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NCT ID: NCT04886401 Recruiting - Clinical trials for Advanced Non Small Cell Lung Cancer

Retrospective Observational Study on Prediction of Response to PD-1 Immunotherapy in Patients With NSCLC

PREDICTION
Start date: April 16, 2021
Phase:
Study type: Observational

Therapeutic antibodies that block the programmed death-ligand 1 (PD-L1)/programmed death-1 (PD-1) pathway have revolutionized immuno-oncology by inducing robust and durable responses in patients with various cancer including advanced non-small-cell lung cancer (NSCLC). However, these responses only occur in a subset of patients, even in case of PD-L1 overexpression. Elucidating the determinants of response and resistance but also of severe immune-mediated adverse events is key to improving outcomes and developing new treatment strategies. Biomarkers that predict immune checkpoint inhibitors efficacy and toxicity are urgently needed and could emerge from characterization of tumor microenvironment. The purpose of PREDICTION project is to elucidate response and toxicity predictive immunophenotypic signatures using a new in situ multiplexed strategy with imaging mass cytometry Hyperion. Patients treated with anti-PD-1 pembrolizumab will be selected on their response and toxicity profiles. Then, tumor samples will be analysed with Hyperion technology, allowing delineation of cell subpopulations and cell-cell interactions, highlighting tumor heterogeneity and to determine correlations between response and toxicity features. The number of co-analysable markers enables global vision on the same tissue section. A better understanding of the tumor microenvironment complex system will lead to discover new predictive biomarkers potentially transferable to current practice.

NCT ID: NCT04897503 Recruiting - Keratoconus Clinical Trials

Corneal Collagen Crosslinking for Keratoconus and Ectasia Using Riboflavin/Dextran or Riboflavin/Methylcellulose

CXL
Start date: April 16, 2021
Phase: Phase 3
Study type: Interventional

This study is being conducted to evaluate the safety and efficacy of isotonic riboflavin for corneal collagen crosslinking for keratoconus and corneal ectasia. will determine the safety and efficacy of corneal collagen crosslinking (CXL) performed with two different riboflavin formulations for reducing corneal curvature.

NCT ID: NCT04935918 Recruiting - Bladder Exstrophy Clinical Trials

EVALUATION OF THE SAFETY AND EFFICACY OF ADJUSTABLE CONTINENCE THERAPY BALLOONS IN BLADDER EXSTROPHY AND INCONTINENT EPISPADIAS PATIENTS

ACT
Start date: April 16, 2021
Phase: N/A
Study type: Interventional

The purpose of this study is to evaluate the effectiveness and safety of a minimally invasive surgical procedure with ACT (Adjustable Continence Therapy) balloons implantation for the treatment of urinary incontinence in children with bladder exstrophy or isolated epispadias. The ACT therapy consists of two small adjustable silicone balloons connected with a tubing to a port, surgically placed around the bladder neck, one on each side of the urethra.

NCT ID: NCT04949919 Recruiting - Clinical trials for End-stage Renal Disease

Physical Fitness/Training and Inflammatory Immune Responses in Patients With End-stage Renal Disease

Start date: April 16, 2021
Phase: N/A
Study type: Interventional

The end-stage renal disease (ESRD) leading two causes of death are cardiovascular diseases and sepsis. Exercise improves low physical fitness, available research concerning its effect on the pro-/anti-inflammatory immune response is scarce. In the current proposal, physical fitness is classified into cardiopulmonary fitness and muscle fitness. Muscle fitness is further divided into three domains: strength, mass, and oxidative capacity. The 3-year proposal plan to recruit 90 patients with ESRD who receive regular HD for more than 6 months. Every participant will go through 3 phases:control phase、training phase and the maintenance phase (within-subject design). The hypothesis of the proposal is as follows. (I) When cardiopulmonary fitness/muscle fitness drops to a certain level, the inflammatory immune response will rise. The proposal aims to find the best biomarkers and their cut-off points among the various indicators of cardiopulmonary and muscle fitness that reflect immune dysregulation. (II) Other than physical fitness, cyclic aerobic and resistance training improves pro-/anti-inflammatory immune dysregulation. Additionally, three months after cessation of training, a thorough assessment will be performed to examine whether a healthy lifestyle behavior modification has been achieved and whether the beneficial effect of physical fitness and immune regulation induced by the training program is maintained. The goal of each year is as follows. FIRST year: To explore the relationship between cardiopulmonary fitness and pro-/anti-inflammatory immune response in ESRD patients under HD; SECOND year: To explore the relationship between muscle fitness and pro-/anti-inflammatory immune response; THIRD year: To evaluate the effects of cyclic aerobic and resistance training on physical fitness and pro-/anti-inflammatory immunomodulation in ESRD patients under HD.

NCT ID: NCT05000489 Recruiting - Clinical trials for Chronic Conditions, Multiple

Perceptions of LARC Among AYA With Chronic Illness

LARC
Start date: April 16, 2021
Phase:
Study type: Observational

The investigators aim to perform a qualitative study exploring attitudes and perceived barriers to Long Acting Reversible Contraception (LARC), both implants and IUDs, among adolescent and young adults (AYA) with chronic illness at CHLA. While the literature examining barriers to LARC uptake is growing, its focus has been on older women and women who are not living with chronic illness. There remains a significant gap in the understanding of: 1. What adolescents and young adults from ethnically diverse, economically underserved communities know about LARCs 2. If and how LARCs fit into their considerations and decision making about contraception choices 3. Perceived barriers to LARC among AYA with chronic medical conditions 4. Information, perceptions, experiences that inform choices that may be unique to AYA living with chronic conditions Research Objectives 1. Explore the impact of the experience of living with chronic medical conditions on AYA patient attitudes toward and acceptance of LARCs 2. Identify AYA patient concerns and perceptions related to historical coercion and reproductive injustice experienced by minority communities that may reduce acceptance of LARC 3. Explore the relationship between patients' perception of pediatric subspecialty care providers' attitudes regarding sexual health and contraception guidance and patients' attitudes toward and acceptance of LARC 4. Identify factors related to patient's age, family's values, and medical condition, as well as historical events or legacies that may impact preference of implant vs intra-uterine device (IUD), independent of safety/medical contraindications, if choosing a LARC method. 5. Explore other social, cultural or psychological factors that influence perception and represent barriers to LARC access Hypotheses 1. The impact of chronic illness on AYA sense of bodily autonomy (including self-concept, history of other medical procedures, and concerns around mortality) reduces the attractiveness of LARC methods. 2. The intersectionality of multiple oppressions, including racism, xenophobia, sexism, and historical reproductive coercion and injustice implicitly reduce the attractiveness of LARC methods for AYA patients from minority communities with chronic medical conditions at CHLA. 3. Pediatric subspecialty providers' attitudes about sex, and comfort with providing patient-centered contraception counseling, as perceived by AYA patients, impact AYA patient attitudes towards and acceptance of LARC. 4. Preference of implant vs. IUD is related to patient's age, family values, and type of medical condition, as well as their knowledge of historical events related to contraception in their community, independent of safety/medical contraindications. 5. Additional perceived barriers, including fear or skepticism about LARC conferred by trusted sources of information such as family or social media, reduce the attractiveness and acceptance of LARC by AYA with chronic medical conditions

NCT ID: NCT05010252 Recruiting - Quality of Life Clinical Trials

The Effect of Cycled Light on Premature Infants and Mothers

Start date: April 16, 2021
Phase: N/A
Study type: Interventional

Irregular lighting and lack of light in premature infants will affect their health, produce negative effects such as physiological and visual development, and also affect the mother's sleep and quality of life. This study is to verify the effect and delay effect of two-week premature infants' light intervention on their physiological indicators and visual development, mother's sleep quality and quality of life. It is planned to be in the Neonatal Moderate to Severe Ward of National Taiwan University Children's Hospital, and the subjects are premature babies born 32 weeks old. Divided into two groups of light intervention group and control group, longitudinal tracking intervention effect and six-week and three-month delay effect.

NCT ID: NCT05097677 Recruiting - Covid19 Clinical Trials

Follow-up of Covid-19 Long Term Sequelae

Start date: April 16, 2021
Phase:
Study type: Observational [Patient Registry]

The protocol, in accordance with the objectives of ORCHESTRA project - Work Package 2, aims at investigating the characteristics and determinants of COVID-19 long-term sequelae. This goal will be reached through the harmonization of follow-up strategies across the participating cohorts to allow a standardized collection of data on COVID-19 long-term sequelae. The result will be a platform including a set of data and biomaterials from large scale international cohorts, that will be uniformly recorded, prospectively tracked and analysed. The ultimate goal will be that of providing evidence to contribute to the optimization and improvement of the management and prevention of COVID-19 sequelae. The follow-up will be organized in multiple levels of tests, according to the capability of each cohort, and will include questionnaires to collect demographic, epidemiological and clinical data, physical examination, radiological exams and biological sampling. The long-term follow-up will also allow the assessment of long-term immunological response to SARS-CoV-2 infection and its association to the vaccination and to different treatment strategies, including monoclonal antibodies.

NCT ID: NCT05114707 Recruiting - Clinical trials for Induction Chemotherapy

Camrelizumab Plus Chemoradiotherapy for Patients With Locoregional Cancer of Nasal Cavity and Paranasal Sinuses

Start date: April 16, 2021
Phase: Phase 2
Study type: Interventional

Patients with locoregional cancer of nasal cavity and paranasal sinuses are candidate for this study. All the eligible patients receive three cycles of induction chemotherapy (docetaxel 60mg/m2+cisplatin 60mg/m2+5-FU2.5g/m2,civ48h, q3w) followed by concurrent two cycles of cisplatin (80mg/m2,q3w) with curative intensity modulated radiotherapy. Besides, camrelizumab (200mg) is administrated every three weeks for a total of 11 cycles since the first day of induction chemotherapy. We aim to evaluate the three years failure free survival of these patients by the combination of camrelizumab with curative radiotherapy and chemotherapy.

NCT ID: NCT05772923 Recruiting - Quality of Life Clinical Trials

Organ Preservation in Rectal Cancer: Contact X-ray Brachytherapy vs Extending the Waiting Interval and Local Excision

OPAXX
Start date: April 16, 2021
Phase: N/A
Study type: Interventional

The goal of this prospective phase II feasibility study is to evaluate two additional local treatment options in rectal cancer patients with a good clinical response after neoadjuvant (chemo)radiation: contact x-ray brachytherapy versus extension of the waiting interval with or without local excision, and to investigate which rate of organ preservation can be achieved.

NCT ID: NCT05943925 Recruiting - Clinical trials for Mild Cognitive Impairment

Dementias and Microbiota Composition: Is Possible to Revert the Dementia Symptoms Reverting the Microbiota Composition?

DEM-BIOTA
Start date: April 16, 2021
Phase:
Study type: Observational

Dementia is the major cause of disability and dependency among older adults worldwide affecting memory, cognitive abilities and behavior, interfering with one's ability to perform daily lives activities. Although age is the strongest known risk factor for the onset of dementia, it is not a natural or inevitable consequence of aging. Dementia not only affects older people, since up to 9% of the cases appear before 65 years. The impact of dementia is highly important in financial terms also in human costs to countries, societies and individuals. Dementia is an umbrella term for several diseases, being Alzheimer's disease (AD) the most common form, contributing to 60-70% of cases. Other major forms include Lewy bodies Dementias (LBDs) and frontotemporal dementia (FTD). The role of the gastrointestinal microbiota in human brain development and function is an area of increasing interest and research. A large number of studies suggest that the gut microbiota can influence the brain, cognition and behavior of the patients, and also modulate brain plasticity, modifying brain chemistry via various mechanisms like neural, immune and endocrine Within these last two years some studies have showed differences in the microbiota of the AD patients from healthy controls. In this sense, increasing number of studies, most of them in animal models, support the notion that probiotics have significant benefit in maintaining homeostasis of the Central Nervous System. And recent studies try to replicate this finding in AD patients with controversial results. The main objective of DEM-BIOTA project is to improve the knowledge of the relationship between microbiota and dementia. DEM-BIOTA will explore the microbiota differences between dementias: AD, LBDs, that includes: Parkinson disease dementia (PDD) and Lewy Body Dementia (LBD) and FTD-behavioral variant, also in Mild Cognitive Impairment (MCI) to study the progression; in our context (Mediterranean diet and lifestyle) and characterize them in relation to neurocognitive and neuropsychiatric symptoms as well as patient functionality (dependency level). Moreover, the capacity of a probiotic compound in reverting or improving neurocognitive and neuropsychiatric symptoms and patient functionality in a sample of AD patients will be also studied.