Kornimate/medical-research-clean huggingface dataset:
polish bifurcation optimal stenting study

Conditions: Coronary Artery Disease

Summary: coronary bifurcation lesions pose therapeutic problems during percutaneous coronary interventions (pci) and are associated with higher rates of periprocedural complications as well as higher rates of in-stent restenosis and stent thrombosis. therefore the optimal approach to coronary bifurcations treatment is still a subject of debate, especially when the side branch is large, not easily accessible and narrowed by a long lesion. one of the proposed alternatives are dedicated bifurcation stents (dbs). however, there is large scarcity of randomized trials with dbs. the aim of polbos i (polish bifurcation optimal stenting) study was to compare two intervention strategies for bifurcation treatment: provisional t-stenting (pts) with any regular drug-eluting stent (rdes), the best treatment strategy at the moment, with stenting of bifurcation lesions with dedicated bifurcation paclitaxel-eluting stent bioss expert® (balton, pl).


Eligibility criteria:
inclusion criteria: * subject able to verbally confirm understandings of risks, benefits of receiving pci for true bifurcation lesions, and he/she or his/her legally authorized representative provides written informed consent prior to any study related procedure. * target main branch lesion(s) located in a native coronary artery with diameter of ≥ 2.5 mm and ≤ 4.5 mm. target side branch lesion(s) located in a native coronary artery with diameter of ≥ 2.0 mm. * target lesion(s) amenable for pci with balloon angioplasty of the side branch. exclusion criteria: * stemi * non-cardiac co-morbid conditions are present with life expectancy \<1 year or that may result in protocol non-compliance (per site investigator's medical judgment). * subjects who refuse to give informed consent. * subjects with lvef\<30% * subjects with moderate or severe degree valvular heart disease or primary cardiomyopathy

Keywords: provisional t stenting dedicated bifurcation stent
medication counselling models for outpatient oral anticoagulation

Conditions: Anticoagulants; Circulating, Hemorrhagic Disorder

Summary: the goal of this clinical trial is to investigate whether telepharmacy-led counselling can improve medication adherence, knowledge, and hospitalisation/mortality compared with pharmacist-led counselling in adult outpatients taking oral anticoagulants.


Eligibility criteria:
inclusion criteria: * ≥18 years old * taking oral anticoagulants * using smartphones that can access the telepharmacy application * agreeing to participate exclusion criteria: * pregnancy or lactation * having cancer * having immunodeficiency disorders or using immunosuppressants * renal impairment (creatinine clearance \<30 ml/min) * hepatic impairment (child-pugh b or c cirrhosis) * heart failure (class iv, new york heart association) * history of myocardial infarction or stroke within the latest 2 months

Keywords: oral anticoagulant counselling distance counselling medication adherence knowledge hospitalisation mortality venous thromboembolism
evaluating the role of neuroinflammation in low back pain

Conditions: Low Back Pain; Back Pain With Radiation; Back Pain Without Radiation; Back Pain Lower Back Chronic; Back Ache; Pain, Chronic

Summary: in this research, the study team will use brain imaging to evaluate the presence of neuroinflammation in the brains and spinal cords of patients with low back pain. the efficacy of minocycline use for low back pain treatment will also be evaluated by observing whether short-term minocycline administration will reduce neuroinflammation and low back pain symptoms.

the goal of this research study is to evaluate whether the central nervous systems of those with low back pain are different from those of healthy, pain-free individuals. specifically, the researchers will test whether "glial cells" (the immune cells of the brain and spinal cord) are more active in patients with low back pain than in healthy volunteers. the investigators' previous study showed that patients with chronic low back pain demonstrated elevations in brain levels of the 18kda translocator protein (tspo), a marker of glial activation. to test this hypothesis, the study team will image the brains and spinal cords of patients suffering from low back pain using integrated magnetic resonance- positron emission tomography (mr-pet), and a radiotracer called \[11c\]pbr28, which tracks levels of glial activation. the efficacy of minocycline as a treatment for chronic low back pain will also be evaluated. a recent study demonstrated a statistically significant reduction in pain in those with lumbar radiculopathy after treatment with minocycline, leading the investigators of this study to believe that minocycline may have potential efficacy in treating other back pain populations. the study team will observe whether a short course of minocycline hydrochloride may reduce glial activation along with self-reported low back pain symptoms. to this end, patients will be evaluated clinically and/or re-scanned after completing a 2-week trial of minocycline or placebo (a sugar pill). this study will be enrolling individuals who have been suffering from sub-acute (short-term) and chronic low back pain.

Eligibility criteria:
inclusion criteria: * the ability to give written informed consent * fluency in english * on a stable pain treatment * chronic or sub-acute low back pain exclusion criteria: * no interventional pain procedures during drug trial * contraindications to mri and pet scanning (including presence of a cardiac pacemaker or pacemaker wires, metallic particles in the body, vascular clips in the head or previous neurosurgery, prosthetic heart valves, claustrophobia) * pregnancy or breast feeding * any use of recreational drugs in the past 6 months * allergy to minocycline or other tetracyclines, or taking medications known to interact with minocycline * any other contraindications to minocycline administration

Keywords: microglia minocycline magnetic resonance imaging positron emission tomography pain astrocytes glia human back pain
study of su011248 in patients with advanced kidney cancer

Conditions: Carcinoma, Renal Cell

Summary: to determine the objective tumor response of single-agent su011248 at a dose of 50 mg orally once daily for 4 consecutive weeks and 2 weeks rest, repeated every 6 weeks in patients with metastatic renal cell cancer (rcc).


Eligibility criteria:
inclusion criteria: * histologically proven renal cell carcinoma with metastases with a component of clear cell histology exclusion criteria: * any cellular therapy (lak, til, dc), any vaccine therapy, mini-transplantation, or systemic molecular-targeting therapy for rcc.

Keywords: ph2, rcc, su011248, sunitinib
sarcopenia and nutritional status in a rehabilitation setting

Conditions: Sarcopenia

Summary: in this pilot observational study the primary outcome is to assess, in a respiratory rehabilitation unit, if there is an association between sarcopenia, assessed by handgrip strenght and bia, and a delayed decannulation time in patients who underwent tracheostomy. secondary outcomes are to assess if there is an association between an increased malnutrition risk (assessed by must), a poor nutritional status (assessed by glim criteria) and a delayed decannulation time and the gut microbiota composition.


Eligibility criteria:
inclusion criteria: * signed informed consent from patients or legal guardians for patients unfit to plead * presence of tracheostomy at admission exclusion criteria: * refusal * pregnancy * pace maker/implantable cardioverter * no legal guardians for patients unfit to plead

Keywords: handgrip strenght bioelectrical impedance analysis (bia) respiratory rehabilitation tracheostomy decannulation gut microbiota glim criteria must
anakinra for preterm infants pilot

Conditions: Prematurity; Extreme; Inflammation

Summary: phase i/ii study of anakinra to prevent the impact of perinatal inflammation in extremely premature infants.

with improvements in antenatal and neonatal care over the last 20 years, now infants are born as early as 22 weeks gestation and survive to discharge from hospital. this increased survival comes with increased risk of long term issues such as cerebral palsy and chronic lung disease. there is strong evidence to show these risks are increased due to an underlying inflammatory process initiated around the time of premature birth. this study aims to prove the safety of treating infants born between 24-27+6 weeks gestation with anakinra, a medication which is similar to an anti-inflammatory molecule the body makes itself called interleukin 1 receptor antagonist (il-1ra). anakinra acts to reduce the inflammatory response and is currently used in adults and children as young as 8 months to manage autoimmune inflammatory conditions. this study looks at the safety of giving anakinra to babies born extremely premature, over the first 3 weeks of life. once safety is established, the investigators will conduct a larger trial studying the efficacy of this treatment for reducing the risk of long-term complications caused by neonatal inflammation in extremely preterm infants.

Eligibility criteria:
inclusion criteria: * born at 24 to 27+6 weeks gestation exclusion criteria: * inability of the legal representatives to consent * any disease or condition that the investigators judge could confound the trial results; these include, but are not limited to, genetic syndromes, severe cardiac abnormalities, substantial pre-/perinatal compromise (profound/severe hypoxia (sao2 \ 3h), congenital diaphragmatic hernia, intrauterine stroke and others. * imminent death

Keywords: anakinra il-1ra bronchopulmonary dysplasia diffuse white matter injury
effects of suboptimal cpap therapy on symptoms of obstructive sleep apnoea

Conditions: Sleep Apnea, Obstructive

Summary: obstructive sleep apnoea (osa) is a highly prevalent sleep-related breathing disorder. the most effective treatment for osa is continuous positive airway pressure (cpap). cpap therapy has been shown to significantly reduce subjective sleepiness and blood pressure in patients with symptomatic osa. its effectiveness tends to depend on its nightly usage and a commonly held view is that cpap should be used for at least 4h/night. however, previous studies have estimated that a considerable proportion of cpap users fail to achieve this. in addition, there is inadequate evidence to support this apparent threshold effect and so it is unclear whether such patients actually benefit from treatment or whether they could be withdrawn from cpap, thus substantially reducing health care costs, or encouraged to increase their nightly usage of cpap. the aim of the proposed project is to study the effect of cpap withdrawal on subjective sleepiness in osa patients using cpap for less than 4h/night on average. we hypothesize that two-week cpap withdrawal in patients with 3-4h/night use will lead to a return of osa-related symptoms. this trial will better establish the minimum level of cpap adherence which could generally be regarded as effective in reducing osa-related symptoms.


Eligibility criteria:
inclusion criteria: * objectively confirmed osa (at the time of original diagnosis) with an oxygen desaturation index (odi, ≥4% dips) of ≥15/h and an ess of \>10. * currently ≥15/h oxygen desaturations (≥4% dips) during an ambulatory nocturnal pulse oximetry performed at the end of a 4-night period without cpap. * eligible patients must have been treated with cpap for more than 12 months with a mean compliance between 3 and 4h/night. apnoea-hypopnoea index (ahi) must be less than 10 with treatment (according to cpap machine download data). exclusion criteria: * previous ventilatory failure (awake pao2\ 6kpa). * unstable, untreated coronary or peripheral artery disease, severe arterial hypertension (\>180/110mmhg). * previously diagnosed with cheyne-stokes breathing. * current professional driver. * age \ 75 years at trial entry.

Keywords: continous positive airway pressure cpap sham cpap cpap withdrawal suboptimal cpap
evaluation of limb function and perception in rehabilitation after traumatic wrist fracture surgery

Conditions: Distal Radius Fractures; Rehabilitation; Body Perception

Summary: the goal of this observational study is to assess the functional and perceptual alterations of the affected limb during rehabilitation in adult orthopedic patients who underwent surgical treatment for distal radius fractures. the main questions it aims to answer are: what is the correlation between functional and perceptual alterations of the affected limb at the beginning and end of rehabilitation? how do these alterations influence rehabilitation duration and effectiveness? participants will: complete the patient questionnaires ((quickdash and alpq). undergo handgrip strength tests and digital dynamometer tests to assess forearm muscle strength. have their range of motion evaluated by a physiotherapist during outpatient visits. no additional diagnostic or instrumental examinations are required beyond routine clinical practice. the study will recruit 100 adult patients, last 24 months, and provide insights into the role of body perception in rehabilitation after wrist fractures.


Eligibility criteria:
inclusion criteria: * adults (≥18 years old) * patients who have undergone surgical treatment with a volar approach for a traumatic distal radius fracture at irccs ospedale galeazzi - sant'ambrogio. * willingness and ability to provide written informed consent. exclusion criteria: * pre-existing neurological, psychiatric, or cognitive disorders that could affect motor function or body perception. * previous fractures of the same limb. * pregnancy or breastfeeding (self-reported).
efficacy and safety of liraglutide in combination with insulin therapy compared to insulin alone in japanese subjects with type 2 diabetes

Conditions: Diabetes; Diabetes Mellitus, Type 2

Summary: this trial is conducted in asia. the purpose of the trial is to investigate the efficacy and safety of liraglutide in combination with insulin therapy compared to insulin alone in japanese subjects with type 2 diabetes mellitus. subjects will remain on their pre-trial insulin therapy.


Eligibility criteria:
inclusion criteria: * type 2 diabetes mellitus (diagnosed clinically) for at least 6 months * current insulin therapy (basal insulin, premixed insulin or basal-bolus regimen) in addition to diet and exercise therapy for at least 12 weeks prior to trial start. their therapy is stable and fluctuation of total daily insulin dose is within plus/minus 20% for at least 12 weeks prior to trial start and current total daily insulin dose equal to or greater than 10 (i)u/day * glycosylated haemoglobin (hba1c) between 7.5 and 11.0% (both inclusive) * body mass index (bmi) below 45.0 kg/m\^2 exclusion criteria: * anticipated change in concomitant medication known to interfere significantly with glucose metabolism, such as, but not limited to systemic corticosteroids, beta-antagonists or monoamine oxidase (mao) inhibitors * recurrent severe hypoglycaemia (more than 1 severe hypoglycaemic episode during last 12 months) or hypoglycaemic unawareness as judged by the investigator or hospitalisation for diabetic ketoacidosis during the previous 6 months * known proliferative retinopathy or maculopathy requiring treatment according to the investigator * treatment with glucagon-like peptide-1 (glp-1) receptor agonist within 12 weeks prior to screening * treatment with any oral antidiabetic drugs (oads) within 12 weeks prior to screening
manual diaphragm release technique effects on tidal volume in elderly

Conditions: Healthy

Summary: question: does manual diaphragm release change kinematics and respiratory function of elderly subjects? design: randomized controlled trial with concealed allocation and double-blinding. participants: 17 volunteers over 60 years old randomized into two groups: 09 in the control group (cg) and 08 in the intervention group (ig). intervention: the manual diaphragm release technique was used on the ig, in two sets of ten deep breaths, with a one minute interval between them. the cg underwent a sham protocol (light touch), with same sets and time of interval. outcome measures: the groups were evaluated using spirometry, manovacuometry and optoelectronic plethysmography (oep), in that order, before and immediately after the intervention.


Eligibility criteria:
inclusion criteria: * over 60 years of age; * a body mass index (bmi) below 30 kg/m2 * non-smokers, self-declared sedentary; * presenting a forced expiratory volume in one second (fev1) and forced vital capacity (fvc) greater than or equal to 80% of predicted; * the ratio between these variables (fev1/fvc) greater than 70% in spirometry exclusion criteria: * showed the inability to understand verbal commands in the evaluation.
validation of a new simplified scoring system for acute calculous cholecystitis

Conditions: Acute Cholecystitis

Summary: acute calculous cholecystitis (acc) is the second most frequent surgical condition in emergency departments. the recommended treatment is surgical treatment (st) and the accepted mortality is \<1%, but in severe and/or fragile patients is higher. despite the tokyo guidelines, there no consensus on who is the unfit patient for st. a recent study has identified 4 risk factors that predicts the mortality in a 92% of patients (acme) and could help to develop new guidelines in acc. the aim of this study is this validation of the new simplified scoring system for mortality in acc.

this is a retrospective single-center observational study of 387 adults with acc during 2 non-consecutive years (2017/2021), including baseline demographic characteristics, comorbidity severity defined as charlson comorbidity index (cci), asa score, tokyo guidelines' severity classification and the new acme score. the primary outcome is to study the prediction of mortality of acme score. secondary outcomes include complications following clavien-dindo's classification, c-statistic, and roc curves.

Eligibility criteria:
inclusion criteria: * the selected patients were among those who had acute cholecystitis according to the tg18 or received a diagnosis of acc in the histopathological report. exclusion criteria: * the study case definition was a "pure acc", therefore, patients with any other concomitant diagnosis potentially influencing outcome such as acute pancreatitis, acalculous cholecystitis, chronic cholecystitis, acute cholangitis, postoperative cholecystitis, gallbladder adenocarcinoma and those who had undergone cholecystectomy as a prophylactic measure in another intervention were excluded from the study.

Keywords: acute cholecystitis cholecystectomy tokyo guidelines postoperative complications mortality high-risk patient
a multi-center, single-arm, prospective non-interventional study to investigate the safety profiles and effectiveness of liposomal irinotecan (onivyde®) in combination with 5-fluorouracil (5-fu) and leucovorin (lv) in chinese patients with metastatic pancreatic cancer as approval condition (seopac)

Conditions: Metastatic Pancreatic Cancer

Summary: the aim of this phase 4 study is to evaluate the safety profile of onivyde in china mainland. primary objective to characterize the safety of onivyde when used under standard clinical practice in china mainland on the following aspects: 1. quantify the rate of grade ≥3 neutropenia (primary objective) 2. serious adverse events and serious adverse drug reactions 3. adverse events and adverse drug reactions secondary objective to describe effectiveness in patients receiving onivyde in combination with 5-fu and leucovorin for the treatment of metastatic pancreatic cancer under standard clinical care in china mainland. (1) overall survival (2) overall response (3) progression free survival (4) quality of life assessment


Eligibility criteria:
inclusion criteria: * the adult patient (≥18 years of age) has given written informed consent to participate in the study. * the patient has been prescribed for onivyde treatment according to the onivyde china mainland smpc. * histologically or cytologically confirmed adenocarcinoma of exocrine pancreas. * documented metastatic disease. * patient deemed not eligible or failed previous treatment with gemcitabine or gemcitabine containing therapy. exclusion criteria: * patients who have experienced a severe hypersensitivity reaction to onivyde or irinotecan hcl. * patients with new or progressive dyspnea, cough, and fever, pending diagnostic evaluation or confirmed diagnostic of interstitial lung disease. * pregnant or nursing (lactating) women. * patients without highly effective methods of contraception during study treatment until 3 months after the last dose of the study drug, specially,7 months for women of childbearing potential and 4 months for male with partners of childbearing potential after the last dose of the study drug. * other additional exclusions may be applied by the investigator according to the contexts, in order to ensure that the study population will be non-interventional but representative of all eligible subjects.
post anesthesia care unit (pacu) weighted blanket study

Conditions: Cardiac Catheterization; Electrophysiology Procedure; Pediatric Cardiology

Summary: this study is being conducted to evaluate the safety and efficacy of weighted blankets to reduce agitation in patients in the post-procedural phase after cardiac catheterization and electrophysiology procedures in the post anesthesia care unit. the study hypothesizes that compared to the traditional and current post-procedural strategy, weighted blanket use will reduce agitation and therefore lessen the need for additional sedation along with a reduction of post-procedure vascular complications.


Eligibility criteria:
inclusion criteria: * patients undergoing cardiac catheterization or electrophysiology procedure * post procedure bedrest plan for greater than (\>)2 hours * duration of recovery planned for 11th floor cardiac pacu exclusion criteria: * patients less than (\<) 40 pounds (18 kilogram (kg)) * patients \> 220 pounds (100 kg) * recovery anticipated to not be in our cardiac pacu * posttraumatic stress disorder * claustrophobia * uncontrolled seizure disorders * open heart surgery within 30 days * severe pulmonary hypertension * severe asthma * sleep apnea requiring continuous positive airway pressure (cpap) * known diaphragm paresis * home vent/cpap * restrictive lung disease (such as patients with scoliosis) * higher risk for upper respiratory airway occlusion (such as patients with down syndrome) * cast, brace or splint, fractures * degenerative muscular disorder (such as patients with cerebral palsy) * areas of impaired skin integrity * gastrostomy tube * percutaneous endoscopic gastrostomy * tracheostomy * chest tube(s) * pacu procedures required (within 1 hour post arrival): post operative (post op) echocardiogram, post op xray, post op electrocardiogram

Keywords: weighted blanket post anesthesia care unit recovery agitation pediatrics pediatric cardiology emergence delirium