Kornimate/medical-research-clean huggingface dataset:
pre- vs. postoperative thromboprophylaxis in pancreatic surgery

Conditions: Pancreas Cancer; Pancreas Neoplasm; Surgery; Thrombosis; Bleeding

Summary: thromboprophylaxis for pancreatic surgery can be commenced either preoperatively or postoperatively. despite a clear trade-off between thrombosis and bleeding in pancreatic surgery patients, there is no international consensus when thrombosis prophylaxis should be commenced in patients undergoing pancreatic surgery. there are no prospective randomized trials in this field, and current guidelines are unfortunately based on very low quality evidence, that is, a few retrospective studies and expert opinion. both american and european thromboprophylaxis guidelines for abdominal cancer surgery support the preoperative initiation of thromboprophylaxis, but these guidelines do not specifically address the increased bleeding risk associated with pancreatic surgery. on the contrary, dutch guidelines recommend postoperative thromboprophylaxis only, because of lack of evidence for preoperative thromboprophylaxis. enhanced recovery after surgery (eras) society guidelines recommend preoperative thromboprophylaxis in pancreatic surgery, but the guidelines provide no supporting evidence for this recommendation. overall, the amount of evidence is scarce and somewhat contradictory in this clinically relevant field of thromboprophylaxis in pancreatic surgery. the aim of this study is to compare pre- and postoperatively initiated thromboprophylaxis regimens in pancreatic surgery in a randomized controlled trial.


Eligibility criteria:
inclusion criteria: all patients undergoing either 1. pancreaticoduodenectomy or total pancreatectomy (for any indication) or 2. distal pancreatectomy for suspicion of cancer exclusion criteria: 1. patient on anticoagulative medication (heparin, low-molecular weight heparin, warfarin, direct oral anticoagulants) during the month (30 days) preceding surgery 2. emergency operation (e.g. for trauma, infection or pancreatitis) 3. age \< 18 years 4. allergy or other contraindication to planned low-molecular weight heparin 5. inability to give written informed consent 6. pancreatic resection not performed (removed from analyses after randomization)
stribild in non-nucleoside resistant patients (sinnr study)

Conditions: HIV; Illicit Drug User

Summary: the sinnr study will evaluate the virologic efficacy (viral load \<50 copies/ml)and safety of stribild administered for 48 weeks to hiv-infected current or recent illicit drug users.

the sinnr study is a pilot, observational, open label study. it will evaluate the virologic efficacy (viral load \<50 copies/ml), safety, and immunologic response of stribild administered for 48 weeks to hiv-infected current or recent illicit drug users. approximately 30 hiv-infected current or recent illicit drug users (≥19y.o.,\<70y.o.) from vancouver infectious diseases centre and regina general hospital, university of saskatchewan will be taking an oral 1 stribild tablet once a day for 48 weeks. additionally, adherence to stribild over 48 weeks and quality of life will be measured in this population.

Eligibility criteria:
inclusion criteria: 1. participant is at least 19 years of age and less than 70 years of age infected with hiv and requiring antiretroviral therapy on medical grounds and who has acquired hiv infection through illicit drug use. 2. participant has documented resistance to nnrtis, with the presence of one or more primary resistance mutations (stanford database), on current or previous therapy. 3. the primary care provider decides to prescribe stribild. 4. participant has no ongoing issues that would lead to significant non-compliance with the study procedures even in the presence of optimal adherence support structures. 5. participant is able to read and write in the language of the questionnaires and give informed consent. 6. participant must not be taking any medication that could interact with stribild. 7. if female, participant must have a negative pregnancy test and agree to use, for the duration of the study, a method of birth control that has a history of proven reliability as judged by the investigator. exclusion criteria: 1. participant has previous exposure to stribild. 2. participant has documented resistance to any of the components of stribild. 3. participant is pregnant or breast-feeding. 4. participant has a contraindication to the use of stribild for any reason. 5. participant has active hepatitis b (hbsag positive). 6. participant has any of the following abnormal laboratory test results at screening: hemoglobin less than 10.0 g/dl, absolute neutrophil count less than 750 cells/ml, platelet count less than 50,000/ml, alt or ast less than 5x upper limit of normal (uln), creatinine less than 1.5 x uln. 7. participant, in the opinion of the principal investigator, is unlikely to comply with the study protocol or is unsuitable for any other reason.

Keywords: stribild hiv illicit dgug user
verily clinical study watch analytical validation study

Conditions: Healthy Population; Chronic Disease

Summary: this study is designed to evaluate the performance of the verily clinical study watch for the quantification of participants' movement and pulse rate when the wearer is at rest.


Eligibility criteria:
inclusion criteria: * participant is ≥ 22 and ≤ 80 years old * participant understands the study requirements and is able and willing to provide written informed consent * participant is without significant limitation in ability to participate in the study, in the opinion of the investigator * participant owns a smartphone with a data plan and be the primary user of the smartphone; smartphone must be compatible with the applications used in the study * participant is a us resident exclusion criteria: * participant has tremor or significant life-threatening arrhythmia * participant is allergic to nickel or metal jewelry * participant has a known severe allergy to polyester, nylon, or spandex * participant has a known allergic reaction to adhesives or hydrogels * participant has a tattoo covering the area where the watch face would rest on either wrist * participant has planned international travel during the study
anti-angiogenesis therapy using thalidomide in multiple myeloma

Conditions: Multiple Myeloma

Summary: the purpose of this research is to study how helpful thalidomide is in controlling the myeloma disease and to study any side effect resulting from thalidomide.

patients will receive thalidomide in the oral form (by mouth). then the dose of thalidomide will be increased each week until week 7 as long as there are no significant side effects. after week 7, patients will continue to receive thalidomide as long as there is no toxicity requiring the treatment to be stopped and as long as there is no evidence of rapid tumor growth during the treatment with thalidomide. routine physical examinations and blood tests will be done to monitor the effect of treatment and the toxicities encountered, if any, and provide the available treatments for side effects accordingly. blood tests will be done once a month for the first six months of receiving thalidomide.

Eligibility criteria:
inclusion criteria: * all patients must have a confirmed diagnosis of previously treated, active multiple myeloma * myeloma protein should be evident from which to evaluate response * must be 18 years of age or older. women of childbearing age and fertile men must use a medically acceptable means of birth control while on study and for 6 months thereafter. * patients must sign an informed consent to participate in this study, and be fully aware of the known teratogenic potential of this drug * patients must have a total white blood cell count of 2,000 k/microliters. patients may be anemic or thrombocytopenic provided this is felt to be due to extensive marrow involvement with myeloma * patients must have adequate liver function as demonstrated by a direct bilirubin of \< or = 2.0 mg/dl. exclusion criteria: * patients must not have an active infection requiring parenteral antibiotics * no other concurrent therapy for myeloma is permitted while on thalidomide

Keywords: multiple myeloma thalidomide anti-angiogenesis
safety and efficacy of sx600 administered by lumbosacral transforaminal epidural injection for radicular pain

Conditions: Lumbar Radiculopathy

Summary: this is a phase i/ii, double-blind, parallel-group, randomized, placebo-controlled multi-centre trial in 180 patients randomized 1:1:1 to receive the imp (dexamethasone acetate microspheres for extended-release injectable micro-suspension, sx600 at 12.5 mg or 25.0 mg) or placebo (0.9% sodium chloride for injection, bp) via transforaminal epidural injection to the lumbosacral epidural space.


Eligibility criteria:
main inclusion criteria: * adult aged 18 to 65 years, capable of providing informed consent, capable of complying with the outcome instruments, and meeting the attendance requirements for review as defined in the study * presenting with a history of radicular pain of duration of 4 weeks to 6 months, having failed conservative therapy. * mean worst daily leg pain score of ≥5.0 and ≤9.0 * women of child-bearing potential must use a medically accepted method of contraception for the duration of the study plus 30 days and register a negative pregnancy test prior to dosing main exclusion criteria: * documented history of allergy or intolerance to components of the investigational medicinal product, relevant radiologic contrast media, or local anaesthetics * is pregnant or lactating * has been taking corticosteroid medications routinely in the past 6 months or has received an epidural corticosteroid injection within 12 weeks of screening * has a bmi greater than 40 kg/m2 * has radiological evidence of clinically significant foraminal stenosis at l4-l5 or l5-s1 or of clinically significant spinal stenosis, or spondylolisthesis (grade 2 or higher). (note, asymptomatic foraminal stenosis at other spinal levels is not excluded). * has diabetes mellitus (type 1 or type 2)- prior confirmed hba1c or ogtt * has a history of significant leg pain unrelated to disc herniation that would significantly compromise assessment of back or leg radicular pain * has had lumbar back surgery * has received an implantable device for pain management

Keywords: sciatica low back pain lumbosacral radiculopathy leg pain
changing minds - supporting depressed elderly people with an individually tailored service model

Conditions: Depression; Psychological Well-Being

Summary: depression is one of the leading causes of emotional suffering in later life. it has been estimated that 2-5% of community-dwelling elderly people suffer from major depression, but according to recent studies, as much as 25 % have clinically significant depressive symptoms.typically, depressive symptoms in the elderly are treated solely with antidepressants. the aim of this project is to study the effects of a comprehensive psychosocial intervention on the psychological well-being, quality of life and use of services in depressed elderly people. in addition, the processes of intervention are studied from the perspective of the participants as well as the service system. the research is conducted in collaboration with the city of espoo. the design of the study combines clinical trial with qualitative process analysis.


Eligibility criteria:
inclusion criteria: * age 60+ exclusion criteria: * severe memory disease

Keywords: depression aging psychological well-being psychosocial intervention
facilitating the implementation of interim methadone to increase treatment access

Conditions: Opioid-use Disorder

Summary: the primary aim of this study is to evaluate the effectiveness of implementation facilitation (if) in promoting increased accessibility to methadone treatment.

this is a type 3 implementation-effectiveness type study using a modified stepped wedge design. the study's purpose is to examine the effectiveness of implementation facilitation (if) to prompt participating opioid treatment programs (otps) to utilize interim methadone treatment and other approaches to reduce otp admission delays. interim methadone treamtent is an evidence-based practice permitted under federal otp regulations to provide methadone treatment without routine counseling for individuals requesting methadone treatment who otherwise would not be able to be admitted to such treatment within 14 days of request. the study will be conducted at six otps in the us that are unable to admit individuals within 14 days of their request for methadone treatment. the otps will participate in a baseline pre-implementation phase, an implementation phase, followed by a sustainability phase. otps will be randomly assigned in groups of two to the order in which they will initiate the implementation phase. if will be delivered at the level of the otp staff and their state health department official responsible for otp oversight. otp staff and state health department officials will be interviewed regarding facilitators and barriers to implementing interim methadone and other approaches to reduce admission delays. de-identified data will be gathered from the otps on the effectiveness of if in prompting the implementation of interim methadone and reducing admission delays.

Eligibility criteria:
inclusion criteria (staff): * otp staff * state health department staff responsible for otp oversight exclusion criteria: * unwilling to be interviewed inclusion criteria (otp applicants): * requesting admission to otp exclusion criteria: * none

Keywords: implementation facilitation interim methadone treatment opioid treatment program
provider perspectives on beta-lactam therapeutic drug monitoring programs in the critically ill

Conditions: Sepsis; Critical Illness

Summary: the purpose of the study is to characterize various healthcare practitioners' perspectives on implementation of beta-lactam therapeutic drug monitoring in critical care practice.


Eligibility criteria:
inclusion criteria: * providers involved with beta-lactam tdm for critically ill patients exclusion criteria: * none

Keywords: pharmacokinetics therapeutic drug monitoring mixed methods implementation science beta-lactam antibiotic
exercise intolerance in heart failure

Conditions: Heart Failure With Normal Ejection Fraction

Summary: the investigators are studying whether metabolic abnormalities in cardiac and skeletal muscle in patients with heart failure with preserved ejection fraction (hfpef) are associated with debilitating exercise intolerance.

this research is being done to better understand why patients with heart failure have difficulty exercising and performing some activities of daily living. heart muscle and skeletal muscle (in the legs and arms) depend on normal metabolism (the conversion of foods to chemical fuel) to function properly. investigators will measure metabolites in the heart and leg muscles, including the levels of high energy phosphates and lipids (fats) using magnetic resonance (mr) techniques. high-energy phosphates serve as a source of energy, which is used by the heart and skeletal muscle for contraction. magnetic resonance uses magnetic fields to measure the levels of these substances.

Eligibility criteria:
inclusion criteria: * patients of either gender who are greater than 21 years of age (no upper age limit), * permission of patient's clinical attending physician, * previous clinical diagnosis of hf with current new york heart association (nyha) class ii-iii symptoms for at least 1 month, * left ventricular ejection fraction (ef) \>50% by echocardiography, mri, ct or x-ray or nuclear ventriculography within prior 12 months, * stable medical therapy for at least 30 days (no addition or removal or major (\>100%) dose change of renin-angiotensin-aldosterone system (raas) antagonists, beta-blockers, or calcium channel blockers for hypertension). exclusion criteria: * unable to understand the risks, benefits, and alternatives of participation and give meaningful consent, * contraindications to mri such as implanted metallic objects (pre-existing cardiac pacemakers, cerebral clips) or indwelling metallic projectiles, * significant valvular abnormalities, * pregnant women (women of childbearing potential will undergo blood or urine pregnancy testing), * history of clinical cad or significant epicardial coronary disease (\>50% stenosis) in major coronary artery by x-ray or ct angiography unless (a) the patient underwent prior successful revascularization with percutaneous coronary angioplasty within the prior three years and (b) there are no residual lesions of \>50% on the most recent coronary angiographic study. * history of infiltrative cardiomyopathy or constrictive pericarditis, * cor pulmonale, * significant pulmonary disease, * estimated glomerular filtration rate (egfr) \<20ml/min, * any condition other than hf which could limit the ability to perform a 6mw or cardiopulmonary exercise test (cpet) test (e.g., critical peripheral vascular disease, significant orthopedic or neurological conditions), * any diseases other than hf which are likely to significantly alter the patient's global perception of status or quality of life over a period of 6 months. * significant peripheral vascular disease

Keywords: heart failure with preserved ejection fraction hfpef
graded exposure and mindfulness meditation for patients post-acl reconstruction

Conditions: Anterior Cruciate Ligament Injuries

Summary: to evaluate the effect of graded exposure and mindfulness meditation after aclr, the investigators will determine the effect of graded exposure and mindfulness meditation to 1) decrease self-reported injury-related fear and reinjury anxiety, and 2) improve lower extremity reaction time when compared to a waitlist control group.

injury-related fear after anterior cruciate ligament reconstruction (aclr) is associated with secondary acl injury and slower reaction time. graded exposure (ge) and mindfulness meditation (mm) have reduced injury-related fear, but has not been explored together in patients post-aclr. ge and mm delivered via the headspace application is feasible for individuals post-aclr. gemm allows athletic trainers' to easily implement mm into their practice. the aim of this randomized single-blinded clinical trial is to determine the efficacy of 5-weeks of gemm to decrease injury-related fear and reinjury anxiety and improve reaction time in participants 1 to 5-years post-aclr. participants will be randomized into a gemm group or waitlist control group. participants will complete the photographic series of sports activities for aclr, reinjury anxiety inventory, the tampa scale of kinesiophobia-11 and a lower extremity reaction time task pre and post the 5-week period. the investigators hypothesize that participants in the gemm group will exhibit decreased injury-related fear and reinjury anxiety and faster reaction time when compared to the waitlist controls.

Eligibility criteria:
inclusion criteria: * ages 18-25 years * have self-reported levels of fear on the tampa scale of kinesiophobia-11 and the photographic series of sports activities for aclr * injured their knee playing or training for sports (recreational or organized) * have a history of unilateral aclr * 1 to 5-years post-aclr exclusion criteria: * history of secondary acl injury * do not exhibit elevated injury-related fear * concomitant surgeries at the time of acl reconstruction

Keywords: rehabilitation
effects of inspiratory muscle training on blood pressure levels in hypertensive individuals

Conditions: Hypertension

Summary: this research aims to evaluate the effects of inspiratory muscle training (imt) on blood pressure, in inspiratory muscle mechanoreflex, autonomic cardiovascular control in subjects with hypertension.

patients with hypertension will be selected through the outpatient hypertension of the hospital of clinics de porto alegre, for convenience. subsequently, patients will be subjected to test respiratory muscle strength (manometer), respiratory muscle resistance, cardiopulmonary exercise testing (maximum), evaluation of cardiac reflex sensitivity and autonomic control test and induction of inspiratory muscle mechanoreflex with occlusion plethysmography at baseline before the start of the training protocol. patients will randomize inspiratory muscle training for 30 minutes a day, 7 days a week, for 8 weeks with muscle training device (powerbreathe). there will be a weekly monitoring in the clinical research center of the institution where the maximal inspiratory pressure (mip) and respiratory training techniques will be reassessed and readjusted (40% of mip). the control group will be submitted to respiratory training techniques with muscle training device (powerbreathe) without load. after this period, all initial tests will be reassessed. a healthy control group study with 10 normotensive individuals will be included.

Eligibility criteria:
inclusion criteria: participants will be selected from the medical records in search of basic health unit and hypertension clinic - hospital of clinics of porto alegre (hcpa), porto alegre - rs: * diagnosis of essential hypertension with systolic blood pressure ≥140 mmhg and / or diastolic blood pressure ≥ 90 mmhg without treatment or use of antihypertensive; * only taking diuretics (monotherapy) or none; * body mass index ≤ 29.9 kg / m²; * not engaged in physical activity; * inspiratory muscle strength ≥ 70% of predicted. * inclusion of normotensive individuals with systolic blood pressure \<130 mmhg and/or diastolic blood pressure \<85 mmhg by ambulatory blood pressure monitoring (abpm). exclusion criteria: * blood pressure ≥ 160/100 mmhg * pregnant and lactating women; * deep vein thrombosis; current or previous. * diabetes mellitus; * orthopedic impairments, musculoskeletal, neurological and / or cognitive impairment, or even other diseases that compromise participation in the proposed protocol; * acute myocardial infarction within the last 6 months; * hearth failure; * angina pectoris; * pulmonary impairment from any source; * current smoking.

Keywords: breathing exercises; autonomic control; blood pressure.
analysis of four-fragment fractures of the proximal humerus: the interest of 2d and 3d imagery and inter- and intra-observer reproducibility

Conditions: Reproducibility; Four Part Fracture; Proximal Humerus Fracture; Hertel's Criteria

Summary: fractures of the proximal humerus are increasingly frequent, with numbers tripling between the 1970s and the 2000s. among these fractures, those involving the tuberosities and also the anatomic neck are a therapeutic challenge. for this type of fracture (neer's four-part fracture) the degree of displacement of the fracture needs to be understood in order to provide suitable treatment and apprehend the risks in its evolution. there is indeed, in this type of fracture, a risk of humeral head ischaemia, which will carry considerable weight in the therapy adopted. the usual classifications, such as the ao or the neer classification, have shown their limitations in terms of reproducibility and are not suitable for the prognostic assessment of these four-fragment fractures of the proximal humerus. the radiographic parameters described by hertel in 2004, on the other hand, seem to be far more relevant to routine clinical practice. the use of the scanner to improve reproducibility of the classification of these proximal humerus fractures is still controversial. the scanner is the rule to guide therapeutic strategy for complex fractures, although the reproducibility of the different assessment criteria has never been studied.

the aims of the present study were firstly to analyse inter-observer and intra-observer reproducibility for the different criteria proposed by hertel, using three types of imagery (standard radiographies, 2d and 3d scans) and secondly to assess the relevance of the use of the scanner to improve reproducibility

Eligibility criteria:
inclusion criteria: * proximal humerus fracture * standard radiographs, a 2d scan with axial, sagittal and coronal sections, and high-resolution 3d reconstructions performed in emergency settings when the patient arrived in the care facility

Keywords: proximal humerus fracture