Kornimate/medical-research-clean huggingface dataset:
observational study of diffuse large b cell primary breast lymphomas treated with rchop +/- xrt

Conditions: Lymphoma; Non-Hodgkin's Lymphoma

Summary: this is a multi-center observational study to assess addition of rituximab in the treatment of previously untreated patients with diffuse large b-cell lymphomas(dlbcl) over an enrollment period of 60 months. patients in this study are enrolling for the collection of their data on observations made during normal clinical practice.


Eligibility criteria:
inclusion criteria: * previously untreated patients with dlbcl of the breast. * patients must have cd20 positive tumors. * stage ie or iie. * must have at least one objective measurable or evaluable disease. baseline measurements and evaluations must be obtained within 4 weeks of registration to the study. * patients must not have historical or radiographic evidence of cns metastasis including previously treated, resected or asymptomatic brain lesions or leptomeningeal involvement. * patients must have an ecog performance status 0-2. * patients must have adequate organ function as evidenced by the following laboratory studies (within 2 weeks prior to registration): * creatinine clearance \>= 50 ml/min * total bilirubin \<= 2.0 mg/dl and ast \<= 2 x upper limit of normal. if documented hepatic involvement with lymphoma, total bilirubin can be \<= 3 x \*uln, and ast \<= 5 x uln. * absolute neutrophil count \>= 1500/mm3 and platelet count \>= 100,000/mm3. if documented bone marrow involvement with lymphoma, absolute neutrophil count \>= 500/mm\^3 and platelet count \>= 50,000/mm\^3. * patients must be age \>= 18 years. * women must not be pregnant or breast feeding due to potential harmful effects to the fetus/baby. women of childbearing potential and sexually active males are strongly advised to use an accepted and effective method of contraception. * patients must not have an active infection requiring parental antibiotics. * patients with known hiv infection are excluded. * patients must have a normal left ventricular ejection fraction to be eligible.
amg 386 (trebananib) in ovarian cancer (trinova-2)

Conditions: Fallopian Tube Cancer; Ovarian Cancer; Primary Peritoneal Cancer

Summary: to determine if amg 386 plus pegylated liposomal doxorubicin (pld) is superior to placebo plus pld as measured by progression-free survival (pfs) the hypothesis for this study is that amg 386 plus pld will prolong pfs compared to placebo plus pld in women with recurrent partially platinum sensitive or resistant epithelial ovarian, primary peritoneal or fallopian tube cancer.


Eligibility criteria:
inclusion criteria: * histologically or cytologically documented invasive epithelial ovarian, primary peritoneal, or fallopian tube cancer * radiographically documented disease progression either on or following the last dose of the prior regimen for epithelial ovarian, primary peritoneal, or fallopian tube cancer * subjects must have had one prior platinum-based chemotherapeutic regimen for management of primary disease containing carboplatin, cisplatin, or another organoplatinum compound. * female 18 years of age or older at the time the written informed consent is obtained * adequate organ and hematological function exclusion criteria: * subjects who have received more than 3 previous regimens of anti cancer therapy for epithelial ovarian, primary peritoneal or fallopian tube cancer * subjects treated with prior pegylated liposomal doxorubicin (pld) or any anthracycline-based or mitoxantrone-based chemotherapy * subjects with primary platinum-refractory disease * subjects with platinum-free interval (pfi) \> 12 months from their last platinum based therapy * history of central nervous system metastasis * major surgery within 28 days prior to randomization or still recovering from prior surgery

Keywords: fallopian tube cancer primary peritoneal cancer amg386 pegylated liposomal doxorubicin recurrent epithelial ovarian cancer
tornado-omics techniques and neural networks for the development of predictive risk models

Conditions: Oxidative Injury; Stress Physiological; Discogenic Pain; Cardiovascular Risk Factor; Space Maintenance; Epigenetic Changes; LONGEVITY 1; Neuroplasticity; NGS

Summary: the goal of this observational study is to define a personalized risk model in the super healthy and homogeneous population of italian air force high-performance pilots. this peculiar cohort conducts dynamic activities in an extreme environment, compared to a population of military people not involved in flight activity. the study integrates the analyses of biological samples (urine, blood, and saliva), clinical records, and occupational data collected at different time points and analyzed by omic-based approaches supported by artificial intelligence. data resulting from the study will clarify many etiopathological mechanisms of diseases, allowing the creation of a model of analyses that can be extended to the civilian population and patient cohorts for the potentiation of precision and preventive medicine.

the high-performance pilots of the italian air force are "super healthy" individuals subjected to particular working conditions, as changes in temperature, pressure, gravity, acceleration, exposure to cosmic rays and radiation, which determine psycho-physical adaptation mechanisms to maintain homeostasis. however, this environmental exposure may potentially affect human health, well-being and performance. the study aims to collect exposure data, clinical, physiological data through biosensors and molecular parameters (at different time point), to be integrated by an artificial intelligence algorithm expressly trained to create reliable risk models. the final outcome will consist of the identification of significant biomarkers of pathological risk, in order to better understand the etiopathological mechanisms of many human diseases and apply early and personalized countermeasures to maintain and empower workers' health status and performance, avoiding clinical symptom presentation.

Eligibility criteria:
inclusion criteria: * being part of the italian air force, as in active flight service or ground staff * age between 26 and 38 years * consent to collect biological samples and use the wearable device to monitor exposure parameters exclusion criteria: * age \ 39 years * no signature on informed consent

Keywords: pilots air force epigenetic change environmental exposure
mascot - post marketing registry

Conditions: Coronary Artery Disease; Atherosclerosis

Summary: to collect post marketing surveillance data on patients receiving at least one combo bio-engineered sirolimus eluting stent when used according to the instructions for use. data will be collected in order to assess the long term safety and performance of the combo stent in routine clinical practice.

the multicenter, multinational, prospective registry population consists of patients who undergo percutaneous coronary intervention (pci) with (attempted) placement of at least one combo stent (according to the instructions for use) as part of routine clinical care. approximately 2,500 patients from 50 centers in europe and asia will be entered into the registry. patients entered into the registry are followed for one year. the registry is considered finished when all patients have completed the 12 month follow-up. a follow-up is scheduled at 30 days, 6 months and 12 months post procedure. follow-up is obtained at a planned regular visit to the outpatient clinic, or by telephone contact with the patient.

Eligibility criteria:
in general, consecutive patients are included in the registry. patients are only excluded from registration if any of the following conditions apply: 1. undergoing pci for treatment of stent thrombosis 2. high probability of non-adherence to the follow-up requirements (due to social, psychological or medical reasons) 3. currently participating in another investigational drug or device study in which a routine angiographic follow-up is planned 4. a life expectancy of \<12 months 5. explicit refusal of participation in the registry

Keywords: intracoronary stent drug eluting stent sirolimus endothelial progenitor cells
efficacy and safety of qge031versus placebo and omalizumab in patients aged 18-75 years with asthma

Conditions: Asthma

Summary: this study assessed the effect on asthma control of different dose levels and regimens of qge031 in asthma patients that are inadequately controlled with inhaled steroid and beta-2 agonist medication. safety was assessed also. comparison was to placebo and omalizumab. information from this study was planned to support the design of future studies.


Eligibility criteria:
key inclusion criteria: * a diagnosis of allergic asthma , uncontrolled on current medication. * history of at least 1 asthma exacerbation during the last 1 year * forced expiratory volume in one second (fev1) of ≥ 40% and ≤ 80% of the predicted normal value; reversibility following administration of bronchodilator must also be demonstrated (historical positive reversibility or bronchoprovocation result can be used). key exclusion criteria: * baseline ige levels or body weight outside the omalizumab dosing table. * use of tobacco products within the previous 6 months (social occasional smokers may be included). * recent asthma attack/exacerbation or asthma worsening/ respiratory infection.

Keywords: asthma asthma control allergy atopic ige double-blind placebo omalizumab
clinical comparison of bulk-fill and incremental composite

Conditions: Tooth Disease

Summary: the clinical performance of a 5-mm bulk-fill and an incremental resin composite in class ii restorations will be evaluated and compared. after recruiting participants with at least 2 approximal caries lesions, all restorations will be placed by a single clinician. all caries lesions will be removed before restoring. cavities will be divided into two groups: a 5 mm bulk-fill composite resin \[filtek™ bulk fill posterior, 3m espe, st. paul mn, usa (fb)\] and an incremental posterior composite resin \[filtek ultimate universal, 3m espe, st. paul mn, usa (fu)\] all restorative procedures will be conducted according to manufacturers' instructions. restorations will be scored using modified united states public health service (usphs) criteria after a week (baseline) 6, 12, 24, 36 and 48 months. descriptive statistics will be performed using chi-square tests.


Eligibility criteria:
inclusion criteria: * age range will be 18 to 65 * patients should have at least 2 approximal caries lesions require restoration * healthy periodontal status * a good likelihood of recall availability exclusion criteria: * poor gingival health * adverse medical history * potential behavioral problems
study for evaluating the value of a multi biomarker approach in metastatic gep nets

Conditions: Gastroenteropancreatic Neuroendocrine Tumors

Summary: this exploratory study aims to evaluate the diagnostic, prognostic and response predictive value of a multi biomarker strategy in patients with gastroenteropancreatic neuroendocrine tumors (gep nets) originating from the midgut or pancreas. using a recently developed methodology enabling the evaluation of 92 concomitant cancer biomarkers will provide an interesting approach to solve this question (lundberg et al 2011).


Eligibility criteria:
inclusion criteria: * provision of written informed consent prior to any study related procedures. * suspected of suffering from a metastatic midgut net or pancreatic non-functional net (who grade 1 or 2, up to 10% ki67). * male or female aged 18 or older. exclusion criteria: * previously treated for the net disease with pharmaceutical treatment, peptide receptor radionuclide therapy (prrt) or radiation therapy(surgery of primary tumour is accepted) * has any mental condition rendering the subject unable to understand the nature, scope and possible consequences of the study, and/or evidence of an uncooperative attitude. * suffering from a malignant disease or previously treated for a malignant disease within the last 6 months. * suffering from a chronic inflammatory disease. * suffering from a renal and/or liver disease.
the impact of the certified child life specialist on children's pain during immunizations

Conditions: Pain

Summary: the purpose of this study is to provide the first systematic evidence that certified child life specialists reduce pain during vaccine administration and improve caregiver visit satisfaction in the pediatric primary care setting.


Eligibility criteria:
inclusion criteria: * children 4-12 years of age presenting to mchs red wing for a well child examination and vaccine administration. * parents or caregivers of any age presenting to well child examination with child. * legal guardians of all participants must provide verbal consent. * patients must provide verbal assent for participation.verbal assent will be waived for children younger than 6 years. exclusion criteria: * children with autism or other severe developmental disabilities. * children must be able to communicate pain before and after vaccine administration using the fps-r.
gender differences in musculoskeletal assessment methods in patients with chronic mechanical low back pain

Conditions: Gender Differences; Musculoskeletal Assessment; Chronic; Low Back Pain

Summary: this study is an observational test-retest study designed to investigate the effect of gender on core strength, balance, spinal mobility, and hamstring flexibility in patients with chronic non-specific low back pain (ns-lbp).

low back pain (lbp) is the primary contributor to years of disability. individual features (age, physical fitness), psychosocial factors (stress, anxiety, and depression), and occupational factors (hard physical work, bending and twisting motions, and vibration) have all been linked to the development of lbp, which is thought to have a complex etiology.

Eligibility criteria:
inclusion criteria: * both sexes will be involved. * patients suffer from chronic ns-lbp for more than 3 months. * patients' age ranges from 18 to 40 years, and body mass index ranges from 18 to 25 kg/m2. * patients with sufficient cognitive abilities that enable them to understand and follow instructions. exclusion criteria: * history of spinal trauma or fractures. * osteoporotic patients. * patients using analgesics during the last 3 months. * pregnant or lactating females. * neurological musculoskeletal diseases that affect the lower back (eg, spondylosis, spondylolisthesis, disc injuries). * previous spinal surgery. * posture deformities. * cauda equina symptoms related to the spine, including changes in bowel and bladder control. * signs of severe pathology (eg, malignancy, inflammatory disorders). * patients with severe psychiatric disorders.
comparison of mechanical power calculations of volume control and pressure control modes

Conditions: Ventilator-Induced Lung Injury

Summary: the management of ards, which is one of the important problems of intensive care patients, has gained popularity with the pandemic. mechanical ventilation is an important life-saving treatment in ards patients. however, when not used correctly, it can cause ventilator-induced lung injury (vili). therefore, lung protective ventilation should be applied to minimize vili in ards patients. mechanical power is one of the parameters that guides intensivist in predicting vili.

the goal of mechanical ventilation in ards patients is to improve oxygenation by reducing the work of breathing . with this aim, the orientation towards sensitive ventilation strategies has increased in the light of experience and scientific data from the past to the present. today, the concept of mechanical power (mp) has been developed, which combines different variables, such as tidal volume, drive pressure, gas flow, respiratory rate, and peep, which have been associated with vili in various studies, into a single parameter. in this study, the investigators used the simplified mp equation (mpvcv (simpl)) developed by gattinoni et al. for power calculation in volume control mode and the simplified mp equation (mppcv(simpl)) developed by becher et al. for power calculation in pressure control mode. thus, the investigators aimed to compare the volume control and pressure control modes over the concept of mp.

Eligibility criteria:
inclusion criteria: * patients with confirmed covid-19 diagnosis in intensive care unit (icu) and diagnosed with ards according to berlin criteria * intubated patients which treated in the supine position on the second day of icu admission exclusion criteria: * patients with a known diagnosis of copd * patients experiencing hemodynamic instability during ventilation * prone pozisyonda olan hastalar * patients receiving inotropic support * patients with missing data
contribution of pancreatic αcells function to blood glucose regulation in chinese type 2 diabetics- the effect of sitagliptin on glucagon secretion, insulin secretion and insulin resistance in chinese type 2 diabetics

Conditions: Insulin Secretion; Insulin Resistance

Summary: 1. the purpose of this study is to determine whether sitagliptin therapy suppress glucagon release and improve glucose control in chinese type 2 diabetic. 2. there are different effects of sitagliptin therapy on blood glucose regulation, pancreatic alpha \& beta cell function are different in lean (bmi\ 25) chinese type 2 diabetics. 3. the purpose of this study is to determine whether glucagon release may contribute over 30% to the hyperglycemia in chinese type 2 diabetics.


Eligibility criteria:
inclusion criteria: 1. age: 25\~60 years 2. duration of disease \< 3 years,no drug treatment for diabetes 3. newly diagnosed type 2 diabetic patients (fasting plasma glucose \> 7.0mmol/l or/and 2h postprandial blood glucose\>11.1mmol/l who 1999) 4. fasting plasma glucose \< 10 mmol/l exclusion criteria: 1. type 1 diabetes 2. dka, infection and other stress status 3. autoimmune disease 4. hepatic and renal diseases

Keywords: glucagon dipeptidyl peptidase-4 inhibitor
evaluate anti-adhesive effect and safety of a mixed solid of poloxamer, gelatin and chitosan(mediclore®)

Conditions: Gynecologic Disease

Summary: the purpose of this study is to evaluate the efficacy and safety of mediclore®, as an antiadhesive barrier, which is made of poloxamer, gelatin and chitosan.


Eligibility criteria:
inclusion criteria: * patients with gynecological disease (benign disease) * patients who written informed consent * patients without clinically significant lab exclusion criteria: * having enrolled another clinical trials within 1 month * immunosuppression or autoimmune disease * anticoagulant, general steroids within a week from surgery * serious diseases (heart failure, renal failure, liver failure, uncontrolled hypertension, diabetes mellitus, coagulation deficiencies) * patients with previous history of surgery at the same operate site
intervention for monitoring of salt intake in hypertensive patients

Conditions: Hypertension; Salt; Excess

Summary: sodium is an essential nutrient for humans, but excessive sodium consumption is causally associated with high blood pressure and increase risk of cardiovascular diseases. dietary sodium consumption of greater than the recommended daily amount of 5 grams of salt or 2,000 mg of sodium is a major risk factor for cvd-related mortality. from recent national survey, thai people had consumed more than 9.1 g of salt per day, which was nearly two times above who reference level. dietary salt reduction was unsuccessful because of lacking awareness, and the higher threshold to detect salt taste in chronic high salt ingestion. to create awareness in the community, we should be educated, managed the environmental for salt reduction, and used salt meter to detect sodium content in daily food. this study aimed to compare the efficacy of intervention; education, reformulation, environmental change and used salt meter compared with standard treatment alone in terms of salt intake reduction and blood pressure.

a randomized-controlled trial was conducted in adult 18-70 years old with hypertensive patients (sbp\>130 mmhg) in uthaithani. participants were randomized to intervention groups (education, reformulation, environmental change and used salt meter) and control group (standard education and treatment). trial was followed up for 12 weeks. the primary objective was change in 24-hour urinary sodium excretion between groups and secondary objectives was change in systolic and diastolic blood pressure.

Eligibility criteria:
inclusion criteria: * adults 18-70 years of age with hypertension * systolic blood pressure \> 130 mmhg * provided informed consent to participate in the study exclusion criteria: * participants with end stage kidney disease * history of adjust antihypertensive agents or diuretic within 2 weeks before enrollment * pregnant or breastfeeding women * adjustment of any antihypertensive agents during study period * participants with salt supplement

Keywords: hypertension salt salt reduction
changes of cerebral glucose metabolism after 12 weeks of paroxetine treatment in panic disorder

Conditions: Panic Disorder

Summary: panic disorder is one of the most prevalent and disabling psychiatric disorders. brain regions such as amygdala, hippocampus, periaqueductal gray (pag), locus coeruleus, parahippocampal gyrus, frontal cortex, and thalamus has been reported to be related with the pathophysiology and treatment outcome in panic disorder. paroxetine has been used as primary agent for treatment of panic disorder but there is little information on how paroxetine affects the brain function in patients with panic disorder. the specific aim of this study is to examine the differences in brain activity between responders and nonresponders and to determine the predictor of paroxetine treatment in patients with panic disorder in terms of brain activity.


Eligibility criteria:
inclusion criteria: * panic disorder 20-60 years exclusion criteria: * history of major psychosis (schizophrenia or bipolar disorder), social phobia, obsessive-compulsive disorder, and generalized anxiety disorder, and posttraumatic stress disorder, alcohol abuse and dependence, current regular use of benzodiazepines * less than 17 on the ham-d

Keywords: panic disorder paroxetine pet
combined rf surgery of the tongue base and uvulopalatopharyngoplasty (uppp) for obstructive sleep apnea

Conditions: Sleep Apnea Syndrome

Summary: introduction: the aim of the study was to investigate the effectiveness of combined bipolar radiofrequency surgery of the tongue base (rfbt) and uvulopalatopharyngoplasty (uppp) in a single session for obstructive sleep apnea (osa) and to determine whether this combination is safe and well tolerated.


Eligibility criteria:
inclusion criteria: obstructive sleep apnea not treated by cpap exclusion criteria: a history of previous surgery for osa and only one level of airway obstruction