Kornimate/medical-research-clean huggingface dataset:
cohort study comparing short daily hemodialysis (hd) with conventional hd

Conditions: End-stage Renal Disease; Thrombocytopathy; Cardiovascular Diseases

Summary: this study is examining the effects of short daily hemodialysis on platelet function, fluid volume control, arterial stiffness and patient quality of life, as compared to conventional hemodialysis.

bleeding is a common cause of morbidity and mortality in patients with end stage renal disease. a major cause of uremic bleeding is due to platelet dysfunction. it has been theorized that in renal failure, toxins accumulate, some of which inhibit primary hemostasis. all aspects of normal platelet function are affected. platelet function has previously been difficult to quantify but recently a novel test, the platelet function analyzer (pfa-100) has been determined to be both sensitive and specific in assessing platelet function. conventional hemodialysis (chd) has been shown to partially correct thrombocytopathy. enhanced uremic clearance can now be attained through the use of short daily hemodialysis (sdhd). cardiovascular disease is the most common cause of mortality in dialysis patients, accounting for 40% of deaths. volume overload is associated with high blood pressure, left ventricular hypertrophy and elevated markers of inflammation and these factors have been associated with increased cardiovascular mortality. sdhd has been shown to control blood pressure and limit volume expansion. pulse wave velocity (pwv) has been used to assess arterial compliance and reduction of arterial elasticity of large and small arteries which have been associated with cardiovascular outcomes.

Eligibility criteria:
inclusion criteria: * patient is enrolled in short daily hemodialysis program * patient is minimum of 18 years old exclusion criteria: * patient is unable to consent due to language barrier * patient is unable to consent due to cognitive difficulties * patient refuses consent

Keywords: hemodialysis platelet function analyzer bioimpedance pulse wave velocity end stage renal disease
ovariopexy for adhesion prevention after laparoscopic removal of endometriosis of the pelvic side wall or the ovary

Conditions: Endometriosis; Adhesion; Surgery

Summary: prospective randomized trial comparing ovariopexy over 2, 4 or 6 days vs placebo after surgery because of endometriosis of the pelvic side wall or the ovary or both


Eligibility criteria:
inclusion criteria: * premenopausal * wants to participate * removal of endometriosis of the pelvic side wall or ovary exclusion criteria: * postmenopausal * cannot give informed consent * no endometriosis during operation * no opening of pelvic side wall or ovary during the operation * pregnant * breast feeding

Keywords: endometriosis ovariopexy adhesion prevention laparoscopy complications amh
clinical study on huatuo zaizao pills for post-stroke treatment

Conditions: Ischemic Stroke

Summary: the purpose of this study was to evaluate the improvement of limb motor function and nerve function of patients with htzz during stroke rehabilitation. a total of 80 subjects will be randomly assigned to huatuo zaizao pill group or the control group.

this is a prospective, randomized controlled clinical trial. eighty patients with phlegm and blood stasis block syndrome of ischemic stroke were randomly assigned to hua hua reconstruction group or control group at a ratio of 1:1. the treatment period is 12 weeks. the purpose is to evaluate its efficacy and safety, provide an objective basis for precise treatment of traditional chinese medicine, and improve clinical efficacy. the main result is the changes of mas scores 12 weeks days after taking the drug. the secondary result is the change in nihss, fugl-meyer and bi.

Eligibility criteria:
inclusion criteria: * 1.aged between 35 and 75 years old * 2.with a disease course between 2 weeks- 24weeks * 3.meeting the diagnostic criteria of ischemic stroke * 4.signed and dated written informed consent. * 5.4≤nihss score≤22 exclusion criteria: * 1.unstable vital signs, or serious heart, liver, lung, kidney and other organ diseases * 2.exclude transient ischemic attack(tia) * 3.patients who are participating in clinical trials of other drugs within the past 1 month * 4.pregnant or breastfeeding women * 5.athletes, epileptics, allergic to this product

Keywords: huatuo zaizao pill stroke rehabilitation limb spasticity motor recovery traditional chinese medicine
an observational study of patients with chronic hepatitis c undergoing treatment with pegintron and rebetol in clinical practice in belgium (study p05494)(withdrawn)

Conditions: Hepatitis C, Chronic; Hepatitis C

Summary: this is an observational study of patients undergoing treatment with pegintron and rebetol for chronic hepatitis c in clinical practice in belgium. treatment will not be administered as part of the study. safety parameters will be assessed retrospectively. efficacy parameters, such as relapse rates and sustained virologic response rates, will be assessed prospectively. the objective of the study is to examine any associations between safety, virologic, histologic, demographic parameters and patient outcome (relapse rates and sustained virologic response rates).


Eligibility criteria:
inclusion criteria: * male and female adult (18 years or older) subjects for whom the treating physician has decided to start treatment with pegintron® and rebetol® and reaching the end-of-treatment time point. * for the prospective component, evidence of treatment response at eot after a complete course of therapy as per smpc. * subjects must demonstrate their willingness to participate in the study and comply with its procedures by signing a written informed consent. * subjects must be diagnosed with chronic hepatitis c (genotypes 1, 2, 3, 4, 5 or 6). * subjects must be free of any clinically significant disease that would interfere with study participation. exclusion criteria: * for prospective component of the study: patients not achieving end-of-treatment response after a complete course of therapy as per smpc.
the effect of glp-1 on glucose uptake in the brain and heart in healthy men

Conditions: Type 2 Diabetes; Stroke; Myocardial Infarction

Summary: type 2 diabetes mellitus, t2d is a disease characterized by an immense growing prevalence world wide with an increased risk of myocardial infarction and stroke. glp-1 has convincing effects on the high glucose levels in type 2 diabetic patients and is well tolerated. new animal studies indicate a protective effect of glp-1 in the brain and the heart. the mechanism behind this is yet not known. the study hypothesis is that glp-1 will stimulate glucose-uptake in the brain and heart independent of insulin and thereby exert its protective effects.

type 2 diabetes mellitus, t2d is a disease characterized by an immense growing prevalence world wide. t2d is associated with a three-fold increase in cardiovascular complications (myocardial infarction and stroke) leading to significantly higher morbidity and mortality in this group of patients. the prospective british diabetes study (ukpds) showed that neither diet alone nor the pharmaceutical treatment utilized (sulphonylurea, metformin, insulin) were able to reduce these macrovascular complications. glp-1 (glucagon-like-peptide-1)is an incretin with convincing effects on glycaemia in type 2 diabetic patients with little or no risk of hypoglycaemia. new research in animal models has shown a potential protective effect in the brain and heart in association with ischaemic damage. the mechanism behind this protective effect is not known. the effect of native glp-1 on glucose uptake in the brain and heart will by visualized by fluoro-deoxy-glucose fdg-pet-scan during normoglycaemia in healthy young men. at the same time a pancreatic/pituitary clamp will be performed. the hypothesis is that glp-1 directly will stimulate glucose uptake independent of the pancreatic hormones and through this mechanism exert its neuro- and cardioprotective actions. comparisons: fdg-uptake in the brain and heart with glp-1 infusion compared to placebo.

Eligibility criteria:
inclusion criteria: * healthy men * age 20-50 years * caucasian * bmi 20-30 kg/m2 exclusion criteria: * diabetes in subject and 1.degree relatives * any disease of clinical relevance

Keywords: type 2 diabetes glp-1 pet brain heart
evaluation of four reconstructions after total gastrectomy

Conditions: Gastric Cancer; Nutrition

Summary: there are four capital reconstructions after total gastrectomy which is widely used in china. life quality is the only standard to evaluate postoperative results of different reconstructions. in order to determine the best reconstruction after total gastrectomy, we designed this study to compare life qualities of four reconstructions.


Eligibility criteria:
inclusion criteria: * patients should be younger than 80 years old with adequate renal, pulmonary, and heart functions. exclusion criteria: * death or other reason which cause information discontinue

Keywords: gastric cancer total gastrectomy reconstruction life quality
safety and efficacy study of epitope peptide to treat hla-a*24 disease controlled advanced non-small cell lung cancer

Conditions: Non-small Cell Lung Cancer

Summary: the investigators previously identified three novel hla-a\*2402-restricted epitope peptides, which were derived from three cancer-testis antigens, urlc10, cdca1, and kif20a, as targets for vaccination against lung cancer. in this clinical study, the investigators examine using a combination of these three peptides the safety, immunogenicity, and antitumor effect of vaccine treatment to prevent relapse of the disease for hla-a\*2402-positive advanced non-small cell lung cancer patients whose disease are controlled after any standard therapies.

the purpose of this study is to evaluate the safety, tolerability, immune response and clinical efficacies of hla-a\*2402 restricted epitope peptides urlc10, cdca1, and kif20a emulsified with montanide isa 51 for disease controlled advanced non-small cell lung cancers. the investigators previously identified three novel hla-a\*2402-restricted epitope peptides, which were derived from three cancer-testis antigens, urlc10, cdca1, and kif20a, as targets for cancer vaccination against lung cancer. in this phase i/ii trial, the investigators examine using a combination of these three peptides the safety, immunogenicity, and antitumor effect of vaccine treatment for hla-a\*2402-positive advanced non-small cell lung cancer patients whose disease are controlled after any standard therapies, but who do not have any options for additional standard ones to prevent .future relapse of the disease.

Eligibility criteria:
inclusion criteria: 1. nsclc whose disease are controlled after any standard therapies, but who do not have any additional standard ones to prevent .future relapse of the disease. 2. ecog performance status 0-2 3. age between 20 to 85 4. clinical efficacy can be evaluated by some methods 5. no prior chemotherapy, radiation therapy, hyperthermia or immunotherapy within appropriate periods 6. life expectancy \> 3 months 7. laboratory values as follows 1500/mm3 \ 75000/mm3 asparate transaminase \< 3 x cutoff value alanine transaminase \< 3 x cutoff value total bilirubin \< 3 x cutoff value serum creatinine \< 2x cutoff value 8. hla-a\*2402 9. able and willing to give valid written informed consent exclusion criteria: 1. active and uncontrolled cardiac disease (i.e. coronary syndromes, arrhythmia) 2. myocardial infarction within six months before entry 3. breastfeeding and pregnancy (woman of child bearing potential) 4. active and uncontrolled infectious disease 5. concurrent treatment with steroids or immunosuppressing agent 6. other malignancy requiring treatment 7. non-cured traumatic wound 8. decision of unsuitableness by principal investigator or physician-in-charge
clinical trial of light therapy for epilepsy

Conditions: Epilepsy

Summary: this study is designed to investigate whether light therapy may be an effective treatment for some people with epilepsy. light treatment is already an established treatment for depression. the chemical systems in the brain that are disrupted when someone becomes depressed, overlap with some of those that can be affected during some epileptic seizures. the investigators have designed this study to see whether light therapy may also lead to a decrease in seizures in people who have epilepsy. the study will be a placebo controlled trial. this means that half of the participants will receive a therapeutic dose of light therapy from a light box, whilst the other half will only receive a placebo light treatment.

the aim of this study is to investigate a new, non invasive treatment for epilepsy that may be useful as an adjunctive therapy for people whose seizures are poorly controlled with anti epileptic drugs. light therapy is a well established treatment for some forms of depression. from the cellular level to epidemiological studies, there are numerous strands of evidence in the scientific literature that indicate that light therapy could be also an effective treatment for some people with epilepsy. the proposed study is a randomised placebo controlled trial of light therapy. one hundred people with medically refractory epilepsy will be recruited. participants will be randomised to receive either therapeutic or placebo doses of light therapy from an identical device for 30 minutes a day during the treatment phase of the study. the statistical power of this study design is \>90% to detect a 25% reduction in seizure frequency during the treatment phase. although this therapeutic approach is more likely to be palliative than curative, it represents a non invasive and relatively inexpensive add-on treatment option for a sub group of patients who may have reached the end of the road in other medical and surgical treatment options.

Eligibility criteria:
inclusion criteria: * adult * medically intractable epilepsy * min 4 complex partial seizures/ month exclusion criteria: * ability to give informed consent * underlying progressive neurological condition

Keywords: seizures light therapy
serial measurement of a plasma stroke biomarker panel in patients undergoing cardiac surgery with cardiopulmonary bypass

Conditions: Cardiac Surgery

Summary: the purpose of this study is to investigate changes in new plasma stroke biomarker panel in patients undergoing cardiac surgery with the use of cardiopulmonary bypass.


Eligibility criteria:
inclusion criteria: * age \> 18 years * elective cardiac surgery with the use of cardiopulmonary bypass exclusion criteria: * patients undergoing emergent procedures * patients with preoperative mechanical support
genetic and immunologic characterization of iei

Conditions: Immunity Disorders; Inborn Errors of Immunity

Summary: inborn errors of immunity (iei) include clinically heterogeneous rare genetic diseases depending on mutations in about 300 different genes. clinically, this group of diseases is characterized by the presence of infectious, inflammatory, autoimmune, and lymphoproliferative symptoms. understanding the pathogenesis of these diseases can guide the implementation of targeted therapies and improve prognosis. in recent years, iei have been described that do not necessarily present with repeated infectious symptoms but rather with autoimmune, lymphoproliferative, and autoinflammatory manifestations, or with forms of immunodeficiency with a spectrum of susceptibility to one or few infectious agents. in this case, simple laboratory tests are not sufficient to characterize the disease since no particular immunophenotypic changes are evident. to correct classify the patients and to improve knowledge on the pathogenesis of the diseases, complex immunologic-functional studies are required. these studies should be started prior to genetic analysis, with the aim of targeting and narrowing it down. although the ever-decreasing costs of next generation sequencing (ngs) methods make it convenient to analyse many genes or even the entire exome simultaneously, the analysis of the data resulting from ngs can be complex and provide results of uncertain interpretation. in these cases, immunologic-functional studies can clarify the real causal role of the identified genetic variants. the identification of genotype-phenotype correlation is crucial to establish new therapeutic targets for diseases orphan of specific etiological treatments. in vitro and in vivo disease models are key tools to test drugs repositioning, as was the case for lapaquistat in the treatment of periodic fevers caused by de-regulation of the cholesterol metabolic pathway.


Eligibility criteria:
inclusion criteria: * subjects with suspected iei exclusion criteria: * no consent from the patients' guardians * subjects undergoing hematopoietic stem cell transplantation.

Keywords: inborn errors of immunity genotype-phenotype correlation drugs repositioning genetics
conditions of realization of the echocardiography in newborns

Conditions: Premature Newborn

Summary: experimental nociceptive stimulation of the fetus and neonate induces pulmonary artery vasoconstriction. the investigators assessed whether echocardiography for ductus arteriosus screening may generate this hemodynamic response and whether postural support would be able to modulate it. study design prospective, single center, randomized study in less than 29 weeks of gestation neonates, with a post natal age \< 48 hours, and requiring invasive mechanical ventilation. crossover design with order of echocardiographies determined by computer randomization: in one group ultrasounds are performed with postural support, than standard conditions, in the other, ultrasounds are performed in standard conditions than with postural support. the objective of the study is to assess the ratio of the acceleration time/ejection time of pulmonary arterial flow. the others objectives are to assess echocardiographic-doppler features (ductus arteriosus shunt pattern, pulmonary flow pattern, estimated systolic pulmonary arterial pressure, right and left ventricular functions using tissue doppler imaging and speckle-tracking echocardiography), pain assessment with a clinical scale and heart rate variability analysis.


Eligibility criteria:
inclusion criteria: * newborn than 30 weeks of gestation neonates, * newborn with a post natal age \< 48 hours, * newborn requiring invasive mechanical ventilation. * signed consent form of parent exclusion criteria: -

Keywords: echocardiography postural support preterm neonate
the safety and feasibility of reduced port robotic distal gastrectomy using single-site for surgical treatment of early gastric cancer

Conditions: Gastric Cancer

Summary: gastric cancer is one of the most common malignancy worldwide. surgical resection of the tumor is the only curative treatment for gastric cancer. however, surgical procedure accompanies postoperative pain and prolonged hospitalization. to lessen the surgical trauma and stress, minimally invasive surgery were introduced. laparoscopic gastrectomy was accepted as safe and effective alternative to open gastrectomy. furthermore, reduced port and single port laparoscopic gastrectomy are considered to minimize the surgical trauma during gastrectomy. however, limitations of laparoscopic approach using reduced port includes unergonomic posture of surgeon, physiologic tremor and collision of instruments. to overcome these limitations, robot surgery using novel single-site technology enabled surgeons to perform the surgical procedure reducing the number of trocar from three to one for insertion of scope and two robotic arms. previously, successful application of single-site technology for cholecystectomy and hysterectomy were reported. the aim of this study is to validate the safety and feasibility of reduced port robotic distal gastrectomy using single-site technology for the surgical treatment of gastric cancer.


Eligibility criteria:
inclusion criteria: 1. a resectable, tissue confirmed adenocarcinoma of the stomach 2. early gastric cancer curable by distal gastrectomy 3. age: 20-70 4. ecog: 0-1 5. asa score 1-3 6. a patient who signed the informed consent exclusion criteria: 1. advanced lesion with metastatic cancer 2. lesion which is curable by emr or esd 3. previous major abdominal surgery 4. complicated gastric cancer (obstruction or perforation) 5. history with other primary tumor within 5 year 6. active other primary tumor 7. vulnerable subjects (pregnant women, illiterate)

Keywords: robot surgery reduced port single-site safety feasibility
tracebook: the clinical proof of concept on the intensive care.

Conditions: Critical Illness; Safety Issues

Summary: the effectiveness of current checklists is hampered by lack of acceptance and compliance. recently, a new type of checklist with dynamic properties has been created to provide more specific checklist items for each individual patient. the proof of concept of this dynamic clinical checklist (dcc; bja 2017 (doi: 10.1093/bja/aex129)) was tested in a simulation trial with improved outcomes and high acceptance scores. the purpose of this study is to investigate if the outcomes of this real-life clinical proof of concept study are similar with the outcomes of the simulation trial for the intensive care unit (icu) ward.

method a prospective single center (catharina hospital eindhoven) controlled before-and-after study. the before period will be used as control group in which ward rounds and nurse handovers will be observed by the investigators for two months. then tracebook will be introduced and clinicians, icu doctors and nurses, will be able to use checklists of tracebook for ward rounds, their shifts and handovers in which they will be observed for two months. the goal is at least 120 observations per period. endpoints the primary outcome is the percentage of items that were checked per ward rounds and nurse handovers during the before and the after implementation period. secondary outcomes will be clinical outcomes of admitted patients, pharmacist specific outcomes, specific checkable item related outcomes, and user experience and acceptance scores. hypothesis tracebook, with the use of digital dynamic checklists, improves compliance to care processes on the intensive care with a high user acceptance score.

Eligibility criteria:
inclusion criteria: * physicians working on the icu * all admitted patients on the icu during the study periods. exclusion criteria: * physicians objecting participation in the trial

Keywords: checklist intensive care unit clinical decision support systems medical errors patient safety