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NCT03765398
Older adults often display gait instability, impaired balance control and cognitive decline that lead to falls and fall risks. Approximately 60% of the elderly people with cognitive deficits experience a detrimental fall each year. Such motor and cognitive impairments further decreases physical activity levels in this population leading to restricted community integration, social behavior, depression and long-term disability. With the help of computer technology, studies have employed virtual-reality based interventions to address the above-mentioned concerns including sensori-motor, balance control and cognitive impairments. Previous studies have demonstrated promising results on improving the behavioral outcomes, and have identified such interventions have the potential to improve the underlying neurophysiological outcomes as well. While VR based training studies have demonstrated remarkable improvement in the balance control and gait parameters, physical activity levels and fall risk reduction, the gains on cognitive function is less pronounced. There is little evidence that VR-based training can explicitly address the higher executive cognitive domains associated with balance control and falls. Further, the effect of VR-based training on balance control and cognitive function is unknown among the older adults with mild cognitive impairment. Therefore, to address the cognitive domains explicitly, the current study aims to test the applicability of Wii-Fit Nintendo along with an additional cognitive load delivered via VR-based cognitive-motor training paradigm (VR-CogMoBal) in older adults with mild cognitive impairment. Lastly, the study also aims to identify the effect of such training on the underlying behavioral and neural outcomes. The behavioral outcomes will be assessed via performance on dual-tasking and clinical measures in the laboratory. The underlying neural outcomes will be assessed via fMRI outcomes. In order to determine the generalizing training effect at community level, a pilot sub-study to determine the physical activity levels post 4 weeks of training will also be conducted.
NCT04573660
The AV-MDR is a prospective, non-randomized, open-label, multi-center registry. The purpose of the AV-MDR study is to proactively collect and evaluate clinical data on the usage of the devices in scope within their intended use with the aim of confirming safety and performance throughout their expected lifetime, ensuring the continued acceptability of identified risks, detecting emerging risks on the basis of factual evidence, ensuring the continued acceptability of the benefit-risk ratio, and identifying possible systematic misuse or off-label usage such that the intended use can be verified as appropriate.
NCT05182476
Study to evaluate the safety and efficacy of luvadaxistat compared with placebo on improving cognitive performance in participants with schizophrenia.
NCT05274451
This study will evaluate the safety and tolerability of LYL797, a ROR1-targeted CAR T-cell therapy, in patients with ROR1+ relapsed or refractory triple negative breast cancer (TNBC), non-small cell lung cancer (NSCLC), platinum-resistant epithelial ovarian cancer/ fallopian tube cancer/ primary peritoneal cancer (Ovarian cancer), or Endometrial cancer. The first part of the study will determine the safe dose for the next part of the study, and will enroll patients with TNBC, NSCLC, Ovarian or Endometrial cancer. The second part of the study will test that dose in additional patients with TNBC, NSCLC, Ovarian or Endometrial cancer.
NCT04410978
Primary Objective: To assess efficacy of daily SAR442168 compared to a daily dose of 14 mg teriflunomide (Aubagio) measured by annualized adjudicated relapse rate (ARR) in participants with relapsing forms of MS Secondary Objective: To assess efficacy of SAR442168 compared to teriflunomide (Aubagio) on disability progression, MRI lesions, cognitive performance and quality of life To evaluate the safety and tolerability of daily SAR442168 To evaluate population pharmacokinetics (PK) of SAR442168 and relevant metabolites and its relationship to efficacy and safety To evaluate pharmacodynamics (PD) of SAR442168
NCT01937117
This research is being done to determine if early changes on a type of imaging procedure called PET (Positron Emission Tomography) can predict which patients are most likely to respond to the combination of trastuzumab and pertuzumab when given prior to surgery.
NCT04963231
The purpose of this study was to evaluate the safety and efficacy of once daily subcutaneous (SC) administration of setmelanotide in participants with obesity and specific gene variants in the MC4R pathway.
NCT05573035
This is an open-label, multi-center, dose-escalation study with expansion cohorts, designed to evaluate the safety and anti-tumor activity of LYL845, an epigenetically reprogrammed tumor infiltrating lymphocyte (TIL) therapy, in participants with relapsed or refractory (R/R) metastatic or locally advanced melanoma, non-small cell lung cancer (NSCLC), and colorectal cancer (CRC).
NCT05568706
This is a Phase 2b, randomized, double-blind, placebo-controlled study of EDP-938 administered orally for the treatment of non-hospitalized adult subjects with confirmed RSV infection who are at high risk for complications after RSV infection.
NCT05987163
This is a prospective, randomized, evaluator-blinded, comparator-controlled, parallel group, multicenter study in the U.S. for correction of moderate to severe dynamic facial wrinkles and folds, such as nasolabial folds (NLFs).
NCT03345095
The standard of care for newly diagnosed glioblastoma includes surgery, involved-field radiotherapy, and concomitant and six cycles of maintenance temozolomide chemotherapy, however the prognosis remains dismal. Marizomib has been tested in patients with newly diagnosed and recurrent glioblastoma in phase I and phase II studies. In patients with recurrent glioblastoma, marizomib was administered as a single agent or in combination with bevacizumab (NCT02330562). Based on encouraging observations, a phase I/II trial of marizomib in combination with Temozolomide+Radiotherapy(TMZ/RT) followed by Temozolomide (TMZ) in newly diagnosed glioblastoma has been launched (NCT02903069) which explores safety and tolerability of this triple combination and which shall help to determine the dose for further clinical trials in glioblastoma. In this context, given that marizomib has been established as a safe addition to the standard TMZ/RT --\>TMZ, a phase III study is considered essential to establishing its impact on overall survival.
NCT06544564
This study is designed to assess the clinical effectiveness of Membrane Wrap, a human amniotic membrane for the management of difficult to heal partial- or full-thickness venous leg ulcers (VLUs)
NCT03884556
This is a phase 1/1b study of TTX-030, an antibody that inhibits CD39 enzymatic activity, leading to accumulation of pro-inflammatory adenosine triphosphate (ATP) and reduction of immunosuppressive adenosine, which may change the tumor microenvironment and promote anti-tumor immune response. This trial will study the safety, tolerability, pharmacokinetics, and anti-tumor activity of TTX-030 as a single agent and in combination with an approved anti-PD-1 immunotherapy and standard chemotherapies.
NCT05947084
A 4 month growth monitoring study of healthy term infants fed iron fortified infant formula. Infants will be fed ad-libitum for 16 weeks and growth will be evaluated in terms of weight gain over the 16 weeks.
NCT06472765
The central premise of this study is that the intricate balance and diversity of the vaginal microbiome plays a pivotal role in the onset, progression, and severity of various gynecological conditions. Specifically, the research aims to investigate how imbalances in microbial communities, such as the overgrowth of pathogenic bacteria or the depletion of beneficial ones, are linked to conditions like Bacterial Vaginosis, Candidiasis, Urinary Tract Infections, Vaginal Atrophy, and others. By employing PCR testing and the outcomes of next-generation sequencing (NGS) of the microbiome, the study seeks to identify distinct microbial profiles and patterns that are characteristic of each condition. This nuanced understanding is expected to lead to more accurate and early diagnosis, facilitating personalized and effective treatment strategies that go beyond the conventional, often indiscriminate use of antibiotics.
NCT03573089
During end-stage kidney disease, clinical guidelines suggest reducing elevated phosphate levels in the blood. However, the effect of lowering blood phosphate levels on important patient-centred outcomes has never been tested. This trial will evaluate whether compared to high levels, lowering blood phosphate levels would reduce death or major events due to heart disease, improve physical health, and be cost-effective.
NCT04455620
This was an open-label, multicenter Phase I/IIa dose escalation, safety, pharmacokinetic and pharmacodynamic (PD) study of BNT151 with expansion cohorts in various solid tumor indications. The study was planned to be performed in Part 1, Part 2A, and Part 2B with adaptive design elements. Part 2 was not conducted because of the clinical study being terminated early. The monotherapy dose escalation, (Part 1) of this clinical study enrolled participants with various solid tumors that are metastatic or of advanced unresectable stage for whom there was no available standard therapy likely to confer clinical benefit, or participants who are not candidates for such available therapy. Dose escalation followed an accelerated titration design, i.e., started with single participant cohorts followed by larger participant cohorts informed by the 3+3 design. Part 1 of the study also planed to implement a dedicated biomarker cohort in BNT151 monotherapy. The biomarker cohort was planned to recruit participants at selected sites in the United States (US) only. The objective of the cohort was to observe PD activity and drug-induced changes in the blood and tumor and only to generate data for exploratory endpoints or additional research. However, the biomarker cohort was not opened, and therefore no data were generated. During combination dose escalation (Part 2A), participants with squamous cell carcinoma of head and neck, and hepatocellular carcinoma were planned to be enrolled and treated with a combination of BNT151 and pembrolizumab. Once Part 2A was completed, participants with renal cell carcinoma, non-small cell lung cancer, and triple negative breast cancer were planned to be enrolled (Part 2B) and treated with a combination of BNT151 with the respective standard of care (SoC).
NCT04633447
The primary purpose of this study is to evaluate the efficacy of guselkumab compared to placebo, in combination with a 26-week glucocorticoid (GC) taper regimen, in adult participants with new-onset or relapsing giant cell arteritis (GCA).
NCT05685004
This randomized study is designed to compare the combination of TVI-Brain-1 immunotherapy and standard therapy compared to standard therapy alone as a treatment for newly diagnosed MGMT unmethylated glioblastoma patients. The patients' own cancer cells collected after surgery are combined into a vaccine to produce an immune response that significantly increases the number of cancer neoantigen-specific effector T cell precursors in the patient's body. These cancer neoantigen-specific T cells are harvested from the blood, subsequently stimulated and expanded, and infused back into the patient.
NCT01541254
The purpose of this study is to evaluate the safety and probable benefit of the Low-profile Visualized Intraluminal Support (LVIS™ and LVIS™ Jr.)devices from MicroVention, Inc. when used to facilitate endovascular coiling of unruptured wide-neck intracranial aneurysms with bare platinum embolization coils.