Kornimate/medical-research-clean huggingface dataset:
resuscitation registry in chd

Conditions: Cardiac Arrest; Congenital Heart Disease

Summary: children with congenital heart defects are far more likely to suffer a cardiovascular arrest and be in the need of cardiopulmonary resuscitation than healthy children or those with diseases of other organ systems, especially after cardiothoracic surgery. due to a lack of data, the exact number of resuscitations in this patient cohort, as well as the morbidity and mortality, is unknown. this study aims to register all cardiovascular arrests in pediatric patients with congenital heart disease and study the mortality and morbidity with a special focus on the neurodevelopmental outcome.

background and aim: children with heart defects, especially those after heart surgery, have an up to ten times higher risk for an in-hospital cardiac arrest, compared to children without heart disease. although this patient cohort is particularly vulnerable, these events and outcomes are not systematically monitored in germany. we designed a prospective multicenter-registry study aiming to record in-hospital cardiac arrests of children with congenital- (chd) and acquired heart disease in germany. methods: a web-based registry was designed, prospectively collecting data (patient´s demographics, cpr data, post-resuscitation care and clinical course, neurological outcome and follow-up), according to the utstein template. all children (0-18 years) with heart disease suffering a cardiac arrest requiring resuscitation of ≥ two minutes will be included. the primary outcome is survival to discharge, the secondary outcome is morbidity, with a particular focus on neurological morbidity. an inclusion of 10-20 children/centre/year is anticipated. as this is an observational study, no intervention is planned. results: this registry will provide data on the mortality, early and mid-term neurologic outcome, and quality of life after cardiac arrest of children with heart disease in germany. correlations between patients´ characteristics, resuscitation characteristics and post-resuscitation care with primary and secondary outcomes will be analyzed. conclusions: by systematically recording and analyzing the outcome after in-hospital cardiac arrest in children with chd, this study is an important first step to close knowledge gaps regarding the risk factors and outcome of cardiac arrest in this patient group, and aims to improve care and outcomes of these vulnerable patients.

Eligibility criteria:
inclusion criteria: * congenital heart defects, congenital heart arrhythmia, familial cardiomyopathies, inflammatory heart diseases * pediatric resuscitation (chest compressions ≥2min) in hospital or on arrival in hospital * age \<18 years * informed consent of the parents or legal representative exclusion criteria: * absence or withdrawal of informed consent of the parents or legal representative * do-not-resuscitate-order (dnr)

Keywords: pediatric resuscitation outcome congenital heart disease neurodevelopmental outcome
emd and/or bone substitute for the treatment of class ii furcations

Conditions: Periodontal Disease

Summary: to clinically evaluate the treatment of mandibular class ii furcation defects with enamel matrix derivative (emd) and/or a bone substitute graft make of beta tricalcium phosphate/hydroxyapatite (βtcp/ha).

to clinically evaluate the treatment of mandibular class ii furcation defects with enamel matrix derivative (emd) and/or a bone substitute graft make of beta tricalcium phosphate/hydroxyapatite (βtcp/ha). forty-one patients, presenting a mandibular class ii buccal furcation defect, probing pocket depth (ppd) ≥ 4 mm and bleeding on probing, will be included. they will be randomly assigned to the groups: 1- emd (n = 13); 2- βtcp/ha (n = 14); 3- emd + βtcp/ha (n = 14). relative gingival margin position (rgmp), relative vertical and horizontal attachment level (rvcal and rhcal) and ppd will be evaluated at baseline and 12 months. the mean horizontal clinical attachment level gain will be considered the primary outcome variable.

Eligibility criteria:
inclusion criteria: * males and females, between 18-75 years of age; * presence of a mandibular molar with buccal class-ii furcation defect, presenting pd ≥ 4mm, bleeding on probing (bop), minimum (\<1 mm) or no gingival recession after non-surgical therapy; * good general health; * minimum interproximal bone loss (\< 2 mm). exclusion criteria: * pregnant or lactating; * required antibiotic pre-medication for the performance of periodontal examination and treatment; * suffered from any other systemic diseases (cardiovascular, pulmonary, liver, cerebral, diseases or diabetes); * had received antibiotic treatment in the previous 3 months; * were taking long-term anti-inflammatory drugs; * had received a course of periodontal treatment within the last 6 months; * smokers.

Keywords: regenerative therapy randomized clinical trial (rct) enamel matrix derivative hydroxyapatite-beta tricalcium phosphate buccal furcation
urology database to evaluate clinical information and improve patient care.

Conditions: Incontinence; Prostate Cancer; Interstitial Cystitis; Urinary Retention; Pelvic Organ Prolapse

Summary: the purpose of initiating the urology database is to evaluate the outcomes of urology procedures and medical management to enhance the care and treatment of urology patients.

the current study population will include all patients having had a radical prostatectomy for the treatment of prostate cancer, surgical prolapse repair as well as patients having had interstim sacral nerve stimulator implantation. the database will house data extracted from the medical records. patient demographics, and preoperative, intra-operative, postoperative, and follow-up clinical data will be collected.

Eligibility criteria:
inclusion criteria: all patients undergoing radical prostatectomy, pelvic organ prolapse repair and neurostimulator (interstim) implantation at william beaumont hospital beginning january 1, 1998, as well as other urology patients as research questions are identified. only patients who have accepted william beaumont hospital's privacy notices will be included in the database. exclusion criteria: patients not acknowledging acceptance of william beaumont hospital's privacy notices.

Keywords: incontinence prostate cancer interstitial cystitis
changing physical activity behavior in individuals with type 2 diabetes using counceling and information from continuous glucose monitoring

Conditions: Type 2 Diabetes Mellitus

Summary: the purpose of this study was to develop a nurse counseling intervention to increase physical activity behavior in people with type 2 diabetes and to improve their health

diabetes affects 20.8 million americans and is the fifth leading cause of death in the united states. although physical activity is a cornerstone in the treatment of diabetes, it is difficult to change physical activity behaviors and up to 60% of individuals with diabetes do not participate in regular physical activity. the use of a nurse counseling intervention based on established behavior change theory with technology-derived graphical representations of glucose information created a unique opportunity to test the feasibility of motivating people with type 2 diabetes to change physical activity behaviors. the consent form described the study protocol, participant expectations, benefits, risks, and the process of maintaining participant confidentiality.

Eligibility criteria:
inclusion criteria: * diagnosis of type 2 diabetes mellitus * three month blood sugar test (hba1c) \> 7.5% * not receiving insulin to manage diabetes * not engaged in a physical activity program more than 2 days per week * able to read and speak english exclusion criteria: * not able to walk ¼ mile in 10 minutes * taking glucocoricoids * serious health problems, such as heart problems, found on examination.

Keywords: type 2 diabetes mellitus glucose monitor graphs physical activity
improving osteoporosis care in high-risk home health patients

Conditions: Patient Compliance; Communication; Osteoporosis; Fractures, Bone

Summary: specific aims: we propose a three-year study to develop a high-intensity intervention to improve osteoporosis care and test a novel intervention in a group-randomized trial of 27 home health offices and 1,000 patients referred to home health care with a history of fracture. aim 1. develop an intervention to promote osteoporosis treatment that includes: (1) training to enhance nurse-patient and nurse-physician risk communication regarding osteoporosis and fracture risk; (2) automated prompts within the home health agency's electronic medical record system to promote appropriate osteoporosis management; and (3) implementation of osteoporosis-related standardized care pathways and order sets. aim 2. conduct a group-randomized trial to test the effectiveness of the intervention to promote initial use of osteoporosis medications and adherence to treatment after discharge from home health. we hypothesize that: h1: patients in the intervention group will have increased initial receipt of osteoporosis prescription medications and calcium/vitamin d supplements to prevent and treat osteoporosis compared to patients receiving usual care; h2: patients in the intervention group will demonstrate increased persistence in the use of these therapies compared to those receiving usual care. secondary aims (sa) will include exploratory analyses of fracture related morbidity and mortality, patient-reported quality of life, and health services utilization and costs.


Eligibility criteria:
inclusion criteria: * patients will be identified as "at-risk" if they are referred to home health care for post-fracture care or if they are admitted for another reason and have a previous diagnosis of fracture. exclusion criteria: * patients in hospice, with a life expectancy \< 1 year, over 95 years old, or with concomitant metabolic bone diseases (e.g. paget's disease of bone) will be excluded.

Keywords: osteoporosis fracture communication prescription medication
a study of gc1102(recombinant hepatitis b immunoglobulin) in chronic hepatitis b patients

Conditions: Hepatitis B

Summary: the purpose of this study is to evaluate the efficacy and safety of gc1102 in combination of nucleo(t)ide analogues (nas) in patients with chronic hepatitis b


Eligibility criteria:
inclusion criteria: * patients who had this study information explained to them and understood it, voluntarily decided participation, and provided written consent * patients who aged ≥19 and ≤ 65 years at the time of signing the consent form * patients with chronic hepatitis b who have been taking nucleos(t)ide analogue antivirals 24 weeks before screening * patients whose hbsag and hbv dna in blood; 10 iu/ml ≤ hbsag titer ≤ 1,000 iu/ml and negative(-; below the limit of detection of 10 iu/ml) hbv dna in the screening test exclusion criteria: * patients who have hepatic diseases (e.g., autoimmune hepatitis) from causes other than hepatitis b * patients who have history of liver transplantation, or liver transplantation schedule during the study * patients who co-infected with hav, hcv, hdv and hiv * patient with vasculitis * patients who had a loss of blood or donated blood of ≥ 400ml within 8 weeks before the screening * patient who have active infection(other than chronic hepatitis b infection) requiring continual treatment with antibiotics or antivirals (except for clinically insignificant temporary infection such as cold)

Keywords: gc1102 gc1102b chronic hepatitis b virus chb nas nuc
prospective comparison of pull-peg and pull-peg with gastropexy

Conditions: Peristomal Infection Rate; Postinterventional Bleeding; Postinterventional Mortality Rate

Summary: the study aims to compare the conventional pull-percutaneous endoscopic gastrostomy (pull-peg) with a pull-peg with gastropexy suture regarding the peristomal infection rate.

pull-percutaneous endoscopic gastrostomy (pull-peg) is currently the standard technique for enteral nutrition in patients with swallowing disorders. fistula and peristomal infection rates are one of the most common early complications which are caused by bacterial transmission through the oropharyngeal passage of the tube and by bacterial translocation out of the stomach into the abdominal wall. retrospective data have shown that if pull-pegs are attached with a gastropexy suture, the abdominal wall and stomach are fixed tightly and peristomal infection rates can be reduced significantly. this randomised study wants to compare the peristomal infection rate of standard pull-pegs and pull-pegs with gastropexy suture. peristomal infection rate is detected by classical inflammation rates including erythema, exsudates, and induration, development of pus, or focal peritonitis.

Eligibility criteria:
inclusion criteria: * patients aged 18 and over with an indication for a peg-insertion exclusion criteria: * asa-classification \>4 * female patients who are pregnant or breast feeding * existing contraindications for a peg-implantation

Keywords: pull-peg pull-peg with gastropexy peristomal infection rate
remifentanil and nitroprusside for controlled hypotension

Conditions: Hypotension, Controlled

Summary: the purpose of this study is the comparison of the cardiovascular effects of remifentanil and nitroprusside for controlled hypotension


Eligibility criteria:
inclusion criteria: * patients who underwent endoscopic sinus surgery exclusion criteria: * patient who took any drug to influence this study * patient with cardiovascular disease, renal disease or liver disease

Keywords: remifentanil nitroprusside hypotension
effect of externally implantable tissue expansion device on scar length

Conditions: Skin Lesion

Summary: the purpose of this study is to assess whether brief use of an externally implantable tissue expansion device following excisional skin cancer surgery will significantly reduce the diameter of the final wound defect, and hence the length of the final linear primary closure. the secondary objective is to assess the functional benefits, if any, associated with use of the tissue expander.


Eligibility criteria:
inclusion criteria * subjects ages 18-80 years old * subjects who are undergoing an excision of a large cutaneous lesion * subjects with an immediate post-excision wound defect at least 2.5 cm in diameter * subjects undergoing surgery on the trunk or extremities * the subject has willingness and the ability to understand and provide informed consent for the use of their tissue and communicate with the investigator. * subjects who are willing to undergo no other treatments for the scars for the duration of the study. exclusion criteria * subjects with scalp wounds * subjects who are unable to understand the protocol or give informed consent
field shape and amplitude sensitivity exploratory study (contour study)

Conditions: Chronic Neuropathic Pain in the Low Back and Legs

Summary: the study aims to better understand how to program spinal cord stimulation for the treatment of chronic low back and leg pain


Eligibility criteria:
key inclusion criteria: * documented average low back pain intensity of at least 6 out of 10 and greater or equal than average leg pain intensity over 7 days during screening (numerical rating scale) * stable daily pain-related medication prescription and intake of ≤100mg morphine-equivalents * capacity to describe and rate pain intensity, complete study measurements, and use the study device (e.g. patient remote control, charger, diary ratings) (physician discretion) key exclusion criteria: * presence of pain or psychological condition that in the opinion of the investigator may interfere with the subject's ability to rate their pain and communicate such ratings * previous spinal cord stimulation trial or is already implanted with an active implantable device(s) (e.g. pacemaker, drug pump, implantable pulse generator)

Keywords: chronic neuropathic pain in the low back and legs subperception spinal cord stimulation
prospective study for the application of cytosorb® in critically ill patients

Conditions: Rhabdomyolysis; Acute Liver Injury; Cytokine Storm

Summary: the mortality of critically ill patients is persistently high and requires targeted therapy of pathophysiological disorders. one approach to optimize therapy is the use of the cytokine adsorber cytosorb®, which has a ce certification for the indications hyperinflammation, rhabdomyolysis and liver failure and is therefore frequently used in patients with sepsis, polytrauma and acute liver failure. although few clinical data describe the efficiency mostly retrospectively, there are no data on real-time elimination performance and saturation kinetics during the course of treatment. these questions should be answered by the present study.


Eligibility criteria:
inclusion criteria: * intensive care therapy * hyperinflammation or acute liver dysfunction or rhabdomyolysis * need of continuous renal replacement therapy * treatment with cytosorb (decision of the attending physician) exclusion criteria: - other reasons for cytosorb application

Keywords: cytosorb adsorption kinetics saturation critically ill patients
home-based growth charts in indonesia

Conditions: Child Growth

Summary: the investigators developed a home-based growth chart that offers a simple and inexpensive way for caregivers to have access to simple health and nutrition information guided by behavioural economics analysis as well as to track their child's linear growth, empowering them to act to improve their child's nutrition. results from a pilot study conducted in rural zambia suggest that growth charts installed in homes can increase awareness and reduce early-life growth deficits, particularly among children experiencing growth faltering. the main objective of this study is to assess the impact and cost-effectiveness of growth charts through a cluster-randomized trial in indonesia. the primary outcome is child height-for-age z-score.

the study is divided into two phases. in the first phase, growth chart development activities will be conducted in two villages in each of manggarai timur and trenggalek districts to ensure the chart design is compatible with the local context and chart information is understandable to caregivers. focus group discussions (fgds), key informant interviews (kiis), and door-to-door user testing will be conducted in each village. results from the fgds and kiis will inform a draft growth chart design that will then be user tested in 10 households in each village. qualitative interviews will be conducted with each household approximately two weeks after chart installation to gather insights on the usability of the growth chart. the chart design will then be finalized for use in the second phase of the study. in the second phase, 1,480 caregiver-child dyads will be recruited and enrolled in the study as part of a baseline survey. dyads will be sampled using a two-stage procedure. 110 villages will be selected proportionate to national census population size. all sub-villages ("dusun") within selected villages will be randomly assigned into two groups: 1) growth chart; and 2) control. eligible caregiver-child dyads with children between 9 and 14 months will be selected from each sub-village.

Eligibility criteria:
inclusion criteria: * caregivers must be 19 - 55 years old * one child of either gender, 9-14 months old * caregiver can have other children * caregiver of any occupation and income level * live in manggarai timur and trenggalek during inception exclusion criteria: -caregivers with a cognitive disability

Keywords: home-based growth charts child nutrition growth faltering stunting indonesia
feasibility study comparing standard fbt and guided self-help fbt for adolescent anorexia nervosa

Conditions: Anorexia Nervosa

Summary: this study examines a parent only guided self-help for family based treatment (gsh-fbt) for adolescents between the ages of 12 and 18 diagnosed with anorexia nervosa. preliminary data collected in a previous study suggest that a guided parental self-help version of fbt (gsh-fbt) has similar outcomes as therapist provided fbt.

in this study, families will be randomized to either receive 12 weekly online sessions of guided self-help for family based treatment (gsh-fbt), or 15 sessions of online, professionally delivered, standard fbt over the course of 6 months. potential subjects will be recruited from stanford university, mcmaster university, other local medical programs and clinics, and online advertisement to the population at large. if participants are deemed eligible, participants will be invited for a baseline interview during which the investigators will conduct interviews and collect questionnaire measures. participants will complete a follow-up interview at the end of treatment and 3-month after end of treatment.

Eligibility criteria:
inclusion criteria: 1. participants are 12-18 years of age 2. participants live with a family (some families may contain only one parent) 3. family members fluently speak and read english and have access to a computer with internet 4. participants meet dsm-5 criteria for an (both subtypes) 5. ibw between 75% and 88% 6. participants are medically stable for outpatient treatment according to the recommended thresholds of the american academy of pediatrics and the society of adolescent medicine 7. participants are not engaged in another individual or family based psychotherapy trial during the duration of treatment sessions in the study. 8. medications for comorbid psychiatric disorders are ok; randomization will balance groups through tracking. exclusion criteria: 1. associated physical illness that necessitates hospitalization 2. psychotic illness in any form, mental retardation, autism, or any other mental illness that would interfere with the use of psychotherapy. 3. current dependence on drugs or alcohol 4. physical conditions (e.g. diabetes mellitus, pregnancy) known to influence eating or weight 5. previous (5 or more sessions of) or current fbt-an 6. participants and family members do not have an adequate understanding of spoken english and are not able to speak and read english in order to participate in family therapy and the assessments. 7. current weight is less than 75% or above 88% of expected weight given age and height.

Keywords: fbt family based treatment guided self-help