Kornimate/medical-research-clean huggingface dataset:
immunogenicity and safety evaluation of different sequential immunization strategies by sabin ipv and bopv in chinese infants

Conditions: Polio

Summary: the purpose of this study is to evaluate the immunogenicity and safety of different sequential immunization strategies by sabin ipv and bopv in chinese infants.


Eligibility criteria:
inclusion criteria: * parent/legal acceptable representative is willing and able to understand the protocol requirements and provide informed consent. * participant is aged ≥ 60 days to ≤ 75 days. * participant without preventive inoculation of polio vaccine and previous history of polio. * subject and parent/guardian able to attend all scheduled visits and comply with all trial procedures. * body temperature ≤ 37.5℃. exclusion criteria: * known allergy to any constituent of the vaccine. * known acute illness, severe chronic disease, acute exacerbation of chronic disease and fever. * known or suspected impairment of immunologic function, or receipt of immunosuppressive therapy or immunoglobulin since birth. * reported the history of allergies, convulsions, epilepsy, mental illness and brain disease and clear serious systemic reaction. * known bleeding disorder. * receipt of the whole blood, blood plasma or immunoglobulin before the trial vaccination. * reported the history of acute illness had need systemic antibiotics or antiviral treatment of infections in the 7 days preceding the trial vaccination. * an acute illness with or without fever (temperature ≥ 38.0℃) in the 3 days preceding enrollment in the trial. * participation in any other intervention clinical trial. * any condition which, in the opinion of the investigator, would pose a health risk to the subject or interfere with the vaccine.

Keywords: immunogenicity safety sabin ipv bopv
effect of sublingual immunotherapy on platlet factor4 level in children

Conditions: Allergic Rhinitis

Summary: better management and improving outcome of children with allergic rhinitis

the prevelance of allergic respiratory diseases has been increased worldwide and affect 1of 5 persons of general population . ards are triggered by exposure to allergen and includes allergic rhinitis with or without conjunctivitis and bronchial asthma. ards are associated with decreased quality of life and increased economic burden . allergen-specific immunotherapy is the only disease modifying therapy preventing the evolution of ar to asthma, and its efficacy has long been known since observations by leonard noon in 1911. allergen immunotherapy for ar is currently considered when showing strongly suggestive symptoms of ar which interfere with daily activities or sleep, and having evidence of ige sensitization to ≥1 clinically relevant allergen . the european academy of allergy and clinical immunology (eaaci) recommends treatmentof children with moderate to severe ar with allergen immunotherapy. it includes sublingual immunotherapy (slit) and subcutaneous immunotherapy (scit).subcutaneous immunotherapy (scit) has been the gold standard, whereas sublingual immunotherapy (slit) has emerged as an effective and safe alternative . sublingual immunotherapy (slit) is the only treatment that regulates the immunological process during development of allergic rhinitis (ar), rather than simply treating symptoms. platelet activation occurs during antigen-induced airway reactions in allergic and asthmatic subjects. raised levels of platelet-derived mediators, such as the platelet factor-4 (pf4), it is observed in plasma and bronchoalveolar lavage fluid of atopic individuals, and has the ability to activate eosinophils, increase expression of fc-igg and fc-ige receptors, and stimulate basophils to release histamine.

Eligibility criteria:
inclusion criteria: * 1. children with moderate to severe allergic rhinitis according to allergic rhinitis and its impact on asthma (aria) guidelines\[9\], which interfere with daily activity or sleep. 2. children aged (6-12) years with clinical history of allergic rhinitis for at least one year. 3. children with allergic rhinitis who failed medical treatment, desire an alternative to pharmacotherapy. 4. sex : male and female. exclusion criteria: - 1. children with chronic lung \& heart diseases as: asthma and anatomical malformation for respiratory system. 2. disorders: gastro esophageal reflux disease, cystic fibrosis and epilepsy. 3.children with chronic drug use: oral or nasal corticosteroids, antiepileptic and immunosuppressive.
ursofalk tablets (500 mg) versus ursofalk capsules (250 mg) in the treatment of primary biliary cirrhosis

Conditions: Primary Biliary Cirrhosis

Summary: the purpose of this study is to compare the efficacy of ursofalk 500 mg tablets versus ursofalk 500 mg capsules in the treatment of primary biliary cirrhosis (pbc).


Eligibility criteria:
inclusion criteria: * negative pregnancy * signed informed consent * histologically proven non-cirrhotic liver disease exclusion criteria: * histologically proven cirrhosis * pbc stage ii+iv * positive hiv serology
effect of dalfampridine (4-ap) on genioglossus muscle activity in healthy adults

Conditions: Sleep Apnea, Obstructive

Summary: in this protocol the investigators will test the effect of dalfampridine (a potassium channel blocker) on genioglossus muscle activity (emg gg) during wakefulness and sleep in healthy control subjects.

two overnight sleep studies, a placebo night and a drug night, will be performed approximately one week apart in random order. the placebo or drug will be administered 3 hours before lights out. at least 10 minutes of quiet wakefulness will be recorded to quantify the subject's awake emg gg activity before the administration of placebo/dalfampridine. emg gg activity will be measured again 10 mins before lights off and during stable nrem and rem sleep (free of arousals and other artifacts). during the second part of the night, the subjects will be connected to a modified continuous positive airway pressure (cpap) machine (pcrit3000, respironics) which can provide a wide range of pressures between 20 and -20 cmh2o in order to modify upper airway pressure and measure change in emg gg as a function of epiglottic pressure (muscle responsiveness).

Eligibility criteria:
inclusion criteria: * healthy control subjects exclusion criteria: * cardiovascular disease other than well controlled hypertension * history of seizures
efficacy & safety of viaderm-hpth(1-34) compared to forteo sc in postmenopausal women with osteoporosis

Conditions: Osteoporosis

Summary: the purpose of this study is to assess the clinical efficacy, safety, and tolerability of viaderm-shpth \[1-34\] transdermal delivery in comparison to subcutaneous injection of rhpth\[1-34\] following 3-month treatment in postmenopausal women with osteoporosis


Eligibility criteria:
main inclusive criteria: * post-menopausal women aged between 55 to 85 years (inclusive) * posterior-anterior lumbar vertebral and/or femoral neck bmd t-score by dxa ≤-2.5 sd. * have normal serum pth, thyroid stimulating hormone (tsh) (only for patients treated with thyroid hormone), and prolactin values. main exclusive criteria: * subjects who have a clinical significant or unstable medical or surgical condition that may preclude safe and complete study participation * current diagnoses of disorders known to affect bone metabolism including hyperthyroidism, hyperparathyroidism, osteomalacia, or paget's disease * prior osteoporosis treatment with fluoride or strontium at any time; or any iv treatment with bisphosphonates in the past or oral bisphosphonate for more than 1 month in the past 24 months prior to randomization. * any condition or disease that may interfere with the ability to have, or to evaluate a dxa scan

Keywords: osteoporosis transdermal hpth(1-34)
colorectal cancer screening intervention in uwpn clinics

Conditions: Colorectal Neoplasia

Summary: the purpose of this study is to determine if a prototype colorectal cancer screening program with the services of a cancer prevention specialist will increase utilization of appropriate colorectal cancer screening tests.

colorectal cancer is the second leading cause of cancer death in the united states. colorectal cancer screening is widely recommended, but generally under-utilized. previous studies have shown that only a minority of people over the age of 50 are screened for colorectal cancer with either fecal occult blood testing or flexible sigmoidoscopy. barriers to screening include patient and provider-related factors. an innovative program to support primary care providers in providing necessary education about colorectal cancer screening, to provide reminders when screening tests are due, and to facilitate requesting and follow-up of screening tests may help address some of these barriers to providing screening services. in this proposal, we will develop and implement a primary care based-colorectal cancer screening program to supplement clinical services provided in a primary care practice network. this network uses an electronic medical record and has established referral patterns for gastrointestinal endoscopy services, radiology, and pathology. in the proposed screening program, we will develop a colorectal cancer screening module to supplement the existing electronic medical record. this module will enable providers to review risk factors for colorectal cancer, prior screening history, and need for future screening in one easily accessible location. the information provided by this module will be supplemented by the services of a cancer prevention specialist. this person will oversee enrollment of patients into the program, provide patient education about colorectal cancer screening, and facilitate ordering or referral for screening or follow-up tests. outcome measures will include utilization of screening rates, patient knowledge about screening tests, and provider acceptance of the program. if successful, this program may be useful to other large primary care practices, and may also help to improve utilization of other types of cancer prevention services.

Eligibility criteria:
inclusion criteria: * age 50 years and over, enrolled for medical care in the uwpn clinics exclusion criteria: * primary care physicians feel they would not benefit from colorectal cancer screening, unwilling or unable to complete study procedures

Keywords: colorectal cancer mass screening
the natural history of small airways physiology in diseased and healthy states

Conditions: Asthma; COPD; Interstitial Lung Disease; Cystic Fibrosis; Patients Requiring Lung Transplant

Summary: spirometry is a useful clinical tool for the assessment and monitoring of lung disease, however, it does not provide information on peripheral airways resistance. on the contrary, impulse oscillometry (ios) may provide information not only on airway resistance (rrs) but also on the elastic properties of the lung (xrs). in addition, multiple breath nitrogen washout (mbnw) utilizes the exhalation of nitrogen gas from the airways to determine changes in lung ventilation and derive small airways indices (that tells us about small airways calibre). this method, like ios, allows a precise assessment of small airways function. even though patients with asthma may show some reduction of the caliber of the small airways these changes are more a feature of patients with copd. the study team hypothesize that ios and mbnw measurements may detect these differences and provide different resistance profiles for asthma and copd. furthermore, the study team would like to investigate the relationship between airway inflammation and small airway disease by measuring exhaled nitric oxide (no) at multiple exhalation flow rates. this technique allows the partitioning of no produced in the central airways from that generated more peripherally in the lung, providing valuable information on the activity of inflammation in different parts of the respiratory system. the study team hope that the combined use of ios, mbnw and no will identify a possible correlation between inflammation and small airway dysfunction.

background the main objective of this study is to measure the damage of the small airways in lung disease exploring the "silent zone" with methods that have not been used before together in the same patients. furthermore, because this is a 4 year longitudinal study, the study team will investigate the time related changes of small airway function in lung disease and normal healthy subjects. the study will also investigate the relationship between small airway resistance and inflammation.

Eligibility criteria:
inclusion criteria: * male or female, aged between 18-85 years; * volunteers who are able to give written informed consent patients meeting the diagnostic criteria for asthma, copd, ild, cf, chronic cough. exclusion criteria: * upper respiratory tract infection within the previous 28 days * any history or evidence of renal, cardiovascular, gastrointestinal or hepatic disease * any history and evidence of neuropsychiatric disease * treatment with antibiotics within 4 weeks prior to the study * alcohol, drug abuse or any other condition associated with poor compliance * breast feeding * pregnancy * are unable to provide written informed consent

Keywords: resistance reactance inflammation lung function respiratory function
cu programme of idarucizumab for japanese patients

Conditions: Hemorrhage

Summary: the objective is to collect the safety data of idarucizumab for patients treated with dabigatran who require rapid reversal of the anticoagulant effects of dabigatran in cases of uncontrolled or life-threatening bleeding or when emergency surgery or urgent procedures are required.


Eligibility criteria:
inclusion criteria: * currently taking dabigatran etexilate. * age \>= 20 years at entry. * written informed consent * group a: -- uncontrolled or life-threatening judged by the physician to require a reversal agent. * group b: * a condition requiring emergency surgery or invasive procedure where adequate hemostasis is required. emergency is defined as within the following 8 hours. exclusion criteria: * contraindications to study medication including known hypersensitivity to the drug or its excipients (subjects with hereditary fructose intolerance may react to sorbitol). * group a: * patients with minor bleeding (e.g. epistaxis, hematuria) who can be managed with standard supportive care. * patients with no clinical signs of bleeding. * group b: * surgery or procedure which is elective or where the risk of uncontrolled or unmanageable bleeding is low.
the effect of lactate clearance oriented haemodynamic therapy on the outcome of patients with septic shock

Conditions: Septic Shock

Summary: the purpose of this study is to explore and assess possible outcome benefits of lactate clearance\>30% vs scvo2 ≥70% in 6 hours as the protocol goal that evaluated adequacy of during early resuscitation of septic shock through a single-center randomized controlled study. the investigators anticipate to collect 300-400 qualified patients with septic shock who were selected from critically ill patients admitted to the department of critical care medicine. the participants can be randomized divided into lactate clearance group and scvo2 group. the investigators compared the treatment and the relevant parameters changed after different target. 28-day mortality, icu and hospital lengths of stay, ventilator-free days, and new emerged organ failure were collected and compared. 28-day survival curves were drew between these two group. and the adverse events of the treatment have also been compared. through this study, the investigators want to answer that whether lactate clearance-oriented therapy can reduce the mortality in patients with septic shock, compared with scvo2-oriented protocolised therapy.


Eligibility criteria:
inclusion criteria: * patients with septic shock were assessed for inclusion, which required that patients be older than 18 years with confirmed or presumed infection, met two or more criteria for systemic inflammatory response syndrome \[16\], and evidence of refractory hypotension or a serum lactate level above 4 mmol per liter. * refractory hypotension was defined as a systolic blood pressure lower than 90 mm hg, or a mean arterial pressure of less than 65 mm hg , after an intravenous fluid challenge of 20 ml or more per kilogram of body weight. * patients had to be enrolled in the study within 2 hours after the earliest detection of septic shock and within 12 hours after arrival icu. exclusion criteria: * the patients were excluded if they meet any one of follows: an age of less than 18 years, pregnancy, an acute cerebral vascular event (glasgow coma score \< 5), acute myocardial infarction or acute coronary syndrome, massive pulmonary embolism, status asthmaticus, a primary diagnosed cardiac dysrhythmias, contraindication to central venous catheterization, active gastrointestinal hemorrhage, massive intra abdominal infective focus without drainage, severe bronchopleural fistula, seizure, during chemotherapy or immunosuppressive therapy, or end stage of the diseases.

Keywords: lactate clearance systemic central venous oxygen saturation septic shock haemodynamic therapy
improving blood glucose control with a computerized decision support tool: phase 1

Conditions: Critically Ill; Hyperglycemia

Summary: the purpose of this study is to: 1. refine and validate a computerized bedside decision support tool blood glucose management in critically ill adult and pediatric icu patients. 2. monitor how often low blood sugar levels occur during use of the bedside tool. 3. determine how the computerized tool effects the workload of the icu nurses.

this first phase will be a prospective cohort study. we will validate the bedside tool in at least 4 adult and at least 4 pediatric icus and if necessary we will modify the bedside tool. the computerized bedside tool will be considered refined if \>90% of the generated instructions are accepted and if the percent of glucose values in the 70-110 mg/dl range are equivalent to our pilot experience rate of 55%, and if the rate of glucose values less than or equal to 40 mg/dl is less than 0.5% of glucose measurements.

Eligibility criteria:
inclusion criteria: 1. pediatric icu: proposed indications by pediatric clinicians at participating icus for glucose control in their icus would include patients who require mechanical ventilation for greater than 24 hours and/or require a vasoactive infusion (e.g. dopamine \>3 mg/kg/min, dobutamine, epinephrine, or vasopressin). 2. adult icus: proposed indications by clinicians in participating icus for glucose control in participating adult icus include critically ill patients with an anticipated icu length of stay of 3 or more days. exclusion criteria: 1. pregnancy (negative pregnancy test required for females of child-bearing age) 2. age less than one month 3. inborn errors of metabolism that the clinician suspects will affect glucose homeostasis 4. acute or chronic liver disease with any documented episode of blood or plasma glucose \<60 mg/dl within the 24 hours prior to study entry 5. diabetic ketoacidosis (critically ill patients with insulin dependent diabetes not in ketoacidosis will be eligible if attending physicians intend to use intravenous insulin as part of ordinary care) 6. severe chronic liver disease (child-pugh score \>10)

Keywords: glucose insulin computer critical care
mechanical bowel preparation versus no bowel preparation for esophageal cancer surgery

Conditions: Esophageal Cancer

Summary: the study type was designed as a prospective multicenter randomized controlled study. the patients will be divided into intervention group and control group, 281 patients were needed for each group and 562 patients would be needed totally to show this difference. due to a possible loss of 14%, the final sample size was calculated to be 652 patients. the intervention group will not implement mechanical bowel preparation(mbp) before surgery; the control group will receive routine preoperative mbp for oral administration of compound polyethylene glycol electrolyte powder and fasting water. perioperative complications, intestinal recovery speed and quality of life will be investigated between the two groups.

patients allocated to mbp will be instructed by the study nurse to prepare their bowel mechanically by drinking 3\~4l of polyethylene glycol (polyethylene glycol electrolytes powder 68.56g; shenzhen, china) with water before 6pm in the evening the day before the surgery. patients allocated to nbp were instructed to not prepare the bowel. the receipt of the allocated intervention will be controlled by study nurse asking the patients on the morning of the surgery whether they had acted as instructed by the allocation. this information will be also concealed from treating physicians and surgeons, data collectors, and data analysts, until the primary and secondary outcomes were analyzed. all patients will follow the eras protocol. prophylactic intravenous antibiotics (cephamycin 1000mg) will be given to all patients 30 minutes before skin incision. the prophylactic intravenous antibiotics will re-administered if the surgery lasted longer than 3h from the first antibiotic dose. surgical skin preparation will involve taking a bath well the night before operation without shaving the hair. just before skin incision, the area will then washed three times with denatured 80% alcohol to left to dry.

Eligibility criteria:
inclusion criteria: * patients who were scheduled for esophageal cancer resection in participating centers were eligible for inclusion. exclusion criteria: * need for emergency surgery; * previous chronic constipation or diarrhea; * previous abdominal surgery; need for colonic reconstruction; * other indications for mechanical preparation or contraindications; * allergy to drugs used in the trial (polyethylene glycol)
covid-19 and multisystem inflammatory syndrome in children (mis-c) risk / world health organization (who)

Conditions: Sars-CoV-2 Infection; MIS-C

Summary: this study is a multicenter, international, non interventional, retrospective study about sars-cov-2 and multisystem inflammatory syndrome (mis-c) reinfection risk in children.

this study is based to data collection of cases (patients with mis-c) compare to controls (patients with sars-cov-2 infection) occurring between 01 sep 2021 and 30 apr 2022. for this study cases and controls group will be matched for analyses. the main of this study is to evaluate the difference of risk of occurrence of mis-c between a first sars-cov-2 infection and a reinfection with sars-cov-2.

Eligibility criteria:
inclusion criteria: group 1: cases * patients with mis-c (following sars cov-2 infection) * hospitalised between the 01 sep 2021 and 30 apr 2022 * under 18 years of age * not vaccinated for sars-cov-2 group 2: controls * patients not hospitalised, treated by outpatient care * with documented sars-cov-2 infection between the 01 sep 2021 and 30 apr 2022 * matched with a case on age (+/- 6 months), gender and country * not vaccinated for sars-cov-2 exclusion criteria: - refusal to participate by patient relative or legal representative