Kornimate/medical-research-clean huggingface dataset:
university of central florida cerebank

Conditions: Biospecimen Donation; Brain Injury; Brain Diseases

Summary: millions of persons are affected by brain diseases. the cerebank will be used to support research studies aimed at improving the diagnosis and treatment of brain diseases. brain diseases can be inherited; developed due to diseases or aging; or can be due to trauma. the central florida does not have a brain biobank to meet the needs of research. therefore, it is necessary for the university of central florida to establish a brain biobank.

the purpose of the university of central cerebank is to be a brain repository to support the research of the faculty of the university of central florida college of medicine. these research studies aim at improving the diagnosis and treatment of brain diseases, such as dementia, to advance medicine. the donated brains will be used for research and educational purposes.

Eligibility criteria:
inclusion criteria: * be 18 years or older. * able to provide informed consent. persons who are unable to provide an informed consent will need a legally authorized representative (lar) to sign the informed consent. exclusion criteria: * minors (under age 18). * prisoners. * pregnant women.

Keywords: donate biobank brain biospecimen alzheimer's disease autism huntington's disease
functional mri study of cortical modifications to light stimulation in patients with photophobia

Conditions: Dry Eye Syndrome; Photophobia

Summary: photophobia is a common and disabling symptom in patient with dry eye syndrome. the aim of this study is tried to better understand this complain analyzing brain activation during a luminous stimulation to highlight modification of cortical activation.

dry eye syndrome is a frequent and underestimated disease whose incidence tends to increase because of the population ageing and behaviors modification (time spent using screens increased, wearing of contact lenses...). photophobia deteriorates the quality of life in patients with dry eye syndrome decreasing outdoor activities. this symptom is not understood and does not seem to be linked with dry eye syndrome severity. the study will compare cortical activation after luminous stimulation of 16 patients eyes (8 patients with dry eye syndrome and photophobia vs 8 asymptomatic patients) using functional mri (fmri). the primary study endpoint was the extent of magnetic signals in visual cortex after luminous stimulation. secondary endpoints were the spatial activation extent in the 3 areas of the visual cortex (brodmann areas 17,18,19).

Eligibility criteria:
inclusion criteria: * symptomatic subjects : presence of bilateral photophobia with an impact on daily activities (driving, outdoor activities, screens use, socio-professional activities...) in a context of patent dry eye syndrome * asymptomatic subjects : no dry eye syndrome and no photophobia * patients able to understand medical information and sign consent. exclusion criteria: * ophthalmological pathologies of cornea, iris, optic nerve or retina * mri contraindications (metallic prosthesis, pacemaker, claustrophobia) * neurological pathology which may affect mri results * subjects under legal protection

Keywords: functional mri
action observation in children with diplegic cerebral palsy

Conditions: Diplegic Cerebral Palsy

Summary: a new rehabilitative approach, called aot, based on the discovery of mirror neuron system (mns), has been used with promising results on the upper limb (ul) function in some studies in children with cerebral palsy (cp). the purpose of the present trial is to provide evidence by an rct, preceded by a pilot study, that customized and home based aot training is an effective rehabilitation tool in children with diplegic cp (dcp) and that its effects are greater than standard care. both hands assessment (boha) is chosen as primary outcome measure and a sample size of 27 per group is required. the rehabilitation lasting 8 weeks will be provided at home by an ict platform able to deliver, manage, monitor and measure a personalized aot.

a two-arm, evaluator-blinded, randomized trial (rct), preceded by a pilot study, will be conducted according to consort guidelines. each participant will be randomized to either: 1. intervention group (experimental group). children will receive immediately the system for 8 weeks. 2. standard care group (control group). children will continue standard care at the end of the project, if the study results will be positive, children enrolled in the control group will be able to have the same treatment as the experimental group, if necessary. the system will provide an in-home, individualized, intensive treatment based on the aot. the system will be delivered at home and the children will perform a 60-minute training session at least 5 days a week for 8 consecutive weeks (total of 40 hours). follow-up assessment (outcome measures) will be conducted before (t0) and post-intervention at 1 weeks (t1), and then 8 and 24 weeks after the aot intervention/standard care (t2 and t3). the primary endpoint will be t1. clinical assessments will be administered by a therapist blind to group assignment in each centre. scoring of videotaped clinical outcome measures will be performed by therapists blind to group allocation and assessment order.

Eligibility criteria:
inclusion criteria: * diagnosis of diplegic cerebral palsy (dcp) (gmfcs level i to iv - children may have been achieved an independent gait) * age between 5 and 16 years * macs level i-iv * sufficient cooperation and communicative understanding to perform assessments and participate in the intervention * caregivers able to commit and collaborate in a rehabilitative intensive home * subjects and parents able to commit to the intensive rehabilitation program for a period of 8 weeks. exclusion criteria: * exclusion criteria will be uncontrolled seizures and ul botulinum injections or orthopaedic surgery in the previous 6 months or during the study period.

Keywords: tele-rehabilitation action observation mirror neurons ict
neoadjuvant study investigating degarelix in patients suffering from prostate cancer

Conditions: Prostate Cancer

Summary: the purpose of this phase 3b trial was to see how well a new trial drug (degarelix) works in terms of reducing the size of the prostate volume in prostate cancer patients who were scheduled to undergo subsequent radiotherapy for treatment of their prostate cancer. prior to receiving radiotherapy, it is recommended that patients with intermediate to high risk prostate cancer are pre-treated with hormone therapy (so-called neoadjuvant therapy) which is known to reduce the size of the prostate and thereby decrease the required radiation field and enable a more safe and effective treatment. in this trial, participants were randomly selected (like flipping a coin) to receive either degarelix given alone or a standard hormone therapy (combination of goserelin and bicalutamide. the treatment was given for three months and the prostate size was measured by ultra sound at the beginning and at the end of the trial. the participants were required to come to the clinic for 5 or 6 visits during the three months.


Eligibility criteria:
inclusion criteria: * patient has given written informed consent before any trial-related activity is performed. * has a confirmed prostate cancer in which this type of treatment is needed. exclusion criteria: * previous treatment for prostate cancer * previous trans-urethral resection of the prostate * patients who are lymph node positive or have other metastatic disease * use of urethral catheter * current treatment with a 5-alpha reductase inhibitor or α-adrenoceptor antagonist. * history of severe untreated asthma, anaphylactic reactions, or severe urticaria and/or angioedema. * hypersensitivity towards any component of the investigational product * other previous cancers within the last five years with the exception of prostate cancer and some types of skin cancer. * certain risk factors for abnormal heart rhythms/qt prolongation (corrected qt interval over 450 msec., torsades de pointes or use of certain medications with potential risk) * clinical disorders other than prostate cancer including but not limited to renal, haematological, gastrointestinal, endocrine, cardiac, neurological, psychiatric disease, alcohol or drug abuse or other conditionals as judged by the investigator.
cardiometabolic effects of rapid glucose excursion

Conditions: Diabetes Mellitus, Experimental

Summary: the effects of rapid glucose excursions, induced by intravenous bolus application of glucose in healthy probands, on cardiometabolic and inflammatory parameters will be investigated

background: it is well known that people with diabetes have a five times higher risk of dying of cardiovascular death than non-diabetics. however not only hyperglycaemia per se but also glycaemic variability is currently particularly regarded as a risk factor for cardiovascular and microvascular complications. intermittent blood sugar excursions with pronounced fluctuations between high and low values instead of constant, even increased blood sugar exposure, have been shown to be more harmful in several studies. aim: the aim of this study is to determine the effect of rapid glucose excursion versus continuous glucose infusion on cardiovascular and metabolic parameters in healthy volunteers. methods/design: in this study, ten healthy male subjects will be studied on two occasions. in a random order the subjects will receive 3 times 20 grams of glucose intravenously as a bolus or, on the other occasion, 60 grams of glucose continuously over 3 hours. cardiometabolic biomarkers will be analysed serially to analyse the effects of glucose excursions. prospect: glycaemic variability may be a crucial factor in the development of diabetic complications, but there is currently a lack of conclusive evidence. the causes and mechanisms of these negative influences on the cardiovascular system due to high glucose variability have not been sufficiently investigated and are therefore not fully understood so far. to date, however, there have been no studies with acutely altered glucose concentrations in healthy volunteers that have investigated the effects on traditional as well as recently identified cardiovascular and metabolic biomarkers. knowledge of such effects may improve the therapeutic strategy in diabetic patients.

Eligibility criteria:
inclusion criteria: * men aged 18 years or older with no disease history * written informed consent exclusion criteria: * receiving any medication * probands who suffer from infectious disease
clearance of inflammatory cytokines during renal replacement therapy using the emic®2 filter

Conditions: Acute Renal Failure

Summary: this study will be conducted in patients with sepsis and acute kidney injury needing renal replacement therapy. the aim is to investigate whether continuous renal replacement therapy with the emic®2 filter leads to removal of pro-inflammatory middle molecular weight cytokines from the blood.

in patients with acute kidney injury (aki) and sepsis requiring renal replacement therapy, the investigators aim to determine whether continuous veno-venous haemodialysis with an emic®2 filter leads to clearance of the following mediators interleukin (il) -1 alpha, il-1 beta, il-2, il- 4, il-6, il-8, il-10, tissue necrosis factor alpha (tnf-α), vascular endothelial growth factor (vegf), interferon gamma, monocyte chemotactic protein-1 and epidermal growth factor.

Eligibility criteria:
inclusion criteria: * adult patients (≥18 years) in the critical care unit with aki and sepsis * clinical decision that citrate based continuous veno-venous haemodialysis (cvvhd) is necessary exclusion criteria: * lack of consent * pre-existing dialysis dependent renal failure * life expectancy \<24 hours * patients with haemoglobin \<7g/dl (unless transfused for clinical reasons) * need for extracorporeal membrane oxygenation (ecmo)
a controlled study to assess the effectiveness of aerobic exercise as an augmentation therapy for inpatients with major depressive disorder

Conditions: Major Depressive Disorder

Summary: we will evaluate the effect of a short-term aerobic exercise program as an adjuvant treatment in patients with depression undergoing standard clinical antidepressant medication therapy as compared to the effect of stretching exercise. in addition, the effect of exercise on plasma biological markers will be examined and observed changes correlated with clinical antidepressant effects. we hypothesize that the aerobic exercise group will achieve a significantly higher response rates of depressive symptoms, will also have a greater degree of change in the plasma markers, than the control stretching group.

the patients will be randomly assigned to 3 weeks of augmentation therapy (in addition to the antidepressant medication, which will be continued) with either: 1) aerobic exercise or 2) stretching exercise (control group). random assignment to each group will be stratified according to previous response to treatment as determined by a psychiatrist and review of the antidepressant treatment history form (athf) and by gender. severity of depression will be rated at the first baseline visit and every week during the exercise program using the hamilton depression scale (ham-d 21 items), clinical global impression scale (cgi) (observer-rated) and beck depression inventory (bdi) and visual analog scale (self-rated). blood samples will be obtained four times during the study - before and after the first exercise session and before and after the last exercise session. the blood taken before the exercise sessions will be used to assay thyroxine, cortisol, insulin, opioid peptides and cytokines such as il-6 and tnf-α in the plasma. the blood taken after the exercise sessions will be used to re-examine variables expected to be altered immediately after exercise such as cortisol, opioid peptides, catecholamines and cytokines.

Eligibility criteria:
inclusion criteria: 1. diagnosis of major depressive episode (mde) in the context of mdd according to dsm-iv criteria, without psychotic features. 2. hamilton depression scale (21 items, ham-d) total\>14 with item 1 (depressed mood) \>2. 3. physical capability to perform aerobic exercise or stretching exercise. 4. competent and willing to give written informed consent exclusion criteria: 1. current, significant physical illness that will preclude exercise training. 2. any physical impairment that can interfere with exercise training. 3. current psychotic features. 4. treatment with electroconvulsive therapy.
impact of caloric and protein adequacy on postoperative clinical outcomes of patients undergoing major abdominal surgery

Conditions: Surgery; Postoperative Complications; Cancer; Energy Supply; Deficiency

Summary: the role of nutritional therapy (tn) in the surgical patient is well described in the literature and is associated with reductions in postoperative complications, length of hospital stay, and mortality. adequate determination of caloric and protein requirements is an essential step in the tn institution, avoiding hypoalimentation and hyperalimentation. thus, it is essential to understand the changes in energy expenditure after surgery and its relation with nutritional status. in addition, little is known about the effect of nutritional therapy and caloric adequacy on parameters such as phase angle and dynamometry. thus, the objective of this study is to evaluate the changes in energy expenditure after major abdominal surgeries and to evaluate the phase angle and dynamometry as possible markers of nutritional therapy. energy expenditure will be assessed by indirect calorimetry. functionality will be assessed by means of dynamometry and 6-minute walk test. nutritional diagnosis will be given through subjective global assessment. energy and protein intake will be monitored and registered daily. phase angle will be obtained by performing bioelectrical impedance.


Eligibility criteria:
inclusion criteria: * over 18 years old * patients admitted for major abdominal surgery * sign the consent form exclusion criteria: * length of hospital stay less than 3 days * pregnancy * patients who, for any reason, can not perform indirect calorimetry
hypertension as a reason for concellation of elective minor abdominal surgery

Conditions: Hypertension Secondary; Surgery

Summary: during the anesthesia outpatient consultation, patients proposed for minor abdominal surgery, known hypertensive patients are selected. on the day of the procedure, we check the blood pressure figures. if the numbers are high: sbp ≥ 180 and/or pad≥110: we start by a filling as well as a dose of 1 mg midazolam iv and the blood pressure figures are re-evaluated. if 3 measurements blood pressure figures remain above the threshold values: surgery is postponed and the patient will be included to group (a) for canceled. if the blood pressure figures are correct, the surgery is accepted and the patient will be included in the group (na) for not canceled.

during the anesthesia outpatient consultation, patients proposed for minor abdominal surgery, known hypertensive patients are selected. if the blood pressure figures are balanced in the previous 12 months, they are included in the study and the anesthesiologist informs them of the study protocol and obtains their consent. on the day of the procedure, the patient is admitted to the operating room. we begin warming the patient and carry out standard monitoring, then, we check the blood pressure figures. if the numbers are high: sbp ≥ 180 and/or pad≥110: we start by a filling as well as a dose of 1 mg midazolam iv and the blood pressure figures are re-evaluated. if 3 measurements blood pressure figures remain above the threshold values: surgery is postponed and the patient will be included to group (a) for canceled. if the blood pressure figures are correct, the surgery is accepted and the patient will be included in the group (na) for not canceled.

Eligibility criteria:
inclusion criteria: * patients aged 18 or over, consenting * known hypertensive patients. * patients proposed for planned minor abdominal surgery (≤ 2 hours). exclusion criteria: * patients not premedicated (antihypertensive treatment) non-inclusion criteria: * patient refusal .history of hypertensive emergency within 06 months.
the evaluation of the acute effect of water-pipe smoking on the endothelial function and the respiratory system

Conditions: Healthy

Summary: title: the acute effect of narghile smoking on endothelial function, and exhaled breath condensate (ebc) and pulmonary function tests in healthy volunteers. objectives: to evaluate the acute effect of one cession of narghile smoking on endothelial function, airway inflammation as assessed by exhaled breath condensate (ebc) in healthy volunteers. design: prospective study evaluating these parameters before and after 30 minutes of narghile smoking. the changes in inflammatory parameters pre and post smoking will be evaluated blindly. sample size: 50 participants participant selection: adults subjects who smoke narghile . intervention: each subject will undergo evaluation including a respiratory questionnaire, endothelial function , pulmonary function tests , exhaled breath condensate (ebc) and carboxy- hemoglobin levels . all measurements will be evaluated before and after one cession of 30 minutes narghile smoking.


Eligibility criteria:
inclusion criteria: * age \> 18 y.o. * have smoked water-pipe at least once before. exclusion criteria: * breast feeding women. * s/p bacterial or viral infection, last 2 weeks * p.o. steroids * water-pipe smoking, last 24 hours * cigarette smoking, last 6 hours * intensive exposure to smoke (fire), last 24 hours * s/p intensive care hospitalization, last 3 months

Keywords: water pipe smoking acute effect endothelial healthy adults who smoke narghile
cone beam computed tomography (ct) (cbct) with and without a customized vacuum immobilization device (cvid)

Conditions: Rectal Cancer

Summary: this study is designed to investigate whether or not the use of a customized vacuum immobilization device (cvid) to immobilize rectal cancer patients undergoing preoperative pelvic radiation therapy improves the positional stability of patients during each radiation treatment. this question is more relevant now in the era of image-guided radiation therapy (igrt). using state of the art igrt technologies such as cone beam ct (cbct) scanning, assessments of the accuracy of treatment delivery can be made during a course of radiation therapy allowing for patient set-up corrective strategies to be implemented. the use of cbct scanning may minimize any potential benefit of of a cvid if the patient's pretreatment position can be corrected prior to treatment and our current immobilization strategy results in a stable patient position. while it is seemingly intuitive to assume that the use of cvid results in better patient stability, there is actually little data to support this.

rectal cancer accounts for 5% of all cancers diagnosed in canada for both men and women between 1995 and 2004 (public health agency of canada _ health 2004). preoperative radiotherapy (rt), with or without chemotherapy, is an accepted treatment for patients with locally advanced rectal carcinoma followed by surgical resection (bosset and horiot 2001; sauer, fietkau et al. 2003; birgisson, talback et al. 2005). the current standard treatment at princess margaret hospital (pmh) is preoperative pelvic radiation therapy to a total dose of 50 gy/25 fractions/5 weeks. the total radiation dose is reduced to 45 gy/25 fractions/5 weeks when there is a concern about the volume of small bowel within the treatment volume. radiation therapy is delivered with 5-fluorouracil (5-fu), 225mg/m2/24h, by protracted venous infusion (pvi) or oral capecitabine, 825 mg/m2 bid for 5 weeks, starting the first day and completing the day of last day of radiation therapy.

Eligibility criteria:
inclusion criteria: * any rectal cancer patient who is to receive a 5 week course of preoperative pelvic radiation therapy with or without concurrent chemotherapy * prone treatment position * age 18 years or older * informed consent exclusion criteria: * inability to provide informed consent * inability to tolerate treatment in the prone position * pregnancy * patients with unilateral or bilateral metallic total hip replacements

Keywords: cone beam ct in rectal cancer patients immobilizing rectal cancer patients image guided radiotherapy in rectal cancer patients
ldl-cholesterol lowering effect of kb2115 as add on to ezetimibe

Conditions: Hypercholesterolemia

Summary: eprotirome (kb2115) is a liver selective thyroid hormone that can induce hyperthyroidism in the liver, while an euthyroid state is preserved in the extrahepatic tissue. eprotirome has in clinical trials demonstrated pronounced reduction of several independent risk factors for the development of atherosclerotic cardiovascular diseases. the purpose of the study is to assess the efficacy and safety of kb2115 as add on therapy to ezetimibe following 10 weeks of exposure compared to placebo. the aim of the study is to assess efficacy (ldl-cholesterol lowering effects) and safety of kb2115 and to define a clinically relevant dose or dose range for future studies.


Eligibility criteria:
inclusion criteria: * males or females aged 18 to 75 years * patient with primary hypercholesterolemia with an ldl-cholesterol \> 3.0 mmol/l * at randomization, diet as instructed by the investigator during the last 4 weeks prior to randomization and willingness to follow these instructions throughout the study exclusion criteria: * history of somatic or psychiatric disease/condition, which may interfere with the objectives of the study

Keywords: eprotirome kb2115 dyslipidemia hypercholesterolemia hypertriglyceridemia