Kornimate/medical-research-clean huggingface dataset:
the study of the effectiveness of tissue equivalent on the basis of cultured cells to heal skin blemishes

Conditions: Neurotrophic Ulcers; Burns

Summary: in russia the treatment nonhealing skin defects often limited to surgical interventions, despite having developed modern methods of treatment of non-healing ulcers and other skin imperfections. during the many years of research we have developed a skin equivalent comprising living cells. during pilot trial showed that the skin equivalent provides healing skin defect within 1-4 weeks in 95% of patients.


Eligibility criteria:
inclusion criteria: * the presence of non-healing ulcer at least a month, an area of not less than 3 cm2 or smaller area of deep defects; * availability of burns ii or iii level; * epidermolysis bullosa; * availability of post-burn scars * defects in the skin after surgery exclusion criteria: * acute and chronic diseases in the acute stage; * autoimmune diseases of connective tissue (collagen); * immunodeficiency states; * system of inflammatory diseases of the skin; * conduct an aggressive corticosteroid therapy; * acute coronary syndrome; * acute disorders of cerebral circulation; * availability of local inflammation in the acute stage; * pregnancy; * breast-feeding. * positive results of the following tests: anti-hiv-1 and -2, hiv-1ag, anti-htl vi and-ii, anti-hbcorag, hbs-ag, anti-hcv, anti-cmv, anti-toxoplasma gondii, rw, neisseria gonorrheae, chlamydia.

Keywords: damage to the skin, the skin equivalent, cell therapy
induction chemotherapy followed by chemoradiotherapy in esophageal cancer

Conditions: Neoplasms

Summary: the contribution of induction chemotherapy before definitive chemoradiotherapy is unknown. the purpose of this study was to compare the efficacy and toxicity of induction chemotherapy followed by definitive chemoradiotherapy versus no induction chemotherapy in patients with inoperable thoracic esophageal squamous cell carcinoma.

108 patients were randomized to receive no induction chemotherapy (ic, arm a) or ic (arm b) before definitive chemoradiotherapy in patients with inoperable thoracic esophageal squamous cell carcinoma. patients assigned to arm b first received two cycles of 3-weekly schedule of ic, consisting of docetaxel 75 mg/m2 on day 1 and cisplatin 75 mg/m2 on day 1. the prescribed dose of radiotherapy is generally 50-60 gy/25-28fr. the concomitant chemotherapy is docetaxel 20 mg/m2 on day 1, cisplatin 25 mg/m2 on day 1, repeated weekly during radiation.

Eligibility criteria:
inclusion criteria: 1. histologically confirmed squamous cell carcinoma of the esophagus; 2. localized, nonmetastatic disease (t1-4, n0-1) confirmed by endoscopic ultrasound (eus) and ct scan (according to uicc tnm version 6); 3. absence of distant metastasis of solid organ; 4. not suitable for surgery (either for medical reasons or patient's choice); 5. age at diagnosis 18 to 70 years; 6. eastern cooperative oncology group performance status ≤ 2 7. no prior cancer therapy; 8. no history of concomitant or previous malignancy; 9. hematologic function: wbc ≥ 4.0×109/l, plt ≥ 80×109/l, hb ≥ 10mg/dl; 10. renal function: cr ≤ 1.25×unl; 11. hepatic function: bil ≤ 1.5×unl, alt/ast ≤ 2.5×unl; 12. documented informed consent to participate in the trial. exclusion criteria: 1. younger than 18 or older than 70 years of age; 2. ecog performance status of 3 or above; 3. other cancer history; 4. previous radiotherapy history; 5. subjects with distant metastases; 6. pregnancy or breast feeding. women of childbearing age must use effective contraception; 7. serious cardiovascular disease (congestive heart failure, uncontrollable arrhythmia, unstable angina, myocardial infarction, serious heart valve disease, resistant hypertension); 8. evidence of bleeding diathesis or serious infection.

Keywords: esophageal cancer chemoradiotherapy induction chemotherapy
autologous serum eye drops with contact lenses for corneal epithelial defects

Conditions: Corneal Diseases

Summary: to evaluate the clinical effect of combination of topical 20% (v/v) autologous serum eye drops and a silicone-hydrogel contact lens (cls) in the treatment of recalcitrant persistent epithelial defects (peds) and the recurrence rate of epithelial breakdown with or without continued use of autologous serum eye drops.

dealing with persistent epithelial defects (peds) of the cornea is a challenge for ophthalmologists, and surgical intervention is occasionally indicated for the management of recalcitrant cases that are unresponsive to medical therapy. bandage contact lenses (bcls), especially silicone-hydrogel cls with high oxygen permeability and transmissibility, are useful for treating peds. over the past several years, autologous serum eye drops (ases) are gaining popular and widespread acceptance as adjuvant therapy for various ocular surface disorders, including peds recalcitrant to standard medical therapies.the combination of bcls and ases for peds treatment have also been reported with satisfactory results in a few small series' of ped patients. in this study, we will conduct a prospective interventional study to investigate the therapeutic effects of the combination of topical 20% ases and silicone-hydrogel cls for recalcitrant peds, as well as to compare the recurrence of epithelial breakdown with or without continuous usage of autologous serum eye drops after cl removal. patients with peds for more than 4 weeks without improvement despite previous conventional treatment were treated. silicone-hydrogel scls combined with 20% (v/v) autologous serum eye drops were used until complete re-epithelialization. scls were removed after total re-epithelialization and patients were subsequently randomized divided into two groups: (1) with and (2) without continuous use of topical autologous serum for an additional 2 weeks. ped healing rate and epithelial defect recurrence during a 3-month follow-up were evaluated.

Eligibility criteria:
inclusion criteria: * patients with peds for more than 1-month following conventional treatment, visiting e-da hospital, kaohsiung, taiwan. exclusion criteria: * patients had dry eye syndrome with a schirmer test (\<10 mm in 5 minutes) or lid abnormalities.

Keywords: autologous serum eye drops silicone-hydrogel contact lens persistent epithelial defects corneal epithelial defects
show equivalence of the modified breathid compared to currently approved breathid in h.pylori detection

Conditions: Suspicion of Being Infected With H.Pylori

Summary: the purpose of this study is to confirm equivalence of a new generation breath analyzer (modified breathid) in its ability to detect h. pylori compared to the currently approved breathid® system.

the ¹³c-urea breath test (ubt) is a non-invasive test for detecting the presence of helicobacter pylori (h. pylori) infection by the organism's urease activity. in the presence of h. pylori, the ingestion of urea, labeled with the non-radioactive isotope 13c, results in production of labeled 13co2, which can be quantified in expired breath. each test is performed using a test kit consisting of a 13c-urea tablet and citrica powder to be dissolved in tap water ("13c-urea solution"). before and after ingestion of the 13c-urea solution, samples of exhaled breath can be collected using a nasal cannula for real-time analysis and comparison to baseline concentrations. the patient's exhaled breath is analyzed and the ratio between 13co2 and 12co2 is computed. the patient is considered h. pylori positive when the difference between the ratios exceeds a predefined threshold (5 delta over baseline (dob)). the current device marketed by exalenz is large and costly. exalenz has built a smaller, cheaper and more reliable new generation device for this application. equivalence is being demonstrated in this study.

Eligibility criteria:
inclusion criteria: 1. be at least 18 years of age 2. present with clinical indication of h. pylori 3. have the ability and willingness to sign the informed consent form- exclusion criteria: 1. current serious disease 2. participation in other trials 3. antibiotics and/or bismuth preparations for four (4) weeks prior to test 4. ppi or h2 blockers for two (2) weeks prior to test 5. childbearing or breastfeeding women 6. based on opinion of investigator, subject should not be enrolled in this trial 7. allergy to citrus juice 8. post -eradication therapy for h. pylori

Keywords: helicobacter pylori 13c urea breath test breathid
comparison of insulins aspart and lispro in insulin pumps

Conditions: Type 1 Diabetes Mellitus

Summary: the purpose of the study is to compare the glycemic control between insulins aspart and lispro 48 to 100 hours after pump infusion line change in subjects with type 1 using diabetes using an insulin pump.

continuous subcutaneous insulin infusion (insulin pump therapy) is a well established tool for the management of type 1 diabetes. in clinical trials, insulin pump therapy has been shown to have increased efficacy over multiple daily injections. however, the overall glycemic control in patients using insulin pumps has been disappointing. the recommended duration of "needle use" in insulin pump treatment is 48 hours, based on anecdotal observations. one of the reasons for the suboptimal control may be that patients do not adhere to the advice of changing their pump infusion line every 48 hours. however, it is possible that the loss of glycemic control may be related to instability of insulin in the pump/line. in addition to premeal loss of control after 48 hours of line change, very little is known about post-prandial hyperglycemia leading to loss of efficacy of the insulin via an insulin pump bolus. the development of continuous glucose monitoring system (cgms) and new tests for short term fluctuations in glucose control such as 1,5-anhydroglucitol make it easier to evaluate the impact of short term loss of control in patients using the insulin pump who delay changing their lines. the different variables will be compared between the two insulins using a paired t test. 1. glycemic control will be will be compared 24 to 100 hours after pump infusion line change using cgms and daily serum 1,5-anhydroglucitol. 2. post prandial glycemic excursions in plasma glucose following a standardized breakfast 48, 72, and 96 hours after a pump infusion line change will be compared. 3. the used pump infusion line will be collected from the patient and analyzed for insulin binding to the plastic, as well as other possible effects that may determine its role in loss of glycemic control. 4. comparison of some of the markers of coagulation, inflammation, protein glycation and oxidative stress 48, 72, and 96 hours after a pump infusion line change.

Eligibility criteria:
inclusion criteria: * type 1 diabetes treated with a pump for at least 3 months exclusion criteria: * pregnancy * plasma creatinine \> 1.2 mg/dl * inability to give informed consent * hba1c \> 8% * known or suspected hypersensitivity to trial drugs or any of their components

Keywords: type 1 diabetes mellitus glycemic control continuous subcutaneous insulin infusion continuous glucose monitoring system
effects of tot on performance, independence and fatigue in children with cancer

Conditions: Childhood Cancer; Performance; Functional Independence; Fatigue

Summary: this study aims to explore the effects of task-oriented training (tot) on occupational performance, activities of daily living and fatigue of children in pediatric oncology clinic. hypothesis: there is no effect of tot on occupational performance and satisfaction in children with childhood cancer. there is no effect of tot on functional independence in daily living activities in children with childhood cancer. there is no effect of tot on fatigue levels in children with childhood cancer.


Eligibility criteria:
inclusion criteria: * being between 6 and 14 years of age; * receiving inpatient chemotherapy sessions; * having taken scores higher than 28, 30 and 35 in the mini-mental state exam devised for children of ages 6-8, 9-11 and 12-14, respectively. exclusion criteria: * their disease had recurred, or they were in palliative care; * they or their parents were not fluent speakers of the turkish language; * they were unwilling to take part in the programs.

Keywords: childhood cancer fatigue functional independence occupational performance task-oriented training
the relationship between renal functions and multi drug resistant organisms

Conditions: Chronic Kidney Disease; Glomerular Filtration Rate; Drug Resistance

Summary: ventilator-associated pneumonia (vap) is the most common nosocomial infection in patients receiving invasive mechanical ventilation (mv). antibiotic resistance poses an increasing threat due to the rise of infections caused by multidrug-resistant organisms (mdros).despite the increase in the frequency of mdro colonisation and infection in dialysis patients, it is not known enough whether the risk of multi-drug resistant (mdr) pneumonia increases in mild-to-severe chronic kidney disease (ckd) (egfr \<60 ml/min/1.73 m2) patients not receiving dialysis. therefore, in our study, the investigators aimed to evaluate the relationship between renal functions and mdr vap risk and the specific microbial pattern.

this prospective observational study was performed on adult patients intubated and receiving mv for at least 48 hours in the 42-bed surgical and medical intensive care unit. the study was conducted between august 2019 and january 2021 and approved by the ethics committee of necmettin erbakan university medical school. informed consents were obtained from patients participating in the study or from their relatives. the characteristics of patients with mdro infection associated with different egfr categories in vap patients were recorded.

Eligibility criteria:
inclusion criteria: * patients of 18 years of age and above * a clinical suspicion of vap as defined in the american thoracic society (ats) guidelines * a clinical pulmonary infection score (cpis) \> 6 * no signs and symptoms of infection at the time of admission to the icu exclusion criteria: * acute kidney injury * renal replacement treatment (rrt) * dialysis * renal transplantation * active tuberculosis * malnutrition * immunosuppression (neutropenia, hiv positivity, transplantation, prednisone treatment of ≥20 mg/day, etc.) * any extrapulmonary infection other than vap at the time of being included in the study * respiratory cultures presented fungal agents * normal flora * no growth
changes in the immunomodulatory properties of adipose stromal cells due to hemarthrosis after knee injury

Conditions: Post-Traumatic Osteoarthritis of Knee; Knee Injuries; Hemarthrosis

Summary: the goal of this observational study is to gain insight in the natural course of pro-inflammatory factors and hemarthrosis in patients older than 18 with a recent knee trauma. the main question\[s\] it aims to answer are: * what is the natural course of pro-inflammatory factors and hemarthrosis in knee trauma? * what are the effects of inflammation and hemarthrosis on the anti-inflammatory potential of asc's in order to better determine eligible patients and circumstances for asc's therapy? participants will: * undergo blood withdrawal * undergo knee arthrocentesis for synovial fluid sample collection * physical examination * fill out a questionnaire on knee complaints

recent studies have found an amelioration of post-traumatic osteoarthritis by the use of adipose-derived stromal cells (asc's) in an experimental animal model. this amelioration was only seen under inflammatory conditions. the presence of hemarthrosis has not been taken into account in the before mentioned animal model, and might have cytotoxic effects on asc's and aggravate the inflammatory response. the objective of this study is to gain insight in the natural course of pro-inflammatory factors and hemarthrosis and its effects on the anti-inflammatory potential of asc's in order to better determine eligible patients and circumstances for asc's therapy. therefore the investigators designed a pilot study with exploratory analyses in and with synovial fluid in a longitudinal cohort. our study population will consist of 20 patients, older than 18 years, who sustained a recent knee trauma and are presented to the emergency department.the investigators will gather synovial fluid and blood samples for laboratory analysis perform and physical examination and provide questionnaires for clinical follow-up. the main study endpoint are the anti-inflammatory capacities of asc's in synovial fluid that contains blood as a result of hemarthrosis after knee injury.

Eligibility criteria:
inclusion criteria: * recently suffered an injury of the index knee (rotational or hyperextension) * a swollen joint * inability to mobilise exclusion criteria: * patients with an active inflammatory or infectious comorbid disease (including rheumatic diseases) * patients using systemic immunosuppressant medication * patients with a contra-indication for undergoing a mri-scan (non-compatible implants or claustrophobia for example) * patients with knee prosthesis * patients with coagulation disorders * patients with a history of a cruciate ligament or meniscal injury of the index knee * patients with a tibiofemoral fracture of the index knee due to current distortion * in case the inclusion of the required amount of patient is reached in one the patient groups, additional patients belonging in the same patient group will not be included in the study
sli & pulmonary ha deposition after sah

Conditions: Subarachnoid Haemorrhage (SAH)

Summary: acute lung injury is a common complication of subarachnoid hematoma (sah), and a significant risk factor for death in patients with sah. unlike neurogenic pulmonary edema and pneumonia following brain injury, the clinical causes of pulmonary injury after sah are not intracranial hypertension or pulmonary infection. its occurrence is influenced by the release of catecholamines, the regulatory function of the hypothalamic-pituitary-adrenal (hpa) axis and systemic inflammatory response, but the specific mechanisms are still unclear. therefore, delving into the pathological mechanisms of sah-induced lung injury and developing therapeutic strategies based on the findings is of great importance to improve the prognosis of patients. abnormal accumulation of hyaluronic acid in the lungs has been reported to be closely related to the pathological progression of various pulmonary injury diseases, such as chest trauma, pulmonary infection and chronic obstructive pulmonary disease. from this, the present research is aimed to explore the levels and dynamic changes of hyaluronic acid in the bronchoalveolar lavage fluid and blood of patients with acute lung injury following sah, and to analyze its correlation with the prognosis of pulmonary complications, thereby providing assistance for the clinical diagnosis and treatment of sah.


Eligibility criteria:
inclusion criteria: * age between 18 and 80 years old with independent behavior ability or authorized legal representative. * a documented diagnosis of sah within 5 days. * a hunt-hess scale of ⅳ or ⅴ. * absence of clinical and etiological evidence of pulmonary infection. exclusion criteria: * pregnant or lactating women. * present history of traumatic brain injury or intracranial hemorrhage. * past history of neurological disorders, lung infection within the past six months, cancer, chronic cardiopulmonary diseases, hematological diseases or renal failure. * have participated in clinical trials in the past 4 weeks. * the investigator considers that not appropriate for inclusion.

Keywords: subarachnoid haemorrhage sah acute lung injury ali hyaluronic acid
intravenous vs. intraosseous vascular access during out-of-hospital

Conditions: Cardiac Arrest

Summary: the "intravenous vs. intraosseous vascular access during out-of-hospital cardiac arrest (ivio)"-trial is an investigator-initiated, randomized, parallel group, patient and outcome assessor-blinded, superiority trial of intravenous vs. intraosseous vascular access during adult out-of-hospital cardiac arrest. the intraosseous group will be further randomized to humeral vs. tibial access. the trial will be conducted in the central denmark region. the primary outcome will be sustained return of spontaneous circulation, and 762 patients will be included. key secondary outcomes include survival at 30 days and survival at 30 days with a favorable neurological outcome.


Eligibility criteria:
inclusion criteria: 1. out-of-hospital cardiac arrest 2. age ≥ 18 years 3. indication for intravenous or intraosseous vascular access during cardiac arrest exclusion criteria: 1. blunt or penetrating traumatic cardiac arrest 2. prior enrollment in the trial 3. intravenous or intraosseous vascular access already in place and working when the first trial-participating unit arrives on site
comparison of blood pressure lowering effect between fimasartan and losartan

Conditions: Hypertension

Summary: comparison of blood pressure lowering effect between fimasartan and losartan in the hypertensive patient during night and early morning time


Eligibility criteria:
inclusion criteria: * subject don't have anti-hypertensive drug or who stop anti-hypertensive drug during 2 weeks * office bp: over sisbp 140mmhg or si dbp 90mmhg * 24hr abpm: sbp 130mmhg or dbp 80mmhg (24 hour average) exclusion criteria: * pregnant, trying to become pregnant or breast feeding * subject has secondary hypertension * white coat blood pressure (normal result of 24 hour abpm)
clinical performance and safety comparison of stay safe link® with stay safe® in patient on capd (capd-3)

Conditions: Continuous Ambulatory Peritoneal Dialysis

Summary: this post-marketing study is undertaken to compare the clinical effectiveness and safety of two continuous ambulatory peritoneal dialysis produced by fresenius medical care (fmc), i.e. stay safe® (sts) that is produced by a plant in germany and stay safe link® (ssl) that is produced in malaysia. the study is an open labelled, randomised controlled trial where 434 patients in total will be randomised to either sts or ssl in a 1:1 ratio.


Eligibility criteria:
inclusion criteria: 1. 18 years of age or above 2. end stage kidney failure receiving stay safe® pd system for at least 4 weeks 3. written informed consent exclusion criteria: 1. requirement for 2.5l exchanges 2. requirement for stay safe balance® 3. pd-related infection (peritonitis, exit site or tunnel tract infection) in the preceding 8 weeks or during conversion 4. malfunctioning of pd catheter 5. planned transfer to automated peritoneal dialysis, haemodialysis or transplant within 90 days 6. pregnancy 7. any condition that compromises the integrity of the abdominal wall, abdominal surface, or intra-abdominal cavity, such as documented loss of peritoneal function 8. history of active alcohol or substance abuse in the previous 6 months 9. other medical condition which, in the investigator's judgement, may be associated with increased risk to the subject or may interfere with study assessments or outcomes