Kornimate/medical-research-clean huggingface dataset:
microbiological examination of children operated for congenital lacrimal stenosis

Conditions: Congenital Lacrimal Stenosis

Summary: children with congenital lacrimal stenosis are treated by probing and intubation of the lacrimal drainage system. hypothesis: microbiological findings at the time of insertion and removal of the silicon intubation have an influence on the clinical outcome and success rate of the surgical treatment. microbiological specimens are taken from conjunctiva and nasal mucosa during the two procedures under general anaesthesia and from the silicon tube after removal and examined for bacterial contamination.

children (age 0-14 years) with congenital lacrimal stenosis in whom probing and intubation of the lacrimal drainage system is indicated are included the study after informed written consent by their parents. microbiological specimens are taken bilaterally from conjunctiva and nasal mucosa during the two procedures under general anaesthesia (insertion and removal of the silicon intubation) and from the silicon tube after removal. specimens are examined for bacterial contamination. microbiological findings are correlated with clinical data about the further clinical course and especially the success of the surgical treatment.

Eligibility criteria:
inclusion criteria: age 0-14 years, congenital lacrimal stenosis, informed consent by the parents - exclusion criteria: none -

Keywords: congenital lacrimal stenosis bacteria microbiological
dose escalation study of mln0128 in relapsed or refractory multiple myeloma or waldenstrom macroglobulinemia

Conditions: Relapsed Multiple Myeloma; Refractory Multiple Myeloma; Waldenstrom Macroglobulinemia

Summary: the purpose of this study is to determine the safety, tolerability, maximum tolerated dose and pharmacokinetics of mln0128 in patients with relapsed or refractory multiple myeloma or waldenstrom macroglobulinemia


Eligibility criteria:
inclusion criteria: * age ≥18 years, including males and females; * eastern cooperative oncology group (ecog) performance status (ps) 0-2; * life expectancy of ≥3 months; * does not have diabetes and has normal fasting serum glucose and fasting triglycerides ≤ 300 mg/dl * for women of child-bearing potential, negative serum pregnancy test within 14 days prior to the first study drug administration and use of physician-approved method of birth control from 30 days prior to the first study drug administration to 30 days following the last study drug administration; * male subjects must be surgically sterile or must agree to use physician-approved contraception during the study and for 30 days following the last study drug administration; * ability to swallow oral medications; * ability to understand and willingness to sign informed consent form prior to initiation of any study procedures; exclusion criteria: * have received prior cancer therapy or other investigational therapy within 2 weeks prior to the first administration of study drug. * known impaired cardiac function or clinically significant cardiac disease * hiv infection; * failed to recover from the reversible effects of prior anticancer therapies: * pregnancy (positive serum or urine pregnancy test) or breast feeding; * malabsorption due to prior gastrointestinal (gi) surgery, gi disease;
neonatal seizures in nicu of assuit university children's hospital

Conditions: Neonatal Seizure

Summary: a cross sectional study on neonatal seizures in assuit university children's hospital nicu.

an overview on neonatal seizures in neonatal intensive care unit of assuit university children's hospital , a cross sectional study. the aim of this study is to evaluate the clinical seizures during the neonatal period and its prevalence

Eligibility criteria:
inclusion criteria: * all neonates (preterm and full-term infants) aged 0 to 28 days who are admitted to the neonatal intensive care unit of assiut university children's hospital during the period of the study will be included exclusion criteria: * neonates with multiple congenital anomalies (other than cns anomalies)
safety and dose study of grn163l to treat patients with chronic lymphoproliferative disease(cld)

Conditions: Chronic Lymphoproliferative Diseases

Summary: the purpose of this study is to determine the safety and maximum tolerated dose of grn163l in treating patients with refractory or relapsed chronic lymphoproliferative disease.

imetelstat sodium (grn163l) is a telomerase template antagonist with in vitro and in vivo activity in a variety of tumor model systems. telomerase is an enzyme that is active primarily in tumor cells and is crucial for the indefinite growth of tumor cells. inhibition of telomerase may result in antineoplastic effects. high telomerase levels and short telomere lengths correlate with other markers of poor prognosis in patients with chronic lymphoproliferative disease.

Eligibility criteria:
inclusion criteria: * 18 years of age or older * male or female * chronic lymphoproliferative disease with related biology or similar clinical pattern to b-cell leukemia (cll)including: small lymphocytic lymphoma (sll), t cell prolymophocytic leukemia (t-pll), b cell prolymphocytic leukemia (b-pll), mantle cell lymphoma or other non-hodgkins lymphoma in leukemic phase (peripheral blood circulating malignant cells present), waldenstrom's macroglobulinemia * must have relapsed from or be refractory to prior therapeutic regimens * patients with cll or sll must have received at least one prior purine analogue-based chemotherapy regimen (eg, fludarabine, pentostatin or cladribine) * if previously treated with an anthracycline, anthracenedione, or trastuzumab, must have left ventricular ejection fraction \> 50% * ecog performance status 0-2 * life expectancy 3 months or greater exclusion criteria: * pregnant or lactating women * active 2nd malignancy or history of another malignancy within 2 years, except:treated, non-melanoma skin cancer,treated breast or cervical carcinoma in situ,or resected t1a or b prostate cancer * chemotherapeutic agents within 4 weeks prior to study * high dose ctx with stem cell support within 6 months prior to study * signal transduction inhibitors,or monoclonal antibodies within 4 weeks prior to study * immunotherapy or biological response modifiers within 4 weeks prior to study * systemic hormonal therapy within 4 weeks prior to study * anticoagulant therapy, antiplatelet therapy within 2 weeks prior to study * radiotherapy within 4 weeks prior to study * active autoimmune disorder * central nervous system or leptomeningeal involvement * clinically significant cardiovascular disease * known hiv infection * serious/active infection * surgical procedure within 2 weeks

Keywords: chronic lymphocytic leukemia t-cell prolymphocytic leukemia chronic lymphoproliferative diseases telomerase telomerase inhibition
a post market cohort to assess the performance of the spinal modulation neurostimulator system for the management of chronic neuropathic pain of the foot and/or lower leg

Conditions: Chronic Neuropathic Pain

Summary: 14-smi-2013 is a post market, observational, questionnaire based study to assess the effectiveness of the commercially available axium neurostimulator in the management of neuropathic pain of the foot and/or lower limb


Eligibility criteria:
inclusion criteria: 1. subject is at least 18 years old 2. subject is able and willing to comply with the follow-up schedule and protocol 3. chronic, intractable pain in the foot and/or lower leg for at least 6 months 4. failed conservative treatments for chronic pain including but not limited to pharmacological therapy, physical therapy and interventional pain procedures for chronic pain 5. minimum baseline pain rating of 60 mm on the visual analog scale in the primary region of pain 6. subject is able to provide written informed consent exclusion criteria: 1. female subject of childbearing potential is pregnant/nursing, plans to become pregnant or is unwilling to use approved birth control 2. escalating or changing pain condition within the past month as evidenced by investigator examination 3. subject has had corticosteroid therapy at an intended site of stimulation within the past 30 days 4. subject has had radiofrequency treatment of an intended target dorsal root ganglion within the past 3 months 5. subject currently has an active implantable device including implantable cardioverter defibrillator, pacemaker, spinal cord stimulator or intrathecal drug pump 6. subject is unable to operate the device 7. subjects with indwelling devices that may pose an increased risk of infection 8. subjects currently has an active infection 9. subject has participated in another clinical investigation within 30 days 10. subject has a coagulation disorder or uses anticoagulants that, in the opinion of the investigator, precludes participation 11. subject has been diagnosed with cancer in the past 2 years.
prospective cohort study of pancreatic cancer patients treated with proton beam therapy

Conditions: Pancreas Cancer

Summary: pancreatic cancer is one of the few cancers whose survival rate has not improved significantly due to high local recurrence and systemic metastasis despite advances in diagnosis and treatment over the past 40 years. and currently pancreatic cancer is the fifth leading cause of cancer-related death in korea. for this reason, various anti-cancer therapies and radiotherapy have been tested to improve survival. due to recent advances in radiotherapy technology, proton beam therapy (pbt) is a promising treatment for pancreatic cancer because it can reduce radiation dose from surrounding normal tissue while maximizing radiation to tumor tissues due to the distinct physical properties of proton beam. low toxicity have been reported. in addition, retrospective analysis of pancreatic cancer patients (n=37) who performed proton therapy (pbt) from june 2013 to july 2016 showed promising therapeutic performance and less toxicity (survival rate, 19.3 months; grade ≥ 3 toxicity, 0%). in addition, gene polymorphisms of several genes (cd44, cd166, xaf1, mmp9, muc1/4, smad7, smad4 (dpc), rrm1, ercc1, her2, etc.) in pancreatic cancer have been reported to be associated with recurrence and prognosis.

pancreatic cancer is one of the few cancers whose survival rate has not improved significantly due to high local recurrence and systemic metastasis despite advances in diagnosis and treatment over the past 40 years. and currently pancreatic cancer is the fifth leading cause of cancer-related death in korea. for this reason, various anti-cancer therapies and radiotherapy have been tested to improve survival. due to recent advances in radiotherapy technology, proton beam therapy (pbt) is a promising treatment for pancreatic cancer because it can reduce radiation dose from surrounding normal tissue while maximizing radiation to tumor tissues due to the distinct physical properties of proton beam. low toxicity have been reported. in addition, retrospective analysis of pancreatic cancer patients (n=37) who performed proton therapy (pbt) from june 2013 to july 2016 showed promising therapeutic performance and less toxicity (survival rate, 19.3 months; grade ≥ 3 toxicity, 0%). in addition, gene polymorphisms of several genes (cd44, cd166, xaf1, mmp9, muc1/4, smad7, smad4 (dpc), rrm1, ercc1, her2, etc.) in pancreatic cancer have been reported to be associated with recurrence and prognosis. therefore, in this study, a prospective cohort of pancreatic cancer patients treated with proton beam therapy was established to analyze local control, survival, recurrence, toxicity, proton treatment plan information, gene expression information to analyze local control (lc), overall survival (os), recurrence-free surival (rfs), and factors predicting treatment-related toxicity.

Eligibility criteria:
inclusion criteria: * pancreatic cancer patients scheduled to be proton beam therapy * agreed to participate in this study exclusion criteria: -disagreed to participate in this study

Keywords: proton beam therapy cohort study
assessing the relationship between hypoxia and the immune environment in myeloma patients (chime)

Conditions: Myeloma

Summary: the study is looking at how myeloma is related to low oxygen levels (hypoxia) in the bone marrow. this is to understand the disease better. it might also guide treatment in the future. for the study, we will run tests on a portion of the samples taken during a bone marrow biopsy. a bone marrow biopsy is taken as part of the diagnosis or follow up of myeloma. the tests in our study will look closely at the make-up of immune cells in the bone marrow, highlight areas of low oxygen, and look at genetic changes in cells from low-oxygen areas. we will ask patients to take a capsule the day before their bone marrow biopsy containing pimonidazole hydrochloride, a substance which will show up areas of low oxygen on tests. overall we want to know: 1. if myeloma cells 'live' in areas of low oxygen in the bone marrow 2. what are the immune and bone marrow cells which are neighbours of myeloma cells? 3. are there genetic changes in low oxygen myeloma cells for the pilot study, we want to know: 4. can we use new techniques to study questions 1-3? the techniques we want to use are pimonidazole with multiplex immunohistochemistry and single cell rna sequencing. the information we get from the tests will help us get a better understanding of how myeloma works. future studies may also use these results to develop new kinds of drugs for myeloma.


Eligibility criteria:
inclusion criteria: * 1. male or female patients referred to the christie nhs foundation trust from another hospital with proven multiple myeloma which may be either treatment naïve or previously treated. 2. aged 18 or over 3. world health organisation (who) performance status 0 to 2 with no deterioration over the previous 2 weeks and minimum life expectancy of 12 weeks 4. provision of written informed consent 5. willing to undergo a bone marrow biopsy 6. willing to take pimonidazole hydrochloride exclusion criteria: 1. involvement in the planning and/or conduct of the study (applies to staff at the study site) 2. evidence of any significant clinical disorder or laboratory finding that made it undesirable for the patient to participate in the study 3. judgment by the investigator that the patient should not participate in the study if the patient is unlikely to comply with study procedures, restrictions, and requirements

Keywords: multiplex immunohistochemistry hypoxia single-cell rna sequencing pimonidazole myeloma microenvironment metabolomics
reducing symptoms of depression in low-income mothers

Conditions: Depression

Summary: this study will test the effectiveness of a short-term intervention in treating depressed young mothers with young children enrolled in early head start programs.

limited resources, poor social support, and complex life problems contribute to the high prevalence and severity of depressive symptoms in low-income mothers. as depressive symptoms persist, they often rob young mothers of the energy they need for school, job training, and positive interaction with their children, which can negatively affect a child's language acquisition, intellectual development, and social conduct. this study will design and implement a home-based treatment to help young mothers manage their depressive symptoms, increase their social support, manage or resolve life issues, and effectively parent their infant or toddler through the use of ehs resources. mothers will be randomly assigned to receive either home-based interpersonal depression treatment or an attention control/usual care condition for 26 weeks. assessments will be made at study start and weeks 14, 22, and 26. depression scales, interviews, and analyses of videotaped mother-child interactions will be used to assess participants. stress, social support, and use of ehs services will be assessed.

Eligibility criteria:
inclusion criteria: * score of 16 or higher on the center for epidemiological studies depression (ces-d) scale * child who is 6 weeks to 30 months old * child who is enrolled in an early head start program exclusion criteria: * regular use of psychotropic medication * regular use of psychotherapy or drug/alcohol treatment

Keywords: early head start program
clinical evaluation of the causes of contact lens related dry eye

Conditions: Contact Lens Related Dry Eye

Summary: the purpose of this study was to clinically evaluate the potential causes of contact lens-related dry eye.

daily wear soft contact lens wearers reporting significant contact lens-related dryness symptoms were enrolled. late day dryness with contact lenses, intensity grade 3-5, frequency "sometimes / frequently / constantly" as evaluated by a questionnaire was considered significant.

Eligibility criteria:
inclusion criteria: * reports late-day dryness symptoms with contact lens wear on questionnaire. * wears fda group 2 hydrogel, fda group 4 hydrogel, or silicone hydrogel lenses. * consistently uses either polyhexamethylene biguanide (phmb) or polyquaternium-1 (pqt) contact lens care products (i.e. \>6 months including 1 month immediately before enrollment). * other protocol-defined inclusion criteria may apply. exclusion criteria: * wears daily disposable contact lenses. * has significant symptoms related to lens fit or lens deposits. * requires concurrent ocular medication (rewetting drops allowed). * has used restasis® in the last 3 months. * wears punctal plugs fitted in the last 30 days. * has any current systemic or ocular abnormality, infection or disease. * uses any current systemic medication likely to affect tear film, e.g. antihistamines, betaadrenergic blockers, steroids. * has a history of refractive surgery. * other protocol-defined exclusion criteria may apply.

Keywords: contact lens wear multi-purpose solution corneal staining
improving chronic illness management with the apsaalooke nation: the baa nnilah project

Conditions: Chronic Disease

Summary: this is a group randomized trial of an intervention to improve chronic illness self-management.


Eligibility criteria:
inclusion criteria: * ≥ 25 years * ai * diagnosed with diabetes * hypertension * osteoporosis * liver disease * chronic lung disease (asthma, chronic bronchitis or emphysema) * heart disease (coronary artery disease or congestive heart failure) * stroke (completed cerebrovascular accident with neurologic handicap and normal mentation) * chronic arthritis exclusion criteria: * major medical illness that precludes their attendance at 7 meetings * \<25 years of age
observational study of the management of infants with congenital cmv

Conditions: Congenital Cmv

Summary: this is an observational, prospective/retrospective multicentre, cohort study of children diagnosed with ccmv. this study will contribute to a wider study also recruiting participants in europe and other countries worldwide. no investigations or treatment will be carried out that are not part of routine clinical practice. infants with ccmv are routinely followed up from an infectious diseases, audiology, ophthalmology and neurodevelopmental perspective until approximately 6 years of age, or longer if there are ongoing issues. some children will be retrospectively diagnosed with ccmv in later childhood. recruitment can be from any centre that manages these patients and has agreed to participate in the study.

cytomegalovirus (cmv) is the most frequent cause of congenital infection worldwide, occurring in 0.2-2% of live births. it is also the most frequent cause of non-genetic hearing loss, and an important cause of neurodevelopmental delay. clinical diagnosis of maternal infection during pregnancy is unreliable in most patients and laboratory diagnosis can be challenging, especially in non-primary infections. screening of congenital cmv infection (ccmv) in newborns is not recommended in most countries and only targeted screening is performed in some cases (children who fail hearing screening or with abnormalities compatible with ccmv in physical exams). the main focus of the study is to identify patient and treatment characteristics that are associated with outcome. this will allow improved patient care in the future.

Eligibility criteria:
inclusion criteria: patients of either sex that have been diagnosed with ccmv infection: * through confirmed detection of cmv in urine or saliva, by cmv-dna pcr (or viral culture / shell-vial) and/or cmv detection in blood or csf by pcr within the first 21 days of life. * children with ccmv retrospectively diagnosis by positive cmv-dna pcr in dried blood spots (dbs), collected within 21 days of life. * diagnosed by positive cmv-dna pcr in dried umbilical cord blood or donated/stored umbilical cord blood sample * children whose parents give their informed consent to participate in the study * age less than 11 years old exclusion criteria: * refusal to sign written informed consent of parents/ legal guardian.
melody pb1016 surveillance study

Conditions: Dysfunctional RVOT Conduits in Patients With Congenital Heart Defects

Summary: non-randomized, multi-center, prospective surveillance study to investigate and assess the residual risks, and to confirm the currently established safety and performance of the melody tpv pb1016.


Eligibility criteria:
inclusion criteria: * patient eligible to receive melody tpv pb1016 per current instructions for use (ifu) indications at time of study enrollment * patient (or patient's legally authorized representative) is willing to consent to participate in the study and will commit to completion of all follow-up requirements. exclusion criteria: * implantation in the aortic, tricuspid, or mitral position * venous anatomy unable to accommodate a 22-fr size introducer sheath * obstruction of the central veins * clinical or biological signs of infection including active endocarditis * history of intravenous substance abuse * currently participating in an investigational drug or device study
european study to describe hospital stay in patients admitted for acute bipolar manic episodes

Conditions: Acute Bipolar Manic Episode

Summary: this study is being carried out to find out how patients suffering from the acute manic phase of bipolar disease are currently managed with quetiapine immediate release (ir) or quetiapine extended release (xr) in the hospital setting in real life practice, including length of stay.


Eligibility criteria:
inclusion criteria: * patients diagnosed with bipolar disorder (icd-10). * admitted for acute bipolar manic episode from 1st october 2009 to 1st october 2010 * patients treated with quetiapine ir or quetiapine xr during the hospitalization period. exclusion criteria: * patients in which bd is not the main reason for hospitalization * patients admitted for acute bipolar mania episodes but finally diagnosed with mixed or bipolar disorder not otherwise specified (nos) episodes * patients receiving both quetiapine ir and xr during the same hospitalization period.

Keywords: patients admitted as for an acute bipolar manic episode description of management patterns and hospital stay in patients admitted for acute bipolar manic episode and treated with either quetiapine ir or quetiapine xr