Kornimate/medical-research-clean huggingface dataset:
digital intelligent assistant for nursing application

Conditions: Frailty Syndrome; Fall in Nursing Home; Dementia; Delirium in Old Age; Incontinence, Urinary; Incontinence Bowel

Summary: this is an observational study that intends to compare falls or fall-risk related alarms derived from a three-dimensional sensor system with the clinical reality definded by attending nurses.

three dimensional sensor technology (3ds) is available for fall detection and fall prevention (e.g. unwanted getting up in persons with risks for frequent falls) in several institutions in europe and switzerland. 3ds are capable to analyze completely anonymized data and alert nurses towards a dangerous (fall) or potentially dangerous (getting out of bed) event during day- and nighttime. multi-sensor technology has been applied to assess activities of daily living in persons cognitive problems living at home. to our knowledge, 3ds technology has not been examined as part of a structured clinical protocol. in addition, the combination of two digital technologies (3ds and a server based software) as an integrative platform could help to develop algorithms to analyze complex human activities such as using a toilet. automated analyses of such complex activities have the potential to support nursing staff in the future.

Eligibility criteria:
inclusion criteria informed consent given by person or caregiver patients admitted * with or without cognitive decline for any reason * with acute and/or chronic conditions * after any kind of surgery exclusion criteria: 1. for falls assessment by 3d sensors: • based on the multifactorial risk for falls there are no exclusion criteria for falls assessment 2. for the development of toileting algorithm: * severe urine or fecal incontinence * permanent indwelling urinary catheter * permanent urinary or bowel stoma

Keywords: 3d sensors falls detection toileting algorithm
newborn cranial somatic dysfunction - an observational study

Conditions: Somatic Dysfunction of Cranial Region; Somatic Dysfunction of Cervical Spine; Somatic Dysfunction of Lumbar Spine; Somatic Dysfunction of Sacrum

Summary: two prominent osteopathic physician researchers have studied cranial somatic dysfunction in newborns. dr viola frymann published a paper in 1966 on the presence of somatic dysfunction involving 1250 infants. dr. jane carreiro evaluated 1600 newborns in 1993 for cranial somatic dysfunction. this observational study is intended to continue their work in exploring the presence of cranial somatic dysfunction in newborns. the hypothesis is that there is an increased incidence of somatic dysfunction in newborns birthed by primigravid women and in newborns who experienced a longer second stage of labor.

100 newborns will be assessed for somatic dysfunction of the head, cervical, lumbar, and sacral areas. these findings will be compared to the findings of a standard newborn physical exam and the newborn and maternal history. these records will be reviewed for maternal age, parity, gravity, anesthesia during labor, and estimated gestational age. birth history and initial newborn assessments will be reviewed for labor augmentation, duration of labor, length of second stage of labor, presence of instrumental delivery(vacuum extraction, forceps delivery, etc.), multiple birth, and presentation at delivery (breech, transverse, or compound presentation). the purpose of the study is to quantify the presence of somatic dysfunction in the newborn. we will assess any relationships between the identified somatic dysfunctions and factors present in the mother's and newborn's medical history.

Eligibility criteria:
inclusion criteria: * the infant must have been born at nrmc * the infant must be greater than 6 hours old when enrolled * the infant must be less than 72 hours old when enrolled * the mother must volunteer to participate in the study exclusion criteria: * born outside nrmc * infants who are critically ill will be excluded * infants with open spina bifida will be excluded * infants with a cleft lip will be excluded * infants with a cleft palate will be excluded * children who are wards of the state will be excluded

Keywords: newborn cranial somatic dysfunction newborn observational study somatic dysfunction cranial strain pattern osteopathy
exploratory study on the safety, tolerability, and pharmacodynamics of imb-1018972 in subjects with angina due to obstructive coronary artery disease (improve-ischemia)

Conditions: Ischemia; Coronary Artery Disease

Summary: the purpose of this study is to assess the safety and tolerability of imb-1018972 in subjects with obstructive cad and inducible ischemia.


Eligibility criteria:
inclusion criteria: * documented history of stable angina (ccs grading i-iii) or anginal equivalent for ≥1 month prior to screening * ability to safely abstain from beta blockers for 48 hours prior to echo examinations in the opinion of the investigator * preserved lv systolic function, defined as lvef≥50% by any imaging modality * obstructive cad and recent evidence of stress-induced myocardial ischemia exclusion criteria: * women of childbearing potential or who are currently pregnant or breast-feeding * clinically indicated for coronary revascularization (pci/cabg) at time of screening or clinically significant lms or proximal lad stenosis likely to warrant revascularization during the study period in the opinion of the investigator. * type 1 insulin dependent diabetes mellitus (iddm) * presence of pacemaker, cardiac resynchronization therapy and/or implantable cardioverter defibrillator * severe or clinically significant valvular heart disease * clinically significant concurrent condition which could prevent the patient from performing any of the protocol-specified assessments, represent a safety concern if the patient participates in the trial or could confound trial assessments of safety or tolerability
comparison of needling and microneedling plus phototherapy in localized vitiligo patients

Conditions: Vitiligo; Non-segmental Vitiligo

Summary: this randomized controlled trial aims to compare the efficacy of needling versus microneedling, both followed by narrowband uvb therapy, in achieving repigmentation in patients with localized stable non-segmental vitiligo.

the study will enroll 80 patients aged 15-60 years with localized stable vitiligo. participants will be randomized into two groups: one receiving needling and the other microneedling, each followed by nbuvb therapy. the primary outcome is the percentage of repigmentation at 12 weeks, assessed through digital planimetry and standardized clinical photography. secondary outcomes include adverse effects such as erythema, post-inflammatory hyperpigmentation, infection, and scarring.

Eligibility criteria:
inclusion criteria: * both male and female * age 15-60 years * patients having vitiligo for more than 1 year exclusion criteria: * patients with tendency of keloid formation or hypertrophic scarring * patients with any bleeding disorder, coagulation defect or using anti platelets * any local infection at the treatment site * patients who had received systemic therapy in last 6 months

Keywords: vitiligo needling microneedling
vectors post market: a study to assess pain relief using spinal cord stimulation

Conditions: Chronic Pain

Summary: this is a prospective, single-arm, multi-center study evaluating the efficacy of spinal cord stimulation (scs) therapy for pain relief using high dose (hd) stimulation parameters delivered to neural targets identified during current commercial trial stimulation procedures. the study will evaluate changes in back and leg pain from baseline to 3, 6, and 12 months.


Eligibility criteria:
inclusion criteria: * candidate per labeling for an scs system as an aid in the management of chronic, intractable low back and leg pain * presence of low back and leg pain * moderate to crippled disability due to pain * stable pain medications for back and leg pain for at least 28 days prior to enrollment * willing and able to not increase pain medications through the 3-month visit exclusion criteria: * previously trialed or implanted with stimulator or intrathecal drug delivery system * current diagnosis of moderate to severe central lumbar spinal stenosis * major psychiatric comorbidity or other progressive diseases * serious drug-related behavioral issues * pregnant or planning on becoming pregnant * unable to achieve supine position
computer assisted family intervention to treat self-harm disparities in latinas and sexual/gender minority youth

Conditions: Self Harm; Depression; Emotion Dysregulation; Suicidal Ideation; Family Relations

Summary: this study is designed to refine and test the efficacy of a computer assisted culturally informed and flexible/adaptive intervention for latino adolescents for whom self-harm behaviors are a health disparity-specifically, latinas and sexual/gender minority youth.

this study enhances an original computer assisted culturally informed and flexible family-based treatment for adolescents (ca ciffta) to directly address key targets related to self-harm behavior (e.g., depression, emotion dysregulation, lgbt, culture-related stressors, and trauma-related stressors); (b) refines the technological aspects of ca ciffta for web-based delivery; and (c) tests the preliminary efficacy of the new intervention and its delivery system in a randomized trial of 100 hispanic adolescents and their parents. the investigators seek to reduce risk for repeated self-harm by showing treatment effects on depression, emotion regulation, substance use, and family functioning. participants are randomly assigned to ca ciffta or treatment-as-usual and treatment covers a four month period.

Eligibility criteria:
inclusion criteria. the adolescent must: * be 11 to 18 years old; * self-report an act of self-harm in the past 6 months, * meet criteria for cut-off on two of the four underlying/maintaining factors (depression, emotion dysregulation, family conflict, substance use), and * live with at least one parent-figure who agrees to participate in assessments and treatment participants should be willing and able to participate fully in the protocol (e.g., to accept assignment to either condition, to provide sufficient locator information for follow-up, to allow their treatment sessions to be recorded for fidelity/process assessment and supervision). exclusion criteria. youth who: * have a history of dsm v developmental disorders, elective mutism, organic mental disorders, schizophrenia, delusional disorder, psychotic disorder, and bipolar affective disorder. * are actively in crisis and reporting current ideation with a specific plan and with means to complete the plan.
study of synapsis and recombination in male meiosis and the implications in infertility

Conditions: Abnormal Spermatogenesis; Azoospermia

Summary: the aim of this study was to assess meiotic recombination in primary spermatocytes, synaptonemal complex length and the correlation with chromosomal abnormalities in testicular spermatozoa from infertile men with idiopathic non-obstructive azoospermia (noa).

during the first meiotic division in spermatogenesis there are two critical events. first, synapsis between homologous chromosomes and formation of the synaptonemal complex (sc), which regulates sister chromatid cohesion and provides the template for localization of recombination machinery proteins. secondly, recombination between homologous chromosomes, which is essential for the correct segregation. errors during these two processes may induce incorrect segregation of chromosomes and are a major cause of gamete aneuploidy. the aim of this study was to assess meiotic recombination in primary spermatocytes, synaptonemal complex length and the correlation with chromosomal abnormalities in testicular spermatozoa from infertile men with idiopathic non-obstructive azoospermia (noa). prospective cohort study to assess meiotic progression, total length of sc, frequency of recombination and sperm aneuploidy in samples obtained from testicular biopsies from noa patients. the study group was compared with a control group from post-vasectomized (oa) patients. immunocytogenetics with scyp3, crest and mlh1 antibodies for meiotic progression, sc length, and recombination. fluorescence in situ hybridization (fish) for chromosomes 1, 4, 6, 13, 16, 18, 21, 22 in primary spermatocytes and chromosomes 13, 18, 21, x, y on sperm. micromeasure 3.3 program was used for sc length.

Eligibility criteria:
inclusion criteria: * noa patients undergoing icsi with testicular sperm * oa post-vasectomized patients undergoing icsi with testicular sperm exclusion criteria: * abnormal karyotype

Keywords: meiosis synapsis recombination sperm aneuploidy
symptom improvements in gastroesophageal reflux disease (gerd) patients

Conditions: Gastroesophageal Reflux Disease (GERD)

Summary: the purpose of this study is to estimate the effect of azd3355 as an add-on treatment to a proton pump inhibitor (ppi) on gastroesophageal reflux disease (gerd) symptoms in patients with an incomplete response to ppi treatment.


Eligibility criteria:
inclusion criteria: * provision of written informed consent * at least 6 months history of gastroesophageal reflux disease (gerd) symptoms * continuous treatment with proton pump inhibitor (ppi) * ability to read and write exclusion criteria: * prior surgery of the upper gastrointestinal (gi) tract * history of clinically significant diseases other than gerd * need for concomitant medication with drugs that may influence gastrointestinal symptoms

Keywords: heartburn patient reported symptoms proton pump inhibitor
progression of prodromal markers of α-synucleinopathy neurodegeneration in the fdrs of patients with rbd

Conditions: REM Sleep Behavior Disorder; Neurodegeneration

Summary: this study is a prospective study with a mean of 5-year follow-up interval, aims to monitor the progression of α-synucleinopathy neurodegeneration by the evolution of prodromal markers and development of clinical disorders in first-degree relatives (fdrs) of idiopathic rem sleep behavior disorder (rbd) patients and healthy controls.

idiopathic rbd is implicated as an integral part of progression of α-synucleinopathy neurodegeneration, and patients with idiopathic rbd have increased prevalence of non-motor symptoms (or prodromal markers) closely related to parkinson's disease(pd). moreover, the investigator's previous studies have further confirmed the familial aggregation of rbd, and first-degree relatives (fdrs) of rbd patients had more prodromal markers of parkinson's disease compared with fdrs of healthy controls. in these regards, current prospective study aims to map the progression and evolution of prodromal markers (including autonomic dysfunction, olfactory loss, color vision impairment, neurocognitive impairment, neuroimaging of dopamine dysfunction, daytime sleepiness and psychiatric disorders), onset of rbd, and neurodegenerative diseases. finally, other markers, such as physical activity and circadian rhythm and tonic electromyography (emg) activity level, which have been found to be reliably associated with parkinson's disease or other neurodegenerative diseases. in this regard, it is also interesting to investigate whether these indicators will additionally predict the progression of prodromal markers of pd.

Eligibility criteria:
inclusion criteria: 1. chinese aged 40 or above; 2. being capable of giving informed consent for participation of the study; 3. sex-matched. exclusion criteria: 1. younger than 40 years old (as the supposed neurodegenerative process may not have occurred); 2. not capable of giving informed consent for participation of the study.

Keywords: α-synucleinopathy neurodegeneration prodromal markers rem sleep behavior disorder
steroid free immunosuppression or calcineurin inhibitor minimization after basiliximab induction therapy in kidney transplantation: comparison with a standard quadruple immunosuppressive regimen

Conditions: Renal Insufficiency; Kidney Transplantation

Summary: a prospective, open, randomized trial, in which the investigators aim to achieve optimal immunosuppression after renal renal transplantation with maximal reduction of side effects, especially of vascular injury, chronic allograft nephropathy, osteoporosis and malignancies. immunosuppression without steroids and cni minimization is compared to standard immunosuppression, consisting of tacrolimus od, mycophenolic acid and corticosteroids.

before transplantation 300 patients will be randomized 1:1:1 in three groups. group 1 will be treated with basiliximab induction and a three day course of steroids followed by a steroid free maintenance regimen consisting of standard-dose tacrolimus od and mycophenolic acid. group 2 will be treated with basiliximab induction followed by standard-dose tacrolimus od, mycophenolic acid and steroids. group 3 will be treated with basiliximab induction followed by standard-dose tacrolimus od for six months, whereafter the dose will be reduced plus mycophenolic acid and steroids. the total study period will be 2 years. primary endpoint will be renal function, proteinuria and microalbuminuria measured 24 months after transplantation. renal function will be measured by serum creatinine, creatinine clearances and ckd-epi. secondary endpoints will be the degree of tubular atrophy and interstitial fibrosis and the degree of arteriolar hyalinosis in renal biopsies taken at 12 and 24 months after transplantation. biopsies will be evaluated according to the banff criteria for renal allograft biopsy interpretation. quantitative morphometric analysis of interstitial fibrous tissue will be performed using the digital image analysis technique. other secondary endpoints are patient and graft survival, the incidence of allograft rejection, cardiovascular accidents, pulse wave velocity, blood pressure, the number of antihypertensives, lipid profile, the incidence of malignancies, the incidence of infectious complications, the incidence of post transplant diabetes mellitus and the development of osteoporosis.

Eligibility criteria:
inclusion criteria: * recipient of a kidney graft (first of second) from a deceased or living (non-hla identical) donor exclusion criteria: * patients with multi-organ transplants * patients who are receiving a third or fourth transplant * patients who have \> 75% (current of historic) panel reactive antibodies * patients receiving a kidney from a hla identical living donr * female patients who are pregnant or unwilling to used adequate contraception during the study

Keywords: kidney transplantation immunosuppression steroids tacrolimus od
hydration sensor for atopic dermatitis

Conditions: Atopic Dermatitis; Healthy Children

Summary: pilot study of a soft, flexible hydration sensor

assessment of accuracy and feasibility of a skin hydration sensor at detecting differences in skin hydration between skin affected by atopic dermatitis and areas not affected.

Eligibility criteria:
inclusion criteria: * children \<18 years of age * children with new or prior atopic dermatitis diagnosis * english speaking * children who are healthy, aged matched controls exclusion criteria: * individuals who are pregnant
trunk oriented exercises versus whole-body vibration for duchenne muscular dystrophy

Conditions: Muscular Dystrophy, Duchenne Type

Summary: the abdominal muscles play an important role in stabilizing the trunk and providing postural stability. children with duchene muscular dystrophy have weak muscles, which may impair postural adjustments. these postural adjustments are required for gait and dynamic balance during the daily living activities.


Eligibility criteria:
inclusion criteria: * diagnosed as duchenne muscular dystrophy, * aged from 6 to 10 years, * having grade 3+ muscle strength in lower limbs and trunk muscles. * had functional range of motion for upper and lower limb joints, * able to walk alone level i and ii of ambulation function classification system for dmd (afcsd) * exclusion criteria: * congenital or acquired skeletal deformities or cardiopulmonary dysfunction, * had undergone previous orthopedic surgery in lower limbs, * had abnormal motor development or neurological disease that affect balance * and gait, and * behavioral problems causing inability to cooperate during the study.
study for the prevention of nausea in cancer patients receiving highly emetogenic cisplatin based chemotherapy

Conditions: Nausea and Vomiting; Chemotherapy-Induced

Summary: this study was designed to assess the safety and efficacy of an investigational agent administered in addition to a standard anti-emetic regimen for the treatment of chemotherapy induced nausea and vomiting.

phase ii multicentre, randomised, double-blind, placebo and active-controlled, dose-ranging, parallel group study of the safety and efficacy of the oral neurokinin-1 receptor antagonist, gw679769 in combination with ondansetron hydrochloride and dexamethasone for the prevention of chemotherapy-induced nausea and vomiting in cancer subjects receiving highly emetogenic cisplatin-based chemotherapy.

Eligibility criteria:
inclusion criteria: * willing to provide a written informed consent prior to receiving any study-specific procedures or assessments. * diagnosed with a solid malignant tumour and has not previously received chemotherapy. * scheduled to receive chemotherapy conducive to regimens outlined in the study protocol. exclusion criteria: * not received any investigational product within 30 days of enrolment into the study. * must not be pregnant. * must not be of childbearing potential or is willing to use specific barrier methods outlined in the protocol. * must not be scheduled to receive radiation therapy to the abdomen or to the pelvis within seven (7) days prior to starting study medication. * must not be currently under treatment for a condition which may cause nausea or vomiting (i.e., active peptic ulcer disease, gastric obstruction). * must not have a history of peptic ulcer disease.

Keywords: nausea vomiting emesis chemotherapy-induced nausea and vomiting cinv