Kornimate/medical-research-clean huggingface dataset:
calcium and magnesium infusion for the prevention of taxane induced neuropathy

Conditions: Paclitaxel-induced Neuropathy

Summary: this is a pilot study evaluating the feasibility of intravenous calcium and magnesium (ca/mg) infusion for prevention of taxane induced neuropathy in patients with early stage breast cancer receiving adjuvant or neo-adjuvant paclitaxel, either given every 2 weeks for 4 cycles or every week for 12 weeks.

chemotherapy induced peripheral neuropathy (cipn) is a major dose limiting side effect of many cytotoxic chemotherapy, and can be extremely disabling, causing significant loss of functional abilities. calcium and magnesium infusions were shown to decreased the incidence and intensity of neuropathy symptoms related to oxaliplatin. there are currently no effective drugs or treatment modalities for the prevention or treatment of taxane related neuropathy. given the morbidity of taxane induced neuropathy and the safety of ca/mg infusion, it is reasonable to assess the feasibility of this intervention in woman with stage i-iii breast cancer receiving adjuvant or neo-adjuvant paclitaxel treatment, either given every 2 weeks for 4 cycles or every week for 12 weeks. calcium gluconate and magnesium sulfate, 1 g of each agent in 100 ml d5w will be infused over 30 minutes, immediately before and after each dose of paclitaxel. the ca/mg infusion will be given through the same line used for giving chemotherapy. the primary aim of this study is to assess paclitaxel-related neuropathy (grade 2 or greater) as measured by nci common terminology criteria version 3 in patients receiving ca/mg infusion during paclitaxel chemotherapy and compare it with historical controls. secondary endpoints will include other measures of neuropathy and quality of life such as the fact-tax score, taxane-related neuropathy pain as measured by the brief pain inventory-short form (bpi-sf), and measure of cognitive impairment using fact-cog score.

Eligibility criteria:
inclusion criteria: * age \> 21 years * history of stage i-iii breast cancer * patient scheduled to be receiving adjuvant or neo-adjuvant paclitaxel given every week for 12 weeks or given every two weeks for 4 cycles * serum magnesium level ≤ unl * serum calcium level ≤ unl * serum creatinine ≤ 1.5 x unl * signed informed consent exclusion criteria: * pre-existing peripheral neuropathy of any grade * current treatment for arrhythmias * concurrent treatment with anticonvulsants, tricyclic antidepressants, or other neuropathic medications such as carbamazepine, phenytoin, gabapentin, lamotrigine, or concurrent treatment with other neuropathic chemotherapy agents * current narcotic use

Keywords: neuropathy taxane paclitaxel calcium magnesium prevention
comparing reports recorded by the patients at the time at which they feels pain to what patients report at monthly visits to assess symptoms of musculoskeletal diseases.

Conditions: Musculoskeletal Pain

Summary: patients will be introduced to the use of a mobile application for their smartphone to record the ecological momentary assessment (ema). this app will ask the patients to assess their pain and function two times daily for 2 months. after 1 month and at the end of the 2 months, follow-up visits will be performed and patients will be asked to retrospectively evaluate the pain that they suffered and the level of function they had during the last month.


Eligibility criteria:
inclusion criteria: * symptomatic patients * patients able to give informed consent and to follow the protocol of the study (i.e. able to use a smartphone) * patients \>18 years * bmi \ 18.5 * patients with a smartphone with android or ios as operative systems exclusion criteria: * patients unable to follow the protocol of the study (i.e. unable to use a smartphone, not owning a smartphone or unwilling to download or use the application) * patients with a diagnosis of a musculoskeletal injury but without symptoms * patients without a radiological examination confirming the diagnosis of musculoskeletal disease * patients with planned surgery in the following 60 days * pregnant or lactating woman * patients with other diseases causing pain in the involved joint (e.g. rheumatoid arthritis or other rheumatologic diseases). * surgical treatment in the last year and intra-articular injection in the last 6 months
the role of leptin receptors in nash

Conditions: Nonalcoholic Steatohepatitis; Metabolic Syndrome

Summary: nafld is a spectrum of liver diseases associated with varying degrees of hepatic steatosis, inflammation, and in some cases, fibrosis. nafld is a common observation in all demographics, but the prevalence of nafld and nonalcoholic steatohepatitis (nash) is especially high in the morbidly obese population. leptin is a cytokine that is encoded by the ob gene and primarily secreted by adipose tissue. the production of serum leptin increases with progressive obesity. because of this observation, there has been significant interest in potential role of leptin in nafld. our hypothesis is that we will find increased hepatic leptin and leptin receptor expression as the degree of hepatic injury worsens in nafld.


Eligibility criteria:
inclusion criteria: * all patients undergoing elective bariatric surgery, ages 18-65. exclusion criteria: * non-obese patients, ages less than 18 and over 65. pregnant patients.

Keywords: leptin, leptin receptors, adiponectin
study to assess the efficacy and safety of somatostatin in the treatment of acute severe upper gastrointestinal bleeding

Conditions: Peptic Ulcer

Summary: to assess the efficacy and safety of the early administration of somatostatin in infusion during 72 hours plus 2 boluses, compared to placebo in the control of acute severe ugib with suspicion of pub.


Eligibility criteria:
inclusion criteria: * male or female non-cirrhotic patients at least 18 years old suspected to bleed from pu. * patients with haematemesis and/or hematochezia and/or melena which have been observed by a member of a clinical team (gp, hospital physician, nurse, ...). * either, documented signs of hypovolemia related to the current bleeding episode or, occurrence of symptoms of hypovolemia exclusion criteria: * treatment of the present bleeding episode with somatostatin or its analogues, vasoactive drugs, or endoscopic therapy. * any treatment with ppis (iv or per os) within the last 48 hours preceding randomisation. * treatment (endotherapy or pharmacotherapy) for upper gastrointestinal ulcer bleeding in the last 30 days. * deficient haemostasis (platelets \ 1.5 (or prothrombin time \ 40 seconds (or according to the normal ranges validated, from local lab)) * anticoagulant therapy (vitamin k antagonists or heparin including lmw heparins) * terminal stage illness in which endoscopy is contraindicated

Keywords: peptic ulcer bleeding, upper intestinal bleeding, endoscopy, somatostatin
prospective investigation of intra-articular tranexamic acid use in elective hip arthroplasty

Conditions: Blood Loss; Hemoglobin Change; Blood Transfusion; Heterotopic Ossification

Summary: tranexamic acid (trans-4-aminomethyl cyclohexane carboxylic acid) is an antifibrinolytic substance that chemically belongs to the group of e-carboxylic acids. txa is a synthetic amino acid derivative of lysine that competitively inhibits the activation of plasminogen to the serine protease, plasmin. txa is a competitive inhibitor of tissue plasminogen activator, blocking the lysine-binding sites of plasminogen, resulting in inhibition of plasminogen activation and fibrin binding to plasminogen and therefore impairment of fibrinolysis. due to its antifibrinolytic effect (reduction of bleeding), txa has been recently an increasing interest in orthopaedics, especially in elective major joint replacements. the total hip arthroplasties (τηα) are associated with perioperative blood losses exceeding 500 ml. blood loss volumes are dependent on the chosen surgical approach and technique. some patients that undergo elective hip replacement receive at least one blood unit in postoperative care. heterotopic ossification is also a common complication after tha, presented as bone in soft tissue where bone normally does not appear. txa reduces postoperative blood losses and consequently leads to less frequent blood transfusions. this has an impact on the economic burden for the health care system. increased blood loss could lead to longer length of stay at the hospital and the connected economic consequences. txa further reduces the incidence of heterotopic ossification after elective tha. objectives: the aim of this study is to prospectively evaluate postoperative blood losses, hemoglobin decline and associated blood transfusion, heterotopic ossification and other parameters in patients with intraarticular application of tranexamic acid during tha.


Eligibility criteria:
inclusion criteria: * elective hip replacement exclusion criteria: * traumatic hip replacement indication
effect of rygb on alpha- and beta cell function and sensitivity to incretins in patients with type 2 diabetes

Conditions: Type2 Diabetes; Obesity, Morbid

Summary: the aim of the study is to investigate the effect of roux-en-y gastric bypass (rygb) on pancreatic alpha and beta-cell function and for the sensitivity of incretin hormones in patients with pre-operative type 2 diabetes. primary hypotheses: * after rygb, the sensitivity to glp-1 and gip is improved (improved insulinotropic effect). * after rygb, the insulin secretion improves during an oral glucose tolerance test within 3 months postoperatively. * after rygb, the insulin secretion during intraveneous stimulation with glucose or non-glucose (arginin) is unchanged.

design: 12 patients with type 2 diabetes will be recruited. all subjects will undergo 11 study visits: four visits before, three visits at 1 week after surgery and four visits at 3 months postoperatively: * oral glucose tolerance tests (ogtts) with measurement of glp-1 and gip secretion will be performed before and 3 months post-surgery. * hyperglycemic clamps with co-infusion of saline, glp-1 or gip will be performed in a randomised order at three separate study visits in randomized order before, 1 week and 3 months after surgery.

Eligibility criteria:
inclusion criteria: * inclusion criteria for rygb in denmark (ie. bmi \> 35 in the presence of obesity related co-morbidities as type 2 diabetes) * type 2 diabetes * pre-operative: fasting plasma glucose ≥7,0 mmol/l or 2 hour plasma glucose ≥ 11,1 mmol/l (after pausing antidiabetic medication for a minimum of 3 days) * written informed consent. exclusion criteria: * exclusion criteria for rygb (psychiatric illness, obesity triggered by medical treatment for psychiatric illness, mental retardation, alcohol or drug abuse, severe heart-lung disease despite optimal medical treatment, previous serious problems with universal anesthesia, previous peritonitis, large hiatus hernia, diseases of the ventricle / previously complicated upper abdominal surgery, recurrent esophagitis, poor compliance). * type 2 diabetes where antidiabetic medication cannot be paused for 3 days. * pregnancy and breast-feeding. * hemoglobin \<7.0 mmol/l
effects of a comprehensive intervention on blood pressure control in a primary care setting

Conditions: Hypertension

Summary: the implementation of lifestyle modifications, home blood pressure (bp) measurement, and optimization of antihypertensive drug therapy have been shown to improve bp control in tightly controlled research settings. the investigators objective is to determine the effect of these interventions in a primary care setting, with the family practitioners and nurses serving as the interventionists. the investigaotrs hypothesis is that a comprehensive intervention performed in a primary care setting would lead to better blood pressure control.


Eligibility criteria:
inclusion criteria: * aged 35-74 years * untreated office blood pressure of ≥ 160/100 mmhg or on active antihypertensive treatment. exclusion criteria: * severe psychiatric or neurologic illnesses * heart failure (ejection fraction \< 40% or previous hospitalization for heart failure) * hemodynamically significant valvular disease * unstable coronary heart disease * chronic kidney disease (proteinuria \> 1 g/l or a serum creatinine concentration \> 160 mmol/l)
community-based approach to lowering stress through mindfulness

Conditions: Depression; Hypertension

Summary: the goal of this clinical trial is to test a culturally adapted mindfulness-based stress reduction intervention in a community setting for african american adults with high blood pressure (hypertension) and depression. the main questions it aims to answer are: * does participation in a culturally adapted mindfulness-based intervention improve depressive symptoms? * does participation in a culturally adapted mindfulness-based intervention improve blood pressure control? * is the intervention acceptable, appropriate, and feasible as delivered in a community setting? participants will: * participate in an 8-week group-based mindfulness intervention (calm-chicago). during intervention sessions, participants will learn about mindfulness and stress management and complete mindfulness-based activities, such as guided deep breathing and meditation. * complete surveys online * have their blood pressure measured with a non-invasive blood pressure cuff * attend 1 focus group (optional)


Eligibility criteria:
inclusion criteria: * ≥18 years old * lives, works, or spends much of their time in the south side of chicago neighborhood * self-reports diagnosis of hypertension or high blood pressure by a clinician * endorses elevated depressive symptoms as patient health questionnaire (phq)-9 scores ≥10 * not taking antidepressant medication or stable on antidepressant medication for ≥6 months as self-reported exclusion criteria: * \<18 years old * severe mental illness (e.g., bipolar disorder, psychosis) * current suicidal ideation (phq-9 item 9) or recent (past 6 months) suicide attempt * unable to provide informed consent or complete study activities in english

Keywords: culturally adapted african american depression high blood pressure hypertension
virtual reality distraction during arteriovenous fistula puncture

Conditions: Pain Management; Hemodialysis; Virtual Reality

Summary: the cannulation of arteriovenous fistula is a painful procedure in hemodialysis patients. previous studies have shown the effectiveness of virtual reality in reducing pain during needle-related procedures

patients undergoing hemodialysis experience anxiety and pain related to the insertion of hemodialysis needles, estimated 320 times in total per year. the pain experienced is mostly caused by needle insertion into a fistula. pain control is one of the main nursing tasks. pain relief leads to the acceptance of the procedure and ultimately enhances the patients' quality of life. the use of virtual reality to reduce pain and anxiety during the arteriovenous fistula cannulation procedure is based on the concept that the perception of pain can be controlled because an individual is able to process only a limited amount of information at once. as such, the use of virtual reality during painful procedures may serve as a distraction.

Eligibility criteria:
inclusion criteria: * patients who are under- going conventional hemodialysis three times a week * hemodialysis period of one month or more * having a healthy avf access with good function * welling to participate in study exclusion criteria: * patients who have psychiatric diseases * panic disorder, anxiety disorder * dysfunctional fistula * vertigo, issues with sight, hearing, or perception * or use painkillers within three hours before hemodialysis
validation of the turkish version of qualeffo-31

Conditions: Osteoporosis

Summary: the aim of this study is to investigate the adaptation and validity of the quality of life questionnaire of the european foundation for osteoporosis-31 in patients with osteoporosis. thus, to present a scale that will help us analyze the psychometric properties of patients with osteoporosis to the use of the turkish people .

osteoporosis has become an important public health problem due to low bone mass, decreased bone strength and increased risk of fractures. today, the measurement of quality of life plays an important role in the approach to diseases. quality of life questionnaire of the european foundation for osteoporosis-41 (qualeffo-41) has been used for many years as a well-established and fully self-administered questionnaire. in the following years, a shorter and more practical version was needed because the qualeffo-41 contains many questions and takes a long time. for this reason, the questionnaire was updated in 2006 and the version of qualeffo-31 was made and the validity of the current questionnaire was shown. the aim of this study is to conduct the reliability and validity study of turkish version of qualeffo-31 and to evaluate the power of the questionnaire to distinguish patients with osteoporosis.

Eligibility criteria:
inclusion criteria: * to have dual-energy x-ray absorptiometry (dxa) results and thoracolumbar lateral spine x-rays taken for any reason in the last 6 months. * to have calcium, phosphorus, parathormone (pth) and 25-hydroxyvitamin d level in the last 3 months. * to be independently ambulatory. * to have a cognitive capacity to understand and complete the questionnaires. exclusion criteria: * to have malignancy. * to have inflammatory diseases. * to have a metabolic bone disease other than osteoporosis. * to have neuromuscular diseases.

Keywords: osteoporosis questionnaire quality of life qualeffo
effect of core stability exercises and russian electrical stimulation in non-specific low back pain

Conditions: Low Back Pain

Summary: brief summary: low back pain (lbp) is an important public health problem due to the increasing world population and aging. in chronic lbp, exercise therapy is among the first-line treatments. core stabilization exercises (cse), one of the motor control exercises, focus on the activation and control of the deep spinal muscles. recently, some studies have shown that russian electrical stimulation alone or combined with exercise can provide contraction in deep stabilizer muscles and significantly reduce pain in patients with lbp


Eligibility criteria:
inclusion criteria: * the duration of the disease is more than 3 months with pain scores greater than four in the vas disability score of 19% or greater as evident from the modified oswestry disability. exclusion criteria: * neurological or musculoskeletal diseases that affect lumbar spine (e.g: lumbar spondylosis, spondylolisthesis, and lumbar disc injuries) * women during pregnancy and lactation. * history of lumbar spine surgery. * signs of lumbar radiculopathy or myelopathy. * signs of serious pathology (e.g., malignancy, inflammatory disorders, infection
safety study of pegylated interferon alpha 2b to treat polycythemia vera

Conditions: Polycythemia Vera

Summary: the purpose of this study is the identification of the maximum tolerated dose (mtd) of the investigational medicinal product. moreover the safety and tolerability will be assessed and an exploratory analysis of efficacy and biomarker modulation will be performed.


Eligibility criteria:
inclusion criteria: 1. written informed consent obtained prior to any study specific screening activities and able to comply with this protocol. 2. patients age ≥18 years 3. confirmed diagnosis of pv according to either the who criteria (2008, appendix 6) or the psvg (appendix 7) criteria plus jak-2 positivity, including newly diagnosed, pre-treated and on cytoreductive therapy. 4. eastern cooperative oncology group performance status ≤ 2 5. if female of childbearing potential - have a negative urine pregnancy test result within 7 days prior to the scheduled first application of investigational product and agree to employ adequate birth control measures for the duration of the study. exclusion criteria: 1. diagnosis of any other myeloproliferative disorder 2. any clinically significant illness or surgery within 4 weeks prior to dosing 3. systemic infections, e.g. hepatitis b, hepatitis c, or hiv at screening 4. uncontrolled hypertension (systolic \> 150 mmhg and diastolic \> 100 mmhg, or clinically significant (i.e. active) cardiovascular disease: cva/stroke (≤ 3 months prior to enrolment), myocardial infarction (≤ 3 months prior to enrolment), significant coronary artery stenosis, unstable angina, new york heart association (nyha) class 2 or greater congestive heart failure, or serious cardiac arrhythmia requiring medication. 5. previous treatment with interferon for pv 6. concurrent treatment with cytoreductive agents other than hydroxyurea and investigational agents of any type 7. history of malignant disease, including solid tumours and haematological malignancies (except basal cell and squamous cell carcinomas of the skin and carcinoma in situ of the cervix that have been completely excised and are considered cured) within the last 3 years 8. history of severe allergic (like anaphylaxis) or hypersensitivity reactions (like angioedema), any known or suspected intolerance to the investigational product. 9. use of any investigational drug or participation in any investigational drug study within the last 4 weeks 10. clinically significant history or known presence of psychiatric disorders, including but not limited to depression, anxiety and sleep disorders 11. organ transplant, past or planned 12. inadequate liver function defined by serum (total) bilirubin \> 2,5 x uln and/ or ast and alt \> 2,5 x uln 13. clinically significant ecg findings 14. history of renal disease requiring haemodialysis or seizure disorder requiring anticonvulsant therapy 15. pregnant or lactating females (pregnancy test to be assessed within 7 days prior to study treatment start) 16. acute or chronic infections or autoimmune diseases (collagen diseases, polyarthritis, immune thrombocythemia, thyroiditis, psoriasis, lupus nephritis or any other autoimmune disorder).
a novel/common approach for temporalis muscle thickness measurement

Conditions: Sarcopenia; Stroke

Summary: the aim of this study is to propose a new measurement point for temporal muscle thickness (tmt) that can be similarly localized in computerized tomography (ct) /magnetic resonance imaging (mri) and ultrasonography (usg), and to evaluate the reliability and consistency of these measurements.

recently, temporal muscle thickness (tmt) has been proposed as a new marker of whole-body muscle function. in addition, tmt has been shown to be a useful parameter for estimating skeletal muscle mass. measurement of temporal muscle mass with ct and mri has been studied in the literature in recent years. all stroke patients undergo cranial ct or mri examinations at the time of admission. however, the literature indicates that usg can also be used to measure temporal muscle thickness. the recommended measurement points for ct, mri, or usg in the studies performed to date depend on the particular imaging modality, and it does not seem possible to use them interchangeably. the aim of this study is to propose a new tmt measurement point that can be localized in a similar way in ct /mri and usg, and to evaluate the reliability and agreement of these measurements.

Eligibility criteria:
inclusion criteria: * referral to the radiology department for an mri or ct scan exclusion criteria: * medically unstable condition (presence or high risk of impaired consciousness, respiration, or circulation). * vulnerable populations (patients with a terminal illness, people living in nursing homes, unemployed or poor people, people in need of urgent medical care, children, people unable to consent, etc.).