Kornimate/medical-research-clean huggingface dataset:
navi-star thermo-cool catheter for ablation of atrial fibrillation

Conditions: Paroxysmal Atrial Fibrillation

Summary: the objective of this study is to demonstrate that the navi-star thermo-cool catheter can be used to safely and effectively reduce symptomatic episodes of paroxysmal atrial fibrillation in patients with frequent (\>3 episodes/month) or infrequent \<3 episodes/month)atrial fibrillation resistant to at least one class i or class iii antiarrhythmic drug.

the ability of a saline irrigated catheter to deliver rf energy at higher power with a lower electrode-tissue interface temperature, combined with the anatomical guidance of electroanatomical mapping should allow: 1. isolation of the pulmonary veins at the la-pv junction with the same or lower risk of pulmonary vein stenosis; 2. creation of continuous, transmural linear left atrial lesions with the same or lower risk of thromboembolism; 3. these two factors will eliminate documented episodes of symptomatic sustained af in patients with frequent (\>3 episodes/month) or infrequent (\<3 episodes/month); 4. patients with interruption of the vagal response (sinus bradycardia or av block) during stimulation at the sites of left atrial autonomic ganglionated plexi (gp) will have lower recurrence of atrial fibrillation.

Eligibility criteria:
inclusion criteria: 1. age greater or equal to 18 years 2. at least one documented episode of atrial fibrillation (af) within the previous 6 months. 3. failure of at least one antiarrhythmic drug (class i or iii) defined as recurrence of af or adverse effect. 4. informed consent obtained. exclusion criteria: 1. left atrial thrombus 2. acute myocardial infarction within eight (8) weeks 3. atriotomy within eight (8) weeks 4. decompensated heart failure (unless the af is thought to be a significant etiologic factor and af ablation is clinically indicated) 5. pregnancy 6. ablation in a pulmonary vein within 4 months. 7. occurrence of perforation during an ablation procedure performed less than two months prior to the planned ablation date. 8. significant congenital anomaly or medical problem that, in the opinion of the investigator, would preclude enrollment in the study. 9. enrolled in an investigational study evaluating another device or drug 10. unwilling to participate in the study or unavailable for follow-up visits. 11. incarcerated

Keywords: catheter ablation atrial fibrillation
intranasal steroids and the nasal ocular response

Conditions: Seasonal Allergic Rhinitis

Summary: eye symptoms of tearing, redness and itch frequently occur in patients with allergic rhinitis or hayfever. the purpose of this study is to learn whether placing allergen (the substance that causes allergies) in the nose several days in a row will cause an increase in eye symptoms and whether receiving a nasal steroid spray will prevent these eye symptoms.


Eligibility criteria:
inclusion criteria 1. males and females between 18 and 45 years of age. 2. history of grass and/or ragweed allergic rhinitis. 3. positive skin test to grass and/or ragweed antigen. 4. positive response to screening nasal challenge. exclusion criteria 1. physical signs or symptoms suggestive of renal, hepatic or cardiovascular disease. 2. pregnant or lactating women. 3. upper respiratory infection within 14 days of study start.
the effect of sglt-2 inhibitor in patient with atrial fibrillation and diabetes mellitus

Conditions: SGLT-2 Inhibitor; Atrial Fibrillation; Diabetes Mellitus, Type 2

Summary: this study was designed to compare the effects on atrial rhythm control between sglt2 inhibitor and other oral hypoglycemic agents in patients with atrial fibrillation and diabetes mellitus. we are to compare efficacy and safety between these two groups.

this study is a multicenter, prospective open blinded-endpoint design, 1:1 randomized, and controlled study, with total of 716 patients enrolled from 4-5 centers. the primary outcome is recurrence rate of atrial fibrillation within a year, when recurrence of atrial fibrillation is defined as at least one significant atrial fibrillation documented on 24-hour holter ecg. secondary outcomes are atrial fibrillation free survival, atrial fibrillation burden at various time points, ablation rate within a year, atrial fibrillation recurrence rate after ablation within a year, volume of left atrium, nt-probnp, symptom score and quality of life.

Eligibility criteria:
inclusion criteria: * at least one episode of atrial fibrillation\* that is documented during the prior year by any kind of ecg recording. * diabetes mellitus type ii was diagnosed. (hba1c \>6.5%) and are using oral hypoglycemic agents only * at least 20 years old and not older than 80 years old. * normal ecg parameters when measured in sinus rhythm (qrs width ≤120 ms, qtc interval \<440 ms, and pq interval ≤210 ms in a 12 lead ecg) * able and willing to give informed consent. exclusion criteria: * any disease that limits life expectancy under 1 year * subject for another clinical trial within the past 2 months * under 20 years old or over 80 years old * pregnant women * lactating women * drug abuser * type 2 dm treated by recombinant insulin * diagnosis of type 1 dm, mody, or secondary dm * hba1c ≥12% or hba1c \<6.5% at diagnosis * previous treatment with any sglt2 inhibitor * renal dysfunction (egfr-ckd-epi \<30ml/min/1.73m\^2) * chronic cystitis and/or recurrent genitourinary tract infections (3 or more in the last year) * unexplained hematuria at baseline study * systolic bp \>180mmhg or diastolic bp \>100mmhg at baseline study * systolic bp \<95mmhg at baseline study * previous treatment with af ablation * acute cardiovascular event \[e.g., stroke, acute coronary syndrome (acs), revascularization, decompensated hf, sustained ventricular tachycardia, return of spontaneous circulation (rosc)\] \<8 weeks prior to baseline study * severe valvular disease or have prosthetic valve * treatment with chronic oral steroid (\>30 consecutive days) at a dose equivalent to oral prednisolone ≥10mg/d, within the past 1 month * history of any malignancy within 5 years * clinically profound hepatic dysfunction * clinically uncontrolled thyroid dysfunction * patients incapable of completing the trial due to any severe medical condition by clinical decision * patients with poor compliance (defined as 80 - 120%), except for reasonable situations judged by physician
treatment of fifth metatarsal zone 3 fractures

Conditions: Fractures, Stress; Metatarsal Fracture

Summary: the fifth metatarsal is one of the bones where stress fractures can occur. current literature provides support for both operative and non-operative treatment, but is mostly based on retrospective studies. one small randomized controlled trial reported faster recovery in the surgery group, but this study is probably subject to selection bias as well as underpowered design. there is a need to strengthen the knowledge base regarding treatment of stress fractures in the fifth metatarsal. this study seeks to answer whether osteosynthesis with an intramedullar screw fixation gives faster painfree weight bearing compared to non-operative treatment with a walking boot.


Eligibility criteria:
inclusion criteria: * zone 3 fracture exclusion criteria: * neuropathy * open fractures * high energy injuries * associated injury in the same or opposite extremity that may affect treatment or rehabilitation * pressure ulcer(s) * lack of consent competence * fracture radiologically confirmed more than six months ago * no possibility of follow-up at one of the study centers * established pseudarthrosis * medical condition that contraindicates surgery * non-compliance
the glycaemic response of local foods using the continuous glucose monitoring system

Conditions: Diabetes

Summary: this study is carried out to determine the effect of high and low gi of local foods using continuous glucose monitoring system (cgms™) on 24 hour blood glucose profiles.

glycemic index (gi) is a method of classifying foods based on the food's ability to raise the blood glucose level. low gi foods are recommended as participants will have a lower impact on blood glucose concentrations. the research sets out to determine the effect of gi on 24 hour blood glucose profiles in healthy chinese male participants. there will be two test sessions where participants will consume either a high or low gi breakfast, lunch, snack and dinner. participants will take part in two test sessions (each spanning over 3 days and to monitor the participants' glycemic response using a continuous glucose monitoring system (cgms) throughout the period.this study specifically attempts to see how having high and low gi locally consumed meals impact on blood glucose.

Eligibility criteria:
inclusion criteria: * chinese, male * age between 21-50 years * body mass index between 18 to 25 kg/m2 * normal blood pressure (\<140/90 hgmm) * fasting blood glucose \< 6 mmol/l exclusion criteria: * current smoker * have any metabolic diseases (such as diabetes, hypertension etc) * have known glucose-6-phosphate dehydrogenase deficiency (g6pd deficiency) * have medical conditions and/or taking medications known to affect glycaemia (glucocorticoids, thyroid hormones, thiazide diuretics) * have an ongoing infection or currently undergoing treatment at the time of screening * known chronic infection or known to suffer from or have previously suffered from or is a carrier of hepatitis b virus (hbv), hepatitis c virus (hcv), human immunodeficiency virus (hiv)• have active tuberculosis (tb) or currently receiving treatment for tb * have intolerances or allergies to any foods * partake in sports at the competitive and/or endurance levels
effectiveness of black tea mouthwash on plaque formation

Conditions: Gingivitis

Summary: the study was conducted to measure the effectiveness of black tea in reducing the deposits on teeth. it also compares the effect between use of black tea mouthwash and green tea mouthwash to that of chlorhexidine in reducing plaque deposition on teeth in a two weeks long clinical trial among adults of 18-40 years of age.

the study titled "effectiveness of black tea mouthwash on plaque formation: a randomized controlled clinical trial" conducted at department of periodontics,during february 2015 till july 2015 included three interventional arms with 15 subjects each who had chronic generalized plaque-induced gingivitis. all subjects underwent scaling and randomly allocated into three groups as black tea,green tea and chlorhexidine. those in black tea, green tea and chlorhexidine groups advised to rinse with 0.5% black tea, 0.5% green tea and 0.12% chlorhexidine aqueous based solutions for 30 seconds twice daily half an hour after brushing teeth respectively. gingival index (loe and silness 1963) and plaque index (silness and loe, 1964) recorded at baseline and 2 weeks after intervention in all subjects. results were analyzed using spss statistical software version 20.

Eligibility criteria:
inclusion criteria: * 18-40 years old. subjects with at least 20 natural teeth. diagnosed with chronic generalized plaque induced gingivitis. exclusion criteria: * subjects with systemic illness. subjects on antibiotic in the previous six months. subjects with allergy to tea. subjects on medications with effect on periodontium (eg:anti-osteoporotic drugs).

Keywords: gingivitis, black tea, green tea,chlorhexidine, biofilm,
bis monitoring to detect deep sedation

Conditions: Disorder; Mental, Sedative; Depressed Level of Consciousness; Mechanical Ventilation Complication; Psychosis Associated With Intensive Care

Summary: studies have shown that prolonged deep sedation is associated with adverse clinical outcomes in adult intensive care unit (icu) patients. the revised guidelines for management of pain, agitation and delirium by the society of critical care medicine in 2013 also recommended that adult icu patients should be maintained at a light level of sedation. the key point in light sedation strategy is the assessment of depth of sedation. at present, sedation is monitored mainly by the subjective clinical score systems, such as the ramsay scale, the riker's sedation-agitation scale (sas) and the richmond agitation-sedation scale (rass). however, the subjective and intermittent nature of these scales instruments has limited their application in light sedation algorithm. consequently, objective and continuous measurement of the level of sedation would be more desirable in clinical practice. in recent years, objective measures of brain function have been of great interests in the evaluation of sedation level, and bispectral index (bis) has been the most investigated instrument. several studies compared bis with subjective sedation scales in adult icu patients, and yielded conflicting results. the different approaches to select bis value may be the most important reason for these inconsistent agreements between bis and subjective sedation scales. a formal scheme of subjective assessment of the depth of sedation and level of consciousness should incorporate exerting verbal and physical stimuli and observation of the patient's subsequent responses. our primary aim is to clarify the diagnostic accuracy of bis in detecting early deep sedation against the reference standard of subjective scale instrument. we hypothesize that bis monitoring will provide accurate, subjective and continuous evaluation of deepen sedation.


Eligibility criteria:
inclusion criteria: * adult patients are intubated and ventilated within the previous 24 hours, are administered with continuous or intermittent intravenous sedatives and/or analgesics, and are expected to receive mechanical ventilation and sedation for longer than 24 hours exclusion criteria: * age under 18 or over 65 years; * continuously infusion of muscle relaxants; * diagnosed or suspected brain diseases, which including brain trauma, intracranial hemorrhage, stroke, brain tumors, hypoxic-ischemic encephalopathy, epilepsy and meningitis; * diagnosed conditions that resulted in a decrease level of consciousness, which including hypoxemia with partial pressure of oxygen in arterial blood less than 60 mmhg, hypotension with systolic blood pressure less than 90 mmhg, hypoglycemia with blood glucose concentration less than 4.1 mmol/l, anemia with hemoglobin concentration less than 70 g/l, and body temperature below 36 °c.
unidas por vida y salud: increasing breast and cervical cancer screening in el paso

Conditions: Breast Cancer; Cervical Cancer

Summary: the purpose of this study is to develop, implement and evaluate a comprehensive breast and cervical cancer screening program designed to increase uptake of breast and cervical cancer screening among rarely and never-screened low-income women in el paso county and to increase repeat screening among those currently overdue.


Eligibility criteria:
inclusion criteria: * overdue for a repeat mammogram * overdue for repeat cervical screening exclusion criteria: -

Keywords: mammogram pap test
memantine in adult autism spectrum disorder

Conditions: Autism; Asperger's Disorder; Pervasive Developmental Disorder NOS

Summary: the purpose of this study is to see if memantine is helpful in managing problematic symptoms in adults with autism, asperger's disorder, or pervasive developmental disorder not otherwise specified (nos).


Eligibility criteria:
inclusion criteria * participant is currently in treatment in the johns hopkins bayview medical center (jhbmc) * participant has a diagnosis of: * autistic disorder * asperger's disorder * pervasive developmental disorder (pdd) nos * participant meets one of the following criteria: * cgi-s \>= 4 (cgi-s: ________) * participant has the following problematic behaviors (at least one) that might be expected to benefit from memantine: 1. _____________________________________________ 2. _____________________________________________ 3. _____________________________________________ exclusion criteria the patient meets none of the following criteria (mark if absent): * active seizures (patients with a history of seizures, who have been seizure-free on an antiepileptic regimen for six months or more would be eligible). * rett's syndrome or childhood disintegrative disorder * active treatment with an acetylcholinesterase inhibitor * prior or current treatment with memantine * current treatment with lamotrigine * genetic, metabolic or degenerative disorder (excepting fragile x). * brain malformation or known severe brain trauma * pregnancy or breastfeeding * glomerular filtration rate (gfr) \< 30 ml/min

Keywords: autism asperger's disorder pervasive developmental disorder nos adult memantine
opioid use after thyroid and parathyroid surgeries

Conditions: Thyroidectomy; Parathyroidectomy; Opioid Use; Pain, Postoperative

Summary: unnecessary opioid prescriptions for postoperative pain can increase the risk for new, persistent opioid use and dependence. published literature suggests that most patients undergoing thyroid or parathyroid surgery can have their pain effectively managed without opioids following hospital discharge. the purpose of this quasi-experimental, quality improvement study is to develop, implement, and measure the impact of a quality improvement bundle that consists of (1) patient education, (2) provider education, and (3) electronic health record (ehr) enhancements. the proportion of patients who receive new opioid discharge prescriptions for pain management following thyroid or parathyroid surgery at houston methodist hospital for up to 6 months following bundle implementation will be compared to a historical control group.

background: new and persistent opioid use after minor and major surgery is common, and the duration of opioid use following surgery is associated with opioid dependence, abuse, and overdose. most patients undergoing thyroid or parathyroid surgery do not require opioid discharge prescriptions for effective pain management. if opioids are prescribed for these surgeries, up to 7% of patients will use opioids 3 to 6 months after surgery. previously published quality programs that optimized perioperative multimodal analgesia (mma) regimens, provider education, patient education, and shared decision making successfully reduced the proportion of patients discharged with opioid prescriptions to less than 5% following thyroid and parathyroid surgery. study design: this quasi-experimental, quality improvement study compares opioid discharge prescribing practices before and after implementation of the quality improvement bundle. the quality improvement bundle includes patient education, provider education, and ehr enhancements. patients who undergo a thyroidectomy or parathyroidectomy procedure will be included in the study. the historical control group includes patients treated prior to bundle implementation. the post-implementation group includes patients treated within 4 to 6 months following bundle implementation. the primary outcome is the proportion of patients who receive new opioid discharge prescriptions at discharge following a thyroidectomy or parathyroidectomy procedure. this outcome excludes the continuation of previous, chronic opioid therapy.

Eligibility criteria:
inclusion criteria: * adult patients undergoing a primary thyroidectomy or parathyroidectomy procedure at houston methodist hospital during the study period. only index surgeries during the study time frame were included. exclusion criteria: * patients with a hospital length of stay after surgery \>2 days

Keywords: thyroidectomy parathyroidectomy opioid postoperative pain multimodal anesthesia
pre-marketing trial to assess safety and efficacy of 'volumizing filler based on hyaluronic acid and recombinant collagen'

Conditions: Wrinkle; Scar; Laxity; Skin

Summary: study to validate the safety and efficacy of the hyaluronic acid +collagen filler 40 patients will undergo through 3 visits one to asses the health and apply the filler one after 4 weeks to check the results one after 16 weeks for the final check and results validation safety assessed with analysis of the adverse events

the patients chosen with facial laxity characteristics, at the first visit will be assessed and will receive the treatment (microinjections) in the cheekbone area, over the lips and in the marionette lines. after 4 weeks the first visit will assess the change of the tissutal structure with non invasive measurements.

Eligibility criteria:
inclusion criteria: * all sexes * caucasic * 18 to 70 years * non smoker exclusion criteria: * pregnancy * milking * smoker * alcohol or drugs abuse * change of bmi during the study * previous facial surgery, implants, permanent treatments * sensitivity to the product * dermatological difficult frame * health weakness * treated with anticoagulants, antihistaminics, corticosteroids, antidepressants and other drugs impacting on the results

Keywords: hyaluronic acid collagen filler wrinkles
total temporomandibular joint replacement system post approval study

Conditions: Arthroplasty

Summary: post-approval study (pma coa) in order to obtain additional long term safety and effectiveness data \[pma p020016\]

an additional three-year follow-up data will be collected on subjects previously enrolled in the pma study, who had not completed follow-up prior to the pma approval \[pma p020016\].

Eligibility criteria:
inclusion criteria: 1. patients requiring total joint reconstruction due to: arthritis (osteoarthritis, rheumatoid, traumatic) malignancy ankylosis functional deformity avascular necrosis revisions benign neoplasms fracture multiple operated joints 2. patients who are skeletally mature. 3. patients must have at least one of the following criteria for surgical tmj treatment. 1. presence of considerable pain and/or limited function in the joint area. 2. clinical and imaging evidence consistent with anatomic joint pathology 3. previous failure of non-surgical treatment/therapy or a failed implant. 4. high probability of patient improvement by surgical treatment. 4. patients must be able to return for follow-up examinations. 5. patients without serious compromising general medical conditions. exclusion criteria: 1. patients with active infection. 2. patient conditions where there is insufficient quantity or quality of bone to support the device 3. patients with perforations in the mandibular fossa and/or bony deficiencies in the articular eminence compromising support for the artificial fossa component. 4. patients with mandibular and/or zygomatic arch screw holes compromising component fixation 5. patients requiring partial joint reconstruction or other tmj procedures not listed as an indication. 6. patients who are not skeletally mature. 7. patients who are incapable or unwilling to follow postoperative care instructions. 8. patients who are unable to return for follow-up examinations. 9. patients with severe hyper-functional habits 10. patients on chronic steroid therapy.

Keywords: patients requiring total joint reconstruction due to: arthritis (osteo-, rheumatoid, traumatic) malignancy ankylosis functional deformity avascular necrosis revisions benign neoplasms fracture multiple operated joints