rjac/clinicaltrials.gov-summary_and_eligibility huggingface dataset:
Intra-Arrest-Ventilation in Human Cadavers
Status: Not yet recruiting

The study investigates the influence of non-synchronized, intermittent positive pressure ventilation (IPPV), as recommended in the current resuscitation guidelines of the European Resuscitation Concil (tidal Volume (Vt) = 5-6 mL/kg body weight, respiratory rate = 10 min-1) and Chest Compression Synchronized Ventilation (pInsp = 40 mbar; respiratory rate = chest compression rate) with regard to achieving a sufficient tidal volume and the tightness of various supraglottic airway devices (laryngeal mask, i-Gel-laryngeal mask, laryngeal tube) and endotracheal intubation.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  > 17 Years of Age  Exclusion Criteria:  Adult respiratory distress syndrome (ARDS) Severe lung or thoracic injuries pneumothorax Abnormal airways Tracheostoma severe aspirations - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - MaximumAge: 100 Years - StdAgeList: Adult, Older Adult
Effects of Early Sleep After Action Observation and Motor Imagery After Metacarpal Fracture Surgery
Status: Not yet recruiting

The study aimed to investigate the effects of early sleep after action observation and motor imagery (AOMI) training sessions on manual dexterity in patients with hand immobilization after surgical fixation for metacarpals and phalanges fractures.

Fifty-one patients with hand immobilization for surgical fixation of IV or V metacarpals or first phalanges fractures will be randomized into AOMI-sleep (n=17), AOMI-control (n=17), and Control (n=17) group. AOMI-sleep and AOMI-control groups will perform an AOMI-training before sleeping or in the morning respectively, while Control group will be asked to observe landscape video-clips. Participants will be assessed for manual dexterity, hand range of motion, hand disability and quality of life at baseline before and after the training and at 1 month after the training end.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Surgical fixation for IV or V MTC or P1 fracture at the level of the right hand Age 18-40 years old Right-hand dominance  Exclusion Criteria:  Damage to additional hand structure requiring surgery (e.g. tendons, ligaments and nerves) Occurrence of left upper limb injuries Post-surgical complications (e.g. CPRS) Immobilization <12 or >30 days Diagnosis of neurological/musculoskeletal conditions Sports or activities requiring advanced manual skills or sleep deprivation History of psychiatric disorders Sleep disorders (e.g. insomnia, OSAS, REN or Non-REM behavioural disorders) Medication affecting the physiological sleep pattern - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 40 Years - StdAgeList: Adult
Development of Health Monitoring System on Patient's Well Being in Dialysis Context
Status: Not yet recruiting

One of the goals in the Sustainable Development Goals (SDGs) is the availability of a healthy and prosperous life for all ages. This goal mentions health priorities i.e. non-communicable diseases. Chronic kidney failure (CRF) is one of the non-communicable diseases that is the main cause of death and disability both in the world and in Indonesia. The prevalence of CRF in Indonesia is 0.5% with 83.2% of patients being of productive age and the highest number of CRF patients in North Kalimantan, Southeast Sulawesi, DKI Jakarta and Yogyakarta. Monitoring and evaluation of patients with CRF is currently mostly carried out conventionally not using health technology that is integrated with hospital information systems. This study aims to design and provide a health information system for patients with CRF, hereinafter referred to as SIKIDI, which integrates mobile-health applications used independently by patients with existing information systems in hospitals.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  >18 years old has been undergoing hemodialysis >3 months has smartphone  Exclusion Criteria:  emergency hemodialysis - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 65 Years - StdAgeList: Adult, Older Adult
Neoadjuvant SBRT in Localized Advanced HNSCC
Status: Recruiting

The response rate of HNSCC to immune checkpoint blockade was not satisfied. Improving the mPR rate of neoadjuvant immunotherapy through the combination with other treatment methods is an important way to further improve the prognosis of such patients. This study aims to explore the efficacy and safety of PD-1 monoclonal antibody with neoadjvant SBRT and chemotherapy. The triple mode not only can Increase the effectiveness of neoadjuvant therapy，meanwhile，the in situ tumor vaccine inoculation effect generated by enhancing the release of specific antigens after tumor radiotherapy with PD-1 monoclonal antibody achieves a sustained anti-tumor immune effect throughout the body， reducing postoperative adjuvant radiotherapy and chemotherapy. The triple mode has important exploratory value in achieving high quality and long-term survival for patients, and may provides a more efficient mode for locally advanced HNSCC.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Pathologically confirmed initially resectable Localized advanced head and neck squamous cell carcinoma，and plan for surgical resection. Immunohistochemical confirmed the HPV status through P16 immunostaining. Male or female, Between the aged from 18 to 70 years, Able to provide informed consent, comply with agreements, and sign research specific consent documents. ZPS is less than 2. Adequate bone marrow, liver and kidney, heart , lung and other physiological function determined by Researchers, able to tolerate neoadjuvant anti-PD-1, anti-EGFR, and radiation therapy. Subjects are willing and able to comply with visits, treatment regimens, laboratory tests, and other requirements of the study as spe.  Exclusion Criteria:  Any clinical illness, such as hemorrhage, active infection, or mental illness, that can hinder safe participation or adherence of research procedures. Patients who cannot accept radiotherapy in standard treatment. Long term maintenance of oral steroids (≥ 20mg prednisone equivalent per day) is required, excluding patients with inhaled, local, or non absorbable steroids. Autoimmune diseases, including but not limited to inflammatory bowel disease, rheumatoid arthritis, autoimmune hepatitis, systemic sclerosis (scleroderma and variants), systemic lupus erythematosus, autoimmune vasculitis, autoimmune neuropathy (such as Guillain Barre syndrome), etc. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 70 Years - StdAgeList: Adult, Older Adult
The Surface EMG Biofeedback as an Alternative Therapy to Reduce Chronic Low Back Pain
Status: Recruiting

The prevalence of chronic low back pain (CLBP) among the Pakistani population is reported to be as high as 78% leading towards different physiological and psychosocial alterations with the worst cases suffering from disabilities. CLBP is a multifactorial phenomenon in which age, gender, comorbidities, lifestyle conditions, profession, working hours, and different stressors play their roles in its causation. However, different therapeutic techniques have been determined to reduce CLBP. Thus, this study aimed to assess the effectiveness of the biofeedback surface EMG (sEMG) technique in reducing chronic low back pain among sufferers in the long run.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Individuals who constantly experience low back pain for the last three months. Individuals who seek care from healthcare provider due to low back pain Individuals with average pain intensity, were assessed using the Brief Pain Inventory (BPI) over the past week ≥ 2 on a 0-10 scale. Individuals with an average Oswestry Disability Index (ODI) score ≥ 4. Individuals with State-Trait Anxiety Inventory (STAI) score ≥ 20.  Exclusion Criteria:  Age below or above 25 and 75 years, respectively. Females who are pregnant, lactating, or that they anticipate becoming pregnant in the next 3-6 months will be excluded. Individuals having any diagnosed chronic disease. Individuals having any diagnosed neurological disorder including Alzheimer's, Amyotrophic Lateral Sclerosis, Multiple Sclerosis, Parkinson's, Stroke Individuals having any diagnosed motor disorder or had pathologic fractures of the spine, avascular necrosis or osteonecrosis, severe osteoarthritis. Including a history of spine surgery or a hip arthroplasty Individuals with an active cancer Blind individuals Individuals having a body mass index greater than 35 kg/m2 Individuals with clinical depression, that is having a score of 24 or higher on the Center for Epidemiology Depression Scale. Individuals who have used narcotics or muscle relaxants within 30 days before study enrollment. - HealthyVolunteers: No - Gender: All - MinimumAge: 25 Years - MaximumAge: 75 Years - StdAgeList: Adult, Older Adult
Ultrasound Guided Recruitment Manauvere Versus Individualized Positive End Expiratory Pressure in Pediatric Patients Undergoing Laparoscopic Abdominal Surgery
Status: Not yet recruiting

The aim of this prospective randomized controlled study is to compare the effect of US-guided Recruitment Manauvere (RM) versus individualized positive end-expiratory pressure (PEEP) on oxygenation and preventing respiratory complications in pediatric patients undergoing laparoscopic abdominal surgeries.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Age from 3 to 8 years. Both sexes. American Society of Anesthesiologists (ASA) physical status I-II. Children scheduled for elective laparoscopic abdominal surgeries.  Exclusion Criteria:  Parental refusal. Bronchial asthma or any preexisting chest disease. Congenital deformity of the thoracic cage. Patients with a history of thoracic surgery. Cardiac, hepatic, or renal failure. Obese children with BMI at or above 95th percentile of the same age and sex. - HealthyVolunteers: No - Gender: All - MinimumAge: 3 Years - MaximumAge: 8 Years - StdAgeList: Child
Reducing Pain Levels and Increasing Comfort of Premature Infants During Aspiration
Status: Not yet recruiting

The aim of this study was to investigate the effect of using amigurumi octopus on the pain and comfort of the newborn in premature infants undergoing endotracheal aspiration.

It is a randomized controlled quasi-experimental design. The study will be conducted in the neonatal intensive care unit of Health Sciences University Bursa High Specialization Training and Research Hospital. The population of the study will consist of preterm hospitalized in the neonatal intensive care unit during the period of the conducted study. In the calculation of the sample size, the power level is 80% and the significance level is 5%. It was determined by the statistical expert that the number of babies that should be included for each group is 26 and the total number of babies required for the whole study is 52 when the effect size is determined as 0.8 for the investigation of the difference between the experimental and control groups in terms of the premature infant pain profile (PIPP) variable. Based on aforementioned information, the study sample was determined as 80 preterm infants in which 40 for experimental groups and 40 for control groups. Block randomization method will be applied for the randomization of the groups.

PIPP=Premature Infant Pain Scale and Premature Infant Comfort Scale (PBIQ) will be used as a case report form for the collection of the study data. All the patients included in the study will be intervened by the nurse having a neonatal nursing experience by paying attention to aseptic conditions in accordance with the routine aspiration criteria of the unit. Standardization will be ensured by intervening in all patients with the same application by the same nurse.

During the endotracheal aspiration procedure, the octopus will be given to experimental group 10 minutes before the procedure. Babies will be allowed to touch the octopus for 10 minutes during and after the procedure. Physiologic parameters of the infants before, during and after the procedure will be reported and recorded by camera. According to the video recordings, PIPP-R and PICS scale evaluations of the infants will be made by two research nurses other than the main researcher conducting the study. The routine aspiration application steps of the unit will be applied to the control group without any intervention.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Gestational age range of 26-36 weeks The baby should be between postnatal day 0 and 5 (Postnatal day of baby should be between 0 and 5 days.) Need for invasive mechanical ventilator support Need for endotracheal aspiration No analgesic, opioid and sedative medication was applied within the 4 hours before the endotracheal aspiration At least 2 hours passed since the last painful procedure  Exclusion Criteria:  Receiving analgesic medication Major congenital anomaly Having a pneumothorax tube Stage III and intraparenchymal hemorrhage Receiving a sedative medication - HealthyVolunteers: No - Gender: All - MinimumAge: 1 Day - MaximumAge: 5 Days - StdAgeList: Child
Remote Therapeutic Monitoring Exercise Tracking
Status: Not yet recruiting

The purpose of this study is to examine physical activity and exercise behaviors in people with Parkinson's Disease and Multiple Sclerosis over the course of 1-year using a cloud-based remote monitoring platform.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Are ambulatory as their primary means of mobility without an assistive device except for single point cane or walking sticks in community Have a diagnosis of Parkinson's disease (Hoehn and Yahr 1-3), Parkinsonism, or Multiple Sclerosis Personal goal and willingness to address physical activity Have a smart phone (Datos Health app is compatible with any Smart phone device) Willing to accept Datos' Terms and Conditions  Exclusion Criteria:  Individuals with cognitive or communication disorders (including dementia) which would limit their ability to interact with the RTM - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 89 Years - StdAgeList: Adult, Older Adult
Effectiveness of Risk-based Sequential Screening for Esophageal and Gastric Cancer
Status: Not yet recruiting

To evaluate the feasibility, applicability, effectiveness, and health-economic value of the risk-based sequential screening modality for esophageal and gastric cancers, the investigators aim to initiate a community-based randomized controlled trial in Xun County, Henan Province, which is a high-risk region of upper gastrointestinal cancer (UGIC) in northern China.

A total of 258 target villages from all the 11 communities (townships and streets) in Xun County will be randomly selected and assigned to the sequential screening group and the universal screening group at a ratio of 2:1 and the total sample size will be 21,000.

In the sequential screening group, participants in the top 50% risk level (i.e., stratified as the high-risk subgroup) will be offered a standard upper gastrointestinal endoscopic screening. In contrast, all participants in the universal screening group will receive the endoscopic examination. The surveillance strategy for participants with screening-detected premalignant lesions in the sequential screening group will be tailored based on individualized risk assessment using endoscopic characteristics, pathological diagnosis, and biomarkers. Surveillance for participants in the universal screening group will adhere to current guidelines for UGIC screening and clinical treatment.

Detection rates of upper gastrointestinal malignant lesions, early-stage malignant lesions and premalignant lesions, and health-economic indicators such as the unit cost per detected malignant lesions will be compared between the two groups.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Permanent residency in the target villages in Xun County, Henan Province, China; Aged 50 to 69 at the enrollment; Voluntarily participate in this study and provide informed consent.  Exclusion Criteria:  Had a history of endoscopic examination within 5 years prior to the initial interview; Had a history of cancer; Had a history of mental disorder; Positive for hepatitis B virus (HBV), hepatitis C virus (HCV), and human immunodeficiency virus (HIV); Had severe cardiovascular and cerebrovascular diseases; Had severe respiratory disease, dyspnea, or asthmaticus status; Had retropharyngeal abscess, severe spinal deformity, or aortic aneurysm; With physical debility unable to tolerate endoscopic examination, or with difficulty in achieving sedation and self-control; In the acute phase of corrosive inflammation of the upper gastrointestinal tract, or with suspected perforation of the upper gastrointestinal tract; Had massive ascites, severe abdominal distension, or severe esophageal varices; Pregnancy; Had severe history of allergies; Had propensity for bleeding (coagulopathy); Others unable to tolerate the clinical examinations involved in this study. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 50 Years - MaximumAge: 69 Years - StdAgeList: Adult, Older Adult
Open-label Placebo in Manual Therapy
Status: Recruiting

to investigate the effects of placebo in patients affected by low-back pain.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Adult patients (+18 years) who complain of chronic non-specific low back pain for at least 3 months with or without pain exacerbations at the time of recruitment, will be included.  -Patients will need to have a diagnosis of low back pain made by a physician  Exclusion Criteria:  pathologies such as ankylosing spondylitis, infections, fractures, tumors or metastases. Pregnant women patients with previous spinal surgery or undergoing cortisone therapy in the 6 months prior to the trial diseases that may affect the interpretation of results such as fibromyalgia patients currently being treated by other specialists or other manual therapists - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
Computational Assessment of Bioprosthetic Aortic Valve Function
Status: Not yet recruiting

Bioprosthetic valves are usually made of biological tissue that are mounted to a frame and are designed to function similarly to a healthy natural valve. Edwards Magna Ease and Intuity Elite bioprosthetic valves have similar leaflets and mounting designs. However, the valves are implanted in the patient in different ways (one is stitched to the wall of the left ventricular outflow tract, and the other is held in place by the radial force of the valve skirt). The study aims to understand in more detail how the different valves interact with the left ventricular outflow tract and aortic root.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Male and female patients aged 18 years or over. Patients diagnosed with aortic valve disease, and scheduled to undergo Edwards Magna Ease or Intuity Elite and free of exclusion criteria below. The patient is willing and able to understand the Patient Information Sheet and provide written informed consent. The patient must agree to comply with the study imaging protocol as required at prespecified times.  Exclusion Criteria:  Inability to provide valid informed consent. Male and female patients aged < 18 years of age. Contraindications for CT angiography: renal failure (Cr>250 μmol/L or eGFR<30 mL/min) due to the additional risk of contrast medium nephrotoxicity or allergy to iodine. Women of childbearing age who have not had a hysterectomy and/or who may be breastfeeding. History of cardiac pacing device insertion, or any other MRI incompatible device implants. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: 20 informed and consented patients who undergo the Intuity Elite (n=10) and Magna EASE (n=10) valves will be prospectively enrolled. The patients will be evaluated at 3- and 12-months post valve replacement. - SamplingMethod: Non-Probability Sample
Comparison of Teaching Methods of Pelvic Floor Muscle Contraction in Women
Status: Not yet recruiting

The aim of our study; To evaluate the effectiveness of different teaching methods on correct pelvic floor muscle contraction in women who have not received pelvic floor muscle training (PFMT) before. Women who come to the gynecology and obstetrics clinic for examination and volunteer for the study will be randomized with a computer-aided randomization program and divided into 3 groups. First of all, the pelvic floor muscles will be evaluated by ultrasonographic method and perineometer. The first group will be taught pelvic floor muscle contraction with verbal explanation, the second group will be taught with digital vaginal palpation, and the third group will be taught pelvic floor muscle contraction with the help of a perineometer. After the training, the same evaluations will be made again. The number of individuals to be included in the study will be determined by power analysis. As a result of this study, it will be decided which method can be used to teach pelvic floor muscle contraction to women accurately and effectively in clinics. The results of our study will guide clinicians in their preferences for using different teaching methods.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  volunteering to participate in the study, getting a score of 25 or more from the "Mini mental Test", having pelvic floor muscle contraction ability, not having received pelvic floor muscle training before, vaginal examination and volunteering for education.  Exclusion Criteria:  Pregnancy, presence of symptomatic pelvic organ prolapse over stage 2, cooperation problem, presence of urinary infection, epilepsy, and accompanying neurological disease. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: Female - GenderBased: Yes - MinimumAge: 20 Years - MaximumAge: 50 Years - StdAgeList: Adult
Biomarkers in Retinitis Pigmentosa
Status: Recruiting

The objective of this study is to discover biomarkers that demonstrate a correlation between the severity of retinitis pigmentosa (RP) and the thickness of the retinal pigment epithelium (RPE). These biomarkers will serve as prognostic indicators for various kinds of retinitis pigmentosa. The objective of this study is to find biomarkers that establish a correlation between the severity of retinitis pigmentosa and the thickness of the retinal pigment epithelium (RPE), which can serve as a prognostic indicator for Retinitis Pigmentosa.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Patients who are able to read and sign informed consent Patients with Retinitis pigmentosa confirmed by genetic test. Patients older than or equal to 18 years of age  Exclusion Criteria:  Other retinal diseases such as macular hole, retinal detachment, macular neovascularization. Corneal surgery in the last 12 months Glaucoma with pressure above 25 mmHg in the last three months. Best Correct Visual Acuity below 1/10 in at least one eye. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: The patients will be enrolled at the Ophthalmology department of Fondazione Policlinico Universitario A. Gemelli IRCCS.  Patients with diverse kinds of RP with genetic confirmation, no other retinal disorders, pressure under 25 mmHg for three months, and no corneal surgery in the past year are included. - SamplingMethod: Non-Probability Sample