Kornimate/medical-research-clean huggingface dataset:
study of individualized therapy on hyperphosphatemia in maintenance hemodialysis patients

Conditions: Hyperphosphatemia; End-stage Renal Disease

Summary: this study is designed to study and compare the efficacy and cost-effectiveness of individualized phosphate-lowering therapy in comparison with regular guideline-recommended therapy.

hyperphosphatemia in hemodialysis patients has been one of the most difficult conundrums for nephrologist for the past two decades. elevated phosphate contributes to secondary hyperparathyroidism, elevated fgf23 levels, and vascular calcification, which in turn predispose to mortality in this population. current guidelines recommend limiting dietary phosphate intake, strengthening dialysis and using phosphate binders as three therapies for treatment of hyperphosphatemia. yet exact clinical implication remains ambiguous: how intense restricted phosphate intake should be and how dosage of phosphate binders and dialysis should be adjusted accordingly. thus, treatments of hyperphosphatemia have not been effective enough, but appear to be refractory. in the current study, the investigators designed individualized phosphate-lowering therapy based on each patient's phosphate-clearing ability, in order to observe and compare the efficacy and cost-effectiveness of the individualized therapy and the regular guideline-recommended therapy.

Eligibility criteria:
inclusion criteria: * aged 18-70 years' old * dialysis vintage more than 3 months on maintenance hemodialysis patients * using internal arteriovenous fistula * s\[p\] \> 1.45 mmol/l, pth (parathyroid hormone, pth) \< 900 ng/ml * no residual renal function (rrf) * stable dietary habit * clear consciousness and capable of communication * willingness to give written consent and comply with the study protocol exclusion criteria: * severe infection, anemia (hb \< 60 g/l), hypoproteinemia (alb \< 30 g/l) * pregnancy, lactating women * history of severe coexisting diseases such as, but not limited to, chronic liver disease, myocardial infection, cerebrovascular accident, malignant hypertension * history of malignancy * participation in other dietary, drug-related, or any other clinical trials within 1 month * history of complications related to elevated s\[p\] such as, but not limited to primary hypoparathyroidism, type ii vitamin d dependent rickets * history of non-compliance * intolerance to the individualized therapy * in use of calcitonin and diphosphonate

Keywords: individualised therapy hyperphosphatemia hemodialysis clinical trials restricted phosphate diet phosphate binders
adherence, efficacy and safety of an insulin protocol in the critically ill: a prospective observational study

Conditions: Critically Ill Patients

Summary: there is a growing body of evidence in the literature regarding the adverse effects of hyperglycemia in critically ill patients. to target and maintain better blood glucose regulation we implemented an insulin protocol with target blood glucose levels between 81-110 mg/dl.


Eligibility criteria:
inclusion criteria: * surgical or medical critically ill patients * an expected icu-stay of more than 72 hours * age \> 16 years * need for insulin therapy * patients must have an arterial line exclusion criteria: * patients who did not respond to the inclusion criteria * patients with diabetic ketoacidosis * cardiac surgical patients * patients transferred from other hospitals * other study enrollment
effect of calanus oli on intra-abdominal fat, glucose tolerance and lipids in man

Conditions: Overweight

Summary: preliminary studies in rats and mice indicate that calanus oil reduce accumulation of intra-abdominal fat. pilot studies in humans have shown no adverse effects. in the present study 120 subjects, males and females, 20-65 years old, bmi 25-30 kg/m2 will be included and given calanus oli 1 g twice daily versus placebo for 1 year. the hypothesis is that calanus oil will reduce intra-abdominal fat, improve glucose tolerance and lipid profile.


Eligibility criteria:
inclusion criteria: * body mass index (bmi) 25-30 kg/m2 * age 20-65 years exclusion criteria: * diabetes * coronary heart disease last 12 months * unstable angina pectoris * cancer diagnosed the last 5 years * use of lipid lowering drugs * seafood allergy
registry of patients with acute/subacute type b aortic dissection treated by means of the stabilise technique (stabilise)

Conditions: Aortic Dissection

Summary: the aim of the study is to evaluate results of patients treated with the stabilise technique for acute/subacute aortic dissection. results and postoperative events are reported in accordance with the current reporting standards for endovascular aortic repair prepared and revised by the ad hoc committee for standardized reporting practices in vascular surgery of the society for vascular surgery/american association for vascular surgery


Eligibility criteria:
inclusion criteria: * patients with ≥ 18 years of age; * patients presenting with an acute (up to two weeks from the onset) and subacute (between 3 and 12 weeks from the onset) type b dissection with a proximal suitable non-dissected landing zone in the aortic arch or descending thoracic aorta (supra-aortic trunks debranching may be employed to obtain an adequate proximal landing zone); * total aortic diameter of the abdominal aorta (from supra-celiac to infra-renal level) must not exceed 42 mm; * patients able to sign specific informed consent for the study. exclusion criteria: * patients with chronic type b aortic dissection (more than 12 weeks from the onset); * patients with acute type b aortic dissection not treated according to the following treatment protocol; * unwilling or unable to comply with the follow-up schedule; * inability or refusal to give informed consent; * simultaneously participating in another investigative device or drug study; * frank rupture; * systemic infection (eg, sepsis); * allergy to stainless steel, polyester, solder (tin, silver), polypropylene, nitinol, or gold; * untreatable reaction to contrast, which, in the opinion of the investigator, cannot be adequately premedicated; * surgical or endovascular aaa repair within 30 days before or after dissection repair; * previous placement of a thoracic endovascular graft; * prior open repair involving the descending thoracic aorta, including the supra-renal aorta and/or arch; * interventional and/or open surgical procedures (unrelated to dissection) within 30 days before or after dissection repair.
comparing relative peripheral refraction on myopia progression

Conditions: Myopia

Summary: the investigators will test our hypothesis that parameters on peripheral defocus can regulate eye growth: for instance, the relative peripheral refraction measured by multispectral refraction topography (mrt) would be significant different between two groups: fast speed and slow speed of axial length elongation (myopia progression) for 1 year with 2-3 follow-ups. the goal of this observation study is to confirm the value of mrt in clinic. could it predict myopia progression or not? by the parameters on relative peripheral refraction in children myopia, could include any of the following: both genders, 7\~17 years age groups, including healthy volunteers. the main question it aims to answer is: is any of relative peripheral refraction parameters measured by mrt could guide the clinics for predict myopia progression? which parameters from mrt could predict the myopia fast progression at baseline ? there is a comparison between groups. researchers will compare fast myopia progression group versus slow myopia progression group to see if any parameters differs at baseline. participants will be asked to the collection methods (such as spectacles, orhtokeratology, contact lens) and interventions; and each participant would be followed up for at least 2 times in one year to test the axial length and refractive error as well as parameters with mrt.

visual signals from the surrounding retina play a crucial role in the process of emmetropization in the peripheral area of retina and may be a key factor in the development of myopia. peripheral defocus can regulate eye growth, particularly peripheral hyperopic defocus, which is a high-risk factor for promoting eye growth and the onset and progression of myopia. in recent years, with the establishment of new experimental animal models and the emergence of new detection technologies, the relationship between peripheral defocus and myopia has received increasing attention. the axial length of the eye is the most important indicator for assessing myopia progression. about 7000 students from ningbo would be follow-up for the mrt and their myopia progression for at least 1 year.

Eligibility criteria:
inclusion criteria: * will to attend the baseline and all the follow-ups * sign the inform consent form * could co-operate to ask for the correction and accept the axial length measurement and refraction devices including mrt * without eye surgery and trauma history * his/her refractive error and axial length could be measured exclusion criteria: * without data of primary outcome * with only one measurement * others condition that investigators consider not elilgible

Keywords: myopia progression peripheral myopia defocus children refraction
effectiveness of bronchodilator nebulization with and without noninvasive ventilation in copd

Conditions: Chronic Obstructive Pulmonary Disease (COPD); Type 2 Respiratory Failure

Summary: the study aim to evaluate effectiveness of two bronchodilator nebulization strategies in patients with acute decompensated type 2 respiratory failure due to acute exacerbation of chronic obstructive pulmonary disease..

decompensated type 2 respiratory failure during acute exacerbation of chronic obstructive pulmonary disease (copd) is treated with non-invasive ventilation (niv) and nebulized bronchodilators. nebulization during niv can be applied by two methods: in-line nebulization through niv mask and off-niv nebulization during which niv mask is taken off for a short time and reapplied when nebulization is finished. this study is a prospective randomized controlled trial to compare in-line nebulization through niv versus off- niv nebulization. after starting niv in eligible copd patients with type 2 respiratory failure, the baseline end-expiratory lung impedance (eeli) will be measured. patient is randomized to receive either in-line or off-niv nebulization. eeli will be measured again following completion of the nebulization, 15min after niv is restarted (off-niv group) or continued (in-line group). ultrasound measurement of the thickness of the diaphragm will be recorded at baseline, 15min after niv is restarted (off-niv group) or continued (in-line group) and 48 hours after stopping the niv. the main outcome measure, difference in mean end expiratory lung volume at 15min after niv is restarted (off-niv group) or continued (in-line group) between the two nebulization methods will be compared using independent sample t test. thickness of the diaphragm and changes in the arterial blood gases (in terms of ph and carbon-di-oxide) will be compared between in-line nebulization and off-niv nebulization.

Eligibility criteria:
inclusion criteria: 1. age ≥21 years. 2. known or suspected copd (defined by a ratio of forced expiratory volume in 1 second (fev1) to forced vital capacity (fvc) of less than 0.7). 3. acute decompensated type 2 respiratory failure (abg ph ≤ 7.35 and paco2\>45mmhg). 4. clinical decision made to start niv. exclusion criteria: 1. other acute decompensated type 2 respiratory failure related conditions (e.g. neuromuscular, heart failure etc.). 2. pneumonia present in the chest radiograph. 3. other conditions which may change lung impedance (e.g. heart failure or lung fibrosis).

Keywords: chronic obstructive pulmonary disease (copd) nebulization respiratory failure non-invasive ventilation(niv)
a comparison of static and dynamic pet/ct (hypothesis generation study)

Conditions: Oncology; Infections; Inflammation

Summary: the general purpose of this initial study is to evaluate whether parametric pet/ct improves diagnosis and treatment monitoring in select diseases. the specific aim of the hypothesis generation study is: 1. to obtain and compare parametric as well as traditional static pet/ct images and determine the number of lesions identified on each type of scan.

the hypothesis generating study will include a wide range of patients scheduled for pet/ct as part of either pre-therapy staging or treatment response. most scans will be performed with fdg, with indications for pet/ct including hematological, urogenital, thoracic and gynecological malignancies as well as patients with suspected infections and inflammation. we will also include patients referred for pet/ct using other radiotracers, such as tumour markers (68ga-dotatoc, 18f-fdopa, 68ga-psma, 18f-psma). instead of the usual procedure of having the injection of the radiotracer in the waiting room and having to wait 60 minutes before being moved to the scanner room for imaging, the study participants will be injected with the radiotracer already laying on the scanner bed and the scan will commence immediately. therefore, in this study the patients are still only being scanned once, but we are gathering pet information in a different way.

Eligibility criteria:
inclusion criteria: * patients with a planned clinical standard pet/ct as part of pre-therapeutic staging, response assessment scanning or evaluation of infection/inflammation. * good performance status, which permits patients to lay still in the scanner for ca. 70 min. exclusion criteria: * age \ 85 years * patients that can not tolerate a pet scan (f.ex: claustrophobia).

Keywords: pet/ct fdg dynamic whole-body
tacrolimus as secondary intervention vs. continuation of cyclosporine in renal transplant patients with chronic renal allograft failure (craf)

Conditions: Renal Transplantation; Chronic Renal Allograft Failure

Summary: the purpose of this study is to compare renal transplant recipients on cyclosporine maintenance therapy vs. those converted to tacrolimus-based immunosuppression with respect to renal outcomes.

the objective of this study is to compare the incidence, progression and severity of chronic renal allograft failure in at-risk patients who are converted from cyclosporine to tacrolimus-based immunosuppression to patients who remain on cyclosporine.

Eligibility criteria:
inclusion criteria: * patient is at least 3 months post-transplant of a cadaveric or living donor kidney * patient has been on a cyclosporine-based immunosuppression regimen since the transplant * patient has one of the following risk factors for chronic renal allograft failure at the baseline biopsy: * serum creatinine: male: \>=2.0mg/dl (176.8 umol/l); female: \>= 1.7mg/dl (150.28 umol/l) 3 months or later post-transplant * serum creatinine \> 30% increased over post-discharge nadir * patient has had a renal biopsy \> 3 months after transplant and within 6 months prior to enrollment * patient or legal guardian has signed and dated an irb approved informed consent document * female patient has a negative pregnancy test and agrees to practice effective birth control while receiving mycophenolate mofetil (mmf) exclusion criteria: * patient is dialysis dependent and has recurrence of primary or de novo renal disease * patient has an estimated creatinine clearance \<25ml/min * patient has changed maintenance immunosuppressant therapy (e.g., azathioprine to mmf) within 3 months of randomization * baseline biopsy shows acute rejection grade \>=iib using banff 95 criteria or \>= grade iia using banff 97 criteria * patient requires antilymphocyte therapy to treat rejection at baseline or post-baseline biopsy * patient has received an investigational immunosuppressant within 3 months, or has a known hypersensitivity to tacrolimus, or any excipients of the drug * patient is a known carrier of any of the hiv viruses

Keywords: renal transplant cyclosporine tacrolimus intervention interstitial fibrosis tubular atrophy chronic renal allograft failure
effect of gelsectan® in the treatment of low anterior resection syndrome

Conditions: Low Anterior Resection Syndrome

Summary: low anterior resection syndrome (lars) is an intestinal disorder affecting patients undergoing rectal resection for rectal cancer. a possible therapeutic option may be gelsectan®, a class ii device used in irritable bowel syndrome (ibs). the aim of this study is to evaluate the efficacy of gelsectan® in improving the symptoms of lars.

low anterior resection syndrome (lars) affects almost 70% of patients after rectal resection for rectal cancer and is characterized by intestinal symptoms including urgency, fractioned defecation, and fecal incontinence. lars is clinically diagnosed using the lars score: a score higher than 21 indicates the presence of lars and a score higher than 30 indicates severe lars. the treatment opportunities for lars are limited and failure rates are high. gelsectan® is a class ii device containing xyloglucans, xylo-oligosaccharides, pea proteins, and tannins from grape seeds extract, resulting effective in improving intestinal symptoms in patients with diarrheic irritable bowel syndrome (ibs). given the symptomatic similarities between lars and ibs, gelsectan® may represent a valid first line treatment for lars patients. the objective of this study is to provide preliminary data to determine whether the administration of gelsectan® may ameliorate the symptoms of lars.

Eligibility criteria:
inclusion criteria: * patients aged more than 18 years old. * patients who underwent low rectal resection for rectal cancer and who closed the ileostomy at least three months before the screening visit. * patients with a lars score ≥21 and/or clinically relevant symptoms of urgency, increased stool frequency, or fecal incontinence. * patients indicated to treatment with gelsectan® according to the clinical judgment. * oncological chemotherapy or radiotherapy completed at least four weeks before the screening visit. * presence of a functional, intact anastomosis. * female patients of childbearing potential must agree to use a reliable method of contraception. exclusion criteria: * known hypersensitivity to the investigational medicinal product (imp). * any condition that, in the opinion of the investigator, may interfere with the study procedures. * significant anastomotic complications (e.g., strictures, fistula), which may impair the treatment efficacy. * pregnant or breastfeeding women. * inability to comply with the study procedures.

Keywords: low anterior resection syndrome rectal cancer xyloglucans xylo-oligosaccharides
mers-cov infection treated with a combination of lopinavir /ritonavir and interferon beta-1b

Conditions: Middle East Respiratory Syndrome Coronavirus (MERS-CoV)

Summary: this is a placebo-controlled clinical trial to assess the efficacy and safety of a combination of lopinavir/ritonavir and interferon beta-1b in hospitalized patients with mers.

the aim of this study is to investigate the efficacy and safety of lopinavir /ritonavir and recombinant interferon beta-1b combination given with optimal supportive care compared to placebo with optimal supportive care for patients with laboratory-confirmed mers-cov infection requiring hospital admission.

Eligibility criteria:
inclusion criteria at eligibility assessment 1. adult (defined as ≥18 years of age); 2. laboratory confirmation of mers-cov infection by reverse-transcription polymerase chain reaction (rt-pcr) from any diagnostic sampling source; and 3. new organ dysfunction that is judged to related to mers including: hypoxia defined as requirement of supplemental oxygen to maintain oxygen saturations \>90%, hypotension (systolic blood pressure\ 25% from baseline or urine output of \<0.5 ml/kg for 6 hours - risk stage by rifle criteria), neurologic (reduction of glasgow coma scale by 2 or more, i.e. 13 or lower of 15 points), thrombocytopenia (\<150,000 platelets/mm3) or gastrointestinal symptoms that requires hospitalization (e.g. severe nausea, vomiting, diarrhea or/and abdominal pain). exclusion criteria at eligibility assessment 1. suicidal ideation based on history (contraindication to interferon (ifn)-β1b); 2. known allergy or hypersensitivity reaction to lopinavir/ritonavir or to recombinant ifn-β1b, including, but not limited to, toxic epidermal necrolysis, stevens-johnson syndrome, erythema multiforme, urticaria or angioedema; 3. elevated alanine aminotransferase (alt) \>5 fold the upper limit in the hospital's laboratory; 4. use of medications that are contraindicated with lopinavir/ritonavir and that cannot be replaced or stopped during the study period, such as cyp3a inhibitors; 5. pregnancy - eligible and consenting female participants in childbearing age will be tested for pregnancy before enrollment in the study; 6. known hiv infection, because of concerns about the development of resistance to lopinavir/ritonavir if used without combination with other anti-hiv drugs; or 7. patient likely to be transferred to a non-participating hospital within 72 hours.

Keywords: middle east respiratory syndrome coronavirus mers-cov clinical trial lopinavir ritonavir interferon beta
improving overactive bladder treatment access and adherence

Conditions: Overactive Bladder Syndrome; Urinary Incontinence

Summary: overactive bladder (oab) and urinary incontinence (ui) are chronic debilitating and embarrassing conditions that affect 33 million americans. yet, both are underdiagnosed and undertreated with significant financial and health-related consequences. oab syndrome is characterized by urinary urgency, with and without urinary incontinence, urinary frequency, and nocturia. evidence-based treatments are available, including behavioral therapy, pharmacotherapy, and minimally invasive procedures. diagnosis and treatment are also associated with improvement in urinary symptoms and overall quality of life (qol).3 however, 70-80% of treated patients will discontinue use of therapy in the first year due to one of several factors (e.g., cost, tolerability, inadequate effect). in addition, only 4.7% progress to advanced therapies suggesting undertreatment for those that need it most. vulnerable populations are especially at risk, as therapy utilization are lowest among older, lower income, and/or minority groups. poor access, insufficient patient education regarding disease chronicity, expected outcomes, costs, and potential side effects lead to unrealistic patient perceptions about therapy. this leads to suboptimal therapy duration, poor treatment efficacy, adherence, and undertreatment. the study aims to evaluate a tailored patient-centered tool to begin the treatment process.


Eligibility criteria:
inclusion criteria: * female aged 18 years or older * oab symptoms for at least 3 months * english/spanish language skills and cognitive status sufficient to complete all study related materials * behavioral treatment naïve patients * previously treated oab patients without supervised pelvic floor physical therapy or pharmacotherapy within 1 year exclusion criteria: * post void residual urine \> 150ml * confirmed diagnosis of interstitial cystitis/painful bladder syndrome (ic/pbs) * pregnant or breastfeeding patients * patients residing in a nursing home * comorbid neurological conditions, including spinal cord injury, progressive neurologic illnesses (e.g. multiple sclerosis, parkinson's disease) or central nervous system disease (e.g. brain tumor, stroke) * stage 2 or greater pelvic organ prolapse * any history of urethral stricture * any history of pelvic irradiation * any history of bladder malignancy * current symptomatic urinary tract infection (uti), unresolved by the time of enrollment * hematuria without a clinical evaluation * history or current use of indwelling urinary foley catheterization, suprapubic tube or intermittent catheterization * patients with ui treated with onabotulinumtoxina, sacral neuromodulation, or percutaneous tibial nerve stimulation (third line therapies)