Kornimate/medical-research-clean huggingface dataset:
oral care interventions and ventilator associated pneumonia in critically ill children

Conditions: Ventilator Associated Pneumonia

Summary: this experimental study aims to verify the influence of the oral hygiene performance with chlorhexidine digluconate 0.12% in the development of vap in children. the data collection begun in april, 2005 during the performance of the masters degree course dissertation entitled "clinical study about the effect of the oral hygiene with chlorhexidine digluconate 0.12% in the oropharynx colonization of children in intensive care", being performed in a picu of nine beds in a university hospital in the city of são paulo, after approval of the research ethics committee of the institution. the study is composed by three types of variables: independent variable, dependent variables, and complementary variables. the categorical variables will be analyzed in accordance with the person's chi-square test of or fisher's exact test. the numerics will be submitted to the analysis of variance anova or kruskall wallis. for variables with heterogeneous distribution between the groups, the multivariate analysis will be applied to the evaluation of the influence in the determination of the development risk of the dependent variable. the rejection level will be fixed in 0.05 of the nullity hypothesis.

recent progress in identification of oral microorganisms has shown that the oropharynx can be a site of origin for dissemination of pathogenic organisms to distant body sites, such as the lungs. the aims of the study were to compare the oropharyngeal microbiological profile, vap incidence, duration of mechanical ventilation, and length of stay in the intensive care unit of children receiving mechanical ventilation who had pharmacological or nonpharmacological oral care. a randomized and controlled study has been performed in a pediatric intensive unit in são paulo, brazil. the children are randomly assigned to an experimental group that received oral care with use of 0.12% chlorhexidine digluconate or a control group that received oral care without an antiseptic. oropharyngeal and tracheal secretions were collected and cultured on days 0, 2, and 4, and at discharge.

Eligibility criteria:
inclusion criteria: * critically ill children. * age: 29 days to 18 years. exclusion criteria: * newborn age. * pneumonia at picu admission. * tracheostomy. * tracheal intubation higher than 24 hours in the picu admission. * picu los lower than 48 hours. * responsibles declined consent.

Keywords: oral care. chlorhexidine. pediatric nursing intensive care nosocomial infection pneumonia oropharyngeal colonization tracheal colonization
iressa 2nd line phase iii study in japan

Conditions: Non-Small Cell Lung Cancer

Summary: in this study, among the patients with non-small cell lung cancer, those with metastasis or recurrence and previous treatment with chemotherapy will receive gefitinib or docetaxel, and we will compare the effectiveness and safety of gefitinib with docetaxel.


Eligibility criteria:
inclusion criteria: * you are "histologically" or "cytologically" confirmed to have recurrent or metastatic nsclc * you have been treated with chemotherapy including platinums for nsclc. exclusion criteria: * you have received treatment for non-small lung cancer within 4 weeks before your participation in this study (except for specific therapies) * you have or had any disease of acute lung injury, idiopathic pulmonary fibrosis, pulmonary pneumonia, or pneumoconiosis evident on the x-ray * you have or had any disease of radiation pneumonia or drug-induced pneumonia, which requires treatment with corticosteroids
a phase 1 study to estimate the relative bioavailability of fixed combination tablets of azithromycin and chloroquine compared to co-administered individual tablets of azithromycin and chloroquine

Conditions: Malaria

Summary: the primary objective is to estimate the relative bioavailability of fixed azithromycin / chloroquine combination tablets relative to co-administered individual tablets of azithromycin and chloroquine.


Eligibility criteria:
inclusion criteria: * healthy male and/or female subjects between the ages of 18 and 55 years, inclusive (healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ecg and clinical laboratory tests). * body mass index (bmi) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lbs). exclusion criteria: * evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing). * history of febrile illness within 5 days prior to first dose. * any condition possibly affecting drug absorption (eg, gastrectomy). * a positive urine drug screen.

Keywords: bioavailability
a pilot evaluation of adhesives and how they are impacted by out-put

Conditions: Ileostomy

Summary: the study investigates the impact real output (subjects own) and simulated output have on the adhesion of adhesives.


Eligibility criteria:
inclusion criteria: 1. have given written informed consent 2. be at least 18 years of age and have full legal capacity 3. have had an ileostomy for more than one year 4. have intact skin on the area used in the evaluation 5. has an ileostomy with a diameter up to (≤) 35 mm 6. have a peristomal area accessible for application of patches/adhesive strips (assessed by investigating scientist) exclusion criteria: 1. currently receiving or have within the past 2 month received radio- and/or chemotherapy 2. currently receiving or have within the past month received topical steroid treatment in the peristomal skin area or systemic steroid (tablet/injection) treatment. 3. are pregnant or breastfeeding 4. having dermatological problems in the peristomal- or abdominal area (assessed by investigating scientist) 5. participating in other interventional clinical investigations or have previously participated in this evaluation
impact of mindfulness breathing versus storytelling on non- specific insomnia in elderly

Conditions: Insomnia; Sleep Disorder

Summary: this study will be conducted to compare between effects of mindfulness breathing and storytelling on insomnia in the elderly.

sufficient sleep is essential for optimum health just a few of the numerous processes occurring during sleep include memory consolidation, clearance of brain metabolites, and restoration of nervous, immune, skeletal, and muscular systems. despite the significance of adequate sleep, insufficient or disturbed sleep is extremely common. for instance, thirty percent of employed adults report obtaining 6 or fewer hours of sleep per night, approximately one-third of all adults report significant sleep complaints, and the two most common sleep disorders, insomnia and sleep-disordered breathing (sdb), each have prevalence rates exceeding 10% in the adult population. unfortunately, current approaches to treatment are limited . story telling is another common soothing bedtime routine for children that uses pictures and writing. it is also a nursing intervention that can be implemented to comfort hospitalized children with acute illness and increase enthusiasm. story telling is a recommended activity that enhances sleep duration in children. furthermore, it is considered a positive bedtime routine, in addition to praying and brushing teeth, compared to maladaptive bedtime routine, such as watching television, playing with gadgets, and playing games with high-level activities .

Eligibility criteria:
inclusion criteria: * patients who have non-specific insomnia for one month at least. * their ages \> 65 years. * medically stable patients. * current complaint of poor sq (score \> 5 of the sq scale) * body mass index ≤ 35 kg/m2. exclusion criteria: * patients having a well-structured diagnosis of relevant brain illness or * any disease directly affects sleep. * any patient with unstable medical condition * history of chronic insomnia * indication of receiving treatments for depression and anxiety * hearing problem
hypoallergenicity evaluation of a new extensively hydrolyzed formula

Conditions: Cow Milk Allergy

Summary: infants/children with cow's milk allergy will take part in 2 double-blinded placebo-controlled food challenges (dbpcfc) of 2 extensively hydrolyzed formulas in random order. if both food challenges are passed, subjects will be asked to consume the test formula in an at-home open challenge for 7 days.


Eligibility criteria:
inclusion criteria: * born at term (\>36 weeks gestation) * 2 months to \<4 years of age at enrollment * documented cma within 6 months prior to enrollment * otherwise healthy * having obtained his/her legal representative's informed consent exclusion criteria: * children consuming mother's milk at the time of inclusion and during the trial * any chromosomal or major congenital anomalies * chronic medical diseases (ie seizure disorders, chronic lung disease, heart problems (heart murmurs okay)) * immunodeficiency * anaphylaxis to any food * receiving free amino acid formula * subject who in the investigator's assessment cannot be expected to adhere to the study protocol * currently participating in another clinical trial
anti-angiogenesis therapy using thalidomide in patients with waldenstrom's macroglobulinemia

Conditions: Waldenstrom Macroglobulinemia

Summary: the purpose of this research is to study how helpful thalidomide is in controlling the disease and to study any side effects from taking thalidomide.

patients will receive thalidomide in the oral form each night before bed. the dose of thalidomide will be increased each week until week 7 as long as there are no significant side effects. routine physical examinations and blood tests will be done to monitor the effect of treatment and the toxicities encountered, if any, and provide the available treatments for side effects accordingly. blood tests will be done to monitor the tumor response.

Eligibility criteria:
inclusion criteria: * patients must have a confirmed diagnosis of previously treated, active waldenstrom's macroglobulinemia * patients must have adequate hematologic function as demonstrated by total white blood count \> or = 2000/mm3, adequate renal function as demonstrated by serum creatinine \< or = 3.0 mg/dl, and adequate hepatic function as demonstrated by bilirubin \< or = 1.5 mg/dl and transaminases \< or = 4 x uln * all patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines exclusion criteria: * no other concurrent therapy for wm is permitted while on thalidomide * pregnant or nursing women may not participate. before starting treatment, women of childbearing potential should have a negative pregnancy test performed within 24 hours prior to beginning therapy. written report of a negative pregnancy test must be obtained before a prescription for thalidomide is issued. women/men of reproductive potential may not participate unless they have agreed to use an effective contraceptive method. pregnancy testing is not required for 1) women who have been post-menopausal for at least 2 years with no menses, 2) women who have had a hysterectomy.

Keywords: macroglobulinemia waldenstrom thalidomide
adherence to pharmacological antiepileptic treatment in adolescence

Conditions: Epilepsy; Treatment Adherence

Summary: epilepsy and its drug treatment affect fundamental aspects of an adolescent's lifestyle and can have major consequences on self-esteem and sense of identity. for many adolescents it is difficult to live with epilepsy and medication is difficult to accept; the side effects of medication, in particular even small changes in mental status and somatic appearance, are particularly feared and poorly tolerated. while it is true that drug-resistant epilepsies exist (about 30% of cases), it is also true that there exists a pseudo-resistance to drug treatment which is due to inadequate administration or poor adherence to treatment. it is estimated that 21 to 42% of patients on antiepileptic treatment don't adhere to the prescribed therapy. the literature emphasizes that non-adherence to treatment is a crucial problem for people with epilepsy, and that the adolescent population is particularly at risk. as with any chronic drug therapy, the therapeutic relationship plays an important role in the treatment of epilepsy. in adolescence, the communication that occurs within the therapeutic relationship takes on peculiar and specific aspects that go beyond the acquisition of anamnestic data and of what is usually reported explicitly in the interview. communication must be centered on the adolescent's need for independence. appropriate communication can make the adolescent feel more supported and can encourage him or her to gain self-awareness and control on decisions regarding his or her illness. for the physician, knowledge of the adolescent's point of view is indispensable in order to provide all the necessary information in an appropriate, understandable, and acceptable way, while at the same time acting as a mediator of communication. the objective of this project is to describe and analyze adolescents' perception of antiepileptic treatment, their awareness of the disease and of the need for drug treatment.


Eligibility criteria:
inclusion criteria: * diagnosis of epilepsy * age between 12 and 18 years * on treatment with antiepileptic drugs for at least one year * able to understand and complete the questionnaire exclusion criteria: * subjects with moderate to severe intellectual disability

Keywords: adolescence antiepileptic therapy treatment adherence perception
fifth metatarsal orthopedic outcome trial

Conditions: Metatarsal Fracture

Summary: fractures of the shaft, distal to zone three, of the fifth metatarsal often occur after foot distortion. there is very little evidence available regarding the optimal treatment. currently the most common treatment is prolonged cast immobilization. operative treatment has been reported as an alternative and could promote early recovery. no comparative study has been published regarding optimal treatment

objective: the main objective is to determine experienced pain, as measured by nrs-11 score, 3 months after intervention and compare this between the intervention and control group. secondary objectives are functional outcome as measured by aofas lesser toe scale, faam score, progress of nrs-11 score through time and promis mobility/pain interference. furthermore, quality and duration of fracture healing will be compared between groups. the impact on daily life will be compared as measured by duration of return to work and normal footwear. study design: randomised controlled clinical intervention trial study population: humans with an acute shaft fracture of the fifth metatarsal bone, 18 years or older.

Eligibility criteria:
inclusion criteria: * 18 years or older at the time of study entry * informed consent * competent to participate in follow up and fill out questionnaires * dislocated (1mm or more on plain radiography) fracture of the shaft, distal from zone 3, of the fifth metatarsal according to the orthopedic trauma association (ota) classification 87.5.3 a-c exclusion criteria: * open fracture * proximal fifth metatarsal fracture, jones fracture * clinically significant or symptomatic vascular or neurologic pathology on the ipsilateral leg * former surgery or history of development disorder of the contralateral fifth metatarsal * multiple fractured metatarsals in the affected foot * medical history of rheumatoid arthritis * unable to undergo surgical procedure
the effects of exercise program in alzheimer's patients with mild to moderate stage alzheimer's disease

Conditions: Alzheimer Disease; Aerobic Exercise; Breathing Exercise; Resistance Training

Summary: the primary aim of this trial is to investigate the feasibility of an exercise program consisting of respiratory exercises, aerobic exercises and strengthening exercises in mild to moderate alzheimer's disease. the trial also aims to investigate the effectiveness of the exercise program on respiratory symptoms, exercise capacity, cognition, physical performance, depression, sleepiness, activities of daily living and quality of life. patients will be divided into exercise (intervention) and control group by randomization method. the study is planned to be performed with a total of 60 patients, 30 in each group. the patients in the exercise group will be given breathing exercises aerobic exercises and strengthening exercises for 2 days a week for 12 weeks, about 30-40 minutes while the patients in the control group will be provided with suggestions, home exercise program and daily life activities

exercise group was trained 3 times a week under the supervision of a physiotherapist and encouraged to exercise at home on other days

Eligibility criteria:
inclusion criteria: * aged over 65 years * can walk independent exclusion criteria: * can't see * have done any exercise in the last 6 months * have a major and uncontrolled orthopedic, neurological or cardiopulmonary problem that restricts functioning * having non alzheimer's disease dementia
docetaxel plus cisplatin followed by gemcitabine versus gemcitabine plus cisplatin followed by docetaxel for non-small cell lung cancer (nsclc)

Conditions: Non-small Cell Lung Cancer

Summary: the purpose of this study is to evaluate the 1-year treatment failure rate of two sequential chemotherapy regimens: weekly docetaxel plus cisplatin followed by gemcitabine; and gemcitabine plus cisplatin followed by weekly docetaxel。

lung cancer is the leading cause of cancer death in men and women worldwide. shifting trends in the incidence of lung cancer closely follow the patterns of cigarette smoking, although other carcinogens have been implicated. despite intensive treatment over the past several decades, the 5-year lung-cancer survival rate remains a dismal 8-14%. chemotherapy is the primary therapy to patients with stage iiib/iv disease, and most investigators believe that treatment with a combination of two agents is the best first-line treatment for stage iv nsclc. in the late 1970s and 1980s, studies were conducted using combinations of agents. outcomes were improved and these agents were eventually incorporated into clinical practice. weekly docetaxel is being studied in combination with other commonly used nsclc chemotherapeutic agents including carboplatin, navelbine, and gemcitabine. these combinations are being studied in both first- and second-line settings. second line chemotherapy with docetaxel may affect survival (tax 318, 1 year survival 37% vs. 11%). however, the optimal sequence of chemotherapy was rarely explored. weekly docetaxel may offer better tolerability vs. 3-weekly schedule when combining docetaxel to cisplatin. based upon these studied, we choose weekly docetaxel in combination with cisplatin as our regimen. we expected the regimen would be effective and well tolerated.

Eligibility criteria:
inclusion criteria: * histologic or cytologic diagnosis of stage iiib/iv nsclc, no prior chemotherapy * age \> 18 years and \< 75 years * who ps: 0,1 * unidimensional or bi-dimensional measurable disease * neutrophils \> 1.5 109/l, platelets \> 100 109/l, hemoglobin \> 10g/dl, total bilirubin \< 1.5 unl, ast (sgot) and alt (sgpt) \< 2.5 unl, alkaline phosphatases \< 5 unl; except in presence of only bone metastasis and in the absence of any liver disorders * creatinine \ 60 ml/min. * life expectancy \> 12 weeks exclusion criteria: * pregnant, or lactating patients * known clinical brain or leptomeningeal involvement * pre-existing motor or sensory neurotoxicity of a severity \> grade 1 by ncic-ctg criteria * chf, angina or arrhythmias * history of significant neurological or psychiatric disorders * active uncontrolled infection * contraindication for the use of corticosteroids * concurrent treatment with other experimental drugs within 30 days prior to study entry * concurrent treatment with any other anti-cancer therapy

Keywords: combination, chemotherapy,non-small cell lung cancer
role of midodrine and tolvaptan in patients with cirrhosis with refractory or recurrent ascites

Conditions: Cirrhosis; Refractory/Recurrent Ascites

Summary: the development of ascites in the natural history of cirrhosis heralds a worsening of the prognosis to 50% survival at 2 years, and this deteriorates to 30-50% at 1 year when the ascites becomes refractory to medical therapy. hemodynamic alterations and their relation to neurohumoral systems are essential in pathophysiology of ascites formation. the theory that best explain the ascites formation and sodium retention in cirrhotics is portal hypertension leading to splanchnic arterial vasodilatation leading to underfilling of arterial circulation which is sensed by the arterial and the cardiopulmonary receptors leading to sympathetic nervous system activation and activation of the anti-natriuretic factors (raas and arginine vasopressin), resulting in sodium and water retention. the therapeutic options available for patients with refractory ascites are serial therapeutic paracentesis, liver transplantation and transjugular intrahepatic portosystemic shunts.vasopressin v2 receptor antagonists antagonize the antidiuretic effects of vasopressin at the v2 receptor located in the renal collecting duct, they increase free water clearance, and thus may be helpful in mobilizing excess water in conditions associated with water retention including cirrhosis. the use of v2 receptor antagonists in cirrhosis with ascites has been shown to be safe and efficacious. midodrine, an alpha adreno receptor agonist by causing splanchnic vasoconstriction has been used in hepatorenal syndrome (hrs) and for control of ascites in patients with refractory or recurrent ascites. it is possible that vasoconstrictors and aquaretics (v2 receptor antagonists) by acting at different sites in combination may reverse some of the pathogenic events that results in refractory or recurrent ascites.there are no reports on the use of combination of midodrine and tolvaptan in the patients with cirrhosis with ascites. therefore, we plan to study the role of midodrine, tolvaptan and their combination on systemic hemodynamics, renal functions and control of ascites in patients with cirrhosis and refractory or recurrent ascites.


Eligibility criteria:
inclusion criteria:60 consecutive patients with cirrhosis and refractory or recurrent ascites with stable renal function ( creatinine level \<1.5mg/dl for at least 7 days ). exclusion criteria: * presence of gastrointestinal bleeding, hrs, hepatic encephalopathy of grade 2 or higher or infection within 1 month preceding the study or during the study, presence of diabetes, intrinsic renal or cardiovascular disease or arterial hypertension on history and physical examination, abnormal urine analysis, chest radiograph or electrocardiogram, presence of hepatocellular carcinoma or portal vein thrombosis or treatment with drugs with known effects on systemic and renal hemodynamics within 7 days of inclusion .