Kornimate/medical-research-clean huggingface dataset:
safety study of rabies vaccine indirab® five doses (0.5ml) post exposure administered intramuscularly

Conditions: Rabies

Summary: an open label, non-comparative bridging study to evaluate the safety of rabies vaccine indirab® in healthy vietnamese volunteer aged from 5 years old.

the trial is a bridging study to evaluate safety of rabies vaccine indirab® five doses (0.5 ml) post exposure administered intramuscularly in healthy vietnamese volunteer aged from 5 years old. 120 subjects will be enrolled in cho gao district, tien giang province, in which there are 100 adults (≥15 years old) and 20 children (5-\<15 years old). these subjects will be received 5 doses (0.5ml) indirab® on d0, 3, 7, 14 and 28. the frequency, rate and severity of immediate adverse events (ae) within 30 minutes after vaccination, solicited and unsolicited ae within 7 days after each vaccination, the frequency and rate of serious adverse events (sae) within 35 days after the first vaccination will be recorded as evidences for indirab® safety assessment. the subjects to be included from this trial would be representative of the population of vietnam. the protocol has been reviewed and approved by institutional review board of pasteur institute in ho chi minh city and vietnam ministry of health - independent ethics committee and vietnam minister of health.

Eligibility criteria:
inclusion criteria: 1. healthy male or female aged from 5 years old. women of childbearing age must use an appropriate method of contraception. 2. subjects had sign written consent form to participate in the study. with subjects aged from 5 to below 18 years old, parents/legal representative had sign written consent form for children to participate in this study. 3. subject who gave voluntary to comply with the study requirements. exclusion criteria: 1. subjects have atopic allergy or severe allergy to any component of vaccine. 2. subjects with mental illness, mental retardation. 3. subjects with severe acute or chronic disease may affect safety (eg: hepatobiliary disease, kidney disease, diabetes, hypertension...). 4. subjects received rabies vaccine. 5. subjects with hemophilia or receiving a treatment with an anticoagulant, who are at increased risk of serious bleeding during intramuscular injection. 6. subjects who received other vaccine within 28 days before indirab® vaccination, or those who had another vaccination schedule during the study. 7. pregnant or lactating women. 8. subjects had been participated, are participating, are going to participate in any other clinical trials during the period of this study.

Keywords: rabies vaccine safety indirab vietnam
effects of stoss therapy of vitamin d3 on peri-operative outcomes in patients receiving general surgery

Conditions: Vitamin D Deficiency; Surgery

Summary: to investigate whether preoperative supplement with high-dose vitamin d3 can reduce the perioperative risk and enhance recovery

perioperative management for risk reduction in patients undergoing major surgery are taken increasingly important nowadays. the patient factor (age and comorbidities mainly), type of surgery and extent of tissue injury are major contributions to the development perioperative complications. from nutrition support to nutrition therapy, a comprehensive nutrition plays a pivotal role to optimize the above three key factors and hence reduce the perioperative risk. vitamin d, a pleiotropic hormone with extensive physiological effect, is one of the nutrients critical to perioperative outcomes. it not only meets the essential demand of surgical patients, such as wound care, infection control, metabolic support and organ support, but also attenuates oxidative stress, modulates dys-inflammation and repair the damaged organelles like telomere and mitochondria. this is a double-blind, randomized controlled trial in a single center. sixty eligible adult patients who will undergo general surgery are to be included. the experimental group will receive 576000 iu in single oral dose of liquid vitamin d 3\~7 days prior to the surgery. the primary endpoint is rapid recovery index, such as bowel recovery, pain control, sedation and fatigue assessment. the secondary endpoints include perioperative inflammatory indexes, hemodynamic parameters, glycemic control as well as safety evaluation of vitamin d.

Eligibility criteria:
inclusion criteria: * 20 years or older * adult patients who will receive general surgery exclusion criteria: * chronic liver diseases * hypercalcemia * using estrogen drug, bisphosphonate, other durgs to treat bone diseases * sarcoidosis, multiple myeloma or primary hyperparathyroidism * pregnant women * other trial participation
dopamine and muscle function in the heat

Conditions: Muscle Force; Hyperthermia

Summary: our goal is to study the effects of dopamine activity, using ritalin ingestion, on neuromuscular function over the course of a progressive heating and cooling protocol developed in our lab. we hypothesize that ritalin will minimize the previously reported progressive impairment in neuromuscular function with hyperthermia compared to placebo, suggesting that dopamine activity preserves neuromuscular capacity with hyperthermia.

increased core temperature (hyperthermia) has been associated with impaired neuromuscular performance, with the majority of research suggesting that the observed fatigue is related to the central nervous system. small doses of ritalin has been used to study how changes in dopamine activity affects exercise capacity in the heat. this study found that 20 mg of ritalin had no effect on exercise capacity in a thermoneutral environment of 18°c. however, when in a hot (30°c) environment, the ritalin resulted in a 16% improvement in finishing time compared to the placebo trial. interestingly, the higher output during the ritalin-hot condition also resulted in higher rates of heat production and a higher (\~0.6°c) core temperature, suggesting that dopamine enabled greater voluntary tolerance of hyperthermia. this matches recent work from our own work showing that motivational skills training increased both exercise tolerance and final core temperature, and it is possible that dopamine activity played a role in this improvement. ultimately, fatigue is shown in an inability to sustain muscular force. however, the role of dopamine activity on neuromuscular function (e.g., central activation and recruitment of muscle) during hyperthermia is unknown. one study reported that 20 mg of ritalin did not alter neuromuscular function, but this study was done without thermal stress. therefore, our goal is to study the effects of dopamine activity, using ritalin ingestion, on neuromuscular function over the course of a progressive heating and cooling protocol developed in our lab. we hypothesize that ritalin will minimize the previously reported progressive impairment in neuromuscular function with hyperthermia (5, 7) compared to placebo, suggesting that dopamine activity preserves neuromuscular capacity with hyperthermia.

Eligibility criteria:
inclusion criteria: * high aerobic fitness (\>55 ml/kg/min maximal aerobic capacity) exclusion criteria: * diagnosed cardiovascular, respiratory and/or neuromuscular disease, prescription of ritalin or any drugs for hyperactivity within the past 1 year, any current prescription medication (except for asthma/allergy inhalers), any contraindications to ritalin.
fluorescence guided surgery in breast cancer

Conditions: Breast Cancer

Summary: a need for further investigation for fluorescence image-guided surgery in breast conserving surgery (bcs) has arisen following the results obtained from a phase i feasibility breast cancer trial (birdye study: abr nl 37479.042011). the aim of this study is to define the optimal dose of the fluorescent tracer bevacizumab-irdye800cw for intraoperative delineation of breast cancer tissue using the improved and optimized fluorescent tracer and camera system.


Eligibility criteria:
main inclusion criteria: 1. females aged ≥ 18 years. 2. confirmed diagnosis of breast cancer by means of histology or cytology and eligible for breast cancer surgery. 3. tumor size ≥ 5 mm (0, 5 cm) diameter according to anatomical imaging data. 4. who performance score 0-2. 5. life expectancy greater than 12 weeks 6. written informed consent has been obtained 7. in the investigator's opinion, patient is able and willing to comply with all trial requirements. for female subjects who are of childbearing potential, are premenopausal with intact reproductive organs or are less than 2 years post-menopausal: 8. a negative serum pregnancy test prior to receiving the second generation tracer 9. willing to ensure that she or her partner uses effective contraception during the trial and for 3 months thereafter. main exclusion criteria: 1. medical or psychiatric conditions that compromise the patient's ability to give informed consent 2. breast prosthesis in the target breast 3. history of infusion reactions to bevacizumab or other monoclonal antibody therapies 4. concurrent anticancer therapy (chemotherapy, radiotherapy, vaccines, immunotherapy) delivered within the last 6 weeks prior to the start of the treatment 5. significant renal or hepatic impairment. 6. inadequately controlled hypertension with or without current antihypertensive medications. 7. history of myocardial infarction, transient ischemic attack, cerebro vascular accident, pulmonary embolism, uncontrolled congestive heart failure (chf), significant liver disease, unstable angina within 6 months prior to enrollment. 8. patients receiving anticoagulant therapy with vitamin k antagonists. 9. patients receiving class ia (e.g. quinidine) or class iii (e.g. dofetilide, amiodarone, sotalol) antiarrhythmic agents. 10. evidence of qt prolongation on pre-treatment ecg (males \>440 ms, females \>450 ms). 11. magnesium, potassium and calcium levels below lower normal limit which is regarded clinically relevant with regards to study participation.

Keywords: breast cancer image-guided surgery
plasma glp1 and acute myocardial infarction undergoing percutaneous coronary intervention

Conditions: Coronary Angiography; Glucagon-Like Peptide 1

Summary: the purpose of this study is to evaluate the predicting role of plasma glp1 level on major adverse cardiovascular events (mace) in patients with acute myocardial infarction who undergo percutaneous coronary intervention.

acute myocardial infarction (ami) is associated with high mortality and its prognosis differed among patients. primary percutaneous coronary intervention (ppci) is an effective method to treat ami. to accurately predict adverse outcomes following ppci in patients with ami will help doctors develop precise therapeutic strategy in advance. at present how to predict adverse events before ppci is still controversial. in our previous studies, the investigators found that glucagon like peptide -1 (glp-1) can improve cardiac function in patients with ami after pci, other studies have reported that plasma glp-1 levels is negatively correlated with ck-mb in patients with ami, but the relationship between plasma glp1 and prognosis of ami patients after pci has not been reported, the investigators hypothesized that plasma levels of glp1 is associated with major adverse cardiovascular events (mace) after ppci. the investigators planned to evaluate the predicting role of plasma glp1 level on major adverse cardiovascular events (mace) in patients with acute myocardial infarction who undergo percutaneous coronary intervention.

Eligibility criteria:
inclusion criteria: * patients were eligible if they were 18 years or older and presented within 12 h from the onset of symptoms and signs of acute myocardial infarction to the catheterization laboratory. exclusion criteria: * taking drugs of glp-1 analogue and dpp4 inhibitor * cancer patients
evaluation of south africa's national adherence strategy

Conditions: HIV; Tuberculosis; Diabetes; Hypertension

Summary: note that the study is led by south africa national department of health and world bank with support from boston university. the south africa national department of health (ndoh) intends to launch its newly developed national adherence guidelines for chronic diseases (hiv, tb and ncds) throughout south africa in the coming year. early implementation of the "minimum package" of interventions described in the adherence guidelines for hiv patients will take place at 12 primary health clinics and community health centres in four provinces starting in july 2015. to maximize the learning potential of this early implementation stage, ndoh will match the intervention clinics with 12 comparison clinics and randomly allocate intervention or comparison status within the pairs of clinics. this will allow the outcomes of the interventions to be evaluated using a cluster-randomized design and generate data on the costs of implementation and the potential need for adherence support for the other diseases addressed in the guidelines (tuberculosis, hypertension, and diabetes). this protocol is for the evaluation, which will generate information on the effectiveness of minimum package interventions and help improve the design, implementation, and budgeting of the guidelines.

the study will assess the effectiveness of five interventions in the minimum package: 1) fast track initiation counseling for patients eligible for antiretroviral therapy; 2) enhanced adherence counseling for unstable patients on hiv treatment; 3) adherence clubs for stable patients on hiv treatment; 4) decentralized medication delivery for stable patients on hiv treatment; and 5) early tracing of all patients who miss an appointment by two weeks. this study will also estimate for each study site an overall "adherence guideline impact" to provide an indication of the effectiveness of the package as a whole. in addition, the study will estimate the cost of each of the interventions listed above compared to standard of care. finally, the study will describe the cascade of care for tuberculosis, hypertension, and diabetes, three other chronic diseases for which little information currently exists. to evaluate these interventions the study team will work with the national department of health (which will implement the interventions) to randomize 24 clinics in 4 provinces 1:1 to receive the interventions or continue standard of care. all evaluations will use data routinely collected by the clinics, with no study interaction with subjects. a total of 8,256 patients will be enrolled and followed for up to 20 months to estimate short- and long-term outcomes.

Eligibility criteria:
inclusion criteria: * ≥ 18 years old * meet the inclusion criteria for one or more intervention * not resident in the facility's catchment area * recorded intention to transfer care to a different facility within 12 months exclusion criteria: * pregnant and eligible for pmtct

Keywords: medication adherence art counseling adherence guidelines for chronic diseases (hiv, tb and ncds)
outcome of low energy ankle fractures

Conditions: Ankle Fractures

Summary: ankle fractures are among the most common osseous injuries to the lower extremity, and remain a significant source of morbidity for both the young and the elderly. recent cross-national studies have shown a significant increase in the incidence and severity of ankle fractures among the elderly population.


Eligibility criteria:
inclusion criteria: - all types of trumatic ankle fractures due to low energy amenable to surgical open reduction and internal fixation . exclusion criteria: * previous surgery. * disorders of bone metabolism other than osteoprosis (ie, paget disease , renal osteodystrophy , osteomalacia ) * patient with moderate or severe congnitive impairment or patients with parkinson disease or dementia
comparative study on acute pain evaluation between spanish and french hospital emergency unit

Conditions: Pain; EMERGENCY MEDICINE

Summary: today, pain is a difficult affordable subject in spain. there are however 187 units of pain care with a consultations rate in emergency center of more than 60%.for example oxycodone(opioid analgesic)is widely used while it's under used in spain. in the same way meopa(kalinox) is a new approach of pain care daily used as well in france (for example in dislocated shoulder pain, or ulceration care...etc) there are lots of studies relative to chronic pain but not too much about acute pain in spain.that's why we want to focus our study on evaluation of acute pain treatment and efficacy in french and spanish hospital


Eligibility criteria:
inclusion criteria: * patient admitted in emergency center for acute pain. * patient who accept to participate. exclusion criteria: * refusal of patient to participate
use of the french healthcare insurance database

Conditions: Cirrhosis

Summary: hepatocellular carcinoma (hcc) has become the second most common cause of cancer death in the world, estimated responsible for nearly 745,000 deaths in 2012 (9.1% of all cancer deaths).

hepatocellular carcinoma (hcc) has become the second most common cause of cancer death in the world, estimated responsible for nearly 745,000 deaths in 2012 (9.1% of all cancer deaths). this cancer is closely associated with the presence of chronic liver underlying disease and early diagnosis following a systematic surveillance of cirrhotic patients could improve disease-free survival in patients declaring hcc. however, the risk-benefit ratio of such monitoring is discussed. nevertheless, it is recommended in patients with liver cirrhosis, from which the prevalence is estimated between 0.3% and 0.6% in the french population. this debate can lead to a failure to comply with recommendations and promote a large variability in the management of the surveillance of hcc in patients with cirrhosis in practice. data acquisition regarding the current situation in france is required. the objective of this project is to use this database to document current practices concerning monitoring of incidents hcc in cirrhotic patients in france. a retrospective cohort study will be conducted on data from sniiram recorded between 2007 and 2015. the primary analysis will focus on multivariate modelling of the deviation rate from the recommendations (advising the realisation of at least two echodoppler ultrasonographies yearly) with a competitive risk model, taking into account gender, social status, charlson index, age at baseline, the alcoholic etiology of cirrhosis, type of facility and the yearly number of visits to a hepatologist during follow-up. it is estimated that more than 86,000 patients with a minimum follow-up of 3 years will be included in the analysis

Eligibility criteria:
inclusion criteria: - cirrhotic patients aged between 18 and 75 years. (a cirrhotic patient will be defined as a presenting a first occurrence of a codes used in hospitalisation for cirrhosis or as a motive for granting an ald 6 (cirrhosis motivated) financial support ) exclusion criteria: - none

Keywords: oncology hepatology public health liver
effects of the mediterranean diet during pregnancy on the onset of allergies in the offspring

Conditions: Allergies; Obesity; Gestational Complications; Gestational Weight Gain; Perinatal Condition; Birth Weight; Chronic Diseases in Children; Breast Feeding

Summary: allergy prevalence is increasing steadily with some describing as the "epidemic of the twenty-first century". maternal diet during pregnancy has been linked to offspring allergy risk, so it represents a potential target for allergy prevention. the mediterranean diet (md) is considered one of the healthiest dietary models which exerts regulatory effects on immune system, due to the synergistic and interactive combinations of nutrients. we aim to study the effects of md in pregnancy on the onset of allergic diseases at 2 years of age in the offspring.


Eligibility criteria:
inclusion criteria: - healthy women (aged 20-35 years), at first trimester of pregnancy, of at risk for atopy baby exclusion criteria: * concomitant presence of infections; * concomitant presence of malignancies; * concomitant presence of major gastrointestinal malformations; * concomitant presence of immunodeficiencies; * concomitant presence of autoimmune diseases; * concomitant presence of chronic inflammatory bowel diseases; * concomitant presence of functional gastrointestinal disorders; * concomitant presence of celiac disease; * history of abdominal surgery with gastrointestinal resection; * concomitant presence of neuropsychiatric disorders; * concomitant presence of central nervous system disorders; * vegan diet; * twin pregnancy; * concomitant presence of genetic disorders; * concomitant presence of metabolic disorders.
usefulness of therapy monitoring by means of [(18)f]fluoroethyltyrosine-positron emission tomography (fet-pet) in glioblastoma multiforme patients

Conditions: Glioblastoma Multiforme

Summary: the aim of this study is to establish fet-pet as an additional therapy assessment parameter in patients diagnosed with a glioblastoma multiforme receiving radiochemotherapy and adjuvant chemotherapy after previous resection or biopsy.


Eligibility criteria:
inclusion criteria: * neuroradiologically suspected glioblastoma multiforme * histological verification will be obtained either by microsurgery or by stereotactic biopsy. the neuropathological diagnosis will be verified by a reference neuropathologist * patients will undergo radiochemotherapy subsequent to surgical procedure * patients older than 18 years * karnofsky performance score \>=70 * pregnant or nursing female patients will not be included in this study * safe contraceptive methods during the radiochemotherapy and chemotherapy exclusion criteria: * patients in whom informed consent cannot be obtained due to organic brain syndrome or insufficient language skills * patients who cannot lie quiet for a time period of app. two hours during the fet-pet scan * medical history of a metastatic brain disease * patients in whom an mri scan cannot be performed due to claustrophobia metallic protheses or pacemakers etc.

Keywords: glioblastoma multiforme microsurgery stereotactic biopsy radiochemotherapy temodar fet pet molecular imaging
effect of pre-emptive transcutaneous neuro-muscular electrical stimulation for dysphagia in long term intubated patients

Conditions: Deglutition Disorder

Summary: it was well known that long term intubation caused a various kind of abnormal presentations of dysphagia such as the increased aspiration risk, the decreased gag reflex, mucosal pathology, the airway stenosis and so on. it was thought that the freezing and impaired proprioception to be developed as a result of dis-use around the pharynx and the larynx while intubation was one of the reason. preemptive swallowing manual stimulation applied on the oral cavity to avoid the vicious cycle of dis-use was reported to improve dysphagia after extubation. neuromuscular electrical stimulation have been utilized for a wide variety of dysphagia of multiple causes of neuro-muscular disorder. supposing that preemptive transcutaneous neuromuscular electrical stimulation to be delivered to the muscles of being involved in swallowing could decrease the degree of dis-use during intubation so that it could reduce the occurence and severity of dysphagia developed after extubation, the investigators plan to perform randomized prospective double blind placebo controlled clinical interventional study.


Eligibility criteria:
inclusion criteria: * patients to be admitted to the icu due to the respiratory failure and intubated for at least 48 hours exclusion criteria: * past history of intubation * past history or current status of traumatic brain injury * past history or current status of symptomatic stroke * past history or current status of injury of cranial nerves * past history or current status of neuromuscular disorder * patient not to be expected to be extubated * patient to reject the participation * current usage of neuro-muscular blockers

Keywords: intubation electric stimulation deglutition disorder