Kornimate/medical-research-clean huggingface dataset:
a phase iii trial to assess the safety and efficacy of plant cell expressed gcd in patients with gaucher disease

Conditions: Gaucher Disease

Summary: gaucher disease, the most prevalent lysosomal storage disorder, is caused by mutations in the human glucocerebrosidase gene (gcd) leading to reduced activity of the lysosomal enzyme glucocerebrosidase and thereby to the accumulation of substrate glucocerebroside (glccer) in the cells of the monocyte-macrophage system. this is the second trial to utilize a recombinant active form of lysosomal enzyme, glucocerebrosidase, (human prgcd) which is expressed and purified in a bioreactor system from transformed carrot plant root cell line.

this will be a multi-center, randomized, double-blind, parallel group, dose-ranging trial to assess the safety and efficacy of prgcd in 30 untreated patients with gaucher disease. patients will receive iv infusion of prgcd every two weeks at the selected medical center. the duration of the study will be nine months. at the end of the 9-month treatment period (20 visits, 38 weeks) eligible patients will be offered enrollment in an open-label extension study. there will be two treatment groups, 15 patients in each treatment group. treatment group i: 30 units/kg every 2 weeks. treatment group ii: 60 units/kg every 2 weeks. all patients will have pharmacokinetic data collected over approximately 3 hours with frequent blood samples following the first and final doses of prgcd.

Eligibility criteria:
inclusion criteria: * males and females, 18 years or older * confirmed enzymatic diagnosis of gaucher disease * splenomegaly defined as greater than eight times the expected volume (measured volume divided by estimated volume (0.2% of body weight)\] as determined by mri volumetric analysis * female patients of child-bearing potential who agree to use a medically acceptable method of contraception * thrombocytopenia (defined as platelet counts below the lower limit of normal) and/or anemia (defined by hemoglobin level at least 1 g/dl below normal range according to sex and age). * patients who have not received ert in the past or patients whoc have not received ert in the past 12 months and have a negative anti-glucocerebrosidase antibody test. * patients who have not received substrate reduction therapy (srt) in the past 12 months. * ability to provide a written informed consent. exclusion criteria: * currently taking another experimental drug for any condition * pregnant or nursing * presence of hiv and/or, hbsag and/or hepatitis c infections * presence of severe neurological signs and symptoms, defined as complete ocular paralysis, overt myoclonus or history of seizures, characteristic of neuronopathic gaucher disease. * previous anaphylactoid reaction to cerezyme® or ceredase®. * history of allergy to carrots.
comparison between fdg-pet and mri for the assessment of response to intensive chemotherapy in multiple myeloma patients.

Conditions: Multiple Myeloma

Summary: comparison between fdg-pet and mri for the assessment of response to intensive chemotherapy in multiple myeloma patients.

first whole body fdg-pet scan and mri before the start of the treatment. second whole body fdg-pet scan and mri after the end of the treatment. on a basis of patient, comparison between pet and mri will be done tumoral site by site. sensitivity, specificity will be estimated for both techniques. in case of discrepancy, another imaging method or biopsy (if easy to perform) will be serve as standard of reference. kappa coefficients and mc nemar test will be performed to compare the two methods. fdg = fluorodeoxyglucose flucis® (schering-cisbio® international)

Eligibility criteria:
inclusion criteria: * patients from 18 to 65 years old. * de novo histologically proven multiple myeloma. exclusion criteria: * no history of another cancer or of hiv * no history of renal failure
effect of serelaxin versus standard of care in acute heart failure (ahf) patients

Conditions: Acute Heart Failure (AHF)

Summary: this was a multinational, multicenter, randomized, open-label study to confirm and expand the efficacy, safety and tolerability evidence of 48 hours intravenous infusion of serelaxin (30 micrograms/kg/day) when added to standard of care (soc) in patients admitted to hospital for acute heart failure (ahf).

this study was aimed at generating clinical evidence, especially on the short term period (in-hospital and at 30 days) to complement existing and future serelaxin data sets in acute heart failure (ahf).

Eligibility criteria:
inclusion criteria: * systolic blood pressure ≥ 125 mmhg * admitted for acute heart failure (ahf) * received intravenous furosemide (or equivalent) at any time between presentation and the start of screening * egfr on admission: ≥ 25 and ≤75 ml/min/1.73 m\^2 exclusion criteria: * dyspnea (non-cardiac causes) * t \> 38.5°c * clinical evidence of acute coronary syndrome currently or within 30 days prior to enrollment. * significant left ventricular outflow obstruction, uncorrected, such as obstructive hypertrophic cardiomyopathy or severe aortic stenosis (i.e., aortic valve area \ 50 mmhg on prior or current echocardiogram), severe aortic regurgitation and severe mitral stenosis. * ahf due to significant arrhythmias * acute myocarditis or hypertrophic obstructive, restrictive, or constrictive cardiomyopathy (does not include restrictive mitral filling patterns seen on doppler echocardiographic assessments of diastolic function).

Keywords: ahf, rlx030, soc, whf, relax-ahf-eu renal impairment
evaluation of fatty acid levels and growth in infants fed amino acid based (aa) formulas

Conditions: Cow's Milk Allergy; Intolerance to Extensively Hydrolyzed Formulas; Intolerance to Breast Milk

Summary: this clinical trial will compare the amount of fatty acids in whole blood of babies fed one of two study formulas for 4 months.


Eligibility criteria:
inclusion criteria: * 0 to 6 months of age inclusive * born at ≥ 37 weeks gestation * birth weight of 2500 g (5 lb 8 oz) or more * infants suspected to be cow's milk allergic and who do not tolerate extensively hydrolyzed formula or infants intolerant to breast milk * infants with symptoms suggestive of cow's milk allergy * signed informed consent exclusion criteria: * infants who for whatever reasons were not discharged home as per routine * infants with metabolic illness requiring a special formula * infants fed with nasogastric tube
prognostic impact of an oral triglyceride tolerance test in patients after acute ischemic stroke

Conditions: First Ischemic Stroke

Summary: non-fasting triglyceride levels are thought to play a role in stroke. the investigators hypothesise that the results of a standardised oral triglyceride tolerance test in the subacute setting (3-7 days) after the first ischaemic stroke are associated with the risk of recurrent stroke within 12 months after the index event.

since high postprandial triglycerides levels may be a risk factor for stroke, we use a combined oral triglyceride and glucose tolerance test in patients who had a first ischemic stroke. follow-up after one year primarily assesses wether or not a recurrent stroke has occured. the glucose tolerance test is meant to identify patients with metabolic syndrome (and diabetes), since this condition is per se associated with increased levels of triglycerides. potentially, the post-challenge triglyceride levels only play a role in patients without diabetes or metabolic syndrome. for further details see ebinger et al. 'the berlin 'cream\&sugar' study: the prognostic impact of an oral triglyceride tolerance test in patients after acute ischaemic stroke', ijs; 2010,5, 47-51.

Eligibility criteria:
inclusion criteria: * age over 18 years * first ischemic stroke * incidence within less than 7 days * informed consent obtained exclusion criteria: * aphasia (if hampering informed consent) * swallowing disorder * pregnancy * renal or hepatic failure * pancreatitis * cholecystolithiasis * malabsorption * lactose intolerance * psychosis * drug and/or alcohol addiction * expected life expectancyr12 months * inability to sign informed consent * acute coronary syndrome * severe heart valve disorder * heart failure (nyha iii-iv) * severe infectious/rheumatic disease * sever metabolic disease * no oral glucose tolerance test in case of known diabetes
propbm : a modified patient blood management protocol

Conditions: Iron-deficiency

Summary: the introduction of a modified perioperative patient blood management protocol with intravenous iron intervention for iron deficiency anaemic patients would reduce the need for allogenic blood transfusion and reduce perioperative morbidity and mortality.

patient blood management (pbm), refers to "the timely application of evidence based medical and surgical concepts designed to maintain haemoglobin concentration, optimise haemostasis and minimize blood loss in an effort to improve patient outcome. pbm relies on three corresponding aspects: 1. optimising haemopoiesis, 2. minimising bleeding and blood loss 3. harnessing and optimising physiological tolerance of anaemia. therefore, this randomised control trial aims to study the effect of applying a modified patient blood management protocol on the perioperative allogenic blood transfusion incidence, mortality and morbidity in patients undergoing major surgery in gynaecology, intraabdominal surgery and orthopaedics comparing with current practice.

Eligibility criteria:
inclusion criteria: * undergoing major surgery in gynaecology, gastrointestinal surgery and orthopaedics * major surgery defined as either intrabdominal surgery or main joint surgery, risk of blood loss \>15% blood volume * aged between 18 to 80 years of age * the patient must be willing and able to provide written informed consent for the study exclusion criteria: * allergy or known sensitivity to parenteral iron * hypersensitivity to the active substance, iron(iii) isomaltoside or any of its excipients listed in the summary of product characteristics * patients with iron overload

Keywords: intravenous iron isomaltoside(monofer) iron deficiency anaemia patient blood management
effect of introperative ketamine and lidocaine infusion on postoperative opioid consumption in posterior spinal fusion surgery

Conditions: Spine Fusion; Postoperative Pain

Summary: objective: the primary aim of this study was to investigate the effect of ketamine and lidocaine on postoperative opioid consumption in posterior spinal fusion surgery. materials and methods: ethics committee approval was received from our faculty. seventy-five cases between the ages of 18-65, who have an asa (american society of anesthesiologists) risk classification i-ii-iii in the preanesthetic evaluation, planned to be operated by the neurosurgery clinic for lumbar posterior spinal fusion surgery under elective conditions have been included in the study after the informed volunteer consent form was read and approved. the patients were randomly divided into 3 groups using the closed envelope method. the ketamine group (group k) (n = 25), the lidocaine group (group l) (n = 25) and the placebo group (group p) (n = 25). propofol, rocuronium and fentanyl i.v. done. in group k, 0.5 mg / kg i.v. ketamine bolus and 0.25 mg / kg / hr i.v. ketamine infusion was administered. in group l, 1.5 mg / kg i.v. lidocaine bolus and 1.5 mg / kg / hr i.v. lidocaine infusion was administered. in group p, i.v. saline (in the same volume and duration) was applied. maintenance of anesthesia was provided by propofol and remifentanil infusion. the propofol and remifentanil doses were adjusted according to the bis monitoring and the increase or decrease in basal blood pressure and heart rate values of 20% or more. the bis value was kept between 40-60. at the end of surgery, infusions were closed. after extubation, the patients were taken to the recovery room. patient controlled analgesia (pca) prepared with fentanyl was applied to the patients for postoperative analgesia. the pca device was attached for 24 hours postoperatively. postoperative 0-4 hours, 4-8 hours, 8-24 hours and total fentanyl consumption of the patients were evaluated. pain scores were measured at 1, 2, 4, 8, 12 and 24 hours in the postoperative recovery room. intraoperative propofol and remifentanil consumption was recorded. tramadol 1 mg / kg i.v. as rescue analgesia (in patients with vas pain score of 4 and above) done. possible side effects due to opioid, ketamine and lidocaine were followed.


Eligibility criteria:
inclusion criteria: * between the ages of 18-65, who have an asa (american society of anesthesiologists) risk classification i-ii-iii exclusion criteria: * previous spinal surgery, morbid obesity (bmi\> 35 kg / m2), lidocaine, ketamine or opioid allergy. severe cardiac or pulmonary disease, liver or kidney dysfunction poorly controlled hypertension, substance abuse, chronic opioid use, pregnancy, psychiatric disorder, cognitive impairment history of stroke, head injury, and intracranial mass or bleeding and patients who did not want to participate in the study were excluded from the study.
continuous spinal anesthesia in renal transplantation

Conditions: Renal Failure Chronic; Transplant;Failure,Kidney; Anesthesia

Summary: renal transplantation is now recognized as a treatment of choice for patients with end-stage renal disease. an adequate anesthetic technique should achieve hemodynamic stability and enhance perfusion of the transplanted kidney. the aim of this study is to assess the use \& effects of continuous spinal anesthesia for kidney transplantation recipients, compared with balanced general anesthesia.


Eligibility criteria:
inclusion criteria: * asa class iii or iv * end-stage renal disease * renal transplantation candidate patients exclusion criteria: * any condition contra-indicating regional anesthesia * coagulopathy * allergic to any of the drugs used during the procedure

Keywords: continuous spinal anesthesia general anesthesia renal transplantation chronic renal failure
impact of respiratory virus in critically ill patients with acute respiratory failure

Conditions: Acute Respiratory Failure; Acute Respiratory Distress Syndrome

Summary: this is an observational study to evaluate the clinical impact of respiratory virus in the patients with acute respiratory failure


Eligibility criteria:
inclusion criteria: * male or female aged ≥ 19 years * written informed consent by the patient or legally authorized representative * critical illness consistent with acute respiratory failure, to be enrolled within 24 hours of presentation exclusion criteria: * no informed consent * a patient who is judged to be unable to make a voluntary decision by understanding information about this research due to cognitive vulnerability
randomized, prospective comparison of the outcome of toric implantable contact lens (ticl) and q-lasik for the correction of myopia with astigmatism

Conditions: Myopia; Astigmatism

Summary: the objective is to conduct a contralateral prospective clinical study to compare the safety, efficacy, and quality of vision of the staar surgical co. toric implantable contact lens ticl) versus custom laser vision correction (q-lasik) in human eyes for the correction of myopia with astigmatism.


Eligibility criteria:
inclusion criteria: * age: 21-45 years old * documented stable refraction for at least 1 year * (-3.0 to -8.0d of myopia with -1.0 to -4.0d of astigmatism or se from -3.5 to -10d * bscva: 20/20 or better * pupil diameter: smaller than 7mm under mesopic condition * contact lens discontinued 3 weeks and 1 week for hard and soft wearers respectively exclusion criteria: * evidence of progressive or acute disease * evidence of connective tissue disease or clinically significant atopic disease * acd less than 2.8mm from endothelium * ecc less than 2200 cells/mm2 * narrow angle of anterior chamber * residual stromal thickness less than 280 microns

Keywords: keratomileusis, laser in situ phakic intraocular lenses myopia astigmatism implantable collamer lens, toric
beneficial effects of preference on behavior in doc patients (cognicoma)

Conditions: Disorders of Consciousness

Summary: preferred music improves cognitive function in patients with disorders of consciousness (doc). however, it is still unknown whether it is a general effect of music (because of its acoustic features) or an autobiographical effect (because of its emotional and meaningful contents). the aim of the present study was to investigate the effect of sensory modality (auditory versus olfactory) and preference (preferred versus neutral) of the testing context on the performance of four items from the coma recovery scale-revised


Eligibility criteria:
inclusion criteria: * disorders of consciousness (traumatic brain injury, stroke or anoxic encephalopathy) * coma diagnosis (plum and posner, 1966), vegetative state (task force, 1994) or minimally conscious state (giacino, ashwal et al. 2002) * lack of autonomic crisis since one week minimum * medical condition considered stable * patients who do not present hearing loss. peaks i and ii of brainstem auditory evoked potentials (baep) will be normal. exclusion criteria: * hearing problem * uncontrolled epilepsy * autonomic crises * medical unstable state * pregnant or likely to be (interrogation data) or breastfeeding woman

Keywords: vegetative state minimally conscious state music preference
a multi-center trial to compare three doses of meloxicam and placebo in patients with rheumatoid arthritis

Conditions: Arthritis, Rheumatoid

Summary: a 12-week trial consisting of 5 visits (6 if follow up is needed) to find out how effective and safe three different doses of meloxicam are compared with placebo in rheumatoid arthritis. patient will take one dose of study medication daily.


Eligibility criteria:
inclusion criteria: * age greater than or equal to 18 and less than or equal to 80 * diagnosis of rheumatoid arthritis for at least six weeks * taking an nsaid * if female: using adequate contraception * willingness to stop current nsaid until criteria reached to begin study drug * able to provide written informed consent exclusion criteria: * intolerance or hypersensitivity to nsaids or ingredients of trial drug * pregnancy, lactating * use of investigational drug within 30 days prior to entering the trial * history of peptic ulcer or of gastrointestinal hemorrhage except simple hemorrhoidal bleeding * history of cerebrovascular or other bleeding disorder * severe hypertension * other disease that might interfere with safety of the patient or evaluation of trial drug (investigator's opinion) * ra of functional class iv * synovectomy in any large joint within the past 6 months prior to entering the trial or planned during trial * concomitant therapy with anticoagulant, therapeutic doses of aspirin, phenothiazines, lithium, chronic gi-medication, analgesic drug (except acetaminophen up to 4 grams/day) * dmards initiated within past three months or dose changed less than two months before entering the trial * therapy with corticosteroids exceeding 10 mg/day prednisone equivalent or change in dose within 1 month before trial * concomitant therapy with acth within past month before entering the trial. * history of narcotic or alcohol abuse (past 12 months) * abnormal laboratory values * previous participation in the present trial
the usage of telemetric prechamber sensor reservoir in management of normal pressure hydrocephalus. comparisson of benefit for patients with implanted telemetric prechamber sensor reservoir.

Conditions: Hydrocephalus; Normal Pressure Hydrocephalus; Normal Pressure Hydrocephalus Patients

Summary: normal pressure hydrocephalus (nph) is a preventable and treatable cause of dementia. however, as a nosological entity, it is significantly underdiagnosed, often being mistakenly classified as presenile or senile dementia without further investigation. ongoing management is crucial, currently relying mainly on indirect methods-clinical and imaging-based. telemetry offers a real-time, online method to assess actual cerebrospinal fluid pressures, which are crucial for patient management. telemetry allows for tailoring treatment to the individual patient. this project is planned as a pilot study before a more extensive research project.

normal pressure hydrocephalus (nph) is a preventable and treatable cause of dementia. however, as a nosological entity, it is significantly underdiagnosed, often being mistakenly classified as presenile or senile dementia without further investigation. diagnosing nph is not straightforward; it is based on a series of examinations, the results of which determine whether the patient is a responder and therefore a candidate for shunt surgery (implantation of a ventriculoperitoneal shunt). the medical literature identifies additional criteria that predict whether the implantation of the shunt will have a good or poor effect. however, treatment from a neurosurgical perspective does not end there. ongoing management is crucial, currently relying mainly on indirect methods-clinical and imaging-based. telemetry offers a real-time, online method to assess actual cerebrospinal fluid pressures, which are crucial for patient management. telemetry allows for tailoring treatment to the individual patient. this project is planned as a pilot study before a more extensive research project.

Eligibility criteria:
inclusion criteria: * patients with diagnosed communicating hydrocephalus * mini-mental state examination test \> 10 points * absence of any structural lesion on mri or ct * accepted informed consent exclusion criteria: * non-communicating hydrocephalus * structural lesion on mri or ct (tumour, contusion, aneurysm) * mini-mental state examination test \< 10 points * life-expectancy shorter than 1 year * pre-existing other type of dementia (m. alzheimer, vascular dementia) * surgery lasting more than 120 minutes * blood loss more than 500 ml * adverse events during general anesthesia: mean arterial pressure \< 60 mm hg more than 5 minutes, arrythmia with need for pharmacological treatment

Keywords: normal pressure hydrocephalus vp drainage telemetry pressure monitoring
cognitive correlates of antidepressant treatment response in elders

Conditions: Depression

Summary: major depression is a very common health problem affecting older persons. the present standard of treatment is with medications called "antidepressants". antidepressants have been studied extensively in older persons with normal brain function and have been shown to be effective. however, certain types of brain dysfunction called "executive impairment" (inability to do higher order thinking) may lead to poor treatment outcomes. this study will compare how older depressed people with different levels of executive impairment respond differently to standard antidepressant treatment. knowing this information will lead to more rational targeting of available treatments, leading to improved treatment outcomes.


Eligibility criteria:
inclusion criteria: * above the age of 65, * speak english fluently, * experience depression, and * not yet on active treatment. exclusion criteria: * active delirium, * substance abuse, * mental illness other than major depression, * active cns disease, * unstable systematic medical disease, or * current of past psychotic disorder.

Keywords: antidepressants depression zoloft psychiatry psychology
iv versus im administration of oxytocin for postpartum bleeding

Conditions: Postpartum Hemorrhage

Summary: this double-blind, randomized controlled trial will evaluate the effect of the route of administration of 10 iu of oxytocin on the average blood loss postpartum. participants will be randomized to receive 10 iu of oxytocin by iv infusion or 10 iu of oxytocin by injection im


Eligibility criteria:
inclusion criteria: * she is present to give birth to a live fetus * vaginal delivery * willing to participate in the study * able to give informed consent exclusion criteria: * scheduled for a cesarean * reject the placement of an iv during labor (for intravenous infusion) * cannot give informed consent for any reason * not willing and / or cannot answer questions about background

Keywords: oxytocin