Kornimate/medical-research-clean huggingface dataset:
accu-chek® aviva expert study: does use of a bolus advisor improve glycemic control in patients not achieving optimal control using multiple daily injections (mdi)?

Conditions: Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2

Summary: this clinical, prospective, randomized, multi-center study determined if the use of an insulin bolus advisor improves glycemic control as measured by a change in hba1c in patients failing multiple daily injection/intensified conventional therapy (mdi/ict).

eligible participants were randomized to 24 weeks multiple daily injection therapy using either the accu-chek® aviva expert blood glucose meter with an integrated bolus advisor or the accu-chek® aviva nano blood glucose meter and manual bolus calculation.

Eligibility criteria:
inclusion criteria: * must be 18 years of age or older. * diagnosed with type 1 or type 2 diabetes. * recent hba1c \> 7.5% (measured within the last 6 weeks at local laboratory). * on multiple daily injection (mdi) therapy for at least 6 months consisting of 1-2 injections per day of long-acting basal insulin (lantus® or detemir®) and at least 2 injections per day of regular or rapid-acting analog insulin for meal coverage. * subject adjusts meal insulin doses based on carbohydrate content of meals. * subject with type 2 diabetes may be on stable metformin therapy (therapy unchanged during 3 months prior to study). * subject has been in investigator's practice for at least 3 months but may have been seen by another physician in the practice. * subject has completed carbohydrate (cho) training within the last 2 years. exclusion criteria: * subject is on a therapy regimen that conflicts with the study: * neutral protamine hagedorn (nph) or pre-mixed insulin; * oral anti-diabetic agents, with the exception of metformin; * injectable anti-diabetic agents other than long-acting insulin and rapid-acting insulin analogs or regular insulin (eg, fixed dose therapy); * use of sliding scale insulin therapy that determines insulin dosages based exclusively on specific blood glucose (bg) results. * subject has participated in another interventional trial within 6 weeks prior to study. * subject has been diagnosed with any clinically significant infectious disease or major organ system disease, such as gastroparesis or renal disease (at investigator's discretion). * subject has used systemic oral or inhaled steroids for more than 7 days within the last 3 months. * subject is on chemotherapy or radiation therapy (self-reported). * subject is pregnant or lactating or is currently planning a pregnancy.
safety of an inactivated enterovirus type 71 vaccines in healthy children

Conditions: Hand-foot-mouth Disease; Infection; Viral, Enterovirus

Summary: a phase i clinical trialto evaluate the safety of an inactivated enterovirus type 71 vaccine in healthy children (3-11y) and infants (6-35m).

36 eligible children aged from 3 to 11 years and 96 eligible infants aged from 6 to 35 months will be enrolled in the study, they will be randomized to receive different dosage of vaccine candidate or placebo to evaluate the safety of this vaccine

Eligibility criteria:
inclusion criteria: 1. healthy males and females, aged from 6 months to 11 years old health is determined by medical history, physical examination, laboratory examination and clinical judgment of the investigator 2. provided legal identification for the sake of recruitment. 3. subjects and/or parent(s)/legal guardian(s) are able to understand and sign informed consents. 4. birth weight more than 2500 grams exclusion criteria: 1. histroy of hand-foot-mouth disease 2. subject that has allergic history of vaccine, or allergic to any ingredient of vaccine 3. serious adverse reactions to vaccines such as anaphylaxis, hives, respiratory difficulty, angioedema, or abdominal pain 4. congenital malformations or developmental disorders, genetic defects, or severe malnutrition 5. epilepsy, seizures or convulsions history, or family history of mental illness 6. autoimmune disease or immunodeficiency, or parents, brothers and sisters have autoimmune diseases or immunodeficiency 7. history of asthma, angioedema, diabetes or malignancy 8. history of thyroidectomy or thyroid disease that required medication within the past 12 months 9. bleeding disorder diagnosed by a doctor (e.g. factor deficiency, coagulopathy, or platelet disorder requiring special precautions) or significant bruising or bleeding difficulties with im injections or blood draws 10. asplenia, functional asplenia or any condition resulting in the absence or removal the spleen 11. acute illness or acute exacerbation of chronic disease within the past 7 days 12. any history of immunosuppressive medications or cytotoxic medications or inhaled corticosteroids within the past six months (with the exception of corticosteroid nasal spray for allergic rhinitis or topical corticosteroids for an acute uncomplicated dermatitis) 13. history of any blood products within 3 months 14. administration of any live attenuated vaccine within 28 days 15. administration of subunit or inactivated vaccines ,e.g., pneumococcal vaccine, or allergy treatment within 14 days 16. axillary temperature \> 37.0 centigrade before vaccination 17. abnormal laboratory parameters before vaccination 18. any medical, psychiatric, social condition, occupational reason or other responsibility that, in the judgment of the investigator, is a contraindication to protocol participation or impairs a volunteer's ability to give informed consent
the effect of topical application of tranexamic acid in total hip arthroplasty through the direct anterior approach

Conditions: Total Hip Arthroplasty; Postoperative Blood Loss

Summary: the effects of topical application of 3g tranexamic acid for 2 hours prior to opening of the suction drain following a total hip replacement


Eligibility criteria:
inclusion criteria: * patients who will receive a unilateral total hip arthroplasty exclusion criteria: * coagulopathy * allergy to tranexamic acid * preoperative anemia (a hemoglobin value of \< 11g/dl in females and \< 12g/dl in males) * fibrinolytic disorders * a history of arterial or venous thromboembolic disease * pregnancy * breastfeeding * major comorbidities

Keywords: total hip arthroplasty tranexamic acid postoperative blood loss
evaluation of the written information delivered by the general practitioner of the patients presenting to the emergency room for an aggravation of asthma

Conditions: Asthma

Summary: asthma is a common pathology (prevalence 6.4% in 2018, in france), currently managed by the general practitioner in general practice. it is a chronic disease at risk of exacerbation, which can lead to the use of care. the treatment of asthma is based on a basic treatment, to be taken every day, the purpose of which is to avoid acute exacerbations and lead a normal life. there is also an emergency treatment, to be taken in case of sudden worsening of the respiratory state. the asthmatic patient is the first actor in his care. he must be able to react in case of emergency. a good knowledge of the disease and its treatment as well as training in self-management of crises are thus fundamental and must be part of its medical care. the existence of an exacerbation represents a criterion of non-control of the disease, thus a failure of the long-term care of the patient. the optimization of this care includes individual issues aimed at improving the quality of life and collective by reducing the avoidable use of care and thus the expenses related to this disease. it relies on therapeutic education sessions as well as the provision of written information, clear and detailed by the doctor. this information consists of the writing of a detailed medication prescription as well as the dispensing of a written action plan. the action plan must describe the actions to be taken by the patient in case of exacerbation of his asthma, to regain control. regarding the format, it can be coupled to the prescription drug (action plan and prescription on the same prescription) or distinct from the prescription drug (a prescription for drugs and a prescription for the action plan). in some countries, "ready-to-use" action plans have been validated by learned societies, which is not the case today in france. in canada, a study demonstrated in 2006 that 46% of asthmatic patients followed in hospital had an action plan, while the national average was estimated at about 10% in 2010. there is little data in france on the proportion of patients with asthma action plans. unlike the action plan, which is little distributed to the patient, the prescription drug for asthma is always given to the patient at the end of the consultation and specifies the procedures for taking treatments. as part of this work, the investigators are interested in evaluating the written information given to the adult asthmatic patient by their general practitioner: the action plan but also the prescription medication.


Eligibility criteria:
inclusion criteria: * patient whose age is ≥ 18 years * asthma patient * emergency patient counselor for ghpsj for management of worsening asthma * patient followed for his asthma in town by a general practitioner * francophone patient exclusion criteria: * patient opposing his participation in the study * patient under tutorship or curatorship * patient deprived of liberty * patient under safeguard of justice
barrett's esophagus patient registry

Conditions: Barrett Esophagus; Esophageal Adenocarcinoma; Gastroesophageal Reflux

Summary: the ultimate goal of the barrett's esophagus patient registry is to help develop more effective targeted screening strategies and treatment options for barrett's esophagus and esophageal adenocarcinoma (eac). we plan to do by developing a registry that will serve as a platform. examples of analyses could include identifying genetic determinants and biomarkers that predict be, progression of be to eac, as well as the response to therapies.


Eligibility criteria:
inclusion criteria: * barrett's (be): patients who have barrett's esophagus (all stages: barrett's metaplasia, low-grade dysplasia, high-grade dysplasia) based upon standard endoscopic and histologic criteria. * adenocarcinoma (eac): patients who have esophageal adenocarcinoma. * the control cohort will include patients ages 18 and older with no prior history of be and eac. these may include patients who are being seen or have been previously seen at mgh gi associates for conditions including gastroesophageal reflux disease, peptic esophagitis, eosinophilic esophagitis, esophageal motility disorders such as achalasia and nutcracker esophagus. exclusion criteria: * inability or unwillingness to provide blood samples. * history of known bleeding disorders. * currently awaiting organ transplantation. * having an acute or severe chronic illness such as congestive heart failure or any other condition that would prohibit performing the endoscopy.
emergency department re-evaluation software pilot study

Conditions: Emergency Department Waiting Room Congestion

Summary: this is a research study to determine a method in improving emergency department waiting room care by using new software program.

this is a pilot study to determine the effectiveness of an emergency department re-evaluation software, to improve patient flow through an emergency department. the end goal of the study is to provide proof of the efficacy of the software and provide data such that the software can be improved upon. the study will include ed waiting room patients. the study will involve interaction with the software on a tablet for patients and software on a desktop for providers. the providers utilizing the software will not be considered part of the study, but rather focusing on the outcomes of the patients using the software. patients will be selected by the provider as available for re-evaluation. each patient will then be randomized into either a control group (software not used) and a "study" group (software used). data analysis will be performed in conjunction with clinical statisticians at our institution. the risks of this study are primarily derived from patient privacy concerns, which have been addressed in the risk section.

Eligibility criteria:
inclusion: * individuals that are 18 and older who have been identified with completed lab work. * their primary language must be english to follow the instructions of the study. * cognitively sound exclusion: * minors * emergency severity index (esi) class 1 patients * individual who cannot legally give consent * pregnant patients * non-english speakers
cumulative blood pressure load and left ventricular mass

Conditions: Arterial Hypertension

Summary: delay in the diagnosis of systemic arterial hypertension (sah) causes morbid hypertensive status with target organ damage (tod). screening and surveillance of sah used to be performed through self-measurement of blood pressure (smbp) or routinary in clinic blood pressure measurement (cbpm). it is essential to determine the correlation between the cumulative blood pressure load through abpm and the left ventricular mass identified by three-dimensional transthoracic ultrasound (3d-tte). we postulate a directly proportional and statistically significant association between cumulative blood pressure load and left ventricular mass (lvm).

delayed diagnosis of sah causes a morbid hypertensive state, with target-organ damage (tod): brain, kidney, and heart. an early diagnosis and proper follow-up of patients with sah prevents and reduces comorbidities associated with tod. screening and follow-up of sah are traditionally performed by routine self-monitoring of blood pressure (hbpm) or clinic blood pressure measurement (cbpm). ambulatory blood pressure monitoring (abpm) consists of measuring bp every fifteen and thirty minutes for twenty-four hours, using a sphygmomanometer adapted to a portable monitor, which led to the recognition of sah phenotypes often not identified through smbp or cbpm. the abpm offers three types of information: a) the mean bp in twenty-four hours, day and night; b) bp variability; and c) cumulative bp load. cumulative bp load is the percentage of bp measurements above 135/85 mmhg. increased lvm is a consequence of chronic hypertension and early sign of tod at the cardiac level. it has been shown that the variability in nocturnal diastolic bp correlates significantly with lvm, independently of mean bp load. it is likely that an elevated bp load according to abpm correlates with higher tob; however, at the moment, there is no standardized value of bp load that allows predicting the increase in the lvm. for this reason, a standardized cut-off of cumulative bp load is helpful for understanding abpm in the screening sah.

Eligibility criteria:
inclusion criteria: * both sex * between 40 and 79 years old. * low or moderate cardiovascular risk according to the 3american heart association (aha) criteria. exclusion criteria: * patients with tod defined as: the history of cerebrovascular event (cvd); chronic kidney disease (ckd) with glomerular filtration rate (gfr) \<30 ml/min/1.73 m2 or under replacement therapy (renal dialysis). * history of chronic liver disease with a child-pugh b or c. * dependence on alcohol or psychotropic drugs. * history of cancer, regardless of stage or time of treatment. * patients who do not wish to participate in this study.

Keywords: ambulatory blood pressure monitoring blood pressure target organ damage left ventricular mass transthoracic echocardiography
shr1701 alone or in combination with shr2554 in relapsed or refractory classical hodgkin lymphoma

Conditions: Relapsed or Refractory Hodgkin Lymphoma

Summary: this is an open-label, phase i/ii dose escalation and expansion trial. the primary objective of dose escalation phase i study is to evaluate the safety and feasibility of shr1701 in patients with relapsed or refractory classical hodgkin lymphoma. the primary objective of open-label, randomized, phase ii study is to assess the antitumor effect of shr1701 alone or in combination with shr2554 in patients with relapsed or refractory classical hodgkin lymphoma.

in phase i study, patients received intravenous shr1701 30-150 mg/kg every 3 weeks. sequential patient groups received the following doses of shr1701: 30 mg/kg, 60 mg/kg, 90 mg/kg, 120 mg/kg, or 150 mg/kg in a 3+3 design with the intention of determining the recommended dose for phase 2. toxicities are graded according to the common terminology criteria for adverse events, version 5.0. in phase ii expansion study, based on the recommended dose of shr1701 from phase i study, patients are treated with shr1701 alone if cr rate is satisfactory, or randomized to shr1701 monotherapy group or shr2554 plus shr1701 combination group to assess the clinical efficacy of shr2554 plus shr1701 combination therapy.

Eligibility criteria:
inclusion criteria: 1. subjects must have histological confirmation of relapsed or refractory hodgkin lymphoma (hl). 2. 12 to 75 years of age. 3. ecog performance of less than 2. 4. life expectancy of at least 3 months. 5. subjects with lymphoma must have at least one measureable lesion \>1 cm as defined by lymphoma response criteria. 6. subjects must have received two or more lines of previous therapy, and must be off therapy for at least 4 weeks prior to day 1. subjects with autologous hematopoietic stem-cell transplantation are eligible which must be more than 3 months. previous treatment with anti-pd-1/pd-l1 antibodies or cytotoxic t lymphocyte associated antigen 4 (ctla-4) inhibitors are allowed, and must be off therapy for at least 4 weeks. 7. subjects must have adequate marrow, live, renal and heart functions. exclusion criteria: 1. subjects with any autoimmune disease or history of syndrome that requires corticosteroids or immunosuppressive medications. 2. serious uncontrolled medical disorders or active infections, pulmonary infection especially. 3. active alimentary tract hemorrhage or history of alimentary tract hemorrhage in 1 month . 4. prior organ allograft. 5. women who are pregnant or breastfeeding. 6. women with a positive pregnancy test on enrollment or prior to investigational product administration. 7. subjects who are compulsorily detained for treatment of either a psychiatric or physical (eg, infectious disease) illness.
effect of intrapulpal injections on the post-endodontic pain

Conditions: Pulpitis - Irreversible

Summary: to achieve painless treatment in patients with a failed primary ianb, supplementary anesthesia has been advised. the majority of the studies evaluating intrapulpal injections have been performed on asymptomatic teeth. very limited research has been dedicated to the evaluation of different variables in intrapulpal injections in patients with symptomatic irreversible pulpitis. the aim of this study was to evaluate postoperative pain after an intrapulpal anesthesia injection given after a failed inferior alveolar nerve block (ianb), in patients with symptomatic irreversible pulpitis. this prospective, randomized, double-blind clinical trial was carried out at the department of conservative dentistry and endodontics, faculty of dentistry, jamia millia islamia. one hundred and eight adult patients, with symptomatic irreversible pulpits in a mandibular first or second molar received an initial ianb with 2% lidocaine. pain during the endodontic treatment was assessed using a visual analog scale (vas). patients experiencing pain on endodontic intervention were randomly allocated to one of the two treatment groups: one group received a supplementary intrapulpal injection while the other received a supplementary intraligamentary injection the presence of postoperative pain was assessed at 1, 2, 3, and 7 days after treatment.


Eligibility criteria:
inclusion criteria: * symptomatic carious exposed mandibular first or second molars. * positive and prolonged response to thermal sensitivity tests and electric pulp tests. * vital coronal pulp on access cavity preparation. * american society of anesthesiologists class i or ii medical history. * ability to understand the use of pain scales. exclusion criteria: * active pain in more than 1 tooth. * teeth with fused roots. * radiographic evidence of an extra root. * large restorations with overhanging margins. * full crowns or deep periodontal pockets. * known allergy or contraindications to any content of the local anesthetic solution or nsaids * history of known or suspected drug abuse. * taking any drugs which could affect the pain perception, e.g, opiods, antidepressants, anticonvulsants, muscle relaxants, anxiolytics, sedatives, nsaids. 23 * pregnant or breastfeeding patients. * patients with asthma, gastric ulcers, and bleeding disorders.
type 1 diabetes autonomic and vascular function

Conditions: Type 1 Diabetes (Juvenile Onset); Type 1 Diabetes; Diabetes, Autoimmune

Summary: the goal of this clinical trial is to investigate the autonomic and vascular function in men and women with type 1 diabetes. the main questions it aims to answer are: 1. patients with type 1 diabetes exhibit attenuated vascular function during steady-state exercise 2. patients with type 1 diabetes have altered autonomic function at rest and during exercise pressor reflex 3. patients with type 1 diabetes have attenuated muscle sympathetic activity

elevated blood glucose levels in individuals with type 1 diabetes can result in both microvascular and macrovascular complications. research conducted by song et al. revealed that children with type 1 diabetes exhibit abnormal cerebral perfusion. additionally, autonomic mechanisms are affected in type 1 diabetes, as indicated in an animal study which demonstrated that the exercise pressor reflex is exaggerated in both male and female rats during the early stages of the disease. however, whether this also occurs in human patients with type 1 diabetes remains unknown. therefore, in this study we are interested in studying the autonomic control of exercise and vascular function in t1dm humans.

Eligibility criteria:
inclusion criteria: * type 1 diabetes or a healthy control exclusion criteria: * bmi \> 40kg/m2 * cancer with current treatment * hiv * smoker cigarettes * are pregnant or breastfeeding

Keywords: autonomic function exercise pressor reflex muscle sympathetic nerve activity reactive hyperemia