Kornimate/medical-research-clean huggingface dataset:
hcl single arm pilot study in treatment of hyperglycemia of pediatric all

Conditions: High Risk Acute Lymphoblastic Leukemia

Summary: the overall objective of this pilot study is to determine the safety and feasibility of a hybrid closed-loop insulin delivery system for children and young adults with high risk acute lymphoblastic leukemia, during the induction chemotherapy phase while they are exposed to steroids and asparaginase that cause hyperglycemia.

the overall objective of this pilot study is to determine the safety and feasibility of a hybrid closed-loop insulin delivery system for children and young adults with high risk acute lymphoblastic leukemia, during the induction chemotherapy phase while they are exposed to steroids and asparaginase that cause hyperglycemia. insulin therapy would be beneficial in reducing hyperglycemia-associated complications in this period and thereby could improve other outcomes. the primary objective of the current pilot proposal is to demonstrate that hybrid closed loop pump therapy is a safe to be used in children and young adults with high risk acute lymphoblastic leukemia. if successful, the results of this study will be used to plan and support a larger, multi-center clinical trial and a grant proposal.

Eligibility criteria:
inclusion criteria: 1. patients ages 10 years old and above 2. patients who are newly diagnosed with high-risk acute lymphoblastic leukemia 3. patients who have started or will start an induction chemotherapy regimen containing steroid and asparaginase 4. patients (if over 18 years of age) or parent/guardian (if the patient is under 18 years of age) must be fluent in reading and speaking english 5. parent or guardian living in the home with the participant who also receives training on diabetes, cgm, hcl therapy, and the safety protocols exclusion criteria: 1. preexisting diabetes 2. severe psychiatric disease or developmental delays, that might interfere with ability to provide informed consent 3. active skin condition that would affect sensor placement 4. any other medical condition which in the opinion of the investigators impairs the person's ability to safely participate in the trial, including but limited to: 1. significant chronic kidney disease (egfr \<60) or requiring hemodialysis 2. significant liver disease 3. history of adrenal insufficiency 4. history of abnormal tsh consistent with hypothyroidism or hyperthyroidism that is not appropriately treated 5. history of thyroid cancer 5. use of intravenous or oral acetaminophen more than 60 mg/kg/day (maximum 4000 mg/day)
rapid evaluation of pandemic h1n1 influenza vaccine in adults with hiv

Conditions: HIV Infections; H1N1 Influenza

Summary: the purpose of this study is to assess the safety and effectiveness (immune response) to a licensed h1n12009 influenza vaccine in hiv-infected adults. the study will enroll 150 adults (ages 20-59 years). participants will be randomized into 2 groups and will receive either one dose or two doses of a licensed h1n1 vaccine. study procedures include: medical history, blood samples and completing a memory aid. participants will be involved in study related procedures for approximately 6 days.

during the first wave of the h1n12009 pandemic in canada, adults with immune deficiency were more likely to die with severe infections than were other canadians. of 76 deaths attributed to date to this new virus, 37% occurred in persons with immune system compromise. adults with human immunodeficiency virus (hiv) infection constitute a significant proportion of the at-risk population with over 56,000 affected individuals. most such individuals retain some capacity to respond to influenza vaccination. the dosing regimen for the pandemic vaccine will be based on limited studies in the general population, leaving open the question of whether hiv-infected persons can respond satisfactorily to the recommended dosing. availability of an adjuvanted formulation of the pandemic vaccine may improve responsiveness but two doses may be required for the best possible response. thus it would be optimal to evaluate the safety and immunogenicity of the pandemic vaccine among the earliest hiv-infected persons to receive it, to inform the subsequent vaccination of others. the objectives of this study are three-fold: 1. to evaluate the safety and immunogenicity of h1n12009 influenza vaccine in a convenience sample of adults with hiv infection. 2. to compare immune responses of subjects randomized to receive either one or two doses of adjuvanted vaccine to identify the optimal regimen. 3. to complete this evaluation soon after the pandemic vaccine becomes available so as to inform the subsequent use of the vaccine in hiv-infected persons.

Eligibility criteria:
inclusion criteria: * laboratory-confirmed hiv * written informed consent * adults 20-59 years of age exclusion criteria: * allergies to eggs, thimerosal or gentamicin sulphate * life-threatening reaction to previous flu vaccine * bleeding disorder * pregnancy * receipt of blood or blood products in past 3 months * chronic illness * previous lab-confirmed h1n12009 infection * receipt of any non-study h1n12009 or seasonal influenza vaccine for 2009/10

Keywords: hiv vaccine, h1n1 influenza h1n1 influenza vaccine arepanrix pandemic h1n1 2009 influenza hiv preventive vaccine
a study of decreased mental function associated with hiv

Conditions: Cognitive Disorders; HIV Infections

Summary: the purpose of this study is to compare pictures of the brain of hiv-infected people with memory problems before and after treatment with selegiline. selegiline is the study drug received through a5090. hiv patients generally develop memory problems late in the disease. this will be examined using noninvasive proton magnetic resonance spectroscopy (1h-mrs). the effect of the drug selegiline on memory problems also will be examined.

hiv-associated cognitive impairment generally develops during the later stages of the disease. this study proposes to non-invasively examine the pattern and extent of cerebral injury associated with hiv infection and its response to selegiline by using 1h-mrs. the following hypotheses will be tested: selegiline, a compound with antioxidant and anti-apoptotic properties, will reverse the metabolic abnormalities measured by 1h-mrs, and these changes will parallel the degree of improvement in cognitive and functional performance. this is a substudy of actg a5090. the pattern and extent of cerebral injury associated with hiv infection and its response to selegiline are examined using a 1h-mrs. 1h-mrs evaluations are performed at screening and week 24 (or at the time of premature discontinuation) of step 1 of a5090. the screening mrs exams may only be performed once all a5090 screening evaluations (including the lumbar puncture) have been completed and it has been determined that the patient is eligible for a5090 study entry. the screening mrs must be performed prior to a5090 study drug administration. the week-24 mrs must be performed while the patient is still on blinded study drug.

Eligibility criteria:
inclusion criteria patients may be eligible for this study if they: * are enrolled in actg protocol a5090. * meet the inclusion/exclusion criteria set forth for the step 1 phase of aactg protocol a5090. exclusion criteria patients will not be eligible for this study if they have: * claustrophobia (unless sedation with lorazepam or zolpidem allows for safe performance of the mrs). * metallic implants/medical devices (e.g., skull implants or cardiac devices).

Keywords: aids dementia complex selegiline oxidative stress cognition neuroprotective agents brain injuries magnetic resonance spectroscopy protons
an open-label, phase i/ii study of manganese plus radiotherapy in patients with metastatic solid tumors or lymphoma

Conditions: Solid Tumor; Lymphoma

Summary: radiotherapy is a regular care for metastatic solid tumors or lymphoma, and it can induce immunogenic death of tumor cells and a stronger immune response. sometimes, tumor regression would be observed at sites distant to an irradiated field because of the radiotherapy-induced anticancer immune responses, so-called abscopal response. manganese has been confirmed to activate innate immune and function as anticancer immunoadjuvant in pre-clinical studies. this study is designed to assess the abscopal response and safety of combined therapy of manganese and radiotherapy in patients with metastatic solid tumors or lymphoma.


Eligibility criteria:
inclusion criteria: 1. subjects must have histologically proven metastatic solid tumors or lymphoma. 2. subjects must have at least two distinct measurable sites of disease (≥1 cm). 3. ≥ 18 years old. 4. life expectancy of at least 6 months. 5. eastern cooperative oncology group performance status 0-2. 6. subjects must have stable or progressing disease to the ongoing systemic therapy. 7. multiple lines of previous chemo-immunotherapy were permitted. 8. patients with known brain metastases were included in the trial but brain lesions were not eligible as target or non-target lesions. 9. adequate organ function. 10. female participants of childbearing potential must be willing to use an adequate method of contraception for the course of the study through 120 days after the last dose of study drug. 11. male participants of childbearing potential must agree to use an adequate method of contraception, starting with the first dose of study drug through 120 days after the last dose of study drug. exclusion criteria: 1. subjects with any autoimmune disease or history of syndrome that requires corticosteroids or immunosuppressive medications. 2. serious uncontrolled medical disorders or active infections, pulmonary infection especially. 3. prior organ allograft. 4. women who are pregnant or breastfeeding. 5. women with a positive pregnancy test on enrollment or prior to investigational product administration. 6. subjects who are compulsorily detained for treatment of either a psychiatric or physical (eg, infectious disease) illness. 7. subjects with previous or concurrent other malignancies.

Keywords: metastatic radiotherapy manganese abscopal response
assessment of the effect of atorvastatin on prevention of cin in patients undergoing coronary angiography

Conditions: Contrast Induced Nephropathy

Summary: as the effect of statin use before the angiography to prevent contrast induced nephropathy (cin) is not well-known, the aim of the current study is to assess the effect of atorvastatin on prevention of cin in patients undergoing coronary angiography.


Eligibility criteria:
inclusion criteria: * having chronic stable angina who were referred for coronary angiography * non-pregnant female subjects * no history of diabetes mellitus * no history of renal failure * no history of single kidney * no history of cardiogenic shock * no history of unstable angina * no history of myocardial infarction * no history of hypersensitivity to statins * no history of previous intravascular contrast injection during one month before admission exclusion criteria: * glomerular filtration rate (gfr) \<60 * cardiogenic shock

Keywords: coronary angiography chronic stable angina cin
the specificity of cervical facet medial branch blocks

Conditions: Neck Pain; Cervical Facet Arthropathy

Summary: cervical facet arthropathy is a common cause of chronic neck pain. the "gold standard" for diagnosis is either blocking the facet joints, or more commonly blocking the medial branch nerves that innervate the joints. however, many studies have found a high false-positive rate when the nerves are blocked using 0.5 ml of local anesthetic. we will randomize patients to receive either cervical facet medial branch blocks with 0.25 ml of local anesthetic and contrast, or 0.5 ml. we will then do a ct scan to determine the accuracy and specificity of each block. our hypothesis is that using the higher volume (0.5 ml) might be responsible for the high false-positive rate.

inclusion criteria: dept. of defense beneficiaries \> 18 years of age; neck pain \> 3 months duration; cervical paraspinal tenderness exclusion criteria: radicular signs or symptoms; use of anticoagulants or bleeding disorder. outcome measures: the number of blocks whereby the contrast bathes the target nerve; the number of blocks whereby the contrast spreads to the medial branch nerve at the adjacent spinal level; the number of times the contrast diffuses into the intervertebral foramen or epidural space. we will also compare pain relief over 8 hours following the block between both volumes.

Eligibility criteria:
inclusion criteria: * age \> 18 years * chronic neck pain \> 3 months * paraspinal tenderness exclusion criteria: * absence of radicular symptoms * no bleeding diathesis * contrast allergy

Keywords: cervical pain zygapophysial joint specificity
implantable cardioverter defibrillator (icd registry)

Conditions: Heart Failure; Nonischemic Cardiomyopathy; Ischemic Cardiomyopathy; Ventricular Arrhythmia; Complications; Device, Cardiac

Summary: the icd registry™ is a nationwide quality program that helps participating hospitals measure and improve care for patients receiving implantable cardioverter defibrillators (icds) and cardiac resynchronization therapy devices with defibrillator (crt-ds). the icd registry captures the characteristics, treatments, and outcomes of patients receiving (icds). patient-level data is submitted by participating hospitals on a quarterly basis to the american college of cardiology foundation's (accf) national cardiovascular data registry (ncdr) which then produces an outcomes report of the hospital's data, with comparison to both a volume peer group (number of icd patients submitted annually) and the entire icd registry data set.

in january 2005 the centers for medicare and medicaid services (cms) expanded the covered indications for primary prevention implantable cardioverter defibrillators (icds) to incorporate the findings from the sudden cardiac death heart failure trial (scdheft) and the multicenter automatic defibrillator implantation trial ii (madit ii). as part of this expansion, cms mandated that a national registry be formed to compile data on medicare patients implanted with primary prevention icds to confirm the appropriateness of icd utilization in this patient population. responding to this mandate, a collaborative effort of the heart rhythm society (hrs)and the american college of cardiology foundation (accf), utilizing the expertise of the national cardiovascular data registry (ncdr®), developed the icd registry™. enrollment opened on june 1, 2005. cms selected the ncdr icd registry as the mandated national registry in october 2005.

Eligibility criteria:
all u.s and international patients. inclusion criteria: * all patients who receive an icd/crt-d (initial or generator change) for primary or secondary prevention purposes. * all patients with an icd/crt-d undergoing a lead only procedure. * u.s. populations must submit all patients who receive an icd/crt-d (initial or generator change) for primary prevention purposes who are insured by medicare. exclusion criteria: none
self-regulated constraint-induced movement therapy in subacute stroke patients

Conditions: Stroke

Summary: emerging research suggests the use of self-regulation (sr) strategies at improving functional regain in patients with brain injury. sr is proposed to produce an added effect to the effective constraint-induced movement therapy (cimt). this study aimed to examine the efficacy of a self-regulated cimt program (sr-cimt) for function regain of patients with subacute stroke. it was hypothesized that participants receiving the combined treatment (sr and cimt) would have a better functional regain.

background - emerging research suggests the use of self-regulation (sr) strategies at improving functional regain in patients with brain injury. sr is proposed to produce an added effect to the effective constraint-induced movement therapy (cimt). objective - this study aimed to examine the efficacy of a self-regulated cimt program (sr-cimt) for function regain of patients with sub-acute stroke. methods - seventy-six patients were randomly assigned to the self-regulated constraint-induced movement therapy (sr-cimt; n=25), constraint-induced movement therapy (cimt; n=27) or conventional functional rehabilitation (control; n=24) groups, and completed the trial. the sr-cimt intervention was two-week therapist-guided training using the sr strategy to reflect on the relearning of functional tasks with cimt. outcome measurements were for upper limb function (action research arm test, arat, fugl-meyer assessment, fma), daily task performance (lawton instrumental activities of daily living scale, lawton iadl) and self-perceived functional ability (motor activity log, mal) at pre and post intervention intervals, and at one month follow up.

Eligibility criteria:
inclusion criteria: * sustained an ischemic type stroke with lesion in the primary or motor cortical areas resulting in hemiplegia, * had stroke onset of less than 3 months, * were aged above 60, and * had 10 degree active extension in metacarpophalangeal joint and interphalangeal joint, 20 degree active extension of wrist joint exclusion criteria: * had excessive spasticity in the affected limb, as defined by a score of 2 or more on the modified ashworth scale, * had excessive pain in the affected limb, as defined by a score 4 or more using a visual analog scale, * had a score below 19 on the mini-mental status examination (mmse), and * had diagnosed of depression according to diagnostic and statistical manual-iv (dsm-iv) criteria

Keywords: self-regulation constraint-induced movement therapy stroke functional recovery randomized controlled trial
iron and vitamin adminstration prior to joint replacement to prevent transfusion

Conditions: Excessive Amount of Blood / Fluid Transfusion

Summary: to establish the efficacy of screening for anemia and treatment of mild anemia with iron and vitamins prior to thr and tkr as a means of increasing hemoglobin and reducing perioperative allogeneic blood transfusion.

patients with mild anemia will be identified at preoperative clinic visit * patients will be screened for inclusion and exclusion criteria * eligible patients will have laboratory testing performed as follows: cbc, liver and kidney function tests, serum iron, transferrin, ferritin, serum folic acid, vitamin b12 and c-reactive protein * patients will be assigned to a deficient group or non-deficient group depending upon laboratory hematinic values * patients in the "non-deficient' group will be randomized using a computer-generated code to treatment or no treatment * treatment will begin within 2 weeks of laboratory testing and 4-6 weeks prior to surgery. * hematinic therapy will consist of oral ferric hydrochloride polymaltose 200 mg/d and folic acid 0.4 mg/d; sublingual vitamin b12 1000 µg three times a week * on the day of surgery laboratory testing will be performed as follows: cbc, kidney and liver function tests, serum iron, transferrin, ferritin, serum folic acid, vitamin b12 and c-reactive protein. * the same surgical team in each center will operate on all study patients and will be blinded to the preoperative hemoglobin * routine postoperative management will be provided as determined by the treating physicians * blood transfusion will be decided upon by a study physician at each center blinded to the patients' group assignment and preoperative hemoglobin * the primary outcome will be perioperative blood transfusion (from 24 hours prior to surgery until hospital discharge) * secondary outcomes will be length of hospitalization, postoperative wound infection, walking ability across room at 30 days

Eligibility criteria:
inclusion criteria: * age \> 50 years * ability to provide informed consent * elective thr or tkr * mild anemia: hematocrit 29-39% in men, 29-36% in women exclusion criteria: * identified cause of anemia excluding hematinic deficiency * known source of blood loss * known coagulopathy * unstable coronary syndrome in the previous 3 months * pathologic fracture, presence of malignancy * repeat thr or tkr * orthopedic trauma within the previous 3 months * asa class ≥ 4 * creatinine clearance \< 30 ml/min * ast/alt \> 2x upper limit of normal * preexisting use of hematinic agents * planned acute normovolemic hemodilution * refusal to receive blood products

Keywords: hematinic therapy blood transfusion joint replacement
mhealth to improve the experience, adherence to drug treatment and positive mental health

Conditions: Fracture of Femur

Summary: the present study aims to evaluate the effectiveness of a pharmacological nursing educational intervention (efe) with "myplan aplication" about the patient's experience, adherence to pharmacological treatment, and positive mental health of patients with femur fracture.

once the informed consent has been obtained, the investigators will explain to the patient the pharmacological treatment with the support of an aplication (what it is for, how the medication should be taken, possible adverse effects), also the investigators will share time with the patient during the 4 face-to-face training sessions. the investigators will accompany during their hospital stay, offering to pacients telematic support upon discharge with the treatment and until the end of the study. this is a quasi-experimental non-randomized study with 3 phases of data collection. possible adverse reactions, if any, will be recorded.

Eligibility criteria:
inclusion criteria: * diagnosis of femur fracture * knowledge of the spanish language * 24-hour admission to the traumatology unit * level of consciousness on the glasgow scale of 15 * have access to a mobile device * ability to participate in the pilot study * be able to provide written informed consent or obtain consent from a legal representative. exclusion criteria: * presence of psychological pathologies or cognitive impairment * isolation in hospital admission

Keywords: education patient experience adherence medication mental health mobile health nurse mhealth protocol
convalescent plasma in the treatment of covid-19

Conditions: Covid-19; Respiratory Insufficiency

Summary: one hundred patients hospitalized and in need of oxygen treatment due to covid-19 should be randomized and 50% treated with 200 ml convalescent plasma x 3 and 50% given ordinary treatment. primary outcome is number of days the patients need oxygen within 28 days from inclusion. secondary outcome is number of days in hospital, number of days in respirator and mortality. side effects of treatment is monitored.

subjects with previous verified covid-19 are asked to donate plasma 14 days or later after recovery. igg antibodies against covid-19 are measured and only subjects with high titers are accepted. plasmaphereses is done and up to 600 ml plasma is drawn and aliquoted in 200 ml portions. patients with acute respiratory symptoms, verified covid-19, hospitalized and in need of oxygen treatment are asked to participate in the study. the patients are randomized 50/50 to get either convalescent plasma or routine treatment without plasma. the patients randomized to get plasma will have infusion of 200 ml blood group compatible convalescent plasma daily during three days from different donors. the clinical course will be carefully monitored and days with oxygen requirement will be compared between the groups. secondary clinical outcomes as mortality, need of assisted ventilation, total days in hospital and side effects to treatment will be observed.

Eligibility criteria:
inclusion criteria: * verified diagnosis of covid-19 * \<94% oxygen saturation * willingness to participate * ability to sign informed consent exclusion criteria: * unability to understand information and sign informed consent * immunosuppressed patient

Keywords: covid-19 convalescent plasma