Kornimate/medical-research-clean huggingface dataset:
paricalcitol oral therapy in predialysis ckd patients. the greek experience

Conditions: Chronic Kidney Failure; Secondary Hyperparathyroidism

Summary: the purpose of this study is to obtain data on the use of zemplar (paricalcitol) capsules in real-life clinical practice in predialysis patients with chronic kidney disease (ckd) and secondary hyperparathyroidism.

this was a single arm, open, multicenter, non-interventional, post marketing observational study, which has been conducted in 24 sites in greece, under normal clinical practice and as per the locally approved summary of product characteristics (smpc) of study medication (oral paricalcitol). eligible patients were followed up for a 12-month period after enrollment. all study activities were consistent with european union (eu) directive 2001/20/ec section for non-interventional studies. in this study, paricalcitol was prescribed on an on-label basis in an everyday setting to observe drug actions in a distinct geography (greece with \> 250 days/year of sunny days) as well as in a significant subpopulation (chronic kidney disease \[ckd\] stages 3-5 transplanted patients). dose tolerability, treatment effects, as well as maintenance of results were registered for a 12-month period in order to obtain experience in the long term use of paricalcitol capsules. furthermore, in centers where additional blood parameters were examined as part of clinical routine, these were recorded and analyzed.

Eligibility criteria:
inclusion criteria: * patients with secondary hyperparathyroidism in the presence of chronic kidney disease stage 3, 4 or 5 treated with zemplar (paricalcitol) oral for at least 1 month prior to study enrollment * male and female (not pregnant or not planning to be pregnant in the next 12 months) patients \> 18 years of age * signed informed consent by subject * hypertensive and diabetic subjects must be on an optimal and steady medication regimen for more than 30 days exclusion criteria: * contraindications listed in the summary of product characteristics for zemplar capsules apply (appendix i and ii) * parathormone value of \> 1000 pg/ml (sign of tertiary hyperparathyroidism) * treatment with vitamin d within the last 1 month prior to inclusion into the study

Keywords: secondary hyperparathyroidism chronic kidney failure
measurement of hormone levels in patients receiving 17-hpc for preterm delivery

Conditions: Preterm Delivery

Summary: the purpose of this study is to measure hormones in the blood known to affect the timing of delivery after a single injection of 17-p in order to help understand its mechanism of action in preventing preterm delivery.

a recent study by meis and colleagues published in the new england journal of medicine in june 2003 demonstrated a 33% reduction in the rate of preterm delivery in patients with a previous history of preterm delivery who then used weekly 17-p injections in the subsequent pregnancy. this is a milestone in the prevention of preterm delivery and is the reason you have chosen to receive treatment with 17-p. however, how 17-p works to prevent preterm delivery is unclear. knowledge of the mechanism of action of 17-p would help in selecting patients for treatment and may be useful in monitoring the efficacy of therapy. studies have suggested that the timing of delivery depends on a type of placental clock, affected by levels of corticotropin-releasing hormone (crh) and progesterone (p). crh can be thought to act as an accelerator, and p as a brake. serial injections of 17-p beginning in the second trimester of pregnancy may prevent preterm delivery by maintaining progesterone dominance, and be reflected in increased levels of progesterone and/or 17-p, or decreased levels of cortisol and/or crh. these are the hormones that will be measured in this study. results of the study will be important whatever the outcome. if there is no measurable change in the hormones measured, this is important to know and investigation of other markers can be pursued. if there is a measurable change in the hormones measured, then this pilot study could serve to support a larger more definitive study, which could lead to very valuable information relating to the practical use of 17-p for the prevention of preterm delivery.

Eligibility criteria:
inclusion criteria: * spontaneous preterm delivery in a previous pregnancy, are between 15-20 weeks gestation during the current pregnancy, and have already decided whether or not to receive 17-alphahydroxyprogesterone caproate (17-p) for the prevention of preterm delivery. exclusion criteria: * multiple gestation * known fetal anomaly * progesterone or heparin treatment during the current pregnancy * seizure disorder * pre-existing or gestational diabetes * hypertension requiring medication * thyroid or adrenal gland disorder
investigation of hyposafe h02 device in patients with type 1 diabetes

Conditions: Type 1 Diabetes

Summary: this clinical study is designed to collect data for further development of a hypoglycaemia notification algorithm. in addition, information regarding safety will be collected and analysed.

h02 is an implantable continuous eeg recorder that consists of an implant and an external device. the h02 system is based on a subcutaneous eeg measurement and acquisition of the eeg signal from the implant. participant will have the implantable part of h02 implanted under local anaesthesia. after a healing period, the participants will start using the external part of h02. they will wear the external part of h02 as much as possible both during daytime and night-time. the participant will use their own continuous glucose monitoring (cgm) during the study as normal practice. the participants will be exposed to insulin-induced hypoglycaemia once during the study.

Eligibility criteria:
inclusion criteria: * informed consent * type 1 diabetes diagnosed at least five years prior to inclusion in the study * age 18-70 years * impaired awareness, i.e., defined as unaware by the pedersen-bjergaard scale and history of at least one severe hypoglycaemia within the preceding year * use of continuous glucose monitoring at study start exclusion criteria: * high risk of surgical complications * involved in therapies with medical devices that deliver electrical energy into the area around the implant * infection at the site of device implantation * contraindications to the local anaesthetic used during implantation and explantation * have cochlear implant(s) * subject is scheduled to undergo mri scan, ultrasound, radiation, or electrical current induced close to the implant, within 6 months after enrolment * severe cardiac disease * history of stroke/ cerebral haemorrhage and any other structural cerebral disease * active cancer or cancer diagnosis within the past 5 years
betafoam diabetes mellitus foot study

Conditions: Diabetes Mellitus; Foot Ulcer

Summary: this study is to compare the efficacy and safety of medifoam® and betafoam®, which is a new dressing that contains povidone-iodine, in patients with diabetes foot ulcer. 70 patients (35 each arm) are targeted to be enrolled in this study. treatment follow periods are 8weeks.


Eligibility criteria:
inclusion criteria: * adult of age ≥19 years at the time of informed consent * foot ulcers related to diabetes mellitus: * present * type i or ii diabetes mellitus with hba1c \<10%, or serum creatinine ≤ 200 μmol/l * wagner grade i-ii (partial- or full- thickness and not involving bone, tendon, or capsule (probing to tendon or capsule) * post -debridement ulcer bed size ≥ 1\*1cm2 * no clinical signs of infection \& necrosis * site at anywhere below ankle * no vascular abnormalities of the foot by palpation (i.e. the dorsalis pedis should be examined by the physician and characterized as present or absent) exclusion criteria: * pregnant \& lactating females * known allergy to the dressing product including povidone iodine * known hyperthyroidism or other acute thyroid diseases * subject with clinical infection who should be administered antibiotics continuously after enrolment * subject has any condition(s) that seriously compromises the patient's ability to complete this study. * subject has participated in interventional study utilizing an investigational drug within the previous 30 days * subjects with known immune-suppressed state; who undergo chemotherapy or with end-stage renal disease requiring haemodialysis or had kidney transplant surgery previously and with immunosuppressant specifically * subjects requiring skin grafting per physician's discretion * vulnerable subjects as defined by good clinical practice guidelines.

Keywords: foam dressing
oral antibiotic prophylaxis in colorectal surgery

Conditions: Surgical Site Infection; Anastomotic Leak

Summary: the investigators perform a case-control study to compare preparation before elective colorectal surgery. the first group is a prospective patient - registry in all patients with mechanical bowel preparation (mbp) and oral antibiotic prophylaxis the day before colorectal surgery. the second group is a historic collective of patients with mbp only and colorectal surgery. the cases were matches in american society of anesthesiologists (asa) physical status classification system, bmi, operative procedure and risk factors.


Eligibility criteria:
inclusion criteria: * all colorectal resections exclusion criteria: * allergy
a study to compare efficacy, pk, pd, safety and imm of mb09 to prolia® [eu-sourced] in postmenopausal osteoporosis.

Conditions: Postmenopausal Women With Osteoporosis

Summary: this was a randomized, double-blind, parallel, multicenter, multinational study to compare the efficacy, pharmacokinetics, pharmacodynamics, safety and immunogenicity of mb09 versus prolia® in postmenopausal women with osteoporosis

the study was planning to randomise approximately 528 postmenopausal women with osteoporosis aged ≥55 and ≤80 years old with a bone mineral density (bmd) consistent with t-score of ≤ -2.5 and ≥ -4 at the lumbar spine or total hip as measured by dxa during the screening period. screening evaluations were to be completed within 28 days prior to randomisation. on day 1, 528 eligible postmenopausal women with osteoporosis were to be randomised in a 2:1:1 ratio to receive mb09-mb09 (arm 1), prolia-mb09 (arm 2), or prolia-prolia (arm 3) using an interactive response sys-tem (irt). during the main treatment period, subjects received one subcutaneous injection (60 mg/ml) of study drug on day 1 and at month 6. at month 12, after all efficacy and safety assessments have been performed, the subject were to be enter the transition/safety follow up period and were to receive the third dose of study drug. subjects assigned to the mb09 mb09 arm (arm 1) received mb09 on day 1, at month 6 and at month 12. subjects assigned to the prolia mb09 arm (arm 2) received eu-prolia on day 1 and at month 6, and mb09 at month 12. subjects assigned to the prolia-prolia arm (arm 3) received eu-prolia on day 1, at month 6, and at month 12. all subjects were to be followed up to transition period month 6. all subjects received daily supplementation of calcium and vitamin d.

Eligibility criteria:
inclusion criteria: * postmenopausal women, diagnosed with osteoporosis. * aged ≥ 55 and ≤ 80 years at screening. * body weight ≥ 50 kg and ≤ 99.9 kg, and a body mass index of ≤30 kg/m2 at screening. * absolute bone mineral density consistent with t-score ≤ -2.5 and ≥ -4.0 at the lumbar spine or total hip as measured by dual-energy x-ray absorptiometry (dxa). * at least two intact, nonfractured vertebrae in the l1-l4 region and at least one hip joint evaluable by dxa. * adequate organ function. exclusion criteria: * previous exposure to denosumab (prolia®, xgeva®, or denosumab biosimilar) or other monoclonal antibody. * history and/or presence of one severe or more than two moderate vertebral fractures or hip fracture. * recent long bone fracture (within 6 months). * history and/or presence of bone metastases, bone disease or other metabolic disease. * intravenous bisphosphonate administered within 5 years of screening. * oral bisphosphonates ≥12 months cumulative use prior to screening. if used \<12 months cumulatively and the last dose was ≥12 months before screening, the subject could be enrolled. * ongoing use of any osteoporosis treatment or use of prohibited treatment. * other bone active drugs. * history and/or current hypoparathyroidism or hyperparathyroidism, hypocalcemia or hypercalcemia. * other inclusion/exclusion criteria may apply.
survivorship and outcomes of robotically assisted patellofemoral uka

Conditions: Patellofemoral Knee Arthroplasty

Summary: the purpose of the study is to determine the survivorship rate of robotically guided isolated patellofemoral implants at 2, 5 and 10 year postoperative.

the purpose of the study is to determine the survivorship rate of robotically guided isolated patellofemoral implants at 2, 5 and 10 year postoperative.

Eligibility criteria:
inclusion criteria: * over 21 years of age underwent primary robotically guided uka and received an isolated patellofemoral implant at least 24 months post operative as of february 2013 exclusion criteria: * patient will be excluded from participation in the study if they are cognitively unable to answer study questions.

Keywords: osteoarthritis, patellofemoral
evaluation of malondialdehyde in periodontal and cardiovascular disease

Conditions: Metabolic Disease

Summary: malondialdehyde (mda) plays a key role in endothelial function and may be a link for the known interaction of periodontitis and coronary heart disease (chd). the investigators compared the impact of gingival health, periodontitis (cp), chd or of both diseases (cp+chd) on saliva and serum mda levels.

the aim of this study was to evaluate a possible association between both saliva and serum mda levels in patients with cp and with chd and if the serum mda levels are mediated by serum crp

Eligibility criteria:
inclusion criteria: * presence of at least twenty teeth * cp with a minimum of 40% of sites with a clinical attachment level (cal) ≥2mm and probing depth (pd) ≥4mm; * presence of at least ≥2 mm of crestal alveolar bone loss verified on digital periapical radiographs * presence of ≥40% sites with bleeding on probing (bop) exclusion criteria: * intake of contraceptives * intake of immunosuppressive or anti-inflammatory drugs throughout the last three months prior to the study * status of pregnancy or lactation * previous history of excessive drinking * allergy to local anaesthetic * intake of drugs that may potentially determine gingival hyperplasia such as hydantoin, nifedipine, cyclosporin a or similar drugs.
when and how to administer oxytocin for active management of third stage of labour

Conditions: Postpartum Bleeding

Summary: to compare the efficacy of the route and timing of oxytocin administration for active management of third stage of labour (amtsl).

our objective is to determine the most efficient route and timing of oxytocin administration by measuring the duration of third stage of labour, quantitative blood during the first hour after delivery and comparing haemoglobin and haematocrit changes and the need for additional interventions in patients who had either a spontaneous labour or received labour augmentation with oxytocin.

Eligibility criteria:
inclusion criteria: * having a singleton pregnancy above 37th gestational week * normal live vaginal delivery with cephalic presentation * being in active labor exclusion criteria: * fetal demise * multiple pregnancy * known coagulation disorder * presentation anomalies * placental pathology * liver disease * thrombocytopenia * hypertension or being currently on anticoagulants * having a cesarean section, operative delivery or deep vaginal tear * chorioamnionitis * developing hellp syndrome (hemolysis, elevated liver enzymes, and low platelet count) or dic (disseminated intravascular coagulation) before delivery

Keywords: oxytocin active management of third stage of labour
vitamin c to reduce vasopressor dose in septic shock

Conditions: Septic Shock; Sepsis

Summary: randomized, controlled, double blind clinical trial. adult patients admitted to the icu of the hospital español de méxico with a diagnosis of septic shock will be included. patients will be randomized to one of the study groups: intervention group: vitamin c 6 grams in 250 ml of 0.9% saline solution every 24 hours, in continuous infusion for 72 hours. placebo group: 0.9% saline solution 250 ml every 24 hours, in continuous infusion for 72 hours.

randomized, controlled, double blind clinical trial. adult patients admitted to the icu of the hospital español de méxico with a diagnosis of septic shock will be included. patients will be randomized to one of the study groups: intervention group: vitamin c 6 grams in 250 ml of 0.9% saline solution every 24 hours, in continuous infusion for 72 hours. placebo group: 0.9% saline solution 250 ml every 24 hours, in continuous infusion for 72 hours. bottles will be identical, only identified by the sequential number of the patient that has been included. primary objective is to demonstrate that the administration of intravenous vitamin c decreases the dose of exogenous vasopressors in patients with septic shock

Eligibility criteria:
inclusion criteria: * adults * septic shock exclusion criteria: * previous treatment exceeded 24 hours * refusal to participate * do not resuscitate * participation in another trial

Keywords: critical care vitamin c vasopressor intensive care unit
safety study of maraviroc's effect on human osteoclasts

Conditions: HIV Infections; AIDS

Summary: this study is to investigate the safety of maraviroc by examining whether there is bone metabolism dysfunction in actual use of maraviroc in human body, or not, measuring bone mineral density and markers for bone formation, desorption and chemokine.

an observational study to investigate the safety of maraviroc by examining whether there is bone metabolism dysfunction in actual use of maraviroc in human body, or not, measuring bone mineral density and markers for bone formation, desorption and chemokine.

Eligibility criteria:
inclusion criteria: outpatients or inpatients that are treated for hiv infection at aids clinical center of national center for global health and medicine who meet all criteria following: * those whose primary care physician acknowledged the necessity of maraviroc treatment due to multi-resistance hiv strain that is confirmed to have ccr5 tropism. * those who are willing and able to consent to this study * 20 years old or older exclusion criteria: cases applicable to any condition of the following: * those who are not suited for maraviroc (whose hiv strain to be cxcr4 tropism) * others who the principle investigator physician considered to be excluded

Keywords: maraviroc osteoclasts receptors, ccr5 chemokine ccl5
primary cyto-reductive surgery vs neo-adjuvant chemotherapy (nac) in epithelial ovarian cancer

Conditions: Advanced Cancer

Summary: assessment of efficacy of primary cyto-reductive surgery in patients with advanced primary epithelial ovarian cancer in comparison to patients receiving neo-adjuvant chemotherapy (nac) followed by surgery in complete excision of the tumor reaching r0 without significant morbidity.


Eligibility criteria:
inclusion criteria: female patients diagnosed with epithelial ovarian cancer (by histopathology) age ≥ 18 years old advanced defined as (stage 2d or more ) by surgical staging. performance status (ps) according to eastern cooperative oncology group (ecog) ≤ 2 chemotherapy naïve informed consent exclusion criteria: patients previously received chemotherapy or radiotherapy to any part of the abdomen or pelvis. patients with uncontrolled infection. patients with active bleeding or conditions associated with high risk of bleeding. contraindications for surgery contraindications to chemotherapy - bevacizumab
levels of visfatin/nampt in human milk

Conditions: Visfatin Levels in Maternal Milk Samples; Birth Weight

Summary: visfatin, released in maternal milk at different concentrations related to the maternal conditions, could act as a biomarker with a prognostic/predictive value to determine different newborn clinical conditions, particularly the weight loss of the neonate.

the aim of the study is to analyse a retrospective cohort of well characterized mothers in their post-partum period, and to measure visfatin levels through collection of maternal milk samples. they will be collected in three different moments after the birth (48 hours, 7 days and 30 days) and visfatin levels will be analysed through an elisa kit adipogen. in parallel, the levels of visfatin will be evaluated in the maternal plasma/serum collected after 1-2 days postpartum. lastly, correlations between visfatin levels and biological/clinical features of mothers and newborns will be explored.

Eligibility criteria:
inclusion criteria: * healthy male and female infants born after 37 weeks' gestation who do not have conditions related to congenital abnormalities * maternal hospitalization * acquisition of the informed consent form signed by the patient exclusion criteria: * refusal of the patient to participate in the study * presence of hypogalactia or agalactia in the patient

Keywords: newborns visfatin breastfeeding
her2 expression of ctc to predict response in her2-positive advanced breast cancer patients treated with adc

Conditions: Breast Cancer

Summary: to evaluate the predictive and prognostic value of her2 expression of circulating tumor cells in her2-positive advanced breast cancer patients treated with adc


Eligibility criteria:
inclusion criteria: * has pathologically documented breast cancer that: 1. is unresectable or metastatic 2. has confirmed her2-positive expression defined as ihc 2+/ish+ or ihc 3+ 3. was previously treated with trastuzumab and taxane in the advanced setting or progressed within 6 months after neoadjuvant or adjuvant treatment involving a regimen including trastuzumab and taxane * has adequate cardiac, bone marrow, renal, hepatic and blood clotting functions * receives anti-her2 adc treatment * life expectancy \> 3 months * evidence of measurable or evaluable disease (recist 1.1 criteria)in the 28 days before selection * ecog ≤2 exclusion criteria: * has uncontrolled or significant cardiovascular disease * has history of (noninfectious) interstitial lung disease (ild)/pneumonitis that required steroids, has current ild/pneumonitis, or suspected ild/pneumonitis that cannot be ruled out by imaging at screening * has any medical history or condition that per protocol or in the opinion of the investigator is inappropriate for the study