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NCT06893263
Aim: This clinical study investigated the effect of the "cut-out-rescan" procedure under different rubber dam isolation (blue and black) on restorative scanning trueness of two intraoral scanners. Materials and Methods: The initial scans were collected from 20 patients using two dental intraoral scanners (Cerec Primescan, Dentsply Sirona; iTero Element 5D, Align). The 3-dimensional data was obtained from the right or left side of the mandibula between the canine-to-2nd molar area and recorded in .stl format. Then the 2nd premolar was cut with the cutting tool in the related scanner software in a range including 1mm from the adjacent teeth. The determined area was clinically isolated with the rubber-dam and the same quadrant was rescanned to let the software overlap with the cut-out area. In one of the separate appointment sessions given for the treatment of the patient's decayed teeth in this area, this procedure was performed with a blue rubber dam isolation, and in the other, with a black rubber dam isolation.The overlapped scan was recorded in .stl format as the second scan data. The first and second scan data from the 4 scanners were then transferred to the Oracheck (Dentsply Sirona) software program and digitally overlapped to measure the conformity. The deviations detected in the 1st premolar, 2nd premolar, and 1st molar were selectively and jointly assessed in distance (mm) and volume (mm3) for every scanner data. Robust ANOVA and Kruskal Wallis tests were used for the statistical analyses and the significance level was set at \<.050.
NCT04670900
Operative treatment, with tension band wiring or plate fixation, will be compared with non-operative treatment of displaced olecranon fractures (Mayo classification 2A and 2B) in patients 75 years or older.
NCT05921162
This study "A Long-Term Follow-Up Study in Subjects Who Received an Adeno-Associated Viral Vector Serotype 2 Containing the Multi-Characteristic Opsin Gene (vMCO-I) Administered Via Intravitreal Injection" is an observational study and will be conducted following Good Clinical Practice (GCP)- International Conference on Harmonization (ICH) guidelines. Eligible subjects satisfying all inclusion and none of the exclusion criteria will be enrolled. All subject who completed the parent clinical study (NSCT/CT/18/01) will undergo safety and efficacy assessments up to 5 years post study drug injection
NCT06664242
Cardiac Surgery (CH) aims to increase survival and improve quality of life in eligible cardiac patients. However, as with any invasive intervention, pain is one of the main complaints of patients in the post-surgical period. This research is justified by the evaluation of the potential impact of the use of TENS as an alternative for analgesia in reducing the length of hospital stay and directly in the effective cost of patients undergoing cardiac surgeries, in reducing morbidity and mortality, as well as in the quality of life and early return to their daily activities, in addition to reducing the use of drugs and potentially their side effects. The objective of this study is to evaluate the effect of TENS for analgesia in hospitalized patients undergoing cardiac surgery, investigating its efficacy, safety and impact on postoperative recovery.
NCT06893172
Postherpetic neuralgia (PHN) is the most common clinical complication of herpes zoster. PHN can persist for months to years, and in some cases, the pain may last for more than five years. Patients suffering from severe, prolonged pain endure significant distress, which seriously affects their quality of life and daily activities. Moreover, PHN can lead to insomnia, anxiety, depression, or even suicide. Currently, the treatment of PHN primarily focuses on pain management. First-line treatment options include gabapentin, pregabalin, tricyclic antidepressants, and 5% lidocaine patches. Acupuncture is a widely used non-pharmacological therapy. A large number of clinical trials have demonstrated its effectiveness in treating various neuropathic pain conditions, including PHN. Acupuncture not only reduces pain perception but also alleviates anxiety and improves the quality of life for PHN patients. Among different acupuncture techniques, Warm Acupuncture (WA) is considered the most effective for treating peripheral neuropathic pain. Clinical case reports have also shown its pain-relieving effects in PHN patients. However, there has been no study in Vietnam on the effectiveness of WA in pain reduction for patients with PHN. Therefore, this study is conducted to evaluate whether WA is effective in reducing pain and ensuring safety for treating PHN patients with Qi Stagnation and Blood Stasis syndrome. The findings will serve as a basis for the broader application of WA in the treatment of PHN.
NCT06886698
Children undergoing magnetic resonance imaging (MRI) of the brain often need to be sedated to complete the examination, as it is difficult to remain still for a long period, which is required to obtain usable images. During sedation, most patients typically experience a drop in blood pressure, including children. Maintaining an adequate blood pressure under anesthesia is important, as blood pressure is routinely used as a measure to ensure sufficient blood circulation to the body's organs, including the brain. Ensuring adequate blood flow to the brain is one of the cornerstones of all anesthesia, including in children. Therefore, low blood pressure during anesthesia is often treated with standardized interventions, such as blood pressure-raising interventions. These treatments generally restore blood pressure to normal, but how this affects blood flow to the brain in children is not fully known. With the help of modern MRI technology (so-called Arterial Spin Labeling, ASL), blood flow in the brain can be measured quickly and completely safely with high precision. In similar situations with adult patients, it has been observed that while blood pressure-raising interventions successfully normalize low blood pressure, MRI scans show that blood flow to the brain paradoxically decreases despite the increase in blood pressure. It is believed that this may be due to the brain's blood vessels constricting. The investigators now wish to examine this relationship in sedated children undergoing planned brain MRI for certain diagnoses. The investigators hypothesis is that standardized measures intended to raise blood pressure (i.e., the routine treatment used regardless of whether a patient participates in the study or not) normalizes low blood pressure (when deemed necessary to treat according to routine) but does not necessarily lead to improved blood flow to the brain. Primary research question: How does routine treatment of low blood pressure affect cerebral blood flow in sedated children?
NCT06165172
This is a single-center, single-arm, open-label study aiming to assess the safety and feasibility of the MyoRegulator® device when used to treat individuals with amyotrophic lateral sclerosis (ALS). This study is the first use of the MyoRegulator® device to treat individuals with ALS. The main objective of this study is to confirm that individuals with ALS can tolerate the study treatment regimen without any evidence of serious adverse events related to the use of the device. The MyoRegulator® device is a non-significant risk (NSR) investigational non-invasive neuromodulation device that uses multi-site direct current (multi-site DCS) stimulation. It has been used in two completed clinical trials evaluating its efficacy to treat post-stroke muscle spasticity and is currently being evaluated in a third trial in this post-stroke population.
NCT04592198
Phase 2 study to compare efficacy, safety and PK of palonosetron, a long acting 5-HT3 receptor antagonist, by buccal film delivery compared to iv injection for chemotherapy induced nausea or vomiting (CINV). Subjects receive a single dose of palonosetron prior to moderately emetogenic chemotherapy.
NCT05521308
Internal research on the manufacturer's hearing aid products has idenitfied areas in which the investigators can improve the hearing aid frequency response curve. This study aims to investigate the current freqeuncy response curve in the manufacturer's products to variations of these curves to determine if hearing aid users prefer the variations over the manufacturer's standard curve.
NCT06892470
This prospective study aims to compare the visual outcomes following the implantation of two different types of multifocal intraocular lenses (IOLs) in highly myopic patients. The study will evaluate visual quality, refractive outcomes, and patient satisfaction using various visual assessment techniques and subjective satisfaction surveys.
NCT05003245
this study will compare the efficacy and safety of HLX04-O administered by IVT with ranibizumab in patients with active CNV secondary to AMD.
NCT05708105
Moderate-severe intraventricular hemorrhage (msIVH, Grades II-IV) is a significant neurological complication among extremely low gestational age neonates (ELGANs, \<=27+6 weeks) and is associated with long-term neuro-disabilities. In Canada, msIVH affects \~25-30% of the 1300 ELGANs born annually, with little change in incidence over last decade. Typically, it occurs between days 2-7 of age, providing a finite window of opportunity. Instituting therapies at the population level, however, exposes many low-risk infants to side effects, adversely affecting risk-benefit profile and requiring large sample sizes in trials. A targeted preventative approach, though ideal, is currently challenged by our inability to reliably identify at-risk ELGANs early after birth. Near-infrared spectroscopy (NIRS) has emerged as a promising non-invasive bedside neuromonitoring tool. Pilot studies using NIRS, including ours, found lower cerebral saturations (CrSO2) and greater periods of altered cerebral autoregulation in infants who later developed msIVH. However, a systematic planned investigation is needed to establish the predictive characteristics of NIRS-derived markers, using clinically translatable methods (cumulative burden over time-period vs. single time-point values) and identify their relative performance at different time-points during transition. Further, incorporating echocardiographic (ECHO) hemodynamic markers, known to be associated with msIVH, may allow for the establishment of robust multi-model prediction models and the gain of mechanistic hemodynamic insights to inform future management. Hence, our objective is to investigate the utility of multi-modal assessment using NIRS and ECHO for early identification of ELGANs at risk of msIVH, and generate clinically applicable predictive model(s).
NCT04985539
Currently, the Movement Disorders Society (MDS)-UPDRS scale remains the gold standard to document the outcomes in clinical trials for Parkinson's disease (PD). The MDS-UPDRS is far from infallible, as it is based on subjective scoring (using a rather crude ordinal score), while execution of the tests depends on clinical experience. Not surprisingly, the scale is subject to both significant intra- and inter-rater variability that are sufficiently large to mask an underlying true difference between an effective intervention and placebo. Digital biomarkers may be able to overcome the limitations of the MDS-UPDRS, as they continuously collects real-time data, during the patient's day to day activities. In this study the investigators are interested in developing algorithms to track progression of bradykinesia, gait impairment, postural sway, tremor, physical activity, sleep quality, and autonomic dysfunction (the latter being derived from e.g. skin conductance and changes in heart rate variability).
NCT06891716
The goal of this clinical trial is to test whether we can reliably and safely measure the accumulation of pathological protein TDP-43 \[involved in rare forms of dementia such as frontotemporal dementia (FTD) and in amyotrophic lateral sclerosis (ALS)\] using a new positron emission tomography (PET) tracer called \[18F\]ACI-19626. Both healthy people and people with (suspected) TDP-43 accumulation will participate to this trial. The main questions it aims to answer are: * whether \[18F\]ACI-19626 is safe and well tolerated when injected into participants * whether \[18F\]ACI-19626 reliably detects abnormal TDP-43 in the brain using PET technique. * whether there are differences in the amount of this protein between people with diseases related to TDP-43 accumulation in the brain and people without these diseases. Participants will: * Visit the clinic to consent to their participation and to ensure they are eligible (physical and neurological examinations, questionnaires, blood and urine tests, ECG and MRI in some cases). * Visit the clinic to receive the tracer \[18F\]ACI-19626 intravenously and be scanned in a PET scanner, during which blood will be collected. * Receive a phone call from the clinic 2 to 4 days after the PET scan to report any symptoms and side-effects that they may be having. Some of the participants may be asked to come again to the clinic for a second PET scan, allowing the researchers to determine if the measurements with the first PET scan are stable and reproducible.
NCT03380962
Patients who have had a previous allograft failure represent a major problem for transplant centers as they are highly-human leukocyte antigen (HLA) sensitized and unlikely to receive another transplant without significant desensitization. This single center, phase I/II, open label single-arm exploratory study focuses on enrolling twenty patients (ages 15-75) who will begin desensitization therapy to achieve HLA incompatible (HLAi) renal transplantation. Patients who qualify will receive up to 6 doses of clazakizumab 25 mg monthly pre-transplantation. If patients receive an HLAi transplant during the study, the participants will continue to receive another 6 monthly doses of clazakizumab 25 mg, followed by a 6 month protocol biopsy. Patients will continue another 6 doses over 6 months if improvements are seen after the 6th dose of clazakizumab. Patients who develop evidence of persistent allograft dysfunction may have non-protocol biopsies for cause. Patients who receive 12 doses of clazakizumab post-transplant will receive a 12M protocol biopsy.
NCT03381261
To compare Botox-treated and Botox-untreated symptomatic tissues (defined as areas where the head hurts and the pain is felt) of chronic migraine (CM) patients using molecular studies.
NCT03145805
Bupivacaine is a local anesthetic commonly used to manage postoperative pain. Liver resection patients typically have an epidural catheter placed preoperatively through which they receive a continuous infusion of bupivacaine and hydromorphone for up to 5 days postoperatively. The liver metabolizes bupivacaine, and produces proteins that bind with bupivacaine to take it out of circulation and thereby reduce its toxicity. Because a portion of the liver is being removed due to pre-existing liver disease, investigators hypothesize that liver resection patients have an impaired ability to clear bupivacaine from circulation that may increase their susceptibility to bupivacaine toxicity. To assess this, investigators will measure free and bound bupivacaine in liver resection patients postoperatively to determine whether bupivacaine reaches toxic levels. Investigators will also quantify binding protein levels to determine if these levels are reduced after surgery, which could contribute to the elevated bupivacaine levels in these patients. Finally, investigators will monitor patients for signs and symptoms associated with bupivacaine toxicity.
NCT06022003
Approximately 30% of adult AML subjects are refractory to induction therapy. Furthermore, of those who achieve CR, approximately 75% will relapse. FLT3-mutated AML comprise an especially poor prognosis group. Until now, there was no established standard for relapsed subjects with FLT3 mutations and less than 20% will achieve CR with subsequent treatment. In phase 3 Study ADMIRAL Trial, gilteritinib has resulted in CRc in over 25% of subjects receiving 120 mg/day before on study HSCT. With this treatment, the median overall survival is at 9.3 months, furthermore, gilteritinib was well tolerated at the proposed doses. This study has been designed for R/R patients for which gilteritinib as single agent has been showed to be superior to high- and low-intensity chemotherapy (Perl, NEJM 2019, Supp Table S4) and patients included in this study will receive this treatment. Beyond high- or low-intensity chemotherapy, other options available are best supportive car or other clinical trials. The aim of this study is to assess the efficacy and safety of the addition of oral-azacitidine to salvage treatment by gilteritinib in subjects ≥18 years of age with relapsed/refractory FLT3-mutated acute myeloid leukemia
NCT05032105
The purpose of this study is to evaluate the feasibility, safety, and effects on anxiety of high intensity focused ultrasound ablation (FUSA) in patients suffering from treatment-refractory focal epilepsy and anxiety. FUSA is a non-invasive neurosurgical procedure that uses ultrasound waves, sent directly through the scalp and skull, to precisely target small abnormal areas of the brain. For this study, the targeted area of the brain is the anterior nucleus of the thalamus. This brain region may cause seizures and may also be involved in anxiety. The study will test if FUSA is safe and tolerated, and if it reduces anxiety and brain response to threat in patients with anxiety receiving the procedure for partial-onset epilepsy that is resistant to medications.
NCT05972187
The goal of this study is to learn about the effect of heat and humidity on cognition and health. The main question\[s\] it aims to answer are: type of study: interventional participant population: 20-40years, both gender, healthy Participants will be exposed for 4 different sessions of 8 hours at a time, to 32˚ C or 25˚ C in combination with relative humidity of 30 %RH or 70 %RH.
