Kornimate/medical-research-clean huggingface dataset:
home blood pressure in hypertension management

Conditions: Essential Hypertension

Summary: this is a prospective randomized study with two arms: the conventional and ambulatory blood pressure monitoring arm and the home blood pressure monitoring arm. the study will include both previously treated and untreated individuals. before randomization and in the end of the study, measurements will be performed using all three blood pressure monitoring methods (conventional, ambulatory and home) as well as assessment of target organ damage (microalbuminuria, electrocardiogram, echocardiogram, carotid-femoral pulse wave velocity and central blood pressure). the participants will be randomized into one of the two arms. diagnosis and titration will be decided according to either conventional and ambulatory blood pressure measurements or according to home blood pressure measurements. subjects will be followed up for one year.


Eligibility criteria:
inclusion criteria: * untreated hypertensive adults * treated hypertensive adults with uncontrolled blood pressure exclusion criteria: * stage iii hypertension * secondary hypertension * cardiovascular or renal disease * uncontrolled diabetes
comparison between four types of single dose hyaluronic acid injection in patients with knee osteoarthritis

Conditions: Osteoarthritis

Summary: study design: allocation: randomized. endpoint classification: comparative study. intervention model: parallel assignment. masking: double blind (subject, assessed) primary purpose: comparison. official title: intra-articular hyaluronic acid knee injection: randomized control trail. primary outcome measures: * lower extremity functional scale * visual analogue scale * range of motion * kellgren and lawrence class grade estimated enrollment: 100 study start date: december 2012 estimated study completion date: june 2013 estimated primary completion date: december 2013

the study include: 200 knees, 50 knees will have single injection of crespine gel, and 50 knees will have single injection of 2 ampules of intragel, also 50 knees will have single injection of crespine plus gel and 50 knees will have single injection of monovisc the patient will be randomized to crespine gel or to intragel, and crespine plus gel or to monovisc inclusion criteria: patients with osteoarthritis grade ii and iii according to kellgren and lawrence grading were included. exclusion criteria: patients with autoimmune illnesses, active inflammation or infected processes, anticoagulant, and known allergy to hyaluronic acid. target parameters: * lower extremity functional scale * visual analogue scale * range of motion * kellgren and lawrence class grade eligibility: ages eligible for study: 20 years to 70 years genders eligible for study: both accepts healthy volunteers: no criteria inclusion criteria: * age of patients between 20 and 70 years * patients with osteoarthritis grade ii and iii according to kellgren and lawrence grading exclusion criteria: * autoimmune illnesses * active inflammation or infected processes * anticoagulant * known allergy to hyaluronic acid.

Eligibility criteria:
inclusion criteria: * age of patients between 20 and 70 years * patients with osteoarthritis grade ii and iii according to kellgren and lawrence grading exclusion criteria: * autoimmune illnesses * active inflammation or infected processes * anticoagulant * known allergy to hyaluronic acid.
evaluation of the ticcs capacity to identify trauma patients with acute coagulopathy and massive bleeding

Conditions: Multiple Trauma; Massive Bleeding; Early Complication of Trauma

Summary: a prospective single-centre non-comparative non-interventional open study has been designed to validate, in a target number of 100 trauma patients, the correlation between ticcs evaluated on the site of injury and thromboelastography made on a whole blood sample taken at the latest 30 min after patient's arrival in the resuscitation room. the aim of this study was to evaluate the capacity to discriminate trauma patients suffering from active bleeding and arly acute coagulopathy of trauma and needing damage control resuscitation from those without this aggravating combination with a new purely clinical easy-to-measure pre-hospital score: the trauma induced coagulopathy clinical score (ticcs).

it started in january 2012 and was completed in june 2013. the ticcs was to be calculated for each patient. the presence of coagulopathy was to be assessed by thromboelastography measured at the latest 30 minutes after patient's hospital entry or, if not available, by standard coagulation tests (international normalized ratio or prothrombin time, activated partial thromboplastin time, fibrinogen, platelets). haemorrhagic shock was to be assessed by the treating physician at hospital entry on the basis of persistent hypotension due to a demonstrated active bleeding. surgical procedures and transfusion needs (up to 24 hours) were to be recorded all along patients' hospitalization. the transfusion of more than 4 red blood cells units and more than 3 fresh frozen plasma units within the first hour of care was defined as a massive transfusion. we defined two populations of patients. "severe" patients were defined by associating all the following conditions: active bleeding + early acute coagulopathy of trauma + need for massive transfusion + need for emergent surgical or endovascular hemostasis; "non-severe" patients were defined as patients without this 4-conditions association. patients meeting only three of the four criteria or less were thus recorded as "non-severe". quantitative variables were summarized as mean, standard deviation (sd) and range, while frequency tables were used for categorical findings. the cut-off value for ticcs was obtained by receiver operating characteristic curve analysis based on the severity of the patients. group comparisons were done by student t-test for continuous variables and by the chi-square test (or fisher exact test) for categorical variables. each trauma score was characterized by its sensitivity, specificity, positive and negative predicted values and area under the curve (auc). results were considered significant at the 5% critical level (p\<0.05). calculations were performed with the statistical analyses system statistical package for windows (version 9.3).

Eligibility criteria:
inclusion criteria: * every trauma patients admitted in our resuscitation exclusion criteria: * age under 12
new biomarkers associated with the risk of premature delivery.

Conditions: Premature Delivery

Summary: despite the progress made in the organization of care and neonatal care, prematurity remains the main cause of morbidity and perinatal mortality. this study aims to estimate the prognostic value of new biomarkers (proteomic markers) on the occurrence of preterm birth.

despite the progress made in the organization of care and neonatal care, prematurity remains the main cause of morbidity and perinatal mortality. with 7.2% of premature deliveries in france, threat of premature labor remains the leading cause of maternal transfer and hospitalization. in terms of mortality, morbidity and cost, the fight against prematurity remains a national priority in terms of public health. the diagnosis of threat of premature labor at high risk of preterm labor is difficult and clinical and laboratory criteria often remain insufficient. measurement of the cervix by endovaginal ultrasound lacks sensitivity and specificity. among the biological criteria, only fibronectin, which has a good negative predictive value, is used in current practice. despite the use of these two prognostic criteria, only 40% of hospitalized patients will give birth prematurely. recent advances in proteomics allow us to study complex proteomes and compare them. preliminary studies already carried out have revealed families of proteins expressed differently in situations of work or premature delivery. we therefore hypothesize that the study of a woman's vaginal proteome with threat of premature labor may reveal new markers of preterm labor. these markers could help the clinician in its therapeutic management and thus reduce hospitalizations, better target patients requiring tocolytic treatment and optimize the use of corticosteroids. in addition, variations in the proteome may help to understand the physiopathological mechanisms of premature delivery, which are necessary for the development of effective therapeutics.

Eligibility criteria:
inclusion criteria: * pregnant women over 18 years of age * term from 22 to 33 and 6 amenorrhea weeks * single or twin pregnancy * emergency consultant, in participating centers, for a threat of premature labor defined by: uterine contractions greater than or equal to 3 in 30 minutes clinical modification of the cervix ultrasound collar less than 25 mm * free, informed and written consent, dated and signed by the patient and the investigator before any investigation required by the research. * patient affiliated to a social security scheme. exclusion criteria: * premature rupture of membranes * placenta previa * vaginal haemorrhage at the time of sampling * uterine malformation * strapping, open bite * history of strapping and or open bite * conization * fetal malformation * associated vasorenal pathology * sexual intercourse less than 24h * gynecological examination less than 48h * vaginal treatment in progress * polyhydramnios * transfused-transfused syndrome * twin anemia polycythemia syndrome * fetoscopy during pregnancy

Keywords: biological markers
brief cognitive behavioral therapy to enhance benzodiazepine deprescribing

Conditions: Benzodiazepine Use; Insomnia; Anxiety

Summary: the goal of this clinical trial is to conduct a single-arm pilot trial of a brief cognitive-behavioral therapy-enhanced benzodiazepine deprescribing intervention in 20 older adults (aged ≥55 years) prescribed chronic benzodiazepines by their primary care clinicians.

nearly 10% of americans aged 55 years and older fill benzodiazepine (bzd) prescriptions annually. chronic use of bzd place older adults at an increased risk of falls, cognitive impairment, functional decline, preventable hospitalizations, and mortality. research study investigators will conduct a single-arm pilot trial of the intervention in 20 adults aged 55 and older currently taking chronic bzds. the aim is to evaluate feasibility/acceptability of the refined deprescribing intervention using mixed methods. at intervention end, research study investigators will conduct surveys and qualitative interviews with participants to obtain feedback on participant experience and intervention components (e.g., acceptability, usefulness, relevance, satisfaction) as well as views on future format options. using these data and the re-aim (reach, effectiveness, adoption, implementation, and maintenance) framework, research study investigators will further refine the intervention in preparation for larger scale testing and implementation.

Eligibility criteria:
inclusion criteria: * prescribed chronic benzodiazepines by their primary care clinicians at a beth israel deaconess medical center (bidmc) primary care clinic. exclusion criteria: * primary care practitioner (pcp) opt out * severe anxiety or depression symptoms
observational cohort study of sodium, weight and cardiovascular disease

Conditions: Cardiovascular Diseases; Heart Diseases; Hypertension

Summary: to investigate cardiovascular events among individuals with low sodium intake or large weight changes in a prospective observational follow-up of subjects from the trials of hypertension prevention (tohp) study.

background: sodium reduction and weight loss lead to decreased blood pressure (bp). among hypertensives, bp lowering leads to decreased risk of mi, stroke, and cardiovascular death. nonetheless, concerns have been raised about increased numbers of cardiovascular events among individuals with low sodium intake or large weight changes. design narrative: the prospective observational follow-up of the trials of hypertension prevention (tohp) includes cardiovascular events among the 4, 507 surviving participants from the ten clinical centers involved in phases i and ii of tohp. phase i was a randomized trial of the effects of non- pharmacologic interventions, including sodium reduction and weight loss, on bp over 18 months of follow-up with 2,182 participants. phase ii examined the effects of sodium reduction and weight loss on bp over a longer 36-month period in a randomized 2x2 factorial design with 2,382 participants. during follow-up in phases i and ii of tohp, several measures of both weight and sodium excretion were carefully obtained on all participants. the prospective observational follow-up specifically examines whether these values, with an emphasis on average level of sodium excretion and weight changes are predictive of later cardiovascular disease. the follow-up is conducted centrally by mail from the division of preventive medicine, which served as the coordinating center for phases i and ii, and which has been very successful in conducting such large-scale studies by mail. information on cardiovascular events subsequent to the trial periods is collected through june, 2003, representing an average follow-up of approximately fourteen years from the end of phase i and eight years from the end of phase ii. this cohort provides a unique resource to address the impact in a normotensive population of salt restriction and weight change on subsequent cardiovascular events.

Eligibility criteria:
no eligibility criteria
a trial to assess switching from ropinirole, pramipexole or cabergoline to the rotigotine transdermal system in idiopathic parkinson's disease

Conditions: Parkinson's Disease

Summary: the purpose of this trial is to assess whether it is possible for subjects with idiopathic parkinson's disease to switch from ropinirole, pramipexole and cabergoline to rotigotine transdermal system (spm 962) overnight without worsening of parkinson's disease symptoms. subjects who meet eligibility criteria will be switched overnight to treatment with rotigotine transdermal patches at a dose considered equivalent to the dose of dopamine agonist that the subject is currently taking. subjects on ropinirole or pramipexole will take their last dose at bedtime and then apply rotigotine patch(es) upon awakening the next morning. subjects on cabergoline will apply rotigotine patches 24 hours after the final dose of cabergoline. subjects will continue rotigotine treatment for 28 days, during which dose can be increased or decreased as needed. at the end of treatment, subjects can select to enroll in an open-label extension trial. the first subject was enrolled on 28 december 2004. the last subject was enrolled in june 2005 and the last subject visit was conducted in july 2005. this study is now closed.


Eligibility criteria:
inclusion criteria: * idiopathic parkinson's disease exclusion criteria: * not taking a dopamine agonist

Keywords: idiopathic parkinson's disease
longitudinal study of multi-analyte profile for dyslipidemia

Conditions: Dyslipidemia

Summary: the primary objective of this study is to determine any changes in cardiovascular risk among individuals receiving a statin by assessing their multi-analyte profile.

over the past decade there has been a growing debate about the clinical value content of a single individual diagnostic indicator of disease onset, progression or therapeutic intervention. in particular there has been a discussion about the comparative value of a single biomarker versus a panel (3-6 different analytes) versus a multi-analyte profile (\>10 different analytes) of biomarkers to provide high content clinical information about a specific disease onset, progression, remediation or treatment efficacy. with the advent of personalized medicine, and recognition of the high degree of biological variability in human pathobiology, it is important to understand the comparative value of a single biomarker/diagnostic versus a panel versus a profile. in addition, the growth of preventive medicine has spurred the development of "wellness" in individual patients, and the necessity for understanding and measuring the transition from a state of health (wellness) to ultimately a state of full blown disease onset. this complex process occurs via a multitude of biological pathways and networks and manifests at a biochemical and clinical systems level. in a previous study currently being analyzed, maihealth measured a multi-analyte profile of approximately 800 patients consisting of 400 cardiovascular compromised individuals and 400 control patients. this preliminary study was a single time point only, in which 25 individual analytes were measured as well as 3 calculated ratios or values for the 800 individuals. the current study is a small cohort time course study over 6 months involving therapeutic intervention with an fda-approved statin. the overall goal of the study is to determine the predictive capability of a single versus panel versus multi-analyte profile set of biomarkers in cardiovascular compromised patients with therapeutic intervention. the ultimate application of this research is information delivery and behavioral intervention.

Eligibility criteria:
inclusion criteria: * sign and date irb approved consent form * be between 30-65 years of age as of date of consent * have a total cholesterol value of 200-300 (units) * have an ldl cholesterol value of \> 100 (units) * able to speak and understand english * willing and able to participate for the 6 months required by the study * willing and able to provide fasting blood specimens * women of child-bearing potential must have a negative pregnancy test at screening * medically (appropriate) eligible to take the statin as determined by pi exclusion criteria: * have a body mass index (bmi) \> or = 35 * pregnant (or planning to become pregnant during the course of the study) * currently taking a statin or discontinued taking a statin within 9 months of the date of screening

Keywords: cardiovascular multi-analyte statin dyslipidemia
post marketing surveillance of the centrosflo™ tunneled ij catheter

Conditions: Pain; Dialysis Catheter

Summary: the purpose of this study is to demonstrate the stability of blood flow with the centrosflo catheter, during intermittent dialysis over a period of 6 months after placement.

the centrosflo™ tunneled dialysis catheter is a 15f dual-lumen, double-d shaped catheter similar to other "split tip" catheters in the market: outflow ("arterial") and return ("venous") lumens that separate, a subcutaneous dacron® cuff, extension sets with clamps and caps, and construction from carbothane® material. the centrosflo™ catheter contains two small pressure-relief holes near the tips. the main difference of the centrosflo catheter is in the design of the tip. current "split tip" catheters have two free ends that diverge, but are each essentially straight segments. in the centrosflo catheter the arterial lumen bends in an arc back towards the venous lumen, and the venous lumen bends towards the arterial lumen. as a result, the catheter has two curved surfaces that will rest against the vena cava wall to automatically "center" the catheter within the vein. the contact points of the catheter against the vena cava wall should be smaller and more disperse than with current straight-tip or split catheters. the following drawing demonstrates the design of the catheter, showing the current recommendation that the arterial port always be to the left. the goal of the study is to demonstrate the stability of blood flow with the centrosflo catheter, during intermittent dialysis over a period of 6 months after placement. the investigators plan to enroll 10 patients in the study.

Eligibility criteria:
inclusion criteria: * adult patients who are initiating or continuing in-center intermittent hemodialysis who are scheduled to receive a tunneled dialysis catheter in the right or left internal jugular vein * the patients may have had a prior tunneled catheter for dialysis in the right ij site. * patients will be expected to need use of the catheter for more than 45 days exclusion criteria: * patients in whom the catheter is planned to be placed into the same site as an existing catheter, by over-the-wire catheter exchange * patients unable to give informed consent
overall and disease specific survival in patients with confirmed men1 with or without pnet (pancreatic neuroendocrine tumors)

Conditions: Genetic Mutation; MEN1

Summary: objectives: the primary objective of this study is to evaluate the effect of estrogen on the development of the pnet in men1 patients. the secondary objective is to evaluate the overall survival and disease specific survival in patients who have confirmed men1 with or without pnet and a pancreatic neuroendocrine tumor in relation to their hormone status. the secondary objective is to evaluate clinicopathologic features in relation to hormone status.

retrospective review of a prospectively maintained men1 database. the patient cohort consists of all patients with confirmed men1 with or without pnet who are included in the database. the database will be reviewed to obtain patient and disease characteristics, laboratory values, imaging results, hormone parameters (menopausal status, bioidentical hormone use, oral contraception use, gestational status and diagnosis of a prolactinoma) and vital status. for the prospective portion of this study, investigators want to see the impact of estrogen on the pnet forming and progression, and would like to use two equations to assess the estrogen exposure, so investigators should collect the information of menopause, menarche, breast feed, hrt, ocp use and pregnancy. to this end, investigators will contact female patients in the database who are still living, and obtain verbal informed consent to send an email questionnaire regarding their pregnancy and hormone use history.

Eligibility criteria:
inclusion criteria: 1. the patient cohort for this study consists of all patients within the prospectively maintained men1 database within the department of surgical oncology at the university of texas md anderson cancer center. 2. patients with a diagnosis of men1 with or without pnet based on mutational analysis or defined clinical criteria were considered. 3. all patients for whom hormone status variables and survival data are available will be included. exclusion criteria: 1. due to the nature of the questions included in the prospective estrogen questionnaire, only female patients will be verbally consented to receive the questionnaire and obtain prospective data.

Keywords: genetic mutation men1 pancreatic neuroendocrine tumor pnet chart review questionnaire survey