Kornimate/medical-research-clean huggingface dataset:
tto swabs versus baby shampoo in patients with seborrehic blepharitis

Conditions: Seborrheic Blepharitis

Summary: the aim of the study was to compare the efficacy of lid swabs containing tea tree oil (tto) and chamomile oil and baby shampoo (bs) in the treatment of seborrheic blepharitis.

after being informed about the study and potential risks, all patients giving written consent will have a complete ophthalmological examination to determine eligibilty for study entry. at week 0, patients who meet the eligibility requirements will be randomized in a double blind manner (participant and investigator) in a 1:1 ratio using block randomization to lid wipes containing tea tree oil (tto) and chamomile oil or baby shampoo (twice daily).

Eligibility criteria:
inclusion criteria: * diagnosis of seborrheic blepharitis exclusion criteria: * patients with ophthalmological pathologies that may affect the tear film functions including ocular rosacea, contact lens use, history of any ocular surgery, or patients with systemic pathologies or those using systemic medications that may affect the tear film functions * patients younger than 18-year-old * patients who used any treatment for blepharitis within the 6 months prior to the examination

Keywords: seborrheic blepharitis tea tree oil baby shampoo swabs chamomile oil
glucose tolerance in healthy overweight adults

Conditions: Overweight

Summary: the primary objective is to compare the postprandial glycemic response of healthy overweight adults after consuming an amino acid drink mix versus a control drink.


Eligibility criteria:
inclusion criteria: 1. fasting blood glucose level of ≥ 70mg/dl and ≤ 125 mg/dl. 2. subject states that he/she does not have type 1 or 2 diabetes. 3. subject is overweight as defined as waist circumference ≥ 101 cm (40 inches) male; ≥ 88 cm (35 inches) female. 4. subject's bmi is ≥ 25 kg/m2. 5. subject's blood pressure is \< 140 mm hg systolic and \< 90 mm hg diastolic. 6. subject is between 20 and 45 years of age, inclusive. 7. subject is a male or a non-pregnant, non-lactating female, at least 6 weeks postpartum prior to screening visit. 8. if female is of childbearing potential, is practicing birth control 9. if subject is on a chronic medication such as a thyroid medication or hormone therapy, has been on constant dosage for at least two months prior to screening visit. exclusion criteria: 1. subject is eating a low carbohydrate diet such as atkins, zone, or south beach diet plan. 2. subject states that he/she has current infection, has had inpatient surgery, or corticosteroid treatment in the last 3 months or antibiotics in the last 3 weeks prior to screening visit. 3. subject states that he/she has an active malignancy. 4. subject states that he/she has had a significant cardiovascular event ≤ six months prior to screening visit; or stated history of congestive heart failure. 5. subject states that he/she has end-stage organ failure or is status post organ transplant. 6. subject states that he/she has a history of renal disease. 7. subject states that he/she has current hepatic disease. 8. subject states that he/she has a chronic, contagious, infectious disease, such as active tuberculosis, hepatitis b or c, or hiv. 9. subject has taken/is currently taking any herbals, dietary supplements, or medications during the past four weeks prior to screening visit that could profoundly affect blood glucose. 10. subject has taken/is currently taking any herbals, dietary supplements, or medications during the past four weeks prior to screening visit to control hypertension or cholesterol. 11. subject states that he/she has clotting or bleeding disorders.
rapid evaluation of pandemic h1n1 influenza vaccines in young children

Conditions: Influenza

Summary: the purpose of this study is to compare the safety and effectiveness (immune response) to one or two doses of adjuvanted h1n12009 influenza vaccine in young children. an adjuvant is an additive that can boost the immune response. the study will enroll 300 children (ages 6-35 months). participants will receive 2 doses of adjuvanted h1n12009 vaccine 3 weeks apart. study procedures include: medical history, blood samples and completing a memory aid. participants will be involved in study related procedures for approximately 6 weeks.

the goal of this study is to determine if one or two doses of the h1n12009 influenza vaccine are needed in young children, a population group at high risk of influenza infection and subsequent hospitalization. the objectives of this study are two-fold: 1. to compare the safety and immunogenicity of 1 and 2 doses of adjuvanted h1n12009 influenza vaccine in children 6-35 months of age. 2. to conduct the trial soon after the vaccines become available and share the observations with health officials and the public as soon as possible.

Eligibility criteria:
inclusion criteria: * written informed consent provided for the subject by a parent or legal guardian * children age 6-35 months exclusion criteria: * allergies to eggs, thimerosal, gentamicin sulphate or latex * life-threatening reaction to previous flu vaccine * bleeding disorder * pregnancy * receipt of blood or blood products in past 3 months * chronic illness that could interfere with trial participation * compromised immune system * previous lab-confirmed h1n12009 infection * receipt of h1n12009 vaccine * receipt of seasonal influenza vaccine since march 2009

Keywords: vaccine influenza h1n1 influenza vaccine influenza vaccine arepanrix
subcutaneous indwelling of vacuum drainage in total knee arthroplasty

Conditions: Total Knee Arthroplasty

Summary: this prospective, randomized trial asked whether subcutaneous indwelling of vacuum drainage has advantages over intraarticular indwelling in terms of blood loss, bleeding related complications, and functional outcomes in primary total knee arthroplasty (tka). the investigators hypothesized that the subcutaneous indwelling method would reduce blood loss with comparable bleeding-related complications and functional outcomes. the subcutaneous indwelling group demonstrated reduced blood loss with comparable prevalence of bleeding-related complications and functional outcomes. in conclusion, the investigators' study verified the efficacy and absence of risks of subcutaneous indwelling method. so the investigators propose that the subcutaneous indwelling drainage can be a good option to address the problems related to postoperative bleeding after tka.

there are numerous reports in the literature on drainage options after tka, but there is no consensus. many studies have shown no apparent advantage of drainage but routine intraarticular indwelling drainage after tka has been extensively used to avoid complications associated with hematoma formation. it is of interest to determine if it is possible to reduce blood loss while still using drainage. so we came to think about a new and more convenient method-subcutaneous indwelling. theoretically subcutaneous indwelling method which still has the advantages over the intraarticular indwelling method but is more convenient than drain-clamping method may be a better option. so we hypothesized that subcutaneous indwelling method of vacuum drainage has advantages over the intraarticular indwelling method.

Eligibility criteria:
inclusion criteria: * diagnosis of primary osteoarthritis * primary total knee arthroplasty * signed written informed consent * spinal/epidural anesthesia exclusion criteria: * patients with coagulation disorders * revision total knee arthroplasty * simultaneous bilateral total knee arthroplasty * diagnosis other than primary osteoarthritis * patients refusing consents

Keywords: total knee replacement arthroplasty subcutaneous indwelling blood loss complications functional status
objective evaluation of the number of use hour of oxygen therapy in patients receiving supplemental oxygen

Conditions: Chronic Respiratory Failure With Hypoxia; Chronic Obstructive Pulmonary Disease

Summary: the aim of this study is to measure the actual use time in patients receiving supplemental oxygen using a new easy-to-use electronic remote monitoring device (teleox™)

the first phase of the study is observational. oxygen use time of patients with chronic respiratory failure under long term oxygen therapy will be objectively measured using a electronic remote monitoring device (teleox™) over 15 days. the actual use time will be compared to their oxygen prescription. participants whose actual time of use will be less than prescribed will be offered an intervention which will consist of a presentation of the adherence record. the participant will also be asked about the presence of possible barriers concerning the use of oxygen therapy. the collaborator in charge of home visits will attempt to resolve these barriers as much as possible. only participants with an actual time of use less than prescribed will be offered this intervention and will continue the monitoring over a period of 15 additional days.

Eligibility criteria:
inclusion criteria: * long term oxygeno-therapy patients in stable condition without pulmonary exacerbation in the month before inclusion * oxygen prescription for at least 15 hours/day exclusion criteria: * under 18 years old

Keywords: long term oxygen therapy adherence electronic monitoring
methylprednisolone replacement for dexamethasone-induced hiccup

Conditions: Dexamethasone; Hiccup

Summary: dexamethasone is a potent synthetic member of the corticosteroid. it is given to cancer patients undergoing chemotherapy to counteract emetic side effect and essential drug for the chemotherapy-treated patients. hiccup is common adverse effect of corticosteroid especially on dexamethasone varying from 3% to 60% of given patients. discontinuance of dexamethasone relieves most hiccupping cases, but vomiting/nausea rates increase. it is not clear whether hiccup side effect is limited to the dexamethasone only or other corticosteroid group. methylprednisolone, synthetic corticosteroid as similar as dexamethasone, could be considered as antiemetic agent for the patients with receiving chemotherapy. the investigators perform this pilot study under hypothesis that replacing dexamethasone with methylprednisolone could maintain antiemetic role and prevent hiccup.


Eligibility criteria:
inclusion criteria: * age olderthan 21 * a patient on chemotherapy who was diagnosed malignant tumor * a patient who is newly developed hiccup in the course of chemotherapy * a patient with the willingness to comply with the study protocol during the study period and capable of ccomplying with it * a patient who signed the imformed consent prior to the participation of the study and who understands that he/she has a right to withdrawal from participation in the study at any time without any disadvantages exclusion criteria: * a patient with history of uncontrolled seizures, central nervous system disorder or psychiatric disorders that are considered clinically significant by the investigator that would prohibit the understanding of informed consent or that may be considered to interfere with the compliance of the administration of the study medications * a patient with uncontrolled diabetes * a patient who developed uncontrolled serious infection or other uncontrolled serious concomitant diseases * a patient with disease progression after run-in period who is expected to receive another chomotherapeutic agents with different level of emetic risk
a drug interaction study with albiglutide and warfarin

Conditions: Diabetes Mellitus, Type 2

Summary: this open-label study evaluates the pharmacokinetics of warfarin when coadministered with albiglutide in healthy adult subjects. the primary objective is to assess the effect of albiglutide doses on the pharmacokinetics of warfarin.

this phase i open-label study evaluates the pharmacokinetics of warfarin when coadministered with albiglutide in healthy adult subjects. the primary objective is to assess the effect of albiglutide doses on the pharmacokinetics of warfarin.

Eligibility criteria:
inclusion criteria: * male healthy volunteers in good health * no clinically significant diseases or clinically significant abnormal laboratory values * body mass index (bmi) is \>/=18 kg and ≤30 kg/m2 * nonsmoker exclusion criteria: * positive test results for hepatitis b, hepatitis c or human immunodeficiency virus (hiv) * any clinically relevant abnormality * history of any anaphylactic reaction to any drug * history of significant cardiovascular or pulmonary dysfunction * history of excessive bleeding * current or chronic history of liver disease * history of alcohol or substance abuse * history of thyroid disease or dysfunction * history of gastrointestinal surgery or disease * history of pancreatitis * previously received any glp-1 mimetic compound (e.g., exenatide)

Keywords: pharmacokinetics albiglutide warfarin healthy volunteers
enlighten study: the ev-icd post approval registry

Conditions: Ventricular Arrhythmia; Tachycardia

Summary: medtronic is sponsoring enlighten: the ev-icd post approval registry, to further confirm safety and effectiveness of ev-icd in routine clinical practice, following commercial release of ev-icd devices.

the enlighten study is a global, prospective, observational, multi-site registry study. this study is conducted within medtronic's post-market surveillance platform. eligibility for enrollment is based on market release dates for ev-icd system within the geography in which the subject is enrolled. patients enrolled in the enlighten study will be prospectively followed for the life time of device post-implant or until registry closure, patient death or patient exit from the registry (i.e., withdrawal of consent). successfully implanted patients are expected to have scheduled follow-up visits per routine clinical care, at least annually, or as prompted by reportable adverse events. the total estimated registry duration is through lifetime of device.

Eligibility criteria:
inclusion criteria: * patient or legally authorized representative provides written authorization and/or consent per institution and geographical requirements * patient is intended to receive or be treated with a ev-icd device system and must be enrolled prior to the ev-icd device implant procedure exclusion criteria: * patient who is, or is expected to be, inaccessible for follow-up * patient is excluded by local local law * patient is currently enrolled or plans to enroll in any concurrent drug and/or device study that may confound the psr results
preventive analgesia in multiparas undergoing induction of labour

Conditions: Pain

Summary: our study is about providing a better birthing experience by placing and initiating epidural for labour pain before the contractions start. this concept of prevention of pain before its onset is known as preventive - or preemptive -pain management and is well known in surgical and anaesthetic practice. we believe that the use of preventive epidural analgesia will improve the quality of labour epidurals, increase maternal satisfaction and reduce the stress response to labour and delivery.

labour induces a well-documented stress response in both mother and fetus. pain, anxiety and stress associated with labour result in the activation of the sympathetic nervous system, which increases plasma catecholamine concentrations with a resultant increase in cardiac output, peripheral vascular resistance and eventually, reduction in utero-placental perfusion. one aspect that has not been addressed in the literature is the role of preventive analgesia in labour. we believe that the use of preventive epidural analgesia will improve the quality of labour pain, increase maternal satisfaction and reduce the stress response in labour. the multiparous parturients that are scheduled for elective inductions of labour will be offered preventive epidural analgesia. upon placing the epidural, patients will receive, in a double blind fashion, one of two possible epidural drug regimens, which are a saline placebo or 0.0625% bupivacaine with 2 micrograms of fentanyl per millilitre. the patient then undergoes routine induction and management of labour. at any point after induction of labour, patients in either group can request analgesia. upon request for analgesia the standard epidural loading dose and infusion with pcea is initiated. the primary outcome will be the success of analgesia (verbal analogue scale of 3 or less) during the first stage of labor, from first request of epidural analgesia to full dilatation.

Eligibility criteria:
inclusion criteria: * multiparous patients who had previous vaginal delivery, undergoing induction of labour * singleton pregnancy exclusion criteria: * morbid obesity * patients who have received cortisol, opioids or sedatives within the last 24 hours

Keywords: induction of labour bupivacaine consumption prevention
accuracy of lung injury biomarkers in the initial investigation of patients with suspected pneumonia

Conditions: Community-acquired Pneumonia

Summary: the aim of this study is to investigate the diagnostic and prognostic value of surfactant protein d, krebs von den lungen (kl-6), and chitinase-3-like protein 1 (ykl-40) in the initial investigation of patients hospitalized with suspected pneumonia. this to improve the diagnosis of pneumonia, contribute to a more rapid and accurate antibiotic treatment, and assess disease severity to predict short-term and long-term mortality in community-acquired pneumonia patients.

community-acquired pneumonia (cap) is one of the most common infection diseases in the emergency department (ed). diagnosis of pneumonia is challenging as symptoms are often weak and nonspecific and the current methods for focal and etiological diagnosis have low sensitivity and specificity and often deliver results after the antibiotic treatment decision has been made. the abundant and restricted expression of surfactant protein d (sp-d) within the lung makes this protein a specific marker for lung disease. krebs von den lungen-6 (kl-6) is expressed in the lung and is a diagnostic and prognostic marker of interstitial lung disease. the inflammatory glycoprotein chitinase-3-like protein 1 commonly known as ykl-40 is associated with severity of interstitial lung disease. the value of these lung injury markers for diagnosing pneumonia needs further investigation. the investigators hypothesize that surfactant protein d, krebs von den lungen (kl-6), and chitinase-3-like protein 1 (ykl-40) have an impact on diagnosing, prognosis, and treatment of patients with verified cap. the objectives of the study are: * to investigate the diagnostic accuracy of surfactant protein d, krebs von den lungen (kl-6), and chitinase-3-like protein 1 (ykl-40) in the diagnosis of cap * to identify the prognostic value surfactant protein d, krebs von den lungen (kl-6), and chitinase-3-like protein 1 (ykl-40) in relation to adverse events in patients with verified cap

Eligibility criteria:
inclusion criteria: * suspicion of apn assessed by the receiving physician at the ed exclusion criteria: * if the attending physician considers that participation will delay a life-saving treatment or patient needs direct transfer to the intensive care unit. * admission within the last 14 days * verified covid-19 disease within 14 days before admission * pregnant women * severe immunodeficiencies: primary immunodeficiencies and secondary immunodeficiencies (hiv positive cd4 \ 20 mg/day prednisone or equivalent for \>14 days within the last 30 days), chemotherapy within 30 days)

Keywords: surfactant protein d krebs von den lungen ykl-40 c pneumonia lung injury diagnostic markers prognostic markers emergency department
fludarabine, cyclophosphamide, and rituximab in treating patients with prolymphocytic leukemia

Conditions: Prolymphocytic Leukemia

Summary: rationale: drugs used in chemotherapy, such as fludarabine and cyclophosphamide, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. monoclonal antibodies, such as rituximab, can block cancer growth in different ways. some find cancer cells and kill them or carry cancer-killing substances to them. others interfere with the ability of cancer cells to grow and spread. giving fludarabine and cyclophosphamide together with rituximab may kill more cancer cells. purpose: this phase ii trial is studying how well giving fludarabine and cyclophosphamide together with rituximab works in treating patients with b-cell prolymphocytic leukemia.

objectives: * determine the overall and progression-free survival of patients with b-cell prolymphocytic leukemia treated with immunochemotherapy comprising fludarabine, cyclophosphamide, and rituximab. * determine the toxic effects of this regimen in these patients. outline: this is a non-randomized, open-label, multicenter study. patients receive fludarabine iv and cyclophosphamide iv on days 1-3. patients also receive rituximab iv on day 0 in course 1 and on day 1 in courses 2-6. treatment repeats every 28 days for up to 6 courses. projected accrual: a total of 21 patients will be accrued for this study.

Eligibility criteria:
disease characteristics: * diagnosis of b-cell prolymphocytic leukemia * previously treated disease * all binet stages allowed patient characteristics: * life expectancy \> 3 months * ecog/who performance status 0-3 prior concurrent therapy: * no more than 3 prior treatment regimens

Keywords: prolymphocytic leukemia
level of accelerometer-assessed preoperative physical activity and short term outcome after elective cardiac surgery

Conditions: Heart Diseases

Summary: short term morbidity after elective cardiac surgery remains significant. standard predictive models, considering simple patient demographics and clinical parameters, show limited efficiency in individual operative risk assessment. there is growing evidence about daily physical activity as a relevant indicator of preoperative "frailty". although cardiopulmonary exercise testing remains a gold standard, we are looking for more simple tools in order to identify patients with poor physical condition. accelerometry may be an objective and reproductible method to measure physical activity at patient's home.

the aim of this study is to compare accelerometer-assessed preoperative physical activity between two groups of patients with different postoperative length of stay following elective cardiac surgery. in the future, accelerometry could be used to identify patients that may benefit from prehabilitation programs including exercise therapy before elective cardiac surgery.

Eligibility criteria:
inclusion criteria: * adult subject (≥ 60 years) awaiting elective cardiac surgery * patients affiliated or entitled to a social security scheme * patients who have received information about the study and have given their oral consent to participate exclusion criteria: * pregnant woman, * major limitations in physical activity for orthopedic or musculoskeletal reasons * patients under judicial protection (curator or guardianship)

Keywords: post-operative evolution accelerometer cardiac surgery accelerometry preoperative physical activity