Kornimate/medical-research-clean huggingface dataset:
efficacy of a convective prewarming system in prevention of perioperative hypothermia

Conditions: Perioperative Hypothermia

Summary: although several measures for prevention of perioperative hypothermia have been introduced the last decades, perioperative hypothermia is still a frequent complication and associated with a negative outcome. for not long lasting surgery without specific risk for hypothermia the standard procedure for prevention of perioperative hypothermia is insulation. however, the insulation is often not effective enough to prevent intra- and postoperative hypothermia. the implementation of a prewarming is difficult because of variable or schedules and therefore not often applied. in the planed prospective, multicenter, randomised-controlled trial will the efficacy of a convective prewarming system on prevention of intra- and perioperative hypothermia (thermoflect™, tsci, amersfoort, nl) be compared to an intraoperative application of forced air warming with or without passive insulation before induction of anesthesia. the studied prewarming device is easy to use and will be applied on the nursery ward 30-60 minutes before transfer of the patient to the or. perioperative hypothermia is a common complication in general aesthesia. perioperative hypothermia is associated with medical risks as intraoperative impaired coagulation due to reversible platelet dysfunction, a prolonged bleeding time and increased intraoperative blood loss. in the postoperative course the perioperative hypothermia is especially for patients with cardiopulmonary diseases a relevant problem. not at least sensual cold and shivering is uncomfortable for the patient. the study is conducted as a multicenter, prospective, randomised controlled trial. all patients will receive intraoperatively a forced air warming device (termoflect™/mistral air ™). for one intervention group will additionally the insulation with the thermoflect™ will be applied on nursery ward, the second intervention group will receive additionally a convective air warmer/ reflective blanket (thermoflect™/mistral air™, tsci, amersfoort, nl) preoperatively on study day on nursery ward. the aim of the study is to prove the hypothesis that a preoperative insulation with a commercial insulation material (thermoflect™, tsci, amersfoort, nl) leads to a lower incidence of perioperative hypothermia in general anesthesia. the second hypothesis is, that an active prewarming (thermoflect™ with mistral air™, tsci, amersfoort, nl) is associated with a more less incidence of periopative hypothermia.


Eligibility criteria:
inclusion criteria: * age from 18 to 75 years * bmi from 20 to 30 kg/m2 * risk class asa i to iii * scheduled time for surgery 30 to 120 minutes * scheduled anaesthesia with remifentanil, propofol, rocuronium and sevofluran * ability of informed consent exclusion criteria: * adipositas permagna * risk class asa iv to v * hypo- and hyperthyroidism * febrile infection * pregnancy * scheduled time for surgery \ 120 minutes * known incompatibility for midazolam, remifentanil, propofol oder rocuronium

Keywords: perioperative hypothermia prewarming forced air warming insulation
dose response study of nitisinone in alkaptonuria

Conditions: Alkaptonuria

Summary: sonia 1 is an international, multicentre, randomised, open-label, no-treatment controlled, parallel group, dose-response study to investigate the effect of once daily nitisinone on 24-hour urinary homogentisic acid excretion in patients with alkaptonuria after 4-weeks treatment. they study will identify the optimal dose to decrease urine homogentisic acid to near normal levels.


Eligibility criteria:
inclusion criteria a subject must fulfil the following criteria in order to be included in the study: 1. diagnosis of alkaptonuria verified by documented elevated urinary homogentisic acid excretion. 2. age ≥18 years. 3. willing and able to visit the investigational site for study visits. 4. signed written informed consent obtained. exclusion criteria the presence of any of the following will exclude a subject from inclusion in the study: 1. non-alkaptonuria causes of ochronosis. 2. currently pregnant or lactating. 3. known allergy to nitisinone or any of the constituents of the investigational product. 4. use of a protein-restricted diet 5. dietary habits or use of homeopathic therapies that interfere with tyrosine catabolism. 6. current keratopathy, contact lens use or uncontrolled glaucoma. 7. current malignancy. 8. uncontrolled hypertension (blood pressure greater than 180 systolic or greater than 95 diastolic). 9. electrocardiogram changes indicative of myocardial infarction, arrhythmia, tachycardia, bradycardia, left bundle branch block. 10. chest radiographic abnormalities, including an infiltrative, mass, congestive heart failure, embolism, atelectasis. 11. serum potassium \< 3.0 mmol/l. 12. egfr \< 60 ml/min. 13. any hepatic enzymes greater than 3 x upper limit of normal. 14. haemoglobin \< 10.0 g/dl. 15. platelets less than 100 x 109/l. 16. wbc less than 3.0 x 109/l. 17. esr greater than 100 mm/h. 18. history of alcohol or drug abuse. 19. participation in another clinical trial within 3 months of randomisation. 20. treatment with nitisinone within 3 months of randomisation 21. psychiatric illness or neurological disease that interferes with compliance or communication with health care personnel. 22. any other medical condition which in the opinion of the investigator makes the subject unsuitable for inclusion. 23. foreseeable inability to cooperate with given instructions or study procedures.
prolonged sitting on responses to short-term exercise training

Conditions: Atherosclerosis; Metabolic Syndrome

Summary: prolonged sitting has been shown to effect the response to a high fat tolerance test (hftt) after acute exercise. this study will evaluate the effect of prolonged sitting on response to a hftt after a short term training period.


Eligibility criteria:
inclusion criteria: * 18 to 35 years exclusion criteria: * cardiovascular problems (e.g. pre-existing heart issues, coronary artery disease, hypertension, etc.) * respiratory problems * musculoskeletal problems that prevent prolonged sitting or exercise * obesity * susceptibility to fainting * pregnancy
aminomedixtm for kidney protection during radionuclide therapy

Conditions: Radiation Nephropathy

Summary: this is a phase i, and ii, single-center, open-label clinical trial to evaluate the safety and preliminary efficacy information of aminomedix™ in protecting kidneys from radiation-induced toxicity during peptide receptor radionuclide therapy (prrt) with 177lu-dotatate in patients with neuroendocrine cancers. aims of the study: 1. evaluation of the safety of aminomedix ™ infusion. 2. evaluation of kidney radiation dosimetry with and without aminomedix™ using 68ga-dotatate pet/ct imaging as a surrogate marker for 177lu-dotatate. 3. evaluation of the safety and calculation of kidney and tumor radiation dosimetry after aminomedix™ infusion with low dose 177lu-dotatate in patients with neuroendocrine cancers.


Eligibility criteria:
inclusion criteria: 1. patients with neuroendocrine tumors are eligible to be recruited in this project. 2. signed informed consent. 3. patients of either gender, age 18 years or older. 4. na+, k+, cl,: within normal range 5. egfr: \> 50 ml/min 6. serum creatinine: \<150μmol/l. serum creatinine: within normal range or \<120μmol/l for patients aged 60 years or older. 7. negative pregnancy test (urine test or beta-hcg) in women capable of child-bearing. exclusion criteria: 1. known hypersensitivity to amifostine, lysine, arginine, dota, 68gallium, to dotatate or to any of the excipients of 68ga-dotatate. 2. therapeutic use of any somatostatin analogue, including sandostatin® lar (within 28 days) and sandostatin® (within 2 days) prior to study imaging. if a patient is on sandostatin® lar a wash-out phase of 28 days is required before the injection of the study drug. 3. pregnant or breast-feeding women. 4. current somatic or psychiatric disease/condition that may interfere with the objectives and assessments of the study. 5. pre-existing cardiovascular or cerebrovascular conditions such as congestive heart failure, ischemic heart disease, arrhythmias, or a history of stroke or transient ischemic attacks. 6. uncontrolled kidney disease and patients who are under dialysis. 7. current treatment with potentially nephrotoxic drugs such as aminoglycosides. 8. less than 24 hours of withdrawal of antihypertensive medications or uncontrolled hypertension, and diabetes at the time of the study. 9. patients under total or partial parenteral nutrition.

Keywords: radiation nephropathy prrt radiation induced toxicity 177lu-dotatate aminomedix ™
endoscopic ultrasound in diagnosing cancer in patients with localized stomach cancer or esophageal cancer

Conditions: Esophageal Cancer; Gastric Cancer

Summary: rationale: diagnostic procedures, such as endoscopic ultrasound, may help doctors learn the extent of stomach cancer or esophageal cancer. purpose: this randomized clinical trial is studying how well endoscopic ultrasound works in diagnosing cancer in patients with localized stomach cancer or esophageal cancer.

objectives: primary * to determine the additional effect of endoscopic ultrasound (eus) staging compared with a standard staging algorithm on the selection of treatment in patients with gastric or esophageal cancer (goc), including the numbers of patients treated surgically, with multimodality therapy, or with non-surgical means. * to estimate the effect of eus staging on the outcome of care of these patients. * to assess the cost-effectiveness of eus by comparing improvements in patient outcomes with the additional costs of the procedure. * to estimate the proportion of patients with goc who will benefit from eus and therefore to determine the need for eus facilities within a population. outline: this is a multicenter study. patients are stratified according to tumor location (gastric vs esophageal vs gastroesophageal junction) and participating center. all patients undergo standard staging methods. patients with localized tumors are randomized to undergo either endoscopic ultrasound (eus) or no further staging. both groups receive treatment as follows, depending on the type of tumor: * mucosal tumors: patients undergo endoscopic mucosal resection and argon-beam ablation of the surrounding mucosa. * resectable tumors: patients undergo surgery and neoadjuvant chemotherapy comprising cisplatin and fluorouracil. * advanced localized disease without the possibility of complete resection: patients receive chemoradiotherapy or chemotherapy alone depending upon the site. patients with gastric cancer may undergo palliative surgery. quality of life is assessed at 1, 3, 6, 12, 18, and 24 months using questionnaires, including the euroqol eq-5d, the eortc core module qlq-c30, the eortc esophageal module qlq-oes24, and the eortc gastric module qlq-sto22. after completion of study treatment, patients are followed every 3 months for a minimum of 1 year.

Eligibility criteria:
disease characteristics: * diagnosis of gastric or esophageal cancer * localized disease * no metastatic disease patient characteristics: * who performance status 0-2 * american society of anesthesiologists grade 1 (no physiological disturbance) or 2 (minor well-compensated physiological impairment) * must be fit for surgery and chemotherapy prior concurrent therapy: * not specified

Keywords: stage i gastric cancer stage ii gastric cancer stage iii gastric cancer stage i esophageal cancer stage ii esophageal cancer stage iii esophageal cancer
amino acids supplementation and exercise intervention in hemodialysis patients

Conditions: Hemodialysis Complication; Malnutrition

Summary: the goal of this randomized clinical trial is to observe the effect of amino acids (aas)supplementation and exercises in haemodialysis patients . the main question it aims to answer is : does aas supplementation and regular exercises have an effect on the muscle mass and function in haemodialysis patients ? participants will receive daily a total of six tablets of amino acids supplementation divided into three doses. and some participants will also be asked to do intradialytic exercise. researchers will compare the effects of these interventions on the muscle mass and fatigue, among four groups: 1. a group that will be only taking aas supplementation 2. a group taking aas supplementation along with intradialytic exercise 3. a group only performing intradialytic exercise 4. a passive control group this will be monitored through bmi, anthropometric measures, musculoskeletal ultrasound assessment of the quadriceps muscle , fatigue questionnaires and sit and stand test.


Eligibility criteria:
inclusion criteria: * hemodialysis patients due to chronic kidney diseases * age between 18 - 60 exclusion criteria: * frail patients * the patients who refused to participate * growth retarded patients * disabilities

Keywords: haemodialysis patients ketoanalogs malnutrition exercise muscle function
metformin and pioglitazone effects on ykl-40 concentrations in type 2 diabetes patients

Conditions: Type 2 Diabetes Mellitus

Summary: patients with type 2 diabetes are at an increased risk for developing atherosclerosis, largely due to the underlying insulin resistance and chronic low grade inflammation. cardiovascular events could be prevented with proper interventions targeted at ameliorating the aforementioned detrimental processes. ykl-40, a novel surrogate marker of acute and chronic inflammatory states has been implicated to have a putative role in both pathways. given the shared pathway of insulin resistance and atherosclerosis, it is conceivable that anti-diabetes medications are able to modify coronary artery disease risk via direct and indirect amelioration of ykl-40 concentrations. the present clinical trial was therefore launched to examine the comparative effects of metformin and pioglitazone, two commonly prescribed anti-diabetes medications on ykl-40 concentrations in medication-naïve, newly-diagnosed type 2 diabetes patients.


Eligibility criteria:
inclusion criteria: * newly diagnosed type 2 diabetes patients based on american diabetes association criteria for diagnosis of diabetes exclusion criteria: * positive history for taking anti-diabetes medications of any class in the past * positive current history for taking over-the-counter vitamin or anti-oxidant supplements * presence of clinically significant chronic illnesses of the heart, lungs, or kidneys.

Keywords: ykl-40 chronic low grade inflammation type 2 diabetes mellitus metformin pioglitazone
gout self-monitoring aiming to reach target

Conditions: Gout

Summary: this study evaluates whether a supported self-management approach to gout is able to achieve target levels of serum urate, and better control of gout flares.

gout is the most common cause of inflammatory arthritis with recurrent gout flares a cause of reduced quality of life, work absence and disability. effective treatments are widely available and yet many patients never achieve control of their disease. resolution of gout attacks requires sustained lowering of the levels of serum urate, which in practise is seldom achieved. a supported self-management approach to gout has been developed which incorporates self-testing of urate levels and a smartphone application that will prompt participants to self-test and allow clinical researchers to titrate urate lowering therapies. the feasibility of this approach will be evaluated in patients with gout referred to secondary care. participants will be randomised 2:1 to the intervention or a control group. the intervention group will be offered supported self-management incorporating self-testing of serum urate. the control group will receive usual care from their primary care physician. the primary outcome will be the proportion of patients achieving levels of serum urate at or below 0.3mmol/l by 6 months. participants will be followed up for a total of 12 months to assess the broader health and economic impact of the intervention.

Eligibility criteria:
inclusion criteria: * confirmed diagnosis of gout (as per american college of rheumatology criteria) * physician recommendation that escalation of urate lowering therapy with allopurinol or febuxostat is appropriate. * serum urate \>0.36mm/l. * patient has a mobile phone and is able to install goutsmart (gout self-monitoring aiming to reach target urate) application. exclusion criteria: * subject is unable to provide consent * severe renal failure (egfr \<30) or established liver disease * previous adverse reaction to allopurinol or febuxostat
effect of preoperative diet on perioperative gut microbiome

Conditions: Surgical Site Infection

Summary: the aim of the study is to evaluate the gut microbiome (i.e. bacteria, viruses, and fungi that reside in the gut) of people undergoing abdominal surgery, evaluate whether specific diets can change the gut microbiome, and, if so, whether those changes translate into better surgical outcomes.

standard of care: patients undergoing major abdominal colorectal surgery are sometimes advised to eat healthfully prior to surgery, but without more specific recommendations regarding their diet. research activities: 1. screening: eligible patients will be identified through screening the clinic schedules. 2. enrollment: in person or remotely, after the patient is determined to require major abdominal surgery, they will be invited to participate in the study. if they consent to participate, they will be randomized to receive either low-fat/high-fiber diet, high-fermented diet, or continue with their normal diet for 10-14 days prior to the surgery. 3. intervention: at baseline, data will be collected regarding clinical information of the patients (age, body mass index, comorbidities, medications or supplements, physical activity levels, antibiotic or probiotic use in the past six months), and baseline dietary pattern, which will be evaluated through application of a validated food frequency questionnaire (dhq iii). patients in the intervention arms (low- fat/high-fiber diet or high-fermented diet) will receive meal samples during the 10-14 days preceding surgery. patients in the control arm will receive a $25 grocery voucher. adherence to the diet will be assessed through regular check ins with the patients. stool samples will be collected in five timepoints: at the beginning of the study, after the dietary intervention, during surgery, in the first week after the surgery, and between 21-30 days after surgery. the stool samples will be sent for analysis of the microbiome. a fragment of the resected bowel will also be sent for analysis of the mucosal-associated microbiome. 4. closeout: after surgery, all patients will receive the same standard dietary protocol and care, and will be followed for 30 days without any further intervention.

Eligibility criteria:
inclusion criteria: * undergoing major abdominal colorectal surgery with intestinal resection in 2 or more weeks exclusion criteria: * patients who do not speak english or spanish * houseless patients * decisionally impaired patients * presence of ileostomy prior to the surgical procedure * surgery without intestinal resection
patients with acute renal failure during severe covid-19

Conditions: Renal Failure Chronic

Summary: the occurrence of renal failure during severe forms of covid-19 is common (20-35% of patients treated in intensive care) and associated with an unfavorable short-term prognosis, but the medium-term renal outcome is not is not known. the aim of the study is to establish the frequency of chronic kidney failure after aki kdigo 2 and 3 occurring during severe covid-19 in intensive care.


Eligibility criteria:
inclusion criteria: * major subject (≥18 years old) * subject hospitalized in an intensive care unit, strasbourg, nancy or reims hospitals, for severe covid-19 between february 1, 2020 and july 31, 2020. * having presented acute renal failure kdigo 2 (assessed on a doubling of serum creatinine compared to the patient's reference values) or 3 (serum creatinine greater than 3 times the patient's reference, or anuria, or any recourse to extra-purification renal) * having left hospital alive after initial treatment for covid-19 * subject not having expressed his opposition, after information, to the reuse of his data for the purposes of this research. exclusion criteria: * subject having expressed opposition to participating in the study * subject under guardianship or guardianship * subject under safeguard of justice

Keywords: covid-19 sars-cov-2 renal failure
predictors of chronic non-specific low back pain

Conditions: Low Back Pain

Summary: chronic non-specific low back pain (cnslbp) has been defined as a persistent pain in the lower back for at least three months with no known causes. the cnslbp prevalence is estimated of 90% among all types of the lbp. the lbp imposes high direct and indirect costs on the patients and the society. whereas a specific pathology has not been identified for cnslbp, mechanical factors (e.g. changes in muscle length, strength, or endurance) may contribute to the pain and disability.


Eligibility criteria:
inclusion criteria: * patients with chronic non-specific lbp, * lbp duration ≥ 6 months. exclusion criteria: * spinal osteoarthritis, * spondylolisthesis, * history of vertebral fractures.

Keywords: chronic low back pain disability endurance
a study of pf-05280586 (rituximab-pfizer) or mabthera® (rituximab-eu) for the first-line treatment of patients with cd20-positive, low tumor burden, follicular lymphoma (reflections b328-06)

Conditions: Follicular Lymphoma

Summary: this study will compare the safety and effectiveness of pf-05280586 versus rituximab-eu in patients with cd20-positive, low tumor burden follicular lymphoma. the primary hypothesis to be tested in this study is that the effectiveness of pf-05280586, as measured by the overall response rate, is similar to that of rituximab-eu.


Eligibility criteria:
inclusion criteria: * confirmed diagnosis of low tumor burden, cd20-positive follicular lymphoma * ann arbor stage ii, iii, or iv exclusion criteria: * not a candidate for treatment with rituximab as a single-agent * evidence of transformation to a high grade or diffuse large b-cell lymphoma * any previous systemic therapy for b-cell nhl, including chemotherapy, immunotherapy, or steroids * any prior treatment with rituximab * active, uncontrolled infection

Keywords: rituximab follicular lymphoma non-hodgkin lymphoma non-hodgkin's lymphoma