Kornimate/medical-research-clean huggingface dataset:
vitamin d3 supplementation and the t cell compartment in multiple sclerosis (ms)

Conditions: Multiple Sclerosis

Summary: in patients with relapsing remitting multiple sclerosis (rrms), the investigators observed a positive correlation between regulatory t cell (treg) function and vitamin d status. the present goal is to assess whether treg function improves on supplementation with vitamin d3.

in several studies, multiple sclerosis (ms) incidence and disease activity has been related with vitamin d status. we observed that rrms patients who remained relapse free before blood collection had a better vitamin d status than patients who experienced relapses (smolders et al. mult scler 2008;17:1220-1224). since vitamin d3 is a potent promotor of t cell regulation in vitro (smolders et al. j neuroimmunol 2008;194:7-17), we hypothesised that a promotion of treg function in ms patients might underlie its association with ms disease activity. in a cohort of rrms patients, we observed a positive correlation of treg function with vitamin d status (smolders et al. plos one 2009;4:e6635). furthermore, vitamin d status correlated positively with a th1/th2-balance which was more directed towards th2. in the present study, we will assess whether treatment of rrms patients with vitamin d3 promotes t cell regulation. in the present study, rrms patients will be supplemented with vitamin d3, and regulatory t cell tests will be performed before and after supplementation.

Eligibility criteria:
inclusion criteria: * relapsing remitting ms (revised mcdonald criteria 2005) * age \> 18 years exclusion criteria: * progressive ms phenotype * abnormalities of vitamin d hormonal system other than low dietary intake or limited sun exposure * intake of drugs that influence vitamin d homeostasis other than corticosteroids * conditions with in increased susceptibility to hypercalcemia * alcohol or drug abuse * pregnancy or the intention to become pregnant within the study period

Keywords: multiple sclerosis regulatory t cell function vitamin d vitamin d3 25-hydroxyvitamin d
varenicline for cognitive deficits and cigarette smoking in schizophrenia - efficacy and predictors

Conditions: Schizophrenia; Cigarette Smoking

Summary: this is a 8-week double-blind placebo controlled parallel group study of the efficacy of varenicline (chantix) for smoking cessation in schizophrenic patients, and its effect on cognitive function in patients with schizophrenia.at some sits evaluation of smoking measures is extended to 12 weeks. correlations will be made with biological predictors of efficacy: a) measures of nicotinic receptors in lymphocytes b) dnmt1 and gad67 mrna in lymphocytes. subjects will be current cigarette smokers or history of regular smokers.

this was a double-blind placebo controlled study of varenicline and matched placebo in patients with a diagnosis of schizophrenia or schizoaffective psychosis who were treated with antipsychotic medication and were cigarette smokers. three sites (2 u.s., 1 israel) were supported by the stanley grant. a similar independently supported study was conducted in beijing, china. we were allowed to access these data and combine them for our analysis of results. subjects at each site participated in a protocol which was approved by their institutional irb. all subjects signed informed consent. the study evaluated multiple measures of cigarette smoking, cognitive functions by matrics battery (measurement and treatment research to improve cognition in schizophrenia), and psychiatric symptoms by panss (positive and negative symptom scale), sans (schedule for assessment of negative symptoms), and calgary depression scales. lymphocytes were collected for measurement of epigenetically related mrna's.

Eligibility criteria:
inclusion criteria: diagnosis of schizophrenia or schizoaffective disorder current cigarette smoker or history of chronic cigarette smoking age 18-65 currently taking antipsychotic medication exclusion criteria: prior history of hospitalization for acute myocardial infarction or stroke, or persistent angina pectoris with current symptoms patients who have previously tried varenicline and have stopped taking it because of side-effects of severe nausea or vomiting suicide attempt in the last year and or have had prominent or serious suicidal thoughts in the past year women who are pregnant, nursing, or unable to use reliable contraception significant renal impairment(creatinine ≥ 1.5) baseline hamilton depression scores is \>20

Keywords: schizophrenia smoking nicotine cognitive deficits nicotinic receptors cognitive deficits in schizophrenia
different effects of non-calcium phosphate binders on serum calcium

Conditions: Chronic Kidney Disease

Summary: sevelamer hydrochloride (se) can increase intestinal calcium absorption in contrast to lanthanum carbonate (la). study compared effect of la and se on serum and urine phosphate and calcium, and hormones regulating mineral-bone metabolism.

recent experimental studies have shown that a non-calcium based phosphate binder sevelamer hydrochloride can increase intestinal calcium absorption in contrast to lanthanum carbonate. it is unknown whether such the difference may have an effect on bone metabolism and/or modify the development of vascular calcification in patients with chronic kidney disease. the aim of the study was to compare the effect of a single dose of 1000 mg of lanthanum carbonate with 2,4 mg of sevelamer hydrochloride on serum and urine calcium following an oral load of 5 g of calcium carbonate given with a meal with standardized phosphate content.

Eligibility criteria:
inclusion criteria: * adult patient * with egfr ≤45 ml/min exclusion criteria: * hypercalcemia (\>uln), * serum phosphate \>1.2 times normal value * calcium-phosphate disturbances not associated with ckd, e.g. paget disease, osteoporosis, any bone fracture within 6 months before study, multiple myeloma or any neoplastic disease, liver or biliary tract disease, primary hyperparathyroidism

Keywords: chronic kidney disease - mineral bone disorder, phosphate-binders
induction of immunity against measles in pediatric liver transplant recipients

Conditions: Measles

Summary: measles is a vaccine-preventable disease, which can be life-threatening in immunosuppressed children. currently, measles vaccine is not recommended in pediatric orthotopic liver transplant recipients, because it is a live-attenuated vaccine. we want to assess the influence of immunosuppression on immunity against measles in previously vaccinated children and to evaluate the induction of b cell and t cell response against measles elicited by vaccination in children at least 12 months after transplantation.

eligible children in group 2 will receive a standard dose (0.5 ml) of mmr vaccine during the first medical visit (v1). the lot number and the expiration date will both be recorded on the patient's case report form (crf). a serological evaluation 4-8 weeks after mmr will identify children requiring an additional dose given 1-2 months apart, as currently recommended for subjects 1 year-old or with limited immune competence (i.e. hiv-infected children). serological evaluation 4-8 weeks after the second dose or at the one-year follow-up will identify eventual non-responder requiring a third dose. three will be the maximal number of administrated dose according to this protocol. the persistence of measles-specific antibodies will be assessed yearly, when patients come for their routine visit to the transplant center. children who do not need mmr immunization because of protective levels will be monitored yearly for maintenance of antibody levels during routine yearly visits/ blood samplings and will not have further intervention.

Eligibility criteria:
inclusion criteria: * age ≥ 12 months * measles-specific igg antibodies negative (\<0.2 iu/l), as detected by the routine elisa assay * ≥ 12 months from the time of transplantation and ≥ 2 months from the time of an acute rejection episode * steroids \ 1 month. * total lymphocyte count ≥ 750 cells/ul at time of immunization exclusion criteria: * known wild-type measles exposure during the last four weeks * measles-containing immunoglobulins administered within the 5 months preceding the measles vaccine. if the child receives measles-containing ig before an additional dose of mmr vaccine, he/she will be withdrawn from the study * antiviral agents administered during the last four weeks * febrile illness (\>38.5°) in the 72 hours before vaccine administration * chronic aspirin therapy * any other immunization with a live-attenuated vaccine during the last four weeks * pregnancy

Keywords: measles mumps rubella pediatric solid-organ transplant serology vaccine
the italian registry of malnutrition in oncology

Conditions: Cancer; Cancer Metastatic

Summary: the aim of the italian registry of malnutrition in oncology (irmo) is to set up a digital register of newly diagnosed or treated oncologic patients to monitor their nutritional status, early identify malnutrition and investigate the implications of nutritional support management. in particular, this project aims to establish a prospective cohort of cancer patients in order to investigate the effects of nutritional status and management on overall survival (os) and progression free survival (pfs), and analyse the effects of the nutritional management and support on patients' symptoms and qol.

this is a multicentric longitudinal observational study on a cohort of newly diagnosed cancer patients, candidate for active treatment. in italy, no reliable data are still available with regards to the actual implementation of adequate nutritional support management in cancer patients; only "real-world" data collected by administrative databases are available in the context of nutrition in oncology, and this somehow limits the possibility to interpret the evidence from a clinical point of view. hence, the purpose of the intestigators is to collect "real world" clinical data on malnutrition in oncology at the national level, in order to strengthen the evidence and concretely improve nutritional care practices in oncology.

Eligibility criteria:
inclusion criteria: * aged ≥18 years; * new diagnosis of the following cancers: head and neck, oesophagus/stomach, colorectal, hepato-biliary, pancreatic, lung, prostate, other urogenital, breast, gynaecological and, soft tissue sarcomas and melanomas; patients with a new diagnosis of metastatic disease will be also included; * eligible for active treatment; * written informed consent to participate in the study. exclusion criteria: * impossibility to undertake the expected measurements; * impossibility to guarantee the attendance of the follow-up visits.
effects of a multicomponent training in pre-frail elderly

Conditions: Pre-frail Elderly

Summary: this study aim to evaluate the effects of 16 weeks of multicomponent training on postural control, cardiovascular and musculoskeletal systems in pre-frail elderly through nonlinear and linear measurements.

frailty syndrome is described as a clinical state of vulnerability to stress resulting from the decline of resilience and physiological reserves associated with aging. it is also characterized by a reduction of the interaction between systems and that would be reflected by a loss of physiological complexity. physical exercise, especially the multi-component, is pointed out as a key element in the intervention of frail elderly individuals. however, it is still unclear whether the improvement in functional capacity observed with this type of training would be related to changes in the physiological complexity of these elderly individuals. the aim of this study is to evaluate the effect of multi-component training on the dynamics of the cardiovascular, motor, neuromuscular and physical activity levels of pre-frail elderly. thirty-six pre-frail elderly individuals will be divided into intervention (ig, n = 18) and control (cg, n = 18) groups at three different moments (pre-intervention, post-intervention, 16 weeks, and follow-up of detraining of 6 weeks). the complexity will be evaluated by calculating the entropy of the biological signals: a) heart rate, blood pressure (in supine and orthostatic conditions), b) oscillations of the pressure center (in open, closed eyes, after standing in a chair and under dual-task cognitive condition), c) torque oscillations of the knee extensor muscle group.

Eligibility criteria:
inclusion criteria: * \>= 65 years old; * conventional ecg without alterations in rest; * medical release for physical exercise; * understand the instructions and agree to participate. exclusion criteria: * historical stroke which produces loss of strength and aphasia; * several impairment of motor skills; * parkinson disease; * diabetes mellitus; * peripheral neuropathy; * vestibular and visual disorders self-reported in anamnesis; * severe cognitive impairment; * cardiovascular disorders (atrial fibrillation, malignant ventricular arrhythmia; ventricular beats complexes ectopic, sinus tachycardia or supraventricular, second and third degree of atrioventricular block, use of pacemaker in the resting ecg); * unstable angina; * myocardial infarction; * elderly end stage.

Keywords: elderly frailty multicomponent training physical exercise functional capacity complexity physical therapy
continuous double ovarian stimulation.

Conditions: Fertility Issues

Summary: to evaluate the efficacy of the weekly use of corifollitropin alfa in double ovarian stimulation process and to compare it to the conventional protocol with daily medication administration.

the purpose of this pilot study is to evaluate the efficacy of the weekly use of corifollitropin alfa in terms of ovarian stimulation results and its biological outcomes (total number of oocytes retrieved) in case of ovarian stimulation cycles in double stimulation modality (duostim) and in comparison with the conventional duostim protocol: daily administration of gonadotropins.

Eligibility criteria:
inclusion criteria: * patients with indication for duostim protocol * maximum age of 43 years (up to one day before their 44th birthday) at the beginning of the stimulation process. * ability to participate and comply with the study protocol. * to have given written consent exclusion criteria: * finding of ovarian pathology at the time of initiation of stimulation: e.g. ovarian cysts. * concurrent participation in another study.

Keywords: ovarian stimulation
transcranial alternating current stimulation

Conditions: Stroke

Summary: to investigate the efficacy of using transcranial alternating current stimulation (tacs) to enhance the regaining of neurological function among post-stroke patients.

sixty post-stroke patients were randomly assigned to receive 15 sessions of the usual rehabilitation programme with or without tacs. the nih stroke scale (nihss) and the mean blood flow velocity (mfv) and gosling pulsatility index (pi) captured for the middle, anterior, and posterior cerebral artery were the outcome measures. fifteen 30-minute sessions of tacs appear to be effective for enhancing post-stroke patients' neurological function. the haemodynamic measures taken indicated that the regaining of function among the patients was largely attributed to a lowering of the vascular autoregulatory activity together with an increase in blood flow velocity at the middle cerebral artery. future studies should explore the underlying mechanisms mediating the positive effects brought about by tacs in post-stroke rehabilitation.

Eligibility criteria:
inclusion criteria: * diagnosed as first onset intracerebral haemorrhage or infarction (according to icd-10 i61.0-i61.6 or i63.3-i63.6, with or without i69, i.e.: sequelae of cerebrovascular disease) * between 15 and 60 days after the onset * right handedness * no previous neurological or psychiatric disorders * positive transtemporal windows for bilateral middle, anterior, and posterior cerebral arteries insonation (according to the standards set by the transcranial doppler ultrasonographic device (tcd)) * nih stroke scale (nihss) scores between 14 and 24 * not receiving rehabilitation before admission exclusion criteria: * medical comorbidity preventing the patient undergoing the intervention * preceding epileptic fits * having metallic implants in the brain or a pacemaker * history of surgery to the brain

Keywords: brain electrical stimulation sub-acute post-stroke rehabilitation
effects of neural slump mobilization in addition to conventional physical therapy in low back pain

Conditions: Low Back Pain

Summary: low back pain is amongst the most prevalent musculoskeletal conditions worldwide.this condition has a significant impact on the person's quality of life by effecting their various activities of daily living. as of 2017 it remains the leading cause of years lived with disability.various management strategies are used for the treatment of low back pain. in the recent years neurodynamic techniques are being used for the treatment of low back pain. escpecially, patients of low back pain who have neural mechanosensitivity may benefit from neural mobilization techniques. slump stretching is a neurodynamic technqiue which is used to improve the mobility of dural tissue.different studies have shown postive results of slump stretching in patients of low back pain. however no such study has investigated the role of slump stretching in improving range of motiion in low back pain patients.so this study aims to investigate the the effect of slump stretching in low back pain patients specially on low back low back pain is amongst the most prevalent musculoskeletal conditions worldwide.this condition has a significant impact on the person's quality of life by effecting their various activities of daily living. as of 2017 it remains the leading cause of years lived with disability.various management strategies are used for the treatment of low back pain. in the recent years neurodynamic techniques are being used for the treatment of low back pain. escpecially, patients of low back pain who have neural mechanosensitivity may benefit from neural mobilization techniques. slump stretching is a neurodynamic technqiue which is used to improve the mobility of dural tissue.different studies have shown postive results of slump stretching in patients of low back pain. however no such study has investigated the role of slump stretching in improving range of motiion in low back pain patients.so this study aims to investigate the the effect of slump stretching in low back pain patients specially on low back


Eligibility criteria:
inclusion criteria: * patients aged 18-44 years * both males and females * persons with low back pain with a positive slump test * patients with a nprs intensity of at least 5 exclusion criteria: * patients with signs or symptoms of nerve root involvement * pregnant females, patients with history of spinal surgery, patients of spondylolistheis, spinal stenosis and disc herniation. * patients with serious spinal conditions infection, tumors, osteoporosis, spinal fracture
advancing renal transplant efficacy and safety outcomes with an everolimus-based regimen (transform)

Conditions: End Stage Renal Disease (ESRD); Chronic Kidney Disease (CKD); Hemodialysis; Renal Replacement Therapy; Renal Transplantation

Summary: this is a 2-year, randomized, multicenter, open-label, 2-arm study evaluating the graft function of everolimus and reduced cni versus mpa and standard cni in adult de novo renal transplant recipients.


Eligibility criteria:
inclusion criteria: 1. written informed consent obtained. 2. subject randomized within 24 hr of completion of transplant surgery. 3. recipient of a kidney with a cold ischemia time \< 30 hours. 4. recipient of a primary (or secondary, if first graft is not lost due to immunological reasons) renal transplant from a deceased heart beating, living unrelated, living related non-human leukocyte antigen identical or an expanded criteria donor. exclusion criteria: 1. subject unable to tolerate oral medication at time of randomization. 2. use of other investigational drugs at the time of enrollment. 3. history of hypersensitivity to any of the study drugs or to drugs of similar chemical classes. 4. multi-organ transplant recipient. 5. recipient of abo incompatible allograft or complement-dependent lymphocytotoxic (cdc) crossmatch positive transplant. 6. subject at high immunological risk for rejection as determined by local practice for assessment of anti-donor reactivity e.g. high pra, presence of pre-existing dsa. 7. subject who is hiv-positive. 8. hbsag and/or a hcv positive subject with evidence of elevated lfts (alt/ast levels ≥ 2.5 times uln). viral serology results obtained within 6 months prior to randomization are acceptable. 9. recipient of a kidney from a donor who tests positive for human immunodeficiency virus (hiv), hepatitis b surface antigen (hbsag) or anti-hepatitis c virus (hcv). 10. subject with a bmi greater than 35. 11. subject with severe systemic infections, current or within the two weeks prior to randomization. 12. subject requiring systemic anticoagulation. 13. history of malignancy of any organ system. 14. subject with severe restrictive or obstructive pulmonary disorders. 15. subject with severe hypercholesterolemia or hypertriglyceridemia that cannot be controlled. 16. subject with white blood cell (wbc) count ≤ 2,000 /mm3 or with platelet count ≤ 50,000 /mm3. 17. pregnant or nursing (lactating) women. 18. women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using effective methods of contraception during dosing of study treatment.

Keywords: kidney failure dialysis renal failure transplantation