Kornimate/medical-research-clean huggingface dataset:
comparison of oral iron with iv iron in patients with anemia of chronic renal failure not on dialysis

Conditions: Anemia

Summary: the purpose of the study was to compare the efficacy of oral iron (ferrous sulfate) plus erythropoietin to iron sucrose plus erythropoietin for managing anemia patients with chronic renal failure who are not receiving dialysis.

randomized open-label multicenter active-controlled study of anemic patients with chronic renal failure who are not yet receiving dialysis. the duration of the study was five months. after screening procedures including multiple hemoglobin values, patients were randomly assigned to either iv iron sucrose (200mg x 5) or oral iron sulfate (325mg tid)for 29 days. safety assessments included the recording of all adverse events, physical examinations, vital signs, electrocardiograms and clinical laboratory tests. efficacy parameters included hematologic parameters.

Eligibility criteria:
inclusion criteria: * creatine clearance \<40 ml/min * average baseline hemoglobin \< 10.5g/dl * serum transferrin saturation (tsat) \< 25% and ferritin \<300ng/ml exclusion criteria: * blood transfusion within 30days * uncontrolled hypertension * suffering form concommitant disease of the liver * serious bacterial infection * pregnancy / lactation * symptomatic hiv * expected to under dialysis or renal transplant during study

Keywords: anemia chronic kidney disease
anti-pseudomonas immune status and dendritic cell preparation in normal individuals

Conditions: Healthy

Summary: this protocol aims to collect human peripheral blood mononuclear cells for the production of dendritic cells (dc). there are two ways to collect human peripheral blood mononuclear cells in this protocol. one is by using the method of leukapheresis from normal healthy adults. the other is by drawing the blood from normal healthy adults and then getting the buffy coats from the blood.

one objective of these studies on dc is to complete a preclinical development for a human study of a candidate anti-pseudomonas aeruginosa vaccine consisting of autologous dendritic cells primed with heat-inactivated p. aeruginosa (pa) strain poa1 and expressing the t-cell costimulatory molecule cd40 ligand (cd40l). the other objective is to complete a preclinical development for a human study of a candidate anti-anthrax vaccine. prior to testing the vaccine in humans, the food and drug administration will require preclinical and good manufacturing practice (gmp) practice batches of dendritic cells. the intent of the leukapheresis or collecting the buffy coats is to provide the biological materials for this purpose.

Eligibility criteria:
inclusion criteria: * all study subjects must be capable of providing informed consent. * normal male or female, age 18 and older. * not taking corticosteroids * not taking any prescription or over-the-counter medication, except acetaminophen (tylenol) * participants of group a must have adequate peripheral veins for leukapheresis * study subjects should not be taking experimental medications. * females cannot be pregnant. exclusion criteria: * individuals who do not meet the inclusion criteria will be unable to participate in the protocol. * individuals with active infection in the 3 weeks prior to beginning the protocol will not be able to participate. * individuals with evidence of significant cardiac, pulmonary, renal, endocrine, central nervous system, major psychiatric disorder that would prevent compliance or substance abuse, musculoskeletal disease or immunodeficiency disease, (including evidence of human immunodeficiency virus infection, hiv) will be unable to participate in the protocol. * individuals participating in any other experimental clinical studies. * women who are pregnant or nursing. * active or recent drug users

Keywords: healthy volunteers
evaluation of decision compatibility between a multidisciplinary cancer board and chatgpt-4o

Conditions: Cancer; Artificial Intelligence

Summary: this study aims to compare the decisions of a multidisciplinary cancer board at van research and educational hospital with those generated by chatgpt-4o. patient data, including age, gender, comorbidities, clinical findings, laboratory results, radiology, and pathology reports, will be collected and recorded in patient files. these records will then be converted into a textual format appropriate for input into the chatgpt-4o model. statistical analyses will be conducted to assess the level of agreement between the board's decisions and those of chatgpt-4o, providing insights into their compatibility and potential utility in clinical practice.

this study aims to evaluate the agreement between decisions made by a multidisciplinary cancer board at van hospital and those generated by the chatgpt-4o model. a total of 100 cancer patients presented to the multidisciplinary cancer board will be included in the study. patient data, including age, gender, comorbidities, clinical findings, laboratory results, radiology, and pathology reports, will be systematically recorded and reformatted into text suitable for the chatgpt-4o model. the ai model's decisions will then be compared to those made by the cancer board. statistical analyses will be performed to quantify the level of agreement between the two decision sources. the findings will provide insights into the compatibility between human-led multidisciplinary decisions and ai-driven recommendations, highlighting areas of agreement and disagreement. this study will assess the potential utility of chatgpt-4o in clinical oncology decision-making and explore whether ai models can support or complement traditional cancer board processes.

Eligibility criteria:
inclusion criteria: * above 18 y/o * patients diagnosed with malignancy exclusion criteria: * patients who refused to consent

Keywords: clinical decision agreement study cancer artificial intelligence
diabetes exercise and lifestyle trial

Conditions: Diabetes Mellitus

Summary: the objective of this study is to determine the effects of supervised combined aerobic and resistance training, and the effects of stage-matched written materials delivered by mail or internet, alone or in combination, on glycemic control as reflected in a1c (glycated hemoglobin).

background rationale: structured, supervised exercise programs involving aerobic exercise, resistance exercise or their combination resulted in significant improvements in glycemic control in type 2 diabetes. it has also been shown that programs which include a psychological/behavioral component in addition to diet and exercise have been most effective for long-term treatment of obesity in diabetes. the supervised exercise program has stronger evidence for improvement of metabolic control and cardiac risk, but its longer-term sustainability has not been demonstrated, and it is relatively costly. a stage-matched printed materials/pedometer intervention has been shown to increase physical activity over a longer period of time, and likely at a lower per-patient cost than the supervised exercise intervention, but with less evidence for improvement of metabolic control.

Eligibility criteria:
inclusion criteria: * type 2 diabetes * a1c 0.700-0.099 * ability to read and write english * signed icf exclusion criteria: * participation in previous 6 months in exercise \> 2 times per week for at least 20 min per session * insulin therapy changes in medication for diabetes, bp or lipids

Keywords: diabetes exercise printed materials
effects of plant stanol esters on blood flow

Conditions: Atherosclerosis

Summary: plant stanol esters as part of daily diet can decrease serum level of ldl-cholesterol up to 10%. this decrease diminishes the risk of development of premature atherosclerosis and it´s complications (e.g., acute myocardial infarction) in adult human subjects. the purpose of the present study is to evaluate among healthy human subjects (n=100) effects of plant stanol esters (3 grams/day for 6 months) as part of daily diet in margarine on arterial endothelial cells, arterial stiffness, autonomic innervation of the arteries, arterial blood flow and serum fats. the non-invasive arterial measurements (vasera®, endopat® and wincrps®) are performed and blood samples are taken at the beginning and at the end of the 6-month-long study period. also questionnaires concerning healthy, and life and dietary habits are fulfilled. dietary records (twice for a 3-day-period) are done. hypothesis of the study is that a dietary serum cholesterol lowering intervention has beneficial influence on the early prognostic markers of premature atherosclerosis.


Eligibility criteria:
inclusion criteria: * healthy human subjects exclusion criteria: * abnormal liver, kidney and thyroid function * unstable myocardial disease * inflammatory bowel disease * alcohol abuse * pregnancy * any lipid-lowering medication

Keywords: cholesterol plant sterols atherosclerosis arterial stiffness
a study of ly3473329 in participants with impaired and normal renal function

Conditions: Renal Insufficiency

Summary: the main purpose of this study is to assess the amount of study drug (ly3473329) that reaches the bloodstream and the time it takes for the body to get rid of it when given to participants with renal (kidney) impairment compared to participants with normal renal function. the safety and tolerability of ly3473329 will also be evaluated in these participants. the study will last up to 8 weeks including screening period.


Eligibility criteria:
inclusion criteria: * have a body mass index within the range 19.0 to 42.0 kilograms per meter squared (kg/m²) * men who agree to use highly effective or effective methods of contraception, women of childbearing potential (wocp) who agree to use highly effective or effective methods of contraception, and women not of childbearing potential (wnocbp) may participate in this trial * have clinical laboratory test results within the normal reference range for the population exclusion criteria: * have a history or presence of an underlying disease, or surgical, physical, medical, or psychiatric condition that, in the opinion of the investigator, would potentially affect participant safety within the study * have any abnormality in the 12-lead electrocardiogram (ecg), blood pressure and/or pulse rate that, in the opinion of the investigator, increases the risks associated with participating in the study * hemoglobin less than 8 grams/deciliter (g/dl) and/or clinically significant anemia symptoms * have an average weekly alcohol intake that exceeds 21 units per week for males and 14 units per week for females or males older than 65 years of age * smoke more than 10 cigarettes per day or the equivalent * have donated blood of more than 500 milliliter (ml) within 3 months prior to screening
sfee diet management for gestational diabetes mellitus

Conditions: Gestational Diabetes Mellitus (GDM)

Summary: this study aims to evaluate the impact of the self-family-environment empowerment (sfee) diet management intervention on glycemic control, maternal outcomes, and dietary adherence in pregnant women with gestational diabetes mellitus (gdm).

gestational diabetes mellitus (gdm) is a common complication of pregnancy, posing risks to maternal and fetal health. effective management of gdm is critical to improving outcomes. this study aims to evaluate the potential of the self-family-environment empowerment (sfee) diet management intervention in empowering pregnant women with gdm to improve glycemic control, dietary adherence, and maternal outcomes. the study is conducted as a parallel-group controlled trial at the first affiliated hospital of shanxi medical university. participants are allocated to two groups: an intervention group receiving routine care combined with the sfee program and a control group receiving routine care only. the sfee intervention integrates self-management strategies, family empowerment, and community learning, designed to support adherence to dietary recommendations and enhance participants' understanding of gdm management. primary outcomes include fasting blood glucose, postprandial glucose, and hba1c levels measured after a 3-month intervention. secondary outcomes include dietary adherence (assessed via a validated scale), gdm knowledge (measured using a questionnaire), and perceived social support (measured using the perceived social support scale)

Eligibility criteria:
inclusion criteria: * diagnosed with gestational diabetes mellitus (gdm) based on the international association of diabetes and pregnancy study groups (iadpsg) criteria. * aged 18-45 years. * pregnant women between 24-28 weeks of gestation at the time of enrollment. * able to provide informed consent. * access to a mobile phone and internet for study communication and follow-up. exclusion criteria: * pregnant women with complications such as placental abruption, miscarriage, or induced abortion during the study period. * those unable to give informed consent or adhere to the intervention due to medical or personal reasons. * history of severe medical conditions or other factors that might interfere with study participation (e.g., severe mental health conditions).

Keywords: gestational diabetes mellitus, sfee diet management, glycemic control, maternal outcomes, dietary adherence
kidney injury severity and covid-19

Conditions: COVID-19; Kidney Injury

Summary: the authors hypothesize that the sars-cov-2 virus can affect the kidneys, causing them to be damaged. the present study aims to explain the mechanisms of kidney injury in patients diagnosed with covid-19.

in december 2019, an outbreak of the 2019 novel coronavirus disease (covid-19) caused by the sars coronavirus 2 (sars-cov-2) occurred in wuhan, china. it has spread rapidly to other areas in china and worldwide. the most common manifestations of covid-19 included fever, dry cough, dyspnea, myalgia, fatigue and radiographic evidence of pneumonia. complications (acute respiratory distress syndrome, shock, acute cardiac injury, secondary infection, and acute kidney injury) and death may occur in severe cases. recent reports showed that extrapulmonary symptoms (intestinal symptoms in 10-20% of patients) and renal failure in some patients may be associated with the interaction of the virus with angiotensin-converting enzyme 2 (ace-2) receptors in other organs. it was suggested that ace-2 expression in the kidneys can be the cause of kidney injury occurring in a number of patients with sars-cov-2.however, ace-2 is not the only possible cause of kidney injury - sepsis-related cytokine storm can also lead to damage of kidney parenchyma. the present study aims to explain the mechanisms of kidney injury in patients diagnosed with covid-19.

Eligibility criteria:
inclusion criteria: * pneumonia confirmed by ct scans exclusion criteria: * a history of chronic renal failure; * a history of kidney transplantation; * intake of substances with a history of renal toxicity (no later than a month before inclusion); * patients with a single kidney; * refusal of the patient to participate in the study; * absence of sars-cov-2 virus smear from the nasopharynx in pcr.

Keywords: coronavirus infection kidney function
preoperative ct assisted planning for primary total knee arthroplasty

Conditions: Knee Osteoarthritis

Summary: total knee arthroplasty is one of the most common management methods of knee osteoarthritis. patellar complications are one of the important causes of revision total knee arthroplasty. proper placement of the components in the best rotational and axial alignment would achieve better patellar tracking and the best functional outcomes. preoperative ct scan can add information regarding the coronal and rotational alignment of the prosthesis components.

total knee arthroplasty is the gold standard treatment for advanced knee osteoarthritis. in spite of the great advance in the prosthesis design, surgical techniques and rehabilitation programs, only 85% (75% to 92%) of patients with total knee arthroplasty are satisfied with their operations and 30% develops patellofemoral complications. femoral and tibial components malrotation is a crucial cause of postoperative knee pain, patellar instability, and may lead to revision. in measured resection technique the surgical epicondylar axis (sea) is the center of rotation of the knee and the femoral component must be parallel to this axis. the surgical epicondylar axis is difficult to be determined intraoperative by palpation. commonly, surgeons routinely set the femoral posterior condyle resection at three degrees fixed from the posterior condylar line (pcl) because the pcl was found to be three degrees internally rotated from the (sea). the posterior condylar angle on a three-dimensional structure reconstruction of the ct scans in osteoarthritic knees has also been shown as 3.3° ± 1.5°, however, another study documented the posterior condylar angle (pca) in osteoarthritic knees as 1.6° ± 1.9°. also there is a two to three degree difference between the surgical epicondylar axis and the anatomical epicondylar axis. therefore, a routine bone resection of three degrees from the pcl is not universal for all cases and may create malrotation of the femur. ct scan can provide an adequate template with good but not excellent inter and intra observer reliability for exact determination of the surgical epicondylar axis and femoral component rotation. 2. aim/ objectives 1. what is the mean of distal femoral rotation in egyptian population? 2. what is the effect of osteoarthritis on femoral rotation? 3. how much is the accuracy of ct scan in detecting anatomical landmarks to choose the intraoperative femoral component rotation (correlation between radiological and intraoperative findings? 4. is the relation between the anatomical epicondylar axis (aea) in comparison to surgical epicondylar axis (sea) a fixed ratio? 5. what is the relation between thde femoral component malrotation and the coronal alignment and flexion gap balance? 6. can ct scan add a simple planning tool for accurate placement of femoral component and the reproducibility of the preoperative plan in surgery?

Eligibility criteria:
inclusion criteria: * advanced knee osteoarthritis in which total knee arthroplasty is indicated exclusion criteria: * revision total knee arthroplasty
non-linear imaging of skin in vivo

Conditions: Skin Cancer; Skin Condition; Skin Diseases; Skin Lesion; Skin Abnormalities

Summary: the overall objective of this study is to investigate the potential for the vio system to display microscopic skin structure in people of different age, sex, race, and skin health.


Eligibility criteria:
inclusion criteria: 1. subjects, ages 2 - 90 years old. 2. subject, or guardian, if applicable, must be willing to provide written informed consent prior to enrollment and agree to comply with protocol requirements. if applicable, child must be willing to provide written assent prior to enrollment and agree to comply with protocol requirements. 3. subject or guardian, if applicable, must have sufficient mental capacity to understand the informed consent and provide clinically relevant and reliable feedback regarding their experience with the device. 4. subject and guardian, if applicable, must comply with the protocol requirements. 5. subject or guardian, if applicable, must agree that anonymized personal data will be made available to study sponsor and requisite regional and international regulatory bodies. exclusion criteria: 1. any general health condition or systemic disease that may represent, in the opinion of the principal investigator, a potential increased risk associated with device use 2. currently infected with a communicable skin infection (e.g., shingles or methicillin-resistant s. aureus), which does not include local and minimally pathogenic or non-pathogenic infections distant from the imaging location(s) (e.g., warts, acne) 3. any known allergies to any materials used in the preparation of skin and/or device use 4. has a temporary or permanent electrical implanted medical device -
clinical study on acetyl-l-carnitine

Conditions: Peripheral Sensory Neuropathy

Summary: chemotherapy-induced peripheral neuropathy (cipn) is a common clinical dose-limiting adverse drug reaction, and the primary manifestations are different degree of neuromotor, sensorineural and autonomic nervous dysfunction.

this multicenter, randomized, double-blind, placebo-controlled and parallel clinical trial is to observe the efficacy and safety of the acetyl-l-carnitine hydrochloride enteric-coated tablets in treatment of peripheral sensory neuropathy that anti-cancer chemotherapeutics induce.

Eligibility criteria:
inclusion criteria: * patients had signed the informed consent form * male or female * age 18-75 years old * patients who have treated with taxoids, satraplatin and vincristine; the peripheral sensory neuropathy grading after chemotherapy was \>/=grade 3 or grade 2 lasting for one month * the course of neuropathy was \</=6 months * no need to continue chemotherapy according to the condition nor refusing chemotherapy * at least one of the neuroelectrophysiological examine results were abnormal * physical condition score (kps) \>/=60 * anticipated lifetime\>/=60. exclusion criteria: * patients whose peripheral sensory neuropathy was induced by medicines except of the taxoids, satraplatin and vincristine anti-cancer chemotherapeutics * diabetics * peripheral sensory neuropathy was induced by vitamin deficiency, infections, trauma, toxicosis, compression, and ischemia * peripheral sensory neurologic dysfunction that induced by lesions of central nervous system; hereditary neuropathy * patients who have treated by other medicines for peripheral sensory neuropathy in 30 days * patients had treated by other clinical trial medicines or participated into other trials in 30 days * patients had active infections * any clinical problems out of control * women in pregnancy and lactation, subjects with no compliance.

Keywords: chemotherapy-induced peripheral neuropathy (cipn)
effect of glycopyrrolate on nausea and vomiting after ercp operation

Conditions: Nausea and Vomiting

Summary: this study aims to determine the role of glycopyrrolate in preventing postoperative nausea and vomiting of ercp.

this study is a prospective, double-blind, randomized controlled trial. patients who meet the criteria of our center and need to undergo ercp lesion resection will be included and randomly divided into groups. after receiving glycopyrrolate (experimental group) and anisodamine (control group), duodenal peristalsis, biliary and pancreatic treatment time and postoperative nausea and vomiting will be observed during therapeutic ercp. the inhibitory effect of glycopyrrolate on postoperative nausea and vomiting of ercp will be analyzed statistically. main outcome measure: incidence of nausea and vomiting after ercp secondary outcome measures: mean duodenal contractions per minute, duodenal spasm frequency and score, ercp operation time, occurrence of other side effects of medication, remedial medication, and incidence of adverse events

Eligibility criteria:
inclusion criteria: * 1.adults 18-80 years old 2.asa :i-iii 3.patients who are able to give informed consent and are currently planning to have the lesion removed or examined at the descending ercp exclusion criteria:1: use of anticholinergic drugs 2: pregnancy 3: glaucoma 4: myasthenia gravis 5: obstructive gastrointestinal diseases 6: obstructive urinary tract disease (prostatic hyperplasia) 7: heart disease (coronary heart disease, congestive heart failure) 8: hyperthyroidism 9: previous history of abdominal or intestinal surgery 10: chronic renal failure -