Kornimate/medical-research-clean huggingface dataset:
incidence of postoperative delirium incidence in surgical patients: an observational cohort study in new zealand

Conditions: Delirium Confusional State; Complication,Postoperative

Summary: as the population of older adults increases, so too with the number of older adult patients that present for anesthesia and surgery. the development of delirium following surgery has some significant potential effects on patient outcomes; however, pod is often under diagnosed. some studies reported that more than 50% of patients with delirium were undiagnosed by clinical teams. pod is associated with cognitive decline, increased hospital length of stay, discharge to institutional care, mortality and higher healthcare costs. pod contributes significantly to healthcare inefficiency; a diagnosis of pod is estimated by the australian commission on quality and safety in healthcare to cost an additional $27,791 aud. the incidence of pod reported in clinical trials depends on the risk profile of the study population, the frequency and duration of delirium assessments as well as the surgical procedure. reported incidence may also vary due to the presence of high-risk pathways involving multi-specialty management and intervention. pod may present as either hyperactive or hypoactive subtypes, the latter being more difficult to detect. there are few reports on the incidence of pod in new zealand national level datasets, with single centre studies primarily looking at in-hospital delirium and demonstrating an incidence of 11.2 to 29% on mixed and/or medical wards. a review of elderly patients with neck-of-femur fractures found the incidences of pod to be as high as 39%. the current data suggests a significant level of morbidity due to pod in new zealand hospitals, however there is lack of national level data in the surgical population; which is crucial for establishing demographic and regional need for effective intervention.


Eligibility criteria:
eligible patients include those aged 18 years or over undergoing a surgical procedure in any of 71 public or private hospitals

Keywords: anesthesia delirium incidence cognitive decline
pain relief strategies for dressing change in chronic wounds

Conditions: Pain; Chronic Wound

Summary: a small-scale study using interviews to explore patients', carers' and health care professionals' experience of pain relief strategies currently used in uk practice for dressing change in chronic wounds.

in 2012/2013, the national health service (nhs) managed an estimated 2.2 million adults \>18 years of age with a wound, of which 48% were estimated as being chronic. a chronic wound is an open sore in the skin that does not heal, or takes a long time to heal, and frequently comes back. chronic wounds include pressure ulcers (bed sores), venous (vein-related) leg ulcers, and foot ulcers in people who have diabetes. pain is a common experience for people living with chronic wounds and can result from the wound itself, treatments for chronic wounds, including dressing changes; or be anticipatory. pain during dressing change has been reported as the worst part of living with chronic wounds, followed closely by wound cleansing. furthermore, dried out dressings and adherent products are most likely to cause pain and trauma at dressing changes as is gauze, while products such as hydrogels and soft silicone dressings are least likely. evidence suggests that supporting the surrounding skin during dressing removal is not considered a priority, despite evidence that many adhesive products may lead to skin stripping and potential skin trauma and pain. there is at present little recent evidence of pain relief strategies that are currently being used in the uk for dressing change in chronic wounds that includes patients', carers' and healthcare professionals' (people who work in the nhs) use and experience of these. this qualitative research will explore providers' and recipients' self-reported experiences of chronic wound care, and explore strategies used to reduce pain at dressing change. it will ask about the perceived success of these strategies from different participant perspectives, along with how pain is assessed. perceptions of what factors might contribute to pain at dressing change (e.g., dressing and wound type, skill levels) will be captured along with perceptions of what could improve the management of pain at dressing change.

Eligibility criteria:
inclusion criteria: * living with a chronic wound, informally or privately caring for someone with a chronic wound or providing medical care (e.g. dressing change) for someone with a chronic wound * ability to give informed consent * aged aged 18 years or above exclusion criteria: * vulnerable patients (e.g. severe mental illness, learning difficulties, dementia, care home residents) * inability to provide informed consent * inability to communicate in english * not living with a chronic wound, informally or privately caring for someone with a chronic wound or providing medical care (e.g. dressing change) for someone with a chronic wound * under 18 years of age

Keywords: dressing
exploratory study of kpi-121 effect on intra- or subretinal fluid due to retinal vein occlusion/diabetic macular edema

Conditions: Retinal Vein Occlusion; Diabetic Macular Edema

Summary: the primary objectives of the study are to evaluate the safety and effect of kpi-121 0.25% ophthalmic suspension and kpi-121 1.0% ophthalmic suspension on intraretinal or subretinal fluid secondary to retinal vein occlusion or diabetic macular edema.

this is a multicenter, randomized, single-masked study evaluating the safety and effect of topical ocular administration of either kpi-121 0.25% ophthalmic suspension or kpi-121 1.0% ophthalmic suspension in subjects with intraretinal or subretinal fluid secondary to retinal vein occlusion or diabetic macular edema.

Eligibility criteria:
inclusion criteria: * have documented presence of intraretinal or subretinal fluid secondary to retinal vein occlusion or diabetic macular edema at screening exclusion criteria: * treatment with topical, intravitreal injection, posterior sub-tenon's, or periocular corticosteroids within 120 days prior to visit 1 and for the duration of the study * history of uncontrolled glaucoma, iop over 21 mmhg at visit 1, or are being treated for glaucoma in the study eye * any significant ocular disease that could compromise vision in the study eye (including ongoing ocular infection, wet age-related macular degeneration, myopic degeneration with active subfoveal choroidal neovascularization) * known hypersensitivity or contraindication to the investigational product(s) or their components * diagnosis of severe/serious ocular condition that in the judgment of the investigator could confound study assessments or limit compliance; or severe/serious systemic disease or uncontrolled medical condition that in the judgment of the investigator could confound study assessments or limit compliance * exposed to an investigational drug within 30 days prior to visit 1 and for the duration of the study * in the opinion of the investigator or study coordinator, an unwillingness or inability to comply with the study protocol or inability to successfully instill eye drops

Keywords: intraretinal fluid subretinal fluid retinal vein occlusion diabetic macular edema
the effect of body shape on tragus-wall measurement

Conditions: Obesity

Summary: tragus-to-wall distance (twd) measurements is a method to evaluate spinal mobility in ankylosing spondylitis (as) patients and it also takes place in bath ankylosing spondylitis metrology index (basmi). being obese or slim may affect twd. as well as the person's losing or taking weight may lead wrong evaluations, in comparative studies, according to the height or weight uneven distribution of groups may affect the results. the aim of this study is to investigate whether the body shape affect twd or not.

healthy volunteers between 18-65 ages who have no disorder that may disturb posture or erect position (inflammatory diseases, kyphosis, scoliosis, joint deformities)will be included into the study. a wall corner will be used as the measurement platform; the evaluated person will be positioned as described in basmi. a rigid ruler will be placed form anterior superior iliac spine (sias) to the lateral wall, parallel to the back wall; a projection point will be determined and its distance from back wall will be measured (sias-wd). in the same position, projection point of the middle of the humerus head and back wall distance (shoulder-wd) and twd also will be measured. the relationships between these parameters will be statistically assessed.

Eligibility criteria:
inclusion criteria: * volunteers between 18-65 ages exclusion criteria: * subjects with disorders that may disturb posture or erect position * inflammatory diseases, * kyphosis, * scoliosis, * joint deformities

Keywords: tragus-to-wall distance obesity body shape height weight
self-monitoring and reminder texts to increase physical activity after cancer ii

Conditions: Colorectal Cancer; Colon Cancer; Rectal Cancer

Summary: there is a critical need for physical activity interventions in colorectal cancer (crc). the investigators have developed a digital health physical activity intervention, smart pace, which includes a wearable tracker (fitbit) and text messaging and aims to have patients build up to 150 min/wk of moderate activity. in this study, the investigators propose to expand and improve smart pace, including: 1) enrolling patients during chemotherapy; 2) tailoring text messages to individual preferences and treatment timing; and 3) adding resources to support home-based exercise. the study is a 12-week pilot randomized controlled trial (rct) to evaluate the feasibility of this novel digital health physical activity intervention among 48 crc patients on chemotherapy. the specific aims are to: 1) determine the feasibility of the intervention via adherence and attrition, and determine the acceptability of the intervention via questionnaires and semi-structured interviews . 2) estimate the effect of the intervention vs. usual care on physical activity, qol, and symptoms at 12-weeks . and 3) explore the impact of the intervention vs. usual care on fitness, weight, waist circumference, and blood pressure at 12-weeks.


Eligibility criteria:
inclusion criteria: * diagnosed with colon or rectal adenocarcinoma * expected to receive at least 12 weeks of chemotherapy * able to speak and read english * access to a mobile phone with internet and text messaging capabilities * ≥4 weeks since last major surgery and fully recovered * ≥18 years old * physician consent to participate in unsupervised moderate intensity physical activity * eastern cooperative oncology group (ecog) performance status 0-1 exclusion criteria: * engaging in 150 minutes/week or more of moderate physical activity, 75 minutes/week or more of vigorous physical activity, or an equivalent combination * hypertension that is not well-controlled (≥160/90) on anti-hypertensive therapy * any contraindications to exercise, including, but not limited to: brain metastases; current congestive heart failure (new york heart association class ii, iii or iv); serious or nonhealing wound, ulcer, or bone fracture; spinal cord compromise or instrumentation due to metastatic disease; peripheral neuropathy ≥grade 3; advanced chronic obstructive pulmonary disease (copd) on oxygen * serious cardiovascular event within 6 months including, but not limited to, transient ischemic attack (tia), cerebrovascular accident (cva), or myocardial infarction (mi) * has been told by a doctor that he/she has a heart condition and recommended to only engage in medically supervised activity

Keywords: physical activity digital health text messages intervention exercise randomized fitbit
use of a novel volume-stable collagen matrix (vcmx) in the treatment of single gingival recession associated with non-carious cervical lesion partially restored

Conditions: Gingival Recession, Localized; Tooth Abrasion

Summary: gingival recessions (gr) are often associated with non-carious cervical lesions (nccl), resulting, thus, in a combined defect. this mucogingival condition has a different treatment prognosis when compared with a gr without wearing surface associated and frequently requires a surgical-restorative approach to achieve better esthetics and functional results. a limited number of clinical studies assessed different multidisciplinary protocols for the management of single combined defects and there is evidence that the use of dental materials does not harm the periodontal tissues and does not influence the root coverage obtained by means of subepithelial connective tissue graft (ctg). although the association between coronally advanced flap (caf) and ctg provides more predictable and stable outcomes in the long term, its use is related to some drawbacks. different biomaterials have been developed to overcome these limitations as a possible alternative to autogenous graft. however, despite its potential, there is a lack of studies evaluating its use in treating this type of condition. thus, this study aims to assess from a clinical and esthetics point of view and patient-centered outcomes, the use of a new collagen matrix (geistlich fibro-gide®) associated with caf for the management of single combined defects. for such purpose, 50 patients with single rt1 gingival recessions associated with nccl will be enrolled and randomly allocated to one of the following groups: control group (n=25), partial restoration of cervical lesion and coronally advanced flap for root coverage (pr+caf) and test group (n=25), partial restoration of cervical lesion and coronally advanced flap associated with volume stable collagen matrix (pr+caf+vcmx). the two groups will be compared regarding the clinical parameters, among which bleeding on probing (bop), biofilm accumulation (ip), clinical attachment level (cal), recession reduction (recred), and the percentage of combined defect coverage (%cdc). patient-reported outcomes such as post-surgery pain and discomfort, time to recover, the decrease of dentin hypersensitive, and aesthetics will be gathered. a professional assessment will be carried out regarding the aesthetic parameters. all these evaluations will be performed at the baseline and three and six months postoperatively.


Eligibility criteria:
inclusion criteria: * adult \> 20 years old; * systemically healthy * no signs of active periodontal disease; * full-mouth plaque and bleeding score ≤20%; * gingival recession type rt1 associated with nccl b+ on a vital canine or premolar; exclusion criteria: * patients who had had periodontal surgery on the study area; * smokers patients; * pregnant or lactating patients; * ongoing orthodontic treatment; * patients taking medications known to interfere with the wound healing process or that contraindicate the surgical procedure

Keywords: gingival recession tooth abrasion biomaterials
role of t helper 17 and regulatory t cells in delayed graft function

Conditions: Delayed Graft Function

Summary: delayed graft function (dgf) increases risk of acute rejection after kidney transplantation (ktx). interleukin-6, which is produced in dgf, is critical in directing naive t helper cells differentiation towards t helper 17 (th17) and away from regulatory t (treg) cells. the investigators hypothesize there is an increase in th17 and a decrease in treg expression in ktx recipients with dgf compared to those without, leading to immunologic consequences. the investigators will test their hypothesis by measuring in both groups expression of th17, treg, and related cytokines in blood, urine, kidney biopsy, and kidney preservation fluid, and correlating these results with immunologic events.

all adult recipients of a primary kidney transplant will be eligible. subjects will have blood samples drawn from which we will isolate lymphocytes and analyze the treg population based on surface markers as well as a functional assay. the measures of treg function will be compared to outcomes including dgf, graft survival and graft function, as well as the development of immunological complications such as donor-specific antibody production, acute rejection, ifta and opportunistic infection.

Eligibility criteria:
inclusion criteria: * kidney transplant recipients exclusion criteria: * none
the efficacy of spsipb on postoperative pain in patients undergoing reduction mammoplasty surgery: case series

Conditions: Post Operative Pain

Summary: the aim of this study is to investigate the postoperative analgesic efficacy of spsipb and its effect on opioid consumption in patients undergoing reduction mammoplasty.

ten patients had serratus posterior superior intercostal plane block (spsipb) as the intervention. patients had spsipb with 0.25% bupivacaine (total volume of 30 ml) before the surgery in operating room. numerical rating scale (nrs) was used to assess postoperative pain on 1st, 6th, 12th and 24th hour after the surgery. total tramadol consumption was calculated by using patient-controlled analgesia (pca) device. patient satisfaction was assessed by using quality of recovery-15 (qor15) scale. paracetamol was planned as resque analgesic drug (maximum dose: 3 gr/day).

Eligibility criteria:
inclusion criteria: * adult patients older than 18 years of age who underwent reduction mammoplasty under general anesthesia and are american society of anesthesiologists (asa) i-ii-iii according to the asa risk classification. exclusion criteria: * patients who did not give consent, * patients with coagulopathy, * patients with signs of infection at the block application site, * patients using anticoagulants, * patients with local anesthetic drug allergies, * patients with unstable hemodynamics, * patients who could not cooperate during postoperative pain assessment

Keywords: serratus posterior superior intercostal plane block postoperative pain reduction mammoplasty regional anesthesia
a study of the safety and efficacy of fabrazyme in patients with fabry disease

Conditions: Fabry Disease

Summary: people with fabry disease have an alteration in their genetic material (dna) which causes a deficiency of the alpha-galactosidase a enzyme. this enzyme helps to break down and remove certain types of fatty substances called "glycolipids." these glycolipids are normally present within the body in most cells. in people with fabry disease, glycolipids build up in various tissues such as the liver, kidney, skin, and blood vessels because alpha-galactosidase a is not present, or is present in small quantities. the build up of glycolipid levels (also referred to as "globotriaosylceramide" or "gl-3") in these tissues is thought to cause the clinical symptoms that are common to fabry disease. symptoms commonly appear during childhood with pain in the hands and feet. this trial is designed to evaluate the efficacy of a lower dose of fabrazyme in patients who initially received 1.0 mg/kg every 2 weeks of fabrazyme by investigating if the achieved clearance of glycosphingolipid deposits in the vascular endothelium of the kidney can be maintained at a lower dose.


Eligibility criteria:
inclusion criteria: * have clinical manifestations of fabry disease * all patients have to have a plasma αgal activity of \< 1.5 nmol/hr/ml or a documented leukocyte αgal activity of \< 4 nmol/hr/mg * patient or patient's parent/guardian had to provide written informed consent prior to any study-related procedures being performed * patients had to be male and ≥ 16 years of age exclusion criteria: * there is evidence of renal insufficiency, as defined by serum creatinine greater than or equal to 2.2 mg/dl (194.7 μmol/l) and/or has an estimated glomerular filtration rate (gfr) of \<80 ml/min (using the equation derived from the modification of diet in renal disease study (mdrd)) * has undergone kidney transplantation or is currently on dialysis * has a clinically significant organic disease or an unstable condition (with the exception of symptoms relating to fabry disease) that in the opinion of the investigator would preclude participation in the trial * has participated in a study employing an investigational drug within 30 days of the start of this trial * patients who received prior treatment with enzyme replacement therapy for fabry disease * patient was unable to comply with the requirements of the protocol

Keywords: alpha galactosidase a agal rh agal fabry gl3 fabrazyme
tvi-brain-1 in expanded access patient

Conditions: Recurrent Glioblastoma

Summary: tvi-brain-1 is being offered as a potential treatment option to a named patient (emergency use authorization ind) for recurrent glioblastoma as there is no effective systemic treatment available for this disease or patient. tvi-brain-1 is an experimental treatment that takes advantage of the fact that your body can produce immune cells, called 'killer' white blood cells that have the ability to kill large numbers of the cancer cells that are present in your body. tvi-brain-1 is designed to generate large numbers of those 'killer' white blood cells and to deliver those cells into your body so that they can kill your cancer cells.

the tvi-brain-1 treatment involves several steps. first, the patient's cancer will be surgically removed to provide cells for the vaccine. second, the patient will be vaccinated with the vaccine formulation. third, the patient's blood will be filtered for killer t cell precursors which will then be cultured and stimulated to reach a higher (killer) activity level. fourth, the activated cells will be infused into the patient's bloodstream so that they will be able to attack the cancer.

Eligibility criteria:
inclusion criteria: recurrent glioblastoma diagnosis confirmed * age \> 18 * informed consent * diagnosis of grade iv glioma with progression following standard treatment. * must be able to tolerate surgery to provide tumor tissue for vaccine. * must be able to produce viable vaccine from tumor tissue. * karnofsky performance status must be 70 or greater. * negative hiv test. * negative for hepatitis b and c virus. * respiratory reserve must be reasonable. * sufficient renal function. * satisfactory blood counts. * negative pregnancy test for women of childbearing potential. exclusion criteria: * surgically removed cancer reveals that it is not grade iv glioma. * concomitant life-threatening disease. * active autoimmune disease. * currently receiving chemotherapy or biological therapy for the treatment of cancer. * currently receiving immunosuppressive drugs for any reason. * prior treatment with avastin or other anti-angiogenesis treatment within 6 months. * prior treatment with gliadel wafers. * corticosteroids beyond peri-operative period. * psychological, familial, sociological or geographical conditions that do not permit adequate medical follow-up and compliance with the study protocol.