Kornimate/medical-research-clean huggingface dataset:
local infiltration analgesia with ropivacaine versus placebo in bilateral knee arthroplasty

Conditions: Postoperative Pain

Summary: the purpose of this study is to examine whether local infiltration analgesia (lia) with ropivacaine and adrenaline is effective in the treatment of postoperative pain after total knee arthroplasty.

total knee arthroplasty (tka) is increasingly common in the treatment of osteoarthrosis. despite aggressive analgesic regimes, tka is associated with moderate to severe postoperative pain, delaying mobilization and hospital discharge. a relatively new method for controlling postoperative pain after tka is local infiltration analgesia (lia) which consists of local infiltration with ropivacaine and adrenaline.3 studies haved showed promising results of lia, but none have documented a superior analgesic effect versus placebo.patients receiving bilateral knee arthroplasty are recruited to receive lia and placebo infiltration.the aim of the study is to demonstrate an analgesic effect of lia versus placebo.

Eligibility criteria:
inclusion criteria: * patients eligible for total knee arthroplasty * must speak and understand danish * must be able to give oral and written consent exclusion criteria: * alcohol or medicine abuse * treatment with opioids * allergy to local anaesthetics * severe obesity

Keywords: local infiltration analgesia postoperative pain ropivacaine
an open-label, multicenter, expanded access study of oral amn 107 in adult patients with imatinib (glivec®/gleevec®_ - resistant or intolerant chronic myeloid leukemia in blast crisis, accelerated phase or chronic phase

Conditions: Leukemia, Myeloid, Chronic

Summary: an open-label, multicenter, expanded access study of oral amn 107 in adult patients with imatinib (glivec®/gleevec®_ - resistant or intolerant chronic myeloid leukemia in blast crisis, accelerated phase or chronic phase


Eligibility criteria:
inclusion criteria: * patients with imatinib (glivec/gleevec) resistant or intolerant cml in blast crisis, accelerated phase or chronic phase

Keywords: cml in blast crisis accelerated phase oe chronic phase
acute effects of heat, cold and stretching on knee proprioception and vertical jump

Conditions: Healthy

Summary: the aim of our study is to investigate the effects of heat, cold and stretching on knee proprioception and vertical jump. 60 healthy individuals were randomized into hot, cold, stretching and control groups of 15 each. pre-test and post-test measurements were made immediately after the application. knee proprioception was measured with a digital goniometer using the epd (joint position sense) test. vertical jump heights were measured with contact mat by countermovement (cmj) and squat splash (sqs) tests.


Eligibility criteria:
inclusion criteria: * being between the ages of 18-30 * agreeing to participate in the study and being informed approving the volunteer consent form exclusion criteria: * having a history of surgery in the knee area * movement in lower extremity joints that may affect measurements have limitations. * having vision, hearing and balance impairment. * may cause peripheral neuropathy and deep sensory loss, or loss of proprioception may be caused by other mechanisms having diseases. * have a neurological or systemic disease that affects balance and coordination have. * describing very severe pain in any part of the lower extremity. * being pregnant. * having cognitive dysfunction, lack of cooperation * having any disease that may cause inability to dry

Keywords: proprioception vertical jump heat streching cold pack
how to get a better dry weight in end-stage renal disease (esrd) population for improving blood pressure control

Conditions: Blood Pressure; End Stage Renal Disease; Hemodialysis

Summary: end-stage renal disease (esrd) is a common clinical condition. in this population, the prevalence of systemic hypertension is high and its adequate control can determinate the outcome. the first step for a good control of blood pressure in renal patients is adjusting his/her dry weight. actually, dry weight is assessed based on clinical examination and blood pressure. the electrical bioimpedance is a simple and portable device. the investigators design a randomized clinical trial for evaluating two ways of getting the best dry weight for hemodialysis patients. a basal 24h abpm will be taken before the randomization. then, 2 weeks later the dry weight be revised, the investigators will get a second 24h abpm.

end-stage renal disease (esrd) is a common clinical condition over the world. in this population, the prevalence of systemic hypertension is high and its adequate control can determinate the outcome. the first step for a good control of blood pressure is giving a dry weight for the patient. we can understand dry weight or target weight as that one which the patient feels comfortable and there aren't clinical signals of volemic overload as edema, dyspnea, orthopnea, jugular turgency, hepatomegalia. classically, the dry weight is assessed based on clinical examination, blood pressure and experience of hemodialysis staff. the electrical bioimpedance is a very simple method that possibilities access the corporal compartments, including the body water, using a small and not expensive portable device. trying to study new forms for getting the ideal dry weight, we design a randomized clinical trial for evaluating two ways of getting a dry weight for hemodialysis patients. one group will be dry weight fixed by bioimpedance data and in another group the dry weight will by a clinical protocol. we will take a 24h abpm basal from all patients before the randomization. then, 2 weeks later the dry weight be revised, a second abpm will be taken. the results will be compared.

Eligibility criteria:
inclusion criteria: * patients with esrd, clinically stable, under hemodialysis therapy at two clinics in the north of rio grande do sul. exclusion criteria: * clinical unstability, like: infection in course ou recent acute cardiovascular disease (less then 3 months).

Keywords: dry weight blood pressure chronic kidney disease
phase 3 trial in squamous non small cell lung cancer subjects comparing ipilimumab versus placebo in addition to paclitaxel and carboplatin

Conditions: Lung Cancer - Non Small Cell Squamous

Summary: the purpose of the study is to determine whether ipilimumab plus paclitaxel and carboplatin will extend the lives of patients with squamous only non small cell lung cancer more than placebo plus paclitaxel and carboplatin.

the primary objective is to compare overall survival (os) of participants with stage iv/recurrent nsclc of squamous histology who have been randomized to ipilimumab in addition to paclitaxel and carboplatin versus placebo in addition to paclitaxel and carboplatin, and have received at least one dose of blinded study therapy (ipilimumab or placebo).

Eligibility criteria:
for more information regarding bms clinical trial participation, please visit www.bmsstudyconnect.com. inclusion criteria: * non small cell lung cancer (nsclc) - squamous cell * stage iv or recurrent nsclc * eastern cooperative oncology group (ecog) performance status of 0 or 1 exclusion criteria: * brain metastases * autoimmune diseases
et-blockade and exercise-induced vascular adaptations in t2dm

Conditions: Type 2 Diabetes Mellitus

Summary: the purpose of this study is to establish the effect of et blockade on vascular adaptations during an 8-week exercise program in subjects with t2dm. we hypothesize that combining et - blockade with exercise training leads to an acute increase of exercise induced blood flow when compared with exercise alone. we expect that this will lead to an optimization of vascular training effect in t2dm.


Eligibility criteria:
inclusion criteria: * type 2 diabetes mellitus (\>2 years since diagnosis) or controls exclusion criteria: * \<40 years of age * \>65 years of age * smoking * cardiovascular disease * diabetes related manifest vascular complications * type 1 diabetes mellitus * use of glibenclamide * use of hiv drugs * use of calcineurin inhibitors * use of drugs that interfere with cyp3a4 and cyp2c19
neuromodulation for prevention of intensive care unit acquired weakness and post intensive care syndrome

Conditions: Muscle Atrophy; Muscle Weakness; Blood Flow

Summary: post-intensive care syndrome (pics) encompasses persistent physical, cognitive, and psychiatric symptoms following icu discharge, commonly triggered by serious conditions such as respiratory failure, sepsis, and mechanical ventilation. pics prevalence is reported to be as high as 84% up to 12 months in patients with at least 2 days spent in the icu or with mechanical ventilatory support. as a consequence, many patients do not return to they former level of function for weeks, months and even years. muscular affection manifested by muscle weakness is particularly seen and is provoked by a combination of damage to the nerves or directly the muscles fibers. this affection is referred to as cu-acquired weakness (icuaw). one third of the time, lower extremities are affected, often due to prolonged immobilization or sedation. evidence suggests that early mobilization reduces the incidence of icuaw at discharge and improves the number of patients able of stand. however achieving this early intervention is not always feasible due to time or personnel constraints. the purpose of the study is to examine the effectiveness of lower extremity neuromodulation for prevention of muscle deconditioning in patients admitted to the icu.

the purpose of the study is to examine feasibility and acceptability of lower extremity neuromodulation in patients at risk of icuaw. this is a proof randomized controlled trial (rct) study for prevention. eligible participants will be recruited from baylor st luke's medical center (houston, texas). participants will be randomized to intervention group (ig) or control group (cg). the entire cohort will receive daily neuromodulation in the lower extremity (gastrocnemius muscle, achilles tendon) up to 1 hour. the therapy will be provided with a neuromodulation device (tennant biomodulator pro®, avazzia, inc.) that works on high voltage alternative pulsed current. the device will be functional for the ig and non-functional for the cg.

Eligibility criteria:
inclusion criteria: * any patient older than 18 years old admitted to the icu within 2 days. * patient can be intubated with ventilatory assistance or not. exclusion criteria: * less than 48 hours of icu stay. * major foot problems such as active lower extremity wounds, major foot deformity (e.g., charcot foot), and/or previous major amputations. * demand-type cardiac pacemaker, implanted defibrillator, or other implanted electronic devices. * any conditions that may interfere with outcomes or increase the risk of the use neuromodulation therapy based on the judgement of clinicians.

Keywords: neuromodulation skin perfussion muscle dysfunction
pragmatic trial in atopic dermatitis testing long-term control effectiveness of new phototherapy regimen during winter coupled with oral vitamin d supplementation vs. placebo

Conditions: Atopic Dermatitis

Summary: spaced phototherapy sessions during winter as add-on therapy in combination with vitamin d supplementation or not, could be beneficial to improve disease ltc in ad patients

the major therapeutic challenge in patient with atopic dermatitis is long-term control of disease activity (ltc), for which the current tat-based pro-active strategy does not meet all the needs. phototherapy is a good candidate: it is widely used as a second-line treatment in ad with demonstrated efficacy. however, only short-term control has been evaluated; and only 2-3 times a week intensive schedules have been tested and are used in current practice. a novel phototherapy regimen would be required for disease ltc, allowing a trade-off between disease control, uv-induced risks, and patient adherence. vitamin d supplementation is another good candidate: several studies have shown lower serum levels of vitamin d to be correlated with more severe ad; and three short-term, low-power low-quality, placebo-controlled randomised trials testing vitamin d supplementation yielded conflicting results, leaving its therapeutic efficacy undecided for short-term control, and unknown for ltc.

Eligibility criteria:
inclusion criteria: * patients with atopic dermatitis (hanifin and rajka criteria), * aged 15 years or more, * with \> 2 years of disease evolution, * with moderate-to-severe disease (iga \> 2), * patients that have received tat for at least 12 weeks and have symptoms requiring an increase in therapy, * seasonality in disease severity (based on a questionnaire assessing disease improvement during summer), * easy access to a phototherapy cabin (widely implanted in primary care dermatology private practice in france), * effective contraception to be used at least 30 days before initiation of treatment, during treatment and 29 weeks after last administration for women of reproductive age, * written informed consent of the patient * for patients aged between 15 and 18, written informed consent of the parents and of the teenager. exclusion criteria: * any cause of contra-indication for vitamin d supplementation: flare of granulomatosis, primary hyperparathyroidism, * clinical suspicion of hypercalciuria, * indication to a systemic immunosuppressant in the next 2 years, * atopic dermatitis known to be aggravated by uv exposure, * any contra-indication for artificial or solar exposure including: genetic diseases with a predisposition to skin cancer, any history of personal skin cancer (melanoma, squamous cell skin cancer, basal cell skin cancer), lupus, dermatomyositis, any other photosensitizing skin disease, photosensitizing medication (see appendix 2), * more than 100 previous phototherapy sessions in lifetime, * pregnancy or breastfeeding, * persons subject to major legal protection (safeguarding justice, guardianship, trusteeship), persons deprived of liberty.
south miami hospital fibroid registry

Conditions: Uterine Myomas, Leiomyomas, or Fibromas

Summary: the purpose of the fibroid registry is to provide a comprehensive database that captures patient characteristics, clinical outcomes and pot-treatment quality of life measures for patients treated for uterine fibroids. this database will serve as a platform for future comparative effectiveness and other health services research studies.

the proposed research will be a prospective registry study of patients treated for uterine fibroids at the fibroid center located at south miami hospitals center for women and infants. our objective is to establish the fibroid registry: * to collect and review short, middle and long term clinical outcomes data that will help inform and facilitate the decision making process of clinicians and patients on the safest and most effective treatment for symptomatic uterine myomas, leiomyomas, or fibromas. * to be able to critically evaluate the quality of procedures being performed and to ultimately establish a gold standard of care based upon patient and clinical outcomes and characteristics. * to ultimately establish a gold standard of care based upon clinical outcomes and patient characteristics.

Eligibility criteria:
inclusion criteria: 1. patients seeking treatment for uterine myomas, leiomyomas, or fibromas. 2. patients between the ages of 18-89. 3. patients that agree to participate and sign consent. exclusion criteria: 1)patients that decline to participate and/or are younger than 18 or older than 89.

Keywords: myomas leiomyomas fibromas
ziprasidone versus olanzapine in the treatment of schizophrenia.

Conditions: Schizophrenia

Summary: * various studies suggest that patients treated with olanzapine can experience a substantial weight gain, while no changes have been observed in patients treated with ziprasidone. negative consequences on lipid and glucose profiles have also been observed in patients treated with olanzapine. most of the available data belong to short-term studies. however, for most clinical trials the primary variable was an efficacy variable, and included the weight assessment as a secondary variable; they also lack a systematic monitoring of some variables that can play a role in weight gain, as the level of exercise, appetite increase, etc. and we have considered of importance their inclusion in this protocol. previous studies did not assess visceral fat using widely standardized parameters as the waist index, which at certain levels is considered an indicator of the cardiovascular risk, or leptine, highly correlated to the body fat storage. we would like to fit the recently published american diabetes association, american psychiatric association, american association of clinical endocrinologists and north american association for the study of obesity antipsychotic, obesity and diabetes mellitus consensus.22 * schizophrenic patients show a 4-fold probability to die as a consequence of cardiovascular problems compared to the normal population. the antipsychotic treatment can contribute to increase this risk favoring weight gain and the appearance of cardiovascular risk factors associated to obesity (blood hypertension, hyperlipidemia, type ii diabetes mellitus). we intend to obtain a complete cardiovascular risk profile of patients, as well as its change during antipsychotic treatment, including primary cardiovascular risk factors in addition to the analysis of markers that have recently been linked to cardiovascular risk (as reactive protein c). * the study will evaluate the risk of hyperglycemia, insulin resistance and diabetes mellitus, and will investigate the association between glucose homeostasis abnormalities and weight gain in the treated patients. likewise, adiponectine, secreted from adipocytes and a possible link between obesity and insulin resistance will be determined; recent studies show an adiponectine decrease in humans with insulin resistance and obesity; furthermore, prospective studies have shown these changes could predict a higher risk of dm development. * changes have been introduced in the complete evaluation of the patient's metabolic and cardiovascular profiles with the advice, and under the coordination of endocrinologists after a complete review of the subject


Eligibility criteria:
inclusion criteria: * patients with a primary diagnosis of schizophrenia using the dsm-iv-tr criteria * patient's clinical condition should justify treatment initiation with a new antipsychotic drug. exclusion criteria: * patients at immediate risk of committing harm to self or others * concurrent treatment with antipsychotic agents after randomization.
constraint induced movement therapy (cimt)- neuroimaging predictors of positive response to constraint

Conditions: Hemiplegic Cerebral Palsy

Summary: cimt has shown great promise in helping children and adults regain lost function in a disabled limb by forcing its use through an intensive motor training program and constraining the unaffected arm with a cast. however, relatively little is known about the underlying mechanisms of cimt in hemiplegic cp. this project will use an integrated translation model to explore neuroimaging predictors of a positive clinical response to cimt.

the primary research objective is to evaluate neuroimaging predictors of a positive response to cimt in children with hemiplegic cp secondary to a middle cerebral artery territory stroke (mca). a focus on the mca territory is chosen as (1) it targets children with significant hand impairment who have the potential to benefit from cimt, (2) is the most common neuropathological subtype, and (3) allows for enhanced homogeneity for the matching of case and comparison groups. the primary research question is: in children aged 7 to 16 years with hemiplegic cp secondary to an mca stroke, are there neuroimaging predictors of a positive response to cimt, a positive response being defined by an improvement in the assisting hands assessment (aha) one month after cimt? neuroimaging predictor variables include laterality index (li) of the primary m1 and s1 areas on fmri, ihi evaluated by resting state fmri, dissociation of the m1 and s1 for the hemiplegic hand measured by fmri, size and vascular distribution of the mca lesion with t2 weighted mri, and white matter tract abnormality with diffusion tensor imaging (dti). we hypothesize that a negative li, a non-dissociated m1 and s1, low ihi, small size of infarction, and large size of the contralateral corticospinal tract will predict a positive response to constraint. an evaluation of the neuroimaging predictor variables on the persistence of a positive response to cimt at 6 months as measured by the aha will also be explored. a secondary objective will evaluate change in the neuroimaging variables from baseline to one month post cimt by comparing children in the case group who have received cimt and a comparison group who are matched on baseline quest scores.

Eligibility criteria:
inclusion criteria: * diagnosis of hemiplegic cp secondary to an mca infarct * age between 7 and 16 years * ability to co-operate, understand, and follow simple instructions for neuro-imaging outcome measurement: the functional mri protocol will require some cooperation and the child will need to lie still in a confined place for approximately 45-60 min. * no previous cimt within 12-months of study entry or botulinum toxin upper limb injections within 6-months of study entry. exclusion criteria: * none

Keywords: cerebral palsy hemiplegia constraint induced movement therapy
screening for nafld in flanders

Conditions: Non-Alcoholic Fatty Liver Disease

Summary: in the belgian adult population more than half, and numbers are still increasing, of the population is overweight or obese. these people are at risk to develop nafld. however, we lack epidemiological data in belgium. therefore, it is important to do epidemiological studies to investigate nafld prevalence and disease severity based on a non-invasive approach and evaluate how patients are to be referred.


Eligibility criteria:
inclusion criteria: * 18 years or older, * able to understand dutch, * able to understand the informed consent exclusion criteria: * secondary causes of steatosis * excessive alcohol abuse