rjac/clinicaltrials.gov-summary_and_eligibility huggingface dataset:
Lung Cancer Screening by Artificial Intelligence Device
Status: Not yet recruiting

Lung cancer screening is currently not recommended in non-smokers due to paucity of evidence. Emerging evidence suggests that first-degree family history is a strong risk factor for lung cancer in Asian non-smokers. In Asia, lack of resource is a major challenge in successful implementation of lung cancer screening. Artificial intelligence (AI) is a promising tool to overcome this resource. In this study, we aim to study the clinical utility and demonstrate the feasibility of using an AI assisted programme for lung cancer screening in Asian non-smokers with a positive family history. This is a single-arm non-randomized lung cancer screening study. 1000 non-smokers, age 50 to 75 year old, with a first-degree family history of lung cancer, will be enrolled. Participants will undergo low does computed tomography (LDCT) of thorax and blood taking at enrolment. LDCT films will be interpreted by AI softwares for presence of lung nodules. Participants with lung nodules will be further investigated and followed up according to the risk of malignancy. The primary endpoint is the prevalence of early-staged lung cancer detected by first-round LDCT thorax in this population.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Patients are eligible to be included in the study only if all of the following criteria apply:  Age 50-75 years old Non-smoker (defined as less than 100 cigarettes in lifetime) Having a first-degree family history of lung cancer Physically fit for curative treatment if early-staged lung cancer is found Able to provide written informed consent Consent to follow up visits and follow up CT scan if indicated Consent to blood taking for translational research  Exclusion Criteria:  Patients who meet any of the following exclusion criteria at screening are not eligible to be enrolled in this study:  History of malignancy Smoking history (defined as more than 100 cigarettes in lifetime) Clinical symptoms suspicious for lung cancer e.g. haemoptysis, chest pain, weight loss Medical comorbidities that preclude curative treatment (surgery) for lung cancer, such as severe heart disease, acute or chronic respiratory failure, home oxygen therapy, bleeding disorder Pregnant ladies or ladies planning for conception History of tuberculosis or interstitial lung disease Pneumonia requiring antibiotic treatment within the last 12 weeks CT thorax or chest performed within 2 years (including LDCT or CT coronary angiogram) Unable or unwilling to provide written informed consent - HealthyVolunteers: No - Gender: All - MinimumAge: 50 Years - MaximumAge: 75 Years - StdAgeList: Adult, Older Adult
A Comparative Clinical Study to Assess Pain Score and Wound Healing Following Fractional Ablation With a DFG Laser and CO2 Laser
Status: Not yet recruiting

This research study aims assess whether the Difference Frequency Generation (DFG) laser could be a better alternative to the CO2 laser in terms of reduced side effects and patient downtime.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Subjects must be able and willing to provide written informed consent and comply with the requirements of the study protocol; Subjects must be in good general health, based on answers provided during the screening visit; Subjects must be able to read and understand English. Subjects must be above the age of 18. Subjects must have no history of skin conditions that affect the integrity of the skin barrier.  Exclusion Criteria:  Are pregnant or lactating; Have a history of drug or alcohol abuse or have reported habitual alcohol intake greater than 2 standard drinks per day [e.g., 2 beers, 2 glasses of wine, or 2 mixed drinks]; Are smoking or have a history of smoking; Presence of eczema, psoriasis, skin wounds or ulcers, or any other skin disease on the forearms; Have birth marks, tattoos, scars, or any other disfiguration of the skin in the skin area of interest; Presence of sunburn or tan in the treatment area; Use of any topical application of retinoids in the area of interest or systemic retinoids in the past 6 months; Use of any prescription topical medication, such as corticosteroids or hydroquinone on the skin area of interest in the past 6 months; History of blood-clotting abnormality; History of keloid formation or hypertrophic scarring; History of allergic reaction to local anesthesia, aluminum chloride, and/or glycerol; Investigator, interfere with study evaluations or pose a risk to subject safety during the study; Exhibits any clinical conditions or takes any medication which in the opinion of the investigator may interfere with the study or pose a risk to subject safety during the study; Is not able to follow study protocol. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
Gamma Sensory Flicker for Parkinson's Disease Patients With Freezing of Gait
Status: Not yet recruiting

The purpose of the study is to examine the safety of special eyewear and earphones that emit a visual and auditory stimulus in the gamma range (gamma flicker) in patients with Parkinson's disease for 1 hour per day and to assess the effects this stimulus has on reducing a walking problem referred to as freezing of gait (FOG) as well as on a specific spinal fluid chemical marker, amyloid.

Based on previous animal studies this gamma stimulus has the potential as a novel, non-invasive, non-pharmacological approach, to remove amyloid from the brain. The investigators have found in a prior study, that amyloid levels are high in the spinal fluid of Parkinson's patients with FOG.

Parkinson's disease (PD) patients often experience a complex gait disorder known as Freezing of Gait (FOG). FOG is characterized by brief arrests of stepping when initiating gait, turning, and walking straight and patients describe it as their feet being "glued" to the floor. FOG in Parkinson's disease (PD) is a considerable public health burden worldwide. It is a poorly understood gait symptom that has potentially grave consequences as FOG is intermittent and unpredictable in nature, a leading cause of falls with injury, and results in loss of independence.

FOG is generally found to be associated with cognitive decline, particularly executive dysfunction which, in turn, has been associated with higher spinal fluid amyloid (Aβ42) levels in PD.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  PD Diagnosis by UK Brain Bank Criteria Hoehn & Yahr stage I-IV in the off-state FOG noted in medical history FOG confirmed visually by the examiner in the office PD that is levodopa-treated and responsive Able to manage 12 hours of "OFF" dopaminergic medication state Age 50-75 years Able to sign a consent document and willing to participate in all aspects of the study  Exclusion Criteria:  A diagnosis of atypical parkinsonism including vascular parkinsonism Prior treatment with medications that cause Parkinsonism Stage V PD -unable to walk independently when OFF Absence of levodopa response Neurological or orthopedic disorders interfering with gait Dementia precluding completing study protocol including those meeting criteria for dementia with Lewy bodies Major depression based on the Diagnostic and Statistical Manual of Mental Disorders (DSM V) criteria Any medical problems that would preclude participation, including individuals with a history of migraines, tinnitus, or seizures because sensory stimuli can potentially exacerbate these conditions. Profound sensory loss as determined by the investigator. - HealthyVolunteers: No - Gender: All - MinimumAge: 50 Years - MaximumAge: 75 Years - StdAgeList: Adult, Older Adult
The Effect of Dual Task on Manual Ability Performance in Children With Cerebral Palsy
Status: Not yet recruiting

The aim of the study is to investigate the effect of dual task conditions on manual dexterity performance in young people and children with CP between the ages of 7-18 and to compare it with their peers.

Evaluations to be made in the study (children with CP) and control (typically developing peers) groups:

Demographic information, Gross Motor Function Level (GMFCS), Manual Skills Classification System (MACS) and dominant extremity will be noted and the evaluation will begin by applying the Abilhand Kids questionnaire.
Firstly, the child's performance on a single cognitive task will be evaluated in a supported sitting position on a chair. The cognitive task will be the n-back task (counting down task) to be applied in accordance with the level of the child or young person.
Using the Visual Analogue Scale (VAS), participants will be asked to score the difficulty of the cognitive task as a number between 0 and 10.
In order to evaluate the single motor performance of manual skills, the 9-Hole Test will be applied and the times will be recorded by asking to write a given paragraph.
Dual task evaluations will be administered by giving a simultaneous cognitive task while administering the 9-Hole Test and writing a paragraph.
In order to reveal the dual-task cost (DTC), dual-task performance will be subtracted from single-task performance and the difference will be calculated in seconds.
The Body Control Measurement Scale will be applied for body evaluation purposes.

As a result of this study, the changes in manual dexterity and cognitive performance in dual-task conditions in children and adolescents with CP will be revealed. Additionally, changes in this performance in dual-task situations will be compared with a control group of typically developing children.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Participants must be between the ages of 7-15, Not having a chronic disease.  Exclusion Criteria:  Participants must have had Botulinum Toxin applied to the upper extremity in the last 6 months Participants must have had a health problem or had an operation that would affect the musculoskeletal system or dexterity performance in the last year (EX: Distal radius fracture). Having concentration problems such as attention deficit hyperactivity disorder (ADHD). Not volunteering to participate in the study and not signing a consent form. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 7 Years - MaximumAge: 15 Years - StdAgeList: Child
Reading Ability in Childhood Obesity
Status: Recruiting

There is some evidence about the negative impact of overweight and obesity on reading ability, with negative consequences on quality of life and school success.

In this neuropsychological research, the relationship between the characteristics of reading abilities in individuals with obesity (age range between 11 and 16 years) and the skills of motor coordination, postural stability, manual dexterity, including graphomotor skills, and estimation of time is investigated according to the cerebellar deficit theory.

Eligibility:
- EligibilityCriteria: Inclusion criteria  • diagnosis of overweight or obesity  Exclusion criteria:  • concurrent neurological, neurodevelopmental (e.g., autism), motor, somatosensory and/or psychiatric disorders. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 11 Years - MaximumAge: 16 Years - StdAgeList: Child - StudyPopulation: Participants with obesity will be recruited at the beginning of a rehabilitative treatment at the Istituto Auxologico Italiano, IRCCS, San Giuseppe Hospital (Italy). - SamplingMethod: Non-Probability Sample
Renin Angiotensin Aldosterone System In Septic Kids
Status: Recruiting

Prospective observational cohort study; pediatric sepsis vs. healthy pediatric subjects and pediatric sepsis with acute kidney injury (AKI) vs without AKI.

Blood samples and renal ultrasound will be collected on sequential days for septic subject and one time for the healthy patients.

Enzyme-linked immunosorbent assays (ELISA) with be run on serum plasma to compare the renin-angiotensin-aldosterone system (RAAS) between groups.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  pediatric patients age 1 days - 18 years old with sepsis or age 1 day - 18 years and healthy.  Exclusion Criteria:  -pre-existing end stage renal disease (ESRD), chronic renal failure (CRF), home use of angiotensin converting enzyme inhibitor(ACE) or angiotensin receptor blocker(ARB) medications, pre-existing congestive heart failure (CHF), and unrepaired congenital heart disease - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 1 Day - MaximumAge: 18 Years - StdAgeList: Child, Adult - StudyPopulation: Pediatric subjects, age 1 day to 18 years. Septic cohort will meet criteria for sepsis (pSOFA >/= 2 or Phoenix criteria) and healthy cohort. - SamplingMethod: Non-Probability Sample
Virtual Reality Rehabilitation to Promote Motor Recovery in Amputees
Status: Not yet recruiting

Interventional, non-pharmacological crossover study aimed at identify statistically significant differences in postural stability and spatio-temporal gait cycle parameters in patients with lower limb amputation by means of taskoriented rehabilitation training and multisensory feedback generated by an immersive RV environment, aiming at the enhancement of use-dependent brain plasticity. These changes will be compared between the two groups examined, respectively experimental (Caren virtual training phase plus conventional physiotherapy phase) and control (conventional physiotherapy phase plus Caren virtual training phase).

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  unilateral lower limb amputation ability to walk independently age between 18 and 75 years absence of severe comorbidities that may interfere with treatment  Exclusion Criteria:  presence of severe neurological and psychiatric disorders walking with aids - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 75 Years - StdAgeList: Adult, Older Adult
Early Variations in Immune Aging
Status: Not yet recruiting

Background:

Despite an increase in lifespan over the last decades, our healthspan lags behind. In our aging population, it is pressing that we prevent age-related morbidities and associated burden on the health care system. Instead of investigating aging in already aged populations, the currently proposed study aims to elucidate the process of immune aging in relation to biological aging, demographic and lifestyle factors in young and midlife adults, and to identify early biomarkers and pathways associated with fast versus slow immune aging and aging endotypes.

Study design:

A single-center, observational prospective cohort study in the Netherlands. Participants from priorly established cohorts will be invited to join the EVIA-study. We will obtain demographic and basic clinical data and biological samples (blood and stool) at baseline and after three years, with a short, yearly online questionnaire in between.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Aged between 20 and 60 years; Able to communicate orally in Dutch or English; Able to give informed consent.  Exclusion Criteria:  Any systemic disease or condition, or the use of systemic medication, with the exception of the following:  Cardiovascular disease and related medication Metabolic syndrome, including diabetes, hypertension, and hyperuricemia Pregnancy at inclusion (will be recorded during study); Acute illness or fever <1 month before inclusion; Received vaccines or antibiotics 3 months before inclusion; Participation in an intervention trial; Legally incapacitated or unwilling to provide informed consent. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 20 Years - MaximumAge: 60 Years - StdAgeList: Adult - StudyPopulation: Participants for each age group will be recruited via invitation. Former participants from the HFGP cohorts will be invited only if they had originally given permission to be approached for future studies. In case insufficient inclusions result from previous cohorts, we will proceed to recruit new healthy volunteers from the Nijmegen region. In that case, we will promote the study via local newspaper(s), social media, and flyers (will be added to the CMO file should this arise). This way, the recruitment is performed as an open invitation, and any willing participants may reach out to the research team via email or telephone.  This is an observational study to explore natural aging. Participants are not subjected to any intervention. - SamplingMethod: Non-Probability Sample
Short Stature and Psychological Well-being
Status: Recruiting

The first aim of the present study is to evaluate the psychological impact of the condition of short stature (family) in a sample of Italian children, comparing them with subjects of normal stature, measuring their levels of psychological well-being, psychological distress, quality of health-related life and any behavioral issues. The secondary objective is to study the psychological impact evaluated with the tests described below (see methods section) in children with GH deficiency and the effects of replacement therapy (6 months) with GH from recombinant DNA.

Eligibility:
- EligibilityCriteria: Inclusion Criteria: age between 6 and 14 years, of both sexes  35 with familiar short stature (height < 3rd centile according to the Italian reference standards) and their caregivers of reference. Children with familial short stature are characterized by: short stature in other members of the family group, not necessarily the parents, harmonious appearance, without particular clinical signs and normal pubertal development, parallel growth curve below the 3rd centile, bone age corresponding to chronological age. 35 with normal height (height > 25th centile), aged between 6 and 14 years, of normal weight, and their caregivers of reference 10 children, aged between 6 and 14 years, of both sexes, affected by isolated GH deficiency according to the criteria established by AIFA note 39 for this pathology (short stature: ≤ -3 SD or ≤ -2 SD and growth velocity/year ≤ -1.0 SD for age and sex evaluated at least 6 months apart and peak GH at two different pharmacological stimulus tests < 8 ng/ml) and their caregivers of reference  Exclusion Criteria:  children and teenagers with obesity (BMI > 97th centile) are excluded (for the subgroups with familiar short stature or normal height children and teenagers with the presence of organic pathologies at the hypothalamic-pituitary level (assessed by performing brain MRI) (for the subgroup with growth hormone deficiency) - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 6 Years - MaximumAge: 14 Years - StdAgeList: Child - StudyPopulation: 35 children with familiar short stature, 35 with normal height (height > 25th centile), and 10 with growth hormone deficiency and their caregivers of reference (see above the description of the diagnostic criteria). - SamplingMethod: Probability Sample
Evaluation of the Psychological Profile of Adult Patients With Prader-Willi Syndrome
Status: Recruiting

The primary aim of the present study is to investigate the psychological profile of adult patients with PWS and the fatigue experienced by family members. Specifically, the level of psychological well-being, the subjective perception of life quality, and the main characteristics present in terms of psychopathological functioning of subjects with PWS will be investigated. These variables will be investigated in order to detect their presence and the main bonds of interaction, either between them or with other socio-demographic data, in a sample of adults with PWS. At the same time, the presence of psychological distress, levels of well-being quality of life, and coping strategies in family members and caregivers of individuals with PWS will be investigated.

Eligibility:
- EligibilityCriteria: Inclusion Criteria: subjects with a genetic diagnosis of PWS capable of understanding the questionnaires  Exclusion Criteria: subjects with a genetic diagnosis of PWS with cognitive problems (evaluated throughout the Mini-Mental State Examination) - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 55 Years - StdAgeList: Adult - StudyPopulation: Subjects with a genetic diagnosis of PWS, hospitalized at the Division of Auxology, Istituto Auxologico Italiano, Piancavallo-Verbania (Italy) for a 3-week body weight reduction program - SamplingMethod: Non-Probability Sample
Hybrid Closed-loop Insulin Delivery System in Perioperative Diabetic Patients: an Open-label, Randomized Controlled Trial
Status: Recruiting

Perioperative management of glucose levels remains challenging. The purpose of the study is to compare the hybrid closed-loop insulin delivery system with the standard insulin therapy ( insulin pump with CGM, insulin dose controlled by physicians) in controlling glucose levels among patients in the perioperative period.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  1）18~75 years old (including 18 years old and 75 years old),  2）Perioperative patients with need diabetes including type 2 diabetes mellitus and other special types of diabetes mellitus and need insulin therapy;  3）Fasting blood glucose ≥7.0mmol/L or random blood glucose 11.1≥mmol/L;  4）Patients signed the informed consent form and volunteered to participate in the clinical trial.  Exclusion Criteria:  The patients were complicated with diabetic emergencies, such as diabetic ketoacidosis, diabetic hyperosmolar non-ketotic coma, etc. Type 1 diabetes mellitus Patients with severe cardiac and renal organ dysfunction: cardiac function above grade III; Serum creatinine over 442μmol/L; Hemoglobin less than 90g/L; White blood cell count <4.0×109/L or platelet count <90×109/L; Patients had used glucocorticoids for more than 1 week or were currently using glucocorticoids within 1 month before screening Patients who are allergic to drugs specified in clinical protocols Patients who are not suitable for conventional insulin pump therapy. Patients who are allergic constitution and allergic to tape Patients with skin diseases such as rash and prurigo, or abnormal coagulation function; Patients who suffer from mental illness, have no self-control, and cannot express themselves clearly. Other circumstances that investigator considered to be inappropriate for clinical trial participation;  11) Patients with severe complications during or after surgery. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 75 Years - StdAgeList: Adult, Older Adult