Kornimate/medical-research-clean huggingface dataset:
web-based follow-up using cellular phone in type 1 diabetic patients under insulin pump therapy : the pumpnet study

Conditions: Type 1 Diabetes Mellitus

Summary: the purpose of this study is to determine if telecare using modern telecommunication devices can improve the metabolic control and the quality of life of type 1 diabetic patients.

we aim at comparing conventional follow-up of type 1 diabetic patients treated with continuous subcutaneous insulin infusion (csii) (face-to-face visits) with an intensive coaching using the web and the cellular phone network for data transmission and short message service (sms). this telecommunication device is called gluconet. the specific objectives are to measure the efficiency of gluconet in improving metabolic control, reducing health care costs and improving the quality of life of patients.

Eligibility criteria:
inclusion criteria: * type 1 diabetes mellitus * age ≥ 18 * hba1c between 7.5 and 10% * treated with continuous subcutaneous insulin infusion for a minimum of 3 months exclusion criteria: * unstabilized diabetic microangiopathy * ongoing pregnancy or planned pregnancy * unwilling to perform a minimum of 4 capillary blood tests per day * unable to use the gluconet device

Keywords: type 1 diabetes mellitus telecare telemedicine insulin pump therapy
thrive+ pharmacy liaison-patient navigation intervention

Conditions: Healthcare Utilization

Summary: this is a pragmatic comparative effectiveness trial (n=364) to compare two screening and referral program models to address health-related social needs (hrsn) among the intermediate risk population of boston accountable care organization (baco), a medicaid aco. the first study arm is thrive-basic, the low-touch usual care model already implemented in all primary care clinics at boston medical center (bmc) where patients are screened for hrsn and receive a printed paper resource referral guide. the second study arm is thrive+, which enhances the thrive-basic model by engaging a pharmacy liaison-patient navigator to provide targeted navigation services and motivational interviewing to ensure connection to hospital- and community-based resources. the patient navigators will also interface directly with a partner community organization, action for boston community development (abcd), to further help connect patients receiving thrive+ to community resources for hrsn. all patients in our study will receive pharmacy services via an existing pharmacy care program. patients in study arm 1 will be connected to a pharmacy liaison, which is standard clinical practice for intermediate risk aco members in the bmc general internal medicine clinics. patients in study arm 2 will receive systematic screening for and addressing of hrsn (thrive+) via a pharmacy liaison-patient navigator (a pharmacy technician trained as a patient navigator to deploy both pharmacy services and the thrive+ intervention), thereby avoiding duplication of services and multiple touches. assignment to the study arms will be linked to existing pharmacy care program enrollment activities and will be based on medical record number. the investigators' rationale for the study is that if patients' hrsn are addressed, patients will be better positioned to manage chronic conditions, adhere to preventive care plans, and less likely to use the emergency department (a conduit to inpatient care) for ambulatory care-sensitive conditions. the effectiveness of these two models will be compared with respect to alleviating hrsn and reducing acute health care utilization over a 12-month follow-up period.


Eligibility criteria:
inclusion criteria: * identified as within the 3rd to 10th percentile for healthcare utilization and cost among boston accountable care organization (baco) medicaid aco membership at the time of enrollment in the clinical program; and * attend a primary care visit with a primary care provider (pcp-nurse practitioner or physician) in general internal medicine at boston university medical center. exclusion criteria: -patients who are receiving services from the baco complex care management program.

Keywords: thrive patient navigation accountable care organization pharmacy liaison pharmacy services social determinants of health health-related social needs screening and referral medicaid aco aco
lifestyle versus ezetimibe plus lifestyle in patients with non-alcoholic steatohepatitis

Conditions: •Non-alcoholic Steatohepatitis (NASH)

Summary: * nafld (non-alcoholic fatty liver disease) has become the most common cause of liver disease in western countries (hepatic manifestation of insulin resistance); * nafld represents a cardiovascular risk factor; * lifestyle modification(weight loss)is the effective medical treatment recommended for nash (non-alcoholic steatohepatitis); * ezetimibe could represent a novel safe treatment for nafld (patel 2006. here the investigators propose a randomized controlled pilot trial to evaluate the addictive effect of ezetimibe on liver histology, biochemical and sonographic parameters in a small (n.40) number of nash patients randomized for 12 months in two arms: lifestyle vs lifestyle+ezetimibe.

to evaluate the addictive effect of ezetimibe on liver histology, biochemical and sonographic parameters in a small (n.40) number of nash patients randomized for 12 months in two arms: lifestyle vs lifestyle+ezetimibe.

Eligibility criteria:
inclusion criteria: * 1.patients older 18 years * 2.histological diagnosis of possible or definite nash, according to kleiner scorw, within 6 months before randomization - exclusion criteria: * 1)average alcohol consumption \> 20 g per day in women and \> 30 g per day in men * 2)other causes of chronic liver disease 3) history of or planned gastrointestinal bypass or any additional bariatric surgery/intervention 4)hepatic cirrhosis with child-pugh score of b or c, and/or concomitant hcc 5)recent(within 6 months) or concomitant use of agents known to cause hepatic steatosis 7)recent(within 6 months)change in dose/regimen or first treatment with vitamin e, c, betaine, s-adenosylmethionine, ursodeoxycholate, sylimarin, fibrate, statin, pentoxyfilline, angiotensin ii inhibitors, orlistat, sibutramine 8)ongoing or recent therapy (within 6 months) with vitamin d or with medications known to affect vitamin d3 metabolism 9)any additional condition that might interfere with optimal partecipation in the study, according to investigators opinion; 10)be pregnant or breastfeeding.

Keywords: •non-alcoholic steatohepatitis (nash)
key longitudinal associations with risk and glioblastoma outcomes

Conditions: Glioblastoma

Summary: the goal of this observational study is to find out what factors affect the health and risks in adults with glioblastoma (gbm), a grade 4 brain cancer. the main questions it aims to answer are: * how do genetic and immune system factors impact survival and quality of life in gbm patients? * what occupational and medical history factors are linked to the risk of getting gbm? participants will: * fill out an online survey about their medical history and lifestyle. participants will have the chance to give a blood sample (from the outer arm) for genetic and immune system testing. blood samples will be given using a home collection kit provided by the study team.

this observational study aims to investigate the various factors influencing outcomes and risks in adults diagnosed with glioblastoma (gbm). glioblastoma is a highly aggressive and malignant brain tumor, and understanding the factors that affect patient outcomes is crucial for improving management strategies and patient care. the study employs a case-only design where participants will be followed over time to observe how different factors affect their health outcomes. participants will be selected based on their diagnosis of glioblastoma and will be included in the study regardless of current treatment status or disease stage. findings from this study are expected to provide valuable insights into the factors affecting glioblastoma outcomes and may contribute to the development of personalized treatment strategies and risk assessment tools for better management of the disease.

Eligibility criteria:
inclusion criteria: * at least 18 years old * pathologically-confirmed diagnosis of glioblastoma multiforme (gbm) or grade 4 brain tumor * participant is accessible for follow-up (has a working email address) * participant is willing and able to comply with the study requirements exclusion criteria: * those who cannot read either english or spanish * those who cannot view an online survey

Keywords: glioblastoma genetic predisposition to disease risk factors quality of life questionnaires blood sample adult brain cancer observational study personal medical history survival outcomes cancer epidemiology genetics, medical immunologic factors patient outcomes health history occupational exposure
whole blood specimen collection from pregnant subjects

Conditions: Down Syndrome; Edwards Syndrome; Patau Syndrome; Klinefelter Syndrome; Turner Syndrome; DiGeorge Syndrome; Perinatal Infections

Summary: to obtain whole blood specimens from pregnant subjects to be used for research and development and clinical validation studies of prenatal assays.

this sample collection protocol allows for the identification, recruitment, and participation in women who are pregnant and are known to: 1. be at an increased risk for fetal genetic abnormalities 2. be at increased risk for congenital fetal infection by virtue of being positive by initial screening tests, or are known to have an active infection during this pregnancy. 3. possess irregular blood group antigens (the subject or the father of the baby) and are therefore at increased risk for fetal sensitization during this pregnancy.

Eligibility criteria:
inclusion criteria: * subject willing to provide consent to have up to 50 ml of whole blood collected at one or more monthly (≥25 days) clinic visits * subject is pregnant carrying a singleton fetus of 10 to 26 weeks gestational age inclusive * subject is 18 years of age or older * subject is at an increased risk for one or more of the following: * fetal gene and chromosome abnormalities * congenital fetal infection * known to possess irregular blood group antigens (subject or father of the baby) * known to have some other condition amenable to noninvasive prenatal testing exclusion criteria: * pregnancy is non-viable
prevalence of age related macular degeneration (armd) in parkinson's patients and assesment of the role of l-dopa

Conditions: Parkinson Disease; Age Related Macular Degeneration

Summary: age related macular degeneration (armd) is a major and irreversible cause of blindness among the elderly. the sub-retinal space, located between the retinal pigmentary epithelium (rpe) and the external segments of the retinal photoreceptors, plays a crucial role in this pathology. a recent epidemiologic study in the us, has shown that parkinson patients treated with l-dopa, developed only later an armd when compared to the untreated patients. the l-dopa is an endogenous ligand of the gpr43 receptor (g protein-coupled receptors), located on the rpe's cell's apical pole. this receptor, via several intracellular mechanisms, regulates the cell's exosomal and endosomal pathways: it would appear that the l-dopa, by stimulating this receptor, decreases significantly the rpe's exosome release. the contents of the exosomes is still uncertain, however in addition to their signalization role, it seems they transport pro-inflammatory components, possibly helping the cellular recruitment due to the mononuclear phagocytic systems, particularly toxic for the photoreceptors. the aim of this study is to estimate the prevalence of armd in a sample of parkinson's patients followed at fondation ophtalmologique adolphe de rothschild and to compared it to the prevalence of armd of the general population. furthermore the study aims to explore a possible causal link between l-dopa treatment and armd.


Eligibility criteria:
inclusion criteria: * patients aged of 50 years old and more * parkinson's disease exclusion criteria: * patient under a measure of legal protection

Keywords: parkinson disease age related macular degeneration l-dopa
cetuximab, radiotherapy and twice weekly gemcitabine to treat pancreatic cancer

Conditions: Pancreatic Cancer

Summary: this study is designed to establish the safety and efficacy of a combination of erbitux (cetuximab)/gemzar (gemcitabine)/radiation in patients with pancreatic cancer.

the study treatment for this protocol is * loading dose of cetuximab 400 mg/m2 * weekly cetuximab 250 mg/m2 * bi-weekly gemcitabine 50 mg/m2 * daily radiation for 28 fractions * ct scan four weeks after completion of treatment * evaluation by surgeon for resectability

Eligibility criteria:
inclusion criteria: * histologic proof of pancreatic adenocarcinoma * clinical stage i, ii, or iii disease * radiographically measurable disease * tumor tissue for epidermal growth factor receptor (egfr) status by immunohistochemistry * signed protocol consent * karnofsky performance status of at least 70% * age \> or = to 18 years * patients must either not be of child bearing potential or have a negative pregnancy test within 72 hours of treatment. * absolute neutrophil count (anc) \> 1500; platelets \> 100,000/ul. * creatinine \< 1.5 x upper limit of normal (uln) * bilirubin \< 1.5 x uln; ast \< 2.5 x uln. exclusion criteria: * acute hepatitis or known hiv * active or uncontrolled infection * significant history of cardiac disease * prior therapy which affects or targets the egf pathway * prior severe infusion reaction to a monoclonal antibody * any concurrent chemotherapy not indicated in the study protocol or any other investigational agents * any previous chemotherapy or abdominal or pelvic radiotherapy * no prior malignancy is allowed except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or malignancy for which the patient has been disease free for five years. * any severe pre-existing medical or psychiatric condition, which, in the opinion of the attending physician, will interfere with safe and appropriate treatment and follow-up on study

Keywords: stage i, ii, iii pancreatic adenocarcinoma radiographically measurable disease
efficacy and safety of 14-day concomitant therapy for helicobacter pylori infection

Conditions: Helicobacter Pylori Infection

Summary: the purpose of this study is to evaluate efficacy of a 14-day concomitant therapy for the third-line treatment of helicobacter pylori infection, and whether it is safe while maintaining an ideal eradication rates.

helicobacter pylori infects half of the world's population. h.pylori eradication is an effective approach to reduce the risk of developing gastric cancer. however, eradication rates of first-line therapy decreased over years due to the rapidly increasing antibiotic resistance of h. pylori worldwide. an ideal rescue therapeutic regimen to cure refractory h.pylori infection is currently warranted. few published paper evaluated the efficacy of 14-day furazolidone containing concomitant therapy in the third line treatment. this study aims to propose a new concomitant therapy for the patients with two or more treatment failure, and then evaluates whether adverse effects are tolerable. .

Eligibility criteria:
inclusion criteria: * patients aged 18-70 with persistent h. pylori infection. * patients failed at least three different standard eradication therapies before. previous standard eradication therapy was defined as a 10-day or 14-day quadruple regimen designed according to maastricht v report. exclusion criteria: * patients unable or unwilling to receive gastroscopy. * patients treated with h2-receptor antagonist, ppi, bismuth and antibiotics in the previous 4 weeks. * patients with gastorectomy, acute gi bleeding and advanced gastric cancer. * history of allergy to any of the drugs used in the study. * severe concomitant cardiovascular, respiratory, or endocrine diseases,clinically significant renal or hepatic disease, hematologic disorders and any other clinically significant medical condition that could increase risk. * currently pregnant or lactating. * severe neurologic or psychiatric disorders. * alcohol abuse or drug addiction. * patients with compliance lower than 90% in any previous treatment are not included. * inability to provide informed consent and other situations that could interfere with the examination or therapeutic protocol.

Keywords: concomitant therapy rescue treatment
prioriti-mtf study- testing patient response to the ideo

Conditions: Leg Injuries; Trauma

Summary: the goal of the prioriti-mtf study is to help determine whether a new type of custom designed brace, called the ideo ™ along with a physical therapy program, called return to run, improves physical function. this brace was developed for wounded warriors who wanted to return to an active lifestyle. the primary objective of this study is to examine the benefits (and cost-benefits) of an integrated orthotic and rehabilitation program that incorporates the intrepid dynamic exoskeletal orthosis (ideo) and the return to run (rtr) physical therapy regimen, but designed for scalability in the broader military environment (i.e. beyond san antonio military medical center where the program was developed)


Eligibility criteria:
inclusion criteria: 1. ages 18-60 2. currently two or more years out from a traumatic unilateral lower extremity injury at or below the knee 3. healed fractures and able to fully weight bear 4. evidence of either: * weakness of ankle dorsiflexors and /or plantarflexors resulting from leg injury (defined as less than 4 out of 5 on manual muscle test) * limited ankle dorsiflexion (\< 10 degrees) and /or limited ankle plantarflexion (\< 20 degrees) resulting from leg injury * mechanical pain with loading to hindfoot/midfoot (\>= 50 mm on a 0-100 mm visual analogue scale assessing average daily pain) * ankle or hindfoot fusion or candidate for ankle or hindfoot fusion * candidate for amputation secondary to ankle/foot impairment exclusion criteria: 1. ankle plantarflexion or dorsiflexion weakness as a result of spinal cord injury or central nervous system pathology. 2. non-ambulatory 3. surgery on study limb anticipated in next 6 months 4. medical or psychological conditions that would preclude functional testing (ex. severe traumatic brain injury, stroke, renal failure, heart disease, severe anemia) 5. neurologic, musculoskeletal or other conditions affecting contralateral extremity preventing the study of a healthy control limb 6. unable or unwilling to participate in two 4-week pt programs 7. pregnancy 8. non-english speaking

Keywords: major extremity trauma wounded warriors ideo return to run
effect of oral appliance therapy on glucose levels in patients with t2dm and osa: a pilot trial

Conditions: Sleep Apnea, Obstructive; Type 2 Diabetes Mellitus

Summary: this study will evaluate the impact on blood glucose of the use of an oral appliance to treat obstructive sleep apnea (osa) in individuals with type 2 diabetes. an oral appliance is similar to a sports mouth guard or an orthodontic retainer and is an alternative treatment to continuous positive airway pressure (cpap) for osa. oral appliance therapy has not been evaluated in patients with type 2 diabetes with respect to glycemic outcomes. this will be a 1:1 randomized controlled trial: the experimental group will receive the oral appliance and the control group will receive a sham device over the course of approximately 5 months.

osa is quite common in individuals with t2dm, occurring in as many as 60-80% of patients. the standard treatment for osa is with the use of a cpap machine. the cpap provides an air pressure to keep the airways opened during sleep so that a person with osa can breathe normally. when used appropriately, the cpap improves sleepiness and quality of life. however, about half of the patients who receive a cpap prescription cannot tolerate it and thus remain untreated and are potentially at increased cardiovascular and diabetes risk. in light of this, this study aims to see if the use of an alternative treatment for osa, oral appliance therapy, where adherence is generally superior to cpap, will improve cardiometabolic outcomes in individuals with type 2 diabetes. this pilot trial will primarily examine feasibility and assess recruitment rates.

Eligibility criteria:
inclusion criteria: * diagnosis of t2dm using current canadian guidelines * osa with ahi \> 10 events/hour using current american academy of sleep medicine (aasm) criteria for scoring respiratory events exclusion criteria: * on treatment for osa within the past 3 months * professional drivers or patients with an increased risk of driving-related accidents from clinical interview or severe subjective sleepiness (epworth sleepiness scale greater than 15) * sleep apnea with any of the following features: highly severe osa (ahi\>50 and oxygen desaturation index \> 50), severe hypoxemia (spo2\ 10% of recording time), central sleep apnea or cheyne-stokes respirations with a central apnea index \>10 events/hour * coexisting sleep disorder other than osa * active cardiovascular disease, including angina, arrhythmia or congestive heart failure * insufficient dentition or significant periodontal disease or other contraindication for oat as determined by dentist qualified in osa treatment * active and significant psychiatric disease * bmi\>35 * regular use of sedatives or narcotics
pain catastrophizing and routine assessment of patient index data 3(rapid3) in ten categories of rheumatology outpatients

Conditions: Arthritis, Rheumatoid; Spondyloarthritis; Inflammatory Rheumatisms; Systemic Disorders

Summary: fulfilling by all patients consequently seen by 6 rheumatologists in a same outpatient rheumatology clinic (in at least one month period) of a set of 6 questionnaires, including rapid3 and pain catastrophizing scales.

fulfilling by all patients (seen by 6 rheumatologists in a same outpatient rheumatology clinic from a university french hospital in at least one month period) of a set of 6 questionnaires including a rapid3 score (routine assessment of patient index data 3) and pain catastrophizing scale, as well as pain detect and hospital anxiety and depression scale questionnaires (had) , in ten predefined categories of disorders: rheumatoid arthritis; any spondyloarthritis; other inflammatory rheumatisms or systemic disorders; osteoarthritis of the upper part of the body; osteoarthritis of the lower part of the body; back pain and/or radiculalgia; bone disorders, including osteoporosis; tendinosis and other soft tissue conditions; peripheral neuropathy, including entrapment neuropathies; fibromyalgia and related conditions.

Eligibility criteria:
inclusion criteria: * any outpatient aged 18 or more, agreeing to fulfil the set of 6 questionnaires * man or woman coming to the rheumatology department of the nantes university hospital with a senior rheumatologist exclusion criteria: * patients not fluent enough in french or suffering from neurological or psychological disorders making their responses unreliable

Keywords: rapid3 pain catastrophizing
evaluation of the three-seeds mixture treatment in chronic obstructive pulmonary disease patients

Conditions: Cough

Summary: the purpose of this study is to test whether the three-seeds mixture tea reduces sputum and/or cough in copd patients, and if so, to evaluate whether the three-seeds mixture changes the lung microbiome.


Eligibility criteria:
inclusion criteria: 1. males or females ages 50-80 at the time of entry 2. non-smoker for at least 1 year 3. chronic bronchitis with fev1 \<80% and fev1/ fvc \<0.7 and daily sputum production 4. documentation of copd. we define copd as the presence of irreversible airflow obstruction, presence of emphysema on ct scan or both. this determination will be by the pulmonary physicians leading this study. 5. ability and willingness to provide informed consent. exclusion criteria: 1. current smoker 2. asthma or other respiratory diseases 3. frail patients (unintended weight loss, long term fatigue). 4. patients with acute copd exacerbation -