Kornimate/medical-research-clean huggingface dataset:
prebiotic fiber to prevent pathogen colonization in the icu

Conditions: Sepsis

Summary: this is a pilot trial testing enteral feeds that are high versus low in prebiotic fiber in 20 critically ill adults. the long-term goal is to determine the efficacy of fiber for the prevention of pathogen colonization/infection in the icu.

this study will test prebiotic fiber in 20 adults who are receiving broad-spectrum antibiotics in the medical or surgical icu by open-label randomization of patients to approximately 20 g prebiotic fiber/day including 45% short-chain fructooligosaccharides versus 0 g fiber/day by providing one of two feeds. per 10 ounces of feed, both the high and low fiber feeds contain identical micronutrients and have 296 kilocalorie (kcal), 19 g protein, 8 g fat, and 39 g carbohydrates. the sole difference is that the fiber-containing feed has 4 g fiber including 45% short-chain fructooligosaccharides per 10 ounces whereas the other feed has 0 g fiber. randomization will take place at the time the order for enteral feeding is placed. rather than supplying the feed itself, the investigators will supply a randomized recommendation for a feed type (i.e., high vs low fiber) and the feed will be obtained from the hospital pharmacy in the usual manner. determination of the feed rate and duration will be decided on the individual patient's needs by the treating icu team. the primary outcome will be to determine whether high fiber feeds alter the gut microbiome in the face of antibiotics and critical illness, calculated by comparing within-individual microbiome differences from baseline to day 3 in each intervention group.

Eligibility criteria:
inclusion criteria: * medical or surgical icu patients ≥18 years old at our institution; * receiving broad-spectrum antibiotics at the time of enrollment; * deemed appropriate for the study by the treating icu team; * with capacity to give consent or have an appropriate surrogate; * able to undergo assessment within 4 hours of the order for enteral feeds; * expected to receive enteral feeds for ≥3 days but not yet receiving them. exclusion criteria: * inability to receive enteral feeds; * celiac disease or known allergy to fiber; * surgery involving the intestinal lumen within 30 days; * limited treatment goals (i.e., do-not-resuscitate (dnr), do-not-intubate (dni), or no escalation of care); * lack of capacity to consent and lack of an appropriate legally authorized representative.

Keywords: prebiotic fiber
effect of intravenous administration of mannitol on onsd in patients with raised icp

Conditions: Raised Intracranial Pressure

Summary: osmotherapy with mannitol has been a common practice in patients with raised icp. monitoring its effect on icp can be performed invasively and non-invasively. due to a validated correlation between invasive icp monitoring and onsd measurement, it can be a tool to monitor acute and long term effects of osmotherapy non-invasively on icp. this study examines the acute changes in sonographically measured onsd brought about by the administration of mannitol. this can correlate with the changes in icp in such patients and can be utilized as a tool for decision making/ point-of-care utility.

this is a prospective cohort based observational study including 40 patients admitted in the adult icu at our center diagnosed as either a case of tbi/ acute stroke/ intracranial hemorrhages with a mean screening onsd of more than 5mm under mannitol osmotherapy. onsd were measured by a high frequency linear array probe (\>10 hz) at the time of screening. mannitol was then administered at doses prescribed by the treating physician over 20-30 minutes via a dedicated intravenous line. onsds were measured again at 30, 60 and 120 minutes after completion of administration of mannitol. demographic data, baseline ventilator parameters of patients on mechanical ventilation, gcs and mean arterial pressure at each time points were recorded. comparison of variables at these time points were made.

Eligibility criteria:
inclusion criteria: * age \> 18 years * diagnosed as a case of tbi/ acute stroke/ intracranial hemorrhages * screening mean onsd \> 5 mm * under osmotherapy with mannitol in standard doses (0.25 - 1 gm/kg) exclusion criteria: * baseline ocular pathology like tumors, graves' disease and sarcoidosis * previous ocular surgery * decompressive cranial surgery

Keywords: onsd mannitol icp
thrombus aspiration before standard primary angioplasty improves myocardial reperfusion in acute myocardial infarction.

Conditions: Acute Myocardial Infarction

Summary: in patients with acute st-segment elevation myocardial infarction (stemi), percutaneous coronary intervention (pci) may cause thrombus dislodgment and impaired microcirculatory reperfusion. this study was designed to test the hypothesis that thrombus aspiration before standard pci may improve acute myocardial reperfusion, measured by st-segment resolution (str) and myocardial blush grade (mbg), compared with standard pci.

consecutive stemi patients, admitted within 12 hours of symptom onset and scheduled for primary pci are randomly assigned to two treatment strategies: standard pci including stenting and abciximab (group1) or thrombus aspiration with pronto™ extraction catheter (vasc.solutions, minneapolis) before standard pci (group2). patients with cardiogenic shock, previous infarction or thrombolytic therapy are excluded.

Eligibility criteria:
inclusion criteria: * st-segment elevation myocardial infarction patients undergoing primary angioplasty within 12 hours from symptom onset. exclusion criteria: * cardiogenic shock, previous infarction, previous coronary bypass surgery,bundle branch block or pacemaker induced rythm, controindications to iib/iiia inhibitors.

Keywords: acute myocardial infarction primary angioplasty myocardial reperfusion thrombus aspiration
the "motoric cognitive risk" syndrome in the quebec population

Conditions: Cognition Disorders in Old Age; Dementia

Summary: the overall objective of the proposal is to examine the epidemiology of the newly reported "motoric cognitive risk" (mcr) syndrome, which is a pre-dementia syndrome combining subjective cognitive complaint (i.e.; memory complaint) with objective slow gait speed, in the quebec elderly population. cognition and locomotion are two human abilities controlled by the brain. their decline is highly prevalent with physiological and pathological aging, and is greater than the simple sum of their respective prevalence, suggesting a complex age-related interplay between cognition and locomotion. both declines in cognition and locomotion are associated, furthermore the temporal nature of their association has been unclear for a long time. recently, a systematic review and meta-analysis has provided evidence that poor gait performance predicts dementia and, in particular, has demonstrated that mcr syndrome is a pre-dementia syndrome, suggesting that low gait performance is the first symptom of dementia. the uniqueness of mcr syndrome is that it does not rely on a complex evaluation or laboratory investigations. indeed, this syndrome combined subjective cognitive complaint and objective slow gait speed, and is easy to apply in population-based settings. prevalence and incidence of mcr syndrome, as well as its association with incidence of cognitive decline and impairment, have never been reported in canada. nutrition as a determinant of successful aging: the quebec longitudinal study (the nuage study) is a quebec population-based observational cohort study performed in healthy older community-dwellers adults which provides a unique opportunity to: 1) obtain reliable estimates of mcr syndrome prevalence and incidence, 2) determine the distribution of clinical characteristics associated with mcr syndrome, 3) examine the association of mcr syndrome with cognitive decline and incidence of cognitive impairment in the quebec elderly population.


Eligibility criteria:
inclusion criteria: individuals eligible for this study will be participants of the nuage study exclusion criteria: individuals not eligible for the nuage study, no information about cognitive complaint, no measure of walking speed, no follow-up completed
potential benefits of radiotherapy in prone position for breast cancer patients: a planning study

Conditions: Breast Neoplasms; Radiation

Summary: this study has the purpose to investigate the benefit of treating breast cancer patients in prone position. this treatment is compared to the standard technique in our center (supine position with or without respiratory gating). the investigators want to compare the doses on the organs at risk (heart and lungs) in the different techniques.


Eligibility criteria:
inclusion criteria: * indication for radiotherapy of the breast and /or lymph nodes exclusion criteria: * none ( planning study)

Keywords: respiratory gating prone radiotherapy breast cancer
the efficacy of transnasal humidified rapid-insufflation ventilatory exchange during laryngeal microsurgery

Conditions: Apneic Oxygenation

Summary: transnasal humidified rapid-insufflation ventilatory exchange (thrive) was revealed to prolong apneic time with a slow increase in carbon dioxide; thus, has been used for preoxygenation in patients with difficult airways or requiring rapid sequence induction in general anesthesia. however, in patients undergoing hypopharyngeal and laryngo-tracheal surgery, thrive during operation can be advantageous by allowing tubeless surgical field with sufficient oxygenation. therefore, the investigators conducted this study to evaluate the efficacy of thrive on prolonged apneic time with enhanced surgical conditions in patients with laryngeal microsurgery.

patients undergoing laryngeal microsurgery will be randomized into either intubation group or thrive group. on arriving operating room, the patients will be preoxygenated by facemask or high flow nasal cannula with 100% oxygen for 3 minutes according to the allocated group. after inducing general anesthesia, patients in intubation group will be oxygenated by endotracheal tube, while patients in thrive group will be oxygenated by high flow nasal cannula with flow rate of 70l/min. during the surgery, the endotracheal tube can be removed and reintubated in intubation group patients to provide surgical field by a surgeon, respectively. the monitored pulse oximetry, oxygen reserve index, and transcutaneous partial pressure of carbon dioxide will be recorded during surgery.

Eligibility criteria:
inclusion criteria: * patients undergoing laryngeal microsurgery * asa class i-iii exclusion criteria: * patients scheduled for laryngeal microsurgery using co2 laser * patients with increased intracranial pressure * patients with skull base defect * patients with chronic obstructive pulmonary disease * patients with pulmonary hypertension * patients requiring rapid sequence induction

Keywords: airway management high flow nasal cannula laryngeal microsurgery
evaluation of perfusion and oxygenation in muscle of patients with pad undergoing ler

Conditions: Peripheral Arterial Disease

Summary: during this iit, the msot (multispectral optoacoustic tomography ) acuity echo will be used to scan participants with peripheral arterial disease assess msot multispectral optoacoustic tomography (single-wavelength and hemoglobin-related parameters) in the tibialis anterior, and flexor hallucis brevis, at multiple time-points before, during and after interventional lower extremity revascularization (ler ). primary aim of the study ist the comparison of the difference between oxygenated, deoxygenated hemoglobin and oxygenation in the tibialis anterior, and flexor hallucis brevis, at multiple time-points before, during and after interventional lower extremity revascularization.


Eligibility criteria:
inclusion criteria: * • written consent of the participant after being informed * adults above 18 years * participants with pad stage 4 - 6 (rutherford) with indication for interventional ler exclusion criteria: * • participants with previous ler on the same leg * participants less than 18years * pregnancy * participants with tattoos in the scan area * participants with no clinical indication for interventional ler * missing consent form
scan-rescan sub-study of ms paths

Conditions: Multiple Sclerosis

Summary: the primary objective of this sub-study is to calculate the reproducibility and other technical performance measures of various magnetic resonance imaging (mri) image analysis algorithms in order to assess their suitability for detecting changes due to multiple sclerosis (ms) in a real-world setting in participants with ms. the secondary objective of this sub-study is to use the primary endpoint results to calibrate measurements across scanners within each ms paths center.


Eligibility criteria:
key inclusion criteria: * participants (or participant's legal representative) has the ability to understand the purpose and risks of the sub-study and provide signed and dated informed consent and authorization to use protected health information (phi) in accordance with national and l local participant privacy regulations. * diagnosis of relapse-onset ms (relapsing-remitting or secondary progressive). * first ms symptom within the past 1 to 30 years. key exclusion criteria: * initiation of any ms disease-modifying treatment within 4 weeks prior to visit 1. * steroid treatment or suspected ms relapse within 6 weeks prior to visit 1. note: other protocol specified inclusion and exclusion criteria may apply.
gastric capsule examination for iron deficiency anaemia

Conditions: Iron Deficiency Anemia

Summary: this is a pilot prospective single blind controlled trial comparing magnetically steerable gastric capsule endoscopy to conventional oesophagogastroduodenoscopy in diagnosing upper gastrointestinal pathology in patients with recurrent/refractory iron-deficient anaemia.

gastroscopy (ogd) is a useful test for investigating a variety of suspected upper gi disorders. but it is uncomfortable for patients and incurs the risk of intubation and sedation, plus a large proportion of procedures reveal insignificant or no pathology. capsule endoscopy (ce) is the investigation of choice for diseases of the small bowel. it is safe, noninvasive and well tolerated. the use of ce is traditionally restricted to the small bowel, although newer capsules to image the oesophagus and colon are currently in use. previous capsules have failed to adequately image the stomach due to its large volume and rugal folds. recently a magnetic capsule and handheld magnet has been developed (microcam navi, intromedic ltd, seoul, korea) to enable an element of manoeuvrability of the capsule. this is unnecessary in the small bowel where the capsule is propelled along its' tubular structure by peristalsis, but in the capacious stomach this may allow the capsule to be steered to examine all areas of the stomach. the investigators have already conducted two feasibility studies in porcine models with promising results and a trial is currently underway using this equipment to steer the small bowel capsule through the stomach into the duodenum. the next logical step is to compare this technique to the conventional standard of upper gi investigation; ogd. patients with recurrent or refractory iron deficiency anaemia require a combination of gastroscopy and small bowel capsule endoscopy as part of their diagnostic investigations. the investigators wish to undertake a pilot prospective single blind controlled trial comparing magnetically steerable gastric capsule examination to conventional ogd in diagnosing upper gastrointestinal pathology in patients with recurrent/refractory iron deficiency anaemia.

Eligibility criteria:
inclusion criteria: * patients aged 20 years and over. * patients with recurrent/refractory iron deficiency anaemia who require a gastroscopy and small bowel capsule endoscopy as part of their diagnostic investigations. exclusion criteria: * patients under the age of 20 years. * patients with a permanent pacemaker, implantable cardioverter defibrillator or reveal device. * patients with any electronic/magnetic/mechanically controlled devices e.g. sacral nerve stimulators, bladder stimulators. * patients that are pregnant. * patients who are unable to understand or speak english.
study of aspirin and exemestane as adjuvant treatment in breast cancer

Conditions: Breast Neoplasms

Summary: this is a phase ii study to assess efficacy/safety of exemestane with or without aspirin as the adjuvant treatment in postmenopausal breast cancer patients.


Eligibility criteria:
inclusion criteria: * breast cancer after surgery postmenopausal exclusion criteria: * contraindication of aspirin

Keywords: exemestane aspirin quality of life
sequential belimumab and t-cell based therapy in sle

Conditions: Systemic Lupus Erythematosus

Summary: systemic lupus erythematosus (sle) is a disease in which the immune system (the bodily system that fights infection) attacks the body's own cells and tissues, causing inflammation and organ damage if not promptly and appropriately managed. autoantibodies (specific proteins produced by the immune system which participate in attacking self tissues and organs) are the hallmarks of sle which are produced by a specific type of white blood cells called b cells. belimumab (benlysta®) is a monoclonal antibody against the b cells by blocking the action of blys, a protein that prolongs the longevity and enhances the functions of b cells and is found to be elevated in patients with sle, was approved by the fda to treat patients with sle. this study aims to study the effects of belimumab on t cells, another specific type of white blood cells which also play a crucial role in sle, in patients with sle. in this trial, 80 adult patients with sle will be recruited, 40 of them will be assigned to receive intravenous (iv) belimumab with standard of care therapy (soc), and 40 to receive soc only. after 48 weeks of exposure to belimumab + soc and soc alone, the phenotype and functions of t cells will be studied and compared.


Eligibility criteria:
inclusion criteria: 1. age ≥ 21 2. able to understand the details of the trial and willing to give written informed consent and comply with the requirements of the study protocol. 3. patients who fulfill the classification criteria (slicc 2012 or acr 1997) for sle and have active disease (selena-sledai ≥ 6). 4. patients whose sera are positive for ana (titre ≥ 1:80) or anti-dsdna (\>100u/l based on nuh standard laboratory cut-off). 5. patients who are on stable dose of prednisolone (0-40mg/day) and/or non-steroidal anti-inflammatory, antimalarial or immunosuppressive drugs for at least 30 days before first study dose. 6. females of child-bearing potential and non-sterilized males with female partners of child-bearing potential may participate this trial only if they use a reliable means of contraception. 7. females of child-bearing potential must have a negative serum pregnancy test within three weeks prior to baseline. exclusion criteria: 1. they have severe active nephritis and/or active cns lupus and/or other autoimmune diseases e.g. ra, mixed connective tissue disease, scleroderma, dermatomyositis and polymyositis. 2. they are pregnant. 3. they have had previous treatment with any b-cell and t-cell targeted biologic therapy, intravenous (iv) cyclophosphamide within 6 months of enrolment, intravenous immunoglobulins or prednisolone (\>100mg/day) within 3 months.
effect of education of health care workers on the maintenance of venous access devices

Conditions: Vascular Access Devices

Summary: in intensive care units (icu), critically ill patients require various venous access devices for fluid resuscitation, drug therapy, or renal replacement therapy (rrt). these include peripheral intravenous catheters (pivc), specialized venous ports like central venous catheters (cvcs), and hemodialysis ports. the investigators plan to do this pre- and post-intervention study to know the effect of intensive training and education of hcw (doctors and nurses) on the condition of venous access devices in critically ill patients.

phase 1, pre-intervention: the first twelve weeks will include 25 random visits to main icu and point observations of all venous access devices under parameters like condition of dressing, connectors and documentation. this will also include the comparison of incidence of clabsi in the pre and post intervention phase. phase 2, intervention: next four weeks will be an intervention in the form of intensive training and education of the hcw (doctors and nurses). the intensive training will be in the form of an online presentation in which the investigators would have videos on care and maintenance of venous access devices, and the importance of documentation of days of insertion and change of dressing. phase 3, post-intervention: another twelve weeks, post-intervention, again 25 random visits will be done to collect point observations about the same parameters of venous access devices and documentation as done in phase 1. statistical analysis: each of these point observation parameters (for central or peripheral venous access) will be finally categorized as appropriate/inappropriate as per guidelines for best practice. the compiled data from pre and post intervention phases would be compared. all the categorical parameters (appropriate/inappropriate) will be compared using chi-square test. all the quantitative parameters (e.g. incidence of clabsi) will be compared using a paired t-test

Eligibility criteria:
inclusion criteria: * all patients admitted to main icu exclusion criteria: * patients who refuse to give consent

Keywords: intensive care unit health care workers central venous catheters
lapatinib plus trametinib in kras mutant nsclc

Conditions: Colorectal Cancer

Summary: this is an open-label phase i/ii multi-center study consisting of two parts. part a of this study is designed to identify the recommended phase 2 dose (rp2d) of lapatinib combined with trametinib in patients with metastatic krasm and pik3ca wild-type (pik3cawt) non-small cell lung cancer (nsclc). part b is designed to perform a randomized comparison of the lapatinib-trametinib combination versus standard of care therapy in patients with metastatic krasm/pik3cawt nsclc.


Eligibility criteria:
inclusion criteria: * histological or cytological proof of metastatic nsclc; for part b: treated with first line therapy for metastatic disease only. * written documentation of a known pathogenic kras (exon 2, 3 or 4) mutation and pik3ca wild-type (exon 9 and 20) * age ≥ 18 years * able and willing to give written informed consent * who performance status of 0 or 1 (part a and b) exclusion criteria: * any treatment with investigational drugs within 30 days prior to receiving the first dose of investigational treatment. * history of another primary malignancy * symptomatic or untreated leptomeningeal disease * symptomatic brain metastasis * history of interstitial lung disease or pneumonitis * uncontrolled infectious disease or known human immunodeficiency virus hiv-1 or hiv-2 type patients * retinal degenerative disease (hereditary retinal degeneration or age-related macular degeneration), or a history of uveitis, retinal vein occlusion, central serous retinopathy, or retinal detachment * patients with left ventricular ejection fraction (lvef) \< 50%