Kornimate/medical-research-clean huggingface dataset:
automated hovering for congestive heart failure patients

Conditions: Heart Failure

Summary: using a 2-arm, randomized controlled trial (rct) among chf patients at the university of pennsylvania health system (uphs), to test the effectiveness of applying automated hovering to improve outcomes among chf patients at high risk of readmission.

using a 2-arm, randomized, controlled trial (rct) among congestive heart failure (chf) patients at the university of pennsylvania health system (uphs), to test the effectiveness of applying automated hovering to improve outcomes among chf patients at high risk of readmission. this will leverage the electronic medical record (emr), the penn data store (an electronic repository that can be used to identify study cohorts), and the nih-funded way to health platform, which provides linkages between home-based remote monitoring devices and a server that can provide automated feedback to patients. the primary outcome will be hospital readmission rate during the 12 months of study enrollment. secondary outcomes will include cost, medication adherence and death. the investigators will enroll chf patients discharged from uphs and randomize them to either: usual care with no additional intervention; or 1) the provision of wireless pill bottles and scales with daily lottery incentives to encourage daily adherence 2) asked to provide the name and contact information of a family member or friend to serve as their support partner 3) have their weights monitored for clinically significant threshold, with verified weight gains alerts sent to the managing physician through the emr. managing providers will also be sent a weekly report of all weight measurements from the electronic scale.

Eligibility criteria:
inclusion criteria: * patients with a recent university of pennsylvania health system hospital (uphs) discharge of congestive heart failure (chf) aged 18-80 who will receive follow-up in a uphs outpatient clinic. exclusion criteria: * patients will be excluded if they will not or cannot give consent or have a markedly shortened life expectancy (listed for heart transplant,have a ventricular assist device, are inotrope dependent, metastatic cancer, or dementia) * end-stage renal disease (since they may not produce urine and be responsive to diuretics). * on dialysis * heart failure managed with a cardiomems monitor * receiving another remote monitoring/telemedicine intervention * receiving follow up care outside of uphs

Keywords: remote monitoring incentives
zirconium-89-girentuximab pet/ct imaging in renal cell carcinoma

Conditions: Renal Cell Carcinoma

Summary: girentuximab is an antibody against carbonic anhydrase ix (caix), an antigen that is expressed on the cell surface of 95% of clear cell rcc (ccrcc). zr-89-girentuximab pet/ct (positron emission tomography) may be a valuable imaging technique in the diagnosis of patients with rcc. the aim of the present study is to show the impact of the zr-89-girentuximab pet/ct on the clinical management of ccrcc patients.

more advanced imaging methods are needed to reliably distinguish benign small renal masses (srm) from renal cell carcinoma (rcc) to prevent invasive biopsies or unnecessary surgery. similarly, improved imaging methods are needed for unambiguous detection of lesions suspect for metastatic and relapse rcc during follow-up. girentuximab is an antibody against carbonic anhydrase ix (caix), an antigen that is expressed on the cell surface of 95% of clear cell rcc (ccrcc). zr-89-girentuximab pet/ct may be a valuable imaging technique in the diagnosis of patients with rcc. the aim of the present study is to show the impact of the zr-89-girentuximab pet/ct on the clinical management of ccrcc patients. thirty patients will be included in whom conventional diagnostics are inconclusive. during a multidisciplinary team (mdt) the hypothetical next step in the clinical process will be noted (e.g. further diagnostics, treatment or active surveillance). subsequently, in these patients a zirconium-89-girentuximab pet/ct will be performed. patients will receive a single intravenous dose of 5 mg zirconium-89-girentuximab (37 mbq). a pet/ct scan will be acquired 4 or 5 days after injection. the zirconium-89-girentuximab pet/ct will be read by a clinician with extensive experience in radiolabeled girentuximab imaging. the results of the pet/ct will be discussed during the mdt and will be used to decide what the next step in the clinical process will be. this step will be compared with the hypothetical next step from the mdt before the scan.

Eligibility criteria:
inclusion criteria: in order to participate in this study, a subject must meet all of the following criteria: 1. his or her clinician should face a diagnostic dilemma; e.g. * patients with a renal mass of unknown origin, or * patients with a primary renal mass in whom it is unclear whether there is metastatic disease, or * patients with a history of clear cell rcc with a suspicion of relapse or metastatic disease. 2. minimum age 18 years 3. signed informed consent exclusion criteria: * history of a caix-negative or non clear cell rcc. * administration of tyrosine kinase inhibiters within 1 month prior to inclusion. * any medical condition present that in the opinion of the investigator will affect patients' clinical status. - administration of a radioisotope within 10 physical half lives prior to study enrollment * pregnancy or lactation. * known hypersensitivity or haca (human anti chimeric antibodies) against girentuximab.

Keywords: zirconium-89 pet/ct imaging girentuximab
effect of a supervised exercise program in patients with chronic low back pain

Conditions: Low Back Pain; Muscle Atrophy; Diagnostic Imaging; Exercise Therapy

Summary: this study evaluates the effect of a supervised exercise program on paraspinal muscle morphology and function, as well as disability/function in patients with non-specific chronic low back pain. half of the participants will do a targeted paraspinal muscle exercise program, while the other half will do a general exercise program.


Eligibility criteria:
inclusion criteria: 1. chronic nonspecific lbp (\>3 months), defined as pain in the region between the lower ribs and gluteal folds, with or without leg pain 2. currently seeking care for lbp 3. between 18 and 60 years of age 4. english or french speaker 5. score of "moderate" or "severe" disability on the odi questionnaire 6. do not currently engage in sports or fitness training specifically for the lower back muscles (3 months prior the beginning of the study). exclusion criteria: 1. evidence of nerve root compression or reflex motor signs deficits (e.g. weakness, reflex changes, or sensory loss with same spinal nerve) 2. previous spinal surgery or vertebral fractures 3. other major lumbar spine structural abnormalities (e.g. spondylolysis, spondylolisthesis, or lumbar scoliosis \>10°)

Keywords: low back pain; paraspinal muscle; exercise; diagnostic imaging; randomized controlled trial
anti-xa guided dosing of low molecular weight heparin for prevention of venous thromboembolism following traumatic injury: a multicentre pilot randomized trial

Conditions: Venous Thromboembolism (VTE); Trauma Related Injuries

Summary: this multicentre pilot trial will assess the feasibility of a full-scale, randomized trial to determine whether bloodwork guided dosing of blood thinners reduces the risk of clotting in high-risk trauma patients. patients will receive either standard of care dosing or dosing with adjustments based on bloodwork to achieve a minimum therapeutic threshold.

this multicentre pilot trial will assess the feasibility of a full-scale, randomized trial to determine whether anti-xa guided dosing of low molecular heparin (lmwh) reduces the risk of venous thromboembolism (vte) in high-risk trauma patients. patients will receive either standard of care fixed dosing of enoxaparin or 0.5 mg/kg twice daily with dose adjustments to achieve an anti-xa trough level between 0.1 and 0.2 iu/ml.

Eligibility criteria:
inclusion criteria: * patients 18 years of age or older admitted to a hospital ward or intensive care unit following a traumatic injury involving two or more body systems (head, chest, abdomen, pelvis, extremity) and meeting at least one of the following high-risk criteria previously identified in a recent systematic review (1): age ≥ 65, body mass index ≥ 30 kg/m2, injury severity score ≥ 16, pelvic injury with activity restrictions, lower extremity injury with activity restrictions, or surgery during the index hospitalization. to be eligible, patients must be deemed appropriate for pharmacologic prophylaxis by the most responsible physician and randomized with the intention to receive prophylaxis within 48 hours of admission. prior to randomization, there is no restriction on whether or not patients have previously received pharmacologic or mechanical prophylaxis. exclusion criteria: 1. greater than 7 days since time of injury. 2. requirement for therapeutic anticoagulation or dual-antiplatelet therapy 3. unable or unwilling to receive pharmacologic prophylaxis within 48 hours of admission. 4. history of allergic reaction or sensitivity to lmwh. 5. thrombocytopenia with platelets \&lt; 30. 6. expected discharge or transfer from hospital within 72 hours.

Keywords: trauma venous thromboembolism prophylaxis
muscle activity evaluation of maxillary bilateral bounded partial denture fabricated by bre-flex versus peek

Conditions: Maxillary Class III Modification I Edentulous Patients

Summary: evaluation of the muscle activity of masseter in tooth borne partial denture wearers (class iii modification 1 kennedy's classification) with two different denture base materials (breflex and peek) by means of electromyograph.


Eligibility criteria:
inclusion criteria: * all patients must have kennedy class iii modification i upper partially edentulous ridges. * the remaining teeth have good periodontal condition, with no signs of attrition or gingival recession. * all patients have skeletal angle's class i maxillo-mandibular relationship and have sufficient interarch distance. * free from any systemic or neuromuscular disorder that might affect chewing efficiency of masticatory muscles. * free from any tempro-mandibular joint disorder. * the patients have good oral hygiene and low caries index. exclusion criteria: * patients having abnormal habits as bruxism or clenching. * patients having hormonal disorders as diabetes, thyroid or parathyroid hormonal diseases were not included. * teeth with compromised bone support. * patient with xerostomia or excessive salivation. * patient with abnormal tongue behavior and/or size.

Keywords: "nylon denture base" and "peek partial denture"
epirubicin and cyclophosphamide compared with epirubicin and paclitaxel in treating women with metastatic breast cancer

Conditions: Breast Cancer

Summary: rationale: drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. combining more than one drug may kill more tumor cells. purpose: randomized phase iii trial to compare the effectiveness of epirubicin and cyclophosphamide with epirubicin and paclitaxel in treating women with metastatic breast cancer.

objectives: i. compare the activity and toxicity of epirubicin and cyclophosphamide with that of epirubicin and paclitaxel in patients with metastatic breast cancer. outline: patients are randomized to receive either epirubicin and cyclophosphamide or epirubicin and paclitaxel. each drug combination is given every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. projected accrual: a total of 704 patients will be accrued for this study.

Eligibility criteria:
disease characteristics: histologically proven carcinoma of the breast with metastases no cns metastases hormone receptor status: not specified patient characteristics: age: not specified menopausal status: not specified sex: female performance status: not specified life expectancy: not specified hematopoietic: not specified hepatic: bilirubin no greater than 1.25 times upper limit of normal (uln) sgot and sgpt no greater than 2 times uln (no greater than 5 times uln with liver metastases) renal: not specified cardiovascular: ejection fraction within normal range no history of cardiac disease including myocardial infarction, cardiac failure and angina other: not pregnant no prior or concurrent malignancy that is likely to interfere with protocol treatments or comparisons prior concurrent therapy: biologic therapy: not specified chemotherapy: no prior chemotherapy other than adjuvant no prior high dose adjuvant chemotherapy requiring transplantation cumulative dose of doxorubicin no greater than 300 mg/m2 permitted cumulative dose of epirubicin no greater than 400 mg/m2 permitted at least 6 months since prior anthracyclines endocrine therapy: not specified radiotherapy: not specified surgery: not specified

Keywords: stage iv breast cancer
ci-aki in patients with stable cad and comorbidities. are we doing better?

Conditions: Stable Angina; Acute Kidney Injury; Contrast-induced Nephropathy

Summary: patients aged 18-89 with stable cad and comorbidities receiving optimal medical treatment requiring pci with iodinated contrast media. the aim of the study is to assess the prevalence of contrast-induced aki in 2012-2013 and 2017 cohorts and to evaluate the potential risk factors of ci-aki to better guide the prevention in patients of higher risk.


Eligibility criteria:
inclusion criteria: * informed consent * male and female patients 18 y. o. and older * verified stable coronary artery disease (cad) * receiving optimal medical treatment and requiring percutaneous coronary intervention (pci) with iodinated contrast media exclusion criteria: * pregnancy, lactation * conditions affecting the prognosis (kidney failure, liver failure, oncology) * acute coronary syndrome (acs) * stroke * contraindications to pci * therapy with nephrotoxic drugs during the enrolment which cannot be stopped * refusal to sign the informed consent

Keywords: acute kidney injury coronary artery disease contrast-induced acute kidney injury comorbidity ci-aki stable cad
cancer, nutrition and taste - validation of the canut-qva questionnaire on eating habits in cancer patients

Conditions: Hematologic Cancer; Undernutrition; Chemotherapy Effect; Taste Disorders; Chemotherapy-Induced Change; Olfactory Disorder

Summary: cancer patients are at high risk of undernutrition, which is generally more pronounced for solid tumours (upper digestive tract, ear nose and throat (ent), bronchial tubes). this undernutrition leads to major weight loss and cachexia, and may represent the first sign of a call for a diagnosis of cancer. cancer-related undernutrition is multi-factorial origins and has multiple consequences. chemotherapy treatments can induce various adverse effects in patients, including sensory disturbances at the beginning of treatment in addition to disturbances that may already be present before any treatment. the alteration of taste and odour, observed in 86% of patients, can induce a change in food preferences, promote the development of aversions, and therefore, lead to a significant reduction in the pleasure of eating. loss of appetite, decreased food intake and the development of aversions to certain foods are situations experienced by a large proportion of patients treated with chemotherapy. the assessment of taste disorders in patients treated with chemotherapy is established through the use of questionnaires, interviews and taste tests. changes in the perception and identification of salty, sweet, bitter and sour flavours are common in patients treated with chemotherapy. as regards food products, patients report developing olfactory hypersensitivity mainly for food of animal origin, in particular for odours of fish, frying, cheese and eggs. the canut project aims to study the effect of pathology and chemotherapy on gustatory and olfactory mechanisms, and in particular on interindividual differences in the perception and appreciation of food. in order to monitor the evolution of patients' eating habits over time, the diet-related quality of life questionnaire (canut-qva) was constructed from items selected from the well-being related to food questionnaire (wellbfq) after eliminating questions that were too general or expressed in terms of importance to use perception-related responses as a priority. after this part, an evaluation of the 9 dimensions of the canut-qva questionnaire will be performed.


Eligibility criteria:
inclusion criteria: * patient with solid or hematological cancer (any stage of disease and any treatment) diagnosed within 12 months of inclusion. * patient who does not object to participate in the trial * patient affiliated to a social security system exclusion criteria: * minor patient (age \<18 years). * patient under trusteeship, curatorship or protective measures. * patient who has already completed the questionnaire. * patient not sufficiently able to speak french to answer the questionnaire
intra-operative pancreatoscopy in patients with ipmn

Conditions: Intraductal Papillary Mucinous Neoplasm

Summary: to demonstrate the added value of intraoperative pancreatoscopy in patients undergoing partial pancreatic resection for the treatment of intraductal papillary mucinous neoplasm (ipmn) as it pertains to detection of discontinuous (skip) lesions in the remnant pancreas; to generate a hypothesis for a subsequent randomized control trial.

the primary objective of this study is to demonstrate the added value of intraoperative pancreatoscopy in patients undergoing partial pancreatic resection for the treatment of intraductal papillary mucinous neoplasm (ipmn) as it pertains to detection of discontinuous (skip) lesions in the remnant pancreas. a secondary study objective is to generate a hypothesis for a subsequent randomized controlled trial comparing diagnostic accuracy of intra-operative pancreatoscopy and spybite™ with the diagnostic accuracy of intra-operative frozen section in patients undergoing resection

Eligibility criteria:
inclusion criteria: 1. patient scheduled for surgery for suspected md-ipmn or mixed ipmn within 4-6 weeks of enrollment 2. diameter of pancreatic main duct \>5mm on pre-operative mri or ct 3. written informed consent from patient to participate in the study, including compliance with study procedures exclusion criteria: 1. contraindication for pancreatoscopy 2. age: less than 18 years 3. pregnant women, evaluated per local clinical standard

Keywords: ipmn spyglass pancreatoscopy intraductal papillary mucinous neoplasm intraoperative surgical
improving nutritional adequacy of icu survivors in a prospective interventional way: the bright side study

Conditions: Malnutrition

Summary: the objective is to increase caloric adequacy in patients who survived critical illness and are admitted to the ward by the use of a pro-active inclusive nutritional strategy including supplemental parenteral and/or enteral nutrition and/or oral nutritional supplements guided by indirect calorimetry. this enables the investigators to address, within a clinical/scientific context, a recently demonstrated but until now relatively neglected 'dark side' of patient care at uz brussel, comparable to limited global evidence : iatrogenic malnutrition of icu survivors. the use of a newly developed clinical pathway and nutrition strategy (oral, enteral and parenteral) led by a single spoc (single point of contact) for patients surviving intensive care will have a clear objective: to address the nutritional deficit in all patients.


Eligibility criteria:
inclusion criteria: * adult ≥ 18 years * icu stay ≥ 7 days * ward stay ≥ 3 days * nutritional therapy not restricted * heterogeneous diseases exclusion criteria: * patients \< 18 years * icu \< 7 days * ward stay \< 3 days * advanced care planning with impact on nutritional therapy * patients with palliative care * metabolic derangements such as metabolic diseases * pregnancy
patient preferences of a resect and discard paradigm

Conditions: Colonic Polyps

Summary: the investigators conducted a study "resect and discard diminutive polyps: a new paradigm" (irb id # 201105473) from september, 2011 to july, 2013. this study examined whether doctors performing colonoscopy are accurate enough at predicting histology of small colorectal polyps, such that these small polyps could be resected and discarded (instead of being sent to pathology). one of the main advantages of this approach is significant cost savings by reducing pathology costs associated with screening and surveillance colonoscopy. a disadvantage is that there is a 0.03% chance that small polyps contain cancer. there is no data regarding patient preferences toward this approach. the investigators therefore designed a patient survey to determine the patient's view toward this approach.

the american society of gastrointestinal endoscopy (asge) published a review article on a new paradigm in colorectal cancer screening termed "resect and discard". this new paradigm challenges the current practice of sending all colorectal polyps, regardless of appearance or size, to pathology for analysis. "resect and discard" describes a new approach in which small polyps could be removed, but be discarded instead of sent for pathology analysis. this is based on data showing that gastroenterologists can predict the pathology of small colorectal polyps with 80-90% accuracy, and that discarding small polyps would not alter surveillance recommendations. neither the asge document nor published research, however, assessed patient attitudes toward this approach. this study surveyed patients prior to first time screening colonoscopy, in order to determine their preferences about the resect and discard approach; specifically would patients be willing to pay for pathology analysis of small colorectal polyps with their own money, and what factors influence their decision. we also inquired about factors that would influence their decision to pay/not pay pathology costs themselves.

Eligibility criteria:
inclusion criteria: • indication for colonoscopy is screening or routine polyp surveillance exclusion criteria: * indication for colonoscopy other than screening or surveillance * colon cancer identified at time of colonoscopy * known polyposis syndrome, or polyposis identified at colonoscopy