Kornimate/medical-research-clean huggingface dataset:
tc-wyre: taxus express stent vs. cypher stent - what's your real life experience?

Conditions: Coronary Artery Disease

Summary: to compare the relative efficacy and safety of the taxus express2 stents and the cypher stents among a broad, unselected patient population treated in a nationwide, multi-center clinical registry representative of 'real-world,' contemporary clinical practice. a secondary objective is to examine performance of the two stents in pre-specified subgroup populations and examine regional and national patterns in outcomes.


Eligibility criteria:
inclusion criteria: * patients treated with a taxus express2 stent or a cypher stent between april 1, 2005 and june 30, 2005. exclusion criteria: * simultaneous treatment with both taxus and cypher stents during the index revascularization. patients who have undergone previous target vessel(s), stenting procedure within 9 months of the index procedure will be excluded.
sequential immunization with recombinant adenovirus type-5-vectored covid-19 vaccine in health adults based on 3 doses inactivated covid-19 vaccine

Conditions: Immunogenicity and Safety of a Recombinant Adenovirus Type-5-vectored COVID-19 Vaccine Using for Sequential Immunization

Summary: covid-19 is a novel coronavirus infection caused by respiratory droplets and contact transmission. with the spread of the epidemic, it has become a serious threat to global public health. china has launched a full range of vaccination including the third dose of homologous and sequential booster immunization. to further improve covid-19 vaccine immunization strategy, we start the clinic research about sequential immunization with recombinant adenovirus type-5-vectored covid-19 vaccine in health adults based on 3 doses inactivated covid-19 vaccine in zhejiang province.


Eligibility criteria:
inclusion criteria: 1. volunteers aged 18 and above at the time of screening; 2. obtain the informed consent of the volunteers and sign the informed consent; 3. volunteers are able and willing to comply with the requirements of the clinical trial protocol and complete the 6-month study follow-up; 4. have received 3 doses of sinovac/beijing biological novel coronavirus inactivated vaccine with an interval of 6-9 months. exclusion criteria: 1. patients with history or family history of convulsion, epilepsy, encephalopathy and mental illness; 2. those who are allergic to any of the components of the study vaccine, have had a severe allergic reaction to the vaccine in the past, a history of allergy or asthma; 3. serious adverse events related to vaccination occurred after previous vaccination; 4) positive urine pregnancy test in women during lactation or childbearing age; 5) acute febrile disease, infectious disease, sars history; 6) axillary body temperature \> 37.0℃; 7) suffering from serious cardiovascular diseases, such as arrhythmia, conduction block, myocardial infarction, severe hypertension and uncontrolled medication (systolic blood pressure ≥180mmhg and/or diastolic blood pressure ≥110mmhg when measured on site); 8) patients with serious chronic diseases that are in the advanced stage and cannot be controlled smoothly, such as diabetes and thyroid diseases; 9) congenital or acquired angioedema/neuroedema; 10) urticaria 1 year before receiving the test vaccine; 11) no spleen or functional no spleen; 12) patients with chronic obstructive pulmonary disease, pulmonary fibrosis and other pulmonary abnormalities; 13) history of novel coronavirus infection/illness; 14) have traveled to medium or high risk areas or left the country in the past 21 days; have a history of novel coronavirus 2019-epidemiological contact; 15) the researcher made a judgment based on various medical, psychological, social or other conditions that might be contrary to the test protocol or affect the subjects to sign informed consent.
value of percutaneous cholangioscopy after placement of a percutaneous transhepatic biliary drainage

Conditions: Bile Duct Stricture Not Treatable by ERC

Summary: in a prospective study the investigators perform repeated cholangioscopies in all patients that received percutaneous transhepatic biliary drainage (ptbd) for a variety of malignant and benign diseases. endoscopic findings and their correlation with clinical features will be recorded prospectively. the impact on clinical decision will be evaluated.


Eligibility criteria:
inclusion criteria: ptbd with at least 14 french in diameter exclusion criteria: missing informed consent

Keywords: percutaneous transhepatic biliary drainage cholangioscopy
stroke and cpap outcome study 2

Conditions: Sleep Apnea, Obstructive; Stroke; Patient Adherence

Summary: obstructive sleep apnea (osa) is associated with impaired stroke recovery. treatment with continuous positive airway pressure (cpap) may prevent this but is limited by poor adherence. in this study, the investigators enrolled eligible stroke patients undergoing inpatient rehabilitation (ipr) into an intensive cpap adherence protocol (icap) with an aim to increase tolerance and adherence to auto-titrating cpap (apap).

the scouts (stroke and cpap outcome study 2) was a single-arm, open-label study performed at 2 ipr units of the university of washington. eligible stroke patients undergoing ipr were provided an intensive cpap adherence protocol (icap) to increase tolerance and adherence to auto-titrating cpap (apap). the icap included patient education and encouragement, device adjustments, close monitoring of adherence and a 3-night run-in period of apap to identify those patients who 1. have osa and 2. have apap tolerance-- defined as participant willingness to continue apap during ipr and over the 3-month treatment period. if both criteria were met, apap treatment with icap continued during the rehabilitation stay and over a 3-month period. the goal of the intervention was to achieve 50% of subjects meeting apap adherence (an average ≥ 4 hours per night) over the 3-month treatment period. the investigators evaluated if demographic, co-morbid or stroke-specific factors predicted apap adherence and assessed the relationship between apap adherence and neurological recovery from stroke.

Eligibility criteria:
inclusion criteria: * adult patients admitted after acute ischemic or hemorrhagic stroke to one of two inpatient rehabilitation units exclusion criteria: * the investigators will exclude participants if: their stroke was a subarachnoid hemorrhage or due to a secondary cause (vascular malformation, vasculitis, brain tumor, head trauma, or predisposition to bleeding); they have active cpap use, advanced chronic lung disease requiring supplemental oxygen, heart failure (nyha class iii or iv); or they needed a nasogastric feeding tube.
characterization of immune genotypes and antibody profiles to foster the discovery of diagnosticbiomarkers of liver cancer development

Conditions: Hepatitis C Virus Infection

Summary: hepatitis c virus (hcv), which infects more than 185 million people, is a major risk factor. direct-acting antiviral (daa) therapy has significantly improved the eradication of the virus, but has not completely eliminated the risk of hcc, so careful surveillance is necessary. the genetic diversity of the natural killer receptor, histocompatibility antigens (hla) and interferon lambda 4 (infl4) activity, among other factors, have been found to be crucial in directing disease progression. importantly, these markers are detectable years before the diagnosis of hcc. in addition, polymorphic variants attributable to the expression of genes involved in innate-type immune response, such as ifnl4 and hla-e, have been shown to be predictive for the development of hcc and have not yet been extensively studied. the aim of the study is to evaluate novel circulating biomarkers, including the presence of antibodies to specific hcv proteome peptides, ifnl4 expression, and the interaction of specific hla receptors/ligands in a large cohort of hcv-positive subjects in order to create a screening strategy for the early diagnosis of hcv-associated hcc. part of the study will be devoted to describing the immune microenvironment associated with the expression of ifnl4 and hlae, evaluating them as potential prognostic indicators for hcc in hcv-infected subjects undergoing surgery for hcc, as well as in those with advanced/metastatic hcc.


Eligibility criteria:
inclusion criteria: * patients aged ≥18 years with the presence of chronic infection, fibrosis, cirrhosis or hcv- associated hcc * patients able to understand and willing to sign the of informed consent * patients to answer the questions in the questionnaire of enrollment exclusion criteria: * treatment for other oncological diseases * immunodepression congenital or acquired (hiv, organ transplantation, pharmacological)
high water intake to slow progression of polycystic kidney disease

Conditions: Kidney, Polycystic, Autosomal Dominant

Summary: polycystic kidney disease (pkd) is a genetic disease that occurs in 1 in 500 individuals and leads to kidney failure in half of all affected. currently, no treatments exist for pkd. pkd-affected kidney cells divide and multiply inappropriately, and form fluid-filled sacs called cysts. kidney cysts continue to grow throughout life, destroying normal kidney tissue, leading to kidney failure. based on evidence from basic science research it is believed that drinking high amounts of water can slow the abnormal cysts growth. this study aims to look at changes in urine composition with high water intake in pkd-affected persons compared to healthy individuals.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of autosomal dominant polycystic kidney disease by history, ultrasound, ct or mri * healthy subjects without a diagnosis of polycystic kidney disease by history, ultrasound, ct or mri * ages between 18 and 65 * healthy subjects (without polycystic kidney disease) must have an estimated glomerular filtration rate (egfr by the mdrd equation) \> 60 ml/min/1.73 m2 with no history of kidney disease exclusion criteria: * women who are pregnant or nursing * active dependency on drugs or alcohol * diagnosis of syndrome of inappropriate antidiuresis * currently taking a vasopressin agonist or antagonist * blood sodium level less than \< 135 meq/l * for healthy participants, estimated glomerular filtration rate (level of kidney function) less than \< 60 ml/min/1.73 m2

Keywords: autosomal dominant polycystic kidney disease polycystic kidney disease water loading biomarkers
a study to assess infection rate of severe acute respiratory syndrome - coronavirus 2 (sars-cov-2) and it's affect on quality of life in adult volunteers in lake county, illinois

Conditions: Severe Acute Respiratory Syndrome - CoronaVirus 2 (SARS-CoV-2)

Summary: coronavirus disease 2019 (covid-19) is an infectious disease caused by severe acute respiratory syndrome coronavirus 2 (sars-cov-2). lung failure is the main cause of death related to covid-19 infection. the main objective of this study is to assess infection of sars-cov-2 and how quality of life is affected in adult volunteers in lake county, illinois. volunteers will be recruited through digital advertisements and participants will be required to fill an online questionnaire. upon consent, participants will be required to provide nasal swab and blood sample. approximately 1250 adult volunteers living or working in lake county, il will be enrolled. participants will be followed for approximately 9 months and will be required to provide nasal swab and blood samples every 3 months and complete questionnaires every 2 weeks. there may be higher treatment burden for participants in this trial. participants will be monitored by medical assessments, blood tests and questionnaires.


Eligibility criteria:
inclusion criteria: * currently living or employed in lake county, illinois. * have regular access to computer, smartphone or tablet and sufficient internet access to connect to study platform. * willing and able to provide informed consent for collection of online data and of respiratory and blood specimens. * willing and able to follow the procedures of the study. * able to complete survey in english or spanish. exclusion criteria: * unable to provide informed consent. * unable to perform the requested study tasks and unable or unwilling to assign a proxy informant to complete the tasks. * hospitalized at the time of study enrollment.

Keywords: severe acute respiratory syndrome - coronavirus 2 sars-cov-2 coronavirus disease 2019 covid-19
food rheology and feeding in lean and obese humans

Conditions: Obesity; Overweight; Diabetes

Summary: the 2010 national health objectives call for a reduction in the prevalence of obesity. the marked recent increase in overweight and obesity prevalence implicates behavioral factors in the etiology of the epidemic. the present proposal hypothesizes the trend is attributal, in part, to increasing consumption of energy-yeilding beverages since they are a significant and increasing source of dietarty energy and they elicit weaker appetitive and dietary responses than solid foods.

three human studies are propsed to more fully characterized attributes of liquids and solids that may account for the differential appetitive responses they elicit, potential contributory mechanisms as well as the dietary implications of their consumption. study 1 will contrast the acute effects of fluid and solid foods varying in macronutrient content on satiation, satiety and feeding. study 2 will determine if the pattern of fluid and solid ingestion influences satiety and feeding by monitoring appetitive and dietary responses to energy and macronutrient matched fluid and solid loads ingested as meal components or between meal snacks. to better assess the clinical implications ofdiets incorpprating liquid or solid supplements. study 3 will entail chronic ingestion of matched energy yeilding fluid or solid loads with concurrent measurement of appetite, dietary intake, energy expenditureand body weight/composition.

Eligibility criteria:
inclusion criteria: * bmi 18-23 or 27-35 * weight stable * constant habitual activity pattern * low fruit/vegetable consumer * non-restrained eater exclusion criteria: * diabetic * taking medication known to influence appetite

Keywords: obesity food intake human energy balance beverage
ocular discomfort assessment after intravitreal injections

Conditions: Macular Degeneration; Diabetic Retinopathy; Retinal Artery Occlusion; Myopia, Degenerative

Summary: in this study, ocular discomfort following intravitreal injection in naïve patients will be studied, as well as the efficacy of wetting agent (optive eyewash) to prevent ocular discomfort.

in naive patients, the two first intravitreal injections will be studied. within the first injection, no wetting agent will be delivered. within 72hours after this first intravitreal injections, patients will be contacted by phone by a nurse to complete questionnaires on quality of life and on ocular pain and eye discomfort. after the second injection, a treatment with wetting agent will be prescribed. with 72hours after the second injection, quality of life, ocular discomfort as well as acceptability and tolerance of the eye drops will also be assessed by a phone questionnaire.

Eligibility criteria:
inclusion criteria: * patient over 18 years old * patient with social healthcare * patient understanding french language * patient requiring anti-vegf treatment by intravitreal injection exclusion criteria: * patient treated by ozurdex® before * patient with known and treated ocular dryness * non naive patient for intravitreal injection * hypersensitivity to carmellose * patient who received wetting agent within the 3 last months * history of povidone-iodine allergy * pregnant or breastfeeding mother

Keywords: intravitreal injection amd diabetic retinopathy retinal artery occlusion myopia, degenerative eye drops
distal radius steroid

Conditions: Fractures, Bone; Fractures, Closed; Radius Fracture Distal

Summary: the primary goal of this study is to compare functional outcomes (range of motion \[flexion, extension, supination, pronation\], return to work, of patients with distal radius fractures who receive intraoperative glucocorticoids to those that do not. secondary goals include comparison of pain control (number of pain pills consumed, visual analog scale (vas) pain scores) between patients with distal radius fractures who receive intraoperative glucocorticoids to those that do not. the primary endpoint of this study will occur when 18 patients in each test-group complete the 6 month follow up visit for study.

this will be a prospective, randomized, partially blinded, controlled trial where patients are randomized in a centralized fashion into 2 groups: a) control group with no intraoperative glucocorticoids administered or b) test group with administration of 10 mg glucocorticoids intraoperatively followed with a 6-day oral methylprednisolone taper course prescribed as a medrol dose pack. each group will enroll 30 patients for a study total of 60 over approximately a one year enrollment period. randomization will be set up using sealedenvelope.com simple randomizer. the randomization process will ensure balance between both arms based on sex and age of patients enrolled. all patients scheduled for distal radius orif will be screened to meet inclusion/exclusion criteria. patients will be randomized preoperatively by the research coordinator, based on a 1:1 weighting, upon obtaining to consent to either control or test group. post-op therapists will be blinded to the patient treatment group until completion of protocol activities for each patient. after surgery, patients will be followed for a duration of at least 6 months. interval follow-up information will be collected at 10 days, 6 weeks, 3 months, and 6 months. 3-view wrist radiographs will be taken at each follow-up visit.

Eligibility criteria:
inclusion criteria: * intra- or extra-articular distal radius fractures (ao 23-a2,3; 23b-1,2,3; 23c-1,2,3) treated with open reduction internal fixation (orif) * age \>18 exclusion criteria: * open fractures * pathologic fractures * concomitant ipsilateral upper extremity fracture (not including distal ulna) * medical contraindication to systemic glucocorticoids (insulin-dependent diabetes mellitus, history of avascular necrosis, allergy) * narcotic dependence * women who are pregnant or breastfeeding
management of health-related qol impairment, including pain, depression and anxiety, in people with haemophilia a and b

Conditions: Haemophilia A; Haemophilia B

Summary: the puropse of this non-interventional register and survey study is to identify the patterns of prescribed pain, anti-depressive and anti-anxiety medication and management of pain, depression and anxiety for people with haemophilia. the study will be conducted in the nordic countries (sweden, norway, denmark, finland) and the aim is to cover the entire haemophilia population in the register part of the study.


Eligibility criteria:
inclusion criteria: * part a population will be defined by having: * at least one health care contact with main diagnosis haemophilia a or haemophilia b, and/or; * at least one prescription of factor viii or factor ix concentrates, or; * bypassing agents used in the treatment of pwh during the inclusion period. * part b1 population: relevant physician at each htc with direct and frequent patient contact. * part b2 population: pwh 5 years or older listed at participating htcs exclusion criteria: * na

Keywords: blood coagulation disorder haematologic diseases coagulation protein disorder hemorrhagic disorder genetic diseases, inborn pain anxiety pain medication anxiety medication
glp-1 mediating dpp-4 inhibition in type 2 diabetes

Conditions: Type 2 Diabetes

Summary: to determine the extent to which the effects of treatment with laf237 100 mg qd on glucagon secretion are mediated by glucagon-like-peptide 1 (glp-1) in type 2 diabetic patients and healthy subjects.

design: this two center study employs a double blind, placebo controlled, cross-over study in patients with type 2 diabetes (t2d) and healthy volunteers with comparable age, gender and bmi distribution. subjects (40 patients and 40 healthy volunteers, referred to as subjects in remaining part of the document) will be randomized to 100 mg laf 237 qd or placebo for two 10-day treatment periods in a cross-over design. thirty two (32) efficacy evaluable patients are required to complete the study. each subjects will participate in an approximate 14-day screening period, a 2-week wash-out period from metformin, a 1-day baseline period and a 10-day treatment period followed by a 2-4 week wash-out period and a second treatment period. an end of study evaluation will be conducted following the completion of the second treatment period or in the event of early withdrawal or termination of the patient. at screening, subjects meeting inclusion/exclusion criteria will begin a weight maintenance diet containing 50% carbohydrates, 30% protein and 20% fat. patients will receive guidance on dietary maintenance at screening and will stay on this diet from screening to the end of study evaluation. following the screening visit, enrolled patients will start a 2 week drug wash-out period where oral hypoglycemic medication will be discontinued. during the drug wash-out period, all patients will monitor their glucose levels two times a day (prior to breakfast and dinner) using a glucometer. additionally, at one week intervals, patients will perform a seven point blood glucose test, where glucose measurements will be made prior to and two hours after each meal, and prior to bed. weekly telephone calls will be made to each patient, where the results of these glucose tests will be recorded. patients will be discontinued from the study during the wash-out period if fasting glucose levels exceed 200 mg/dl on any two consecutive measurements.

Eligibility criteria:
inclusion criteria: * treatment with either diet/exercise or metformin * hba1c 6.5 - 9.0 % * fasting plasma glucose 6.0 - 11.0 mmol/l * body-mass-index 20.0 - 35.0 kg/m² * healthy controls were required to have a normal oral glucose tolerance test (75g) and no first-degree relatives with type 2 diabetes nor a personal history of gestational diabetes exclusion criteria: * significant heart, kidney (serum creatinine ≤ 123 µmol/l in woman and ≤ 132 µmol/l in men), liver (transaminases \< 2fold upper limit of normal) and gastrointestinal disease

Keywords: gastric inhibitory polypeptide (gip) glucagon-like peptide 1 (glp-1) dpp-4 inhibition; exendin [9-39] gastric emptying glucagon incretin insulin secretion normal glucose-tolerant