Kornimate/medical-research-clean huggingface dataset:
closed incision disposable negative pressure wound therapy in immediate postmastectomy breast reconstruction

Conditions: Breast Cancer; Breast Reconstruction

Summary: the study aimed to assess the impact of the use of closed incision negative pressure wound therapy (cinpwt) after immediate breast reconstruction on the number of surgical-site complications, skin surface temperature, objective elastic and viscoelastic and subjective scar's quality to determine risk factors that could be considered as indications for prophylactic cinpwt application.

breast cancer excluding skin cancer is the most commonly diagnosed cancer after lung cancer among women. in recent years, the incidence rate of breast cancer has been rising by 0,3% annually. screening tests are designed to diagnose breast cancer in possible early stadium of disease. rapid diagnosis and efficacy of neoadjuvant and adjuvant therapies influence on immediate breast reconstructions after skin (ssm) and nipple-sparing mastectomies (nsm). the prophylactic methods of reducing a higher wound healing complication rate after neoadjuvant and adjuvant therapies are crucial. the study aimed to assess the impact of the use of closed incision negative pressure wound therapy (cinpwt) after immediate breast reconstruction on the number of surgical-site complications, skin surface temperature, objective elastic and viscoelastic and subjective scar's quality to determine risk factors that could be considered as indications for prophylactic cinpwt application. the analysis included data from anamnesis, details of performed surgical procedure, measurements of skin surface temperature with skin-thermometer® probe, measurements of skin elasticity with cutometer® probe, and scar assessments according to posas v2.0 questionnaire for patient and observer.

Eligibility criteria:
inclusion criteria: * \>= 18 years of age * indications for immediate breast reconstruction exclusion criteria: * pregnancy or lactation, * use of steroids, use of immune modulators known to affect wound healing; * tattoos in the area of the incision; * breast skin conditions such as cutis laxa;

Keywords: breast cancer closed incision negative pressure wound therapy breast reconstruction
validation of the schiller br-102 plus pwa device to measure central and peripheral hemodynamics

Conditions: Aortic Stiffness; Hypertension

Summary: the significance of parameters of the central hemodynamic is based upon their strong association with left ventricular hypertrophy and target organ damage at the heart. noninvasive, auscultatory/ oscillometric and therefore easy applicable measurements of the central hemodynamic such as presented by the schiller br-102 plus pwa device implicate highly promising potential for research and daily clinical praxis for improved cardiovascular risk assessment on the population level. the purpose of this study is to evaluate the validity of the central and peripheral blood pressure and central arterial stiffness measured with the device br-102 plus pwa from schiller (schiller ag, baar, switzerland).

the proposed study is an open, monocentric cross-sectional research study for the evaluation of the validity of the central and peripheral blood pressure and central arterial stiffness measured with the device br-102 plus pwa from schiller (schiller ag, baar, switzerland). for that purpose measurement of the respective parameters in cardiovascular disease free individuals will be compared with validated devices and the agreement between the devices will be statistically analyzed. central blood pressure and central arterial stiffness are clinically increasingly meaningful parameters of the cardiovascular system that allow improved, early cardiovascular risk stratification. the significance of parameters of the central hemodynamic is based upon their strong association with left ventricular hypertrophy and target organ damage at the heart. noninvasive, auscultatory/ oscillometric and therefore easy applicable measurements of the central hemodynamic such as presented by the schiller br-102 plus pwa device implicate highly promising potential for research and daily clinical praxis for improved cardiovascular risk assessment on the population level.

Eligibility criteria:
inclusion criteria: * healthy individuals free of clinically relevant cardiovascular diseases or diabetes based on medical history and physical examination. * heart rhythm: sinus rhythm * blood pressure range: 10 to 12 subjects in each of the three systolic blood pressure (sbp) and three diastolic blood pressure (dbp) recruitment ranges (low, medium, high). exclusion criteria: * cardiac arrhythmia (atrial fibrillation, frequent extrasystoles) * pacemaker-dependent * pregnancy after the 6th month of the pregnancy * body mass index (bmi)\>30 kg/m2 * known significant carotid or femoral artery stenosis * impalpable arterial pulse at site of measurement * age under 18 years.

Keywords: validation pulse wave analysis blood pressure monitoring
a study of prevalence and clinical characteristics of tic disorders in children at sohag university hospital

Conditions: Tic Disorder, Childhood

Summary: tics are brief, sudden, repetitive movements and/or sounds that increase with stress, anxiety, transitions, or excitement. tics occur most commonly in children and adolescents, with boys more frequently affected than girls the american academy of child and adolescent psychiatry states that tics affect up to 10 percent of children during their early school years. . the exact pathophysiologic mechanisms are unknown, but the disorders are likely to be due to disturbances of the cortico striatal- thalamo -circuitry. risk factors for tic disorders include. genetics: tics tend to run in families, so there may be a genetic basis to these disorders. sex: men are more likely to be affected by tic disorders than women. they are divided into motor tics (e.g., blinking, shrugging shoulders, grimacing, or jerking) and vocal tics (e.g., throat clearing, sniffing, grunting) . patients describe an inner urge or a local premonitory sensation, which is then relieved by performing the tic. the tic can be voluntarily suppressed for short periods of time. tics increase with stress, anxiety, transitions, and excitement, and decrease with distraction. the american academy of child and adolescent psychiatry states that tics affect up to 10 percent of children during their early school years .the most notable tic disorder is tourette syndrome, in which both physical and verbal tics occur in the same individual, often at the same time. transient tic disorder also involves both types of tics, but they often occur individually . tic disorders are classified into 3 categories : transient tic disorders involve motor or vocal tics that last for more than 4 weeks but less than a year. chronic tic disorders involve either motor tics or vocal tics (but not both) that last for more than a year. tourette syndrome, in which both physical and verbal tics occur in the same individual conditions associated with tic disorders, especially in children with ts, include: anxiety, adhd, depression ,autism ,spectrum disorder learning difficulties ,ocd speech and language difficulties, sleep difficulties other complications associated with tic disorders are related to the effect of the tics on self-esteem and self-image . some research! has found that children with ts or any chronic tic disorder experience a lower quality of life and lower self-esteem than those without one of these conditions


Eligibility criteria:
inclusion criteria: * -age between 3 and 18 years * all patients suffering from tics and fulfill diagnostic criteria according to dsm v exclusion criteria: * - patients with age below 3 years and after 18 years old
comparative effectiveness of rehabilitation services for survivors of acute ischemic stroke

Conditions: Ischemic Stroke

Summary: retrospective analysis of get with the guidelines-stroke data linked with medicare claims and the avail longitudinal data sets to assess patterns, predictors, and outcomes associated with the use of rehabilitation services following hospitalization for ischemic stroke. primary completion defined as the end of primary analyses, consistent with the end of the pcori cycle i grant period. study completion defined as acceptance of final research report and lay abstract by pcori.

the investigators will seek to answer three questions: 1. what are the person- and system-level factors associated with use of rehabilitation services following acute ischemic stroke? 2. among stroke survivors discharged to short-term inpatient rehabilitation, are high-intensity services performed at an inpatient rehabilitation facility (irf) more effective than lower intensity services performed at a skilled nursing facility (snf), at improving patient outcomes at 3 and 12 months? 3. among stroke survivors discharged home, is early follow-up with a physician more effective than follow-up after 7 days at 3 and 12 months?

Eligibility criteria:
inclusion criteria: * acute ischemic stroke within the get with the guidelines-stroke data set for 2006-2008, and successfully linked to medicare claims through 2009 exclusion criteria: * death during index hospitalization
the effects of oculomotor training on pain, cervical range of motion, joint position sense, endurance, and balance in individuals with mechanical neck pain

Conditions: Mechanical Neck Pain

Summary: the aim of this study was to investigate the effects of oculomotor training on pain, cervical range of motion, joint position sense, endurance and balance in individuals with mechanical neck pain.


Eligibility criteria:
inclusion criteria: * diagnosed with mechanical neck pain * neck pain lasting longer than 3 weeks * individuals aged 18-50 years * score of 5 or higher on the neck disability index exclusion criteria: * having received physical therapy in the last 6 months * presence of congenital anomaly on cervical radiography * neurological deficit detected in physical examination * diagnosis of vertebrobasilar artery insufficiency * diagnosis of vestibular disease * presence of a rheumatic disease * presence of structural scoliosis * history of spinal surgery * pregnancy * malignancy * eye disease/strabismus other than refractive errors * active use of anti-inflammatory medication * any mental condition that may prevent adherence to exercises

Keywords: mechanical neck pain
pilot study of bydureon to treat diabetes in hiv-infected adults

Conditions: Human Immunodeficiency Virus Infection; Diabetes Mellitus

Summary: this pilot study will evaluate the effects of the anti-diabetic drug bydureon (exenatide extended-release formulation) on blood sugar levels and serum markers of inflammation in a cohort of 12 hiv-infected adults on combination antiretroviral therapy (cart) with untreated diabetes mellitus. previous studies have shown that high levels of persistent systemic inflammation predict the development of cardiovascular and metabolic diseases in hiv-infected persons on cart (a group at very high risk of atherosclerosis and myocardial infarction). bydureon has demonstrated potent anti-inflammatory effects in prior studies of non-hiv infected persons, which suggests that this agent may represent a unique and preferred medication for the treatment of insulin resistance in hiv-infected adults. the investigators hypothesize that short-term (16 weeks) therapy with bydureon will improve glucose tolerance and significantly reduce circulating plasma levels of interleukin-6 (il-6) and highly-sensitive c-reactive protein (hscrp), two biomarkers strongly implicated in the development of cardiovascular and metabolic diseases in diabetic, hiv-infected, cart-treated adults.

no further information. this was a single-arm trial to add an additional anti-diabetic medication to patients already known to be diabetic. the primary endpoint assessed whether the intervention reduced inflammation. there was no control arm.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years * body mass index ≥ 25 kg/m2 * glycosylated hemoglobin (a1c) value ≥ 6.5% or having a fasting blood glucose ≥ 126 mg/dl * on stable antiretroviral therapy for ≥ 12 months (with a fully suppressed plasma hiv-1 rna level) * negative serum pregnancy test (females only) exclusion criteria: * history of pancreatitis * screening serum lipase value greater than or equal to 2 times the upper limit of normal (≥ 420 u/l) * history of pancreatic cancer or thyroid cancer in patient, a first-degree relative, or a grandparent * history of multiple endocrine neoplasia (men) 2 syndrome * history of gastroparesis, inflammatory bowel disease, and/or other severe gastrointestinal disease * estimated glomerular filtration rate (egfr) ≤ 50 mls/minute * documented history of hypoglycemia (blood glucose \<40 mg/dl) * active moderate-heavy alcohol use (more than 2 drinks/day) or \>4 drinks in a single 24 hour period * on an anti-diabetic medication within 3 months of enrollment * on an hmg-coa reductase inhibitor (statin) within 3 months of enrollment * persons on a didanosine (ddi) and/or stavudine (d4t)-containing cart (due to the heightened risk of pancreatitis)

Keywords: hiv diabetes
pilot study to assess lung shunting of yttrium-90 microspheres using pet/ct

Conditions: Advanced Adult Primary Liver Cancer; Liver Metastases; Localized Unresectable Adult Primary Liver Cancer; Recurrent Adult Primary Liver Cancer

Summary: this pilot clinical trial studies positron emission tomography (pet)/computed tomography (ct) in finding beads after yttrium-90 bead therapy in patients with primary liver cancer or cancer that has spread to the liver (metastatic) that can not be removed by surgery. imaging procedures, such as pet/ct after yttrium-90 bead therapy, may help see if the beads are present in the lung and compare the results with the pre-therapy imaging.

primary objectives: i. to estimate the absolute difference in post-therapy yttrium-90 microsphere hepatopulmonary shunt fraction and the pre-therapy technetium-99m macroaggregated albumin hepatopulmonary shunt fraction in patients with unresectable primary hepatic malignancy and hepatic metastatic disease. secondary objectives: i. to quantify and compare the pre-therapy technetium-99m macroaggregated albumin particle sizes and post-therapy yttrium-90 microsphere sizes. outline: patients receive routine pre-therapy technetium-99m macroaggregated albumin. patients then undergo routine radioembolization with yttrium-90 microspheres. within 36 hours after radioembolization, patients undergo pet/ct imaging. available imaging, clinical, interventional and surgical follow-up data for 2 years after completion of enrollment in the study will be obtained.

Eligibility criteria:
inclusion criteria: * patients who undergo intra-arterial hepatic 99mtc maa evaluation in anticipation of 90y microsphere radioembolization exclusion criteria: * patients who are unable to give consent * prisoners

Keywords: yttrium-90 radioembolization hepatic malignancy hepatic metastatic disease
reducing anxiety problems among children indicated to have developmental language disorder

Conditions: Developmental Language Disorder and Language Impairment; Anxiety Disorders and Symptoms

Summary: this study aims to pilot a world-first intervention, a mental health intervention augmented for children indicated with developmental language disorder (dld). it serves as a proof-of-concept of how existing observational studies on these topics at the centre for research in child development (c.f. tran-sen; gibber) can be translated into interventions. mental health problems here are defined as anxiety type problems of social anxiety, specific phobia, separation anxiety and generalised anxiety. dld is defined as a marked difficulty in oral language in the absence of biomedical causes (bishop et al., 2017). this randomised pilot answers three uncertainties in preparation for a future definitive randomised control trial (rct).

this pilot aims to answer three uncertainties for a future randomised control trial (rct), namely (1) is the proposed intervention's efficacy sufficient (2) are the proposed methods of recruitment sufficient (3) are the proposed measures of evaluation sufficient hypotheses: (1) piloted intervention is sufficient for definitive rct as 90% confidence intervals contain expected improvement versus treatment-as-usual (2) piloted recruitment methods are sufficient for definitive rct as recruitment rate is \>4/month, dropout rate\ .70.

Eligibility criteria:
inclusion criteria: * shows signs of elevated anxiety, fear or stress, as rated on anxiety measures conducted by this study * enrolled in primary 1 to 6 in a ministry of education primary school * signs of a language difficulty \[either one of the following\] 1. existing clinical opinion/report of this when child \>5 years old 2. score \<10th percentile on language measures conducted by this study exclusion criteria: * conditions which exclude developmental language disorder (e.g. autism, intellectual disability, hearing impairment, other biomedical conditions). * non-anxiety disorder as primary mental health disorder * currently receiving treatment for anxiety disorder (e.g. pharmacotherapy or psychotherapy).
methotrexate followed by fludarabine in patients with t-cell large granular lymphocytic leukemia

Conditions: T-Cell Large Granular Lymphocytic Leukemia

Summary: rationale: drugs used in chemotherapy, such as methotrexate and fludarabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. purpose: this phase ii trial is studying how well methotrexate works as first-line therapy and fludarabine works as second-line therapy in treating patients with t-cell large granular lymphocytic leukemia.

objectives: primary * determine remission rates and duration of remission in patients with t-cell large granular lymphocytic (t-lgl) leukemia needing intervention because of anemia or neutropenia and are treated with parenteral methotrexate (mtx) as first-line therapy * determine remission rate and duration of remission in patients who fail to respond to mtx therapy and are subsequently treated with fludarabine as second-line therapy. secondary * determine the side effects of these drugs in these patients. * determine the rate of molecular remissions in patients treated with these drugs. outline: this is a nonrandomized, open-label, multicenter study. patients receive methotrexate subcutaneously once weekly in the absence of disease progression or unacceptable toxicity. patients not achieving a response to methotrexate receive fludarabine iv on days 1-3. treatment with fludarabine repeats every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity. projected accrual: a total of 30 patients will be accrued for this study.

Eligibility criteria:
disease characteristics: * confirmed diagnosis of t-cell large granular lymphocytic (t-lgl) leukemia * must have concurrent anemia or neutropenia patient characteristics: * life expectancy ≥ 2 years * not pregnant * fertile patients must use effective contraception * no other malignancy * no active infection prior concurrent therapy: * no prior immunosuppressive treatment * no previous treatment with methotrexate or fludarabine

Keywords: t-cell large granular lymphocyte leukemia anemia neutropenia
the roles of il-9/e-cadherin and ferroptosis in intestinal mucosal barrier injury in sepsis

Conditions: Sepsis; Intestinal Mucosal Barrier; Ferroptosis

Summary: the investigators aim to evaluate the roles of il-9/e-cadheirin and ferroptosis in the intestinal mucosal barrier injury of sepsis. the results of this study would lay the foundation for revealing the mechanisms of een improving immune imbalance of sepsis and provide a new idea to the early treatment of sepsis.


Eligibility criteria:
inclusion criteria: 1. clinical diagnosis of sepsis 2. within 3 days of sepsis onset before icu admission 3. no artificial nutrition (enteral or parenteral nutrition) were provided before icu admission exclusion criteria: 1. ileus 2. digestive tract hemorrhage 3. inflammatory bowel disease 4. cancer or chronic organ dysfunction (e.g., hepatic or renal dysfunction) 5. malnutrition or immunodeficiency 6. long-term use of hormones
safety and efficacy of imatinib in combination with high dose chemotherapy for acute phase chronic myelogenous patients

Conditions: Chronic Myeloid Leukemia

Summary: the aim of this phase i/ii trial is to determine the dose of daunorubicine to be associated with cytarabine and imatinib for induction therapy in patients with chronic myelogenous leukemia in myeloid acute phase.

study design imatinib: starting at day -3: 600mg/day; continuous administration in combination with cytarabine: continuous iv/24h: 100mg/m² ; 7 days and daunorubicine: 4 levels level 1: 0 level 2: 15mg/m² ; 3 days level 3: 30mg/m² ; 3 days level 4: 45mg/m² ; 3 days

Eligibility criteria:
inclusion criteria: * cml ph+ (assessed by cytogenetic or fish) * acute phase with ≥ 20% bone marrow blasts (m0 to m6 , excluding m3) * age ≥ 18 year at inclusion * ps grade 0 to 2 (ecog) * adequate and organ function, defined as the following: total bilirubin \<1.5x uln, sgpt \<3x uln, creatinine \<1.5x uln. * informed consent signed up exclusion criteria: * active malignancy other than cml or non-melanoma cancer of the skin * current treatment with another investigational agent * patients with grade 3/4 cardiac disease or any other serious concurrent medical condition. * patients who are pregnant or nursing. all patients of childbearing potential must practice effective methods of contraception while on study. * patients with mental illness or other condition precluding their ability to give informed consent or to comply with study requirements patients with performans status 3-4

Keywords: cml acute phase imatinib mesylate cytarabine daunorubicine
a multiple ascending dose study of r1511 in patients with type 2 diabetes mellitus.

Conditions: Diabetes Mellitus Type 2

Summary: this 4 arm study will evaluate the pharmacokinetics, pharmacodynamics, safety and tolerability of multiple ascending doses of r1511 compared to placebo in patients with type 2 diabetes mellitus. the starting dose of r1511 will be 100mg po bid for 5 1/2 days; this dose will be escalated in subsequent groups of patients to a potential maximum of 1200mg po bid for 5 1/2 days after a satisfactory assessment of blinded safety, tolerability, pharmacokinetic and pharmacodynamic data of the previous dose. the anticipated time on study treatment is \<3 months, and the target sample size is \<100 individuals.


Eligibility criteria:
inclusion criteria: * adult patients, 18-65 years of age; * type 2 diabetic patients; * naive to anti-diabetic therapy, or taken off current anti-diabetic therapy for \>=2 weeks before first treatment. exclusion criteria: * type 1 diabetes mellitus; * clinically significant cardiovascular disease.