Kornimate/medical-research-clean huggingface dataset:
auto-antibody dosage from blood spots for diagnosis of type 1 diabetes and celiace disease

Conditions: Celiac Disease in Children; Diabetes Mellitus, Type I; Screening

Summary: early diagnosis of type 1 diabetes and celiac disease is very useful, allows early therapy and prevents deaths from the onset of diabetic ketoacidosis. this is a pilot study on screening of autoantibodies of type 1 diabetes and celiac disease in tuscany patients. the study aims to evaluate the concordance between the screening results obtained using two different matrix (blood drop spots on card and serum) in the search for autoantibodies for celiac disease and for type 1 diabetes. moreover, it will be evaluated the feasibility and acceptability of the screening on a sample of the population enrolled in the territory through the participation of pediatricians.


Eligibility criteria:
inclusion criteria: * patients aged 2-13 years * patients with a confirmed diagnosis of type 1 diabetes or celiac disease (positive controls) and children who do not have type 1 diabetes or celiac disease or autoantibodies associated with these pathologies (controls) * obtained informed consent exclusion criteria: * none
nitrous oxide for analgesia during office urethral bulking

Conditions: Pain; Stress Incontinence, Female

Summary: this study is designed to determine primarily if there is a difference in perceived pain in patients receiving urethral bulking with calcium hydroxylapatite using local lidocaine versus local lidocaine plus nitrous oxide gas. patients will be randomized to a control group (local lidocaine plus room air) or a intervention group (local lidocaine plus 50% nitrous oxide/50% oxygen inhaled mixture). their pain will be assessed immediately after the procedure, and their recollection of pain will also be assessed at their 2 week post-procedure visit. there are other secondary outcome measures as well; please see outcome measures section for full description.


Eligibility criteria:
inclusion criteria: * female patients * greater than or equal to 18 years old * with demonstrable stress incontinence on supine stress test * undergoing calcium hydroxylapatite injection for urethral bulking for the first time * able to consent to the study and procedure exclusion criteria: * \< 18 years old * prior urethral bulking therapy * predominant urge incontinence symptoms * contraindications to nitrous oxide * pre-existing significant cardiopulmonary disease * hypotension defined as systolic blood pressure (bp) \< 90 or diastolic bp \<50 on initial bp in the office * chronic pain disorders (specifically fibromyalgia, chronic pelvic pain, sciatica or chronic low back pain, painful bladder syndrome) * chronic narcotic use (defined as taking a narcotic medication \>3 days per week during the past two weeks) * pregnancy * conditions of air trapping (bullous emphysema, bowel obstruction, pneumothorax, intracranial air, middle ear conditions, status post recent diving, recent eye surgery) * lidocaine allergy * neurologic diseases impairing pain perception.
evaluation of lung clearance index in cystic fibrosis (cf) patients, infected with p.aeruginosa

Conditions: Chronic Lung Infection With Pseudomonas Aeruginosa in Cystic Fibrosis

Summary: the purpose of the study was to evaluate lung clearance index (lci) by a standardized procedure in a well characterized study setting and to assess feasibility of lci as a more sensitive method than forced expiratory volume at 1 second (fev1) to measure effectiveness of antibiotic therapy in patients with cf aged 6 years and older with mild to moderate lung disease.

this study was terminated prematurely. the reason for trial termination was challenge with enrollment and patient recruitment. a significant decrease in the eligible patient population had been identified as main driver.

Eligibility criteria:
inclusion criteria: * confirmed diagnosis of cf * patients with elevated lci of ≥ 7.5 at screening * patients with fev1 of ≥ 50% predicted at screening * use of inhaled tobramycin in a 28 days on / off regimen in the past 3 months before screening * chronic lung infection with pseudomonas aeruginosa exclusion criteria: * patients who are regularly receiving more than one class of inhaled anti-pseudomonal antibiotic * patients who have used oral or intravenous anti-pseudomonal antibiotics within 28 days prior to on-phase of study drug * pregnant or nursing (lactating) women * change in dose, formulation or strength of the study drug in the past treatment cycle before screening * history of hearing loss or chronic tinnitus * infection with burkholderia cenocepacia complex other protocol-defined inclusion/exclusion criteria may apply

Keywords: cystic fibrosis, pseudomonas aeruginosa, lung clearance index, multiple breath washout, inhaled tobramycin, inhaled antibiotics.
developing an mhealth application to improve cancer chemotherapy symptom management

Conditions: Colon Cancer; Rectal Cancer

Summary: this research project addresses critical gaps in cancer symptom management through the creation of a mobile chemotherapy symptom management application. this application will assess for the presence and severity of common chemotherapy side-effects and provide personally tailored symptom-related video and narratives to enhance self-management of cancer and treatment-related symptoms. this study will examine patient acceptance and use of this mhealth application (called mychemocare) in a prospective trial of cancer patients (n=60) who are receiving chemotherapy for colorectal cancer at the university of michigan comprehensive cancer center.


Eligibility criteria:
inclusion criteria: * diagnosed with colon or rectal cancer * expected to live at least 6 months * initiating chemotherapy for the first time in their treatment history * physically and mentally able to participate * able to read english * willing and able to sign informed consent exclusion criteria: * a treatment plan that does not include cytotoxic chemotherapy for colon or rectal cancer * a medical history that includes cancer with the exception of in situ cancers of the cervix and basal cell cancers of the skin * a current diagnosis that includes multiple cancers (this does not exclude metastatic disease) * received prior cytotoxic chemotherapy for any reason * a diagnosed psychiatric disorder
diabetic peripheral neuropathic pain (dpnp)

Conditions: Diabetic Peripheral Neuropathic Pain

Summary: the purpose of the study is to evaluate the efficacy of study drug (bms-954561) as compared to placebo in the treatment of patients with diabetic peripheral neuropathic pain (dpnp).

allocation: randomized stratified; intervention model: cross-over versus comparator + placebo

Eligibility criteria:
inclusion criteria: * type i or type ii diabetes with painful, distal, symmetrical, sensory-motor neuropathy attributed to diabetes, of at least 6 months duration. * score of ≥3 on michigan neuropathy screening instrument * the patient is able to satisfactorily complete, in the investigator's judgment, the cognitive battery. * based on patient diary information collected during the screening/baseline period, the patient has completed at least 5 of 7 daily diary entries and has an average weekly pain rating of at least 4 on the 11-point pain rating scale, in the week immediately prior to randomization (baseline visit). * male or female, 18-85 years of age. exclusion criteria: * history of complete lack of response to pregabalin (at least 300 mg qd for 4 weeks) or gabapentin (at least 1800 mg qd for 4 weeks). * other severe pain that may potentially confound pain assessment. * hemoglobin a1c \> 9% * hemoglobin ≤ 9 g/dl * estimated glomerular filtration rate (egfr) according to the re-expressed abbreviated (four-variable) modification of diet in renal disease (mdrd) study equation ≤ 50ml/min/1.73m2 * patients who have been on a stable dose of anticonvulsant, anticholinergic, diabetic meds, nicotine replacements, or any other smoking cessation meds for \<4 weeks prior to randomization. patients who are on stable doses for ≥ 4 weeks prior to randomization are allowed, however, there should be no adjustments to the dose of these medications during study. * patients currently on more than one drug for treatment of neuropathic pain (low dose opioids or antidepressants). patients are allowed to participate if on a stable dose of for at least 4 weeks prior to randomization (day1) and should remain stable during study.
energy specific far infrared radiation treatment for aids

Conditions: HIV Infections

Summary: the investigators are proposing that energy specific electromagnetic radiation of the central nervous system, the viscera and the endocrine system has the potential to enhance the immune system; thereby enhancing the production of killer cells to fight and destroy the human immunodeficiency virus.

acquired immune deficiency syndrome or acquired immunodeficiency syndrome (aids or aids) is a collection of symptoms and infections resulting from the specific damage to the immune system caused by the human immunodeficiency virus (hiv) in humans. the late stage of the condition leaves individuals prone to opportunistic infections and tumors. although treatments for aids and hiv exist to slow the virus' progression, there is no known cure. the investigators are postulating that energy specific electromagnetic radiation of the central nervous system, the viscera and the endocrine system has the potential to enhance the immune system; thereby enhancing the production of cd4+ t cells and other killer cells to fight and destroy the human immunodeficiency virus. the primary end point is to determine the therapeutic effects of far infrared radiation (5μm to 20μm wavelength) on hiv/aids.

Eligibility criteria:
inclusion criteria: * 1 year and above exclusion criteria: * none

Keywords: hiv aids radiation far infrared treatment acquired immunodeficiency syndrome complimentary therapies
dyslipidemia in cardiovascular disease

Conditions: Dyslipidemia

Summary: a multi-center, randomized, double-blinded equivalence clinical trial to evaluate efficacy and safety of lipilou 20 mg versus lipitor 20 mg in hypercholesterolemic patients with higher risk cardiovascular disease in korea.


Eligibility criteria:
inclusion criteria: 1. dyslipidemic patients with high-risk cardiovascular disease meeting more than 1 requirement below (ldl-c ≥ 100mg/dl) 1) coronary artery disease * diagnosed with atheroma in coronary ct or angiography, or spect positive or treadmill test positive 2) diabetes mellitus 3) intervened with stent in coronary artery disease more than 1 year before 4) diagnosed with atheroma in carotid artery 5) peripheral artery disease 2. aged 20\~85 years 3. volunteers consented with participating clinical trial and submitted consent paper exclusion criteria: 1. experimental examination at screening 1) active liver disease or more than 2 x uln of ast/alt 2) creatine kinase \> 2 x uln 3) creatinine \> 2.5mg/dl 4) triglycerides \> 500mg/dl 2. intervened with stent in coronary artery disease less than 1 year before 3. hyper-sensitive or resistant to other hmg-coa reductase inhibitors, or experienced serious adverse events 4. patients taking dyslipidemic treatments within 4 weeks (hmg-coa reductase inhibitors, fibrates, nicotinic acids or bile acid resins, etc.) 5. as uncontrolled dm patients, hba1c≥11% or fasting plasma glucose ≥200mg/dl 6. dbp \> 100mmhg, sbp \> 160mmhg 7. diagnosed with myopathy 8. appear to be a risk of myopathy below * renal impairment or prior renal dysfunction * hypothyroidism * genetic defects or family history of myopathy * experienced prior muscle toxicity with taking statins or fibrates * prior liver disease or higher intakes of alcohol * aged over 70, and a risk of myopathy 9. women pregnant or breast-feeding 10. women capable of pregnancy without using contraceptives 11. contra-indicated medically or mentally, or forbidden legally 12. enrolled to other clinical trial within 4 weeks 13. impossible to participate clinical trial according to investigator's decision

Keywords: dyslipidemia
uemr versus hsp in the treatment of pedunculated colorectal polyps less than 10mm in size

Conditions: Pedunculated Colorectal Polyp

Summary: a prospective, single-center, open-label, randomized controlled study to compare the effectiveness and safety of underwater endoscopic mucosal resection (uemr) and hot snare polypectomy (hsp) in treating pedunculated colorectal polyps less than 10mm in size.

1. patients are undergone screening, surveillance, or therapeutic colonoscopy at the endoscopy department of gastrointestinal endoscopy center of huadong hospital affiliated to fudan university. 2. randomize patients with pedunculated colorectal polyps less than 10mm in size into 2 interventional groups based on random function of statistical package for the social sciences (spss) 20.0, including (1) group 1: underwater endoscopic mucosal resection (uemr) and (2) group 2: hot snare polypectomy (hsp). 3. collecting variables which consist of primary and secodary outcomes.

Eligibility criteria:
inclusion criteria: * aged between 35 and 80 years * pedunculated colorectal polyps less than 10mm in size in screening, surveillance or therapeutic colonoscopy * 0-isp or 0-ip according to paris classification * patients must sign an informed consent form prior to registration in study exclusion criteria: * unsuitable for removal by uemr or hsp * suspected malignancy * history of inflammatory bowel disease or colorectal resection * familial adenomatous polyposis or lynch syndrome * patients taking anticoagulant and antiplatelet agents before the examination * inadequate bowel preparation, defined as a boston bowel preparation scale score \< 6 * asa \>=3 * pregnancy or breastfeeding * severe comorbid disease involving the heart, lungs, liver, or kidneys. * concurrent serious conditions, including other active malignancies or severe infectious diseases

Keywords: pedunculated colorectal polyp underwater endoscopic mucosal resection hot snare polypectomy
non-invasive melanoma assessment using a topical fluorescence reagent and optical imaging

Conditions: Skin Lesions

Summary: the use of mds to access the presence of melanoma in the skin.

a topical agent is applied to suspicious skin lesions and imaged. the images are analyzed to provide a score that correlates with the probability for the presence of melanoma in the lesion.

Eligibility criteria:
inclusion criteria: * individuals with skin lesion with one or more of the abcde features and recommended for a skin biopsy. * the lesion is accessible to the imaging device, with at least 1 cm of skin around the lesion that is accessible to the mds. * male and female ≥ 21 years old. * subject is capable of giving written informed consent. * primary excision. exclusion criteria: * the lesion is less than 1 cm from the eyes. * the lesion is on the palms of hands or soles of the feet. * mucosal lesion. * pregnant females. * low study procedure compliance. * patients who are mentally or physically unable to comply with all aspects of the study. * undergoing chemotherapy. * minor or legally incompetent and not able to sign the consent form. * patient previously tested by mds and was diagnosed with melanoma during the study.

Keywords: melanoma skin cancer
the vitamin k2 and d3 intervention trial in children and adolescents with the low-energy fractures

Conditions: Fracture Healing; Vitamin D3; Deficiency of Vitamin K2

Summary: a prospective, three- month, randomized, double-blind, placebo-controlled, intervention trial (rdbpc), investigating the effect of vitamin k2 (menaquinone-7) and vitamin d3 on the healing process of low-energy bone fractures in children and adolescents

at the admission of patients to the orthopedic outpatient clinic, presence of low- energy fractures will be established based on the anamnesis, physical examination and radiological evaluation. tests to obtain the baseline blood levels of vitamin d3 will be performed, and only children with vitamin d3 levels lower than 30ng/ml in the blood will be included in the study. the selected population will then be randomly assigned by an independent investigator to the three study groups, receiving daily for three months identical- looking soft gel capsules (1 capsule/patient/day) containing supplements of vitamin d3 2,000 iu, 90 mcg of vitamin k2 as menaquinone-7 combined with 2,000 iu d3, and olive oil-containing placebo capsules respectively. during the 3-month follow-up visits to the outpatient orthopedic clinic, the pediatric orthopedist will examine the patient, evaluate the x-ray, and determine the progress in bone union and the range of joint motion. the patients will visit the clinic on weeks 1,2,4,6,8, and 12. the compliance taking the supplements will be assessed by registering a pill count returned by a patient during the scheduled visit. the blood samples will be collected upon admission to the study, day 0, and after the 3-month regimen. the blood samples will be collected for evaluation of bone turnover markers and the status of vitamin k and vitamin d3. the primary evaluation endpoints will include: the dynamics of fracture healing, changes in levels of osteocalcin, and vitamin k and vitamin d3 levels against the placebo group. the bone fracture healing milestones will be based on bone union defined as the absence of pain and the presence of bridging callus in three of the four cortices seen on the front rear projection and lateral radiographic views of the bone. delayed union is defined as incomplete consolidation at 90 days

Eligibility criteria:
inclusion criteria: * age \< 18 years * presence of low-energy fracture * vitamin d serum level \<30ng/ml exclusion criteria: * age \> 18 years * lack of low-energy bone fracture * oral anticoagulants treatments, which interfere with vitamin k cycle * current supplementation with vitamin vitamins k2 or vitamin d3 * osteogenesis imperfecta and other bone diseases * vitamin d concentration \> 30ng/ml

Keywords: vitamin d vitamin k2 low-energy fractures fracture healing children
to investigate agreement between the em-3000 and the predicate device noncon robo pachy (f&a) (cellchek xl)

Conditions: Cornea

Summary: the purpose of this study is to evaluate the precision and agreement of the study device, a specular microscope, in comparison to a currently commercially available specular microscope in establishing substantial equivalence of the two devices in clinical use for diagnostic purposes of the human cornea.

the observational clinical investigation is intended to measure agreement between two diagnostic instruments of the eye's corneal endothelium. the study device is the em-3000 specular microscope and the control device is the noncon robo pachy (f\&a) (cellchek xl) specular microscope. both instruments measure corneal endothelial cell layer parameters including cell density, coefficient of variation, percent hexagonality, and central thickness. the primary variable is the measurement of agreement between the two instruments for the four parameters described. the secondary variables include repeatability (intra-investigator) and reproducibility both inter-investigator, and inter-instrument. additionally, measurements of agreement will be made on the em-3000 using automated analysis with and without touch-up.

Eligibility criteria:
inclusion criteria: * eyes with one of the following corneal conditions: non-pathologic younger eyes (18-50 yrs) non-pathologic older eyes (51-80 yrs) pathologic adult eyes (29-80) exclusion criteria 1. seriously ill or unconscious subject, mentally ill person, mentally handicapped person, person who is unable to read or write. * non-pathologic subjects who have the following conditions : 2. history of corneal transplant 3. long term fuch's dystrophy (and other corneal endothelial dystrophy) 4. guttata 5. history of cataract or ocular surgical procedures that render the cornea opaque or otherwise impact its ability to be imaged using the investigational device 6. long term pmma contact lens use longer than 5 years -pathologic subjects 7. keratoconus
non-antithrombotic therapy after transcatheter aortic valve implantation trial

Conditions: Aortic Stenosis; TAVI(Transcatheter Aortic Valve Implantation); Aspirin; DAPT(Dual Antiplatelet Therapy); SAPT(Single Antiplatelet Therapy)

Summary: aspirin group: aspirin 100mg will be started within 24 hours after randomization, and continued aspirin 100mg/day the end of the study period. non-antithrombotic group: no antithrombotic agents will be administered after randomization until the end of the study period.


Eligibility criteria:
inclusion criteria: 1. patients who underwent transfemoral tavi for aortic stenosis 2. patients aged 20 years or older at the time of informed consent 3. patients who have a thorough understanding of the subject of the study and who have agreed in writing to participate in the study exclusion criteria: 1. those with perioperative complications at the time of tavi (conversion to open heart surgery, coronary artery occlusion, annulus rupture, cardiac tamponade, vascular dissection, cerebral infarction/cerebral hemorrhage, new atrial fibrillation, new atrioventricular block) 2. individuals requiring antiplatelet agents for reasons other than tavi (history of myocardial infraction, history of pci（percutaneous coronary intervention）, history of evt（endovascular treatment）, history of cerebral infraction and transient ischaemic stroke, with significant coronary artery narrowing, with high-grade carotid artery narrowing, and others judged as requiring antiplatelet therapy by the chief researcher or a sub-investigator) 3. patients requiring oral anticoagulants (patients with atrial fibrillation, history of pulmonary embolism or deep venous thrombosis, and other patients who are deemed to require anticoagulation therapy by the investigator or coinvestigator) 4. patients with egfr（estimated glomerular filtration rate） \<30 and patients on hemodialysis/peritoneal dialysis. 5. patients with a history of valve replacement in the heart valves. 6. patients who are pregnant, have childbearing potential, wish to become pregnant, or are breastfeeding. 7. patients who have a concomitant medical illness associated with expected survival less than one year. 8. patients who have the contraindications for aspirin. 9. patients with a diagnosis of severe allergy to aspirin or a history of hypersensitivity. 10. patients requiring a legally acceptable representative, patients unable to obtain written informed consent, or patients unable to understand the outline or purpose of the study. 11. other patients for whom the principal investigator or the coinvestigator judges the participation in the study inappropriate.