Kornimate/medical-research-clean huggingface dataset:
physical activity and fviii elimination: relevance to personalized therapy in severe hemophilia a

Conditions: Hemophilia A

Summary: in persons with severe haemophilia a infused factor viii half-life and other pharmacokinetic can vary according to determinants such as blood group, von willebrand factor (vwf) level or age. however, fviii pharmacokinetics (pk) has not been throughly studied in patients with severe ha as a function of daily physical activity. it si known that vigorous intensity physical activity/exercise can transiently but significantly increase circulating levels of endogenous vwf and consequently fviii in normal subjects and in patients with moderate or mild haemophilia a. the proposed study is a proof of concept one as it will be aimed at investigating the relation between daily physical activity, measured by sensewear armband device, as number of daily steps and pk variability of infused rec-fviii concentrate. this kind of investigation has never been done and it is a great interest also for the evaluation of patient's qualitiy of life.

in persons with severe haemophilia a infused factor viii half-life and other pharmacokinetic can vary according to determinants such as blood group, von willebrand factor (vwf) level or age. however, fviii pharmacokinetics (pk) has not been throughly studied in patients with severe ha as a function of daily physical activity. it si known that vigorous intensity physical activity/exercise can transiently but significantly increase circulating levels of endogenous vwf and consequently fviii in normal subjects and in patients with moderate or mild haemophilia a. the proposed study is a proof of concept one as it will be aimed at investigating the relation between daily physical activity, measured by sensewear armband device, as number of daily steps and pk variability of infused rec-fviii concentrate. this kind of investigation has never been done and it is a great interest also for the evaluation of patient's qualitiy of life. physical examinations at screening and subsequent study visits a physical examination will be performed on the following body systems being described as normal or abnormal: general appearance, headand neck, eyes and ears, nose and throat, heart, abdomen, extremities and joints, lymph nodes and neurological. at screening, if an abnormal condition is detected, the condition will be described on the medical history crf. at study visit, if a new abnormal or worsened abnormal pre-existing condition is detected, the condition will be described n the crf.

Eligibility criteria:
inclusion criteria: * patients 12-60 yo with severe ha under fviii concentrates prophylaxis will be selected at the haemostasis and thrombosis center of the fondazione policlinico gemelli irccs rome (fpg) exclusion criteria: * all patients with malignant tumors or * patietnts treated with anticoagulant / antiplatelet agents * patients suffering from other congenital coagulation disorders (von willebrand disease, other congenital deficiency of coagulation factors or severe thrombocytopenia (\< 30,000 plt/ul)
the recovery of cardiovascular patients with depression

Conditions: Coronary Artery Disease; Depression; Cardiovascular Diseases

Summary: cardiovascular disease increases the risk of depression and vice versa. many cardiovascular patients are subjected to percutaneous coronary intervention (pci). potential biomarkers for the development, the course and the recovery of both diseases are in the focus of interest of many studies. one of the biomarkers that stands out is brain derived neurotrophic factor (bdfn). bdnf plays a significant role in regulating vascular growth and repair but also stimulates the survival, differentiation, and conservation of neurons. the aim of the study is to detect the depression in patients undergoing pci and to determine the impact of psychiatric treatment on the functional recovery and on the changes of bdnf.

it has been shown that cardiovascular disease increases the risk of depression and vice versa. a significant proportion of cardiovascular diseases are coronary artery disease; most of these patients are subjected to percutaneous coronary intervention (pci). that population of patients, which is under greater risk of depression, has been passing through the health system without adequate management of psychiatric difficulties. despite the abundance of the data regarding the concomitancy of cardiovascular disease and depression, potential biomarkers for the development, the course and the recovery of both diseases are still in the focus of interest of many studies. one of the biomarkers that stands out is brain derived neurotrophic factor (bdfn). bdnf plays a significant role in regulating vascular growth and repair but also stimulates the survival, differentiation, and conservation of neurons. its' serum level is reduced in cardiac failure and acute coronary syndrome, and indicates a higher risk of coronary incident in angina pectoris. bdnf is also reduced in depression, but increases during a pharmacological treatment along with the clinical improvement. therefore the aim of the study is to detect the occurrence of depression in patients undergoing pci and to determine the impact of psychiatric treatment on the functional recovery of those patient and the correlation with the changes of serum levels of bdnf. this represents the objectivization of the tertiary type of prevention intervention for recovery of cardiovascular patients who are currently passing through the investigator's health system with unrecognized psychiatric comorbidity.

Eligibility criteria:
inclusion criteria: * patients on day of percutaneous coronary intervention due to angina pectoris or myocardial infarction * without antidepressant drugs or major tranquilizers more than one year exclusion criteria: * symptoms of myocardial infarction lasting more than 12 hours * left ventricle ejection function (lvef) less than 40% * earlier presence of cardiomyopathy * acute infection

Keywords: brain derived neurotrophic factor bdnf psychosocial indicators depression cardiovascular disease
superselective intra-arterial chemotherapy treatment for retinoblastoma- 5 year results from turkey

Conditions: Retinoblastoma

Summary: retrospective review of 5-year long term outcomes of superselective intra-arterial chemotherapy treatment in retinoblastoma in a single institute. the treatment outcomes, globe salvage rates and complications of superselective intra-arterial chemotherapy both for treating naive patients (primary treatment group) and for patients who received systemic chemotherapy previously (secondary treatment group) were evaluated.


Eligibility criteria:
inclusion criteria: * patients diagnosed with unilateral/bilateral retinoblastoma exclusion criteria: * patients with trilateral retinoblastoma * extraoculer involvement * patients with blood dyscrasias, bleeding and clotting disorders

Keywords: enucleation globe salvage superselective intra-arterial chemotherapy
outcome of combined tramadol and paracetamol versus pentazocine as labour analgesia among parturients

Conditions: Labor Pain

Summary: labour is a very painful experience and epidural analgesia is considered the gold standard for pain relief in labour. epidural scarcity, cost and shortage of skilled personnel to administer it is a limitation to it's usage in developing countries. parenteral opioid analgesics such as pethidine and pentazocine are effective labour analgesia commonly used in developing countries but are limited by their side effects. this limitation in their use call for the need for alternative analgesic with similar or superior analgesic effect but with minimal side effects.the study is aimed at evaluating the efficacy and safety of combined tramadol and paracetamol in reducing labour pain among parturients.

there is paucity of data in our environment looking at the efficacy and safety of combined tramadol and paracetamol in relieving labour pain. this study will offer us great opportunity to evaluate their synergistic effect in labour when compared to the commonly used single opioids such as pethidine or pentazocine. it would be a double blinded randomized controlled trial. one hundred and sixty-six pregnant eligible women in labour would participate in this study. participants will be randomized equally into two study arms ( tramadol plus paracetamol study arm and pentazocine study arm) after informed consent. the tramadol plus paracetamol study arm will receive 100mg of tramadol plus 600mg of paracetamol intramuscularly in a 2ml and 5ml syringe respectively while the pentazocine study arm will receive 30mg of pentazocine and 2 milliliters of water for injection as placebo intramuscularly in a 2l and 5 ml syringes respectively. both drugs will be administered to the participants at 4-6cm cervical dilatation during labour. the outcome measures will be evaluated within 5 hours in labour and an hour immediately after delivery. the need for additional rescue analgesia will be assessed as well. fetal outcome on both arms will be noted too.

Eligibility criteria:
inclusion criteria: * all pregnant women who presented in spontaneous labour at term, carrying singleton live fetus in active phase of labour with cervical dilatation of 4-6cm who gave consent to participate in the study exclusion criteria: * women with severe medical conditions such as diabetes mellitus, severe pre-eclampsia, cardiac, liver and renal disease * preterm labour * intrauterine fetal death * fetal presentation other than cephalic * patients with previous caeserean section * history of hypersensitivity to paracetamol, tramadol and pentazocine * complications such as antepartum haemarrhage, polyhydramnious, premature rupture of membrane * use of any kind of analgesia before recruitment * multiple gestation * all other delivery except spontaneous vertex delivery labour that was induced or augmented

Keywords: tramadol paracetamol pentazocine labour analgesia efficacy safety
vitamin e for oxaliplatin-induced peripheral neuropathy prophylaxis

Conditions: Peripheral Neuropathy

Summary: introduction: oxaliplatin (ox) is a frequently used platinum-based medication that is a part of many chemotherapy regimens for the treatment of several gastrointestinal malignancies. one of the most important limitations to its use is the induction of both acute and chronic peripheral neuropathy (pn). previous studies have shown that vitamin e can reduce the incidence of cisplatin-induced pn by 50%. in this study, the investigators aimed to determine if vitamin e could also prevent ox-induced acute pn

this was a prospective, phase ii, randomized pilot study. patients were randomized 5 days before the start of ox to receive either vitamin e at 400 mg daily or placebo, until after the end of the ox-based chemotherapy regimen. the investigators evaluated pn intensity using the ctcae version 3 and specific ox pn gradation scales. the investigators included patients with colorectal and gastric cancers scheduled to receive ox-based chemotherapy. both groups received calcium and magnesium supplements before and after oxaliplatin infusions.

Eligibility criteria:
inclusion criteria: * ecog performance status 0 or 1 * older than 18 years * new diagnose with colorectal or gastric cancer * scheduled to receive oxaliplatin-based regimens exclusion criteria: * excluded patients with a previous history of pn or with symptomatic pn at entry into the study * excluded patients who received other chemotherapy regimens (except isolated 5-fluorouracil) * patients currently receiving gabapentin, carbamazepine, amitriptyline, amifostine or multivitamins

Keywords: oxaliplatin vitamin e neuropathy peripheral prophylaxis
post-marketing surveillance study of eribulin on the status and factors for the development of peripheral neuropathy in japan.

Conditions: Breast Cancer; HER2-negative Breast Cancer

Summary: the primary objective of the study is to clarify factors affecting the incidence of peripheral neuropathy in patients treated with halaven. a total of 590 patients will be enrolled in this study with 295 patients in the treatment group of primary or secondary chemotherapy and 295 patients in the treatment group of tertiary or later chemotherapy.


Eligibility criteria:
inclusion criteria: patients with her2-negative inoperable or recurrent breast cancer. exclusion criteria: patients with high-grade bone marrow depression (absolute neutrophil count less than 1,000 /mm\^3, absolute platelet count less than 75,000 /mm\^3). patients with a history of hypersensitivity to the ingredients of halaven. women who are pregnant or may be pregnant. patients with a history of use of halaven.

Keywords: her2-negative inoperable or recurrent breast cancer japan eribulin mesylate
a study of saquinavir soft gelatin capsules combined with other anti-hiv drugs in hiv-1 infected patients

Conditions: HIV Infections

Summary: to examine the efficacy of saquinavir sgc (soft gel capsules) in combination with other antiretrovirals in hiv-1 infected patients currently treated with saquinavir hgc (hard gel capsules) measured by the absolute change in plasma hiv-1 rna during the 24 weeks of study treatment.

eligible patients will be stratified by hiv-1 rna level into 2 populations: 1) \>= 5,000-30,000 hiv-1 rna, 2) \> 30,000 hiv-1 rna. all patients will be randomized to 1 of 3 treatment arms: arm a - saquinavir soft gel capsules (sqv sgc) + 2 new nucleoside analogs (reverse transcriptase inhibitors \[rtis\]), arm b - sqv sgc + nelfinavir + stavudine (d4t) or a new rti, or arm c - sqv sgc + ritonavir + d4t or a new rti. all patients will undergo plasma hiv-1 rna determinations, cd4 lymphocyte counts, hematology and chemistry blood work at baseline, weeks 4, 8, 12, 16 and 24.

Eligibility criteria:
inclusion criteria patients must have: * documented hiv infection. * cd4 \> 100 cells/mm3. * saquinavir hgc-experienced patients (\>= 3 months cumulative therapy). required: \>= 3 months cumulative saquinavir hgc therapy.

Keywords: hiv-1 drug therapy, combination acquired immunodeficiency syndrome hiv protease inhibitors rna, viral saquinavir anti-hiv agents viral load
avelumab in first-line nsclc (javelin lung 100)

Conditions: First Line Non-Small Cell Lung Cancer

Summary: the purpose of this study was to demonstrate superiority with regard to overall survival (os) or progression free survival (pfs) of avelumab versus platinum-based doublet, based on an independent review committee assessment, in non-small cell lung cancer (nsclc) participants with programmed death ligand 1+ (pd-l1+) tumors.


Eligibility criteria:
inclusion criteria: * male or female subjects aged greater than or equal to (\>=) 18 years * with eastern cooperative oncology group performance status (ecog ps) of 0 to 1 at trial entry * at least 1 measurable tumor lesion * with histologically confirmed metastatic or recurrent (stage iv) non-small cell lung cancer (nsclc) * with availability of a recently-obtained, formalin-fixed, paraffin-embedded (ffpe) tissue sample containing tumor (biopsy from a non-irradiated area preferably within 6 months) or a minimum number of 10 (preferably 25) unstained tumor slides cut within 1 week, and suitable for pd-l1 expression assessment * subjects must not have received any treatment for systemic lung cancer, and have an estimated life expectancy of more than 12 weeks * other protocol defined criteria could apply exclusion criteria: * subjects whose disease harbors a egfr mutation, or anaplastic lymphoma kinase (alk) rearrangement are not eligible. * other exclusion criteria include prior therapy with any antibody or drug targeting t cell coregulatory proteins, concurrent anticancer treatment, or immunosuppressive agents * known severe hypersensitivity reactions to monoclonal antibodies (grade \>= 3 nci ctcae v 4.03), history of anaphylaxis, or uncontrolled asthma (that is, 3 or more features of partially controlled asthma), and persisting toxicity related to prior therapy of grade \> 1 nci-ctcae v 4.03. * subjects with brain metastases are excluded, except those meeting the following criteria: brain metastases that have been treated locally and are clinically stable for at least 2 weeks prior to randomization, subjects must be either off steroids or on a stable or decreasing dose of \<= 10 mg daily prednisone (or equivalent), and do not have ongoing neurological symptoms that are related to the brain localization of the disease. * other protocol defined criteria could apply

Keywords: avelumab msb0010718c non-small cell lung cancer
chlorhexidine & pneumonia in nursing home residents

Conditions: Pneumonia; Respiratory Infection

Summary: the purpose of this study is determine if topical oral application of a chlorhexidine antimicrobial spray will significantly reduce pneumonia and respiratory infections, and improve oral health compared to a placebo solution in nursing home residents.


Eligibility criteria:
inclusion criteria: 1. participants must be at least 65 years old. 2. be dependent in 2 or more activities of daily living as noted on the nursing home resident's minimum data set - one must be adl j- personal hygiene. 3. have natural teeth and/or wear complete or partial dentures. 4. expected to be a resident in a nursing home for two years. exclusion criteria: 1. existing pneumonia. 2. history of chlorhexidine reaction or allergy and/or multiple medication or substance allergies. 3. receiving chlorhexidine oral application at enrollment as prescribed by physician or dentist.

Keywords: pneumonia elderly chlorhexidine respiratory pathogens
the study of different cycles of high-dose dexamethasone in the treatment of itp

Conditions: Thrombocytopenia

Summary: primary immune thrombocytopenia is an autoimmune disorder characterised by decreased platelet counts and increased bleeding risk. corticosteroids have been the standard initial treatment of primary immune thrombocytopenia for more than 30 years. the aim of this randomized controlled trial is to compare the efficacy and safety of high-dose dexamethasone in treating new-diagnosed primary immune thrombocytopenia (itp) in di-cycle and tri-cycle.

in this multicentre, open-label, randomized controlled trial, about 118 new-diagnosed itp patients will be enrolled from five tertiary medical centres in china. eligible participants are randomly assigned (1:1) to 2 groups: group dex2 and group dex3. in group dex2, dexamethasone was administered orally at 40 mg per day for two cycles (days1-4, and days 11-14). in group dex3, dexamethasone was administered orally at 40 mg per day for three cycles (days1-4, days 11-14, and days 21-24). the clinical effect, onset time, duration of efficacy and adverse reactions were observed to compare the efficacy and safety of two different plans.

Eligibility criteria:
inclusion criteria: * participant must be at least 18 years of age at the time of the screening. * participant may be male or female. * participant has a confirmed diagnosis of newly diagnosed itp according to the 2019 international working group assessment at screening, and has a baseline platelet count of less than 30 × 10\^9 cells per l or had bleeding manifestations, or both. exclusion criteria: * participant has evidence of a secondary cause of immune thrombocytopenia (e.g. leukemia, lymphoma, common variable immune- deficiency, systemic lupus erythematosus, autoimmune thyroid disease, past medical history of untreated h. pylori infection) or to drug treatments (e.g. heparin, quinine, antimicrobials, anticonvulsants) or participant has a multiple immune cytopenia, e.g. evan's syndrome. * participant has clinically life-threatening bleeding (e.g. central nervous system bleeding, menorrhagia with significant drop in hemoglobin). * participant has a history of coagulopathy disorders other than itp. * participant has a history of arterial or venous thromboembolism (e.g. stroke, transient ischemic attach, myocardial infarction, deep vein thrombosis or pulmonary embolism) within the 6 months prior to randomization or requires anticoagulant treatment. * participant has 12-lead ecg with changes considered to be clinically significant upon medical review at baseline. * participant has severe renal impairment (glomerular filtration rate less than 45ml/min/1.73 m2). * participant has 3 × upper limit of normal of any of the following: alanine aminotransferase, aspartate aminotransferase, or alkaline phosphatase. * participant with any of the following conditions: severe immunodeficiency, active or previous malignancy, human immunodeficiency virus (hiv), hepatitis b or c virus infection, pregnancy or lactation.

Keywords: itp dexamethasone
pulmonary and systemic hepatocyte growth factors in patients with copd

Conditions: Chronic Obstructive Pulmonary Disease

Summary: the role of hgf and kgf in copd is poorly known. plantier et al found that cultured fibroblasts harvested from patients with emphysema produced less hgf (but similar amounts of kgf) than controls, and bonay et al found a direct relationship between the severity of airflow obstruction and hgf mrna content in lung samples of smokers. these two studies suggest, therefore, that the pulmonary regulation of hgf may be abnormal in patients with copd. however, both hgf and kgf can also be released by extra-pulmonary organs, thus having the potential to act systemically. given the current clinical relevance attributed to the systemic effects of copd, in this study we compared the levels of hgf and kgf in the pulmonary (bronchoalveolar lavage (bal) fluid) and systemic compartment (circulating blood) of smokers with and without copd and never smokers.

background: the potential role of growth factors in copd has begun to be addressed only recently and is still poorly understood. in this study we investigate potential abnormalities of hepatocyte growth factor (hgf) and keratinocyte growth factor (kgf) in patients with copd. methods: to this end, we compared the levels of hgf and kgf, measured by elisa, in bronchoalveolar lavage (bal) fluid and in serum in 18 patients with copd (62 ± 2 yrs, fev1 57 ± 4% ref, x ± sem), 18 smokers with normal lung function (58 ± 2 yrs., fev1 90 ± 4% ref) and 8 never smokers (67 ± 7 yrs, 94 ± 4% ref). results: we found that, in bal, hgf levels were higher in patients with copd than in the other two groups whereas, in serum, hgf concentration was highest in smokers with normal lung function (p\<0.01). kgf levels were not significantly different between groups, neither in blood nor in bal, (most values were below the detection limit). conclusions: these results highlight a different response of hgf in bal and serum in smokers with and without copd that may be relevant for tissue repair in copd.

Eligibility criteria:
inclusion criteria: * patients with copd (gold ii-iii) 1, smokers without chronic bronchitis or dyspnea and with normal lung function, and never smokers who required bronchoscopy for clinical purposes. exclusion criteria: * acute exacerbation last three months * chronic lung diseases (asthma, bronchiectasis and interstitial lung diseases) and cardiac, hepatic or renal failure. * systemic steroid treatment

Keywords: chronic obstructive pulmonary disease emphysema inflammation repair