Kornimate/medical-research-clean huggingface dataset:
low-level laser therapy versus high frequency on pressure ulcers treatment

Conditions: Pressure Ulcer

Summary: patients admitted in the emergency service that have pressure ulcers will be selected by eligibility criteria and randomized into three groups according to the adopted therapy: wound dressing (cg); wound dressing + high-frequency generator group (gaf); and wound dressing + low-level laser therapy group (glbp).

wound dressing is considered the standard treatment for pressure ulcers, however, despite its proven efficacy, it's a long-term healing process. among physiotherapy resources available for pressure ulcers treatment, the most used are low-level laser therapy and high-frequency generator. even though the individual effects of both are evidenced on literature, there are no randomized clinical trials evidencing the effects of low-level laser therapy and high-frequency generator in comparison to wound dressing on pressure ulcers treatment.

Eligibility criteria:
inclusion criteria: * pressure ulcers with rate ii or iii; * not receiving pressure ulcer treatment. exclusion criteria: * presence of necrotic tissue needing debridement * pregnancy * discomfort during treatment * pressure ulcers with area bigger than 30cm2 * extensive tunneling * diabetes mellitus (dm) * severe metabolic disease * use of corticosteroids or vasopressors * immunosuppression * pacemaker * neoplasia * hemorrhage * sensibility disorders * metalic device.

Keywords: pressure ulcer low level laser therapy dressings
evaluation of a novel diagnostic kit for the detection of placental alpha-microglobulin-1 in the prediction of preterm birth in women presenting with signs and symptoms of preterm labor

Conditions: Preterm Birth

Summary: currently, the american college of obstetricians and gynecologists (acog) indicate in their most recent practice bulletin on the management of preterm labor that many tests to identify women at risk of preterm birth have been proposed and evaluated; however, only ultrasonography and fetal fibronectin testing have been shown to have benefit. ultrasonography to determine cervical length, fetal fibronectin testing, or a combination of both may be useful in determining which women are at high risk for preterm delivery. however, their clinical usefulness may rest primarily with their ability to identify women who are least likely to deliver (i.e. their negative predictive value). therefore, there is an urgent need for a test with a high positive predictive value in order to accurately predict imminent delivery to allow for salutary intervention.


Eligibility criteria:
inclusion criteria: * patients presenting for emergency obstetrical care at an emergency room or labor \& delivery unit with signs, symptoms or complaints suggestive of preterm labor (ptl) * uterine contractions, with or without pain * intermittent lower abdominal pain * dull backache * pelvic pressure * bleeding during the second or third trimester * menstrual-like or intestinal cramping, with or without diarrhea * patient is not "feeling right" * gestational age between 200/7 and 366/7 * consenting to be part of the trial exclusion criteria: * presented for regularly scheduled obstetrical care with symptoms * \< 18 years old and not emancipated consenting minor * \ 30 mm * cervical dilatation \> 3 centimeters * overt rupture of the fetal membranes (rom) as indicated by visualized leakage of fluid from the cervical os * heavy vaginal bleeding * received tocolytic medications for treatment of threatened preterm delivery prior to collection of the cervicovaginal specimens or cervical length measurements * suspected placenta previa * cervical cerclage in place * a symptom not associated with idiopathic threatened preterm delivery (e.g. trauma) * digital exam prior to specimen collection
application of citrate dialysate in chronic haemodialysis

Conditions: Chronic Renal Disease

Summary: study investigating the safety and efficacy of the citrate dialysis solution compared to standard acetate dialysis solution. use of citrate dialysis solution is not associated with a clinically relevant development of adverse events. it is hypothesized that citrate dialysate may provide a local anticoagulation effect in the dialyser improving removal of uremic toxins.

it is hypothesized that citrate dialysate may provide a local anticoagulation effect in the dialyser improving removal of uremic toxins. study investigating the safety and efficacy of the citrate dialysis solution compared to standard acetate dialysis solution. use of citrate dialysis solution is not associated with a clinically relevant development of adverse events.

Eligibility criteria:
inclusion criteria: * signed informed consent * patients of either sex aged ≥ 18 years * stable chronic dialysis patients undergoing a 3x/week high-flux dialysis for at least three months * patients without planned or predictable changes within diet, anticoagulation and medication regimen exclusion criteria: * pregnancy or lactation or woman in child bearing age without effective contraception * planned surgeries or hospital stay within the next 9 weeks * use of catheter as vascular access for dialysis * severe comorbidities not allowing to follow the study protocol * concomitant participation in another study * previous participation in this study

Keywords: citrate dialysate dialysis calcium
tamoxifen resistance in women with stage i, stage ii, stage iiia, or stage iiib breast cancer

Conditions: Breast Cancer

Summary: rationale: studying samples of blood from patients with breast cancer in the laboratory may help doctors identify and learn more about biomarkers related to tamoxifen resistance. purpose: this laboratory study is looking at tamoxifen resistance in women with stage i, stage ii, stage iiia, or stage iiib breast cancer.

objectives: * identify women who are resistant to tamoxifen citrate and other drugs for the treatment of breast cancer by testing their plasma for the presence of proteins (e.g., macrophage migration inhibition factor) encoded by resistance-inducing genes (rigs). * provide retrospective data on the predictive value of rigs to serve as the basis for a prospective clinical trial of these genes as predictors of drug resistance. outline: this is a multicenter study. patients are stratified according to response during tamoxifen citrate (tam) therapy (resistant group \[i.e., those who develop recurrent breast cancer while being treated with tam\] vs conditionally sensitive group \[i.e., those who have disease-free survival for over 3 years after initial diagnosis while being treated with tam\]). patients undergo blood collection at baseline, within 3 weeks of initiation of tam therapy, and then every 6 months for 3 years or until relapse, whichever comes first. samples are analyzed by enzyme-linked immunosorbent assay for expression of protein biomarkers (i.e., kallikrein gene 10, macrophage migration inhibition factor, prolyl carboxypeptidase, queuine trna-ribosyltransferase, and kinesin) encoded by resistance-inducing genes. an additional blood sample is obtained from patients at the time of relapse, if available. patients also undergo assessment of medical history, personal habits, and characteristics of breast cancer (e.g., tumor histology, stage, and grade) at baseline.

Eligibility criteria:
inclusion criteria: * histologically confirmed invasive breast cancer * initial pathologic stage i-iiib disease * no stage iv disease * meets the following criteria for breast cancer therapy: * received prior primary local therapy for breast cancer * scheduled to begin tamoxifen citrate as adjuvant therapy for breast cancer within 3 weeks * hormone receptor status: * estrogen-receptor positive tumor * female * pre- or post-menopausal * must be able to donate 20 ml of blood exclusion criteria: * severe anemia, defined as hemoglobin \< 11 g/dl * psychiatric history that would preclude obtaining informed consent

Keywords: stage i breast cancer stage ii breast cancer stage iiia breast cancer stage iiib breast cancer
ea treatment with different waveform for subacute bp:study protocol for a randomized controlled trial

Conditions: Bell Palsy

Summary: bell palsy (bp) is a relatively common clinical disease, which leads to functional and esthetic disturbances for patients and results in a lowered quality of life. electroacupuncture received attention in the management of bp. the aim of this study is to evaluate the curative effect of different waveform of electroacupuncture on peripheral facial paralysis in subacute stage and to screen out the optimal waveform.

this parallel-group, multicenter randomized clinical trial (rct) will be conducted at the outpatient clinic of three hospitals in china.a total of seventy-five eligible patients will be randomly divided into low frequency continuous wave(n=25) ,discontinuous wave(n=25) and dilatational wave (n=25) groups.all groups will receive traditional acupuncture treatment at selected acupoints (bl2,gb1,gb14,st2,si18,st4,st6,st7,sj17,ex-hn16,ex-hn5,li4),additionally,receive different waveform of electroacupuncture treatment for 20 minutes three times per week for four weeks.facial nerve grading system 2.0 (fngs 2.0) will be used to assess the curative effect at baseline and at 4 weeks after treatment, as the primary outcome.sunnybrook facialgrad-ingsystem(sfgs) and facial disability index (fdi)scale will be measured and analyzed at baseline and at 4 weeks after treatment, as secondary outcomes.in addition,amplitude ratio of the affected/healthy side will be another secondary outcome tested by enog at bsaeline.

Eligibility criteria:
inclusion criteria: 1. patients meet the clinical classification criteria for bp, diagnosed by specialist. 2. 1-3 weeks from onset. 3. male or female patients aged 18-65 years. 4. fngs2.0≥4 5. clearly aware, able to complete normal communication, signed informed consent. exclusion criteria: 1. facial paralysis due to other causes, such as stroke, guillain-barre syndrome, multiple sclerosis, encephalitis, facial nerve tumors, skin tumors, parotid tumors, and facial nerve trauma;. 2. patients with hunter's syndrome. 3. patients with bilateral facial nerve palsy. 4. patients with hemifacial spasm as the the main clinical symptoms. 5. patients with severe cardiovascular and cerebrovascular diseases, liver, kidney, hematopoietic system diseases, malignant tumors and systemic organ failure, pregnant or lactating patients. 6. patients with a tendency to bleed easily, who are not suitable for electroacupuncture such as installing a pacemaker, or who cannot cooperate with treatment for other reasons. 7. participants in other clinical trials within the last 3 months.

Keywords: bell palsy peripheral facial paralysis clinical study acupuncture treatment
product performance of a new silicone hydrogel contact lens

Conditions: Myopia

Summary: the objective of this study is to evaluate the product performance of kalifilcon a, compared to the johnson \& johnson acuvue oasys® 1-day with hydraluxe™ (senofilcon a) daily disposable contact lens and alcon dailies total1® (delefilcon a) daily disposable contact lenses when worn by current soft contact lens wearers on a daily disposable wear basis.


Eligibility criteria:
inclusion criteria: * 18 to 40 years old on the date the icf is signed and have capacity to provide voluntary informed consent. * myopic and require lens correction from -0.50 to -6.00 diopter (d) with 0.25 d steps, in each eye. * correctable through spherocylindrical refraction and with soft spherical contact lenses to 32 letters (0.3 logarithm of the minimum angle of resolution \[logmar\]) or better (2 meters distance, high-contrast chart) in each eye. * free of any anterior segment disorders. * adapted soft contact lens wearers and willing to wear their study lenses for at least 8 hours per day on a daily disposable wear basis for approximately 2 weeks. * access to internet connection and personal email to send/receive emails. * habitually wear either alcon's air optix aqua, air optix with hydraglyde, air optix night \& day, bausch + lomb's purevision 2, bausch + lomb ultra, coopervision's biofinity, johnson \& johnson acuvue oasys® with hydraclear™, or acuvue vita soft contact lenses. exclusion criteria: * participating in any drug or device clinical investigation within 2 weeks prior to entry into this study (screening/dispensing visit) and/or during the period of study participation. * have worn gas permeable (gp) contact lenses within the last 30 days or who have worn polymethylmethacrylate (pmma) lenses within the last three months. * have any systemic or ocular disease currently affecting ocular health in the investigator's opinion may have an effect on ocular health during the course of the study. * using any systemic, topical or topical ocular medications that will in the investigator's opinion, affect ocular physiology or lens performance.currently wear daily disposable, monovision, multifocal, or toric contact lenses. * refractive astigmatism of greater than 0.75 d in either eye. * anisometropia (spherical equivalent) of greater than 2.00 d. * amblyopic. * have had any corneal surgery (e.g., refractive surgery).
rapid antidepressant effects of leucine

Conditions: Major Depressive Disorder

Summary: this randomized double-blind placebo-controlled crossover study seeks to evaluate the antidepressant effect of l-leucine, an essential amino acid, in patients with major depressive disorder (mdd).

this is a pilot phase ii clinical trial of l-leucine to test its efficacy in reducing depressive symptoms in mdd patients, especially those who exhibit increased inflammation. the determination of increased inflammation will be done post-hoc. during the screening visit, all study participants will provide demographic information and complete self-report assessments and clinician evaluations and examinations. blood and urine tests will also be performed. all participants who meet eligibility criteria and are willing to proceed with the study will enter this 6-week study after being randomized to two-week course of either l-leucine or placebo. in this cross-over study, participants will be crossed over to the second treatment after 2 weeks of washout. the study period will last 42 days (6 weeks) from the baseline visit. both l-leucine and placebo will be provided as an effervescent mixture powder. investigators hypothesize that mdd subjects will have greater reduction in depression severity on leucine as compared to placebo.

Eligibility criteria:
inclusion criteria: * current primary diagnosis of nonpsychotic major depressive disorder. * stable antidepressant dose of no more than one antidepressant medication for 4 weeks and no anticipated changes during the study period. * stable doses of all concomitant medications for over 6 weeks. * no more than two failed antidepressant trials of adequate dose and duration, as defined by atrq, in the current episode. exclusion criteria: * psychiatric co-morbidity posing safety risk. * pregnant or breastfeeding or plan to become pregnant over the ensuing 2 months following study entry or are sexually active and not using adequate contraception * exclusionary psychiatric conditions (such as substance dependence in the last 6 months, substance abuse in the last 2 months, or lifetime history of psychotic disorders. * unstable or terminal general medical condition (gmc). * concomitant medications that interact with l-leucine (e.g. sildenafil). * vagus nerve stimulation, ect, or rtms, or other somatic antidepressant treatment during current episode * inadequately controlled hypothyroidism. * therapy that is depression specific, such as cbt or interpersonal psychotherapy of depression. * hypersensitivity to l-leucine * have maple syrup urine disease.

Keywords: antidepressant inflammation biomarker depression treatment resistant depression leucine
mri results in dupuytren's contracture before and after injection with xiaflex

Conditions: Dupuytren's Disease

Summary: the purpose of this study is to determine the effects of xiaflex on your finger through mri.

collagenase injections for the treatment of dupuytren's contracture is a newly approved protocol which has shown early efficacy. there are very few studies which examine the mri appearance of dupuytren's disease. there are no studies that evaluate the condition of the cord after collagenase injection.

Eligibility criteria:
inclusion criteria: * subject has a diagnosis of dupuytren's disease affecting only the metacarpophalangeal joint of the 4th or 5th finger. * subject has only one finger affected by the disease. * patients will be 35 years of age of older. * patients will be able to read, speak, and understand english or have available adequate translation assistance and be able to provide voluntary written consent to participate. exclusion criteria: * female patients who are nursing or pregnant, or plan to become pregnant during the treatment phase. * patient has a chronic muscular, neurological or neuromuscular disorder that affects the hands. * patient has known allergy to collagenase or any other excipient of xiaflex. * patient has received any collagenase treatments before the first dose of xiaflex. * patient with abnormal coagulation, including patients who have received anticoagulant medications other than low-dose aspirin within 7 days of the injection.

Keywords: dupuytren's contracture
the effect of physostigmine on cognitive functioning in the immediate period after sedation for colonoscopy

Conditions: Cognitive Dysfunction

Summary: the purpose of this study is to determine whether the administration of physostigmine in combination with sedation for colonoscopy can minimize the cognitive decline at the time of hospital discharge

physostigmine, a tertiary cholinesterase inhibitor, which prevents the breakdown of ach by inhibiting the enzyme acetylcholinesterase (ache), crosses the blood-brain barrier (bbb), and elevates brain ach levels. physostigmine has been shown to improve attention, and performance in working memory. it has also been shown to produce analgesia following systemic or central administration. patients undergoing colonoscopy under sedation of propofol and fentanyl show cognitive decline in the immediate period following the procedure. in this study, half the patients will receive physostigmine in combination with the sedation, and their cognitive functioning at the time of hospital discharge will be assessed by standard neuropsychological tests, and compared to that of patients without physostigmine.

Eligibility criteria:
inclusion criteria: * over18 years old * asa i-iii * fluency in hebrew, russian, or arabic * absence of serious hearing or vision impairment exclusion criteria: * history of head trauma, neurological diseases, alcoholism, drug abuse, consumption of psychotropic drugs or antidepressants * heart failure (nyha \> 3) * liver failure * respiratory problems (asthma, etc.)

Keywords: sedation cognitive decline physostigmine colonoscopy
navigate - improving survival in vulnerable lung cancer patients

Conditions: Lung Cancer

Summary: half of patients with lung cancer face a limited life span of one-year survival, which is characterized by severe physical and psychological symptoms. differences in stage, comorbidity but also treatment may explain a large proportion of the social inequality in lung cancer survival. some vulnerable patients may not receive first line treatment as planned either due to poor performance status or if they are not able to adhere to treatment appointments. knowing how to navigate the health system may be a barrier preventing vulnerable patients in receiving optimal treatment. the primary aim of this randomised, controlled trial is to test whether a nurse-led individually tailored program including systematic screening of symptoms using pros and a physical training program will significantly improve overall survival among vulnerable lung cancer patients compared with standard care. secondary outcomes include adherence to cancer treatment, symptom burden and health related quality of life.

during an 18-month period, consecutive newly diagnosed (\< 1 week) lung cancer patients will be pre-screened for eligibility and invited to participate at departments of oncology or respiratory medicine in denmark. participants (n=518) will be randomized (1:1) to standard treatment plus the intervention (intervention group) or standard treatment (control group) and followed for 1 year. patients randomized to the control group will receive standard treatment and care consisting of a nurse and a physician, who sees the patient at treatment schedules and during follow-up, i.e. every 3 months for the first 2 years and subsequently annually up to 5 years. data will be collected from the intervention and the control group at baseline within 2 week after diagnosis, and 3, 6 months and 12 months after diagnosis. physical tests will be performed at baseline and after 3 and 6 months. baseline physical tests will be allowed after randomization if patients have difficulties in attentending the physiotherapy department within 2 weeks after their diagnosis. considering that participating patients are vulnerable with limited resources we will proactively support patients in responding to questionnaires electronically, on paper or via telephone as per patient's preference allowing evaluation of the secondary outcomes as well as covariates and mechanisms. the primary outcome and treatment factors will be obtained from the lung cancer clinical database and individual medical journals. in order to develop costutility analyses, information on use of health services will be retrieved from the national registers.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years of age * diagnosed with nsclc at all stages regardless of treatment intension at the participating departments * performance status ≤ 2 * vulnerable according to pre-defined criteria exclusion criteria: * severe untreated psychiatric disorder (e.g. psychosis) or cognitive problems (e.g. dementia) preventing informed consent * not able to receive treatment * not able to read and understand danish -
extension study to evaluate the long-term efficacy and safety of everolimus in liver transplant recipients

Conditions: Liver Transplant Recipient

Summary: the reason for this extension is to evaluate the long-term safety and efficacy of two concentration-controlled everolimus regimen in de novo liver transplant recipients. the most important long-term safety assessments include evaluation of renal function, progression of hcv related allograft fibrosis, and other treatment related effects at month 36 post-transplantation compared to extension baseline (months 24 post-transplantation).


Eligibility criteria:
inclusion criteria: * written informed consent * ability and willingness to adhere to study regimen * completed core study with assigned regimen; exclusion criteria: patients fulfilling any of the following criteria are not eligible for inclusion in this study: * severe hypercholesterolemia or hypertriglyceridemia. * low platelet count. * low white blood cell count. * positive test for human immunodeficiency virus (hiv). * systemic infection requiring active use of iv antibiotics. * patients in a critical care setting. * use of prohibited medication. * use of immunosuppressive agents not utilized in the protocol. * hypersensitivity to any of the study drugs or similar drugs. * pregnant or nursing (lactating) women * women of child-bearing potential not using a highly effective method of birth control. other protocol-defined inclusion/exclusion criteria may apply

Keywords: liver transplantation everolimus calcineurin inhibitors tacrolimus renal function progression of hcv related allograft fibrosis