Kornimate/medical-research-clean huggingface dataset:
impact of treatment with oral anticoagulants of patients with fractures of the upper end of the femur

Conditions: Direct Oral Anticoagulants (DOACs); Femoral Fractures; Surgery

Summary: in 2023, oral anticoagulant treatments (anti xa: apixaban , rivaroxaban, etc.) are tending to replace anti vitamin k treatments in many medical indications. their prescription is increasing rapidly in the elderly. in this context, the nimes university hospital receives a large number of elderly patients who have suffered a fracture of the end of the femur requiring surgery and who are taking anti xa drugs.to avoid massive intra- and post-operative haemorrhage, surgical management is postponed because of the need to suspend the treatment, allowing a return to near-normal biological haemostasis within a few days. no consensus has been reached on the withdrawal period required to authorise surgery, as the elimination kinetics of the drug are altered in this context (elderly patients, dehydration, hypovolaemia, impaired renal function). a plasma assay (threshold of \<30 to 60 ng/ml) has been proposed without any real justification. this waiting period exposes the elderly to excess mortality. reversing these treatments by adding coagulation factors would be an attractive alternative, as it would allow surgery to be performed earlier, but this would expose patients to an increased thrombotic risk. before considering a prospective randomised study (early vs delayed surgery on aod), we wish to retrospectively analyse data on patients admitted to the nimes university hospital on anti xa and operated on for fracture of the upper end of the femur between 1 january 2022 and 1 june 2023


Eligibility criteria:
inclusion criteria: * adult patient \> 65 years * emergency admission for isolated fracture of the upper end of the femur * requires osteosynthesis surgery * hospitalized in geriatric perioperative unit, chu nimes (upog) * on anti xa therapy prior to hospitalisation exclusion criteria: * patients under court order or not affiliated to a social security scheme * outpatient surgery * multiple fractures and/or other associated surgery * not admitted to upog * no surgery
comparison of the efficacy of duloxetine and pregabalin in patients with knee osteoarthritis with mix type pain

Conditions: Knee Osteoarthritis

Summary: osteoarthritis (oa) is a common degenerative joint disorder associated with chronic pain at older age.it is known that patients with osteoarthritis experience nociceptive and neuropathic pain to varying degrees. addition of molecules targeting neuropathic pain to conventional therapy has been shown to improve treatment response in the management of osteoarthritis.the aim of our study is to evaluate the effect of duloxetine and pregabalin on pain, functional capacity, quality of life, depression, anxiety and sleep patterns in knee osteoarthritis.

a total of 66 patients (aged 40-69) with knee osteoarthritis were randomized into two treatment groups to receive either duloxetine 60mg/day or pregabalin 300mg/day. the patients were evaluated before and one month after treatment and three months after treatment using the visual analog scale (vas-pain), neuropathic pain diagnostic questionnaire (dn4), short form-36 (sf-36) questionnaire, western ontario and mcmaster university osteoarthritis i̇ndeks (womac), beck depression scale (bds), beck anxiety akalası (bas), pittsburg sleep quality index (psqi).

Eligibility criteria:
inclusion criteria: * aged 40-69 * diagnosed with knee osteoarthritis according to the american college of rheumatology (acr) criteria * grade 2-3 knee osteoarthritis according to kellgren-lawrence grading system * vas-pain score: 4 and above * neuropathic pain diagnostic questionnaire (dn4) score: 4 and above * body mass index value: 40 and below exclusion criteria: * a history of trauma or surgical operation in the knee region * diabetes mellitus * fibromyalgia * inflammatory rheumatic disease * central or peripheral neurological disorder * severe cardiac, pulmonary, or malignant disease * invasive treatment for knee last 3 months

Keywords: knee osteoartrhritis duloxetine pregabalin pain
molecular mechanisms of malignant cerebral edema after lhi

Conditions: Cerebral Edema

Summary: the study is to explore the molecular mechanisms underlying the occurrence of malignant cerebral edema (cerebral hernia) after large hemispheric infarction. acute lhi (\<=48h) patients that develop cerebral hernia or not within 5 days post-stroke onset, as well as the healthy controls will be studied. the participants will be followed for up to 6 months post stroke-onset, and their modified rankin scale (mrs) will be recorded. a mrs score of 0-4 is considered as a favorable outcome while a score of 5-6 as an unfavorable one.

a total of 80 patients with acute large hemispheric infarction (lhi) within 48h after occurrence admitted into nicu of xuanwu hospital as well as 40 healthy volunteers will be recruited. the patients' baseline characteristics, treatment and changes of clinical conditions will be recorded, and icp monitoring (d2-d7 post-stroke), chest x-ray (d2, d7, d14 post-stroke), ecg (d2, d7, d14 post-stroke), cerebral vascular ultrasound, tcd and head mri (t1wi, t2wi, flair, dwi) on d2 and d14 post-stroke will be performed. blood samples from both the lhi patients (d2, d4, d7, and d14 post-stroke) and the controls will be analyzed for neu, tnf-alpha, il-1b, il-6, il-8, il-17, icam-1, vcam-1, mpo, ne, mmp-9,mirna, free dsdna, h3cit and netosis levels. all patients were treated for brain edema with osmotic medications-either intravenous 20% mannitol or 10% hypertonic saline. in addition, some patients were treated with decompressive surgery.the patients will be followed up to 6 months and their modified rankin scale (mrs) will be recorded. a mrs score of 0-4 is considered as a favorable outcome while a score of 5-6 as an unfavorable one. statistical differences in the different parameters between different groups at different time points will be analyzed by spss 22.0 software.

Eligibility criteria:
inclusion criteria: * 1. 18-80 years old; * 2. clinical diagnosis of large hemispheric infarction * 3. within 48h after stroke onset. exclusion criteria: * 1. clinical diagnosis of severe infection; * 2. clinical diagnosis of severe heart, liver or kidney diseases; * 3. clinical diagnosis of bleeding tendency, active bleeding or hematological diseases; * 4. malignant tumor; * 5. modified rankin scale (mrs)\<2 before stroke onset.

Keywords: mechanism, cerebral edema, large hemispheric infarction
assessment of airways mechanical properties by fot and lir during anesthesia

Conditions: Anesthesia

Summary: the aims of the present study are: 1. to evaluate the effect of the induction of anaesthesia and paralysis in terms of changes in oscillatory mechanics parameters 2. to evaluate the mechanical properties of the respiratory system in terms of input and transfer oscillatory impedance in response to peep changes

it has been recently shown that respiratory system reactance (xrs) obtained by the forced oscillation technique (fot) at 5 hz is more reliable than dynamic compliance for assessing lung collapse and the effects of lung rms in a porcine ali model ( ref.1,2). specifically, xrs (and its derived variable cx5, the oscillatory compliance at 5 hz) identifies the minimum positive end-expiratory pressure (peep) level required to maintain lung recruitment with high sensitivity and specificity. moreover, it has been recently demonstrated that xrs may be used to identify the lowest level of peep able to prevent atelectasis and that peep setting strategy based on maximizing xrs is able to limit lung injury compared to oxygenation-based approach in a porcine lavage model of lung injury. ( ref.3) recently, at the biomedical engineering department of politecnico di milano measurements of chest wall displacement have been successfully performed by means of an optical sensor realized using a laser self-mixing interferometer (lir). the advantage of this approach is that it is contact-less, that by deflecting the laser been it is possible to scan any region of the chest wall surface and that it allows to measure also low-frequency vibrations. protocol 1. the baseline pulmonary function will be assessed by spirometry before surgery. 2. just before surgery measurements of oscillatory mechanics will be performed at the following stages: * awake patient * spontaneous ventilation through the laryngeal mask after induction of anesthesia * pressure controlled ventilation (pcv) after the administration of neuromuscular blocking agent and intubation and peep 0 cmh2o * pcv with peep 5 cmh2o * recruitment maneuver (rm) (peak pressure 30 cmh2o and peep 15 cmh2o) for 2 minutes * pcv with peep 5 cmh2o after rm at each stage the following measurements will be performed: * input impedance at 5-11-19 hz by fot * the movements of the chest wall assessed by laser interferometry (lir) applying two different stimulating waveforms: 5-11-19 hz and 100 hz * functional residual capacity (frc) * arterial blood gas measurement (abg)

Eligibility criteria:
inclusion criteria: * age \>18 years * asa i-ii, scheduled for elective surgery requiring general anesthesia * signed informed consent exclusion criteria: * patient refusal * bmi \> 35 * co-existing respiratory disease (copd, asthma, restrictive lung disease) * pregnancy

Keywords: forced oscillatory technique laser interferometry intravenous anesthesia mechanical ventilation pressure controlled ventilation airways mechanical properties respiratory system reactance oscillatory mechanics atelectasis
fetal neurobehavioral development in methadone maintained pregnancies

Conditions: Opioid-Related Disorders

Summary: the purpose of this study is to examine differences in fetal neurobehavior at peak (2 hours after oral dose) vs. trough (2 hours before oral dose) maternal plasma methadone levels.

this study will examine differences in fetal neurobehavior at peak (2 hours after oral dose) vs. trough (2 hours before oral dose) plasma methadone levels. anecdotal clinical observations suggest that fetal activity is increased at trough methadone levels and decreased at peak methadone levels, yet the investigators do not understand how in utero methadone exposure affects fetal neurobehavioral state development.

Eligibility criteria:
actively enrolled pregnant patients in cap sa treatment. inclusion criteria: * maternal age 18-40 years * single intrauterine fetus * estimated gestational age of 32 weeks * dsmiv criteria for opioid dependence according to e-module of the scid * daily methadone maintenance at a stable dose for greater than a week exclusion criteria: * concurrent dsmiv axis i diagnosis that would preclude informed consent procedures (i.e., schizophrenia, major depression) or confound study outcomes (e.g., alcohol dependence) * presence of a serious medical or psychiatric illness requiring chronic medication or other intervention (i.e., hiv infection) that may confound data interpretation * evidence of preterm labor * evidence of prescription drug use (e.g., antidepressants, tranquilizers) * presence of major congenital fetal malformation * recent use (last month) of other illicit drugs (e.g., cocaine, marijuana) based on self report or positive on-trak urine drug toxicology at time of actograph sessions * split methadone dosing schedule

Keywords: methadone fetus
prospective rct lidocaine & levobupivacaine on block dynamics after subparaneural popliteal sciatic nerve block

Conditions: Musculoskeletal Diseases or Conditions

Summary: sciatic nerve block at the popliteal fossa is indicated for foot or ankle surgery, and the introduction of ultrasound guidance (usg) has improved the ease and accuracy of the performance of this block. recent studies proved that subparaneural injection is associated with faster block onset, higher block success rate, and prolonged block duration suggesting subparaneural compartment of the sciatic nerve is a desirable site for local anaesthetic injection. data from an ongoing trial in the investigator's institution comparing the block dynamics of subparaneural injection of 30ml 0.5% levobupivacaine (chirocaine) above and below the bifurcation of the sciatic nerve at popliteal fossa has also shown that the time to 'readiness for surgery' was faster when the injection was performed below the bifurcation of the sciatic nerve. lidocaine (xylocaine) has a better pharmacokinetic and pharmacodynamics profile than levobupivacaine and is also widely used as local anaesthetic agent in clinical practice. since there is no data comparing the block dynamics of lidocaine and levobupivacaine, this study aims to study and compare the block dynamics of lidocaine and levobupivacaine when given as a subparaneural injection below the bifurcation of the sciatic nerve at the popliteal fossa. in this study, the investigator hypothesizes that the use of lidocaine as the sole agent for this block will fasten the time to 'readiness for surgery' as compared to levobupivacaine when given as a subparaneural injection below the bifurcation of the sciatic nerve at the popliteal fossa.

this study will involve performing ultrasound guided subparaneural popliteal sciatic nerve block for 40 patients by using either lidocaine or levobupivacaine. both are commonly used local anaesthetics for regional anaesthesia in daily clinical practice. patients will be enrolled from the elective orthopaedic surgical list at prince of wales hospital after informed consent.

Eligibility criteria:
inclusion criteria: * american society of anesthesiologists (asa) physical status i-iii * adult and scheduled to undergo elective forefoot surgery under regional anaesthesia exclusion criteria: * patient refusal * asa physical status \> iii * pregnancy * neuromuscular disorder * prior surgery in the popliteal fossa * coagulopathy * allergy to local anaesthetic drugs * skin infection at the site of needle insertion

Keywords: rct lidocaine (xylocaine) vs levobupivacaine sciatic nerve block
percutaneous ethanol injection for primary papillary thyroid microcarcinoma

Conditions: Papillary Thyroid Cancer

Summary: we assess the effectiveness of percutaneous ethanol ablation for the treatment of thyroid cancer.

we hypothesize that percutaneous ethanol ablation (pea) for primary papillary thyroid microcarcinoma (ptmc) has equivalent oncologic outcomes to current treatment options including observation, thyroid lobectomy and total thyroidectomy. in addition, we hypothesize that it will yield superior long-term quality of life, including measures of pain, voice, and cosmesis than standard surgical therapy (total thyroidectomy). if our hypotheses are correct, the findings of this study have the potential to fundamentally change clinical management of this group of patients. this study was changed from its initial design: a 2 arm study comparing pea to surgery (amended april 30, 2015). the change in design was made based on several discussions within yale endocrine surgery, with patients diagnosed with ptmc, and knowledge of other institutions performing pea for ptmc as standard of care. the study team had been contacted by numerous potential subjects interested in pea who were unwilling to be randomized to surgery. because patients interested in pea appeared to be firmly against the idea of thyroidectomy, we believed that we would be unable to enroll sufficient patients to this study as the protocol originally stood.

Eligibility criteria:
inclusion criteria: * age 18 years and older * diagnosis: single, cytology-proven papillary thyroid carcinoma measuring 1 cm or less in diameter (microcarcinoma, t1a), without visible extrathyroidal extension, and with negative central and lateral neck lymph nodes by ultrasound exclusion criteria: * patient refusal to participate * history of prior thyroid or parathyroid surgery * previous recurrent laryngeal nerve injury * inability to make decisions or comply with follow up * co-existing indication for thyroidectomy * aggressive cytological or molecular features * multifocal papillary thyroid carcinoma * pregnant or breast-feeding * anatomically unfavorable location of the tumor (proximity to recurrent laryngeal nerve or trachea) * documented or suspected distant metastasis * history of radiation to neck or face * family history of thyroid cancer
effect of "therapeutic monitoring" on blood glucose control in type 2 diabetes

Conditions: Type2 Diabetes

Summary: the purpose of this study is to conduct a multicenter prospective randomized controlled clinical trial, evaluating the effects of "therapeutic monitoring" on blood glucose control in type 2 diabetes.

in our study, about 480 type 2 diabetes patients will be enrolled from multiple centers in china. all participants will be randomly assigned into either the intervention group or the control group. all patients will be given basic diet, lifestyle instruction according to guidelines from home and abroad. the intervention group will be instructed to adjust the diet according to the ambulatory glucose profile (agp) and the recorde log monitored by the continuous glucose monitoring system, thereby implementing "therapeutic monitoring". all patients will maintain the drug treatment unchanged and make the glucose level as far as possible within the target range (\>3.9 and ≤10mmol/l), and record the amount of various food, then maintain the dietary pattern and the amount unchanged until the end of the study. the primary objective is to evaluate the effects of "therapeutic monitoring" on blood glucose control in type 2 diabetes, as measured by change in hba1c level from baseline to 12-week follow-up in both intervention group and control group. the secondary endpoint are 1) 1)difference in tir (time in range, time in target glucose range, 3.9-10.0mmol/l) at 12 weeks in both groups. 2)fasting plasma glucose (fpg), lipids and other metabolic related components and parameters such as bmi will be measured. 3)using questionnaires to evaluate the patients' satisfaction with flash glucose monitoring system.

Eligibility criteria:
inclusion criteria: * type 2 diabetes defined as who(1999) diagnostic criteria; * hba1c ≥ 7% and ≤ 9% at screening; and fasting plasma glucose ≥ 7.0mmol/l, and \<13.3mmol/l; * duration: 3 months\~15 years; * bmi: 24\~ 28 kg/m2; * using 1-3 oral medications when enrolled, and the treatment pattern was stable for at least 3 months and can maintain during this study period; * sign the informed consent. details please see the study protocol. exclusion criteria: * there are serious diabetic complications, heart, brain, liver and kidney diseases, allergic diseases and organic diseases; * the subject is currently pregnant, intends to become pregnant or is unwilling or unable to contraception during the study (female only); * the subject has symptoms or signs of skin lesions, scab, redness, infection or edema at the sensor application site that may affect the accuracy of sensor application or interstitial glucose measurements; * the subject has a concomitant disease and the investigator believes it will affect the study or pose a risk to the safety or benefit of the subject or research worker. * an x-ray, mri, or ct examination is scheduled during the study period, and the appointment could not be changed to before the study started or after the study ended; * take aspirin \> 200 mg / day, and the drug may be added during the entire study period; details please see the study protocol.
diabetes homeless medication support single arm treatment development trial

Conditions: Type 2 Diabetes; Homeless Persons

Summary: this single-arm trial of the diabetes homeless medication support intervention alone (n=15) will test the perception and feasibility of anticipated study procedures.

this study is of a set of studies with an overall goal to develop and pilot test a collaborative care intervention using motivational interviewing and behavioral activation alongside education and psychosocial support to improve medication adherence tailored to the experiences of people experiencing homelessness and diabetes (dh). our team's central hypothesis is that medication adherence and diabetes self-care (and eventual glycemic control, health care use/cost) will improve with an intervention tailored to the unique context of dh. this protocol addresses a pilot study to test patient perceptions of the feasibility and acceptability of study procedures and refine the d-homes treatment manual through test cases (n=15). with a hypothesis that the d-homes manual and study procedures will be feasible and acceptable to dh as measured by self-report and post-treatment interview.

Eligibility criteria:
inclusion criteria: 1. age 18 yrs. or older 2. english-speaking 3. homelessness by federal definition in the last 12 mo. 4. self-reported diagnosis of type 2 diabetes, later verified in medical record 5. plan to stay in local area or be reachable by phone for the next 16 weeks 6. willingness to work on medication adherence and diabetes self-care 7. hba1c \>/= 7.5% exclusion criteria: 1. inability to provide informed consent (e.g., presence of a legal guardian, prisoners) 2. active psychosis or intoxication precluding ability to give informed consent 3. pregnant or lactating females. 4. patients who choose to opt out of research.

Keywords: type 2 diabetes homeless persons delivery of health care, integrated primary care social determinants of health
a phase 1, study of the safety and tolerability of alv003 in healthy adult volunteers and subjects with well-controlled celiac disease

Conditions: Celiac Disease

Summary: to assess safety and tolerability of alv003 in healthy volunteers and patients with celiac disease

a phase 1, two stage, single dose, single-blind, placebo controlled, dose escalation, crossover study of the safety and tolerability of alv003 in healthy adult volunteers and subjects with well-controlled celiac disease

Eligibility criteria:
inclusion * health status 1. healthy volunteers must be in good health 2. celiac disease must be well controlled and in good health * either male or non-lactating, non-pregnant females who are postmenopausal, sterile or using at least two acceptable and highly effective birth control methods. * body mass index (bmi) of \< 30 kg/m2, exclusion * a positive urine test for alcohol or illegal drugs at screening. * the subject has received an experimental drug within 30 days of the present study. * history of substance abuse, within the last 5 years * clinically significant abnormal lab values, as determined by the pi * alcohol consumption of \> 2 standard drinks equivalents per day12. positive pregnancy test within 7 days prior to study drug administration. * history of any medically significant condition considered by the pi to adversely affect participation in the trial

Keywords: celiac disease
ankle equinus contracture treated with dynamic splinting

Conditions: Ankle Equinus; Ankle Contracture; Diabetes Mellitus

Summary: the purpose of this study is to determine if the ankle dorsiflexion dynasplint system (ds) is effective in treating contracture for patients with ankle equinus secondary to diabetes mellitus.


Eligibility criteria:
inclusion criteria: * previous diagnosis diabetes mellitus * reduced flexibility in arom of extension in the ankle * less than 10º maximal, active dorsiflexion, while upright * impaired gait pattern exclusion criteria: * previous surgical treatment for this pathology * previous surgery of the achilles tendon or triceps surae * current treatment with corticosteroids * current treatment with botulinium toxin-a (botox), lower extremity * current treatment fluoroquinolones (antibiotic medication) * current use of muscle relaxant medications * fibromyalgia * stroke, cva, brain injury, spinal cord injury, or any neural pathology causing plasticity or hypertonicity * current participation in manual, physical therapy * treatment with electrical stimulation assisting ambulation (i.e. bioness, walkaide, parastep, etc.) * preexisting open sores on foot or leg

Keywords: ankle equinus ankle contracture diabetes mellitus dynasplint afd