Kornimate/medical-research-clean huggingface dataset:
balancing risk: red blood cell transfusion strategies in cardiac surgery

Conditions: Anemia

Summary: the primary purpose of this study is to determine the best blood level to begin transfusing red blood cells in individuals undergoing cardiac surgery. the secondary aim is to determine the impact of red cell transfusion on health-related quality of life following surgery.

consecutive consenting patients who meet the inclusion criteria will be randomized to one of 2 transfusion groups based on their hct value. hematocrit groups: 1. 24% 2. 28% red blood cell transfusion will be given only when hematocrit values fall below the assigned group value. when the hematocrit value falls to a value less than the value for the randomized group a 1 unit rbc transfusion will be administered. following administration of the 1 unit transfusion a repeat hct is performed; if the hematocrit value responds to transfusion and is greater than or equal to the randomized group no further transfusions will be administered. a measurement of the patient's hct after each unit of rbc administered is required prior to administering additional units. if a patient's hematocrit is greater than the value for the group which they are randomized, no transfusion of rbc is necessary. other management decisions are left up to the discretion of the care team. adherence to the treatment protocol will be required for the patients in the operating room, intensive care unit and postoperatively until discharge from the hospital. before surgery, the patient will be asked to respond to a quality-of-life questionnaire. follow up phone calls will be made by study personnel at 1 and 3 months after surgery to ask the same questions.

Eligibility criteria:
inclusion criteria: * all primary and reoperative adult cardiac surgical patients undergoing cardiopulmonary bypass for coronary artery bypass grafting, coronary artery bypass grafting with a valve procedure, isolated valve procedures and ascending aortic repair for aneurysm or dissection procedures. exclusion criteria: * age less than 18 years * congenital procedures * emergencies * descending thoracic aortic aneurysm repairs * left or right ventricular assist devices * left ventricular aneurysm resections * heart or lung transplantation * those unable to receive blood for religious reasons

Keywords: surgery cardiopulmonary bypass coronary artery bypass graft valve procedure hematocrit level outcomes
intraarticular leukocyte-rich and leukocyte-poor prp for osteoarthritis of the knee

Conditions: Osteo Arthritis Knee

Summary: to compare the efficacy of intraarticular knee injection between leukocyte-rich and leukocyte-poor platelet-rich plasma in knee osteoarthritis treatment

participants were randomized into 3 groups (leukocyte-rich platelet-rich plasma (lr-prp), leukocyte-poor platelet-rich plasma (lp-prp), and corticosteroid (cs)). the primary outcome of this study is the western ontario and mcmaster universities osteoarthritis index (womac) and was measured pre-treatment and post-treatment at follow-up at 1, 3, and 6 months

Eligibility criteria:
inclusion criteria: * age greater than or equal to 50 years old, plain radiographs knee ap shows kellgren-lawrence classification 1-4, refuse the use of nsaids for 2 weeks. exclusion criteria: * 1) previous intra-articular injection therapy in the past 6 months; 2) previously treated with intra-knee prp injection; 3) history of knee arthritis from other causes such as rheumatoid arthritis, pseudogout or infectious joints 4) history of blood disorder including anemia and thrombocytopenia (hb \ 15, varus \> 20, flexion rom \ 20) 7) pregnancy and lactation

Keywords: oa knee prp leukocyte concentration osteoarthritis knee
impacts of different art regimens on lipid metabolism in people living with hiv

Conditions: HIV Infection; Combined Antiretroviral Therapy

Summary: to compare the dynamic changes of lipid metabolism of people living hiv who treated with different antiretroviral therapy (art) regimens such as biktarvy evg/c/taf/ftc, dtg/ftc/tdf, tdf/3tc/efv, etc. and to assess the safety and efficacy of different antiretroviral therapy.

this was a prospective observational study aiming to evaluate dynamic changes of lipid metabolism in people living hiv who treated with different antiretroviral therapy (art) regimens. at the same time, cardiovascular risk and the incidence of non-alcoholic fatty liver disease are assessed so as to compare the effects of different regimen on cardiovascular risk and nafld and hope to discover several cardiovascular risk-related individual lipid species.

Eligibility criteria:
inclusion criteria: 1. people with hiv aged 18 years and older 2. treated with stable antiretroviral therapy 3. plasma hiv-1 rna below 50 copies per milliliter for at least six months 4. without other comorbidities or concomitant medications 5. good compliance and can cooperated with the follow-up 6. willing to participate in the study and sign informed consent. exclusion criteria: 1. pregnant or breast-feeding 2. patients with poor treatment compliance 3. patients refused to attend the regular follow-up examination 4. patients with severe cardiovascular and cerebrovascular diseases or liver and kidney dysfunction 5. acute infection (malaria, tuberculosis, helminthiasis, pneumonia, meningitis), moderate or severe malnutrition and diarrhea in the last 3 months 6. take medications that may interfere with lipid metabolism throughout the study, such as statins/fibrates, antidiabetic 7. participated in other clinical trials within 3 months. 8. patients with severe mental illness

Keywords: hiv antiretroviral therapy lipid metabolism
impact of restriction of the non paretic upper limb rehabilitation of patients a with stroke:randomized clinical trial

Conditions: Stroke

Summary: to evaluate whether the restriction of the non paretic upper limb (ul) is a factor that could interfere at the sensorimotor ul recovery for chronic stroke subjects and to verify the impact on daily function, quality of life. in this pilot, randomized, blind and allocation concealment clinical trial, nineteen individuals with chronic stroke was randomly assigned, after the first evaluation, into two groups: group without restriction (g1), subject only to the specific training of paretic ul, and restricted group (g2), which underwent specific training of paretic ul and use of the restriction of non paretic ul


Eligibility criteria:
inclusion criteria: * ability to actively extend at least 10° at the metacarpophalangeal the wrist; * more than 6 months post onset of stroke; exclusion criteria: * mini-mental state examination; * no excessive spasticity in any joints of the affected.

Keywords: hemiparetic cognitive balance
morphologic evolution and remodeling of intracranial atherosclerosis: a longitudinal study by 3d-rotational angiography

Conditions: Ischemic Stroke; Atheroscleroses, Cerebral

Summary: this study is to elucidate the morphologic evolution and remodeling of icad under stringent control of cardiovascular risk factors.

the investigator has conducted extensive research on icad by transcranial doppler ultrasound, ct angiography and perfusion studies, magnetic resonance imaging (mri) and digital subtraction angiography (dsa) respectively. currently, the investigator applied 3-dimensional rotational angiogram (3dra), a selective intra-arterial catheter-based imaging technique that had a superior spatial resolution compared with ct, mri or dsa in depicting minute (\<3mm) angio-architecture. through 3dra, the investigator could appreciate the icad patho-anatomy from a near-infinite number of planes, analyzing the stroke mechanisms and morphological changes with much improved precision. a neuro-radiologist and a stroke neurologist blind to time sequence will measure the geometric parameters and the luminal narrowing by wasid method.

Eligibility criteria:
inclusion criteria: 1. patient is 30 to 85 years of age, inclusive. 2. patients who have an acute infarct in diffusion-weighted mri compatible with artery-to-artery thrombo-embolism and a relevant intracranial atherosclerotic stenosis ≥60%. 3. patient who has no contra-indication for the proposed imaging tests. 4. patient understands the purpose and requirements of the study, and has provided an informed consent. exclusion criteria: patient with any of the following conditions would be excluded: 1. stroke etiology uncertain or unrelated to intracranial atherosclerosis, such as cardioembolism, moyamoya disease, small vessel disease or primary angiitis of cns. 2. a tandem stenosis \>50% at extra-cranial internal carotid artery. 3. bleeding propensity: active peptic ulcer disease, major systemic hemorrhage within 30 days, thrombocytopenia (platelets \ 1.5). 4. a medical condition that would not allow the patient to adhere to the protocol or complete the study.

Keywords: ischemic stroke 3d-rotational angiography morphology atherosclerosis
prognostic value of different nutritional screening tools in acute pancreatitis

Conditions: Acute Pancreatitis; Malnutrition

Summary: the goal of this observational study is to compare the prognostic value of different nutritional screening tools to predict the course of acute pancreatitis. the main questions it aims to answer are: * which nutritional screening tool performs best to predict length of hospital stay? * which nutritional screening tool performs best to predict clinical outcome (disease severity, length of hospital stay, mortality, need for rehospitalization)? participants will answer questions regarding their nutritional status and undergo basic anthropometric assessments (e.g. measurement of waist circumference) to evaluate their risk of malnutrition.

malnutrition seems to be related to an adverse outcome of acute pancreatitis. however, it is still unclear which of the various available nutritional screening tools is suited best to predict the clinical outcome in hospitalized patients with acute pancreatitis. therefore, in this study we compare the predictive performance of 6 different nutritional screening tools that are commonly applied in clinical practice regarding their respective associations with severity of acute pancreatitis, length of hospital stay, mortality and need for rehospitalization. to determine patients' nutritional status, subjects will be inquired about their recent food intake as well as body weight and undergo basic anthropometric assessments according to the different screening tools. six months after the initial diagnosis patients will be contacted via mail to report on need for rehospitalization due to acute pancreatitis during this time period.

Eligibility criteria:
inclusion criteria: * verified diagnosis of acute pancreatitis * provision of informed consent exclusion criteria: * pregnancy * inability to provide consent

Keywords: acute pancreatitis nutritional screening
brain function in premenopausal women receiving tamoxifen with or without ovarian function suppression for early-stage breast cancer on clinical trial ibcsg 24-02

Conditions: Breast Cancer; Fatigue; Sleep Disorders

Summary: rationale: learning about the long-term effects of adjuvant tamoxifen (t), adjuvant tamoxifen with ovarian function suppression (t+ofs), and exemestane with ovarian function suppression (e+ ofs) on brain function may help doctors plan cancer treatment. purpose: this study is looking at brain function in premenopausal women who are receiving adjuvant tamoxifen (t) alone against those receive adjuvant tamoxifen (t+ofs) or exemestane (e+ofs) with ovarian function suppression (ofs) for early-stage breast cancer on clinical trial ibcsg-2402.

objectives: primary: \* to evaluate and compare the changes in cognitive function over one year in premenopausal breast cancer patients who receive adjuvant tamoxifen (t) alone against those receive adjuvant tamoxifen (t+ofs) or exemestane (e+ofs) with ovarian function suppression (ofs). outline: this is a multicenter study. objective cognitive function was measured with the cogstate computerized test battery. the cogstate battery consists of seven tasks: detection, identification, monitoring, memory, learning, international shopping list task (islt), and islt-delayed recall. performance speed is measured for the detection, identification and monitoring tasks and performance accuracy is measured for the memory, learning, islt, and islt-delayed recall. measures of performance speed are normalized using measures of performance accuracy (%) are normalized using arcsine transformation. the main outcome measure is a composite score which is the average of these task scores (after transformation and standardization by age-specific norms). patients complete these assessments at baseline (i.e. before start of protocol hormonal therapy) and approximately one year after randomization to the parent ibcsg 24-02 (soft) study. data were collected separately for the t+ofs and e+ofs participants in the parent study, ibcsg 24-02 (soft). the sample size for this co-soft substudy was small, so the analysis plan was revised to pre-specify collective analysis for all patients receiving ofs.

Eligibility criteria:
disease characteristics: * histologically confirmed breast cancer * completely resected disease * registered for clinical trial ibcsg-2402, but not yet started protocol hormonal therapy * has not yet received any of the following adjuvant endocrine therapy, either before or after registration on ibcsg-2402: * tamoxifen, exemestane, or gonadotropin-releasing hormone (gnrh) agonist * ovarian irradiation * bilateral oophorectomy * hormone receptor status: * estrogen and/or progesterone receptor positive * each tumor must be hormone receptor positive patient characteristics: * premenopausal * can speak and read the local language(s) fluently prior concurrent therapy: * see disease characteristics

Keywords: cognitive/functional effects psychosocial effects of cancer and its treatment fatigue sleep disorders stage ia breast cancer stage ib breast cancer stage ii breast cancer stage iiia breast cancer
low dose albumin versus standard dose albumin in high risk spontaneous bacterial peritonitis.

Conditions: Spontaneous Bacterial Peritonitis

Summary: aim:- a randomized non-inferiority trial comparing low dose albumin versus standard dose albumin in high risk spontaneous bacterial peritonitis. methodology in this non-inferior randomized controlled trial one group will receive low dose albumin: 20% albumin 0.75 g/kg at diagnosis and 0.5 g/kg after 48 hours and other group will receive standard dose albumin: 20% albumin1.5 g/kg at diagnosis and 1 g/kg after 48 h (duration of infusion 6 hours). study population: patients of age \> 18 years of age with cirrhosis of liver who are admitted in ward/intensive care unit diagnosed with spontaneous bacterial peritonitis. study design: randomized controlled trial study period: september 2019- september 2020 sample size: 300 (150 cases in each group) if there is a true difference in favour of the experimental treatment of 5 % then 270 patients are required to be 80% sure that the upper limit of a one sided 95% confidence interval (or equivalently a 90 % two-sided confidence interval) will exclude a difference in favour of the standard group of more than 5 %. and if the investigators consider 10% drop out final sample size is 270+30=300. 150 in each limb. cases will be randomly allocated in 2 groups by block randomization method with block size taken as 10. monitoring and assessment: all the parameters of the objective and also noted any adverse effects. adverse effects: nausea, vomiting, fever with chills, dyspnea stopping rule: in the event of any of the adverse effects during therapy. expected outcome of the project: proportion of patients having new development or progression of acute kidney injury by day 7


Eligibility criteria:
inclusion criteria: 1. \>18 years of age 2. cirrhosis with sbp (community acquired, health care associated and nosocomial) and baseline serum bilirubin ≥4 mg/dl and/or scr ≥ 1 mg/dl. exclusion criteria: 1. antibiotic treatment within one week before the diagnosis of sbp (except for prophylactic treatment with norfloxacin) 2. significant cardiac failure, pulmonary disease 3. known ckd ( chronic kidney disease)or findings suggestive of organic nephropathy (proteinuria, haematuria, or abnormal findings on renal usg) 4. hepatocellular carcinoma 5. hiv (human immunodeficiency virus) infection; 6. gi (gastrointestinal) bleed within 1 month before the study 7. ileus 8. grade 3 to 4 hepatic encephalopathy 9. other types of infection 10. shock 11. presence of any potential causes of dehydration (such as diarrhoea or an intense response to diuretic treatment) within one week before the diagnosis of sbp). 12. baseline serum bilirubin \<4 mg/dl or s. cr \< 1 mg/dl 13. serum creatinine level of \> 3.0 mg/dl.
effect of a low-carb dietary intervention in obese patients: a pilot trial

Conditions: Glucose Intolerance; Obesity

Summary: effects of a 6 months low-carb dietary intervention on glycemic control, body composition and gut-brain interaction in obese and lean patients with and without glucose intolerance or diabetes


Eligibility criteria:
inclusion criteria: group a: healthy lean controls * healthy normal weight subjects with a body-mass index of 19.0-24.9kg/m2, hba1c \<5.7% and fasting glucose \<5.6 mmol/l * normal eating habits * stable body weight for at least three months * informed consent as documented by signature group b: pre-diabetic or diabetic obese * pre-diabetic/diabetic obese with a hba1c \>5.7% and/or fasting glucose \>5.6 mmol/l) and body-mass index \> 30kg/m2, otherwise healthy * normal eating habits * stable body weight for at least three months * informed consent as documented by signature exclusion criteria: group a: healthy lean controls * pre-existing low carb diet (less than 45% of daily energy intake by carbohydrates) * pre-existing diet (vegetarian, vegan, gluten-free etc.) * psychiatric illness * alcohol abuse, (smoking allowed) * regular intake of medications, (oral contraceptives allowed) * intake of antibiotics within the last 3 months before inclusion * regular intake of pro- or prebiotics * chronic diseases of the gastrointestinal tract, history of gastrointestinal surgery with major changes to the gastrointestinal tract (e.g. bariatric surgery) * clinically relevant acute or chronic inflammatory disease * pregnancy * participation in another study with investigational drug within the 30 days preceding and during the present study. group b: pre-diabetic or diabetic obese * pre-existing low carb diet (less than 45% of daily energy intake by carbohydrates) * pre-existing diet (vegetarian, vegan, gluten-free etc.) * psychiatric illness * alcohol abuse, (smoking allowed) * regular intake of medications (except: oral contraceptives, metformin, sglt-2, statins, and antihypertensive, which are allowed) * intake of antibiotics within the last 3 months before inclusion * regular intake of pro- or prebiotics * chronic diseases of the gastrointestinal tract, history of gastrointestinal surgery with major changes to the gastrointestinal tract (e.g. bariatric surgery) * clinically relevant acute or chronic inflammatory disease * pregnancy * participation in another study with investigational drug within the 30 days preceding and during the present study.
bispectral-electroencephalography (eeg) in first time hemodialysis

Conditions: Renal Failure Acute Chronic

Summary: the severity of minimal dialysis disequilibrium syndrome (dds) is currently detected and graded clinically using clinical criteria. bispectral index (bis), an electroencephalographic (eeg) derived parameter is widely used in anesthesia and critical care setting to detect effects of anesthetic/hypnotic drugs. the aim of our study was to assess the discriminative power of bis monitoring to accurately detect dds.

design: a consecutive, clinical, validation study. setting: medical university of graz (graz, austria). patients: twenty consecutive patients undergoing first hemodialysis are enrolled at medical university of graz, haemodialysis unit. agitated patients or patients who fell asleep during the recording are excluded from the final analysis. during the first dialysis session of approximately 3 h, patients were observed for signs of disequilibrium; headaches, dizziness, nausea, vomiting, if they become obtunded, have visual impairments or cramps. accordingly patients were divided into 2 groups; the "dds group" of patients who experienced one of the dds symptoms of headaches, dizziness, nausea, vomiting, become obtunded, have visual impairments or cramps and patients who do not experience any of the dds symptoms in the "non-dds group" an assigned nephrologist will assess the physical and mental status of the patients.

Eligibility criteria:
inclusion criteria: * first time renal dialysis exclusion criteria: * subjects' consumption of sedatives/hypnotics psychotropic drugs, or concomitant neurological disorders affecting mental state such as hepatic encephalopathy, stroke, stupor or dementia and renal transplant patients.
intra-hepatic chemotherapy in patient with non-resectable liver metastases from breast cancer

Conditions: Metastatic Breast Cancer; Liver Metastases

Summary: this is a phase ii trial evaluating intra-hepatic chemotherapy with oxaliplatin every second week in combination with systemic capecitabine and in patients with a her2-positive tumour in combination with trastuzumab (herceptin®) in patient with non-resectable liver metastases from breast cancer. only patients without extrahepatic disease are included.


Eligibility criteria:
inclusion criteria: * informed consent * age \> 18 years * performance status 0-1; expected survival ≥ 3 months * patient with histologically or cytologically confirmed locally advanced or metastatic adenocarcinoma of the breast * liver metastases not suitable for local treatment * extrahepatic disease should be excluded by pet-ct-scan. * no progression on treatment with capecitabine. * prior treatment with taxane (adjuvant or for metastatic disease) * metastases \< 70 % of the liver * neutrophile granulocytes \> 1.5 x 109/l og thrombocytes \> 100 x 109/l * bilirubin \< 2.0 x unl (upper normal limit). * creatinine-clearance \> 30 ml/min. * inr \< 1.6. * if the patient is her2-positive:baseline lvef ≥ 50 %. exclusion criteria:- * history of chemotherapy within the 4-week period prior to the start of trial medication * other current or prior malignant disease except adequately treated and cured carcinoma in situ of the cervix or squamous cell carcinoma of the skin. * previous treatment with oxaliplatin * cytotoxic or experimental treatment within a 14 days period before start of trial medication * the patient is not allowed to participate in other clinical trials. * any clinical symptoms suggesting peripheral neuropathy \< or equal to grade 2 or cns metastases (in case of clinical suspicion on cns metastases a mr or ct scan should be performed within 4 weeks before inclusion * other severe medical conditions e.g. severe cardial disease or ami \< 1 year * presence of diseases which prevent oral therapy. • patients with uncontrolled infection * pregnant or lactating women * women capable of childbearing not using a sufficient non-hormonal method of birth control * patients not able to understand the treatment or to collaborate. * prior serious or unsuspected reaction after treatment with fluoropyrimidine * known prior hypersensitivity reactions to the agents. if the patient is her2-positive: • dyspnoea in due to complication related to malignant disease e.g.lung metastases with lymphangitis or other conditions with need of supportive oxygen.

Keywords: breast cancer metastatic liver metastases intrahepatic chemotherapy