Kornimate/medical-research-clean huggingface dataset:
mecapegfilgrastim(peg-g-csf) for prophylaxis of chemotherapy-induced neutropenia in patients with lymphoma

Conditions: Chemotherapy-induced Neutropenia; Lymphoma

Summary: neutropenia is one of the most frequent adverse effects of chemotherapy, and the main factor to limit the dosage and the continuation of chemotherapy.a newly pegylated rhg-csf was independently developed by jiangsu hengrui medicine co., ltd, china. phase 1a, 1b and phase 2 trials have shown that pegylated rhg-csf has decreased renal clearance, increased plasma half-life, and prolonged efficacy in compare with ﬁlgrastim. this study is to evaluate efficacy and safety in chemotherapy-induced neutropenia of once-per-cycle mecapegfilgrastim injection(peg-g-csf) and daily g-csf in patients with lymphoma patients.

this is a randomized, controlled study. a total of 170 lymphoma patients who are eligible are planned to randomized assigned into two groups to receive mecapegfilgrastim fixed dose of 6 mg or filgrastim 5 µg/kg/day during chemotherapy. the primary endpoint is the duration of grade ≥3 neutropenia in cycle 1. the secondary endpoints include incidence of grade ≥3 neutropenia and febrile neutropenia (fn) in cycle 1-4, the pharmacoeconomics and safety profile are also evaluated.

Eligibility criteria:
inclusion criteria: 1. age 18 to 75 years; 2. patients with primary malignant lymphoma confirmed by histopathology or immunomolecular biology and requiring treatment with multi-cycle high-intensity chemotherapy regimen; 3. ecog performance status ≤ 1; 4. anc ≥1.5×109/l, plt≥80×109 /l, hb≥ 75g/l, wbc ≥3.0×109/l; 5. subjects with pregnancy ability must agree to use reliable contraceptive measures from screening to 1 year after treatment; 6. patients must sign informed consent and be willing and able to comply with the requirements of visits, treatment, laboratory tests and other research requirements stipulated in the research schedul. exclusion criteria: 1. lymphoma central involvement; 2. recipients of hematopoietic stem cell transplantation or organ transplantation; 3. currently conducting clinical trials of other drugs; 4. there is an uncontrollable infection with body temperature ≥38℃; 5. liver function examination: total bilirubin (tbil., alanine aminotransferase (alt. and ascetic aminotransferase (ast. were all 2.5 times the upper limit of the normal value of \>; if they were caused by liver metastasis, the upper limit of the normal value of \> was 5 times;renal function test: serum creatinine (cr. \>2 times the upper limit of normal value 6. patients with serious chronic diseases of heart, kidney, liver and other important organs; 7. patients with severe uncontrolled diabetes; 8. pregnant or lactating female patients.
effect and utilization of protected time among interns on extended duty-hour call shifts

Conditions: Fatigue; Sleep Deprivation; Depression

Summary: this study will test the feasibility and effectiveness of protected time for physicians in training during 30 hour shifts in a medical intensive care unit. the primary outcome will be fatigue. secondary outcomes include the amount slept while on call, depression, and burnout.

background: the institute of medicine has proposed 5 hour naps for residents on extended overnight call-duty shifts citing resident and patient safety. concerns raised about this recommendation include increased handoffs, truncated continuity, and if residents would be able to effectively use the protected time for sleep. objectives: the purpose of this study is to test if protected time for sleep during extended duty overnight shifts improves resident fatigue and if they actually utilize the time for sleep. methods: all interns rotating through the medical intensive care unit from october 2009 through october 2010 will work extended shifts every 3rd night. on sunday through thursday nights they will have a 5 hour protected period from 2 am to 7 am. during this time they will relinquish their pager and cell phone to the night float pgy2 or pgy3 who is already responsible for the icu patients. the four hours between 2 and 6 am are entirely protected. from 6 am to 7 am, interns will be expected to start computer rounding on the icu patients and to begin progress notes for the remaining members of the icu team but still have no pager, cell phone, or cross coverage duties. on friday and saturday nights there will be no protected time but these interns will have 42 consecutive hours off following their extended shift. results from the october 2009 to october 2010 protected time cohort of interns will be compared with two comparison groups from the same institution and the same medical intensive care unit during the academic year june 2008 to june 2009. the first comparison group is interns working 30 hour shifts every 3rd night without any protected time and an average of 80 hours per week. the second comparison group is interns working a maximum shift length of 16 hours and an average of 60 hours per week. the primary outcome will be measurement of fatigue (daytime multiple sleep latency tests). secondary outcomes include the amount slept as measured by actigraphy, assessment of burnout (maslach burnout inventory) and depression (beck depression inventory-ii).

Eligibility criteria:
inclusion criteria: * interns in the providence st. vincent medical center internal medicine residency program who are rotating through the medical intensive care unit. exclusion criteria: * refusal to consent to participate

Keywords: signs and symptoms internship and residency fatigue medical errors burnout, professional actigraphy personnel staffing and scheduling workload adult intensive care units prospective studies work schedule tolerance disorders of excessive somnolence guideline adherence internal medicine education
intensified multifactorial intervention in patients with type 2 diabetes and microalbuminuria

Conditions: Type 2 Diabetes

Summary: the purpose of this study is to determine whether intensified multifactorial intervention comprising both behaviour modification and polypharmacy can reduce the risk for late diabetic complications compared to standard treatment in patients with type 2 diabetes and microalbuminuria.

the overall description of the steno-2 study is stated in four protocols approved by the regulatory authorities in denmark. the protocol identification numbers are ka 92071gm (4 years intervention ), ka-99035g (8 years intervention ), ka-99035-gs (13 years follow-up since intervention start) and h-ka-99035-gs (21 year follow-up since intervention start). the aim of the study was to determine whether intensified multifactorial intervention comprising both behaviour modification and polypharmacy can reduce the risk for late diabetic complications compared to standard treatment in patients with type 2 diabetes and microalbuminuria. the primary end point after four years of intervention was to progression to diabetic nephropathy with other microvascular complications as secondary end points. the primary end point after eight years of intervention was a composite cvd endpoint with microvascular complications as secondary end points. the interventional part of the study was ended in december 2001 after a total of eight years of intervention. from that time on, all patients were followed in a post-trial study. also, during post-trial period all patients in both original treatment arms received similar treatment resembling the treatment given in the original intensive arm of the study. the aim of the post-trial follow-up was to investigate the effect of intensified multifactorial intervention on i) mortality and ii) years of life gained, respectively, with such an interventional approach. endpoints in the two parts of the post-trial follow-up: part one at 13 years since start of intervention: primary endpoint: total mortality. secondary endpoints: cardiovascular endpoints as defined previously; microvascular disease. part two at 21 years since start of intervention: primary endpoint: difference in median time to 50% mortality in each of the two original treatment groups secondary endpoints: cardiovascular endpoints as defined previously; recurrent cardiovascular events; microvascular disease.

Eligibility criteria:
inclusion criteria: * type 2 diabetes * microalbuminuria exclusion criteria: * stimulated serum c-peptide concentration less than 600 pmol/l * pancreatic insufficiency or diabetes secondary to pancreatitis * alcohol abuse * non-diabetic kidney disease * life-threatening disease with death probable within 4 years of study start
current value of axillary ultrasound in the staging of breast cancer. is bsgc still necessary?

Conditions: Breast Cancer

Summary: aus/fnac allows the identification of tumors without axillary tumor involvement, or with low axillary tumor burden, many of which do not benefit from slnb, in the staging of early breast cancer. objective: to calculate the negative predictive value of aus/fnac in those patients with breast cancer who meet acosog z0011 criteria.


Eligibility criteria:
inclusion criteria: * age ≥ 18 years * tumors with acosog z0011 criteria, except positive slnb (ct1-t2; cn0; breast-conserving surgery; whole-breast radiotherapy) * axillary study with aus/fnac. * slnb/alnd (gold-standard). exclusion criteria: * tumors without confirmation of axillary histologic status (no gold-standard) * tumor in pregnancy or breastfeeding. * tumors in the male. * tumors treated with neoadjuvant chemotherapy * tumors that do not meet acosog z0011 criteria. * tumors without axillary study using aus/fnac

Keywords: breast cancer axillary ultrasound sentinel lymph node biopsy axillary management
gerd treatment with transoral incisionless fundoplication (tif) following hiatal hernia surgery

Conditions: Gastro Esophageal Reflux

Summary: the investigators prospectively studied ninety nine gerd patients following laparoscopic hiatal surgery combined with transoral incisionless fundoplication at two community hospitals. general surgeons and gastroenterologists participated in the study. gerd questions were recorded before and at six and twelve months.

gerd unresponsive to medical therapies can be treated by laparoscopic nissen fundoplication or endoluminal techniques. the investigators have extensive experience with transoral incisionless fundoplication(tif). tif is not indicated in patients with a hiatal hernia larger than 2 cm. performing a hiatal hernia repair(hhr) in those cases will make a patient eligible for tif. hhr followed immediately by the tif procedure under the same anesthetic session is called a hybrid-tif (htif). the study examines the safety and efficacy of this approach. prospective data were collected from patients who underwent htif at two 300 bed community hospitals. questionnaires were administered before the procedure, and mailed at 6 and 12 mos. they were the gerd-hrql-health related quality of life, rsi-reflux symptom index, and gsrs-gastrointestinal symptom rating scale. the study continues with the new esophyx-z device

Eligibility criteria:
inclusion criteria: * patients with typical or atypical gerd who want a surgical solution to control symptoms. * patients need a 2-5 cm hiatal hernia and have a bmi of less than 36. exclusion criteria: * hiatal hernias larger than 5 cm and bmi greater than 36.

Keywords: gerd hiatal hernia repair transoral incision less fundoplication
mitochondria-targeted system therapy combined with radiofrequency ablation for early-stage non-small cell lung cancer

Conditions: Non Small Cell Lung Cancer

Summary: lung cancer is the leading cause of cancer related mortality. among them, non small cell lung cancer accounts for 85%. only part of patients could be treated with radical surgery. mitochondria-targeted system therapy combined with radiofrequency ablation could be an alternative treatment. small sample clinical cases verified that this therapy could be an efficacy and safe treatment in a short period. the primary aim of this trial is to determine if the efficacy of mitochondria-targeted system therapy combined with radiofrequency ablation is comparable to that of standard surgical interventions for patients with non-small cell lung cancer.


Eligibility criteria:
inclusion criteria: * the patient can understand and voluntarily join the study, sign the informed consent form, and the compliance is good. * patients with single nodule. * before iib period according to the eighth edition of the tnm staging period. * no mediastinal lymph node metastasis. * no prior anticancer treatments including surgery, radiation,chemotherapy or local treatments. * eastern cooperative oncology group performance status of 0 to 1 * sufficient organ functions exclusion criteria: * active bacterial or fungous infection. * simultaneous or metachronous (within the past 5 years) double cancers. * patients with contraindications to radiofrequency ablation and inability to complete treatment; * women during pregnancy or breast-feeding. * uncontrollable diabetes mellitus. * patients with severe heart, lung, kidney disease or other systemic diseases who have been judged to have a severe impact on survival or who are pre-assessed to be unable to tolerate thoracoscopic surgery
soluble beta-glucan (sbg) as treatment for diabetic foot ulcers

Conditions: Chronic Diabetic Foot Ulcers

Summary: the purpose of this study is to determine whether the application of soluble beta-glucan (sbg) onto diabetic foot ulcers improves the healing of the ulcers.


Eligibility criteria:
inclusion criteria: * type 1 or type 2 diabetes mellitus * age ≥ 18 years * one or more full-thickness ulcers at or below the level of the malleoli, which do not extend to tendon, joint, or bone * the ulcer (or index ulcer, if appropriate) must have been present for at least 4 weeks prior to day 0 but not longer than 2 years * ankle:brachial pressure index (abpi) \>0.7, or the presence of two palpable pulses on the affected foot * ulcer area \>25 mm2 but \<500 mm2 * written informed consent exclusion criteria: * pregnancy, lactation or absence of adequate contraception for women with child bearing capacity * abpi \< 0.7 * serum albumin \< 2.0 g/dl * gangrene on any part of the foot with the study ulcer * presence of signs of clinically significant foot infection on day 0 * chronic renal failure with calculated gfr \<30 ml/min * surgical procedure (other than debridement) on the foot with the study ulcer in the 28 days prior to day 0 * hba1c 12% or more * current alcohol or drug abuse * participation in other studies in the preceding 28 days * an ulcer on a foot affected by acute charcot osteoarthropathy
clinical trial of deferasirox combination treatment with deferiprone in thalassaemia patients

Conditions: Beta-thalassemia Major

Summary: background: three iron chelators now available on the market differ in toxicity and organ specificity; evidence on standardized chelation protocol remains inconclusive, but patients with transfusion-dependent beta-thalassemia treated with dfo infusion show significant differences in the limitations of daily activities, physical activity, and quality of life when treated with oral chelator. with licensing of dfp in america, it is reasonable to combine dfp with dfx. patients find two oral chelators more acceptable than one oral and one injectable. this pilot study rates use of dfp for improving iron excretion profile of deferasirox. methods: the investigators enrolled 13 beta-thalassemia patients in china medical university children's hospital in may 2009-october 2011. five refused to take part in pharmacokinetics; they only participated in iron excretion study. seven with irregular bowel function were unable to collect feces in the screening period as baseline data. subjects were randomly assigned and rotated to undergo all treatments (with informed consent): (a) single oral dose of dfx 30 mg/kg once daily, (b) single oral dose of dfp 40 mg/kg twice a day, (c) oral doses of dfx and dfp administered sequentially (dfx 30 mg/kg/d, deferiprone 40 mg/kg/d and deferiprone 40 mg/kg/d at 7-hour intervals). three-day drug dosage was followed by four-day washout. collections of urine and stool proceeded 24 hours per day, each analyzed separately. through a venous catheter, serial blood samples (1 ml/each sampling) were collected in glass tubes containing heparin as anticoagulant at time 0 (pre-dosing) and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 6, 7, 8, 10, 12 and 24 hours after dose; plasma concentrations of dfp and dfx were measured.


Eligibility criteria:
inclusion criteria: * 18 years of age or older * serum ferritin greater than 2000 ng/ml, * serum creatinine within normal range for a measuring laboratory * platelet count exceeding 140000/mm3 * body weight at least 40 kg * none had a history of clinical significant of gastrointestinal, hepatic, renal, endocrine, oncologic, infectious, pulmonary or cardiovascular disease exclusion criteria: * hiv positive, history of immunologic hypersensitivity to any medication * women pregnant or breast feeding * drug or alcohol abuse * patients showed abnormal or irregular bowel function (defined as more than three bowel movements a day or less than one bowel movement every other day) * receiving warfarin, digoxin, or anti-arrhythmic or antiseizure medication.
efficacy and safety study of xp12b in women with menorrhagia

Conditions: Menorrhagia; Heavy Menstrual Bleeding

Summary: the purpose of this study is to determine whether xp12b is effective and safe in the treatment of women with heavy menstrual bleeding associated with menorrhagia.


Eligibility criteria:
inclusion criteria: * women with menorrhagia * 18-49 years of age * regularly occurring menstrual periods exclusion criteria: * history or presence of clinically significant disease or abnormalities that may confound the study * history of bilateral oophorectomy or hysterectomy * hormone therapy

Keywords: heavy menstrual bleeding menorrhagia
use of biofeedback and virtual reality as facilitators of emotional recognition in the treatment of aggressive outbursts

Conditions: Passive-Aggressive Personality Disorder

Summary: the methodology will be applied for the treatment of aggressive episodes. many people show this kind of behavior associated with several psychological disorders like austistic spectrum disorder (asd). it will be studied the effect of aggressive outbursts on several physiological signals (heart rate (hr), breathing rate (br), electroencephalography (eeg), etc). the use of those signals in a biofeedback loop could help patients recognize their internal states and avoid imminent aggression. the study want to verify the efficacy of a cognitive therapy that includes biofeedback and virtual reality (vr) and find out the most significant physiological features that are affected by these episodes.

the first goal is to register the scene together with physiological values before, during and after at least up to four aggressive outbursts at home. next an outburst is induced and physiological signals before, during and after the aggressive episode are recorded. after it the participants go to a new relaxation phase for another 10-minute period using the vr. in following sessions, they are trained to identify their physiological response when they are relaxed and when an outburst is coming. to do that, the vr system receives and shows the physiological information on the virtual scenario. in following sessions, teenagers are then treated with cognitive, behavioral and emotional self-regulation therapies, which have proven their effectiveness for managing anger and learning positive coping skills. the underlying theory is that people can minimize their negative feelings and behaviors when they are aware of their irrational beliefs and work to change their minds, by focusing on them continuously. at the end of the experiment, the number of aggressive episodes in the last weeks of the intervention will be measured. the differences between the new scores, with respect to the initial ones, will be used to assess the efficacy of the intervention.

Eligibility criteria:
inclusion criteria: * previous diagnosis of adhd, asperger syndrome or oppositional defiant disorder (odd) combined with a lack of control of their aggressiveness. * positive impulsivity result obtained with any of the fol- lowing tests: score lower than 25 in cacia \[13\], lower than 50 in capi-a \[14\], greater than 75 in stroop \[15\] or greater than 115 in wcst \[16\]. * intermittent outburst episodes (verbal aggression includ- ing both arguments and temper tantrums, and physical aggression towards self or others) with a frequency of once a week in the two months prior to the beginning of the intervention. exclusion criteria: * participants will be excluded if they report (a) current (past month) psychopharmacotherapy, (b) a history of bipolar or psychotic disorder, or (c) a traumatic head injury with a loss of consciousness in excess of 60 minutes.

Keywords: aggressive episodes emotional dysregulation physiological signals virtual reality biofeedback
a new oxygen mask for carotid endarterectomy under local anaesthesia

Conditions: Stroke; TIA; Surgery; Anaesthesia; Carotid Stenosis

Summary: the purpose of this study is to determine the effectiveness of oxygenation and patient-acceptability of a novel oxygen face mask in patients undergoing carotid endarterectomies (ceas).

carotid endarterectomy (cea) is a procedure to remove plaques from a carotid artery (one of the two main arteries supplying blood to the brain). the procedure is effective at reducing the risk of subsequent stroke. to access the artery, an incision is made in the artery wall which means that the artery must be clamped in order to prevent blood loss. consequently, the blood supply (and therefore oxygen supply) to the brain is reduced. to ensure that the patient has sufficient oxygen to avoid brain damage, this procedure is often carried out under local anaesthetic as this means the anaesthetist can talk to them during the operation; by this means they can determine the patient's conscious level and whether or not they need supplementary oxygen. there are various ways to administer the supplementary oxygen. most oxygen masks completely cover the mouth and nose which inevitably limits patient-doctor communication. oxygen is therefore usually administered via nasal tubes. however, the actual level of oxygen taken in by the patient is very hard to measure, and at best is only 40%. a novel mask with an open design. by creating a 'vortex' of oxygen it can deliver higher concentrations of oxygen to the patient without significantly interfering with doctor-patient communication and, at the same time, improving patient comfort. we wish to test the efficacy of this mask during cea and plan to do this by measuring the oxygen content of blood directly using blood samples; we also monitor markers of brain damage which may occur from lack of oxygen. finally, we will survey the patients as to acceptability of the mask.

Eligibility criteria:
inclusion criteria: * male or female * booked for carotid endarterectomy under local anaesthetic * competent to consent to inclusion exclusion criteria: * patient refusal and inability to provide consent * patients who are unable to understand instruction or communicate effectively * aged below 16 years * decreased conscious level during the period of study

Keywords: endarterectomy, carotid carotid stenosis oxygen mask