Kornimate/medical-research-clean huggingface dataset:
efficacy and safety study of aspirin for the prevention of renal artery stenosis in renal transplantation recipients

Conditions: Renal Transplant

Summary: the anastomotic and peripheral stenosis of the transplanted kidney artery is one of the most important causes of graft failure in renal transplantation. the injury of vascular intima and the formation of microthrombosis may play a significant role in the stenosis of transplanted renal artery of recipients. inhibiting this process with aspirin may protects against the stenosis of transplanted renal artery. this is a prospective, randomized, controlled, clinical trial to investigate the efficacy and safety of prevention of renal artery stenosis in recipients.


Eligibility criteria:
inclusion criteria: 1. the patients with the first renal transplantation were stable; 2. age ≥ 18 years old; 3. other anticoagulants and non steroidal anti-inflammatory drugs were not taken at the same time; 4. in the past 3 months, there was no acute cardiovascular and cerebrovascular disease or infection; 5. the rejection of acute and chronic renal transplantation was excluded; 6. the thrombus formation of transplanted kidney was excluded. exclusion criteria: 1. allergic or intolerable to aspirin; 2. previous transplant history; 3. age \< 18; 4. take other anticoagulants or non steroidal anti-inflammatory drugs at the same time; 5. history of active gastrointestinal bleeding or severe peptic ulcer; 6. patients with bleeding tendency or severe liver disease; 7. cerebral hemorrhage, cerebral infarction or acute infection occurred within 3 months; 8. acute and chronic rejection; 9. thrombus formation of transplanted renal vessels; 10. any condition that increases the risk of adverse events or discontinuation.
alcochange: an open label pilot study of smartphone monitoring for alcoholic liver disease

Conditions: Alcohol-Related Disorders

Summary: alcohol contributes to over 5% of deaths worldwide, and death rates from alcohol-related liver disease (arld) in the uk continue to rise sharply. on-going alcohol use in arld leads to markedly increased mortality (thursz et al, 2015), and maintaining abstinence is a key therapeutic goal. however, there are no effective pharmacological therapies for maintaining abstinence. brief intervention (bi) is an effective psychological tool for reducing alcohol use, but is difficult to scale widely. alcochange is a smartphone app and breathalyser (alcochange), which facilitates self-monitoring and delivers bis in response to patient triggers. the aim of this open-label study is provide alcochange to 60 patients with arld, to determine compliance with the app/breathalyser and changes in self-reported alcohol consumption. recruitment of inpatients/outpatients with arld and recent alcohol use will take place at royal free london. the inclusion criteria are: intent to maintain abstinence, possession of compatible smartphone. the exclusion criteria are: inability to provide consent. participants will be assessed at baseline and 3-months. the primary endpoint is self-reported alcohol use (units/week, timeline follow-back). secondary endpoint is compliance with the app (monitored remotely).


Eligibility criteria:
inclusion criteria: * presence of arld * age 18-70 * intent to maintain abstinence * possession of compatible smartphone exclusion criteria: - inability to provide consent.
fenofibrate in dyslipidemia and metformin-controlled diabetes

Conditions: Dyslipidemia/Glucose Metabolism Disorder

Summary: the primary objective was to assess the effect of 3-month treatment of low and standard doses of fenofibrate in combination with stable dose of metformin on fasting triglycerides levels in patients with type 2 diabetes and dyslipidemia.


Eligibility criteria:
inclusion criteria: * type 2 diabetes mellitus exclusion criteria: * type 1 diabetes, uncontrolled type 2 diabetes, - hba1c ≥ 10 % - fasting plasma glucose \> 300 mg/dl - triglycerides \> 500 mg/dl

Keywords: treatment of dyslipidemia and of type 2 diabetes mellitus
mental health in refugees and asylum seekers

Conditions: Affective Disorders

Summary: the objective of this study is to investigate a stepped and collaborative care model (sccm) for adolescent and adult refugees suffering from depression living in germany.

a prospective, cluster-randomized intervention study, conducted in seven german cities and comprising a total of 476 patients, should compare effectiveness and efficiency of this sccm as compared to a 'treatment as usual' (tau) condition. the fundamental principle of the examined care model is to provide patients with mild and moderate depression with accessible and affordable treatments, which are located outside the usual psychiatric-psychotherapeutic institutions (e.g. peer-to-peer-approaches or smartphone based interventions). the acquired insights from the stepped care model, as well as concerning the individual low barrier interventions for adolescents and adults, can be used immediately for benefitting the provision of care of refugees but also for improving care of other communities with lacking access to health care systems. the generated disease figures from the nationwide screening process can be utilized directly to manage the provision of mental health fostering offers for refugees by federal institutions and social health insurance companies. in both treatment arms (sccm and tau) and independent of intervention form participants will be assessed at four time periods after the initial screening process: baseline (t1), after week 12 (t1), after week 24 (t2), after week 48 (t3). following clinical measurement tools will be used at all time periods: * refugee health screener (rhs-15) * patient health questionnaire (phq-9) * patient health questionnaire-adapted (phq-a) \* * montgomery-åsberg depression scale (mådrs) * mannheimer modul ressourcenverbrauch (mrv) * brief resilience scale (brs) * general self-efficacy scale (gse) * world health organization quality of life (whoqol-bref) * child \& adolescent trauma screening (cats)\* following clinical measurement tools will be used at baseline (t1): * demographics / migration questionnaires * m.i.n.i. international neuropsychiatric interview * m.i.n.i. kid international neuropsychiatric interview\* * harvard trauma questionnaire (htq) following clinical measurement tools will be used at baseline (t0) and after post-intervention (t1): * cultural differences subscale * credibility / expectancy questionnaire following clinical measurement tools will be used at baseline (t0), after post-intervention (t1) and follow-up 1 (t3): - strengths and difficulties questionnaire (sdq) \*adolescents only

Eligibility criteria:
inclusion criteria: * obtained a statutory health insurance * approved residence status as a refugee, asylum seeker or asylee * mother tongue in arabic or farsi/urdu or speaks english or german fluently * age between 16-65 years * participants shows relevant depressive symptoms measured by the phq-9 or phq-a exclusion criteria: * an existing schizophrenia or degenerative disorder * missing informed consent * possible suicidality * uncertain residence status
climb: cns lymphoma imaging and molecular biomarkers study

Conditions: CNS Lymphoma

Summary: a prospective imaging and translational tissue study in cns lymphoma to enable further disease characterisation and the development of potential predictive and prognostic biomarkers.

as a single centre exploratory study, this trial will recruit patients with newly diagnosed primary cns lymphoma and will look at the molecular aspects of the disease in the tissue collection and imaging response assessments using cca with respect to progression free survival.

Eligibility criteria:
inclusion criteria: * subjects capable of giving informed consent, or if appropriate, if subject's capacity is deemed limited due to cns involvement, a consultee can provide consent on their behalf. some patients with pcnsl may be incapable of providing their own consent due to the neurological effects of their disease. in these cases the patient will be classed as an incapacitated adult and a legal representative will be sought in accordance with english or scottish law as applicable (see 7.2.1) * a radiological or histological diagnosis of primary cns lymphoma. * have not received prior cns directed therapy. prior use of steroids is permitted. * participants aged ≥18 years old. exclusion criteria: - involvement of lymphoma outside of the cns
study of efficacy of phenytoin in therapy of patients with bronchial asthma

Conditions: Bronchial Asthma

Summary: the purpose of this study was evaluation the efficacy of antiepileptic drug phenytoin (diphenine) in the treatment of bronchial asthma.

effective therapy of asthma still remains quite serious problem. according current opinion of leading specialists, asthma is an inflammatory disorder. but asthma also is a paroxysmal disorder: many specialists underline paroxysmal clinical picture of asthma. according to some authors, neurogenic inflammation may play important role in asthma mechanism. but migraine and trigeminal neuralgia are also neurogenic inflammatory paroxysmal diseases, and some antiepileptic drugs, like diphenine and valproates, are very effective in therapy of these diseases - more than in 80% of cases. if bronchial asthma also is paroxysmal inflammatory disease, we can suppose a possibility that some antiepileptic drugs also may show high efficacy in asthma therapy. taken in consideration this hypothesis, we performed a double-blind, placebo-controlled 3-month trial for evaluation of phenytoin (diphenine) efficacy in treatment of patients with bronchial asthma.

Eligibility criteria:
inclusion criteria: * out patients * bronchial asthma has been known at least for 1 year * absence of long-term remissions of asthma (lasting more than 1 month) * poorly controlled asthma, due to various reasons * non-smokers exclusion criteria: * presence of concomitant acute or chronic severe diseases * abnormal baseline haematology, blood chemistry or urinalysis * allergy or adverse reactions to investigational drug * age younger than 18 years old * long-term history of smoking * pregnancy or lactating

Keywords: bronchial asthma phenytoin, diphenine antiepileptic drugs efficacy
next generation personalized neuroblastoma therapy

Conditions: Neuroblastoma; Cancer

Summary: the purpose of this research study is to match genomic aberrations in tumor cells at time of relapse to rationally designed combinations of molecularly targeted agents. this study will be done in two parts: part i: tumor will be accessed at study entry via a biopsy and subjected to deep sequencing to identify protocol-specified biomarkers for therapy assignment. part ii: if the tumor contains a genetic change defined by the study as being actionable, and other criteria are met, participants will be assigned to therapy based upon the genetic changes identified in the tumor biopsy.


Eligibility criteria:
inclusion criteria: * aged ≥1 years to ≤ 21 years * relapsed or refractory neuroblastoma * a sufficient interval between the last dose of prior anti-cancer therapy (including cytotoxic and biological therapies) and enrollment in this study, to allow recovery from the acute toxic effects of all prior anti-cancer therapy. please contact site for specific details * adequate bone marrow function (bone marrow may be involved with tumor. contact site for specific details) * adequate renal function, defined as creatinine clearance or radioisotope glomerular filtration rate (gfr) ≥ 70 ml/min/1.73 m2 or serum creatinine based on age/gender normal (contact site for details) * adequate liver function, defined as total serum bilirubin ≤ 1.5 times the upper limit of normal and alanine transaminase (alt) ≤ 110 u/l. * adequate cardiac function, defined as corrected qt interval (qtc) ≤ 480 msec and shortening fraction \> 27% * males and females who are sexually active must agree to use effective contraception during and for 3 months after treatment exclusion criteria: * subjects taking certain drugs or herbal medications that impact drug metabolism and/or cardiac function that cannot be discontinued (contact site for details). * subjects with concurrent severe and/or uncontrolled concurrent medical conditions that could compromise participation in the study (contact site for details) * other concomitant therapies: * corticosteroids initiated for tumor therapy within 7 days prior to study enrollment * other anti-cancer agents * other investigational drugs * hematological growth factors * radiation therapy * subjects \< 0.5m2 * pregnant or lactating females * sexually active males unless they use a condom during intercourse while taking study drug/s and for 3 months after study drug discontinuation and thus do not attempt to father a child in this period.

Keywords: neuroblastoma cancer genetic profiling ceritinib ribociclib nepenthe
treatment of cancer-anorexia using megestrol acetate concentrated suspension in lung or pancreatic cancer patients

Conditions: Anorexia; Cachexia; Weight Loss

Summary: purpose of the study is to compare the effects of megestrol acetate concentrated suspension and placebo on caloric intake for the treatment of cancer-associated anorexia in patients with lung or pancreatic cancer


Eligibility criteria:
inclusion criteria: * stage ii, iii,or iv lung or pancreatic cancer * fair, poor, or very poor appetite * cancer associated anorexia/cachexia * weight loss perceived to be associated with diminished appetite * eastern cooperative oncology group performance score of 0, 1, 2 * life expectancy \>3 months * alert and mentally competent * women of child-bearing potential required to use an adequate and reliable method of contraception. post-menopausal women have to have been so for at least 1 year * screening laboratory values must not be clinically significant (some exceptions per protocol) exclusion criteria: * brain, or head and neck metastases that may interfere with food consumption * aids-related wasting * radiation therapy to the head and neck, abdomen, or pelvis within past 6 weeks, or anticipated during course of the study such that the result may interfere with food consumption * conditions that interfere with oral intake, or ability to swallow * absence of a normally functioning gut * mechanical obstruction of the alimentary or biliary tract, or malabsorption syndrome * intractable or frequent vomiting that regularly interfere with eating * clinically significant diarrhea * history of recurrent thromboembolic events, a thromboembolic event in past 3 months, or long-term anticoagulation treatment for thromboembolism * uncontrolled diabetes mellitus, or symptomatic hypoadrenalism * poorly controlled hypertension, or congestive heart failure * pregnant/lactating females * use within past 30 days of an appetite stimulant * use within past week, or planned use during the study of parenteral nutrition or tube feedings * chronic use of steroids within past 3 months (intermittent short-term use allowed) * current use of or not willing to abstain from using illicit substances * allergy, hypersensitivity, or contraindication to megestrol acetate

Keywords: megestrol acetate anorexia cachexia lung cancer pancreatic cancer unintended weight loss body weight appetite megace es
study comparing arthrodesis technique of thoracic and/or lumbar spine by posterior approach performed by robot-assisted surgery (robot mazor x stealth ™) versus conventional surgery

Conditions: Osteosynthesis; Mazor Robot; Spinal Surgery; Arthrosis; Spine

Summary: osteosynthesis by pedicle screwing is the reference technique since the 1980s, due to the quality of the mechanical grip of the screw in the pedicle, despite difficulties of placing the implant in this narrow tunnel. this precision was improved by fluoroscopy, then by navigation, which made it possible to reduce the extra-pedicular placement of the screws and consequently the complications. since the 2000s, robotic has been developed in all areas, including medicine and surgery, (da vinci robot in urology) and several robots are currently marketed for spinal surgery, medtronic's mazor x stealth ™ robot being the most successful. the aim of this study is to evaluate on a prospective randomized comparative study the quality of the placement of the screws as well as the occurrence of complications, the clinical results and the medico-economic interest that robotic surgery can bring.


Eligibility criteria:
inclusion criteria: * male, female, over 18 years old, * any patient operated for thoracic and/or lumbar spine arthrodesis (spondylolisthesis, asymmetric disc disease, spinal instability, spinal deformities, advanced disc disease), * patient having given his free, informed and written consent to participate in the study, * patient able to answer questionnaires, able to communicate in the language of the country of the study, * negative pregnancy test, * patient affiliated to a social security scheme or beneficiary of such a scheme. exclusion criteria: * minor, * psychological disorders, * addiction to analgesics, * chronic infection, * history of instrumented lumbar surgery, * bmi greater than or equal to 40kg/m², * pregnant or breastfeeding woman, * patient participating in another clinical study, * protected patient: adult under guardianship, curatorship or other legal protection, deprived of freedom by judicial or administrative decision.
helicobacter pylori eradication in subjects with non-alcoholic fatty liver disease

Conditions: Non-alcoholic Fatty Liver Disease

Summary: the aim of study was to evaluate the effect of helicobacter pylori eradication on liver function tests, lipid profile, homeostasis model assessment-ir (homa-ir) index, and anthropometric measurements (body mass index and waist circumference)in subjects with non-alcoholic fatty liver disease.

helicobacter pylori (hp) antigens have been found in the liver of individuals with benign and malignant liver diseases. the role of hp in the pathogenesis of non-alcoholic fatty liver disease (nafld) is controversial. this randomized double blind clinical trial was performed in dyspeptic patients with positive antibody to hp and the evidence of fatty liver in ultrasonography. after excluding other causes, participants with persistent elevated serum aminotransferase levels were presumed to have nafld. those with nafld liver fat score greater than (-0.64) and positive urea breath test (ubt) were enrolled. they were randomly assigned to lifestyle modification alone or lifestyle modification plus hp eradication groups. quadruple therapy (omeprazole, amoxicillin, bismuth subcitrate, and clarithromycin) for hp eradication was performed in two weeks. hp eradication was documented by ubt. fasting serum glucose, alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, triglyceride, cholesterol, high and low-density lipoprotein, homa-ir, and anthropometric measurements (body mass index and waist circumference) were checked at baseline, eight weeks, and twelve weeks from the beginning of study.

Eligibility criteria:
inclusion criteria: * dyspeptic patients with positive antibody to h.pylori and persistent elevated aminotransferase levels with the evidence of fatty liver in ultrasonography, who were referred to a gastroenterology clinic exclusion criteria: * alcohol use (more than 20 gram per day in men and 10 gram per day in women per day), heart disease (ischemic or congestive), hepatic disease (viral hepatitis, autoimmune hepatitis, wilson disease, hemochromatosis, liver mass lesion), renal disease (serum creatinine concentration of \> 1.5 mg/dl), any severe systemic co-morbidities, neoplasm, using any hepatotoxic medication during the past 3 months, previous history of peptic ulcer, previous history of h.pylori eradication, and pregnant or lactating women.

Keywords: steatohepatitis, helicobacter pylori, insulin resistance, alanine aminotransferase, aspartate aminotransferase,
a study of hs219 in chronic kidney disease patients on hemodialysis with hyperphosphatemia

Conditions: Hyperphosphatemia; Chronic Kidney Disease

Summary: this was a study to evaluate the efficacy and safety of hs219, chitosan-loaded chewing gum, when given three times a day for 3 weeks to the hemodialysis (hd) patients with hyperphosphatemia whose serum inorganic phosphorus was not well controlled with calcium carbonate or sevelamer hydrogen chloride.


Eligibility criteria:
inclusion criteria: * written informed consent given * able to comply with the study procedures and medication * on a stable hd regimen (at least 3 x per week) for ≥ 3 months * subject receiving calcium carbonate or sevelamer hydrochloride as a phosphate binder at screening, must have been on a stable regimen (dose and medication) for at least 1 month * a mean serum inorganic phosphorous in the previous 3 tests : \> 5.5 mg/dl and \< 9.0 mg/dl * removal rate of blood urea nitrogen (bun) ≥ 60% * rate of salivary flow by saxon test ≥ 1 g/2 min exclusion criteria: * blood purification therapy other than hd * current clinically significant intestinal motility disorder * possible parathyroid intervention during the study period * history of malignancy and severe cardiovascular disorders such as heart disease, angina, congested heart failure, valve stenosis, atrial fibrillation and arrhythmia * history of allergy against active ingredient * receipt of any investigational drug within 30 days of informed consent

Keywords: hyperphosphatemia hemodialysis chitosan
a study to assess the tolerability and efficacy of akst1210 in patients on hemodialysis with cognitive impairment

Conditions: Cognitive Impairment; End Stage Renal Disease

Summary: this study will evaluate the tolerability, feasibility, and efficacy of the akst1210 column in subjects with end-stage renal disease with cognitive impairment (esrd-ci) undergoing hemodialysis 3 times per week.

in this study, approximately 26 men and women on dialysis due to end stage renal disease and who have cognitive impairment will be randomly assigned to receive akst1210 or control during each hemodialysis session for 3 months. the primary objective is to assess the safety and tolerability of akst1210, and secondary objectives include changes in cognitive assessments as well as the feasibility of using akst1210 in this setting.

Eligibility criteria:
inclusion criteria: * on chronic hemodialysis due to end-stage renal disease for ≥ 12 months. * score on the montreal cognitive assessment (moca) ≥ 16 and ≤ 23. * body mass index (bmi) ≥ 20 and ≤ 36. * the subject must be able to follow the study protocol, receive the treatment in the established timeframe, and continue during the follow-up interval. * the subject must have sufficient visual and auditory acuity to reliably complete all study assessments. * provided a signed and dated informed consent form. exclusion criteria: * subjects for whom adequate anticoagulation cannot be achieved. use of antiplatelet drugs (e.g., aspirin or clopidogrel) is allowed. * history of hypersensitivity to heparin. * pregnant or breast-feeding women or women who are planning to become pregnant. * clinically significant abnormalities on screening ecg including qt interval corrected for heart rate (qtc) (using fridericia's correction formula) of ≥ 500 ms in men and ≥ 520 ms in women. * clinically significant and unexpected abnormalities in this patient population in complete blood count, complete metabolic panel, coagulation, and thyroid stimulating hormone (tsh). * subjects with a hemoglobin level \< 9.0 g/dl. * concurrent or recent participation in another investigational clinical trial. prior clinical trial subjects must have discontinued investigational agents at least 30 days prior to screening. * subjects planning to receive renal transplantation during the study. * any other condition and/or situation that the investigator believes may interfere with the safety of the subject, study conduct, or interpretation of study data.

Keywords: renal disease renal failure, chronic end stage kidney disease chronic kidney failure kidney disease cognitive decline mental deterioration cognition disorder