Kornimate/medical-research-clean huggingface dataset:
effect of vitamin d replacement on immune function and cognition in ms patients

Conditions: Multiple Sclerosis (MS)

Summary: assessing the immune activation in ms patients deficient in vitamin d and whether vitamin d supplementation reverse the immune activation evaluating whether vitamin d deficiency result in lower cognitive performance in ms patients and the effect of vitamin d supplementation on reversing the cognitive impairment?

we will compare the immune responses in patients with vitamin d deficiency (serum level \ 35 ng/ml). we will focus on proliferation and cytokine production to myelin basic protein (mbp) and myelin oligodendrocyte glycoprotein (mog) peptides and on the percentage of th1 (ifn gamma producing cells) and th17 (il-17 producing cells) during in vitro polarization assays. our hypothesis is that patients with low vitamin d have increase proliferation to mbp and mog and increased production of pro-inflammatory cytokines (ifn gamma and il-17) and that vitamin d supplementation will decrease this pro-inflammatory profile. we will measure cognitive performance in patients with vitamin d deficiency (serum level \ 35 ng/ml) after adjusting for educational levels and disease duration. we hypothesize that low vitamin d has a negative effect on cognitive performance and that vitamin d supplementation will improve cognitive function.

Eligibility criteria:
inclusion criteria: 1. definite diagnosis of multiple sclerosis following the revised mcdonald ms diagnostic criteria 2. male and female aged 18 and above 3. on interferon-β treatment (rebif®, avonex®, or betaseron®) 4. no signs of active inflammation or attack or new lesions on mri exclusion criteria: 1. treatment with immune modulating/ suppressive drugs other than ifn-b within 6 weeks prior to enrolment 2. pregnancy 3. hypercalcemia 4. eglomerular filtration rate\<60 5. history of primary hyperparathyroidism, hypercalcemia, renal dysfunction, cardiac disease, malignancy, or granulomatous disease 6. the occurrence of an exacerbation (defined as an episode of neurologic dysfunction lasting at least 24 hours) within 4 weeks of enrollment 7. history of dementia or related disorders 8. history of traumatic brain injury 9. diagnosis of epilepsy or history of seizure 10. diagnosis of psychiatric disease, substance abuse/dependence, alcohol abuse/dependence 11. currently, on any of the following medications lithium, or thiazide diuretics

Keywords: multiple sclerosis (ms)
do you need to assess myocardial ischemia in type 2 diabetes

Conditions: Type 2 Diabetes

Summary: dynamit is a prospective, randomized, multicenter, open strategy trial run in 45 french hospitals. diabetic patients with no evidence of coronary artery disease and at least 2 additional cardiovascular risk factors are randomized to screening for silent ischemia using a bicycle exercise test or dipyridamole single photon emission computed tomography (n=316), or follow-up without screening (n=315). all have access to cardiovascular prevention according current guidelines. the main end point is time to death from all causes, non-fatal myocardial infarction, non-fatal stroke, or heart failure requiring hospitalization or emergency service intervention.


Eligibility criteria:
inclusion criteria: * patients 55 to 75 years old had type-2 diabetes and at least two of the following cardiovascular risk factors: * urinary albumin excretion \> 30 mg/l or \> 30 mg/24 hours, * treated or untreated hypertension, * treated or untreated lipid abnormality, * peripheral arterial disease, * history of transient ischemic accident, * tobacco consumption * familial history of premature cardiovascular disease. exclusion criteria: * history of myocardial infarction, coronary artery disease, or stroke, * previous positive stress test or myocardial perfusion imaging, * negative stress test or myocardial perfusion imaging within the last three years
kinetic study of cd8+ cmv-specific cellular immunity in renal transplant patients after receiving thymoglobulin

Conditions: Renal Transplant Infection

Summary: renal transplant candidates who have cmv-specific, cd8+ t-cells, are cmv-seropositive and carry hla-a1 and/ or hla- a2 alleles have a high probability to maintain this type of immunity during the three first months after the transplant, despite induction immunosuppressive therapy (thymoglobulin).


Eligibility criteria:
inclusion criteria: 1. renal transplant recipients with cmv-positive serology. 2. patients with pre-transplant, cmv-specific cd8+ t cell-mediated immunity, i.e. ifnγ levels ≥0.2 ui/ml (qf-cmv reactive). 3. adults over 18 years of age. 4. patients receiving induction therapy with thymoglobulin (at least a cumulative dosage of 1mg/kg). 5. patients receiving prophylaxis with valganciclovir (900 mg/day, adjusted to kidney function) until day 90 after transplant. 6. patients who signed an informed consent exclusion criteria: 1. multivisceral transplantation, including pancreas-kidney transplantation. 2. hiv infected patients. 3. patients who cannot comply with the monitoring protocol.
coagulation and fibrinolysis as virulence factors for invasive staphylococcus aureus and streptococcus infections

Conditions: Infective Endocarditis; Necrotizing Fasciitis

Summary: the aim of this study is to investigate the role of staphylokinase, streptokinase and mmp activation in invasive staphylococcal and streptococcal infections.


Eligibility criteria:
inclusion criteria: * all patients that undergo surgical treatment for invasive streptococcal or staphylococcal infections, including acute infective endocarditis and necrotizing fasciitis, from the uz leuven university hospital exclusion criteria: * none

Keywords: virulence factors
dose ranging study of magnesium iron hydroxycarbonate in haemodialysis subjects with hyperphosphataemia

Conditions: Chronic Kidney Failure

Summary: magnesium iron hydroxycarbonate is a phosphate binder that absorbs phosphate from food, reducing the amount that the body can absorb. the purpose of this study is to determine how well a range of different doses of fermagate are tolerated by the subjects in the trial.

high levels of phosphate in the blood are linked with serious effects, due to calcium imbalances (high levels of parathyroid hormone (pth), bone disease, formation of calcium deposits in the body, and blood-vessel disease. current guidelines indicate that blood phosphorus levels should be maintained between 1.13 to 1.78 mmol/l in patients who receive hemodialysis. the purpose of this study is to determine the range of dosages which are tolerated by patients with hyperphosphatemia, undergoing haemodialysis.

Eligibility criteria:
inclusion criteria: * male or female subjects on active haemodialysis, aged 18 years or over who are able to comply with study procedures * written informed consent given * on a stable haemodialysis regimen (three times per week) for at least 3 months and be unlikely to change their dialysis prescription during the study period * on a stable dose of phosphate binder for at least 1 month prior to screening * willing to abstain from taking any phosphate binder or oral magnesium-, aluminium- or iron-containing products and preparations, other than the study medication * willing to avoid any intentional changes in diet such as fasting, dieting or overeating * on a dialysate magnesium ion concentration of ≤1.0 mmol/l for at least 1 month prior to screening exclusion criteria: * received a cardiac transplant * heart failure according to new york heart association (nyha) functional iv classification * participation in any other clinical trial using an investigational product or device within the previous 4 weeks * a significant history of alcohol, drug or solvent abuse in the opinion of the investigator * any disease or condition, physical or psychological, which in the opinion of the investigator would compromise the safety of the subject or increase the likelihood of the subject being withdrawn * clinically significant laboratory findings (at screening for this subject population) in the opinion of the investigator * any history of recent clinically significant malignancy * a significant illness (excluding renal disease) in the 4 weeks before screening * a history of poorly controlled epilepsy * female subjects who are lactating or pregnant. women of childbearing potential (pre-menopausal and not surgically sterilised) unless they are using a reliable contraceptive method, that is, barrier methods, hormones or intrauterine device * allergy to magnesium iron hydroxycarbonate or sevelamer or any component of the formulations * any condition that affects the reliability of measuring qt interval, for example, an irregular heart rhythm such as atrial fibrillation or frequent ectopic activity

Keywords: hyperphosphataemia phosphate binder
pnf technique in adhesive capsulitis

Conditions: Adhesive Capsulitis

Summary: adhesive capsulitis is painful movement restricted condition linked with pain, restricted range of motion and difficulty in performing daily life activities. multiple treatment options are there for its treatment. however, role of peripheral neuromuscular facilitation in this regimen is still under consideration.

adhesive capsulitis or peri-arthritis or frozen shoulder is self-limiting condition of unknown etiology that usually affects middle aged population of 40-70 years and rarely it occur secondary to rheumatoid arthritis, osteoarthritis, trauma or immobilization of shoulder joint. it is characterized by development of dense adhesions, capsular thickening and restrictions which limits active and passive shoulder range of motion (rom) with scapular dyskinesia.the aim of the of the study is to investigate the effects of scapular proprioceptive neuromuscular techniques with routine physical therapy on pain, scapular dyskinesia, shoulder ranges of motion and functionality in patients with adhesive capsulitis. proper functioning of upper extremities requires both motion and stability of scapula on thorax. prolonged immobilization of shoulder joint leads to ankylosis of joint and scapular dyskinesia. this study will help with a positive effect by using a non-invasive, less painful, cost effective and time saving approach of scapular proprioceptive neuromuscular facilitation techniques among joint mobilization and other therapeutic approaches like intra articular injections and manipulation under anesthesia on alleviating pain, muscle strength, shoulder ranges of motion and early restoration of normal functioning of shoulder joint.

Eligibility criteria:
inclusion criteria: * diagnosed cases of stage ii \& iii adhesive capsulitis * referred by orthopedic physician * duration of stage approximately 1 month * both male and female * age: 40-70 years exclusion criteria: * recent history of trauma * dislocation or fractures of shoulder * history of diabetes and hypertension * congenital shoulder deformity * previous surgery patients * patients with diagnosed cardiovascular disease * patients with malignancy

Keywords: adhesive capsulitis scapular pnf technique shoulder range of motion
a stuty on the treatment and nursing care of cipn patients with traditional chinese medicine hot package

Conditions: Chemotherapy

Summary: the combination of platinum and taxane drugs has a chemotherapy-induced peripheral neuropathy (cipn) rate of 73% to 83%. its symptoms can not only limit daily activities and cause a variety of accidental injuries, but also easily cause negative emotions and seriously affect the quality of life. modern western medicine lacks effective clinical intervention methods, and the treatment of acupuncture points with traditional chinese medicine is simple to operate, easy to observe adverse reactions, and is suitable for continuous self-treatment outside the hospital after training, saving patients time to travel to and from the hospital, and high patient acceptance. due to the similarity of the pathogenesis of some traditional chinese and western medicine in cipn and the effectiveness of its application in patients with dpn, this study evaluated the effect of specific formulations of chinese medicine on cipn by comparing the degree of nerve damage between the following formulations of chinese medicine hot packs in patients with platinum combined with paclitaxel chemotherapy and the control group.

a random group generator was used to divide the sample of 90 cases, and 45 cases in the control group and 45 cases in the intervention group. control group: the chemotherapy was strictly followed by the drug use routine, administered by central vein, paclitaxel and platinum administration rate were set at 180ml/h, and routine health guidance was given before and after chemotherapy. intervention group: in addition to the usual nursing measures of the control group, traditional chinese medicine hot bao acupoint treatment and home care were used. patients in both the intervention and control groups were assessed for peripheral neuropathy on the 14th day after the completion of each two rounds of chemotherapy, and the nci-ctcae, fact/gog-ntx, and kpss score scales were assigned according to the patient-reported outcomes.

Eligibility criteria:
inclusion criteria: * adult and kinetic patients expected survive with tumor for more than 1 year. those who use platinum in combination with paclitaxel for chemotherapy for the first time; voluntarily agree to participate and sign a consent form exclusion criteria: * those who are allergic to platinum, paclitaxel or chinese herbal medicine ingredients; patients with diabetes mellitus, raynaud's syndrome, central or peripheral nerve disease symptoms; those who cannot judge their own symptoms; pregnant / lactating women; patients with advanced rheumatoid arthritis, severe joint deformity or incapacitation; those with other immune system diseases； patients who have not completed the chemotherapy regimen; patients who were not treated with hot acupuncture points as prescribed (missed dosing ≥ 3 times per week); incomplete collection of clinical data; subjects who voluntarily request to withdraw from this treatment, or are unwilling to continue treatment.

Keywords: chemotherapy-induced peripheral neuropathy/cipn hot compress with chinese herbal packets
effect of pparγ2 polymorphism and nsaids on acute alcohol-induced changes in serum estrogens among post-menopausal women

Conditions: Breast Cancer

Summary: postmenopausal women, stratified by a peroxisome proliferator-activated receptor gamma-2 (pparg) polymorphism, were given the following treatments in a random order with a 5w wash-out period: a 400mg ibuprofen tablet or a placebo tablet; both treatments were followed after 30min by a single acute dose of 0.4g alcohol per kg bw. serum estrogen levels were measured before and at three timepoints after alcohol intake. it is hypothesized that the acute decrease in estrogen sulphate and other markers of estrogens after alcohol intake is modulated by ibuprofen and by pparg genotype.

in a pilot human intervention trial we aimed to determine the effect of the pparg pro12ala polymorphism and the pparγ stimulator, ibuprofen, on sex-hormone levels following alcohol intake in postmenopausal women. seven women with pparg pro12ala and 18 pparg wildtype women were included.the study was performed as a randomised, double-blinded, placebo controlled 2x24 h crossover study. the volunteers were randomised to 1 of 2 groups who got the two treatments in different orders. treatment 1 was a placebo tablet with water followed after 30min by an alcoholic drink providing 0,4g alcohol per kilogram bw and treatment 2 was an ibuprofen tablet (400mg) with water followed by the same alcoholic drink. the two treatments were separated by a 5-7 weeks washout period. alcohol was supplied as 7.7% ethanol in a lime-flavoured drink and was consumed over 15 min. edta-plasma was collected 40min before and 30, 60 and 90 min after ethanol intake as well as after 24 hours. ibuprofen (400mg) was provided together with 100ml water 30min before the ethanol. urine was collected throughout the 24 hour interval. serum estrone, estrone sulphate, serum estrogen-binding globulin (shbg), and ethanol were determined. it is hypothesized that the acute decrease in estrogen sulphate and other markers of estrogens after alcohol intake is modulated by ibuprofen and by pparg genotype.

Eligibility criteria:
inclusion criteria: 1. postmenopausal (last menses at least 1 year earlier); 2. having a weekly alcohol use of less than 14 drinks 3. having a bmi of 18-35; exclusion criteria: 1. a history of alcohol abuse 2. alcohol abstaining 3. history of hysterectomy before last menses with preservation of both ovaries (unless a medical confirmation for the postmenopausal status exists or the participant is 60 years or older); 4. major health problems, such as ulcers, heart diseases, diabetes or cancer 5. previous or current use of hrt 6. taking prescription medications that could interfere with the study (i.e. daily use of nsaids and/or medication that interact with pparγ e.g. cholesterol lowering medicine); 7. being allergic to alcohol and/or ibuprofen 8. smoking

Keywords: ppar-gamma estrogens nsaids polymorphism metabolomics
40 week extension study of asenapine and olanzapine for bipolar disorder (a7501007)(completed)(p05857)

Conditions: Bipolar Disorder

Summary: bipolar disorder is characterized by mood swings that range from from high (manic) to low (depressed) states. sometimes, symptoms of both depression and mania are present (mixed episodes). asenapine is an investigational medication for the treatment of manic or mixed episodes of bipolar disorder. patients who completed study a7501006 (a 9 week extension study) could continue with the same treatment that they had been receiving: asenapine or olanzapine (a medication that is already approved for the treatment of bipolar mania) in a 40 -week continuation study.


Eligibility criteria:
inclusion criteria: * have completed asenapine 3-week and 9 -week studies for the treatment of an acute manic or mixed episode and not had any major protocol violations.. exclusion criteria: * patients with unstable medical conditions or clinically significant laboratory abnormalities.
impact of the coordinated intervention of the healthcare facilities pharmacist and the dispensary pharmacist on the care pathway for cancer patients treated with oral therapy

Conditions: Advanced or Metastatic Solid Tumor; Relapsed Hematologic Malignancy

Summary: the rise of oral therapies in the management of cancers has considerably changed the patient care path. if the oral route is preferred by patients because it offers a better quality of life, it is not without impact for patients and the health professionals involved in their management in their care. indeed, the use of the oral route shifts part of the responsibility for monitoring treatment towards the patient, thereby leading to compliance problems, drug interactions and the management of adverse effects.these risks can cause complications or compromise the effectiveness of treatment, and generate additional costs for the investigator's health system. the study proposes to involve healthcare facilities pharmacist and the dispensary pharmacist with all other health professionals.first, the hospital pharmacist will operate before the initiation of an oral route to perform a clinical pharmaceutical analysis of drug prescriptions. then after the primary prescription and finally during a follow-up consultation 3 months after the initiation of treatment. the hypothesis of the study is that the coordinated intervention of the hospital pharmacist and of the dispensary pharmacist would improve the tolerance of oral treatments by reducing the number of serious adverse effects found, as well as improve the, quality of life, patient and professional satisfaction


Eligibility criteria:
inclusion criteria: * patient aged 18 years old or more * having given his written consent to participate in the study * patients with advanced or metastatic solid tumor or relapsed hematologic malignancy * with an initiation of oral therapy * performance status 0, 1 or 2 exclusion criteria: * patient receiving ongoing intravenous (iv) or subcutaneous (sc) anticancer treatment * patient receiving ongoing oral therapy * patient receiving first-generation hormone therapy * patient receiving ongoing a coordinated pharmaceutical path * patient participating in a therapeutic education program including a pharmacist * patient already included in an interventional clinical trial * oral therapy with temporary authorisation * patient in a health or medico-social institution * patient protected, under guardianship or unable to give free and informed consent * patient does not speak french * patient unable to read french * patient unable to undergo the medical monitoring of the trial for geographical, social or psychological reasons. * patients 70 years old with cognitive disorders identified by the g-code

Keywords: anti cancer oral therapy pharmaceutical intervention adverse events drug interactions coordinated care pathway drug related problem adherence quality of life pharmaceutical care clinical pharmacy oncology pharmacy hospital pharmacist patient satisfaction patient care team community pharmacist
glucocorticoids and skin healing in diabetes (gc-sheald)

Conditions: Diabetes Mellitus, Type 2

Summary: the study aims to investigate effects of inhibiting glucocorticoid activation on skin function and wound healing in patients with type 2 diabetes. half of patients will be given a drug to inhibit glucocorticoid activation and the other half will be given a placebo.

glucocorticoids are known to impair skin function and wound healing which are also compromised in patients with type 2 diabetes. the enzyme 11 beta-hydroxysteroid dehydrogenase type 1 (11β-hsd1) activates glucocorticoids in target tissues including skin. pre-clinical data demonstrate that 11β-hsd1 inhibition improves skin function and wound healing but this has not been investigated in man. using the 11β-hsd1 inhibitor azd4017, we will investigate if 1. oral azd4017 inhibits 11β-hsd1 activity in skin 2. azd4017 is safe and well-tolerated in patient with t2dm 3. oral azd4017 regulates skin function 4. systemic glucocorticoid levels and skin 11β-hsd1 activity, independently or in combination correlate with measures of skin function study feasibility will also be assessed; if successful, data from this pilot study will inform power calculations for a future trial to investigate the ability of 11β-hsd1 inhibition to promote foot ulcer healing in type 2 diabetes.

Eligibility criteria:
inclusion criteria: 1. able and willing to consent 2. type 2 diabetes with hba1c ≤11% (≤97 mmol/mol) at screening while taking standard therapy at a stable dose for ≥10 weeks exclusion criteria: 1. women of child-bearing potential 2. active leg/foot ulceration 3. clinically relevant acute electrocardiogram anomalies 4. uncontrolled hypertension 5. endocrine disorder (other than type 2 diabetes ), including type 1 or secondary diabetes (except treated hypothyroidism) 6. gilbert's disease 7. alanine aminotransferase and/or aspartate aminotransferase and/or alkaline phosphatase \>1.5x upper limit of normal (uln) 8. bilirubin \>1.5x uln 9. estimated glomerular filtration rate \<45 ml/min/m2 10. creatine kinase \>2x uln 11. drug abuse within the last year 12. any glucocorticoid treatment within 3 months of screening 13. anti-coagulant medication 14. probenecid therapy 15. medical/surgical procedure or trauma during drug administration or one week after drug cessation (excluding skin biopsies) 16. involvement in trial planning and/or conduct 17. participation in other clinical study within 1 month 18. deemed inappropriate to participate by the trial team

Keywords: skin wound healing 11 beta-hydroxysteroid dehydrogenase type 1