Kornimate/medical-research-clean huggingface dataset:
texture and colour enhancement imaging in improving detection and miss rate of premalignant lesions

Conditions: Adenoma; Sessile Serrated Adenoma

Summary: texture and color enhancement imaging (txi) is a newly developed image-enhancing endoscopy technology that has show potential in improving detection of colorectal lesions. this multicenter, randomized, tandem trial is aimed at evaluating whether txi is superior to wli endoscopy in terms of diagnosis of premalignant lesions.


Eligibility criteria:
inclusion criteria: patients aged 45-85 years and scheduled for screening colonoscopy who provided written informed consent exclusion criteria: surveillance, diagnostic or therapeutic colonoscopy patients with an already known or suspected colorectal tumour patients with alarming symptoms and signs, including haematochezia, melena, weight loss or anaemia without specific causes, an abdominal mass and positive digital rectal examination pregnant or lactating women patients with gastrointestinal tract obstruction patients with inflammatory bowel diseases, hereditary crc syndromes or serrated polyposis syndrome patients with abnormal blood coagulation or taking antiplatelets or anticoagulants within 7 days before colonoscopy patients with failed cecal intubation patients with poor bowel preparation quality that necessitated a second bowel preparation patients with a history of colonic resection

Keywords: texture and color enhancement imaging colonoscopy adenoma detection rate sessile serrated lesion detection rate adenoma miss rate sessile serrated lesion miss rate
comparison of two modes of transcutaneous electrical nerve stimulation (tens) in chronic neuropathic radiculalgia

Conditions: Neuropathic Pain; Radiculopathy

Summary: this study will compare 2 types of transcutaneous electrical nerve stimulation (tens) to treat chronic neuropathic pain. tens involves the application of electrical stimulation to the skin via surface electrodes to stimulate nerve fibres for pain relief.

tens is already recommended in clinical practice to treat chronic neuropathic pain. the objective of this study is to compare the efficacy of 2 different modes of tens: conventional tens (c-tens) and mixed-frequency tens (m-tens). randomization will determine the mode that the patient has to test during the first month. each patient will test successively each mode during 1 month at home (3 sessions 1 hour/day). then, the patient will test the other mode during the second month. up to 6 months, the patient will be free to use the mode of tens he wants.

Eligibility criteria:
inclusion criteria: * patients aged 18 years old or older * patients with chronic neuropathic radiculalgia from at least 3 months of evolution * radiculalgia vas \> or egal to 40/100 * neuropathic pain diagnostic (dn4) score \> or egal to 4 * patient who has accepted to participate in the study by signing the informed consent form exclusion criteria: * pregnancy * dermatosis in the painful dermatome * venous or arterial thrombosis of the lower limbs * patient with active implantable medical device * severe cognitive disorders * patient under a legal protection regime(guardianship/curatorship/guardianship of justice) * previous use of tens to treat radiculalgia

Keywords: tens
wound infiltration and breast cancer surgery

Conditions: Breast Cancer

Summary: prospective double blind randomized evaluation of the effect of surgical wound infiltration with ropivacaine versus placebo in patients scheduled for breast surgery with axillary lymph node dissection

this is a prospective, double-blind, randomized, single centre study adult asa i - ii patients, scheduled for unilateral mastectomy or tumorectomy associated with axillary lymph node dissection are included in the study. patients receiving opioid or any other analgesic treatment for chronic pain before surgery, patients with known allergy to local anaesthetics, and patients with acquired or genetic haemostatic abnormality are excluded. patients are allocated randomly into two groups on the morning of surgery, using random numbers and sealed envelopes. general anaesthesia using propofol and sufentanil for induction, and sevoflurane in the treated group infiltration is performed with a ropivacaine 7.5 mg.ml-1 solution and in the control group with an isotonic saline solution. in the two groups patients are operated under general anesthesia with propofol, sufentanil, sevoflurane and nitrous oxide for maintenance. twenty milliliters of the allocated solution are used at the end of the surgical procedure to infiltrate the subcutaneous and deep layers at the level of the breast and axilla surgical incision. postoperatively, 8 tablets of paracetamol 500 mg were let at patient' disposal every 24 hours for 3 days. if pain control is not adequate patients receive 5 mg of subcutaneous morphine as a rescue. pain intensity is measured on a visual analogue scale graded from 0 to 100. measurements are performed at rest and on operated arm abduction, at 2, 4, 6, 12, 24, 48, and 72 hour after the end of surgery. the value of maximum abduction angle is noted. to evaluate quality of life patients are asked to score on a 4 points scale graded from 0 (the worst) to 3 (the best) the following items: sleep - fatigue - global activity - relationship with relatives - state of mood. a global score is attributed to each patient as the sum of categorical scores. evaluation is performed at 24, 48 and 72 hour after the end of surgery. patients are evaluated at two month for residual pain at rest and on movement using a visual analogue scale and for quality of life as previously defined.

Eligibility criteria:
inclusion criteria: * adult asa i - ii patients, scheduled for unilateral mastectomy or tumorectomy associated with axillary lymph node dissection exclusion criteria: * patients receiving opioid or any other analgesic treatment for chronic pain before surgery, patients with known allergy to local anaesthetics, and patients with acquired or genetic haemostatic abnormality

Keywords: breast surgery : postoperative pain; ropivacaine
mind-body skills groups for the treatment of war-related trauma in children in gaza

Conditions: Posttraumatic Stress Disorder

Summary: the objective of this study is to determine whether participation in a mind-body skills program by war-traumatized children in gaza will result in improvement of posttraumatic stress symptoms, depression, and decreased hopelessness compared to a control group.


Eligibility criteria:
inclusion criteria: * having experienced a political violence or war-related criterion a stressor * meeting the american psychiatric association (dsm-iv-tr) criteria for ptsd according to screening scores on the child ptsd symptom scale exclusion criteria: * former psychosocial or medical treatment for mental health conditions * significant cognitive impairment
synergy between patient and clinician: using a trauma-informed care plan

Conditions: Trauma and Stressor Related Disorders; Violence, Structural; Violence, Domestic; Violence, Sexual

Summary: the goal of this prospective study is to test the: acceptability of trauma-informed care plans; the intervention appropriateness; and the feasibility of the trauma-informed care plans in the electronic health care record. patient seen in various health care settings and how have complex health care needs will be invited to participate in this study. the aims to are: aim 1: explore the acceptability of trauma-informed care plans, the appropriateness of trauma-informed care plans, and the feasibility of trauma-informed care plans(ticp) when used by clinicians on the health care team (hctc). hypothesis 1: hctc using the ticp will report its acceptability, feasibility, satisfaction and ease of use. hypothesis 2: hctc will report heightened awareness of intersection of trauma and social determinants of health. hypothesis 3: hctc will report more awareness of the patient's unique preferences and will be better informed regarding the unique plan of care for their patient. aim 2: explore the impact of having a ticp by patients understanding how the ticp may have improved their experience around care and treatment. hypothesis 1: patients will report: improved satisfaction with their care. hypothesis 2: patients will report feeling better known by hct. hypothesis 3: will report less stress and anxiety related to health care encounters.


Eligibility criteria:
inclusion criteria: * patients ( ages 18-60) * who have frequent health care appointments * have complex health care needs * consent to participate in study * english or spanish speaking. exclusion criteria: * patients less than 18 and older than 60. * patients too ill (medically/phytologically) to consent. * suicidal or homicidal patients.

Keywords: trauma violence abuse
to evaluate the long-term safety and efficacy of hsk16149 in chinese patients with peripheral neuralgia

Conditions: Peripheral Neuropathic Pain

Summary: investigate the long-term(52 weeks) safety and efficacy of hsk16149 capsules in chinese patients with periphcral neuralgia

investigate the long-term(52 weeks) safety and efficacy of hsk16149 capsules in chinese patients with peripheral neuropathic pain

Eligibility criteria:
inclusion criteria: 1. subjects who completed double-blind treatment and safety follow-up in hsk16149-201/301. 2. able to understand and voluntarily sign informed consent. exclusion criteria: 1. medication compliance was \< 80% in double-blind studies. 2. in double-blind study, eot visit (v10) egfr\< 60 ml/min//1.73m2 3. significant safety concerns or adverse events that did not recover before taking the drug in this study arose in the double-blind study. 4. hepatitis b surface antigen (hbsag) positive or hepatitis c virus antibody (hcv ab) positive during screening \[further hepatitis b virus deoxyribonucleic acid (hbv dna) titer detection or hepatitis c virus ribonucleic acid (hcv rna) detection (beyond the detection limit of assay need to be excluded)\], human immunodeficiency virus antibody (hiv) ab) positive, serum antibody to treponema pallidum (tp ab) positive (further test for treponema pallidum titer, if positive, excluded). 5. women who are pregnant, planning to become pregnant during the study, or breastfeeding; participants were not expected to use reliable contraceptive methods (including condoms, spermicides, or intrauterine devices) for 28 days after signing up for the icf or planning to use progester-containing contraceptives during this period. 6. the researcher judged that the study could not be completed according to the scheme or that it was difficult to participate in the study due to safety.
study to evaluate the performance of cardiacsense ppg sensor

Conditions: Atrial Fibrillation

Summary: study to evaluate the performance of the cardiacsense1's embedded ppg under different environmental and physical conditions

the clinical study is a prospective, open, single-center, and controlled study to evaluate the performance of a ppg sensor in the cardiacsense1 device. the cardiacsense1 is a wrist worn device designed to detect atrial fibrillation (af). the af detection of the device is based on a portable photoplethysmograph (ppg) sensor that is designed for continuous heart rate monitoring. the photoplethysmograph is a noninvasive circulatory signal related to the pulsatile volume of blood in the tissue. twenty (20) subjects (female and male) that do not suffer from atrial defibrillation and additional four (4) patients who are diagnosed as suffering from atrial fibrillation will be enrolled to the study. comparison of cardiacsense1 ppg individual peak detection to the corresponding recorded activity of an fda-cleared ecg holter, on a beat-by-beat basis will be performed on the following conditions: all subjects will be exposed to 45 minutes of indoor standard office fluorescent light and 45 minutes to outdoor sunlight during mid-day. in addition, subjects will be asked to walk for 1 minute once every 10 minutes and will be exposed to an indoor environment of 22±3 - 28±3 degree celsius for 45 minutes and outdoor temperature of at least 15 degree celsius, on the other 45 minutes. 4 subjects will be tested in the following conditions: driving a car for 30 minutes; high wrist hair density subjects; two subjects 65 y/o or older, two subjects 30 y/o or younger; two subjects with bmi below 18.5 (underweight) and two subjects with bmi over 30 (obesity); two subjects with skin type 6 (fitzpatrick) and two subjects with skin type 5; four subjects with diagnosed persistent atrial fibrillation.

Eligibility criteria:
inclusion criteria: * age of eighteen to eighty-five (18-85) years * ability and willing to sign informed consent form * for subjects in groups other than heart arrhythmias- self-declared not to be diagnosed with any arrhythmia * compliance with hair, age, bmi skin and heart arrhythmia variables as defined above exclusion criteria: * concurrent enrollment in another device or drug trial that has not completed the primary endpoint or clinically interferes with the current study endpoints. * subject with low perfusion indicated by the watch * pregnant or breastfeeding woman (women of child-bearing potential must have a negative pregnancy test within screening period).

Keywords: cardiology
characterizing guideline adoption and treatment quality in clinical routine of german hfref care

Conditions: Heart Failure

Summary: this is a multicenter, non-randomized, non-interventional cohort study with prospective and retrospective collection of primary data on heart failure with reduced ejection fraction (hfref) patient treatment and care following a decompensation event in different types of heart failure unit (hfu) or non-hfu centers across germany.

this study aims to describe quality of care of hfref patients following a decompensation event in different center types (=settings) utilizing the quality indicators for the care and outcomes of adults with heart failure as specified by the heart failure association in 2022. no strict visit schedule will be imposed on participants to avoid interference with routine clinical care. hfref patients will be treated according to the local routine in terms of medication, visit frequency and types of assessments performed and only these data will be collected as part of the study from patient files.

Eligibility criteria:
inclusion criteria: 1. patients who provide written informed consent to participate in the study 2. male or female patients ≥ 18 years of age 3. patients with diagnosis of heart failure with reduced ejection fraction (hfref) and hf treatment according to the summaries of product characteristics (smpcs) 4. decompensation event up to three months prior to inclusion exclusion criteria: 1. simultaneous or planned participation in an interventional research study 2. participation in this study at another site e.g. in a hfu network 3. patients incapable of understanding and signing the informed consent form

Keywords: heart failure hfref patient management quality of care quality indicators
vaccination adjuved against hepatitis b in sns workers typed as no responders to conventional vaccines

Conditions: Hepatitis B; Hepatitis; Hepatitis, Viral, Human; Hepatitis B Immunization

Summary: health workers with biological risk in their tasks, who have been vaccinated as non-responders to conventional vaccination against hepatitis b. to provide health workers-staff with an additional protection tool against hepatitis b infection. to evaluate the efficacy of the adjuvanted vaccine in healthy nonresponders to conventional hepatitis b vaccine.

an interventional, phase 4, single group assignment, without masking (open label), preventive clinical trial was carried out in health workers with biological risk in their tasks, who have been filed as non-responders to conventional vaccination against hepatitis b. methods: 67 health workers with biological risk in their tasks, who have been filed as non-responders to conventional vaccination against hepatitis b, were enrolled in the clinical trial. all participants were from 18 years up to 64 years old. the criteria defining them as non-responders to the conventional hepatitis b vaccine is anti hbsab titers \< 10 mui/ml following the application of six doses of conventional vaccine at 20 lg doses (two complete guidelines). the objective of this study was to provide health workersstaff with an additional protection tool against hepatitis b infection, and to evaluate the efficacy of the adjuvanted vaccine in healthy non-responders to conventional hepatitis b vaccine.

Eligibility criteria:
inclusion criteria: * nhs workers -including university students doing their internships in health centres dependent on the national health system (inclusion of students is regulated and limited by specific instructions on labour prevention in each autonomous community). * criteria defining them as no responders to the conventional hepatitis b vaccine: anti hbsab titers \<10 miu / ml following the application of six doses of conventional vaccine at 20 μg doses (two complete guidelines). exclusion criteria: * known allergy to the active substance or any of the other ingredients of the medicinal product (included in section 6 of the product data sheet). * subjects that have ever had an allergic reaction to any vaccine against hepatitis b. * subjects have a serious infection with fever. * subjects for whom informed consent is not obtained. * subjects that have not revoked the consent initially signed.
effects and mechanism of two hybrid exercise-cognitive trainings in mild ischemic stroke with cognitive decline

Conditions: Stroke Patients With Cognitive Decline

Summary: the purposes are to: (1) examine and compare the effects of two hybrid interventions on brain plasticity, physiological biomarkers and behavioral outcomes, including cognitive and physical functions, from pre- to post-training; (2) understand the neural mechanisms of cognitive recovery following two hybrid interventions using the functional magnetic resonance imaging (fmri); (3) examine the long-term benefits of the two hybrid therapies; (4) to identify the correlations between brain activity, biomarkers and behavioral measures.

cognitive decline after stroke is highly associated with functional disability. empirical evidence shows that exercise combined cognitive training may induce neuroplastic changes that modulate cognitive function. however, it is unclear whether hybridized exercise-cognitive trainings can facilitate cortical activity and physiological outcome measures and further influence on the cognitive function after stroke. we aim to investigate the effects of two hybridized exercise-cognitive trainings on brain plasticity, physiological biomarkers and behavioral outcomes in stroke survivors with cognitive decline. this study is a single-blind randomized controlled trial. a target sample size of 75 participants will be recruited. stroke survivors with mild cognitive decline will be stratified by mini-mental state examination scores and then randomized 1:1:1 to sequential exercise-cognitive training, dual-task exercise-cognitive training or control groups. all groups will undergo trainings 60 min/day, 3 days/week, for a total of 12 weeks. the primary outcome is the resting-state functional connectivity and neural activation in the frontal, parietal and occipital lobes in functional magnetic resonance imaging. secondary outcomes include physiological biomarkers, cognitive functions, physical function, daily functions and quality of life. this study may differentiate the effects of two hybridized trainings on cognitive function and health-related conditions and detect appropriate neurological and physiological indices to predict training effects. this study capitalizes on the groundwork for non-pharmacological intervention of cognitive decline after stroke.

Eligibility criteria:
inclusion criteria: 1. stroke occurring at least 6 months prior to enrollment 2. age range from 20 to 80 years 3. mmse score \< 28 or moca\<25 4. able to follow the study instruction 5. adequate cardiopulmonary function to perform aerobic exercise 6. able to walk with or without assistive devices exclusion criteria: 1. unstable medical history (e.g., recent myocardial infarction) that might limit participation 2. concomitant with other neurological disorders (e.g., parkinson's disease, amyotrophic lateral sclerosis, multiple sclerosis) 3. current participation in another interventional trial 4. any contraindication to mri (metallic implants, claustrophobia, seizure, pacemakers, et al) 5. pregnant woman
interactive perioperative teaching platform (iptp)

Conditions: Tonsillar Hypertrophy; Adenoid Hypertrophy; Cryptorchidism; Hypospadias; Hydrocele

Summary: the proposed study will assess whether an interactive perioperative teaching platform (iptp) provided to families of patients undergoing ambulatory pediatric surgery will reduce families' anxiety, and improve satisfaction and understanding, relative to current practice. the iptp will educate patient families on the continuum of their child's surgical experience, from arriving at the hospital through registration, the operating room (or), and the hospital floor. an active video format will be used to provide instructions for navigating the hospital; describe induction of anesthesia and the surgical procedure; and provide post-surgery and post-discharge instructions for pain management. a comparison cohort of patients undergoing surgery without access to the iptp will be recruited to assess the benefits of the iptp for improving metrics of family satisfaction, preoperative anxiety, and postoperative understanding of discharge instructions.


Eligibility criteria:
inclusion criteria: * children aged 0-18 years * undergoing adenotonsillectomy or orchiopexy, hydrocele or hypospadias repair * only patients booked for ambulatory surgery in the main operating room (or) exclusion criteria: * patients will be excluded if they have previously undergone surgery or require a translator
misoprostol before elective caesarean section for decreasing the neonatal respiratory morbidity

Conditions: Transient Tachypnea Newborn; Cesarean Delivery Affecting Fetus

Summary: neonatal respiratory distress may occur in either term or preterm newborns with a higher relative risk in preterm, and whether born vaginally or through caesarean section, but in a higher percentage after elective caesarean section whose rate is rising. prostaglandins may be given about one hour before an elective caesarean section after excluding the presence of contraindication to their use to decrease the neonatal respiratory diseases and thus, the number of children who suffered from bronchopulmonary dysplasia that occurs frequently in children who had previously ttn will diminish.


Eligibility criteria:
inclusion criteria: * age: 18 years or more. * term singleton pregnancy (38 - 38+6 weeks gestation). * planned for elective transverse lower segment caesarean section with an indication. exclusion criteria: * women with history of significant cardiac disease, eclampsia, pre eclampsia, epilepsy, severe asthma, severe allergic condition, vascular disease, renal or hepatic disease. * women with contraindication to prostaglandins as glucoma or known hypersensitivity to prostaglandins or specifically for misoprostol. * psychological problem or mental disease that renders the patient not able to understand the nature, scope, and sequences of the study. * pregnancies with known foetal malformation/s or chromosomal aberration.