rjac/clinicaltrials.gov-summary_and_eligibility huggingface dataset:
Effects of a Computerized Cognitive Stimulation Intervention Adapted to the Level of Cognitive Reserve
Status: Not yet recruiting

Normal ageing presents subtle cognitive changes that can be detected before meeting the criteria for Mild cognitive impairment (MCI). Older people with low cognitive reserve and who receive limited cognitive stimulation are at greater risk of deterioration. In this regard, cognitive stimulation (CS) has been identified as an intervention that reduces this risk, provided that its design considers the differences in the level of cognitive reserve (CR) acquired throughout life and the baseline level of cognitive functioning. The general objective of this study is to evaluate, through a randomized clinical trial, the effectiveness of a computerized cognitive stimulation program, designed and adapted from Occupational Therapy based on the level of cognitive reserve in older adults in Primary Care. 100 participants will be randomized in a stratified manner according to the level of cognitive reserve (high/low), assigning 50 participants to the control group and 50 participants to the intervention group. The intervention group will carry out a computerized cognitive stimulation intervention designed and adapted from occupational therapy according to the level of cognitive reserve, through the "stimulus" platform. The main result expected to be achieved is the improvement of higher brain functions. As secondary results, the investigators expect that those cognitive aspects most vulnerable to ageing will decrease more slowly (in areas such as memory, executive function, attention and processing speed) and that the cognitive reserve of the participants will increase, in addition to being able to balance gender differences in these aspects. The investigators think that these results can positively impact the creation of adapted, meaningful and stimulating CS programs in older adults to prevent MCI and experience healthier ageing.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Age: ≥ 60 years. With score in Lobo's Mini-cognitive Examination (MEC-35) (Lobo, A., Escolar, V., Ezquerra, J., & Seva Díaz, 1979) between: 28-35 points (Friedman et al., 2012; Vinyoles Bargalló et al., 2002). Non-institutionalized persons, belonging to the health centers where the study was conducted. With a minimum educational level (knowing how to read and write). Who do not present hearing, visual or communication difficulties that would prevent them from completing the cognitive training.  Exclusion Criteria:  People with mild cognitive impairment or Alzheimer's disease (AD). People with significant functional impairment. People who have received any type of professionalized cognitive stimulation therapy in the last year. People with significant psychiatric conditions, such as major depressive disorder or schizophrenia. People who are taking medications that may adversely affect cognitive function, such as anticholinergics, tranquilizers and anticonvulsants. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 60 Years - StdAgeList: Adult, Older Adult
The Effect of Adaptogen Elixir on Sleep Improvement
Status: Not yet recruiting

This study aims to examine the effectiveness of Adaptogen Elixir herbal drink in relieving emotions and improving sleep quality. Participants will be randomly assigned to either the placebo group or the Adaptogen Elixir herbal drink group, with 25 participants in each group. On the day of the experiment (week 0), participants are required to collect blood and saliva samples, fill out questionnaires assessing sleep disorders and stress condition, and use a sleep monitoring system to track their sleep and autonomic nervous system conditions. Subsequently, participants will be given the experimental samples and instructed to consume them continuously for 4 weeks following the instruction. Follow-up assessments will be conducted in the 2nd and 4th weeks, participants are required to collect blood and saliva samples, fill out questionnaires assessing sleep disorders and stress condition, and use a sleep monitoring system to track their sleep and autonomic nervous system conditions.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Adults aged above 18 years old. Individuals experiencing insomnia issues (PSQI > 5) or high levels of anxiety (GAD-7 > 9). No medication use or regular use of sleeping pills or antidepressants in the past month. No ongoing mental illnesses. No ongoing physical illnesses. No other sleep disorders. No circadian rhythm issues. No consumption of sleep or stress-related supplements in the past month.  Exclusion Criteria:  Pregnant or breastfeeding women. Individuals with significant organic diseases such as organ transplants, epilepsy or seizures, liver or kidney diseases, malignant tumors, endocrine disorders, or a history of alcohol or substance use disorders. Individuals known to be allergic to any components of the product. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - MaximumAge: 65 Years - StdAgeList: Adult, Older Adult
Lateral Pelvic Lymph Node Dissection for Rectal Neuroendocrine Neoplasms Undergoing Laparoscopic Total Mesenteric Excision
Status: Recruiting

The purpose of this study is to investigate the metastatic status of lateral pelvic lymph nodes in rectal neuroendocrine neoplasms (rNENs) undergoing laparoscopic total mesenteric excision (TME). The hypothesis is that the rate of lateral lymph node metastasis is underestimated in rNENs undergoing TME, necessitating concurrent lateral Pelvic lymph node dissection.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Biopsy proven rectal neuroendocrine neoplasm (neuroendocrine tumor and carcinoma);  Meets any one of the following conditions:  Preoperative imaging examinations reveal that the maximum diameter of the tumor is greater than 2cm. Preoperative imaging examinations reveal that the maximum diameter of the tumor is between 1-2cm and the clinical staging is T2 or higher. Preoperative imaging examinations reveal that the maximum diameter of the tumor is between 1-2cm and is categorized as Grade 3 differentiation. Recurrence after local excision under endoscopy. Eastern Cooperative Oncology Group(ECOG) performance score ≤ 1; Written informed consent;  Exclusion Criteria:  Complete intestinal obstruction; Hepatitis activity and peripheral neuropathy (such as peripheral neuritis, pseudo meningitis, motor neuritis, and sensory impairment); Significant organ dysfunction or other significant diseases, including clinically relevant coronary artery disease, cardiovascular disease, or myocardial infarction within the 12 months before enrollment; severe neurological or psychiatric history; severe infection; active disseminated intravascular coagulation； Pregnancy or breastfeeding; Alcohol abuse or drug addiction; Concurrent uncontrolled medical condition; - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 75 Years - StdAgeList: Adult, Older Adult
National Robotics-Assisted Radical Prostatectomy Database
Status: Not yet recruiting

Surgical notes are detailed reports written by surgeons during and after surgeries. These notes cover everything from the techniques, instruments used, any issues with the surgical procedure and post-surgical care for the patient. This information is a treasure trove for researchers because they can study it to understand how surgeries go, what works best, and how certain treatments affect patients.

By looking closely at these notes, researchers can find patterns and trends, helping them in understanding what makes surgeries successful and identify the best ways to perform them. This information is crucial for creating guidelines based on solid evidence. Also, these surgical notes are a goldmine for looking back at past surgeries to see how they have affected patients in the long run.

The real power for research comes when we combine these surgical notes within the Electronic Medical Records (EMR) and research databases. This makes it easy to collect information systematically, making it simpler for researchers to study a large number of cases. Unfortunately, not many people have paid attention to this idea for a long time, leading to big gaps in the data collection.

To address this issue, we aim to create a database that collects information from surgical notes effortlessly. This includes details about how surgeons are trained and how they progress. It's important to make sure that doctors work aligns with research - which is the best way to address data collection issues. This data can also help record different technical aspects of surgery and different surgeons' learning curve, making it easier to compare and improve training. Thus, we aim to standardise notes that are the same across different hospitals conducting robotic-assisted surgeries for prostatectomy.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  TTo be eligible to participate in this database, an individual must meet all of the following criteria: (a) Individuals who consent to participate, (b) within the age range of 16 to 90 years, (c) confirmed diagnosis of localized prostate cancer (PCa) and (d) patients receiving medical attention at hospitals engaged in collaborative efforts with the designated database.  Exclusion Criteria:  Participants are not eligible to take part in the database: (a) Individuals who have not undergone robotic surgery for prostatectomy, (b) without a diagnosis of prostate cancer or (c) who decline to provide consent for the collection of their health information and (d) under the age of 16 years. - HealthyVolunteers: No - Gender: Male - GenderBased: Yes - GenderDescription: Males who are diagnosed with localized Prostate cancer - MinimumAge: 16 Years - MaximumAge: 90 Years - StdAgeList: Child, Adult, Older Adult - StudyPopulation: The database will entail recruitment of retrospective and prospective patient cohorts to collect and analyse data. Retrospective data from the last five years will be obtained from the medical records. Prospective data will be collected from each participating site. - SamplingMethod: Probability Sample
Proteomics and Metabolomics of Body Fluid in Patients With Narcolepsy
Status: Not yet recruiting

Narcolepsy (NRL) is a rare chronic central nervous system dysfunction disease, which is more common in children and adolescents, and less common in adults. Its typical clinical features include excessive daytime sleep, paroxysmal cataplexy, sleep paralysis and sleep hallucination. In addition to the above typical manifestations, patients with narcolepsy can also manifest as hyperappetite, weight gain, multiple dreams, sleep fragmentation, anxiety and depression and other emotional disorders. In particular, in narcolepsy type 1 with cataplexy, cataplexy episodes can be confused with falls caused by seizures, transient ischemic attacks or neuromuscular disorders, or even mental conversion disorders. Due to its diverse clinical symptoms, it is easy to be missed and misdiagnosed.

At present, the pathogenesis of narcolepsy is still unclear, and its pathogenesis may be related to immune, genetic, environmental, infection, central nervous system degeneration and other factors. This study aims to investigate the changes of body fluid proteomics and metabolomics in patients with narcolepsy, and to provide an important basis for the pathogenesis of narcolepsy.

Eligibility:
- EligibilityCriteria: Inclusion Criteria  All patients met the diagnostic criteria of the International Classification of Sleep Disorders, Third edition (ICSD-3).  Exclusion Criteria  primary hypersomnia or hypersomnia due to shift work, sleep deprivation and other sleep rhythm disturbances; excessive sleep due to drug abuse; suffering from Parkinson's disease, Alzheimer's disease and other nervous system diseases and mental diseases; complicated with heart, lung, liver, kidney, blood endocrine system and other basic diseases, or acute chronic infection in a short period of time; Use of sedatives, hypnotics, antidepressants, lithium and dopamine receptor antagonists for two weeks before examination; patients who cannot cooperate with PSG and MSLT due to various factors. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 5 Years - MaximumAge: 100 Years - StdAgeList: Child, Adult, Older Adult - StudyPopulation: Patients with narcolepsy - SamplingMethod: Probability Sample
Litfulo Capsules Special Investigation
Status: Not yet recruiting

The objective of this Study is to confirm the safety during the long-term use of this drug and the effectiveness during the use of this drug under the actual use in the patients treated with this drug.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Patients must meet all of the following inclusion criteria to be eligible for inclusion in the study:  Patients with alopecia areata who start receiving this drug for the first time after the contract date of this study Patients who have not participated in a clinical trial (clinical study) of this drug  Exclusion Criteria:  Patients meeting any of the following criteria will not be included in the study:  Patients previously enrolled in this study Patients with a history of treatment with this drug (including investigational product) - HealthyVolunteers: No - Gender: All - MinimumAge: 12 Years - StdAgeList: Child, Adult, Older Adult - StudyPopulation: Patients with alopecia areata who received LITFULO - SamplingMethod: Probability Sample
Phosphoproteomic Profile of Children With Down Syndrome
Status: Not yet recruiting

One of the major causes of cognitive disorders limiting the learning abilities of children with Down's syndrome is excess activity of the DYRK1A protein kinase, whose gene is located on chromosome 21. Consequently, variations in the level of phosphorylation, and hence activity, of DYRK1A target proteins involved in synaptic transmission, could identify mechanisms underlying these cognitive disorders.

Several studies have shown that plasma proteins can reflect a pathophysiological brain state. We plan to carry out a phosphoproteomic study to determine the phosphorylation profile of plasma proteins in children with Down's syndrome, and identify potential DYRK1A-dependent pathophysiological mechanisms and biomarkers involved in the natural course of cognition in children with Down's syndrome.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Clinical diagnosis of free and homogeneous trisomy 21, Body mass index (BMI): 15-25, Able to understand the study based on the pictorial information leaflet and give agreement/assent to participate, Parent present on the day of the visit to validate their child's consent/assent, if applicable.  Exclusion Criteria:  Celiac disease, Autoimmune dysthyroidism, Type I autoimmune diabetes, Alopecia, Other autoimmune diseases, Current infectious pathology, History of infantile spasms, Autism spectrum disorders, Epilepsy, Central nervous system infections, Leukemia not in remission, Anti-inflammatory treatments (NSAIDs, local or systemic corticosteroids). - HealthyVolunteers: No - Gender: Male - MinimumAge: 6 Years - MaximumAge: 12 Years - StdAgeList: Child - StudyPopulation: 30 Children with Down Syndrome and 30 children without genetic abnormality - SamplingMethod: Probability Sample
Phenotyping of Idiopathic Pelvic Pain With Real-time Uterine Imaging and Relugolix-Combination Therapy Treatment
Status: Not yet recruiting

The mechanisms underlying variable efficacy of Relugolix-Combination Therapy (REL-CT) in mitigating unexplained pelvic pain will be evaluated with uterine imaging techniques and quantitative sensory testing.

Eligibility:
- EligibilityCriteria: Inclusion Criteria  Idiopathic pelvic pain (40 participants):  Self-report an average non-menstrual pelvic pain rating of ≥ 2/10 (on a 0 to 10 Numeric Rating Scale) over the past 6 months. Not have received a prior diagnosis attributed to a secondary cause (e.g., leiomyoma, endometriosis).  Endometriosis (20 participants)  Self-report an average non-menstrual pelvic pain rating of ≥ 2/10 (on a 0 to 10 Numeric Rating Scale) over the past Previously confirmed surgical diagnosis of stage III-IV endometriosis, indicating potential remission.  Exclusion Criteria:  History of blood clots, Allergies to REL-CT ingredients Diabetes Migraines Osteoporosis Vascular disease Hormone-sensitive cancers Smoking. Missing limbs Paralysis, Conditions associated with irregular menses Congenital conditions affecting reproductive function Intrauterine device use Pelvic inflammatory conditions Active genitourinary infections, Inability to read or comprehend the informed consent document written in English History of metallic implants, history of metallic injury, any condition precluding investigation with MRI BMI exceeding 40 Uncontrolled thyroid dysfunction Adrenal dysfunction Renal disorders Liver disorders Coagulopathy, Gastrointestinal conditions or surgeries that may affect absorption - HealthyVolunteers: No - Gender: Female - MinimumAge: 18 Years - MaximumAge: 35 Years - StdAgeList: Adult
Impact of Barre Stretching Among Dental Hygiene Students
Status: Not yet recruiting

The healthcare profession of dental hygiene can be a highly stressful academic path and occupation. Physical stressors can quickly lead to postural disturbances and musculoskeletal disorders (MSDs) due to instrument grasping while under muscle tension, working with vibrating instruments, and performing repetitive micromovements. Chronic, high stress levels have the potential to lead to burnout, fatigue, and other health problems, which can impact a student's ability to perform well in their clinical rotations and didactic studies and may translate into their workforce experiences after graduation.

The purpose of this study is to determine whether a relationship exists between Barre stretching and reported stress and pain levels among entry-level dental hygiene students.

This study will be a 6-week experimental randomized control trial (RCT) where participants will be assigned to a 15-minute Barre stretching and breathing video two times a week for the experimental group or control group. The continuous dependent variables in this study will be the reported stress levels and reported pain levels of the entry-level dental hygiene students. The independent variable will be the Barre stretching intervention. The participants will include students at two universities enrolled in an entry-level dental hygiene program as first-year students.

Baseline data collection for each participant will be obtained, and the study will be analyzed using descriptive statistics, a paired t-test and independent t-test. The statistical significance level will be set at P=0.05.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Participants of this convenience sample will be entry-level dental hygiene students (aged 18 or over) without any significant health limitations that will prevent the student from participating in Barre stretching movements.  Exclusion Criteria:  Entry-level dental hygiene student individuals who are under the age of 18 and with significant health limitations that will prevent them from participating in Barre stretching movements, will not be included in the study. Significant health conditions will include unstable joints or recent joint replacements and/or history of back/spinal injuries. Significant health conditions deeming participants exempt from participation will include unstable joints or recent joint replacements, and/or history of back/spinal injuries. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
The Effect of Heart Sound and White Noise on Pain and Physiological Parameters During Hepatitis B Vaccine Injection
Status: Not yet recruiting

It can cause physiological and behavioral changes in infants such as pain, tachycardia, hypoxemia, increased blood pressure, grimacing, prolonged crying, and irritability. Vaccination is an important part of neonatal nursing care. Newborns express their pain nonverbally and behaviorally. Therefore, any pain assessment is based on the ability of others to recognize pain symptoms. This randomized controlled trial was planned to evaluate the effect of heart sound and white noise on pain and physiological parameters during intramuscular injection of hepatitis B vaccine in newborns. This randomized controlled study used parallel trial design.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Gestational age of 38-41 weeks, Newborn birth weight >2500 g Stable vital signs before the procedure, Postanatal age between 2-28 days, No contraindications to the administration of hepatitis B vaccine Delivery of the newborn to the mother after birth Consent of the parents of the newborn to participate in the study Fasting less than 3 hours/30 minutes before feeding A valid score on the newborn hearing screening test Newborn not crying before vaccination  Exclusion Criteria:  Newborn babies requiring respiratory support, Newborns with any neurological disorder (seizures) Newborns taking opiates or born to mothers taking opiates Newborns receiving muscle relaxants, sedatives, analgesics Babies with major congenital anomalies Neonates with an APGAR score of less than 7 at 5 minutes Neonates who have undergone surgery Newborns with birth trauma (especially rapid delivery) Conditions that may prevent communication with parents (e.g. speech problem) Hearing impairment Newborns who will be transferred to another hospital - HealthyVolunteers: No - Gender: All - MinimumAge: 2 Days - MaximumAge: 28 Days - StdAgeList: Child
The Diagnostic Accuracy of Advanced Imaging in Identifying Suspected Skin Cancer (Basal Cell Carcinoma) Around the Eyes
Status: Not yet recruiting

The purpose is to investigate the diagnostic value (sensitivity and specificity) of dermal-Optical Coherence Tomography (D-OCT, VivoSight Dx), in patients with clinically suspected BCC lesions inside the periocular region and compare these results to previous reports using D-OCT in diagnosing lesions outside the periocular area.

The Hypotheses:

The sensitivity and specificity of D-OCT in diagnosing BCC inside the periocular region is comparable to previous reports on BCC lesions outside the periocular region when the standard D-OCT probe is used.
The sensitivity and specificity of D-OCT in diagnosing BCC inside the periocular region is increased when the customised D-OCT probe is used.
The sensitivity and specificity of D-OCT in diagnosing periocular BCC is comparable to punch biopsy when both standard and the customised D-OCT probes are used.
D-OCT with the 10 and 20-millimeter standoff is capable of subtyping periocular BCC.
The inter-observer variation in diagnosing and sub-typing periocular BCC decreases with increasing experience in the scanning procedure.
The number of scans to correctly interpret D-OCT decreases with increasing experience in the scanning procedure.
Delineation of periocular BCC tumour extension is possible using both D-OCT probes

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Clinically suspected periocular BCC. Biopsy-verified BCC Clinically suspected relapse of periocular BCC Age more than 18 years at baseline. Legally competent, able to give verbal and written consent Communicate in Danish verbally as well as in writing Willingness to participate and able to give informed consent and can comply with protocol requirements.  Exclusion Criteria:  Anatomical circumstances that make OCT-scanning impossible, i.e., extensive scarring of eyelids, or large ulcerating crusts that hampers scanning Unwillingness to undergo a skin biopsy or excision of lesion. Inability to sign informed consent. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Consecutive enrolment of newly referred patients under the diagnosis "clinically suspected BCC" in the periocular area - SamplingMethod: Non-Probability Sample