Kornimate/medical-research-clean huggingface dataset:
hemoglobin levels for blood transfusions during and after surgery

Conditions: Blood Transfusion; Surgery

Summary: the goal of this pilot clinical trial is to learn if it is achievable to conduct a large-scale clinical trial whereby, the investigators will compare two ways of deciding when to give a blood transfusion during surgery. participants in this study are adults undergoing surgery with a risk of significant blood loss. the main question it aims to answer is: * is a trial designed to definitively test and compare two different red blood cell transfusion strategies feasible? participants will: * receive blood transfusions during surgery based on a higher (less than 90 g/l) or a lower (less than 70 g/l) hemoglobin value. * complete questionnaires at 30 and 90 days after surgery.

during some surgeries, there is a risk of significant blood loss. to manage this, blood transfusions may be needed to replace lost blood. transfusion strategies during surgery vary among physicians and hospitals. current guidelines are broad and suggest it is okay to limit blood transfusions during surgery. however, some anesthesiologists worry that not giving enough blood might cause problems for patients. on the other hand, many cancer surgeons are concerned that giving too much blood could lead to worse outcomes for cancer patients. this difference in opinions shows why clinical trials are needed to guide future practices. the purpose of this study is to test a new protocol that is designed to definitively test and compare two different red blood cell transfusion strategies. it is hypothesized that this trial will be deemed feasible. topgun-pilot is a pragmatic, individually randomized, parallel-arm, vanguard, randomized controlled trial. if feasibility is demonstrated, patients enrolled in the vanguard pilot will be rolled into the definitive topgun trial. this trial is meant to be pragmatic in nature, whereby the study protocol is simple to implement, outcomes are relevant to patients, physicians, and healthcare administrators, and data collection is limited. management of patients prior to, during, and after the intraoperative transfusion strategies will be at the discretion of individual practitioners. a total of 384 patients will be randomized across 3 hospitals (4 sites) in ontario and quebec.

Eligibility criteria:
inclusion criteria: * adult patients, age ≥18. * elective or urgent surgery. * risk of red blood cell transfusion of at least 10 percent. * preoperative hemoglobin of less than 130 g/l. * intraoperative hemoglobin of ≤ 100 g/l at any time during surgery. exclusion criteria: * active major hemorrhage as indication for surgery (e.g. ruptured aneurysm, polytrauma, etc.). * acute coronary syndrome or myocardial infarction within the past 6 weeks. * cardiac surgery. * liver transplantation. * surgery for moderate to severe (glasgow coma scale (gcs) score ≤ 12) traumatic brain injury. * pregnancy or obstetrical surgery. * patient refusal of blood products. * inability to provide consent.

Keywords: red blood cell transfusion hemoglobin threshold blood loss management liberal transfusion practice restrictive transfusion practice intraoperative
functioning disturbance in chronic back pain: altered muscle metabolism

Conditions: Chronic Non-specific Low Back Pian

Summary: the main objective of this study is to investigate the muscle metabolism in individuals with chronic non-specific low back pain (cnslbp) to enhance our understanding of chronic back pain.


Eligibility criteria:
the nscbp group: * at least 6 patients will be included in this study. * all patients referred to vestfold hospital trust, kysthospitalet, diagnosed with chronic nscbp \>3 months duration will be invited to participate in the study. the invitation will be in a written form. exclusion criteria: * anamnesis of medical or drug abuse, * surgery on the musculoskeletal system of the trunk, * known congenital malformation of the spine or scoliosis, * body mass index \> 27 kg/m2, * systemic-neurological-degenerative disease, * history of stroke, * psychiatric disorder, * pregnancy and abnormal blood pressure. the subjects will be asked not to use any medications except for paracetamol preparations one week before examination and instructed not to perform any back-straining exercise for 48 h prior to the study, except for ordinary daily working and/or leisure activities.
chest drain insertion assisted by virtual reality

Conditions: Pneumothorax Spontaneous Primary; Pneumothorax Spontaneous Secondary; Pleural Effusion

Summary: clinical study aiming to investigate the potential benefit of the use of virtual reality helmet as a distractor during chest drain insertion to alleviate patients\&#39; pain and anxiety


Eligibility criteria:
inclusion criteria: * indication of chest drain insertion for pleural effusion or primary spontaneous pneumothorax * patient who received clear and loyal information abotu the study protocol * patient who consented to participate to the study * patient aged 18 years old or older * patient affiliated to the french health system exclusion criteria: * patient aged less than 18 years old * patient in emergency situation * patient with severe heart condition * patient allergic to silicone * patient with severe psychiatric or mental disorder * patient with binocular vision anomaly * patient with pacemaker or defibrillator * patient wearing a hearing aid that cannot be removed * patients under the influence of alcohol or drugs, nausea, fatigue, emotional or anxiety disorders, migraine, headaches, infectious disease * patient with past medical history of epilepsia or convulsion -- persons covered by articles l. 1121-5 and l1121-8 of the french public health code: * pregnant, parturient or breast-feeding women, * persons of full age subject to a legal protection measure (guardianship, curatorship, safeguard of justice) * adults unable to give their consent * persons deprived of their liberty by a judicial or administrative decision, persons under psychiatric care under articles l. 3212-1 and l. 3213-1. * person able to give consent but unable to write * person able to give consent but unable to read french * patient unable to consent to the study

Keywords: virtual reality chest drain pain management chest tube anxiety management
fractionated dosing study: study to evaluate darbepoetin alfa for the treatment of anemia in subjects with non-myeloid malignancies

Conditions: Non-Myeloid Malignancies; Anemia; Cancer

Summary: the purpose of this study is to characterize the pharmacokinetics/pharmacodynamics (pk/pd) of darbepoetin alfa administered at a subcutaneous (sc) dose of 0.45 mcg/kg three times weekly (tiw) in anemic patients with non-myeloid malignancies receiving multicycle chemotherapy.


Eligibility criteria:
inclusion criteria: * non-myeloid malignancy * currently receiving 3-week cyclic chemotherapy treatment with a minimum of 2 additional cycles of chemotherapy planned at the time of enrollment * anemia predominately due to cancer or chemotherapy (hb \>= 9.0 and \< 11.0 g/dl) at the time of screening * 18 years of age or older at the time of screening * eastern cooperative oncology group (ecog) score 0-2 * adequate liver and kidney function exclusion criteria: * known primary hematologic disorder, which could cause anemia, other than non-myeloid malignancies * history of chronic myeloid leukemia (cml), acute myeloid leukemia (aml), myelodysplastic syndrome (mds), acute lymphocytic leukemia (all), hairy cell leukemia, burkitt's lymphoma, or lymphoblastic lymphoma * serum folate \<= 2.0 ng/ml or vitamin b12 \<= 200 pg/ml at screening (anemia related to nutritional deficiencies) * iron deficiency \[transferrin saturation (tsat) \< 15% and serum ferritin \< 10 ng/ml\] at screening * other diagnoses not related to cancer or chemotherapy, which cause anemia (ie, hemolysis, bleeding, sickle cell anemia) * clinically significant inflammatory disease as determined by the investigator (eg, rheumatoid arthritis, crohn's disease) * clinically significant co-morbid medical or psychiatric conditions that may impact subject safety or confound the ability to evaluate study endpoint as determined by the investigator * unstable or uncontrolled cardiac disease or condition (ie, angina, congestive heart failure, or cardiac arrhythmia) * diastolic blood pressure \> 100 mmhg at screening * known hypersensitivity of erythropoietic-stimulating proteins (esps) or any excipients * known history of pure red cell aplasia * known positive antibody response to an esp * use of investigational agents not approved or any indication during the previous 30 days prior to enrollment * esp therapy (i.e., recombinant human erythropoietin \[rhuepo\] or darbepoetin alfa) within 21 days prior to screening or between screening and the first dose of study drug * rbc transfusion(s) within 21 days prior to screening * pregnant or breast-feeding women - previously enrolled in this study * known to be hiv, hepatitis b or c positive * any disorder that would compromise the ability of the subject to give written informed consent and comply with study requirements and procedures

Keywords: non-myeloid malignancy chemotherapy-induced anemia oncology clinical trials pharmacokinetics darbepoetin alfa aranesp amgen
influence of polymorphisms in the atp6v1 gene of the v-atpase on the development of incomplete distal renal tubular acidosis

Conditions: Acidosis, Renal Tubular; Nephrolithiasis; Vacuolar Proton-Translocating ATPases

Summary: purpose 1. to compare the performance of the two currently employed urinary acidifications tests in stone formers, the furosemide/fludrocortisone and ammonium chloride loading test. 2. to study the impact of polymorphisms in the genes atp6v1b1, atp6v0a4 and slc4a1 on urinary acidification in stone formers.


Eligibility criteria:
inclusion criteria: * one or more episodes of nephrolithiasis exclusion criteria: * absence of informed consent * all conditions affecting renal acidification * pregnancy * nursing

Keywords: renal tubular acidosis v-atpase kidney stones
aspirin combined with clopidogrel versus intravenous alteplase for acute minor stroke

Conditions: Ischemic Stroke

Summary: an open-label, blinded endpoint, randomized controlled trial that includes patients diagnosed with non-disabling, non-large vessel occlusion, acute minor stroke within 4.5 hours of onset. eligible participants would be randomly assigned to the thrombolysis group (intravenous alteplase) and the dual antiplatelet group (oral aspirin plus clopidogrel). the primary outcome is the proportion of the excellent functional outcome (modified rankin scale 0-1) at 90 days.


Eligibility criteria:
inclusion criteria: 1. aged 40-80 years. 2. diagnosed with acute ischemic stroke, nihss ≤ 5 and single item score ≤ 1 for vision, language, single limb, and no impairment of consciousness. 3. time from symptoms onset to randomization within 4.5 hours; the onset time refers to the "last known normal" (lkn). 4. absence of large vessel occlusion on cta. 5. pre-stroke mrs ≤ 1. 6. signed informed consent. exclusion criteria: 1. clinically confirmed valvular or non-valvular atrial fibrillation requiring anticoagulation therapy. 2. intracranial hemorrhage or subarachnoid hemorrhage suggested by ct scan. 3. acute coronary syndrome suggested by electrocardiogram. 4. history of gastrointestinal bleeding. 5. planned sequential ivt or endovascular treatment. 6. history of allergy to aspirin, clopidogrel, and/or alteplase. 7. systolic blood pressure exceeding 185 mmhg and/or diastolic blood pressure exceeding 110 mmhg despite antihypertensive treatment. 8. blood glucose ≤ 2.7 mmol/l. 9. epileptic seizures during a stroke attack. 10. recent trauma (\<15 days). 11. recent intracranial or spinal cord surgery, head trauma, or stroke (\<3 months). 12. history of intracranial hemorrhage, aneurysm, vascular malformation, or brain tumor. 13. active visceral hemorrhage (\<22 days). 14. history of anticoagulant use within 24 hours prior to onset. 15. platelets \ 40 seconds on heparin, or pt \> 15 or inr \> 1.7, or known bleeding disposition. 16. anticipated life expectancy \< 3 months. 17. pregnant or lactating women. 18. participation in other clinical trials. 19. any condition that, in the judgment of the investigator, makes the patient unsuitable for this study or where this study may impose a significant risk to the patient (e.g., inability to understand and/or comply with study procedures and/or follow-up due to psychiatric disorders, cognitive or emotional impairment).
information, motivation, behavioral skills model on urinary incontinence and quality of life in men

Conditions: Overactive Bladder; Quality of Life

Summary: multiple studies have shown that education based on the imb model is effective at bringing about health-related behavior change. the imb model was found to be effective in developing healthy behaviors aimed at maintaining heart health, providing behavior to prevent smoking addiction, diabetes management, correct nutrition in iron deficiency anemia, and using condoms to prevent hiv. there are no studies in the literature regarding the adaptation of the imb model to behavioral therapy in patients with oab or urinary incontinence. to address this, there we aimed to investigate the effect of the imb model on urinary incontinence and quality of life in men with oab.

this study aimed to investigate the effect of the information, motivation, behavioral skills model (imb) on urinary incontinence and quality of life in men with overactive bladder. this is a single-center, parallel-group, open-label, randomized controlled clinical trial. this study was conducted between february 2018 and february 2019, with a total of 60 male patients admitted to the urology clinic of a training and research hospital. patients over the age of 18, male, and with overactive bladder were included in the study. participants were randomized into two equal groups: the intervention group (n=30) and control group (n=30). structured bladder training with the imb model was applied to the intervention group. this model was not applied to the control group. the primary outcome was the mean score change over the severity of incontinence measured by the international consultation on incontinence questionnaire-short form (iciq-sf). the other outcomes were measured by the urogenital distress inventory (udi-6), incontinence impact questionnaire-7 (iiq-7), and urinary incontinence information rating scores. all outcome measures were evaluated before and 6 months after the training. bladder training with imb model was found to be effective at ameliorating urinary incontinence and improving quality of life in patients with an overactive bladder.

Eligibility criteria:
inclusion criteria: * male patient * over 18 years old * overactive bladder * urge urinary incontinence * voluntarily agreed to participate in the research exclusion criteria: * benign prostatic hyperplasia * prostate cancer * congenital urinary anomalies * neurological or spinal cord injury, * diabetes mellitus * hypertension * a mental disability * receive medical treatment for incontinence

Keywords: incontinence male overactive bladder quality of life
iliac branch device movement during cardiac cycle (ibd-dynamics)

Conditions: Iliac Aneurysm; Angiography; AAA

Summary: the incidence of isolated common iliac artery (cia) aneurysms is low, but in combination with an abdominal aortic aneurysm (aaa) they are found in approximately 20-40% of cases. basically, two different endovascular strategies can be applied to treat a cia aneurysm with, including 1. the coverage and 2. the preservation of blood flow to the internal iliac artery (iia). coil and coverage of the iia is related to ischemic complications, including buttock claudication, erectile dysfunction and the more severe spinal and colonic ischemia. iliac branched devices (ibd) have been developed to exclude cia aneurysms preserving the iia and currently three alternatives are on the market. clinical results of these devices are promising but loss of patency is not uncommon. the major difference between the two devices is the iia component. the cook ibd uses a -non-dedicated iia component, while in the gore® excluder® iliac branch endoprosthesis (gore ibe device) a dedicated self expanding stent is used. stresses and forces exerted onto the endograft by aortic pulsatility may have an effect on the durability and functioning of the endograft. intermittent hinchpoints could also have an effect on stent integrity and stenosis. by evaluating endograft movement during the cardiac cycle (ecg-gated cta) it is possible to assess the stress and force exerted onto the endograft. this might help gain insight into mechanisms underlying potential endograft failure, and aid procedural planning and the development of future devices with long-term durability. the choice for device is not part of this study.

objectives:to compare the mobility of the hypogastic artery during the cardiac cycle before and six weeks after implantation of the gore ibe device in conjunction with its dedicated self expandable internal iliac component (sub-study a);and to quantitatively characterize the displacement of stents with regard to the main body and native iia during the cardiac cycle on an implanted iliac branched endograft in conjunction with a non-dedicated iia component (cook ibd with advanta v12 or fluency) with those in conjunction with a dedicated self expandable internal iliac component (gore ibe device). (sub-study b) study design: sub-study a \& b: multicenter observational case studies study population: sub-study a: 15 prospectively included patients and sub-study b: 15 patients in each group that have been treated in the period october 2006 - july 2016.

Eligibility criteria:
inclusion criteria: * sub-study a. scheduled endovascular aneurysm repair using the gore ibe device. * sub-study b. patients that have been treated with an iliac branched device in the past in conjunction with either a dedicated iia component (gore ibe device) or non-dedicated iia component (cook ibd) and who are scheduled for follow-up imaging within the period july 2016-january 2017. exclusion criteria: * no specific exclusion criteria. patients will be treated according to the hospital's standard practice.
effect of vitamin k in critically ill patients

Conditions: Coagulation Factor Deficiency; Coagulopathy, Consumption; Vitamin K Deficiency

Summary: critically ill patients with spontaneously prolonged pro-thrombin time, where administration of intravenous administration of phytomenadione (vitamin k) has been ordered by the treating physician will be identified. after signed informed consent baseline samples will be collected. phytomenadione will be given and 24 hours after administration new blood samples will be collected. several different advanced coagulation and vitamin k-assays will be performed before and 24 hours after vitamin k administration.

vitamin k-deficiency is common in the peri-operative and intensive care setting. it is often seen in patients with prolonged prothrombin complex (pk-inr). a prolonged (pk-inr) is sometimes treated with intravenous vitamin k, even in non-warfarin treated or non-liver failure patients. despite the development of this practice the knowledge about how intravenously given vitamin k affects routine coagulation status and other advanced laboratory coagulations assays is rare. the aim of this study is to investigate the effects of intravenously administered vitamin k on routine coagulation status and on advanced coagulation and vitamin k-assays in post-operative- and critically ill patients with prolonged pk-inr. patients with spontaneously prolonged pk-inr are routinely given intravenous vitamin k but it is largely unknown how this procedure affects the included coagulation assays. this research project may contribute to increased knowledge concerning effects of intravenously given vitamin k in critical ill patients with spontaneous coagulopathies. since spontaneous coagulopathy is frequently occurring in critically ill and postoperative patients due to various underlying conditions and current evidence for vitamin k administration is based on scarce evidence more research in this area is motivated.

Eligibility criteria:
inclusion criteria: * critically ill patients at the postoperative care unit or at the intensive care unit with a prothrombin complex (pk-inr) \> 1.2 during office hours who are ordered parenteral phytomenadione 10 mg will be eligible for inclusion exclusion criteria: * warfarin treatment * treatment with novel oral anticoagulants * hepatocellular carcinoma * liver resection within 6 months * known pre-existing coagulopathy
equivalence of intramuscular (im) versus subcutaneous (sc) applications of long acting pamorelin 11.25 mg

Conditions: Prostate Cancer

Summary: the purpose of this study is to demonstrate the pharmacodynamic equivalence of triptorelin pamoate (pamorelin® la 11.25 mg), applied either im or sc, in terms of the area under the curve \[auc1-85day\] for serum testosterone in patients with advanced prostate cancer.


Eligibility criteria:
inclusion criteria: * histologically or cytologically proven prostate cancer, locally advanced or metastatic, or rising psa (prostate-specific antigen) after failed local therapy, and the patient scheduled to receive androgen deprivation therapy * serum testosterone levels ≥ 125 ng/dl (1.25 ng/ml, 1.25 microg/l, 4.3 nmol/l) measured by any laboratory or on site within the previous 6 months or at study start * karnofsky performance index \> 70 * expected survival ≥ 9 months exclusion criteria: * prior hormonal treatment for prostate cancer including gonadotropin-releasing hormone (gnrh) agonists or antagonists within the last 12 months preceding the study or concomitant treatment with one or more of these substance(s) * any current use or within 6 months prior to treatment start of medications which are known to affect the metabolism and/or secretion of androgenic hormones: ketoconazole, aminoglutethimide, oestrogens and progesterone * patient at risk of spinal cord compression or ureter obstruction * prior hypophysectomy or adrenalectomy