Kornimate/medical-research-clean huggingface dataset:
study comparing a soybean oil-based with an olive oil-based lipid emulsion in icu patients requiring tpn

Conditions: Parenteral Nutrition

Summary: many hospitalized patients who are malnourished or not eating receive intravenous feeding or total parenteral nutrition (tpn). despite improving nutrition, tpn may increase the risk of infections and hospital complications. we do not know why tpn increases hospital complications, but it may be caused by the high sugar or fat content in tpn solutions.

this study compares the effect of a soybean oil-based versus an olive oil-based lipid emulsion in healthy volunteers and in critically ill patients. in healthy volunteers, your blood sugar levels, blood vessel function, and your ability to fight infections will be examined. in icu patients, we examines whether use of the olive oil-based lipid emulsion may decrease the risk of infection and hospital complications.

Eligibility criteria:
inclusion criteria: * age: 18 - 80 years when initiating pn * in medical/surgical icu * has central venous access to administer pn * anticipated to receive pn ≥ 5 days exclusion criteria: * enrolled in an investigative study within the last 30 days prior to study entry * female patients: pregnant or breast feeding * has clinical sepsis (defined as mean arterial pressure (map) \< 60 mmhg on ≥ 2 occasions and unstable bp despite pressor support) within 24 hours prior to study entry * has known cirrhosis or total bilirubin ≥ 10.0 mg/dl * has chronic renal failure (defined as requirement for hemodialysis or peritoneal dialysis therapy), or creatinine ≥ 3.5 mg/dl without continuous renal replacement therapy (crrt), or requires acute post-operative dialysis * has an active malignancy (defined as requiring chemotherapy, radiation, and/or surgical intervention within 90 days prior to study entry) (excluding non-melanoma skin cancer) * has known aids * has a terminal illness (life expectancy \< 7 days) * has undergone organ transplantation * has received pn with lipid within 48 hours prior to study entry * has mental disability to understand the scope and possible consequences of the study and the legally authorized representative is unavailable * has a baseline serum triglyceride \> 400 mg/dl

Keywords: parenteral nutrition lipid emulsion nosocomial infection mortality endothelial function inflammatory markers oxidative stress immune function autonomic nervous system insulin sensitivity carbohydrate metabolism
tdcs and bimanual therapy for children with hemiplegic cerebral palsy

Conditions: Cerebral Palsy; Hemiplegic Cerebral Palsy; Spastic Hemiplegic Cerebral Palsy; Spastic Hemiparesis; Spastic Hemiplegia

Summary: the goal of this study is to test the efficacy of transcranial direct current stimulation combined with bimanual training on hand function in children with unilateral spastic cerebral palsy (uscp). children who enroll in the protocol will be randomized to receive either sham (not stimulating) tdcs plus bimanual training, or active (stimulating) tdcs plus bimanual training.


Eligibility criteria:
inclusion criteria: * diagnosis of congenital hemiplegic cerebral palsy * ability to lift and grasp light objects with affected hand * ability to extend wrist of affected hand 15 degrees * ability to follow instructions and provide informed assent * parent(s) able to provide informed consent exclusion criteria: * seizures after age 2 years * spasticity medication within 6 months before study * selective dorsal rhizotomy * surgery in affected upper extremity within year before study

Keywords: pediatric children non-invasive brain stimulation transcranial direct current stimulation bimanual training hand training
"answers in hours" a randomized controlled trial using microbiome metagenomics for bile duct cultures

Conditions: Benign Pancreatic Neoplasm; Malignant Pancreatic Neoplasm

Summary: this trial evaluates whether testing of bile with nanopore sequencing results in earlier detection of bacteriobilia (bacteria in bile) that may lead to surgical site infections in patients undergoing surgery for benign or malignant pancreatic tumors. surgical site infections are a significant source of poor outcomes in patients undergoing surgery for pancreatic tumors. in most patients who develop this kind of infection, the bacteria identified as causing the infection is also frequently found to be in the bile at time of surgery. usage of nanopore sequencing for detection of bacteria in the bile of patients undergoing surgery may allow doctors to prevent surgical site infections or treat them sooner or more effectively.

primary objective: i. to improve antibiotic stewardship (reducing duration of peri-operative prophylactic antibiotic regimen, reducing administration of broad-spectrum antibiotic) by providing surgical team with rapid oxford nanopore (ont) sequencing data in the early post-operative setting. secondary objective: i. to reduce the cost of care through reduction in surgical site infection (ssi) and improved antibiotic stewardship. outline: patients are randomized to 1 of 2 arms. arm i: patients undergo the collection of bile samples during standard of care surgery. samples undergo routine laboratory testing. arm ii: patients undergo the collection of bile samples during standard of care surgery. samples undergo nanopore sequencing and routine laboratory testing. after completion of study, patients' medical records are reviewed for 30 days.

Eligibility criteria:
inclusion criteria: * \>= 18 year (yr) male (m) or female (f) * undergoing pancreaticoduodenectomy or total pancreatectomy for any benign or malignant indication with informed consent exclusion criteria: * women who are pregnant * patients who are institutionalized or incarcerated * patients without the cognitive capacity to consent * patients undergoing emergency pancreaticoduodenectomy or total pancreatectomy * patients enrolled in similar clinical trials involving use of perioperative antibiotics
hydroxychloroquine and phlebotomy for treating porphyria cutanea tarda

Conditions: Porphyria Cutanea Tarda

Summary: porphyria cutanea tarda (pct) is an iron-related disorder that responds to treatment by phlebotomy or low-dose hydroxychloroquine, but comparative data on these treatments are limited. the hypothesis is that hydroxychloroquine is noninferior to phlebotomy in terms of time to remission. patients with well documented pct are assigned to treatment by randomization if specific criteria are met. all patients are followed until remission - defined as achieving a normal plasma porphyrin concentration.

study design: pragmatic interventional study primary study objective: to determine and compare time to remission with treatment with low-dose hydroxychloroquine or repeated phlebotomy in participants with pct. secondary study objective(s): 1. to assess the effects of susceptibility factors on responses to treatment of pct by these methods. 2. to determine and compare rates of recurrence of pct after treatment with low-dose hydroxychloroquine or phlebotomy. study population and main eligibility/ exclusion criteria: treatment: hydroxychloroquine 100 mg twice weekly for up to 24 months by mouth vs. phlebotomy 450 ml biweekly until target serum ferritin reached, or up to 24 months. safety issues- 1. side effects of phlebotomy or hydroxychloroquine, which are the same as in clinical practice. primary outcome measures: 1. time to achievement of a normal plasma total porphyrin level. 2. tolerability and safety of both treatments secondary outcome measures: 1. time to 50% reduction in plasma porphyrin levels. 2. time to 75% reduction in plasma porphyrin levels. 3. time to normal urinary porphyrin levels 1. time to disappearance of a plasma fluorescence peak at neutral ph. 2. time to normalization of urinary total porphyrins. 3. time to normalization of the urinary total porphyrin pattern by hplc 4. effects of susceptibility factors such as hepatitis c, inherited urod deficiency, etc. on efficacy and safety of the two treatment methods. 5. rates of recurrence after each type of treatment and the effects of susceptibility factors on recurrence rates. statistical considerations (sample size and analysis plan): time to achieving biochemical endpoints will be determined from individual subject data. outcome measures such as time to remission will be compared using cox proportional models to study the effects of susceptibility factors on the hazard ratio to compare the two treatments. additional modeling will assess factors affecting the frequency of recurrence and seasonality effects using logistic regression modeling and log-rank testing, respectively. sponsors: national institutes of health (nih)

Eligibility criteria:
inclusion criteria: * documented porphyria cutanea tarda (pct) * willing to give informed consent * age 18 or greater exclusion criteria: * blistering skin lesions due to another condition

Keywords: porphyria, rare disease, orphan disease, iron metabolism
an investigational drug study in healthy adult volunteers in a model of insomnia (0928-007)

Conditions: Insomnia

Summary: a study to evaluate the safety and effectiveness of an investigational drug for insomnia (a sleep disorder).


Eligibility criteria:
inclusion criteria: * healthy adults who are between the ages of 18 and 64 exclusion criteria: * adults who are diagnosed with insomnia
a research study of how different amounts of a new medicine nnc0148-0287 c (insulin 287) works on the blood sugar of people who are japanese with type 1 diabetes when given once a week

Conditions: Diabetes Mellitus, Type 1

Summary: this study will look at how insulin 287 works, if it is safe and the side effects in people who are japanese with type 1 diabetes. the study will test how insulin goes through your blood, how long it stays there and how the blood sugar is lowered. insulin 287 is a new medicine. insulin glargine is already approved to treat diabetes. the study doctors can prescribe insulin glargine. the participants will get both of the insulins in a random order. the participants will get 8 weekly doses of insulin 287 and 14 daily doses of insulin glargine. there will also be a run-in period of 2 days to 7 weeks when the participants inject insulin glargine every day before they start insulin 287 period or insulin glargine period. all doses will be injected under the skin. during the run-in period, the participants adjust the insulin glargine dose and make their blood sugar levels stable. from the run-in period, the participants will take insulin aspart as bolus insulin. the study will last for about 16 - 28 weeks. the participants will have 24 visits with the study doctor. there will be 3 glucose clamps where the participants' blood sugar is tested over time. the participants cannot be in the study if the study doctor thinks that there are risks for their health.


Eligibility criteria:
inclusion criteria: * male or female, japanese subjects, aged 20 - 64 years (both inclusive) at the time of signing informed consent. * diagnosed with type 1 diabetes mellitus greater than or equal to 1 year prior to the day of screening. * current daily basal insulin treatment greater than or equal to 0.2 u/kg/day. * body mass index between 18.5 and 28.0 kg/m\^2 (both inclusive). * hba1c less than or equal to 9.0%. exclusion criteria: * history or presence of any clinically relevant respiratory, metabolic, renal, hepatic, gastrointestinal or endocrinological conditions (except conditions associated with diabetes mellitus). * female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using adequate contraceptive methods. * known or suspected hypersensitivity to trial products or related products
metagenomic next-generation sequencing for diagnosis of ascites infection in end-stage liver diseases

Conditions: Ascites Infection

Summary: ascites is the most common complication of cirrhosis, and its development is associated with substantially increased mortality. ascites infection including spontaneous bacterial peritonitis (sbp), bacterascites and fungal infections. sbp is one of the most feared complications of ascites. the easl guidelines recommend that diagnostic criteria of sbp is defined on the ascitic fluid polymorphonuclear leucocytes (pmn) count ≥250 cell/μl, with or without ascites fluid positive culture. however, in clinical practice. up to 30% of hospitalized patients are considered as suspicious sbp, and treated as sbp without a laboratory-confirmed cause of infection. and is present in 10-30% of all hospitalized patients with ascites. besides, fungal infection in ascites was aslo related to high mortality in cirrhosis patients. thus, to diagnose ascites infection promptly is the key step to prevent the complication. since, the sensitivity of bacterial culture is limited even if ascites is directly injected into blood culture bottles at the besides. new method to identified the pathogen is needed. here, we aim to use metagenomic next-generation sequencing(mngs) to provide the first-ever demonstration of precision medicine for the diagnosis of ascites infection in hospitalized patients, with immediate impact on clinical care and patients outcomes. the method of mngs is undertaken by bgi genomics company which is a licensed clinical diagnostic laboratory in china. in this multicenter and prospective clinical study, we are planning to detect ascites sample by mngs and compare the performance of mngs and routine microbiological testing. ultimately, we aim to improve the diagnosis of ascites infection and improve patients' outcomes.

the study is divided into 2 parts: firstly, the study will test 3 types of sample by means of mngs, including ascites fluid, peritoneal dialysis fluid and postoperative drainage fluid and evaluate the sensitivity and specificity of ngs. secondly, the clinical validation of mngs will be performed in multicenters for ascites infection in cirrhosis patients. furthermore, the study will collect the paired plasma sample for ngs testing at the same time to evaluate the protential sources of microorganisms in ascites.the aim of the study is to observe the performance of mngs in ascites infection diagosis and the protential clinical effect in cirrhsis patients.

Eligibility criteria:
inclusion criteria: 1. hospitalization cirrhotic patients; 2. age \>18 years old; 3. paitents with ascites at hospital admission. exclusion criteria: 1. pregnant women; 2. hepatic tumor or extrahepatic related cancer; 3. identified secondary peritonitis; 4. ascites not related to portal hypertension; 5. not provide written consent.

Keywords: ascites infection ascites mngs
a single-arm, expanded access study of zanubrutinib in participants with b-cell malignancies

Conditions: Waldenström Macroglobulinemia

Summary: this is a multicenter expanded access study of zanubrutinib monotherapy for participants with b-cell malignancies who are ineligible to enroll into any available zanubrutinib clinical trials


Eligibility criteria:
key inclusion criteria: 1. histologically confirmed diagnosis of wm with r/r disease or treatment-naive and considered by their treating physician to be unsuitable for standard chemoimmunotherapy regimens 2. eastern cooperative oncology group (ecog) performance status of 0 to 2 3. absolute neutrophil count (anc) ≥ 0.75 x 109/l, independent of growth factor support; and platelet count ≥ 50 x 109/l, independent of growth factor support or transfusion within 7 days of study entry 4. creatinine clearance of ≥ 30 ml/min 5. aspartate aminotransferase (ast)/serum glutamic-oxaloacetic transaminase (sgot) and alanine aminotransferase (alt)/serum glutamic pyruvic transaminase (sgpt) ≤ 3 x upper limit of normal (uln) 6. total bilirubin level ≤ 2 x uln (unless documented gilbert's syndrome) key exclusion criteria: 1. prior exposure to a bruton tyrosine kinase (btk) inhibitor 2. evidence of disease transformation at the time of study entry 3. ongoing requirement for systemic corticosteroid other than systemic adrenal replacement therapy 4. chemotherapy given with antineoplastic intent, targeted therapy, radiation therapy or antibody-based therapy within 4 weeks of the start of study drug 5. ongoing toxicity of ≥ grade 2 from prior anticancer therapy 6. prior or concurrent active malignancy within the past 2 years 7. clinically significant cardiovascular disease 8. unable to swallow capsules or disease significantly affecting gastrointestinal function 9. active fungal, bacterial and/or viral infection requiring systemic therapy 10. known infection with hiv, or serologic status reflecting active viral hepatitis b (hbv) or viral hepatitis c (hcv) infection as follows 11. pregnant or lactating women 12. history of stroke or intracranial hemorrhage within 180 days before first dose of study drug 13. history of severe bleeding disorder 14. active central nervous system (cns) involvement by wm and/or lymphoma note: other protocol defined inclusion/exclusion criteria may apply.

Keywords: wm treatment naive relapsed/refractory
evaluation of the predictive value of the microvesicle coagulo-lytic balance in the recurrence of venous thrombosis

Conditions: Venous Thromboembolism (VTE)

Summary: venous thromboembolism (vte) including deep vein thrombosis (dvt) and pulmonary embolism (pe) affects about 1,200,000 individuals each year in europe. about 50% of vte are unprovoked and 20% of these patients will face a recurrent event after the usual three to six-month course of anticoagulant treatment. to date, most patients are given prolonged anticoagulant treatment. however, anticoagulant treatment are associated with a major risk of bleeding (3%/year). thus an accurate identification of patients with unprovoked vte with a low risk of recurrence is needed to avoid unnecessary anticoagulant treatment with a risk of bleeding. over the past few years, microparticles (mps) which are small vesicles originating from the budding of cellular membranes have emerged as important biological entities regulating hemostasis. mps expose at their surface procoagulant molecules such as phosphatidylserin and tissue factor (tf). all data obtained in mouse models support a role of mps in venous thrombosis mediated by the tf activation. moreover, results from clinical studies showed that tf-mps was associated with the risk of venous thrombosis. however, the predictive value of tf-mps in the recurrence of vte is unknown. besides, no study has taken into account the recent progresses in the understanding of the role of mps in haemostasis. indeed, mps vectorize molecules which are not only procoagulant but also profibrinolytic. the net result depends on a balance between both activities (the coagulo-lytic balance). this balance is can be measured by two complimentary assays on mps. we hypothesized that the coagu-lytic balance of mps is associated with an increased risk of vte recurrence after stopping the anticoagulant treatment.


Eligibility criteria:
inclusion criteria: * adult patients with a vte history with at least 3 months of anticoagulant treatment. exclusion criteria: -
evaluation of functional and nutritional parameters in fit acute leukemia patients

Conditions: Acute Leukemia

Summary: this single-center observational prospective longitudinal study will assess cognitive, physical, and nutritional performance in acute leukemia patients undergoing intensive chemotherapy. patients will provide informed consent prior to enrollment. hematologists will oversee clinical management and approve evaluations, while physical and rehabilitation medicine specialists and a nutritionist will conduct assessments. performance will be evaluated at admission, discharge, and three weeks (21 days) after starting chemotherapy.

this is an observational prospective longitudinal single-center study. all patients will be required to agree to participate in the study and to sign an informed consent prior to enrollment. during the course of the study, the hematologists will manage the patients as per clinical practice and give clearance to perform each evaluation. all functional assessments and tests will be carried out by trained healthcare personnel with experience in the field of rehabilitation (either a physical and rehabilitation medicine resident, a specialist, or a physiotherapist). a nutritionist will take care of assessing the nutritional aspects. the aim of this study is to analyze the cognitive, physical and nutritional performance of al patients hospitalized to receive intensive chemiotherapy (ic). each item will be assessed at admission and discharge from the ward and after three weeks from the start of chemotherapy. modifications of the considered items will be annotated and compared throughout the courses of chemotherapy, as well as relationship with indices of response and survival (disease free survival, overall survival) will be explored. such an effort will help further understanding how hematologic inpatients perform during ic treatment and what are the consequences on their quality of life and activities of daily living.

Eligibility criteria:
inclusion criteria: * age above 18 years * patients affected by acute leukemia * inpatients performing intensive chemotherapy * patients with no restrictions on mobilization * signed written informed consent in accordance with ich/eu/gcp guidelines and national and local laws. exclusion criteria: * age \<18 years * any medical condition that the attending doctor judges as limiting to perform study related tasks

Keywords: acute leukemia rehabiltation quality of life nutrition
europainclinics® study iii (prospective observational study)

Conditions: Disc Herniations

Summary: in this prospective observational trial the effect of the disc fx microinvasive therapy should be examined in (approximately 150) adult patients with low back pain.

patients will be selected from 4 participating clinics from czech and slovak republic. trial will compare evolution of patient's health state, changes of low back pain and other neurological conditions during time period (6 and 12 month) after miniivasive interventional pain release procedure - disc fx. back pain due to lumbar disc disease in our population is a very common problem. the treatment options range from physiotherapy to fusion surgery. when all conservative treatment is failed than in some cases with suitable conditions of intervertebral disc is possible to avoid classical disc surgery with minimally invasive surgery techniques. a number of minimally invasive procedures have also been developed in the recent past for its management. one of them is disc fx procedure. disc fx is an innovative system allowing for a safe and effective approach to a damaged disc without injury to the surrounding structures. this method provides an option for those people who have not benefited from conservative treatment, and are not yet ready for major surgery. it is a minimal-access procedure performed on an out-patient basis. its big advantage is the fact that the patient may go home the same day. the procedure consists of three phases: during the first phase, the disc is punctured with a special needle that functions as a working channel. this needle is used to remove part of the degenerate inner tissue. then, using a radio-frequency probe, the disc is sealed to minimize the risk of repeated herniation. in the final step, the pathological nerves in the back part of the disc are destroyed with the use of radio-frequency. trial will compare evolution of patient's health state, changes of low back pain and other neurological conditions during time period (6 and 12 month) after miniivasive interventional pain release procedure - disc fx.

Eligibility criteria:
inclusion criteria: * patients who undergo disc fx therapy exclusion criteria: * no