Kornimate/medical-research-clean huggingface dataset:
zostavax™ safety study in subjects ≥ 60 years of age (v211-020)

Conditions: Herpes Zoster

Summary: the purpose of the study is to evaluate the general safety of zostavax™ in subjects 60 years of age or older as required by the fda.


Eligibility criteria:
inclusion criteria: * 60+ years of age * signed an informed consent prior to the start of study * non-feverish, (less than 101.0°f / 38.3°c) on day of vaccination * females must be postmenopausal or have a negative pregnancy test exclusion criteria: * a history of allergic reaction to any vaccine component (including gelatin or neomycin) * prior receipt of any varicella or zoster vaccine * any live virus vaccine administered within 4 weeks before the start of the study or scheduled during the 42 days after vaccination * any inactivated virus vaccine, except for flu vaccine, administered within 7 days before the start of the study or scheduled during the 42 days after vaccination * subject is pregnant or breastfeeding * participation in an investigational drug or vaccine study within the last 30 days prior to the start of the study or expected during the 42 days after vaccination * an ongoing illness (including active untreated tuberculosis) that might interfere with or prevent the subject from completion of the study * use of immunosuppressive therapy. subjects taking corticosteroids such as prednisone should be excluded. excluded immunosuppressive therapies also include chemotherapeutic agents used to treat cancer or other conditions, and treatments associated with organ or bone marrow transplantation * known or suspected immune dysfunction that is caused by a medical condition or any other cause. examples of medical conditions associated with immune dysfunction include congenital immunodeficiency, human immunodeficiency virus (hiv) infection, organ or bone marrow transplantation, leukemia, lymphoma, hodgkin's disease, multiple myeloma, or generalized malignancy. subjects with a history of cancer who are not on active treatment and are not thought to have a weakened immune system at the time of enrollment will be eligible * any active use of non-topical antiviral therapy including but not limited to acyclovir, famciclovir, valacyclovir, ganciclovir, foscarnet, brivudine, and cidofovir
efficacy and safety of sipjeondaebo-tang on korean patients with cold hypersensitivity in the hands and feet (sdt)

Conditions: Cold Hypersensitivity

Summary: gachon university, gil oriental medicine center


Eligibility criteria:
inclusion criteria: * female subjects aged 19 to 59 years have a complaint of chh. * patients must include at least one or more of the following symptoms: * those who have the symptoms of chh in normal temperature which most individuals feel no cold; * those who have the symptoms of extremely cold hands in cold temperature exposure; * those who are on the return to a warmer environment, the symptoms of cold hands is not completely rewarmed; * those who have 4 cm or greater of vas chh score; * a thermal differences between the palm (pc8) and the upper arm (lu4) may be higher than 0.3℃; * those who can comply with all study-related procedures, medications, and evaluations; * given a written informed consent form. exclusion criteria: * patients with calcium antagonists or beta-blockers with the purpose of treating chh; * those who have one or more finger gangrene or ulceration; * those who are diagnosed by hypothyroidism or currently medicated to thyroid drugs; * those who are diagnosed by autoimmune disease or have a positive ana test result; * those who are diagnosed by carpal tunnel syndrome or have a positive tinel and phalen's tests; * those who are diagnosed with cervical disc herniation or (malignant) tumor disease; * those who are diagnosed with diabetes; * those who are currently medicated to drugs that may affect to chh symptoms, such as anticoagulants etc; * those who have moderate level of liver dysfunction (each of ast, alt greater than 100 iu/l) or kidney dysfunction (cr 2.0mg/dl); * those who do not (cannot) abide by treatment and follow up due to the mental illness such as behavior disorder, depression, anxiety neurosis, schizophrenia, or serious mental illness; * those who are diagnosed with moderate anemia and hematologic disorders (adult non-pregnant women hemoglobin (hgb) level less than 7g/dl, hematocrit (hct) level less than 26%, white blood cell (wbc) level greater than 11,000/mm3); those whose systolic blood pressure (sbp) 180mmhg or diastolic blood pressure (dbp) is greater than 100 mmhg based on average value of at least 2 measurements; * those who are suspected arrhythmia that showing up on ecg, or diagnosed by heart diseases, such as, ischemic heart disease and so on; * those who are addicted to alcohol or drugs; * those who are pregnant (positive urine-hcg) or lactating or have the chances of pregnancy; * those who are diagnosed with malignant tumor * those who are currently participated in other clinical trials; * those who are able to understand and speak korean; * those who are judged to be inappropriate for the clinical study by the researchers.

Keywords: cold hypersensitivity korean medicine sipjeondaebo-tang cold intolerance
time outdoors as an intervention for myopia in children

Conditions: Myopia

Summary: the purpose of this study is to determine whether improved outdoor time has an effect on the onset and progression of myopia in children.

1. to evaluate the effect of increased time outdoors on the incidence of myopia in non-myopic children; 2. to evaluate the effect of increased time outdoors on the progression of myopia in myopic children; 3. to explore if there is dose-response effect of time outdoors on the incidence and progression of myopia.

Eligibility criteria:
inclusion criteria: 1. at baseline be enrolled in grade 1 and 2 of primary schools; 2. have a parent or guardian who is able to read and comprehend mandarin and give informed consent as demonstrated by signing a record of informed consent; 3. children verbally consent when registration for examination exclusion criteria: 1. any systemic or ocular pathology that may affect the refractive error status of the eye; 2. strabismus and amblyopia; 3. intellectual disability; 4. using any anti-myopia treatments (orthokeratology, atropine, accommodation function training, acupuncture, auricular point sticking, progressive addition spectacle lenses or other anti-myopia contact lenses). 5. not suitable for inclusion in the study as deemed by the investigator.

Keywords: myopia outdoor time children intervention prevention
the effectiveness and safety of livia® transcutaneous electrical nerve stimulation (tens) in women suffering from primary dysmenorrhea.

Conditions: Dysmenorrhea

Summary: this is a randomized, controlled, multi-center, single-arm, crossover, double-blind clinical study assessing the livia transcutaneous electrical nerve stimulation (tens) in women suffering from dysmenorrhea. the study will be conducted at community clinics. advertisement will be used to publish and promote recruitment. the study will include 3 visits: screening visit and two consecutive visits each one after monthly menstrual period. treatment will be self-administrated and during the study, the subjects will be requested to complete home diaries.


Eligibility criteria:
inclusion criteria: 1. women between the age 18 to 45 years 2. women reporting painful menstruation during the last 3 menstrual cycles. 3. pain vas score of at least 60 based on previous menstrual cycle 4. subject is willing and able to comply with the study protocol and provide written informed consent to participate in the study. 5. subject must agree to consistently use effective contraception throughout the study. (subject not treated with oral contraception should use any contraception other than oral). exclusion criteria: 1. participation in any other investigational study within 30 days prior and/or at the date of subject consent. 2. woman with a significant medical condition such as: cancer, diabetes (type i and ii), irritable bowel disease ibd, immunodeficiency, autoimmune disease, etc. that in the investigator opinion, participation in the study would place the patient at an unacceptable risk. 3. pregnant woman 4. a woman who is diagnosed with secondary dysmenorrhea associated with uterine myomas, endometriosis, adenomyosis, etc. 5. a woman who has cardiac condition with cardiac pacemakers, implanted defibrillators, or other implanted metallic or electronic devices.

Keywords: livia tens safety and efficacy menstruating women
screening for coronary artery disease using fluoroscopy during coronary angiography

Conditions: Coronary Artery Disease

Summary: the aim of this study is to evaluate the effects of screening using the fluoroscopy-save function on reduction of radiation exposure and quality of angiogram during cardiac catheterization when compared to traditional cinematography-guided coronary angiography.

the study will be a prospective, randomized study of patients undergoing clinically-indicated coronary angiograpy in the new york university (nyu) langone medical center cardiac catheterization laboratory. patients will be randomized to one of two coronary angiography protocols: (1) coronary anatomy visualized under fluoroscopy, documented using the fluoroscopy-save function, and further visualized using cinematography only when higher quality is necessary (fluoroscopy-save technique) versus (2) coronary anatomy visualized and documented using cinematography alone (standard technique). the primary outcome will be a measure of radiation exposure to the patient, surface peak skin dose, as measured by the gafchromic xr rv3 film strip, which is placed under the patient's back during the procedure. other outcome measures will include radiation output recorded by the fluoroscopy machine, amount of contrast used, and quality of angiograms performed. to determine if the quality of the angiograms performed using the fluoroscopy-save technique is non-inferior to the standard technique, one extra picture will be taken at random using the mode that the study was not randomized to. for example, in the fluoroscopy-save group, a picture that was not visualized under cinematography during the study will be repeated and documented under cinematograpy. in the standard group, a picture will be repeated and documented using the fluoroscopy-save function. these 2 pictures from each study will then be collated and put together in no particular order with all identifiers removed. these single pictures will be read by 2 interventional cardiologists not involved in the study in a blinded fashion. the degree of coronary artery disease as determined by these 2 readers will be compared between the fluoroscopy-save picture and cinematography picture.

Eligibility criteria:
inclusion criteria: * patients will be recruited from the cardiac catheterization laboratory at the nyu langone medical center. * patients will be eligible if they are more than 18 years of age and are referred for coronary angiography. exclusion criteria: * patients will be excluded if they have reduced renal function since they must receive as minimal of contrast amount as possible, and if their abdominal circumference is \> 45 inches since the quality of images under fluoroscopy alone is poorer in patients with increased abdominal girth.

Keywords: cardiac catheterization radiation
the effects of limb elevation during gout flare episodes

Conditions: Gout Flare

Summary: the goal of this open-label randomized controlled trial is to explore the benefit of limb elevation in inpatient gout flare episodes, compared with standard treatment the main questions are; * is limb elevation able to reduce pain during gout flare episodes to a greater degree compared with standard treatment ? * is is limb elevation able to reduce joint swelling during gout flare episodes to a greater degree compared with standard treatment ? participants will be divided into 2 group; 1. limb elevation group 2. control group all participants will receive standard medical therapy consisting of colchicine 0.6 mg per day plus prednisolone 30 mg per day for 2 days pain score and joint circumference will be recored at recruitment, 24 hour and 48 hour

limb elevation has shown benefit in ankle sprain and venous insufficiency, but its benefit has not been studied in people with gout flare. in this open-label randomized controlled trial, 30 adults diagnosed with gout flare during their hospitalization will be randomized to receive limb elevation plus standard medication for gout flare (limb elevation group) or standard medication only (control group). primary outcome is reduction in 10-point visual analogue scale for pain at 48 hours after enrollment and the secondary outcome is the reduction of the circumference of affected joint at 48 hours after enrollment. comparison of pain score and joint circumference reduction will be made using wilcoxon rank-sum test. our study results may provide some evidence in support of limb elevation as a supplementary non-pharmacological therapy for relief of gout flare.

Eligibility criteria:
inclusion criteria: * aged ≥ 18 years * diagnosis of gout according to 2015 the acr/eular gout classification criteria exclusion criteria: * receive non-steroidal anti-inflammatory drugs or intra-articular corticosteroids or prednisolone \> 10 mg within 24 hours before enrollment * unstable vital sign * receiving joint aspiration for release joint effusion ≥ 10 ml after enrollment * gout flares involve axial joints e.g. hip * glomerular filtration rates \< 30 ml/min/1.73m2 * communication problems

Keywords: gout, arthritis, gout flare
effects of metformin in pre-frail elderly

Conditions: Pre-frail Elderly

Summary: the purpose of this study is to investigate the effects of metformin to prevent frailty in pre-frail non-diabetic elderly. several outcomes measured in this study are frailty status, quality of life, handgrip strength, gait speed, and serum myostatin levels. we hypothesize that metformin for 16 weeks could prevent frailty in pre-frail elderly.


Eligibility criteria:
inclusion criteria: 1. pre-frail elderly; 2. capable to understand and carry-out the instruction. exclusion criteria: 1. unwilling to join the study; 2. diabetes mellitus (oral glucose tolerance test); 3. abbreviated mental test (amt) score \< 8; 4. geriatric depression scale (gds) score \>= 10; 5. body mass index (bmi) \<18,5 kg/m2; 6. malnutrition (according to mini nutritional assessment/mna); 7. liver cirrhosis, severe liver dysfunction, or serum alt levels \>3 times upper normal limit; 8. acute illness during inclusion period, eg. pneumonia, pain due to acute arthritis (visual analog scale \>6/10), stroke attack, crisis hypertension; 9. severe cardiac dysfunction: acute decompensated heart failure and/or chronic heart failure functional class iii or iv (new york heart association classification); 10. severe pulmonary dysfunction: acute exacerbation of chronic obstructive lung disease stage iii or iv (gold classification), and/or pao2 levels \< 60 mmhg; 11. allergy to metformin.

Keywords: frailty pre-frailty metformin elderly quality of life handgrip gait speed myostatin
ultrasound guided lateral femoral cutaneous block (lfcnb) and femoral nerve block (fnb) for postoperative pain control after hip surgery

Conditions: -Postoperative Pain

Summary: evaluation of the combination of lateral femoral cutaneous nerve "single shot" and femoral nerve "single shot" block as effective and safe alternative postoperative analgesic technique after hip replacement surgery.

clinical evaluation via a prospective, double-blinded, randomized clinical trial, whether ultrasound-guided single femoral block and lateral femoral cutaneous nerve blocks with 20 en 10 cc bupivacaine 0.25% respectively vs. the only ultrasound-guided single femoral block with 20 cc bupivacaine 0.25%, given just prior to elective hip surgery procedure, is effective in reducing acute postoperative pain (vas scores) and postoperative opiate consumption.

Eligibility criteria:
inclusion criteria: * primary hip arthroplasty with posterolateral approach. exclusion criteria: * known allergy to levobupivacaine and / or piritramide * known neurological disorders or peripheral neuropathies * existing drug or alcohol abuse * chronic use of pain medication (\> started 3 months ago) not related to the hip suffering * coagulopathy (international normalized ratio) \> 1.4 * thrombocytopenia \<70,000 platelets, * dementia * pregnancy * local infection hip * hepatic and / or renal impairment * bmi\> 45.
eosinophil β1 integrin activation as a biomarker for eosinophilic esophagitis

Conditions: Eosinophilic Esophagitis

Summary: the purpose of this study is to improve the overall management of patients with eosinophil esophagitis. currently, the best way to monitor eosinophil esophagitis is repeating the endoscopy procedure. the investigators plan to identify a biomarker in the blood (a measurable substance) that tracks with disease activity and will reduce the need for follow-up endoscopies.

by definition, eosinophil esophagitis involves the presence of eosinophils in the esophageal mucosa. although incompletely understood, the pathophysiology of eosinophil esophagitis is thought to include food allergen driven inflammation in the esophageal mucosa that triggers release of mediators for recruitment of eosinophils. the mediators, such as eotaxin, invoke eosinophil activation and trafficking into the esophageal tissue. the subsequent release of mediators from eosinophils and other cells, including mast cells and basophils, promotes inflammation and fibrosis resulting in eosinophil esophagitis symptoms. this protocol focuses on early eosinophil activation events in eosinophil esophagitis in the peripheral circulation, specifically activation of surface β1 integrin, as a biomarker for disease activity reflecting eosinophils destined for trafficking into the esophagus. demonstrating a correlation between disease activity and a peripheral biomarker may ultimately facilitate a timelier, less invasive and less costly management strategy for eosinophil esophagitis.

Eligibility criteria:
inclusion criteria: * male or female with no health concerns that might affect the outcome of the study, * age 18 years of age and older * esophageal dysfunction with a predominant symptom of solid food dysphagia and/or esophageal food impaction * esophageal eosinophilia (\>15 eosinophils/hpf) shown on biopsy * in the opinion of the investigator, capable and willing to grant written informed consent and cooperate with study procedures and requirements. exclusion criteria: * major health problems such as autoimmune disease, heart disease, type i and ii diabetes, uncontrolled hypertension or lung diseases other than asthma. the listed health problems are definitive exclusion but decisions regarding major health problems not listed will be based upon the judgment of the investigator, * pregnant or lactating females or has a planned pregnancy during the course of the study.

Keywords: eoe
assessment of a special modality of back muscles strengthening for postural deformations in parkinsonian patient

Conditions: Parkinson Disease; Physical Medicine; Rehabilitation

Summary: parkinson's patients have postural disorders. these disorders are frequent in martinique. physiotherapeutic rehabilitation is essential because these disorders are generally non dopa-sensitive.

postural disorders are very common in martinique, in patients often having an atypical form of the parkinson's disease. physiotherapy rehabilitation is essential because these disorders are generally non-dopa-sensitive. isokinetic muscle strength may reduce postural disorder in parkinson's disease. isokinetic device rehabilitation promotes maximum muscular contraction at constant speed; the resistance of the machine continuously adapting to the force developed by the subject. as the spinal muscle strength gain is superior to conventional post-rehabilitation motor function, the improvement in postural instability should be greater than that achieved with conventional rehabilitation. a better postural support should thus result in a decrease in the risk of falling and an improvement in the quality of walking.

Eligibility criteria:
inclusion criteria: * patient with parkinson's disease or atypical parkinsonian syndrome * age ≥18 years * patient with postural disorders with a cervical arrow\> 6cm in the sagittal plane and / or the axis c7s2 different from 0 in the frontal plane * updrs between 10 and 25/108. * antiparkinsonian treatment stabilized for 8 weeks * mms test\> 25 * insured person or beneficiary of social security exclusion criteria: * patient with a neurological condition other than parkinsonian syndrome * patient with rheumatic disease * patient with a history of trunk surgery * patient with a brain stimulator * cardiac pathology not stabilized * incapacitated adult, or under guardianship, or under curatorship or under judicial protection curatorship
a clinical cohort study on the pathogen spectrum of hepatic virus-caused cirrhosis complicated with infection

Conditions: Liver Cirrhosis

Summary: the goal of this observational study is to expound the population and characteristics of pathogenic microorganisms with co-infection, draw the pedigree of pathogenic microorganisms, and evaluate its influence on disease outcome in patients with hepatic virus-caused cirrhosis. the main questions it aims to answer are: * describe the populations and characteristics of pathogenic microorganisms responsible for co-infections in patients with hepatic virus-caused cirrhosis. * map the spectrum of pathogenic microorganisms, and evaluate their impact on disease regression.

cirrhosis is a chronic progressive disease caused by different etiological factors and characterized by diffuse hepatocellular degeneration and necrosis, abnormal regeneration of hepatocytes, intrahepatic neovascularization, massive proliferation of hepatic fibrotic tissues, and pseudofollicular formation. the number of patients with liver disease in china is about 300 million, and the number of deaths from cirrhosis accounts for 11% of the global deaths from cirrhosis. its etiology is diverse, and hepatitis due to hepatophilic virus infection is still the main cause in china. a recent study by scholars on 11861 patients hospitalized for the first time due to liver cirrhosis in 50 hospitals in china showed that among the causes of liver cirrhosis in china, hbv infection accounted for 71.15% and hcv infection accounted for 8.12%. about two-thirds of patients with cirrhosis and extrahepatic organ failure suffer from sepsis. infections increase the risk of death in patients with cirrhosis, and reports have shown that these patients are hospitalized for twice as long as patients without cirrhotic sepsis and have a hospital mortality rate of up to 50%. this study focuses on the impact of secondary infections on the clinical prognosis of cirrhosis, and proposes to establish a prospective, multicenter clinical cohort of secondary infections in cirrhosis, map infection pathogens, correlate the characteristics of the underlying immune status with the pathogen profiles of secondary infections, and set up an early warning system of secondary infection surveillance, with the aim of early prevention and early recognition of secondary infections, and improvement of prognosis for patients with liver cirrhosis.

Eligibility criteria:
inclusion criteria: 1. hospitalized patients with viral hepatitis cirrhosis agreed to participate in the study and signed an informed consent form; 2. any gender and age between 18-70 years old; 3. hbsag positivity lasting more than 6 months; 4. have clinical manifestations of hepatic decompensation and portal hypertension, laboratory test results, liver imaging or endoscopy and other comprehensive diagnosis of definite cirrhosis. exclusion criteria: 1. patients with other non-hepatophilic causes of cirrhosis; 2. patients who, in the opinion of the investigator, are not suitable for participation in the study.

Keywords: hepatic virus-caused cirrhosis infection pathogen spectrum cohort study