzed.
NCT07011069
To compare the rhomboid intercostal subserratus plane block with the erector spinae plane block regarding their analgesic efficacy and effects on respiratory function for patients undergoing video-assisted thoracoscopic surgery.
NCT02397720
This will be a phase II, open-label, non-randomized study with a safety lead-in phase. There are 3 Arms in this study each with 2 parts. If you are eligible, you will be assigned to an Arm and a part when you join the study. In each arm, you will receive a different combination of study drugs: Arm 1: nivolumab and azacitidine, Ih Arm 2: nivolumab, azacitidine, and ipilimumab, Arm 3: nivolumab, azacitidine, and venetoclax. There are 2 parts in each arm: Part A (dose escalation) and Part B (dose expansion). The goal of Part A of this clinical research study is to find the highest tolerable dose of the study drugs (nivolumab, azacitidine, ipilimumab, and/or venetoclax) that can be given to patients with AML. The goal of Part B of this study is to learn if the dose found in Part A can help to control AML.
NCT04420923
The purpose of this study is to compare two different treatment protocols for wet macular degeneration; the new protocol called "Observe and Plan" against the current standard protocol "Treat and Extend". Studies suggest that patients achieve equally good visual acuity with fewer controls and that they are more satisfied with the new protocol.
NCT06140420
This is a study to see how effective oral naltrexone is as treatment for prolonged grief disorder (PGD). Participants will take their assigned medication for 8 weeks, with monthly visits to assess symptom severity, social connectedness, and adverse reactions.
NCT05531149
The main objectives of the trial are to assess the efficacy and safety of trimodulin as adjunctive treatment to standard of care (SoC) compared to placebo plus SoC in adult hospitalized subjects with non-severe community-acquired pneumonia (CAP) or moderate / severe Coronavirus Disease 2019 (COVID-19) pneumonia. Other objectives are to determine pharmacokinetic (PK) and pharmacodynamic (PD) properties of trimodulin.
NCT06602817
I-gel Plus is a novel supraglottic airway device that has been evaluated in various studies with high success and low complication rates. Feasibility of supraglottic airway devices (SGA) in patients undergoing surgery in prone position has been demonstrated in some pilot studies and case series; however, the evidence is still limited. It is currently uncertain, if the i-gel Plus facilitates appropriate ventilation in individuals undergoing elective surgery in prone position. The primary aim of this single-center non-inferior study is to assess the leak fraction of the i-gel Plus in patients undergoing surgery in prone position and to compare it with data from an existing prospective control cohort in patients undergoing surgery in supine position. Secondary aims are to investigate the oropharyngeal seal pressure and other secondary outcome parameters and to compare them with the control cohort.
NCT06658977
Triumeq is an approved medicine for HIV. The effectiveness of Triumeq in Amyotrophic Lateral Sclerosis (ALS) is being investigated in the Lighthouse II trial. This study aims to assess whether Triumeq is safe and effective at delaying ALS disease progression when given long term. It is available for participants who have completed the Lighthouse II study. The main measurements are safety, tolerability and survival. The study will go for approximately 2 years.
NCT02074839
The purpose of this Phase I, multicenter study is to evaluate the safety, pharmacokinetics, pharmacodynamics and clinical activity of AG-120 in advanced hematologic malignancies that harbor an IDH1 mutation. The first portion of the study is a dose escalation phase where cohorts of patients will receive ascending oral doses of AG-120 to determine maximum tolerated dose (MTD) and/or the recommended Phase II dose. The second portion of the study is a dose expansion phase where four cohorts of patients will receive AG-120 to further evaluate the safety, tolerability, and clinical activity of the recommended Phase II dose. Additionally, the study includes a substudy evaluating the safety and tolerability, clinical activity, pharmacokinetics, and pharmacodynamics of AG-120 in subjects with relapsed or refractory myelodysplastic syndrome with an IDH1 mutation. Anticipated time on study treatment is until disease progression or unacceptable toxicity occurs.
NCT07010900
The goal of this clinical trial is to learn if Platelet-Rich Plasma Injections from Cord Blood (CB-PRP) is useful in Peyronie disease. The primary goal is evaluation of patient satisfaction at 1 and 3 months after treatment completion using the PDQ Questionnaire Secondary Objectives are: * Measurement of penile curvature measured with a goniometer with spontaneous erection before and after treatment (1 and 3 months) * Measurement of penile length in stretching before and after treatment (1 and 3 months) * Evaluation of the improvement in quality of life, through the Short-Form Health Survey 12 (SF-12) health status questionnaire and through the Hospital Anxiety and Depression Scale (HADS) Participants will be randomized in two groups: * penile extender alone * penile extender + CB PRP injection (1 injection every 15 days - 3 in totalinjections)
NCT05994300
External radiation given in 25 fractions or so together with weekly chemotherapy and followed by 5 or 6 fractions of brachytherapy is the standard of care for patients with locally advanced cervical cancer. We hope to develop external moderately hypofractionated radiotherapy of cervical cancer based on adaptive radiotherapy.The objective of this study is to evaluate the efficacy and treatment-related toxicity of moderately hypofractionated adaptive radiotherapy in the treatment of cervical cancer.
NCT06697951
Breathing problems are a leading cause of newborn death/sickness worldwide but most of deaths are in low resources areas. Over 99% of newborn death is in countries with limited healthcare resources like Nigeria and Nepal. Background For newborns who have trouble breathing, breathing with a machine that does not require an invasive breathing tube but only small nasal tubes is associated with lower rates of lung disease and less pneumonia or lung disease than newborns who have a breathing tube going into their lungs to help their breathing. Nasal Intermittent Positive Pressure Ventilation (NIPPV) is often used in high resource countries, but these machines are expensive. NIPPV gives many newborns the extra support needed to help with trouble breathing by providing extra pressure to help more air/oxygen get into their lungs. Neovent was designed to provide NIPPV at a much lower cost than machines than conventional machines. The Neovent has been shown to be safe and the device feasible in a higher resourced nursery than found in most nurseries in Nigeria and Nepal. The primary and critical research gap this study will address is to show that investigators in lower resourced nurseries can use the Neovent thus demonstrating that this device is feasible to provide NIPPV for newborns with breathing problems without any more safety problems that those seen with the continuous positive airway pressure currently used in lower resourced nurseries in Nigeria and Nepal. Aims The investigators believe NIPPV using the Neovent is feasible for use by healthcare providers in lower resourced nurseries in Nepal and Nigeria; that NIPPV provided by Neovent will be as safe as breathing support providing by machine CPAP and newborns on Neovent will not have more nasal irritation or nose bleeds, more stomach problems, or air around their lungs than newborns on machine CPAP. Study design Newborns with mild-moderate breathing trouble whose mother/caregivers agrees will be placed on Neovent for 6 hours and monitored closely for any problems with the machine or newborn that are related to the machine especially injury to the nose, nosebleeds, swollen belly or abdomen, or air around the lungs. Sample size We plan to enroll 70 newborn infants total from both sites in Nepal and Nigeria. Next Steps The next step would be to do a study to determine if the Neovent is as good as other more expensive forms of breathing support for newborn infants.
