Kornimate/medical-research-clean huggingface dataset:
more time better outcome - a randomised trial to investigate the effect of more dietetic time in dialysis patients

Conditions: Renal Failure

Summary: the purpose of this study is to determine whether spending more time with a dietitian will improve dietary compliance in a group of hemodialysis patients, with particular respect to phosphate control.

* randomised prospective controlled trial * stable haemodialysis patients on thrice weekly haemodialysis (urr \> 66%) * either had standard dietetic review - 6 monthly or intensive review - monthly * all patients had to have a serum phosphate \> 1.8 mmol/l over the previous three months to be recruited * study period 6 months, and then patients followed for a further 3 months

Eligibility criteria:
inclusion criteria: * stable chronic hemodialysis patients * serum phosphate \> 1.8 mmol/l sustained over 3 months prior to trial entry adequate dialysis treatment as assessed by urea reduction exclusion criteria: * pregnancy * unable to give consent * phosphate \< 1.8 mmol/l * inadequate dialysis * aged \ 80 * poor nutritional state * weight loss in proceeding three months

Keywords: hemodialysis phosphate calcium phosphate product dietician dietetic advice
treatment of prp on diabetes wound

Conditions: Diabetic Ulcers on Both Feet

Summary: the purpose of this study is to focus on the effect of platelet-rich-plasma on diabtic ulcer foot, as adjuvant treatment along with the standard care of chronic diabetic, and evaluate the efficiency and the clinical application of prp on serious wound healing.

diabetes is a condition in which the body dose not effectively use sugar so that there is too much sugar in the blood. it is estimated that 15% of the diabetics suffer from diabetic food ulcers at some point. the healing process can be slow and easily to be infected with some pathogens so the patients are at risk in amputation. the wound healing process is a complex mechanism involves the interaction of molecular signals and different cell types. platelets play important roles in wound healing. when injury occurs platelets are activated with thrombin and clot is formed. in addition to the function of hemostasis, activated platelets release many growth factors that trigger angiogenesis, extracellular matrix production and cytokine release, which is need for wound healing. platelet-rich plasma (prp) is a portion of plasma fraction of autologous blood having a high concentration of thrombocytes. thrombin induces the activation of prp and results in the release of multiple growth factors, including platelet-derived growth factor (pdgf), vascular endothelial growth factor (vegf), epidermal growth factor (egf), insulin-like growth factor (igf), and transforming growth factor beta (tgf-β). prp is known for the capacity to stimulate cell proliferation and differentiation. prp can also interact with macrophage to improve tissue healing and regeneration, and exhibit potent activities against several kinds of pathogens. our study will focus on the advantage of prp for aiding wound healing for diabetes. prp from autologous blood can be mixed with thrombin in appropriate ratio and inject into the sites around the wound, as adjuvant treatment along with the standard care of chronic diabetic. the wound will be checked 1 to 2 times each week for the evaluation of prp on clinical application.

Eligibility criteria:
inclusion criteria: * diabetic patient who suffers from sereious alcer feet. * age of 20-70 years old exclusion criteria: * patient with systemic disorder * psycho * patient with coagulation abnormality * patient with inflammation
a study to assess if epanutin infatabs 50 mg from germany are similar to dilantin infatabs 50 mg from australia

Conditions: Healthy

Summary: in this study, the bioequivalence of epanutin infatabs® 50 mg (sourced from germany) and dilantin infatabs® 50 mg (sourced from australia) will be assessed. this is intended to be a pivotal bioequivalence study.


Eligibility criteria:
inclusion criteria: * healthy male and/or female subjects between the ages of 21 and 55 years, inclusive. * an informed consent document signed and dated by the subject. exclusion criteria: * evidence or history of clinically significant abnormalities. * any condition possibly affecting drug absorption (e.g. gastrectomy).

Keywords: phenytoin chewable tablets dilantin epanutin infatabs bioequivalence partial seizure tonic-clonic seizure
study to assess safety & tolerability of azd2281 in combination with bevacizumab in patients with advanced solid tumours

Conditions: Neoplasm Metastasis

Summary: phase i, open label, dual centre, dose finding study to evaluate the safety and tolerability of continuous twice daily oral dosing with azd2281 when administered in combination with bevacizumab 10mg/kg given every 2 weeks to patients with advanced solid tumours.


Eligibility criteria:
inclusion criteria: * histologically confirmed metastatic cancer, not amenable to surgery or radiation therapy with curative intent * adequate bone marrow, kidney and liver function in accordance with laboratory parameters set out in the protocol * estimated life expectancy of at least 12 weeks exclusion criteria: * disorders that may put the patient at risk of bleeding, including gastrointestinal perforation, intra-abdominal abcess, major surgery of the chest or abdomen, previous haemorrhage, coughing up blood or thrombotic event * hypertension (high blood pressure) or significant cardiovascular disease * hypersensitivity to chinese hamster ovary cell products or other recombinant or humanised antibodies

Keywords: bevacizumab poly(adp ribose) polymerases metastatic solid tumours parp inhibitor
safety and efficacy of telitacicept in the treatment of systemic lupus erythematosus (sle)

Conditions: Systemic Lupus Erythematosus

Summary: systemic lupus erythematosus (sle) is a highly specific autoimmune disease that involves multiple systems due to abnormal immune activation. it is a classical diffuse connective tissue disease with autoimmune inflammation as its prominent manifestation. b cells are the core of systemic lupus erythematosus (sle) pathogenesis. b lymphocyte stimulator (blys, also called baff) and a proliferation-inducing ligand (april) are signals for b cell maturation. b lymphocyte stimulator (blys) participates in promoting the development and maturation of b cells, while a proliferation-inducing ligand (april) participates in promoting the activation of mature b cells and the secretion of antibodies by plasma cells. telitacicept is composed of the extracellular specific soluble portion of transmembrane activator and calcium-modulating cyclophilin ligand (caml) interactor (taci) and the fragment crystallizable (fc) segment of human immunoglobulin g1 (igg1). it is the only globally approved dual-target biological agent for the treatment of systemic lupus erythematosus (sle) , blocking b lymphocyte stimulator (blys) and a proliferation-inducing ligand (april), hindering the development and activation of b cells, and the production of antibodies, comprehensively inhibiting the maturation, proliferation, and differentiation of b cells at different stages. in this study, the investigators will explore the adherence and influencing factors of telitacicept in systemic lupus erythematosus (sle) patients, its effectiveness, and safety, providing a stronger basis for clinical management of systemic lupus erythematosus (sle) patients.


Eligibility criteria:
inclusion criteria: 1. age ≥ 18 years old, not exceeding 70 years old (including 70 years old); 2. patients diagnosed with systemic lupus erythematosus (sle) according to 2019 american college of rheumatology/european league against rheumatism (2019acr/eular) international classification diagnostic criteria; 3. accepting the treatment of telitacicept. exclusion criteria: subjects who meet any of the following criteria should be excluded from this study: 1. patients with other rheumatic immune system diseases; 2. patients in the active stage of acute and chronic infections; 3. patients using other biologics; 4. patients with wasting diseases such as malignant tumors

Keywords: systemic lupus erythematosus telitacicept adherence safety effectiveness
vivomixx for prevention of bone loss in women with breast cancer treated with an aromatase inhibitor

Conditions: Breast Cancer; Osteoporosis, Osteopenia

Summary: this study evaluates the efficacy of the probiotic food supplement vivomixx in the prevention of bone loss occurring in post menopausal women with breast cancer treated with an aromatase inhibitor. half of the participants will receive vivomixx while the other half will receive a placebo. the primary endpoint is to assess changes of bone turnover markers during the period of 6 months.

aromatase inhibitors function to reduce estrogen levels. they are considered first-line treatment for postmenopausal women with estrogen receptor-positive breast cancer. estrogen depletion leads to significant loss of bone mineral density and an increased fracture risk. one contributing mechanism to "estrogen deficiency associated bone loss" is the increase in systemic and local gut inflammatory responses upon estrogen deficiency. probiotics have been shown to decrease inflammatory cytokine formation in both the systemic circulation and gut. vivomixx is a high potency probiotic medical food designated for the dietary management of inflammatory gut conditions in adults and children and is currently being studied in clinical trials in a wide variety of inflammatory conditions such as asthma and diabetes. in preclinical studies vivomixx has been shown to protect from estrogen deficient bone loss.

Eligibility criteria:
inclusion criteria 1. age≥ 35 years 2. breast cancer stages 1-3 (non metastatic) 3. under treatment with aromatase inhibitors 4. in menopausal status for ≤10y 5. estrogen receptor positive tumor 6. ctx ≥300 pg/ml exclusion criteria 1. distant metastases 2. additional active primary malignancy 3. metabolic bone disease (primary hyperparathyroidism, hyperthyroidism, paget, osteomalacia etc) 4. glucocorticoid treatment (chronic or high dose \>7.5 mg in the last three months) 5. bisphosphonate treatment for more than 3 months in the last 2 years 6. bone densitometry (dxa) t-score \<-2 unless not a candidate for antiresorptive therapy (unwilling/unable to take treatment) 7. lactose intolerant subjects

Keywords: probiotics aromatase inhibitors bone mass postmenopausal
the effect of lanthanum carbonate on fibroblast growth factor 23 ( fgf23) in chronic kidney disease

Conditions: Metabolic Bone Disease

Summary: the aim of the study is to assess the effects of the drug lanthanum carbonate (a phosphorus binder drug) on c-terminal and on fgf23 levels in patients with chronic kidney disease (ckd). targeting fgf23 measurement in ckd patients may impact both the progression of kidney disease and patient mortality.

this is a double blind randomized placebo controlled pilot study. subjects with chronic kidney disease ( ckd) stages 3-5 who are not undergoing renal replacement therapy and have not been started on phosphate binders will be randomized to either lanthanum carbonate 1500 mg daily or placebo for a 60 day treatment period. patient doses will be increased up to a maximum dose of 3000 mg if the serum phosphate is greater than 5.5 mg/dl.

Eligibility criteria:
inclusion criteria: * males and non-pregnant females ages 18 years of age or older * estimated glomerular filtration rate (gfr) between 15-60 ml/min/1.73m * serum phosphate \> 3.5 mg/dl * fibroblast growth factor 2 (fgf2) \> 100 relative units per milliliter (ru/ml) * corrected serum calcium \>8.0mg/dl exclusion criteria: * current use of a phosphate binder * corrected serum calcium \<8.0mg/dl * current use of prescription-based vitamin d therapy * acute kidney injury in last 3 months * significant gi disorder * history of allergic reaction or sensitivity to lanthanum carbonate * history of non compliance with visits or medications that preclude study compliance in the opinion of the investigator * pregnant or able to become pregnant and unwilling to use a birth control method considered reliable by the principal investigator

Keywords: fgf23 ckd fosrenol hyperphosphatemia
ultrasound abnormalities of the salivary glands in primary sjögren's syndrome according to the duration of the disease

Conditions: Primary sjögren's Syndrome

Summary: salivary gland ultrasonography is identified as a valuable diagnostic tool and potential criteria item for disease classification of sjögren's syndrome and evaluate evolution of parenchyma. the investigators have to include 242 patients. the objective is to evaluate the modification of ultrasonographic abnormalities according to disease in primary sjögren syndrome.


Eligibility criteria:
inclusion criteria: * male or female patient ≥ 18 years * primary sjögren syndrome according of age to 2002 or 2016 classification criteria exclusion criteria: * secondary sjögren syndrome

Keywords: primary sjögren's syndrome ultrasonography salivary glands auto-immune disease
the effect of a dietary supplement rich in nitric oxide in patients diagnosed with primary ciliary dyskinesia.

Conditions: Primary Ciliary Dyskinesia

Summary: the purpose of this study is to determine the effect of a dietary supplement rich in nitric oxide (no) on nasal nitric oxide and fractional exhaled nitric oxide (feno),on ciliary beat frequency assessed by high-speed digital video microscopy and on lung function assessed by spirometry in normal patients and patients with primary ciliary dyskinesia (pcd).


Eligibility criteria:
inclusion criteria: experimental group: * pcd patients control group: * patients with no known chronic lung disease * 18 years to 99 years exclusion criteria(both pcd patients and control group): * any other pulmonary co-morbidities and diseases entities like cystic fibrosis, nasal sinus surgery, nasal sinus hypoplasia/aplasia, deviated nasal septum, nasal polyps and with upper respiratory tract infection * patients allergic to beet * a known prolonged bleeding disorder.

Keywords: nitric oxide intranasal nitric oxide beet juice
a us non-interventional, effectiveness and safety study of patients treated with skytrofa

Conditions: Growth Hormone Deficiency

Summary: the goal of this study is to genrate evidence on long-term effectiveness and safety of skytrofa (lonapegsomatropin) in patients with growth hormone deficiency under routine clinical care

patients will be treated according to routine clinical practice, and no additional visits, examinations or tests will be required beyond those performed as part of routine clinical practice except for coas.

Eligibility criteria:
inclusion criteria: * patients who are on treatment with skytrofa (lonapegsomatropin) * patients being clinically managed in usa * patients with an appropriate written informed consent/assent as applicable for the age of the patient exclusion criteria: * patients participating in any interventional clinical study

Keywords: human growth hormone skytrofa
relation between ethanol sclerotherapy for endometrioma systemic immune milieu

Conditions: Endometriosis

Summary: design: prospective interventional study. 69 women with oe were evaluated clinically and by transvaginal ultrasonography (tuv). aest procedure was performed and the collected aspirate and pre-procedural blood samples were collected for estimation of cytokines' levels. at 6-m post-procedure, clinical evaluation and tuv were repeated and serum cytokines' levels were re-estimated.


Eligibility criteria:
inclusion criteria: * women with oe of a mean diameter of \>3 cm exclusion criteria: * women with recurrent oe * a cyst that was suspicious of being malignant * diabetes mellitus * polycystic ovary syndrome * body mass index (bmi) of \>30 kg/m2 * previous surgical interference that resulted in pelvic adhesions
a post-marketing clinical pharmacokinetics study of gabapentin in japanese epileptic subjects with renal impairment

Conditions: Renal Impairment

Summary: the primary objectives of this study are to evaluate the pharmacokinetics (pk) following administration of gabapentin in japanese epileptic patients with renal impairment to confirm if there are any clinically relevant differences between the plasma gabapentin concentration simulated by population pk model, which was used for the evidence of the dose adjustment for the patients with renal impairment, and observed plasma gabapentin concentration.

only one subject was able to be enrolled. given enrollment challenges to identify additional appropriate subjects, discussion was held with the japan pharmaceuticals and medical devices agency (pmda) and it was agreed with the pmda to terminate this study. the study was terminated on december 14, 2010. the study was not terminated due to any safety findings.

Eligibility criteria:
inclusion criteria: * japanese epilepsy patients with renal impairment exclusion criteria: * na

Keywords: gabapentin pharmacokinetics
china antihypertensive trial in acute ischemic stroke

Conditions: Ischemic Stroke

Summary: this randomized trial tests the effect of early blood pressure reduction on major disability and death among patients with acute ischemic stroke in china.

we designed a randomized controlled clinical trial to test: * the effectiveness of blood pressure reduction among patients with acute ischemic stroke (within 48 hours of onset) on the primary outcome, a combination of death within 14 days after randomization and dependency (modified rankin scale ≥3) at 14 day or at the time of discharge, if that occurred before 14 days. * the effectiveness of blood pressure reduction among patients with acute ischemic stroke (within 48-hours of onset) on secondary outcomes: * combination of all-cause mortality and dependency over 3, 12, and 24 months of follow-up * combined vascular disease events over 3, 12, and 24 months of follow-up (vascular deaths, non-fatal stroke, non-fatal myocardial infarction, coronary revascularization, hospitalized or treated angina, hospitalized or treated congestive heart failure, and hospitalized or treated peripheral arterial disease) * recurrent fatal and non-fatal stroke over 3, 12, and 24 months of follow-up * neurological functional status measured by nih stroke score and modified rankin scale at 14 day or discharge after randomization, and over 3, 12, and 24 months of follow-up * all-cause mortality over 3, 12, and 24 months of follow-up * duration of initial hospitalization * changes in systolic and diastolic blood pressure within 24 hours and over 7 days, and 14 days

Eligibility criteria:
inclusion criteria: * age ≥22 years * ischemic stroke onset within 48 hours confirmed by imaging (ct scan or mri) study * systolic bp≥140 and \<220 mm hg and diastolic bp≥80 mm hg * no contraindications to antihypertensive treatment * able and willing to sign informed consent by patients or their direct family members exclusion criteria: * individuals with hemorrhagic stroke * individuals with severe heart failure (ny heart association class iii and iv), myocardial infarction, unstable angina, aortic dissection and cerebrovascular stenosis * individuals in a deep coma * individuals with resistant hypertension \[systolic bp ≥170 mm hg despite use of 4 or more antihypertensive medications for half a year or longer\] * intravenous thrombolytic therapy (such as intravenous rtpa) * individuals who are unable to participate in follow-up examination * current pregnant women

Keywords: ischemic stroke hypertension antihypertensive agents randomized controlled trial
comparison of bacteriostatic saline to buffered lidocaine for ultrasound guided hip joint injection local anesthesia

Conditions: Hip Pain

Summary: the purpose of this study is to compare infiltration pain and anesthetic efficacy between lidocaine and bacteriostatic saline (bs) for ultrasound (us) guided intraarticular hip injections.

local anesthesia is commonly used to reduce pain during joint injections, particularly for deep joints like the hip. lidocaine is the most commonly used local anesthetic in most medical practices. it is well known that lidocaine infiltration itself is painful. many strategies have been studied to minimize pain associated with lidocaine administration, including buffering, warming, and slowing infiltration rate. bs is an alternative local anesthetic that has been shown to be less painful when injected into subcutaneous tissues compared with lidocaine. however, bs use has not been widely implemented for local anesthesia, and it has not been studied in the context of joint injections.

Eligibility criteria:
inclusion criteria: * age 18-75 years * referred for us-guided intraarticular hip injections in the mayo clinic sports medicine center, physical medicine \& rehabilitation clinic, or musculoskeletal clinic exclusion criteria: * chronic opioid use * opioid use on day of procedure * history of fibromyalgia or other diffuse chronic pain syndrome * pain behavior during the clinical encounter as judged by the injectionist * anesthetic administration time outside the designated 5-15 second time frame
bio equivalency 20 mgm orfadin and 20 mgm of nitisonine

Conditions: Hereditary Tyrosinemia, Type I

Summary: he purpose of this study is to determine whether nitisinone 10 mg tablets (test product are bioequivalent to the reference product orfadin 10 mg

detailed description: the specific aim is to conduct a randomized, single dose, three-period crossover bioequivalence study in at least 18 healthy male and female subjects at a single study center to evaluate the in vivo performance of two formulations of nitisinone 10 mg and the reference product orfadin under fasting. a total of 4 healthy female and male volunteers (age 18 to 55 years old) will be entered into the study. volunteers will be determined to be free of significant medical conditions as assessed by medical history, physical examination, and blood and urine tests. volunteers will be randomly allocated to a treatment sequence, before administration of investigational nitinosine determination of succinylacetone (sa) in blood (serum/plasma) and/or urine will be performed. results from samples analyzed at the central laboratory, including determination of nitisinone, will be used in the evaluation of pharmacokinetics, efficacy and safety during the two treatment periods.

Eligibility criteria:
inclusion criteria: * all ht-1 patients receiving orfadin treatment are eligible for entry. * male and female patients of all ages diagnosed with ht-1. * stable lab values, including liver values \<2 uln (alp, alt, ast, bilirubin, inr). * women of childbearing potential willing to use adequate contraception * signed informed consent/assent. exclusion criteria: * any medical condition which in the opinion of the investigator makes the patient unsuitable for inclusion. * enrollment in another concurrent clinical interventional study within three months prior to inclusion in this study. * pregnant women. * lactating women. .known hepatitis b, hepatitis c or hiv infection. * foreseeable inability to cooperate with given instructions or study procedures.