rjac/clinicaltrials.gov-summary_and_eligibility huggingface dataset:
Oral Microbiome Diagnostics of Lung Cancer
Status: Recruiting

The study aims to develop a deep learning-based diagnostic method for lung cancer using the oral microbiome. This innovative approach involves establishing an observational cohort of 576 individuals, including lung cancer patients, non-cancerous benign lung disease patients, and healthy controls, to collect tongue swab samples for 16S rRNA sequencing. Additionally, an international cohort of approximately 1700 individuals will be formed using in silico data. The project will utilize deep learning methods to analyze all data integratively and develop an AI diagnostic algorithm capable of distinguishing lung cancer patients from others. The diagnostic method's performance will be tested in a pilot clinical trial with 96 individuals using a PRoBE design. Led by experts in chest surgery, molecular microbiology, and bioinformatics, the project spans over 30 months and aims to create a non-invasive, easily accessible lung cancer screening method that could lead to significant diagnostic advancements and potential spin-off companies in the field of liquid biopsy/molecular diagnosis.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  To be between the ages of 18 and 65, Not to have a diagnosed lung disease or suspicion thereof, Not to have complaints related to the lungs and/or respiratory tract, Not to have alcohol or severe substance dependency, Not having a hospitalization history in the last year, Not having used antibiotics in the last six months, Not having used products manufactured to support the oral microbiome, such as probiotics (lozenges, sublingual drops) for at least the last six months, Not being pregnant or breastfeeding, Not having undergone dental procedures such as root canal treatment, implants, prostheses, tooth extraction, fillings in the last 6 months Not having dominant immune-origin lesions (such as aphthous ulcers, erythema multiforme, pemphigus), viral-origin lesions (such as herpes, Koplik spots, herpangina), dominant bacterial infections like tonsillitis, and/or thermal or chemical mucosal traumas in the mouth.  Exclusion Criteria:  Not to satisfy inclusion or declining to participate even though all the inclusion criteria are satisfied. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - MaximumAge: 65 Years - StdAgeList: Adult, Older Adult - StudyPopulation: The population consists of a lung cancer group of 192 patients, a non-lung cancer benign lung disease group of 192 patients, and 292 healthy controls. Each subgroups are gender and age matched. - SamplingMethod: Non-Probability Sample
Intrinsic Capacity and Functional Ability Monitoring With an Integrated Data Eco-System for Healthy Ageing.
Status: Not yet recruiting

In this study, 120 older adults (aged 65 years or older) either patients undergoing rehabilitation or older nursing home residents will be provided with an Eforto® device and the eco-System for Healthy Ageing (ISHA) mobile application to self-monitor intrinsic capacity for 4 months (if needed with assistance by an (in)formal caregiver). Preferably, the participants will use their own smartphone because mitigating smartphone-use-related issues.

The aims of the study are:

to evaluate the usability and feasibility of self-monitoring intrinsic capacity by using the ISHA system in rehabilitation and nursing home settings.
to investigate if changes and variability in intrinsic capacity as measured with ISHA are related to changes in functional ability and quality of life.
to explore individual trajectories of intrinsic capacity with the ISHA system.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Aged 65 years or older. Patients living independently at home and undergoing rehabilitation, or older persons living in the residential care community (in a nursing home or in assisted housing). Being able to operate the basic functions of a smartphone (if needed with assistance by an informal caregiver): using a smartphone at least for calls, and minimum 1 other application. Understanding Dutch.  Exclusion Criteria: Being unable to participate in the assessments due to:  Being unable to perform the physical (self)tests (e.g., unable to stand up or walk); Being unable to understand the test instructions; Functional disability of the dominant upper extremity (paresis/paralysis, tremor or recent surgery); Patients undergoing neurological rehabilitation. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 65 Years - StdAgeList: Older Adult - StudyPopulation: Patients undergoing rehabilitation and nursing home residents, all aged 65 years or older. - SamplingMethod: Non-Probability Sample
Cognitive Remediation VR Tool for People With MCI: a Feasibility RCT
Status: Not yet recruiting

The need to promote research in active aging trough multidisciplinary and innovative approaches is strongly indicated by the European Union. Our study aims to assess the feasibility and provide a preliminary measure of effectiveness for an intervention using immersive virtual reality (VR) technology for cognitive remediation (CR) in individuals with Mild Cognitive Impairment (MCI)

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  age 65 and above, a diagnosis of MCI based on DSM-IV criteria [American Psychiatric Association, 2000]  Exclusion Criteria:  failure to meet inclusion criteria, a diagnosis of epilepsy or severe visual impairments due to potential risks associated with extensive virtual reality stimulation, and severe illnesses impeding bi-weekly intervention attendance - HealthyVolunteers: No - Gender: All - MinimumAge: 65 Years - StdAgeList: Older Adult
Non-invasive Monitoring: Impact on Patient Management and Outcomes
Status: Recruiting

Enhancing patient monitoring in SNFs and ALFs is crucial due to challenges in recognizing deteriorating health. Gaps in vital sign checks lead to missed indicators and adverse outcomes. Turtle Shell Technologies' Dozee Pro NX offers continuous non-invasive monitoring, alerting healthcare providers of vital sign changes. This clinical study aims to evaluate Dozee Pro Nx's impact on patient outcomes, practitioner efficiency, and healthcare costs in SNFs and ALFs, addressing gaps in care delivery.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Age 18 years or older. Weight between 40kg-120kgs  Exclusion Criteria:  Terminal illness with a life expectancy of less than 1 month. Have any condition that could interfere with the subject's ability to lie flat or stable on the bed Needs the use of equipment whose operation can interfere with Investigation System operations Patients planned to be transferred from the facility within 72 hours Prisoners Pregnant - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Months - MaximumAge: 120 Years - StdAgeList: Child, Adult, Older Adult - StudyPopulation: The study will be conducted on subjects in the age group above 18 years regardless of gender. The study is done on patients admitted in the SNF who fulfill the inclusion and exclusion criteria - SamplingMethod: Non-Probability Sample
Prospective Study Upon Pulsed Radiofrequency Therapy on Peripheral Nerves Monitoring Pain, Quality of Life, Patient Satisfaction and Efficacy
Status: Not yet recruiting

Neuropathic pain is a chronic condition caused by damage to the somatosensory nervous system. The pain associated with neuropathic pain is often severe and debilitating, and can significantly interfere with the quality of life and daily functioning of affected patients. Current pharmacologic treatments, such as antidepressants, antiepileptics, and opioids, can offer only partial relief for 40-60% of patients, and are often accompanied by severe side effects. This has led to increasing interest in non-pharmacologic management options for neuropathic pain. One such promising treatment option is pulsed radiofrequency (PRF) treatment applied to the affected peripheral nerve in conjunction with local anesthetic and/or corticosteroid medication. Several studies, including case reports, retrospective studies, and small randomized controlled trials, have shown that PRF treatment to the affected peripheral nerve can be beneficial and effective for managing chronic peripheral neuropathic pain. Several peripheral neuralgias, such as thoracic postherpetic neuralgia, occipital neuralgia, pudendal neuralgia, meralgia paresthetica, painful shoulder, post-thoracotomy syndrome, and carpal tunnel syndrome, have been successfully treated with PRF. PRF treatment has garnered significant interest among ultrasound-skilled pain physicians because of its superior, safe, and non-destructive percutaneous approach to peripheral nerves, visualized by today's excellent visual ultrasound guidance. Our academic pain center performs approximately more than 1000 ultrasound-guided peripheral nerve blocks per year on a wide range of peripheral nerves. Moderate evidence for treating peripheral nerves with PRF treatment is available; however, PRF treatment settings such as voltage, number of cycles, and treatment duration vary, and it is not clear which setting contributes most substantially to pain reduction results. The aim of this prospective longitudinal observational data collection is to evaluate the efficacy of PRF treatment applied to peripheral nerves, to observe the clinical course of chronic peripheral neuropathic pain under conditions of routine clinical practice, and to link these observations with clinical outcomes.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Adult patients ≥ 18 Dutch speaking Chronic peripheral neuropathic pain lasting ≥ 6 months with mean NRS pain score of ≥ 4 Patients who are scheduled for an ultrasound guided PRF treatment on a peripheral nerve Willing and able to sign consent  Exclusion Criteria:  - Inability to complete the questionnaires - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: The population of this data collection consists of patients who will receive PRF treatment for chronic peripheral neuropathic pain (duration of pain ≥ 6 months). - SamplingMethod: Non-Probability Sample
A Feasibility Study for Randomization of Code Stroke Imaging Strategies
Status: Recruiting

The purpose of this study is to test feasibility of a comparative effectiveness framework for acute stroke imaging using prospective electronic health data. This is a prospective, cohort feasibility study of patients presenting to the Emergency Department with suspected acute ischemic stroke. The clinical stroke team will not be blinded to the imaging modality given the nature and purpose of the interventions/imaging. Knowledge of the imaging modality used and the knowledge gained from the resulting data will need to be considered for treatment decisions. Blinding will be maintained for data abstraction and analyses. Analysis will be on an "intent-to-scan" basis and all qualifying patients will be included in their assigned cohort.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Age ≥ 18 years Time last known well to presentation ≤ 24 hours Code-stroke (suspected treatable ischemic stroke) called prior to or upon arrival to Emergency Department Presenting to Emergency Department for first time during study period  Exclusion Criteria:  Transfer patients Contraindication for brain perfusion scan Prior inclusion in study - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - MaximumAge: 120 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Patients presenting as Code Stroke to Emergency Department at one of four network stroke centers - SamplingMethod: Non-Probability Sample
Inclusive Positive Behaviour Supports
Status: Recruiting

Background: While positive school climate is important for students' well-being and mental health, school personnel may experience challenges in creating a nurturing school climate. School-Wide Positive Behavioral Interventions and Supports (SW-PBIS) have shown positive effects on school climate, but fewer studies have been conducted in the European context. Aim: The present project aims to investigate the effectiveness of SW-PBIS programs for students' social-emotional skills and academic achievement as well as teachers' and students' perceptions of the learning environment. Furthermore, the study intends to evaluate how school-level factors mediate or moderate the effects of the intervention. In addition, the study includes a qualitative evaluation of the dynamic interaction processes that occur during program implementation in local school contexts. Methods: Data on school- and individual-level measures are collected in intervention and control schools. With regard to challenges in retaining control groups over extended time periods, two waves of recruitment are used. In the first wave, an active control group is used, and data are collected during three time points. In the second wave, a wait-list control group is used, and data are collected during two time points during one school year. Hierarchical regression analyses will be conducted to explore the effects of SW-PBIS on the outcomes of the study. An ethnomethodological approach will be applied to provide a detailed examination of the social interactional and meaning-making practices of different school implementation teams, and the negotiation of normative expectations and rules of conduct in peer-teacher-student interactions in different classrooms. Discussion: The study is expected to contribute knowledge on the effects of the SWPBIS program and how these effects may be mediated or moderated by school-level factors. Combining quantitative and qualitative methods to explore the significance of school contexts in the implementation of the SWPBIS program constitutes the strength of the study. The challenge in the study is the extended period of implementation of SWPBIS, which entails difficulties in retaining a control group over the required time period. Therefore, two waves of recruitment are used, encompassing different procedures of allocation to intervention or control groups.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  compulsory school, grades 4-9; the school have not been previously enrolled in an SWPBIS program by other providers; principal, teachers, students and their parents consent to participate in the study.  Exclusion Criteria:  grades other than 4-9; the school has previously received or is enrolled in SWPBIS program or other PBS program; students or their parents have not consented to participation in the study. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 9 Years - MaximumAge: 15 Years - StdAgeList: Child
Acute Effects of Legume-enriched Meals Compared to Western Diet Meals on Postprandial Metabolism in Participants With Increased Cardiometabolic Risk
Status: Recruiting

The aim of the study is to investigate the postprandial effects of legume-enriched meals compared to Western Diet meals on postprandial metabolism. In this context, older adults with increased risk for cardiometabolic diseases consume 4 mixed meals with 36 g or 62 g of protein either designed according to the Planetary Health Diet with legumes as primary protein source or the Western Diet with animal foods as primary protein source, in a randomized order. In a postprandial observation period of 6 hours, parameters of lipid metabolism, glucose and insulin metabolism, amino acid profile, as well as markers of inflammation and vascular function are analysed. Furthermore, neuropsychological parameters and satiety-associated hormones are investigated.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  written informed consent Non-smoking BMI: 27 - 34,9 kg/m2 Waist circumference (women ≥ 80 cm, men ≥ 94 cm) At least two of the following criteria of metabolic syndrome: Fasting triglycerides in serum: ≥ 150 mg/dL Fasting HDL-Cholesterol in serum: women < 50 mg/dl, men < 40 mg/dL Systolic blood pressure: ≥ 120 mmHg, diastolic blood pressure: ≥ 80 mmHg Fasting glucose in plasma: ≥ 100 mg/dL  Exclusion Criteria:  food intolerances and allergies (especially to legumes) Smoking malabsorption syndromes thyroid diseases impaired renal function chronic liver disease heart failure myocardial infarction insulin-dependent diabetes mellitus chronic inflammatory diseases tumors anemia immunosuppression intake of supplements (e.g., fish oil) Participation in another study other exclusion criteria at the discretion of the physician/ investigator - HealthyVolunteers: No - Gender: All - MinimumAge: 50 Years - MaximumAge: 75 Years - StdAgeList: Adult, Older Adult
Addressing Pain Through Navigator-Led Palliative Care Optimized for Heart Failure (ADAPT-HF)
Status: Not yet recruiting

Using the MOST framework, factorial pilot design, and an iterative, community-based process, the purpose of this study is to pilot test to further develop and refine a palliative care (PC) intervention addressing pain of Black adults (age > 18) with advanced HF. Thirty-six persons with advanced heart failure (HF) will be randomized to receive one of 16 conditions (different combinations of navigator coach-delivered PC pain intervention components).

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Age ≥ 18 African American Diagnosis of advanced heart failure (New York Heart Association Class III-IV or American College of Cardiology/American Heart Association Stage C-D) English speaking Willing to participate Primary residence in CAPC East South Central or West South Central regions* (Alabama, Mississippi, Tennessee, Kentucky, Arkansas, Louisiana, Oklahoma, Texas) Self-endorses pain in the last month Willing to participate in intervention and data collection  Exclusion Criteria:  Age <18 Not African American Ineligible HF classification Self-reported, untreated severe mental illness Dementia Active Suicidal Ideation Active substance abuse Uncorrected hearing loss Unable to respond in English - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
A Digital Active Aging Training Program for Older Adults
Status: Not yet recruiting

The proposed project aims to develop and validate a multi-dimensional digital active aging program integrated with resilience to promote the biopsychosocial functions of older adults aged 60, including Chinese older immigrants in Canada (Study 1) and English-speaking White Canadian older adults (Study 2).

The proposed study takes a typical pretest-training-posttest design. Pretest and posttest: a battery of outcome measures on physical, psychological, and social functions will be administered to all participants. Data will also be used to identify sociodemographic risk predictors for outcome variables (i.e., biopsychosocial functions and resilience). Training: the participants will be randomly assigned to three arms to receive 4 weeks of 16 training/practice/control treatment sessions delivered via Zoom.

In the "active aging with resilience (AR)" condition, participants will complete physical, cognitive, and social engagement training modules, starting with a 30-min resilience-building module. The traditional "active aging" (AA) training involves the same multi-domain active aging training without the initial resilience-building module. The "workshop training" (WT) control condition involves workshops following the same 4-week schedule on aging-related topics.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Study 1(Chinese group):  Aged 60 or over and healthy Chinese migrant (e.g., Canadian citizens, immigrants, visitors that are born and raised in the Chinese culture) Can speak, read and write Mandarin Having access to a computer that has internet and allows Zoom meeting attendance  Study 2(Canadian group):  Aged 60 or over and healthy White Canadian citizen Can speak, read and write English Having access to a computer that has internet and allows Zoom meeting attendance  Exclusion Criteria:  Scored 6 or above on the Short blessed test (SBT) Unfit for light physical exercises Without access to a computer and internet With current or previous mental health diagnosis - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 60 Years - StdAgeList: Adult, Older Adult
A Study to Evaluate the Efficacy and Safety of Tarcocimab Tedromer Compared With Sham Treatment in Participants With Moderately Severe to Severe Non-proliferative Diabetic Retinopathy (NPDR)
Status: Not yet recruiting

This study will demonstrate that tarcocimab 5 mg is superior to sham treatment in participants with moderately severe to severe NPDR.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Signed informed consent prior to participation in the study. Type 1 or 2 diabetes mellitus and HbA1c of ≤12%. Moderately severe to severe NPDR in the Study Eye (DRSS levels 47 and 53 as determined by the reading center based on color fundus photographs), who have not previously received intravitreal medications for DR or DME, and in whom pan-retinal photocoagulation (PRP) can be safely deferred for at least 6 months per the Investigator. CST ≤320 microns and a BCVA ETDRS letter score in the Study Eye of ≥69 letters (approximate Snellen equivalent of 20/40 or better) in the Study Eye at screening and confirmed at Day 1; OR CST >320 and ≤350 microns and a BCVA ETDRS letter score in the Study Eye of ≥79 letters (approximate Snellen equivalent of 20/25 or better) in the Study Eye at screening and confirmed at Day 1.  Exclusion Criteria:  Prior PRP in the Study Eye. Current anterior segment neovascularization (ASNV), vitreous hemorrhage, or tractional retinal detachment in the Study Eye. Prior intravitreal anti-VEGF treatment in the Study Eye for DR or DME. Prior intravitreal or periocular steroid in the Study Eye for DR or DME. Prior use of an investigational intravitreal treatment for DR or DME in the Study Eye. History of vitreoretinal surgery in the Study Eye History of uveitis in either eye. Cataract in the Study Eye that in the judgment of the Investigator is expected to require surgical extraction within 12 months of screening. Significant media opacities, including cataract, in the Study Eye that might interfere with visual acuity, assessment of safety, OCT, or FP. Any history or evidence of a concurrent ocular condition present in the Study Eye, that in the opinion of the Investigator could require either medical or surgical intervention or alter visual acuity during the study Active or suspected ocular or periocular infection or inflammation. Women who are pregnant or lactating or intending to become pregnant during the study. History of a medical condition that, in the judgment of the Investigator, would preclude scheduled study visits, completion of the study, or a safe administration of investigational product. Recent history (within the 6 months prior to screening) of myocardial infarction, stroke, transient ischemic attack, acute congestive heart failure or any acute coronary event. Uncontrolled blood pressure defined as a systolic value ≥ 180 mmHg or diastolic value ≥ 100 mmHg while at rest. Other protocol-specified exclusion criteria may apply. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult