Kornimate/medical-research-clean huggingface dataset:
perioperative fluid therapy in patients undergoing pancreaticoduodenectomy

Conditions: Postoperative Complications

Summary: postoperative complication rates in patients undergoing pancreaticoduodenectomy remain high although the operation techniques have developed a lot in recent years. there is evidence that restrictive intraoperative fluid therapy could decrease postoperative complication rates but the results of the former studies have been somewhat controversial. the aim of this study is to examine whether the intraoperative and postoperative fluid therapy affect to the postoperative complication rates in patients undergoing pancreaticoduodenectomy.

the study is a retrospective cohort study. the first cohort consists of patients who underwent pancreaticoduodenectomy in year 2015 when intraoperative fluid therapy were managed using goal directed fluid therapy technique. the second cohort consists of patients who underwent pancreaticoduodenectomy in year 2017 when intraoperative fluid therapy were based on the consideration of the anaesthesiologist. in 2015 most of the patients spent the first postoperative night in the icu where the fluid management and monitoring of the urine output and vital functions were more controlled than in the normal ward. in 2017 most of the patients got in the regular ward right after the surgery. the aim of the study is to examine whether there are differences in the amounts of the intraoperative and postoperative fluids between the cohorts and does the perioperative fluid therapy affect to the complication rates.

Eligibility criteria:
inclusion criteria: * age 18 or over * patients who underwent pancreaticoduodenectomy in 2015 or in 2017 exclusion criteria: * patients whose patient record information is insufficient

Keywords: pancreaticoduodenectomy clavien-dindo classification pancreatic fistulas
safety and dose study of grn163l administered to treat patients with refractory or relapsed multiple myeloma

Conditions: Multiple Myeloma

Summary: the purpose of this study is to determine the safety and the maximum tolerated dose (mtd) of grn163l when administered to patients with refractory or relapsed multiple myeloma.

grn163l is a telomerase template antagonist with in vitro and in vivo activity in a variety of tumor model systems. telomerase is an enzyme that is active primarily in tumor cells and is crucial for the indefinite growth of tumor cells. inhibition of telomerase may result in antineoplastic effects.

Eligibility criteria:
inclusion criteria: * confirmed diagnosis of multiple myeloma (either secretory or nonsecretory disease) * relapsed or refractory disease * at least two prior treatment regimens * ecog performance status 0-2 * adequate hepatic/renal function and platelet count * if previously treated with an anthracycline, anthracenedione, or trastuzumab, must have left ventricular ejection fraction \> 50% exclusion criteria: * prior allogeneic bone marrow transplant, including syngeneic transplant * known intracranial disease or epidural disease * prior malignancy (within the last 3 years) * clinically significant cardiovascular disease or condition * active or chronically recurrent bleeding (eg, active peptic ulcer disease * prolongation of pt or aptt \> the uln or fibrinogen \< the lln * clinically relevant active infection * serious co-morbid medical conditions, including cirrhosis and chronic obstructive or chronic restrictive pulmonary disease * symptomatic hyperviscosity syndrome * any other cancer therapy within 3 weeks prior to study, except for mitomycin c, nitrosoureas, or high-dose chemotherapy with stem cell support within 6 weeks prior to study * investigational therapy within 4 weeks prior to study * anti-platelet therapy within 2 weeks prior to study, other than low dose aspirin prophylaxis therapy and low dose heparin administration for management of iv access devices * radiation therapy within 4 weeks prior to study * major surgery within 4 weeks prior to study * active autoimmune disease requiring immunosuppressive therapy * known positive serology for hiv

Keywords: myeloma multiple myeloma relapsed multiple myeloma refractory multiple myeloma relapsed or refractory multiple myeloma
renal sympathetic modification in patients with heart failure

Conditions: Heart Failure

Summary: the purpose of this study is to observe the incident of composite cardiovascular events after renal sympathetic modification using thermocool® catheter in patients with heart failure, and evaluate safety and efficacy of the intervention.

heart failure is a clinical syndrome of chronic cardiac dysfunction, with high morbidity and mortality. traditional pharmacological therapies are used in clinical practice without breakthrough for long time. previous studies confirmed that partly blocking sympathetic nerves activity contributed to improve cardiac function in patients with heart failure. renal ablation with sympathetic modification is a new method which is proved to be effective in decreasing sympathetic nerves activity. the investigators hypothesis that renal sympathetic nerves modification is effective and safe in improving cardiac function. this trial is going to recruit 200 patients (ablation group vs control group = 1:1) with a follow-up duration of 3 years. patients in ablation group will receive additional necessary anti-heart failure drugs besides expectant intervention, and patients in control group will receive appropriate anti-heart failure drugs only. the investigators aim to observe the incident of composite cardiovascular events after renal sympathetic modification using thermocool® catheter in patients with heart failure, and evaluate safety and efficacy of the intervention.

Eligibility criteria:
inclusion criteria: * ≥ 18 years old, and ≤ 75 years old of age * more than half a year history of heart failure, except for valvular heart disease * heart failure patients nyha class ii iii iv * left ventricular ejection function ≤ 40% or ≥ 45% (that is heart failure with preserved ejection fraction) with simpson's method * estimated glomerular filtration rate (egfr) of ≥ 45ml/min * is competent and willing to provide written, informed consent to participate in this clinical study exclusion criteria: * patients with acute heart failure * patients with acute coronary syndrome * estimated glomerular filtration rate (egfr) of \< 45ml/min * has the history of renal restenosis or renal stents implantation * has experienced ami (old myocardial infarction is not excluded), unstable angina pectoris, cerebrovascular accidents, and alimentary tract hemorrhage within 3 months * patients with sick sinus syndrome * pregnant women * mental disorders * patients that have allergy to contrast agent * patients that do not go with follow-up * others such as researcher considers it is not appropriate to be included into the study

Keywords: renal artery sympathetic nerves modification heart failure
medical care versus ventricular assist device for the management of end-stage heart failure (mevade)

Conditions: Heart Failure; Heart Transplantation; Heart-Assist Devices

Summary: end-stage heart failure (eshf) represents a major burden in terms of quality of life, mortality and costs. the current practice in france is to treat patients with eshf by a combination of drugs and lifestyle interventions before proposing heart transplant (ht) if there is no contraindication. in the heart and diabetes center of bad oyenhausen (bo) in germany, patients presenting with eshf are preferentially managed by ventricular assist device (vad) therapy. the primary purpose of this study was to compare the outcomes of these two strategies in the management of eshf and associated consumption of resources.


Eligibility criteria:
inclusion criteria: all patients presenting with end-stage heart failure defined as: * a left ventricular ejection fraction ≤25% * or an oxygen consumption peak \< 14 ml/kg/min * or severe symptoms (nyha class iii or iv) despite optimal medical treatment * or a cardiogenic shock exclusion criteria: * age over 70 years * active neoplasia * suspected or active systemic infection * body mass index ≥40 kg/m2 * severe chronic obstruction pulmonary disease * evidence of intrinsic hepatic diseases defined as liver enzyme values ≥ 5 times the upper limit of normal within 4 days before the randomisation, or biopsy proven liver cirrhosis * significant chronic renal impairment with persistent creatinine \>2.5 or clearance \< 25ml/min * pregnant or lactating female * patient under consideration for conventional revascularization procedures, therapeutic valvular repair, left ventricular procedure or cardiomyoplasty * presence of implanted mechanical aortic valve that will not be converted to bioprothesis at the time of ventricular assist device implantation * evidence of intrinsic hepatic diseases defined as liver enzyme values ≥ 5 times the upper limit of normal, or biopsy proven liver cirrhosis * occurrence of stroke within 90 days or history of cerebrovascular disease with major (≥ 80%) extracranial or carotid stenosis documented by doppler study * confirmation by neurologist of impairment of cognitive function, presence of alzheimer's disease or any other form of irreversible dementia or both * major peripheral vascular disease accompanied by pain on rest or leg ulceration * recent history of psychiatric disease that is likely to impair compliance * drug or alcohol dependence * difficult social surroundings

Keywords: end stage heart failure new york heart association functional class iii or iv heart transplantation ventricular assisted devices cardiogenic shock
dose-ranging trial of opc-249 powder inhalation in patients with pain due to osteoporosis

Conditions: Pain Due to Osteoporosis

Summary: the purpose of this study is to examine the efficacy and safety of opc-249 by once daily inhalation at 0 (placebo), 30, 60 or 120 iu for 4 weeks in patients with pain due to osteoporosis.


Eligibility criteria:
inclusion criteria: * patients who fulfill all of the following items * patients with primary osteoporosis * patients who have existing 1-4 vertebral fractures * patients with back pain persisting for one week or more * postmenopausal women between 46 and less than 80 years of age
diagnosing invasive aspergillosis by polymerase chain reaction (pcr) based investigation of bronchoalveolar lavage samples during antifungal therapy

Conditions: Invasive Aspergillosis

Summary: invasive pulmonary aspergillosis (ipa) remains a major cause for morbidity and mortality in patients (pts) with hematologic malignancies. as culture-based methods only yield results in a minority of patients, using non-culture-based methods for detection of aspergillosis in clinical specimens becomes increasingly important. analyzing bronchoalveolar lavage (bal) samples with polymerase chain reaction (pcr) is promising, however, the influence of current antifungal drugs on the performance of this diagnostic tool remains controversial. the aim of the trial is to elucidate on the performance of bal pcr under antifungal treatment.

invasive pulmonary aspergillosis (ipa) remains a major cause for morbidity and mortality in patients (pts) with hematologic malignancies. as culture-based methods only yield results in a minority of patients, using non-culture-based methods for detection of aspergillosis in clinical specimens becomes increasingly important. analyzing bronchoalveolar lavage (bal) samples with polymerase chain reaction (pcr) is promising, however, the influence of current antifungal drugs on the performance of this diagnostic tool remains controversial. the aim of the trial is to elucidate on the performance of bal pcr under antifungal treatment. patients with high risk of invasive aspergillosis and lung infiltrates are sampled via bal, the sample is analyzed for fungal dna by apsergillus specific pcr. clinical data including treatment data is assessed and evaluated.

Eligibility criteria:
inclusion criteria: * immunocomprimised patients with high risk of invasive aspergillosis and lung infiltrates * informed consent exclusion criteria: * children under the age of 5 years * informed consent not available
randomized controlled study comparing a short stem hip prosthesis with a stem of standard length

Conditions: Primary Osteoarthritis of Hip Nos; Secondary Osteoarthritis of Hip

Summary: 80 patients eligible for a total hip replacement (thr) mainly due to primary osteoarthritis were recruited from the waiting list for hip arthroplasty at a university hospital in sweden. the patients were randomized to either cfp or corail stem, both groups received delta cup from lima. randomisation was done using envelopes. patients could only participate with one hip. patients are evaluated with different questionnaires, radiographs and rsa analysis.

the concept of femoral neck preserving hip replacement is intended for the young and active patients. by preserving proximal bone load, the transmission to the proximal femur is supposed to improve and future revision surgery would be facilitated. the hypothesis is that a more conservative resection of the femoral neck could lead to better clinical outcomes compared to a conventional stem. the clinical outcomes and the fixation of a short femoral stem were therefore compared with a stem of standard length. 83 patients were included in our randomized controlled trial where patients either received a collum femoris preserving (cfp) stem or a corail hip stem. clinical outcomes are being assessed, plain radiographs are studied and the early migration is being measured using radiostereometric analysis. all of the patients have gone through 1 year follow-up. the 2 years results will be available at the end of 2017.

Eligibility criteria:
inclusion criteria: * primary osteoarthritis of hip * secondary osteoarthritis due to hip dysplasia or perthes under condition that the collum anatomy is well preserved and largely unaffected by the primary disease * avascular necrosis of femoral head * anatomy suitable for both designs according to preoperative planning exclusion criteria: * previous treatment with cortisone * generalized joint disease

Keywords: short stem
control of assistive devices via brain-computer interface technology

Conditions: Tetraplegia/Tetraparesis; Amyotrophic Lateral Sclerosis (ALS); Quadriplegia; Spinal Cord Injury (SCI); Spinal Cord Injury Cervical

Summary: the convoy study is a clinical trial designed to explore the feasibility of participants from the prime study (nct06429735) using the n1 implant to control various assistive devices. the main goal is to determine whether participants can successfully modulate their brain activity to control devices, such as an assistive robotic arm (ara). this study will assess the effectiveness, consistency, and safety of neural control using the ara and other assistive devices.


Eligibility criteria:
inclusion criteria: * continued enrollment in the prime study. * implanted with the n1 implant. exclusion criteria: * explantation or deactivation of the n1 implant. * insufficient n1 implant bci performance demonstrated. * lack of a suitable physical space to perform research sessions. * any condition which, in the opinion of the investigator, would compromise the candidate's ability to safely participate in the study.

Keywords: brain computer interface robotic arm assistive device neuralink n1 implant neuralink n1 implant als spinal cord injury quadriplegia tetraplegia robot external device control neuroprosthetics
mucosal ige to improve diagnosis of food allergy and food hypersensitivity

Conditions: Food Allergy; Food Hypersensitivity

Summary: aim of the study is to improve the diagnosis of food allergy and hypersensitivity. intestinal homogenates will be used to determine total ige, specific ige, tryptase, histamine and inflammation parameters (ifngamma, tnfalpha). these data will be correlated with serum values and disease status. in addition, organoids from duodenal tissue will be isolated and cultured in vitro and stimulated with the major food allergens. the gene and protein expression will be checked to identify relevant biomarkers.

food intolerances (fi) show an increasing prevalence and represent a particular challenge in clinical practice. the symptoms of a predominantly gastrointestinally mediated food allergy (fa) are similar to the symptoms of other fi (e.g. carbohydrate malabsorption, gluten sensitivity, histamine intolerance, irritable bowel syndrome), so that diagnosis is difficult and often delayed. well-evaluated methods for the clarification of an allergic disease are serological screening (ige against food products or other cross-reacting allergens) and skin prick tests. however, these methodes have their limitations in the diagnosis of seronegative or mainly gastrointestinal-mediated fi. patients often associate the consumption of certain foods with the clinical symptoms, which often leads to strict self-imposed elimination diets, but rarely to the correct identification of the triggering food. in a pilot study, the investigators showed that patients with gastrointestinal fi have elevated mucosal ige levels and tnf using homogenates from intestinal biopsies. another patient subgroup could be identified that showed low allergic parameters (low mucosal ige, low tnf) but high mucosal interferon levels, indicating a non-specific inflammation. in this study, mucosal ige, tryptase, histamine, il4, and inflammatory parameters (e.g. tnf, ifn) from different areas of the gastrointestinal tract will be determined in a larger collective. furthermore, organoids are cultured in vitro from duodenal tissue samples, incubated with blood cells and stimulated with food allergens. the titres of specific ige from the mucosal homogenates will be correlated with serum levels and organoid stimulation results to identify relevant biomarkers. microbiome and metabolome analyses will provide information about the intestinal flora in fi.

Eligibility criteria:
inclusion criteria: * informed consent * patients with suspected food allergy or hypersensitivity * healthy controls with indications for endoscopic diagnostics, e.g. tumour history within the family, exclusion of gastritis exclusion criteria: * pregnant person

Keywords: mucosal ige inflammation parameter
study on the efficacy of alprostadil injection in patients with acute ischemic stroke

Conditions: Stroke

Summary: ischemic stroke has a variety of treatments and currently drug therapy is one of the main treatments.a number of clinical studies have proved that alprostadil (pge1) has pharmacological effects of significant dilation of blood vessels, inhibition of plate aggregation, anti-atherosclerosis and increased cerebral blood flow.evaluate the 90-days efficacy by comparing two groups of patients'(one with alprostadil,another with placebo) mrs.


Eligibility criteria:
inclusion criteria: 1. ischemic stroke diagnosed by ct or mri 2. age: 18-75 years 3. pre-stroke mrs score is 0-1 4. within 72 hours symptoms onset 5. 4 ≤ nihss \<20 6. patient is willing to participate voluntarily and to sign a written patient informed consent exclusion criteria: 1. intracranial tumors, encephalitis or lesions diagnosed by ct or mri 2. patients with thrombolytic therapy 3. low platelet , blood system diseases or other bleeding tendency 4. suspected subarachnoid hemorrhage or aortic dissection coma 5. atrial fibrillation, myocardial infarction, heart valve disease, infective endocarditis, heart rate \<50 beats / min 6. alt or ast continued to rise more than 3 times the upper limit of normal creatinine clearance rate\<30ml/min 7. dementia and mental illness 8. patient who is participating in other trials or has been participated in other trials in recent 3 months
contrast enhanced eus in the evaluation of pancreatic cancer and pancreatic masses

Conditions: Pancreatic Cancer

Summary: contrast enhanced eus with the sonographic contrast agent definity™ has the potential to detect pancreatic cancer at an earlier stage, to improve current method of t staging and assessment of surgical resectability and also to distinguish between benign and malignant pancreatic masses. all these will translate into better clinical outcome, and also avoid unnecessary surgery in situations of unresectable cancers.


Eligibility criteria:
inclusion criteria: * consecutive patients over a 1-year period referred for eus examination due to suspected pancreatic lesions will be enrolled. * age 21 years and above. * ability to provide informed consent exclusion criteria: patients with clinical conditions that preclude the use of definity™ will be excluded. these conditions are: * right-to-left, bi-directional, or transient right-to-left cardiac shunts; * worsening or clinically unstable congestive heart failure; * acute myocardial infarction or acute coronary syndromes; * serious ventricular arrhythmias or high risk for arrhythmias due to prolongation of the qt interval; * respiratory failure; * severe emphysema, pulmonary emboli or other conditions that cause pulmonary hypertension due to compromised pulmonary arterial vasculature; * hypersensitivity to definity™ or its components.
efficacy and safety of idelalisib (gs-1101) in combination with bendamustine and rituximab for previously treated indolent non-hodgkin lymphomas

Conditions: Indolent Non-Hodgkin's Lymphomas

Summary: the primary objective of this study is to evaluate the addition of idelalisib to bendamustine/rituximab on progression-free survival (pfs) in adults with previously treated indolent non-hodgkin lymphoma (inhl). an increased rate of deaths and serious adverse events (saes) among participants with front-line chronic lymphocytic leukemia (cll) and early-line inhl treated with idelalisib in combination with standard therapies was observed by the independent data monitoring committee (dmc) during regular review of 3 gilead phase 3 studies. gilead reviewed the unblinded data and terminated this study in agreement with the dmc recommendation and in consultation with the us food and drug administration (fda).


Eligibility criteria:
key inclusion criteria: * histologically confirmed diagnosis of b-cell inhl, with histological subtype limited to the following 1. follicular lymphoma (fl) grade 1, 2, or 3a 2. small lymphocytic lymphoma (sll) 3. lymphoplasmacytoid lymphoma/waldenström macroglobulinemia (lpl/wm) 4. marginal zone lymphoma (mzl) (splenic, nodal, or extra-nodal) key exclusion criteria: * history of lymphoid malignancy other than those allowed per inclusion criteria. * ongoing drug-induced liver injury, active hepatitis c, active hepatitis b, alcoholic liver disease, non-alcoholic steatohepatitis, primary biliary cirrhosis, extrahepatic obstruction caused by cholelithiasis, cirrhosis of the liver, or portal hypertension. * prior treatment with bendamustine that was not effective. note: other protocol defined inclusion/exclusion criteria may apply.

Keywords: inhl indolent nhl follicular lymphoma cal-101 rituximab bendamustine small lymphocytic lymphoma lymphoplasmacytoid lymphoma waldenstrom macroglobulinemia lpl wm marginal zone lymphoma mzl sll fl gs-1101 pi3k inhibitor idelalisib