rjac/clinicaltrials.gov-summary_and_eligibility huggingface dataset:
RESTART the Prevention of Pressure Ulcers: Comparing the Effectiveness and Cost of a Reactive Static Air Mattress and Alternating Air Pressure Mattress
Status: Recruiting

Pressure ulcers are a global issue and substantial concern for healthcare systems. A review of the literature between January 2000 and December 2012 has revealed that prevalence rate of pressure ulcers in aged care facilities were between 4.1% and 32.2%, and the incidence rates ranged from 1.9% to 59%. Similarly, a systematic review reported that the prevalence of pressure ulcer varied between 0.3% and 46%, and the incidence of pressure ulcer ranged from 0.8% to 34%. Most epidemiological data were obtained from hospitals (38.7%) and institutional long-term care facilities (29.7%).

The costs associated with pressure ulcers are considerable. According to the Agency for Healthcare Research & Quality (2011), the US healthcare system has allocated approximately $ 9.1 - $ 11.6 billion annually for the health care cost of pressure ulcer. In addition to direct treatment-related costs, the development of pressure ulcer also results in litigation and government penalties, and affects hospital performance metrics. A systematic review has reported that the cost for treatment of pressure ulcer was higher than its prevention. That is, the cost per patient per day ranged from € 1.71 to € 470.49 (for treatment) and from € 2.65 to € 87.57 (for prevention) across all settings.

This randomized controlled trial will be performed in a general hospital in a random sample of 308 patients (nursing wards geriatric n=3 and orthopedic (n=3)) who are at high risk of developing pressure ulcers. Patients will be included in the study for a period > 2 hospitalisation days. Skin assessment and risk factor registration will be done on a daily base by the ward nurses. Reliability checks and time measurements will be completed by the researcher.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Norton score < 14 Bed and/or chairfast no pressure ulcers or at least pressure ulcer category I  Exclusion Criteria:  Norton Score >/=14 Pressure ulcers category II, III, IV, deep tissue injury (DTI) or unstageable pressure ulcer Expected length of hospital stay < 2 days Medical contraindication for use of reactive static air support surfaces End of life care (or Do Not Reanimate (DNR) code IV) Age < 18 years - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
Return to Play After ACL Reconstruction With Bone Marrow Aspirate, DBM, and an Internal Brace
Status: Recruiting

The Investigators are studying the effect of an ACL reconstruction on return to play by capturing outcome measures and biomechanics information.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  INCLUSION CRITERIA: All patients must meet the following criteria:  Patients must be age 14-26 years old. Skeletally mature patients, with an ACL deficient knee who desire to have ACL reconstructive surgery using autograft augmentation. Patients must be a tanner stage of 5 and a posteroanterior left hand film x-ray will be obtained to confirm bone age and skeletal maturity Patients with associated meniscal and chondral pathology (except patients falling into exclusion criteria below) will be included in the study; such pathology will be treated at the time of ACL reconstruction at the discretion of the surgeon, and such pathology and treatment will be recorded. An understanding of the purpose of the study and providing written informed consent.  Exclusion Criteria:  EXCLUSION CRITERIA:  Patients with multi-ligament surgery (MCL, PCL, LCL, PMC, or PLC repair or reconstruction), Patients who have undergone previous ACL reconstructive surgery. Patients who are currently pregnant or nursing. Patients who have a current infection at the operative site. Any condition or personal issue that the surgeon deems ineffective to the outcome of the study. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 14 Years - MaximumAge: 26 Years - StdAgeList: Child, Adult - StudyPopulation: patients 14-26 years old with ACL ruptures - SamplingMethod: Probability Sample
A Study of Single and Multiple Doses of LP-005 in Healthy Adult Participants
Status: Recruiting

The purpose of this study is to evaluate safety, tolerability, immunogenicity, pharmacokinetics, pharmacodynamics, and efficacy of LP-005 in healthy volunteers. The study will be conducted in 2 parts: Part 1, the single ascending dose (SAD) is the first in human (FIH) study of LP-005 and Part 2, multiple ascending dose (MAD).

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Healthy males or females aged 18 through 50 years Male subjects with a weight of ≥50 kg, female subjects with a weight of ≥45 kg, and BMI between 19.0 and 26.0 kg/m² (inclusive). Vaccination: Meningococcal Conjugate Vaccine, Serogroups A, C, W, Y (MPV-ACYW) meningococcal conjugate vaccine and Streptococcus pneumoniae vaccine should be given 14 days or more before randomisation. Male subjects and their partners or female subjects must agree to use one or more non-pharmaceutical contraceptive methods (such as total abstinence, condoms, Iuds, partner ligation, etc.) during the trial period and for 6 months after the trial, and do not plan to donate sperm or eggs. The subjects fully understand the purpose, nature, method and possible adverse reactions of the experiment, and voluntarily participate in the experiment and sign the informed consent. The subjects were able to communicate well with the researchers and complete the study according to the protocol.  Exclusion Criteria:  Participants who are immunocompromised or have one of the following underlying diseases: anatomic absence of spleen (including sickle cell disease); congenital complement component deficiencies (complement component 3 and complement component 4). Any history of Neisseria gonorrhea, meningitis infection, and Guillain-Barré syndrome. Contraindications to meningococcal vaccination (previous medical history such as epilepsy or other brain disorders). Presence or suspicion of active viral, bacterial, fungal, or parasitic infection, including herpes, shingles, or cold sores, within 14 days prior to screening. History of unexplained recurrent infections, or use of systemic antibiotics within 90 days prior to dosing. Malignancy or history of malignancy, except non-melanoma skin cancer cured for more than 3 years. Positive HIV test (HIV-Ab), positive hepatitis B virus (HBV) test (HBsAg), positive hepatitis C virus (HCV), positive anti-syphilis helix-specific antibodies. Participation in a clinical trial of any other drug within 3 months prior to screening or within 5 half-lives of other clinical trial drugs (selecting the longer time period). Women who are pregnant, breastfeeding, or at risk of pregnancy. Any condition deemed unsuitable for study participation by the investigator. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - MaximumAge: 50 Years - StdAgeList: Adult
Study Evaluating SC291 in Subjects With Severe r/r B-cell Mediated Autoimmune Diseases (GLEAM)
Status: Not yet recruiting

SC291-102 is a Phase 1 study to evaluate SC291 safety and tolerability, preliminary clinical response, cellular kinetics and exploratory assessments for subjects with severe autoimmune diseases.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Age ≥18 and ≤75  For LN cohort:  Diagnosis of SLE based on the 2019 European League Against Rheumatism (EULAR)/American College of Rheumatology (ACR) Biopsy-proven LN class III or IV, according to 2018 Revised International Society of Nephrology/Renal Pathology Society (ISN/RPS) criteria Refractory disease to ≥ 2 prior treatment regimens  For ERL cohort:  Diagnosis of SLE based on the 2019 European League Against Rheumatism (EULAR)/American College of Rheumatology (ACR) classification criteria for adult SLE Severe or relapsing disease not responding to at least 2 prior recent disease-modifying therapies For AAV Cohort, diagnosed with Granulomatous Polyangiitis (GPA) or Microscopic Polyangiitis (MPA) based on the 2022 ACR/EULAR classification criteria  Exclusion Criteria:  Prior CD19-directed cell therapy including CAR T treatment or other genetically modified cell therapy (e.g., Natural Killer (NK) cell) For LN and ERL Cohorts, central nervous system (CNS) lupus manifestations or history or presence of CNS disorder For LN and ERL Cohorts, diagnosis of anti-phospholipid antibody syndrome For AAV Cohort only, Diagnosis of Eosinophilic Granulomatosis with Polyangiitis (EGPA) as defined by the 2022 ACR/EULAR classification criteria for EGPA - - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 75 Years - StdAgeList: Adult, Older Adult
Upper Extremity and Muscle Oxygenation
Status: Not yet recruiting

The aim of this study was to measure the acute change in oxygen saturation of skeletal muscle during resistance exercise in the upper extremity using near-infrared spectroscopy.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Volunteering to participate in the study Being over 18 years old Having a Body Mass Index (BMI) value between 23-30 kg/m2 Absence of comorbid disease of the orthopedic, neurological, cardiopulmonery system  Exclusion Criteria:  Smoking / alcohol use Presence of orthopedic disease effecting the upper extremity or previous surgery Presence of cardiopulmonery disease that prevents exercise Participants who performed resistance exercise regulary for more than 6 months - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 30 Years - StdAgeList: Adult
Supporting Secondary School Student Wellbeing Through a Mobile App and Wearable Biofeedback
Status: Not yet recruiting

This study aims to investigate the effects of an app and wearable device on the wellbeing of secondary school students. The app will offer support for stress management, sleep improvement, and time management. Additionally, it will provide access to educational resources, text-based coaching, and biofeedback monitoring through the wearable device. The device, worn around the wrist, will measure heart rate variability as an indicator of stress response. Throughout the study, students will complete bi-monthly surveys on sleep, stress, and overall wellbeing. To assess the specific impact of each feature, the app features will be released incrementally over the course of a year. The intervention group, comprising students in their last two years of secondary school, will have access to the app and wearable device, while a control group within the same class will not use the system but will complete the same wellness surveys. Coaches on this platform will come from the Centre for Positive Health Sciences MSc in Positive Health Coaching as part of their continued training in coaching. Coaching will be asynchronous so that students can post questions at any time during the day, but coaches will respond within 24 hours, during office hours. It will be made clear that this is not a therapeutic service and will be directed to other resources for these services. Coaches will file an incident report if a risk arises from a message with participants. Participants will be given guidelines for the type of questions they can ask such as asking for advice for setting goals related to their digital habits and sleeping better. The study&#39;s findings will provide valuable insights into the effectiveness of the app and wearable device in enhancing student wellbeing leading up to their leaving certification exams.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  entering their 5th year in secondary school attending one of the three secondary school programmes involved (St. Wolstans, Gorey CS, and the Rush Youth Reach) receive consent to participate from a parent/guardian in possession of a smart phone  Exclusion Criteria:  students did not return parental consent forms - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - StdAgeList: Child, Adult, Older Adult
Examination of the Effects of Pelvic Floor Exercises on Vaginal and Sexual Health in Postmenopausal Women.
Status: Recruiting

The purpose of this study; To investigate the effects of pelvic floor muscle exercises on vaginal and sexual health in postmenopausal women. Vaginal symptoms such as vaginal dryness, burning and dyspareunia occur in the postmenopausal period. Vaginal symptoms affect sexual function, leading to a decrease in quality of life. In our study, we plan to evaluate vaginal dryness, one of the vaginal symptoms, using Schirmer's Test. Also in our study; Severities of vaginal dryness, burning and dyspareunia will be evaluated with the visual analog scale (VAS), sexual function will be evaluated with the Post-Menopausal Sexuality Questionnaire and Female Sexual Function Scale, vaginal aging will be evaluated with the Daily Effect of Vaginal Aging Scale, and the presence/severity of pelvic floor symptoms will be evaluated with the Pelvic Floor Distress Inventory-20. The cases will be randomized into two groups and pelvic floor exercises will be given to one group. After the exercises are given, vaginal pH and moistness will be evaluated for acute effect. In the other group, vaginal PH and moisture will be measured after 5 minutes. The cases will be followed without any intervention to the control group. After 12 weeks, the same evaluations will be made to both groups and the results will be compared. The data will be compared using appropriate statistical methods (statistical significance value will be taken as p<0.05) and discussed with the literature.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Having applied to Istanbul Training and Research Hospital, Gynecology and Obstetrics Polyclinic Being literate Volunteering to participate in the study Amenorrhea for 12 months Being sexually active BMI < 35 Mini Mental Test Score threshold value for individuals over 65 years of age is 24  Exclusion Criteria:  Active vaginal infection Having a history of active malignancy and receiving radiotherapy and/or chemotherapy accordingly Having received Hormone Replacement Therapy within the last year, Use of local estrogen Coitus in the last two days Pelvic organ prolapse stage 2 or higher Having had mesh surgery Presence of a disease/medication that causes vaginal dryness (e.g. Sjögren's syndrome, Lichen planus, Lichen Sclerosis / use of antidepressants or antihistamines). - HealthyVolunteers: Accepts Healthy Volunteers - Gender: Female - GenderBased: Yes - GenderDescription: Postmenopausal women - MinimumAge: 18 Years - MaximumAge: 80 Years - StdAgeList: Adult, Older Adult
tDCS Interventions for Subthreshold Depressive Symptoms in Young Individuals.
Status: Recruiting

The purpose of this study is to assess the mechanisms of the effect of transcranial direct current stimulation (tDCS) in alleviating subthreshold depressive symptoms in young individuals, and individualized outcome prediction is carried out.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  1) Be between the ages of 12-25; 2) is right-handed on the Edinburgh Handedness Inventory; 3) 2-4 of the 9 depressive symptoms defined by the American Diagnostic and Statistical Manual of Diseases, Fifth Edition (DSM-5), lasting more than 1 week; or more than 5 depressive symptoms lasting more than 1 week but less than 2 weeks (i.e., not meeting criteria for a major depressive episode) (by DSM-5 Clinical Semi-Definitive Interview (K-SADS-PL) (Gilbody et al., 2017, JAMA); 4) Hamilton Depression Scale (HAMD-24) 24 points≥ 8 points, &lt; 24 points; 5) Gender is not limited; 6) Subjects and their families voluntarily participate and sign the informed consent form.  Exclusion Criteria:  1) Individuals with the following diagnoses according to DSM-5: psychiatric disorders due to organic diseases, substance-related and addictive disorders, neurodevelopmental disorders, schizophrenia spectrum and other psychotic disorders, bipolar disorder (assessed by K-SADS-PL); 2) Have two or more DSM-V-defined manic symptoms for 4 days but do not meet the criteria for hypomania or meet the DSM-V defined criteria for hypomanic symptoms for only 2-3 days; 3) Severe or unstable physical illness; 4) have a moderate or higher risk of suicide (as assessed by the Columbia Suicide Severity Scale); 5) Received transcranial direct current stimulation in the past three months (continuous intervention time: &gt;2 weeks); 6) Contraindications to transcranial direct current stimulation, such as brain implants, personal or family history of epilepsy; 7) Magnetic resonance scanning is contraindicated, such as in vivo metal implants. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 12 Years - MaximumAge: 25 Years - StdAgeList: Child, Adult
Effects of a Wellbeing Intervention on Inflammation Through Reward and Threat Processes
Status: Recruiting

This study aims to evaluate how savoring influences reward and threat processes and downstream inflammation. Savoring is designed to enhance positive affect, which may blunt stress responses and reduce downstream inflammation. The investigators aim to examine changes in the brain following the savoring intervention. The investigators are particularly interested in changes in brain activity that are correlated with changes in inflammation-related markers in the blood. In this single-armed pilot trial, the investigators will assess how savoring alters reactivity to rewarding and threatening experiences, and then examine related changes in downstream inflammation. The investigators intend to recruit 20 undergraduate students to complete a 7-week standardized savoring intervention. Participants will complete brain scans, daily diaries, questionnaires, a behavioral task, and blood collection at pre- and post-intervention assessments.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Moderate depression indicated by a PHQ-8 score between 9 and 15; low positive affect indicated by a PANAS score of less than 24; no anxiety to moderate anxiety indicated by a GAD-7 score of less than 15; 18 to 22 years old; English speaking; and willingness to refrain from starting other psychosocial/pharmacological treatments until study completion. Given the small sample size of this study and the lingual limitations of our study staff, we are recruiting only English speaking participants as the burden of translation exceeds the scope of this project.  Exclusion Criteria:  MRI contraindications (left-handedness, claustrophobia, colorblindness, pregnancy, metal implants, and BMI above 35); presence of disease that may influence inflammation (e.g. asthma requiring inhaler, autoimmune or inflammatory diseases, gum disease, sleep disorder, eating disorder); presence of serious medical conditions (e.g. anemia, cancer (current or history), diabetes, endocrine disorder, fibromyalgia, heart problems); presence of disease that may impact patterns of neural activity (e.g. Attention Deficit/Hyperactivity Disorder, bipolar disorder, schizophrenia, head trauma, epilepsy, problems with drugs or alcohol); use of medications that may influence inflammation in last 6 months; bupropion, dopaminergic or neuroleptic medications in last 6 months, consistent with other studies that investigate anhedonia (e.g., Hanuka et al., 2022), given their potential influence upon reward processing; current use of heterocyclics and SSRIs if not stabilized for at least 3 months; history of regular (5-7 times per week) drug use (marijuana, cocaine, stimulant use before age of 15); current nicotine use (more than 11 cigarettes a week or nicotine equivalent); prior or current behavioral activation psychotherapy; and concurrent psychotherapy. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 22 Years - StdAgeList: Adult
Multivariate Approach to the Numerical Assessment of Cortical - Autonomic - VAscular Dynamic Interplay
Status: Recruiting

MANCAVA sets out fundamental methodologies for characterizing human fundamental physiological system interactions at a whole-body level, particularly focusing on the interplay among cortical brain activity, autonomic function, and cerebrovascular autoregulatory mechanisms. By investigating the complex, time-varying mechanisms underlying the multisystem dynamic interactions, novel methods linking various brain areas and reflex functions to target organs and districts such as heart and circulatory system are proposed with the clinical aim linked to the emerging topic of depression.

In this scenario, proper new mathematical tools will allow a significant leap from the current state of the art, paving the way towards a new understanding of leading comorbid contributors to global diseases such as cardiac and cerebrovascular morbidity in mood disorders. In turn, this will provide an integration among physiological and psychological dimensions for a more holistic view on depression.

Researchers, professionals, and patients will all benefit from a comprehensive assessment of brain-mind-body interplay, leading to the new extended definition of default mode/mood network, neurovascular-evoked responses to autonomic stimuli, brain-autonomic consequences of emotional responses, and physiological substrates of depressive states.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  age older than 18 years spontaneous sinus rhythm signed informed consent indication to heart surgery  Exclusion Criteria:  age lower than 18 years absence of sinus rhythm pregnancy impossibility of informed consent - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
eTMS for Veterans and First Responders With PTSD
Status: Not yet recruiting

A battery of physiological and behavioral data will be collected before and after application of eTMS. Participants will be veterans or first responders diagnosed with PTSD. Study will be a double-blind, sham-controlled, parallel group, randomized clinical trial.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Veteran or first responder diagnosed with post-traumatic stress disorder with PCL-5 cutoff of 31 or above  Exclusion Criteria:  Claustrophobia Contraindications to MRI Pregnant Uncontrolled medical, psychological, or neurological conditions Unable to calculate EEG alpha frequency History of ECT or rTMS History of intracranial lesion or increased intracranial pressure History of stroke History of other neurologic conditions Family history of epilepsy Personal history of epilepsy certain medications - HealthyVolunteers: No - Gender: All - MinimumAge: 22 Years - MaximumAge: 65 Years - StdAgeList: Adult, Older Adult
Differences Between Long Distance Road Runners and Treadmill Runners in Achilles Tendon Structure
Status: Not yet recruiting

this study will investigate the structure of the Achilles tendon and functional tests in road runners compared to treadmill runners.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  run regularly at least twice a week for half an hour, over 80% of the training on a treadmill or road  Exclusion Criteria:  pain or injury to Achilles tendon during the 6 months, preventing running for at least 3 days. past Achilles tendon surgeries, sprained ankle in the last six months, lower limb and back pain while running participants who report running with minimalist shoes. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - MaximumAge: 50 Years - StdAgeList: Adult - StudyPopulation: healthy runners who run on a regular basis, without injuries or pain during the last 6 months - SamplingMethod: Non-Probability Sample