Kornimate/medical-research-clean huggingface dataset:
treatment of anastomotic leakage after colon cancer resection

Conditions: Treatment; Anastomotic Leakage; Resection; Colon Cancer

Summary: this international multicentre retrospective cohort study aims to research anastomotic leakage after colon cancer resection and has two main objectives: 1. to identify predictive factors associated with 90-day mortality and 90-day clavien-dindo grade 4-5 complications amongst patients who developed al following colon cancer resection and to develop and validate a prediction model for predicting 90-day mortality as well as the co-primary composite endpoint clavien-dindo grade 4-5 complications. 2. to explore and compare the effectiveness of various treatment strategies for al following colon cancer resection, considering patient, tumour, resection and leakage characteristics.


Eligibility criteria:
inclusion criteria: * aged 18 years or older; * surgical resection for primary colon cancer (ct1-4b, n0-2, m0-1) with formation of a primary colonic anastomosis and with or without diverting stoma; * postoperative al defined as: "any clinical, radiological or intraoperative signs of disrupted integrity of the anastomosis. this also includes suspected leaks with any degree of extraluminal air or fluid on ct, perianastomotic abscess, purulent peritonitis without clear anastomotic defect, or any other suspicious condition in which there is no ultimate macroscopic proof of disrupted anastomosis." * regarding the type of colon cancer resection, the following patients will also fulfil the inclusion criteria: patients who underwent cytoreductive surgery (crs) simultaneous with resection of the primary colon cancer with or without hyperthermic intraperitoneal chemotherapy (hipec), simultaneous ablations/resections of metastasis, multivisceral resection, emergency resection, patients diagnosed with perforated disease/peritumoral abscess or fistula, and acute obstructions. exclusion criteria: * surgical resection for benign colon disease; * recurrent colon cancer resection; * any primary colon malignancy other than adenocarcinoma (e.g. neuroendocrine tumour, gastrointestinal stromal tumour); * any clinical condition that does not fulfil the broad definition of al as used in this study (e.g. only free air on ct that is considered to be compatible with an appropriate postoperative day in the absence of any other clinical signs related to a potential anastomotic leakage)
treatment registry of alectinib in anaplastic lymphoma kinase (alk)-positive, locally advanced or metastatic non-small cell lung cancer in korea

Conditions: Non-Small Cell Lung Cancer

Summary: alectinib was approved by the ministry of food and drug safety (mfds) in korea in oct 2016. the purpose of this registry is to investigate and confirm the type and incidence of newly identified adverse events and any other factors affecting safety and effectiveness of the new drug so that the regulatory authority can manage the marketing approval properly.


Eligibility criteria:
inclusion criteria: - subjects who are administered alectinib at physician's discretion and fall into the approved indication in korea. exclusion criteria: * hypersensitivity to alectinib or any ingredient of alectinib; * pregnant or lactating women; * pediatric subjects (age \</=18 years); * due to the presence of lactose, subjects with rare hereditary problems of galactose intolerance, the lapp lactase deficiency or glucose-galactose malabsorption should not take alectinib.
skin-to-skin after delivery in preterm infants born at 28-32 weeks of gestation

Conditions: Premature Birth

Summary: the aim of the study is to investigate physiological response, social/emotional response and general movements in preterm infants when they are given skin-to-skin contact with the mother (intervention) or standard care (incubator) right after delivery. preterm infants will be randomized to either intervention or standard care group. data on body temperature, blood glucose, hart rate, respiration rate and oxygen saturation will be obtained. in addition the infant will be video-recorded during the first 24 hours and at three months of age for analysis of the general movements.

power calculations are based on a difference in bayley scale of infant development iii, cognitive scale at two years corrected age of about 7,5 mean score =0.5 sd (α=0,05, β=0.80). based on this analysis, 64 preterm infants are needed in each group to yield statistic significance. allowing for withdrawals, the sample size is set to 68 in each group.

Eligibility criteria:
inclusion criteria: * preterm infants at 28-32 weeks of gestation (born 12-8 weeks before term) exclusion criteria: * infants who need immediate medical interventions

Keywords: kangaroo-mother care method stress, physiological
expanded access protocol - blinatumomab in pediatric & adolescent subjects with relapsed/refractory b-precursor all

Conditions: Relapsed/Refractory B-Precursor Acute Lymphoblastic Leukemia

Summary: primary objective: to estimate the incidence of treatment-emergent and treatment-related adverse events during treatment with blinatumomab in pediatric and adolescent subjects with b-precursor all in second or later bone marrow relapse, in any marrow relapse after allohsct, or refractory to other treatments secondary objective(s): to describe key efficacy outcomes, including incidence of complete response (cr) within 2 cycles of blinatumomab, minimal residual disease (mrd) remission within 2 cycles of blinatumomab, relapse free survival (rfs), overall survival (os), incidence of allohsct, and 100-day mortality after allohsct. hypotheses: a formal statistical hypothesis will not be tested. the incidence of treatment-emergent and treatment-related adverse events will be estimated. study endpoints: * incidence of treatment-emergent and treatment-related adverse events * incidence of cr within 2 cycles of blinatumomab * mrd remission within 2 cycles of blinatumomab * rfs * os * incidence of allohsct * 100-day mortality after allohsct study design: multi-center, open-label, single-arm expanded access protocol


Eligibility criteria:
inclusion criteria 101 immunophenotypic evidence of cd19 positive b-precursor all (pro b-, pre b-, common all) 102 age \> 28 days and \< 18 years at the time of informed consent/assent 103 morphological or molecular evidence of relapsed/refractory disease, defined as one of the following: * second or later bone marrow relapse (defined as m3 marrow or m2 marrow or m1 marrow but with mrd level ≥ 10e-3), or * any marrow relapse after allohsct (defined as m3 marrow or m2 marrow or m1 marrow but with and mrd level ≥ 10e-3), or * refractory to other treatments: * for patients in first relapse: failure to achieve a cr following a full standard reinduction chemotherapy regimen * for patients who have not achieved a first remission: failure to achieve remission following a full standard induction regimen * subjects previously treated with blinatumomab may be eligible, if subject ended treatment for reason(s) other than disease progression or intolerability to blinatumomab (note: this does not include patients who have already received blinatumomab treatment on this study, but refers only to patients outside of the 20130320 study) other inclusion criteria may apply exclusion criteria 201 any active acute graft-versus-host disease (gvhd) grade 2 to grade 4 according to the glucksberg criteria or active chronic gvhd requiring systemic treatment 202 immunosuppresive agents to prevent or treat gvhd within 2 weeks prior to blinatumomab treatment (except for topical corticosteroids) 203 active (overt) all in the cns (confirmed by cerebrospinal fluid \[csf\] analysis) or in testes other exclusion criteria may apply
a clinical trial to evaluate the immunogenicity and safety of sipv in a '1+2' sequential schedule with bopv in infants

Conditions: Poliomyelitis

Summary: the purpose of this phrase iii clinical trial is to evaluate the immunogenicity and safety of sabin inactivated poliovirus vaccine (vero cell) in a '1+2' sequential schedule with bivalent oral poliovirus vaccine in 2-month-old infants

this study is a randomized, double-blind, active-controlled phrase iii clinical trial. the purpose of this study is to evaluate the immunogenicity and safety of sipv manufactured by sinovac vaccine technology co., ltd in a '1+2' sequential schedule with bopv in 2-month-old infants. 240 infants aged between 60-90 days will be randomly assigned into experimental group or control group in the ratio 1:1. the experimental group received sipv-bopv-bopv vaccination schedule at one month doses interval (i.e., month 0, 1, 2), and the control group received wipv-bopv-bopv vaccination schedule at one month doses interval (i.e., month 0, 1, 2). the control wipv was manufactured by sanofi pasteur s.a.

Eligibility criteria:
inclusion criteria: * healthy volunteer between 60-90 days old; * healthy volunteers who fulfill all the required conditions for receiving the investigational vaccine as established by medical history and clinical examination and determined by investigators; * proven legal identity; * participants or guardians of the participants should be capable of understanding the written consent form, and such form should be signed prior to enrolment; * complying with the requirement of the study protocol; exclusion criteria: * prior vaccination with poliovirus vaccine; * history of allergy to any vaccine, or any ingredient, excipients and gentamycin sulfate of the vaccine, or serious adverse reaction(s) to vaccination, such as urticaria, dyspnea, angioneurotic edema, abdominal pain, etc; * congenital malformation, developmental disorders, genetic defects, or severe malnutrition; * autoimmune disease or immunodeficiency/immunosuppressive; * severe/uncontrollable nervous system disease (epilepsy, seizures or convulsions) or mental illness; * diagnosed coagulation function abnormal (e.g., coagulation factor deficiency, coagulation disorder, or platelet abnormalities) , or obvious bruising or coagulation disorders; * any immunosuppressant, cytotoxic medicine, or inhaled corticosteroids (except corticosteroid spray for treatment of allergic rhinitis or corticosteroid treatment on surface for acute non-complicated dermatitis) prior to study entry; * blood product prior to study entry; * any other investigational medicine(s) within 30 days prior to study entry; * any live attenuated vaccine within 14 days prior to study entry; * any subunit vaccine or inactivated vaccine within 7 days prior to study entry; * acute disease or acute stage of chronic disease within 7 days prior to study entry; * axillary temperature \> 37.0 °c; * any other factor that suggesting the volunteer is unsuitable for this study based on the opinions of investigators;

Keywords: sabin strain inactivated poliovirus vaccine poliomyelitis safety immunogenicity infant sequential schedule
radiofrequency ablation of symptomatic frequent ventricular premature complexes in pediatric population

Conditions: Ventricular Arrhythmia

Summary: to evaluate the effectiveness and safety of catheter ablation of frequent symptomatic pvcs in the pediatric population as first-line therapy compared with antiarrhythmic drugs.


Eligibility criteria:
inclusion criteria: * symptomatic, frequent, premature ventricular complexes (more than 10,000 according to the 24 hour holter ecg) exclusion criteria: * antiarrhythmic therapy before inclusion structural heart pathology requiring surgical correction; premature ventricular complexes associated with structural heart disease; previously performed radiofrequency ablation due to premature ventricular complexes.

Keywords: pediatric population, ablation
safety and efficacy of propranolol eye drops in treating retinopathy of premature

Conditions: Retinopathy of Prematurity

Summary: the aim of the present study is to evaluate the safety and efficacy of propranolol eye drops in preterm newborns with a precocious stage of retinopathy of prematurity (rop). preterm newborns (gestational age 23-32 weeks) with a stage 2 rop (zone ii without plus) will receive propranolol eye drops treatment until retinal vascularization will be completed. propranolol concentrations will be measured on dried blood spots during the first 3 days of treatment and at the steady state. cardiovascular and respiratory parameters will be continuously monitored. blood samplings checking metabolic, renal and liver functions will be performed periodically, as well as cardiac function, in order to verify the treatment safety. serial ophthalmological evaluations will be planned to monitor the efficacy of the treatment, the rop progression and the possible complications.


Eligibility criteria:
inclusion criteria: * preterm newborns (gestational age 23-32 weeks) with stage 2 rop, zone ii without plus. * a signed parental informed consent. exclusion criteria: * newborns with heart failure; * newborns with congenital cardiovascular anomalies, except for persistent ductus arteriosus, patent foramen ovale and small ventricular septal defects; * newborns with recurrent bradycardia (heart rate \< 90 beat per minute); * newborns with second or third degree atrioventricular block; * newborns with hypotension; * newborns with renal failure; * newborns with actual cerebral haemorrhage; * newborns with other diseases which contraindicate the use of beta-adrenoreceptor blockers.

Keywords: retinopathy of prematurity propranolol eye drops newborns retinal angiogenesis retinal neovascularization
the wound infection after stomy closure between different methods of drainage

Conditions: Wound Infection

Summary: this proposal will investigate the wound condition between different drainage methods of the stoma closure wound. anastomotic leakage is a major complication after colorectal surgery. the protective stoma will decrease the anastomosis leakage rate and severity1. stoma closure is often performed after the condition of the previous protecting site improved. wound infection is not a rare complication after stoma closure, with a reported infectious rate from 3% to 43%. wound infection will result in wound dehiscence, incisional herniation, ileus and the length of hospital stay. lots of the stoma wound closure technique have been developed, including subcutaneous antibiotic material implantation, wound irrigation with iodine, closure wound with a drain tube, secondary closure, delayed primary closure and pursestring closure. but there still is in a debate about the best skin closure test. in division of colorectal surgery shuang ho hospital, two current stoma wound closure methods were subcutaneous jackson-pratt drainage and cutaneous penrose drainage insertion. in the project, clinical outcomes of these two drainage methods will be compared. the subcutaneous. jackson-pratt drainage is used to create negative pressure in subcutaneous closure wound. the negative pressure will extract actively the tissue debris and fluid, avoiding the seroma and pus accumulation. the cutaneous penrose drainage is used to create delayed skin healing, and the tissue debris and fluid will drainage passive by capillary phenomenon. two groups will be distributed randomly. the demographic characters like age, gender, bmi, nutritional status, under chemotherapy, diabetes and past medication history will be reviewed. perioperative clinical data like the method of the anastomosis, operation time, postoperative hospital day, surgical site infection, prolonged ileus, anastomosis leakage, and incisional hernia will be collected. from this study, these two stoma wound closure methods will be evaluated and analyze the risk factors of complication for the stoma wound closure.


Eligibility criteria:
inclusion criteria: * patients suffered from colon or ileum stoma. after the doctor's evaluation, the distal bowel tract was normal. exclusion criteria: * pregnancy, child, psychiatric disorder, behavior disorder, and prisoner. and those patients can't follow the protocol
treatment of headache disorders with acupuncture: observational study: observational study (hdacu)

Conditions: Chronic Headache Disorder

Summary: headache disorders (hds), which are characterized by recurrent headache, constitute a public-health problem of enormous proportions, with an impact on both the individual sufferer and society. the stated goals of long-term headache treatment are to reduce the frequency, severity, and disability associated with acute attacks; decrease the reliance on poorly tolerated, ineffective, or unwanted acute pharmacotherapies; and avoid acute headache medication escalation. there is risk for adverse events, leading some patients to refuse prophylactic therapy. acupuncture is widely used for the treatment of headaches and it may be applied as a single modality as well as part of a more complex treatment program. the objective of this study will be to investigate whether acupuncture in routine clinical practice ((real world data) is more effective than treatment of acute migraine attacks or routine care only in reducing headache frequency.

a cochrane systematic review published in 2016 concluded that acupuncture was at least as effective as, or possibly more effective than, preventive drug treatment for migraine prophylaxis with fewer side effects compared with conventional treatments . cochrane reviews of tension-type headache conclude that acupuncture could be a valuable non-pharmacological tool in patients with frequent, episodic, and chronic tension-type headache. an observational, cross-sectional study, according to the strobe guide, was conducted. the study was carried out in the pain service unit of the son llàtzer university hospital of palma de mallorca, spain. between january 2010 and december 2015, data from patients with chronic refractory headache, which did not respond to conventional treatment for at least 6 months, referred to the pain service unit were examined to ascertain their eligibility.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of headache (\> 12 months) and at least two headaches per month (physicians classified patients according to the criteria of the international headache society to differentiate between patients with, tension-type headache, trigeminal autonomic cephalgias (cluster headache and horton's headache), trigeminal neuralgia, occipital neuralgia, cervicogenic headache and post-surgery headache). * age ≥ 18 years. exclusion criteria: * headache caused by somatic diseases such as hypertension, meningioma or meningoencephalitis * onset of headache less than 1-year before. * acupuncture treatment less than 1-year before

Keywords: acupuncture migraine tension-type headache
percutaneous vertebroplasty versus conservative treatment of pain

Conditions: Pain; Osteoporosis; Fracture

Summary: the purpose of this study is to compare the effect of vertebroplasty with that of traditional medical treatment in the treatment of painful vertebral fractures in osteoporotic patients.

in vertebroplasty a bone cement is injected in one or more fractured vertebra. the indication is pain that needs high doses of analgesics. the cement is a well known product called poly methyl metacrylate (pmma) normally used fixate joint prosthesis. vertebroplasty is done in local anaesthesia. the treatment was introduced in 1984 in france and today thousands of patients have been treated worldwide, but so far no randomized controlled trials have been published.

Eligibility criteria:
inclusion criteria: * new pain in spine (within 6 months) * x-ray verified low energy spinal fracture(s) exclusion criteria: * less than 20% or more than 90% reduction of the vertebral height * lack of pain at fracture level * no need for continuous analgesic treatment * patient no able to communicate * general anaesthesia contraindicated * mri not possible * coagulopathy (not adjustable) * spondylitis * discitis * spinal metastasis

Keywords: osteoporosis vertebra fracture pain percutaneous vertebroplasty polymethylmetacrylate
acute exercise type and cognitive function: an event-related potential study

Conditions: Exercise Training; Neurocognitive Function

Summary: this study aims to examine the effects of different types of acute exercise on cognitive functions in healthy adults.

acute exercise, a single session of exercise, has been shown to enhance cognitive functions. the meta-analysis research has suggested that such benefits might depend upon the types of exercise. however, the predominant types of exercise examined within this area of research are aerobic and resistance exercises. the effects of other types of exercises on cognitive functions are poorly understood. accordingly, this study is going to examine the effects of different types of acute exercise \[i.e., aerobic exercise (ae), aerobic exercise with virtual reality (ae-vr), and combined exercise (ce)\] on cognitive functions. 140-180 healthy young adults will be recruited and then randomly assigned to the ae, ae-vr, ce, and control groups for a 35-minute intervention. cardiovascular fitness will be assessed beforehand. additionally, stroop tasks and several questionnaires will be conducted before and after the intervention. the targeted primary outcomes are changes in cognitive behavior performance (assessed by the stroop tasks) and neuroelectrical indices (e.g., p3 of event-related potential). the secondary outcomes are the changes in exercise enjoyment, motivation, and emotion.

Eligibility criteria:
inclusion criteria: * no major psychiatric illness or physical disease * able to do 30-minutes moderate exercise * normal or corrected-to-normal vision * right-handed * moderate exercise ≤ 150 min/week exclusion criteria: * any neurological, respiratory, vascular, metabolic, or brain-relative disease * any physical limitation or injury * any wounds on the scalp * have experience of using technology products * regular engagement in exercise training programs

Keywords: virtual reality multi-domain exercise executive function inhibitory control