Kornimate/medical-research-clean huggingface dataset:
study of the genome, gut metagenome and lifestyle of patients with incident type 2 diabetes mellitus

Conditions: Diabetes Mellitus, Type 2; Metagenome; Genetic Predisposition

Summary: a case-control study to identify microbiome and genetic differences between healthy people and patients with incident type 2 diabetes mellitus.

two groups of people, one composed of healthy volunteers and the other of patients with incident type 2 diabetes mellitus who never received treatment for their condition, fill in the food frequency questionnaire and the physical activity questionnaire. dna microarray genotyping is used to process the dna samples of the participants. the data on the composition of the participants' gut microbiota is obtained through sequencing of their stool samples.

Eligibility criteria:
inclusion criteria: * confirmed diagnosis of incident type 2 diabetes mellitus exclusion criteria: * hypoglycaemic therapy prescribed for the correction of any type of hyperglycaemia * diabetic ketoacidosis * inflammatory bowel diseases (ulcerative colitis, crohn's disease, coeliac disease) * rheumatoid arthritis * tuberculosis * acute gastrointestinal conditions * irritable bowel syndrome * multiple intestinal polyposis * gallstone disease * acute pancreatitis * oncological diseases * serious mental disorders * recent (\< 6 months) antimicrobial therapy * recent (\< 3 months) proton pump inhibitors therapy * recent (\< 3 months) surgical intervention * recent (\< 3 weeks) use of probiotics, prebiotics, antacids, nonsteroidal anti-inflammatory drugs * pregnancy or breastfeeding * current alcohol/drug abuse or addiction within 12 months prior to screening * planned relocation from the study area during the study * other somatic pathologies or any factors that prevent the inclusion in the study

Keywords: gut metagenetics diabetes mellitus, type 2 genetics microbiome ffq gpaq
endoscopic ultrasound-guided ethanol injection of pancreatic cystic neoplasms

Conditions: Neoplasms, Cystic, Mucinous, and Serous

Summary: cystic tumors of the pancreas are fluid-filled growths. they are often treated by surgical removal. a safe and effective non-surgical treatment is desirable. ethanol (alcohol) injection may treat cysts by killing the lining cells of the cyst, and is an accepted treatment for cysts of other organs. in this study, participants with pancreatic cysts underwent endoscopic ultrasound (eus) guided ethanol injection of pancreatic cysts. this was a pilot study to assess safety and efficacy. the hypotheses of this study were 1) complications of eus guided ethanol injection requiring hospitalization will occur in \<10% of subjects, and 2) eus guided ethanol injection, with retreatment as necessary, will ablate at least 50% of pancreatic cysts.

eus is performed via the mouth under sedation. after a needle is placed into the pancreas cyst under eus guidance, an ethanol solution is placed into the cyst via the needle. the ethanol solution is withdrawn and new ethanol injected, and this process is continued for 5 minutes, repeatedly washing the cyst with the ethanol solution. after this treatment, usual clinical follow-up is obtained including assessments of the cyst by ct or mri scans. if a cyst of significant size persists, additional eus-guided ethanol injections of the cyst were offered.

Eligibility criteria:
inclusion criteria: 1. presence of a pancreatic cystic lesion, \> 1 cm in maximum diameter 2. treatment of the cystic lesion is desired due to symptoms or concern for subsequent malignancy 3. age \> or = 18 years 4. able to give informed consent 5. surgical treatment has been considered, and a surgical consultation offered to the patient, but: 1. subject's cyst does not meet consensus criteria for surgical resection, or 2. subject is deemed a poor operative candidate, or 3. ethanol ablation would allow a subtotal rather than total pancreatectomy, or 4. subject has decided not to undergo surgical treatment. exclusion criteria: 1. known or suspected pregnancy, or nursing 2. history of pancreatitis within past 3 months 3. main pancreatic duct is dilated to \> 4mm in neck, body, or tail 4. cyst is known to communicate with the pancreatic duct 5. cyst has a primarily microcystic architecture on eus 6. cyst is immediately adjacent to the main pancreatic duct on eus 7. cyst has a connection to the main pancreatic duct seen during eus 8. during initial cyst aspiration, more fluid is recovered than expected (suggesting communication to the main pancreatic duct) 9. pancreatic cytology has demonstrated cancer

Keywords: intraductal papillary mucinous neoplasm mucinous cystic neoplasm endoscopic ultrasound ethanol
vestibular rehabilitation and dizziness

Conditions: Dizziness

Summary: the purpose of this study is to determine whether vestibular exercises provide added benefit to balance rehabilitation in older adults with dizziness and normal vestibular function.

dizziness is among the most prevalent complaints for which people seek medical help and the incidence increases with advancing age. dizziness represents a diagnostic and treatment challenge because it is a subjective sensation, refers to a variety of symptoms (unsteadiness, spinning, sense of motion or lightheadedness), and has many potential contributory factors. dizziness is often related to vestibular disease which is treated effectively with vestibular exercises. successful management of dizziness is critical because dizziness is a major risk factor for falls in older adults. there are parallels between the effects of age-related versus disease-related loss of vestibular function - in complaints of dizziness and increased risk for falls. the investigators' question, then, is whether the same exercises that are beneficial for patients with vestibular pathology are beneficial for older patients with dizziness but normal vestibular function. older adults with dizziness who have been referred to audiology for vestibular evaluation will be randomized to receive either standard balance rehabilitation plus placebo eye exercises (con) or standard balance rehabilitation plus vestibular-specific exercises (gs). primary outcomes include symptoms, balance-related confidence, dynamic visual acuity, postural stability as measured by sensory organization test, fall risk as measured by dynamic gait index, and gait speed. assessment will occur at baseline, discharge from physical therapy (pt), 1 and 6 months post-pt.

Eligibility criteria:
inclusion criteria: * at least 50 years of age * documented balance or mobility problems * normal vestibular function, including otolith function exclusion criteria: * cognitive impairment * progressive medical issues that would impact mobility (e.g., parkinson's disease, cerebellar atrophy) * dizziness due to orthostatic hypotension or benign paroxysmal positional vertigo (bppv)

Keywords: rehabilitation aged aged, 80 and over vestibular diseases
seasonal trends of respiratory morbidity in diabetic patients

Conditions: Diabetes Mellitus; Respiratory Complication; Perioperative/Postoperative Complications

Summary: type 2 diabetes mellitus (t2dm) poses a significant burden on the patients and the health care system. the increasing number of surgery performed in elderly population results in an increased number of perioperative t2dm-related adverse effects. t2dm has a prevalence of 30-40% in a population undergoing cardiovascular surgery. cardiac surgery, especially cardiopulmonary bypass (cpb) is also known to deteriorate respiratory mechanics. therefore, the study is aimed at a retrospective analysis of seasonal trends in respiratory consequences of t2dm, i.e.: i: distribution of patients with and without t2dm presenting for elective cardiac surgery during the two-year examination period; ii: characterization of respiratory co-morbidities in the patients, iii: exploring whether the respiratory mechanics at presentation and those caused by cardiac surgery exhibit different trends in t2dm and control patients.

our study is a retrospective analysis of patient records from all patients undergoing elective cardiac surgery between january 2007 to december 2018 at the second department of internal medicine and cardiology centre cardiac surgical unit, university of szeged. electronic and paper documentation will be examined and anonymously analysed for the following information: 1. date of cardiac surgery, 2. type of cardiac surgery procedure, 3. demographic data (age, height, weight), 4. presence of t2dm (previous diagnosis, fasting plasma glucose level, glycated haemoglobin \[hba1c\]), 5. presence of respiratory co-morbidities (e.g. asthma, copd, etc.), 6. presence of other circulatory co-mobidities (e.g. hypertension, previous stroke, vascular stenosis) 6. respiratory mechanical parameters before and after cardiac surgery, 7. presence of perioperative respiratory complications, 8. history of smoking 9. blood gas measurements before, during and after surgery time series statistical analysis of all data will be carried out to discover the presence of seasonal trends in both diabetic and control patients. analysis of variance (anova) will be carried out to explore global differences between diabetic and control patients.

Eligibility criteria:
inclusion criteria: * all patients undergoing cardiac surgery with or without diabetes mellitus, age between 18-85 years during the time period january 2007 to december 2018 exclusion criteria: * patients older than 85 years * patients younger than 18 years

Keywords: cardiac surgical procedures respiratory mechanics seasonal variation
fluconazole prophylaxis for the prevention of candidiasis in infants less than 750 grams birthweight

Conditions: Candidiasis

Summary: the most common etiology of infection-related death or neurodevelopmental impairment in neonates with birthweight \<750 g is invasive candidiasis. over 70% of the premature neonates who develop invasive candidiasis will die or suffer severe, permanent neurologic impairment. fluconazole has been commonly used off-label in the neonatal intensive care unit, but definitive recommendations for its use in the nursery have been hampered by the limited number of well-designed trials. in neonates weighing \<750 g, appropriate dosing is not known, definitive safety and long-term follow up trials have not been completed, and there have not been well-powered trials conducted to establish the efficacy of the product using mortality as part of the primary endpoint. three recent proof-of-concept studies suggest that fluconazole will be safe and effective, and a recently completed pharmacokinetic study is providing data to give preliminary dosing guidance. the next logical step in drug development is proposed by this research: to conduct a pivotal trial to determine the safety and efficacy of fluconazole in premature neonates with 2-year neurodevelopmental follow-up assessment. 362 neonates, with a birthweight \<750g, were randomized at 33 us centers, to twice weekly fluconazole (6 mg/kg) or placebo for the first 6 weeks of life. the primary efficacy endpoint will be candida-free survival at study day 49. the research will establish definitive dosing, safety, and efficacy of fluconazole; it will also provide critical information on the effects of fluconazole on neurodevelopmental impairment and antifungal resistance. potential impact: approximately 17,000 neonates are born \<750 grams each year in the united states. over 5000 will die or develop invasive candida infections. demonstrating safety and efficacy of fluconazole in preterm neonates will improve the survivability and long term outcomes for these neonates.

362 subjects were randomized to the study at 33 us sites. final study visits of month 18-22 corrected age long term follow up were completed. study database is locked.

Eligibility criteria:
inclusion criteria: * informed consent from the legally authorized representative. * \> 48 hours of age and \< 120 hours old at time of first drug administration * \< 750 g birth weight * negative blood cultures for candida exclusion criteria: * history of a hypersensitivity or severe vasomotor reaction to any azole * receiving antifungal therapy for suspected/proven invasive fungal infection * medical condition, in the opinion of the investigator, may create an unacceptable additional risk * diagnosed with invasive candidiasis or congenital candida infection. * liver failure (ast and alt \> 250 u/l) * renal failure (creatinine \> 2 mg/dl) * major lethal congenital or genetic anomalies * triplet or higher multiple gestations

Keywords: candida neonate fluconazole prophylaxis colonization resistance
zenith® txd post-market surveillance in japan

Conditions: Aortic Dissection

Summary: the study is a post-market surveillance study required by japanese regulatory authorities as a condition of approval


Eligibility criteria:
inclusion criteria: * patients with thoracic aortic dissection, including attempted cases * patients with acute stanford type b aortic dissection, including attempted cases exclusion criteria: * stanford type a aortic dissection and/or chronic type b aortic dissection

Keywords: stanford type b aortic dissection malperfusion rupture acute disease endovascular procedures
a random selection of patients from the sentry study who have a bioconverted sentry ivc filter in situ with a minimum dwell time of 24 months from a single center follow up

Conditions: Recurrent Pulmonary Embolism (Disorder)

Summary: ivus evaluation of the bioabsorbable sentry ivc filter 3-5 years post deployment follow up

ivus evaluation of the bioabsorbable sentry ivc filter 3-5 years post deployment follow up

Eligibility criteria:
inclusion criteria: * 18 years of age * signed the informed consent document * participants from the sentry clinical trial willing to undergo one time ivus evaluation ( outpatient ) exclusion criteria: * any filter that remained non converted.
modified melanoma vaccine for high risk or low residual disease patients

Conditions: Malignant Melanoma

Summary: this study is designed for patients who had malignant melanoma and, following tumor removal, are now free of disease, or have only very minor residual disease, and are at a very high risk of disease recurrence. these patients will be treated with the a2/4-1bbl melanoma vaccine, a compatible melanoma cell line that has been engineered to express a molecule termed 4-1bbl, which enhances the chances of the cell line to be recognized by the patient's immune system, and to induce its stimulation. the hypothesis that drives the study states that the immune response against the cell line will also be effective against the residual tumor that may still be present in the body.


Eligibility criteria:
inclusion criteria: 1. patients included in this protocol must carry one or more of the following tissue typing alleles: hla-a2, -a24, -a33, -b35, -b49, -cw04/12(04/08). we estimate that 50% of melanoma patients will be eligible. 2. cutaneous malignant melanoma ajcc stage iib (\>4 mm) or iic (ulcerated melanoma \>4mm). 3. metastatic melanoma ajcc stage iii (nodal involvement, n1-3a,b) post-surgical removal of lymph nodes. 4. metastatic melanoma ajcc stage iv, completely resected. 5. non-resectable metastatic melanoma of low burden disease and normal ldh who have undergone at least two treatment lines, including chemotherapy (dtic, temodal, taxanes, platinum compounds), anti-ctla-4 (ipilimumab) and b-raf inhibitor if harboring the v600e braf mutation in their tumor. 6. non cutaneous malignant melanoma of respective stages including uveal and mucosal melanoma. 7. melanoma can be of either mutant or wild-type b-raf. 8. karnofsky performance status \> 80 (normal activity with effort). 9. no active cardio-respiratory disease. 10. not pregnant or nursing. women must take contraceptives during the treatment period.hematocrit \>25% and wbc \>3000. 11. informed consent of the patient. exclusion criteria: 1. administration of cytotoxic drugs or extensive radiotherapy less than 28 days prior to protocol administration. 2. active brain metastases requiring corticosteroids. 3. concurrent malignancy (other than skin cancer, carcinoma in situ of cervix and early stage prostate cancer). 4. active serious infection. 5. allergy to penicillin. 6. patient's will to withdraw from the study at any stage. 7. hiv and chronic hepatitis b and c carrier

Keywords: malignant melanoma vaccine cell line high risk residual disease
functional electrical stimulation with rowing as exercise after spinal cord injury

Conditions: Spinal Cord Injury; Paraplegia; Tetraplegia

Summary: currently, those with spinal cord injury (sci) demonstrate increased prevalence of obesity (75%) cardiovascular disease (30 - 50%), type ii diabetes (21%) and osteoporosis in the legs (100%) when compared to the general population. it is important to identify the modes and intensities of exercise most likely to generate a reduction in these inactivity-related diseases in this population. therefore, the main purpose of this pilot research project is to implement and test a form of a spinal cord injury-specific exercise, known as fes rowing (fes: functional electrical stimulation).


Eligibility criteria:
inclusion criteria: * have a spinal cord injury, c5-t12 (level), ais a-d (severity) * be aged 18-75 for duration of study * medically stable and healthy enough to complete exercise requirements * willing and able to complete the at-home training requirements as prescribed * willing and able to complete the exercise sessions as prescribed * willing and able to complete the vo2 testing throughout the study * willing and able to complete the dexa (dual-energy x-ray absorptiometry) scans during the study * able to understand and follow written or verbal instructions from study staff exclusion criteria: * current pressure ulcer(s) at sites of electrical stimulation * previous spontaneous or low-impact leg fracture * previous diagnosis of cardiovascular disease (ie enlarged heart, heart murmur) * unsatisfactory results of ekg (electrocardiogram) screening test * known thyroid dysfunction * kidney disease * cancer * blood pressure \> 140/90 mmhg * currently taking blood pressure medication * history of epilepsy * current hand, arm or shoulder injury * current deep vein thrombosis * implanted electronic cardiac device (pace maker, defibrillator, etc) * ventilator-dependent * unable to follow written and verbal instructions
an allergen biocube (abc) study evaluating the onset of action of fluticasone furoate nasal spray and olopatadine nasal spray compared to placebo

Conditions: Allergic Rhinitis

Summary: the purpose of this study is to evaluate the onset of action of fluticasone furoate nasal spray compared to olopatadine nasal spray and placebo nasal spray in reducing nasal allergic signs and symptoms following ragweed exposure in the allergen biocube (abc) after single dose administration and six consecutive days of treatment.


Eligibility criteria:
inclusion criteria: * provide written informed consent and signed hipaa form; * be able and willing to follow all instructions and attend the study visits; * if female and of childbearing potential, be not pregnant, nursing or planning a pregnancy, be willing to submit a pregnancy test at visit 1 and at exit visit, and to use adequate method of birth control * have a positive history of seasonal allergic rhinitis to ragweed; * have a positive skin test reaction to ragweed of within the past 24 months; * manifest sufficient allergic rhinitis symptoms during ragweed exposure in the abc exclusion criteria: * manifest symptoms of clinically active allergic rhinitis at the start of visit 1 or visit 2; * known intolerance or allergy to antihistamines or corticosteroids; * have a compromised lung function at visit 1; * have significant nasal anatomical deformities or any condition that does not allow subject to breathe through the nose (includes, but is not limited to: septal deviation, septal perforations, nasal polyps, rhinitis medicamentosa) * have had any nasal surgical intervention in the past; * have planned surgery (nasal, ocular or systemic) during the trial period or within 30 days thereafter; * use disallowed medications (topical, topical ophthalmic, systemic and/or injectable treatments and all anti-allergy therapies including prescription, over the counter or homeopathy, and over the counter sleeping aids) during the study or appropriate pre-study washout period
study of inv-102 ophthalmic solution in adults with moderate to severe dry eye disease

Conditions: Dry Eye Disease

Summary: phase 2 study to assess the efficacy of topically administered eyedrops of inv-102 during 4-week repeat dosing in subjects with moderate to severe dry eye disease.


Eligibility criteria:
key inclusion criteria: * subjects ≥18 and \<75 years of age * presence of moderate to severe dry eye disease (ded) in at least one eye key exclusion criteria: * presently using prescription eyedrops, except those used for dry eye disease, which must be discontinued 4 weeks prior * use of over-the-counter (otc) eyedrops except for lubricant eyedrops or artificial tears, within 1 week prior to initiation of study drug dosing * history or evidence of ocular infection within the previous 30 days * blepharitis or meibomian gland disease requiring the use of either topical or systemic antibiotics within 2 months * allergic conjunctivitis requiring treatment within 30 days * unable to discontinue contact lens wear for 2 weeks prior and for the duration of the study

Keywords: dry eye keratoconjunctivitis sicca
the differences of complications between lpd(laparoscopic pancreaticoduodenectomy) and opd(open pancreaticoduodenectomy)

Conditions: Pancreatic Neoplasms

Summary: main objective: this project intends to design a simulated rct project and clinically relevant rct study to target, selecting the study titled "short-term outcomes following laparoscopic vs open pancreaticoduodenectomy in patients with pancreatic ductal adenocarcinoma: a randomized clinical trial (short-term outcomes of laparoscopic versus open pancreaticoduodenectomy in patients with pancreatic ductal adenocarcinoma)", use the cases in the pancreatic cancer special disease cohort database, compare the differences in complications and short-term prognosis between patients with pancreatic cancer after laparoscopic and open pancreaticoduodenectomy, investigate the efficacy and safety of laparoscopic pancreaticoduodenectomy, and provide the basis and reference of real-world data for clinical relevant studies. secondary objective: to predict the incidence of postoperative complications and short-term outcomes of pancreatic cancer patients by comparing the difference of complications and short-term prognosis between laparoscopic and open pancreaticoduodenectomy, and to improve the treatment power of patients scheduled for surgery and postoperative patients.


Eligibility criteria:
inclusion criteria: * age: 18 years old, with no gender limit; * histologically confirmed or clinically diagnosed as pancreatic cancer by mdt (multidisciplinary team), without histopathological evidence; * patients may receive lpd or opd according to the mdt evaluation; * patients understand and are willing to comply with the trial; * signed written informed consent before patient enrollment; * patients who meet the clinical guidelines for intent to treat. * those who met each of the above criteria were included in the study. exclusion criteria: * patients with distant metastasis found before or during surgery, including peritoneal, liver, distant lymph node metastasis, and other organ involvement; * patients who need pancreatic neck or pancreatic tail, total pancreatic resection or other palliative surgery; * preoperative anesthesia asa score of 4 points; * a history of other malignant tumors; * pregnant or lactating women; * patients with severe mental disorders; * mdt evaluates patients with vascular invasion and requiring vascular resection based on abdominal imaging data; * patients who have participated in other clinical trials within 3 months. those who meet any of the above criteria were not included in the study.

Keywords: pancreatic cancer lpd opd complication