Kornimate/medical-research-clean huggingface dataset:
open-label pharmacokinetic study of iron isomaltoside 1000 (monofer®) administered by 500 mg iv bolus injection or 1000 mg intravenous to patients with ckd

Conditions: Non-dialysis Dependent Chronic Kidney Disease

Summary: the purpose of this study is to assess the pharmakokinetic properties of higher doses (500 mg and 1000 mg) of monofer® in patients suffering from non-dialysis dependent chronic kidney disease.


Eligibility criteria:
inclusion criteria: 1. men and women, aged more than 18 years. 2. weight above 50 kg. 3. subjects diagnosed with ndd-ckd with mdrd calculated egfr between 15-59 ml/min. 4. hb \< 11.0 g/dl. 5. either or both of the following iron stores indicators below target {serum ferritin \< 100 ug/l and transferrin saturation (tfs) \<20%}. 6. life expectancy beyond 12 months by principal investigator's judgement. 7. willingness to participate after informed consent. exclusion criteria: 1. anaemia predominantly caused by factors other than renal impairment or iron deficiency (according to principal investigator s' judgment). 2. iron overload or disturbances in utilization of iron (e.g. haemochromatosis and haemosiderosis). 3. drug hypersensitivity (i.e. previous hypersensitivity to iron dextran or iron mono- or disaccharide complexes or any excipients of the study drug). 4. subjects with history of multiple allergies. 5. decompensated liver cirrhosis and hepatitis (alanine aminotransferase (alt) \> 3 times upper normal limit). 6. history of immunocompromise and/or history of hepatitis b and/or c 7. active acute or chronic infections (assessed by clinical judgment), supplied with white blood cells (wbc) and c-reactive protein (crp). 8. rheumatoid arthritis with symptoms or signs of active joint inflammation. 9. pregnancy and nursing (to avoid pregnancy, women have to be postmenopausal (at least 12 months must have elapsed since last menstruation), surgically sterile, or women of child bearing potential must use one of the following contraceptives during the whole study period and after the study has ended for at least 5 times plasma biological half-life of the investigational medicinal product: contraceptive pills, intrauterine devices (iud), contraceptive depot injections (prolonged-release gestagen), subdermal implantation, vaginal ring, and transdermal patches). 10. extensive active bleeding necessitating blood transfusion. 11. planned elective surgery during the study. 12. participation in any other clinical study within 3 months prior to screening. 13. untreated b12 or folate deficiency. 14. other i.v. or oral iron treatment or blood transfusion within 4 weeks prior to screening visit. 15. esa treatment within 8 weeks prior to screening visit. 16. serum ferritin \> 500 µg/l 17. any other medical condition that, in the opinion of principal investigator, may cause the subject to be unsuitable for the completion of the study or place the subject at potential risk from being in the study or interfere with study drug evaluation. example, uncontrolled hypertension, unstable ischemic heart disease or uncontrolled diabetes mellitus.
study to evaluate the efficacy of hepastem in urea cycle disorders paediatric patients (hep002)

Conditions: Urea Cycle Disorders

Summary: the aim of the study is to assess the efficacy of hepastem treatment in paediatric patients suffering from urea cycle disorders.


Eligibility criteria:
main inclusion criteria: * paediatric patients \< 12 years prior to infusion * patient presents with ucd * patient shows patency of the portal vein and branches, with normal flow velocity as confirmed by doppler us and accessibility of the portal vein and /or affluants. main exclusion criteria: * patient has mild disease severity, easily controlled under standard of care therapy, with no recurrent metabolic crises. * patient is registered on a liver transplant waiting list or is scheduled for living donor liver transplantation before the end of the study. * patient presents acute liver failure. * patient presents clinical or radiological evidence of liver cirrhosis. * patient presents or has a history of hepatic or extrahepatic malignancy. * patient has a known clinically significant cardiac malformation. * patient has a personal history of venous thrombosis, or has a clinically significant abnormal value for protein s, protein c, anti-thrombin iii, and /or activated protein c resistance (apcr) at screening. in case of known family history, a complete coagulation work-up should be performed. in all above described cases, results need to be discussed with pb before enrolling the patient in the study. * patient had or has a renal insufficiency treated by dialysis.

Keywords: urea cycle disorder ucd cell therapy stem cell
phase i study in advanced solid tumors

Conditions: Solid Tumors

Summary: dose escalating study of orally administered indibulin at twice daily schedule in subjects with solid tumors.


Eligibility criteria:
inclusion criteria 1. subjects with histological or cytological confirmation of advanced cancer, refractory to standard therapies for their condition 2. ≥ 18 years of age 3. ecog performance score ≤ 2 (see appendix 3) 4. eligible subjects must have at least one measurable lesion as defined by recist guidelines (see appendix 4). if the measurable disease is restricted to a solitary lesion, its neoplastic nature should be confirmed by cytology/histology. measurable lesions must not have been in a previously irradiated field or injected with biological agents. 5. life-expectancy ≥ 12 weeks 6. adequate bone marrow, liver and renal function as assessed by the following laboratory requirements to be conducted \< 2 weeks prior to baseline: * creatinine ≤ 1.5 x upper limit of normal (uln) or a calculated creatinine clearance ≥ 50 cc/min * total bilirubin ≤ 1.5 x uln * alanine transaminase (alt) and aspartate transaminase (ast) ≤ 2.5 x uln * white blood cell count ≥3.0 x 109/l * absolute neutrophil count (anc) ≥1.5 x 109/l * platelets ≥100 x 109/l * hemoglobin ≥ 10 g/dl 7. written informed consent in compliance with ziopharm policies and the human investigation review committee with jurisdiction over the site. exclusion criteria 1. new york heart association (nyha) functional class ≥3 or myocardial infarction within 6 months (see appendix 5) 2. uncontrolled cardiac arrhythmia other than asymptomatic atrial fibrillation 3. pregnant and/or lactating female (a reliable method of contraception must be used in all men and in women of childbearing potential during the study and for 3 months after last study drug administration). 4. uncontrolled systemic infection (documented with microbiological studies) 5. anticancer chemotherapy or immunotherapy during the study or within 4 weeks of study entry. mitomycin c or nitrosureas should not be given within 6 weeks of study entry. 6. radiotherapy during the study or within 3 weeks of study entry 7. surgery within 4 weeks of start of study drug excluding tumor biopsy for pharmacodynamic parameters 8. investigational drug therapy outside of this trial during or within 4 weeks of study entry 9. history of an invasive second primary malignancy diagnosed within the previous 3 years except for stage i endometrial/cervical carcinoma or prostate carcinoma treated surgically, and non-melanoma skin cancer 10. substance abuse, medical, psychological or social conditions that may interfere with the subject's participation in the study or evaluation of the study results 11. any condition that is unstable or which could jeopardize the safety of the subject and his/her compliance with the study protocol.

Keywords: cancer tumor solid tumor advanced tumor
central venous catheter insertion site and colonization in pediatric cardiac surgery

Conditions: Central Line-associated Bloodstream Infection (CLABSI); Central Venous Catheter Associated Bloodstream Infection; Heart; Surgery, Heart, Functional Disturbance as Result; Congenital Heart Disease; Newborn; Infection

Summary: randomized controlled trial comparing femoral vs internal jugular insertion site of central venous catheters (cvc) in newborns and infants undergoing cardiac surgery. the experimental hypothesis is that the jugular insertion site is superior to the femoral in terms of catheter colonization.

background: in adult patients, the femoral site of insertion of cvc is notoriously at higher risk of colonization and central-line associated bloodstream infection (clabsi) than other sites (jugular or subclavian). in pediatric patients, the femoral site is more commonly used than in adult patients, but there is no sound data on catheter colonization and clabsi related to the insertion site. the experimental hypothesis of this randomized controlled trial (rct) is that the jugular insertion site is less likely to induce catheter colonization and clabsi than the femoral site. methods: 160 patients under 1 year and scheduled for cardiac surgery will be included in this rct; patients will be randomly allocated to the jugular (j group) or femoral (f group). cvc insertion will be performed by one out of three selected expert operators. the primary endpoint is the catheter colonization based on identification of bacterial grow into the catheter at removal time; clabsi and crbsi rate based on the same bacterial identification into the catheter tip and in the blood culture performed in case of signs and symptoms of infection. secondary endpoints are mechanical complications defined as arterial puncture immediately identified during procedure, hemothorax and pneumothorax; and procedural difficulty during insertion defined as number of attempts, no guidewire progress, duration of the procedure (time from the completion of the sterile precaution barriers and the catheter fixation.

Eligibility criteria:
inclusion criteria: planned cardiac surgery age \<1 year eligibility for both insertion sites (jugular and femoral) for cvc availability of at least one out of the three chosen expert operators exclusion criteria: emergency surgery known vascular anatomic anomalies previous cardiac surgery in the last 6 months no expert operator availability intensive care unit before surgery central venous catheter inside at the time of randomization withdraw criteria (only for the first endpoint): impossibility to placement catheter in the selected site.
evaluation of treatments for homeless youths

Conditions: Substance Abuse

Summary: youth who leave home for the streets are at significantly more risk for a multitude of problems, yet little research is available to guide treatment intervention efforts with this population. studies document high rates of substance use, hiv risk, mental health problems, teenage pregnancy and criminality. research to date examining homeless, street living youth has been primarily descriptive; less effort has been directed towards developing and evaluating treatment interventions for this group. the majority of homeless youth do not receive substance abuse treatment, with one study reporting that only 15% of street living youth report ever receiving mental health services. the effectiveness of the community reinforcement approach (cra) with street living youth was studied in our recently completed stage 1 trial. the proposed study is a stage ii clinical trial examining outcome of cra individual therapy as compared to two interventions commonly employed, yet little researched, with this group. all clients will be randomized to one of three theoretically distinct interventions: (1) cra therapy, (2) motivational enhancement therapy (met), or (3) case management (cm). the relative effectiveness of these interventions will be evaluated at 3, 6, and 12 months post-baseline. the social ecology theory of development (bronfenbrenner, 1979) guides our change hypotheses and intervention. proposed change mechanisms (mediators) for each intervention will be evaluated. differential treatment response as a function of ethnicity, gender, age, sexual orientation and abuse (moderators) will be investigated to better understand the interventions. the study will also examine how, if at all, treatment engagement, retention and expectations impact youth response to the three treatments. information gained through this project may help address the gap in our understanding of how best to effectively intervene with a group at high risk for continuing health and psychological problems.


Eligibility criteria:
inclusion criteria: 1. youth are between the ages of 14-20. 2. youth have plans to remain in the columbus areas for at least 12 months. 3. youth meets abuse or dependence dsm-iv criteria for psychoactive substance use or alcohol disorder, as assessed by the computerized diagnostic interview schedule for children (cdisc, shaffer, 1992). 4. youth agrees to participate in the assessment and treatment intervention. 5. youth meets criteria for homelessness as defined by dhhs. exclusion criteria: 1. evidence of unremitted psychosis or other condition which would impair their ability to understand and participate in the intervention or consent for research participation (as determined by cdisc).

Keywords: substance abuse homelessness hiv risk behavior
a comparison between the repeatability of probing pocket depths achieved with manual and automated periodontal probes

Conditions: Periodontal Disease

Summary: the aim of the study is to determine the best method for measuring the extent and severity of the gum disease by comparing the repeatability of probing depths achieved by a manual probe when compared to an automated probe. hypothesis the null hypothesis to be tested includes * the automated probe does not improve the reproducibility of periodontal probing when compared to manual probing recordings * the automated probe shows no advantage when comparing the reproducibility of * moderate sites * deep sites * single vs. multirooted teeth * different sextants * different surfaces of teeth buccal vs. palatal/lingual mesial vs. mid vs. distal

measuring the clinical attachment loss using a periodontal probe is the benchmark by which attachment loss is diagnosed in periodontal disease. the accuracy and reproducibility of the probing measurements is an essential part of diagnosis, treatment planning and assessment of the treatment outcome. there are inherent errors associated with probing that have been identified in the literature. these relate to the operator technique, the probe used and the state of inflammation of the periodontal pocket/crevice. the aim of this study is to compare the reproducibility of probing measurements using a probe tip with millimeter markings up to 15mm in the florida probe ® handpiece. this tip will be used to allow conventional clinical measurements to be recorded at the same time as the electronic recordings on the florida probe ®. the examiner would take the manual probe measurement and be blind to the electronic reading taken. the sites under question will have a second measurement recorded to allow assessment of the repeatability of the recordings. therefore, from 2 probing passes 4 measurements would be obtained 2 manual and 2 electronic readings.

Eligibility criteria:
inclusion criteria: * age 18 and over * diagnosis of periodontitis (any form) but must have at least 2 sites in at least 1 sextant with a bpe code 4( pockets ≥ 5.5mm) at the time of screening * patient consent gained and has agreed to be a part of the study exclusion criteria: * any medical condition that would exclude them from having the measurements taken * any medical problem that would make participation difficult * if they do not have sufficient sites where probing depths are required.

Keywords: probing manual probe automated probe periodontal disease
randomized controlled trial comparing residual kidney function in patients undergoing three or four exchanges capd

Conditions: End Stage Renal Disease; Anuria; Peritonitis

Summary: the purpose of this study was to explore the impacts of different continuous ambulatory peritoneal dialysis (capd) dosage (three 2-liter exchanges capd vs. four 2-liter exchanges capd) on residual kidney function, technique survival, patient survival, and peritonitis in incident chinese peritoneal dialysis patients.

1. the primary end point for this study was changes in residual kidney function including gfr, daily urine volume (uvol), and anuria-free survival. gfr and uvol were evaluated within 1 week before capd initiation (the baseline), and then at month 1, 6, 12, 18 and 24. at the same time, body weight, blood pressure, daily net ultrafiltration, dialysis adequacy, peritoneal solute transport rate, and biochemical parameters etc. were assessed. once an episode of peritonitis or other serious reversible intercurrent illness occurred, all the assessments were delayed one month after being cured. anuria was termed by daily uvol permanently less than 100 ml. 2. the secondary end points included technique survival, patient survival and peritonitis. technique failure was defined as switching to maintenance hemodialysis.

Eligibility criteria:
inclusion criteria: * incident capd patients aged 18 to 80 years * gfr ≥ 2 ml/min and uvol ≥ 500 ml/day exclusion criteria: * have a history of maintenance hemodialysis or renal transplantation * anticipated life expectancy less than 6 months * with active malignancy, acute infection, significant heart failure or in other severe conditions * unable to give informed consent

Keywords: peritoneal dialysis dose residual kidney function technique survival patient survival peritonitis
impact of ra therapy compliance on patient-reported outcomes

Conditions: Rheumatoid Arthritis

Summary: several observational studies have evaluated the comparative treatment costs associated with each agent, particularly those within the anti-tnf class, but few have evaluated the impact of therapy compliance, persistence, treatment patterns on patient reported outcomes, healthcare utilization and costs, using a provider database. this study is designed to fill in this information gap.

cohort observational

Eligibility criteria:
inclusion criteria: * adults with moderate to severe ra who are currently using a dmard exclusion criteria: * psoriatic arthritis (psa), psoriasis (pso), ssystemic lupus erythematosus (sle), non-disease modifying anti-rheumatic disease (non-dmard) use

Keywords: rheumatoid arthritis therapy compliance
effect of remote intervention in patients with scad

Conditions: Stable Chronic Angina; Ischemic Heart Disease; Coronary Artery Disease; Heart Diseases; Myocardial Ischemia

Summary: the study was a multicenter, two-arm, parallel, open-label, prospective clinical trial that evaluated a remote intervention with 1 year of follow-up.

objective: this study is intended to verify the effect of a remote intervention on adherence to drugs and risk factors control in patients with stable coronary artery disease. study design: the study was a multicenter, two-arm, parallel, open-label, prospective clinical trial that evaluated the effect of a remote intervention on adherence to drugs and risk factors control in patients with stable coronary artery disease with 1 year of follow-up. study intervention: participants in the experimental group received remote guidance from the cardiac rehabilitation team in the community hospital every month after enrollment. the control group had no special intervention. all patients received follow-up at 6 months and 1-year follow-up. outcome measures: the primary outcome was medication adherence. secondary outcomes included smoking, drinking, blood pressure, body mass index, ldl cholesterol, hba1c, and major adverse cerebral cardiovascular events(macce). medication compliance consists of the following five medications: aspirin, p2y12 receptor antagonist, statin, acei/arb and beta-blocker. statistical analysis: values of analyzed endpoints between intervention group and control group will be compared according to the analysis plan. we'll follow a prespecified analysis plan and subgroup analysis will be conducted accordingly.

Eligibility criteria:
inclusion criteria: 1. aged between 18-99 years 2. diagnosed with scad according to guidelines by coronary cta or coronary angiography (including stable angina, ischemic cardiomyopathy, and the stable course after acute coronary syndrome) 3. have sufficient chinese language proficiency to reading, speaking and listening 4. live with at least one caregiver or guardian in the household 5. presence of stable hemodynamics without using vasopressor 6. able to individually consent 7. not participating in any other clinical trial exclusion criteria: 1. unable to provide informed consent 2. unable to be involved in clinical follow-up and treatment 3. suffered comorbidity with a life expectancy of less than 1 year 4. have contra-indication to cardiac rehabilitation 5. acute coronary syndrome 6. history of noncompliance with medical therapy 7. severe valvular disease or valvular disease likely to require surgery or percutaneous valve replacement during the trial 8. planned major surgery necessitating interruption of antiplatelet therapy 9. inability to comply with the protocol 10. has any condition that, in the opinion of the investigator, would make participation not be in the best interest of the subject or that could prevent, limit or confound the protocol-specified assessments
analgesic effect in children of low-dose ketamine for mucositis treated by patient-controlled analgesia with morphine

Conditions: Cancer; Mucositis

Summary: hypothesis : low dose ketamine has an analgesic effect in children with mucositis treated by patient-controlled analgesia with morphine

double blind versus placebo multicenter phase iii trial of kétamine in children with chemotherapy induced-mucositis treated by patient-controlled analgesia with morphine

Eligibility criteria:
inclusion criteria: * painful mucositis * child from 5 to 18 years. * presenting mucitis induced by chemotherapy or a conditioning of graft hematopoïetic. * a pain not controlled by systematic paracetamol (10mg/kg/4h) or a the propacetamol (20mg/kg/4h). * not presenting a neurological or psychological difficulty at the use of the pca or a eva. * first morphine amount going back to less 48h, and lass administration dating of more than 4h at the time of the beginning of the perfusion of ketamine/placebo (eva \> 30 after stop morphine). * assent signed by the parents and each time possible by the child. exclusion criteria: * the child was already included in the study. * the age of psychomotor development is lower than 5 years * presence of a depression or a major depressive episode according to definition dsm iv. * hepatic or renal anomaly major (rank 3 or 4 of the scale of toxicity nci ctc v2.0) * bilirubin\>3n * gamma wp\>3n * sgot or sgpt \>5n * creatinin\>3n

Keywords: mucositis pain morphine ketamine
efficacy and safety of 17-beta estradiol in treatment of atrophic vaginitis

Conditions: Menopause; Postmenopausal Vaginal Atrophy

Summary: this trial was conducted in the united states of america (usa). this trial aimed for a comparison between the effect of two different doses of estradiol on parameters related to efficacy and safety.


Eligibility criteria:
inclusion criteria: * generally healthy * postmenopausal * hysterectomized or non-hysterectomized * moderate or severe vaginal dryness and soreness exclusion criteria: * known, suspected, or past history of breast cancer * known, suspected, or past history of hormone-dependent tumor * genital bleeding of unknown etiology * acute thrombophlebitis or thromboembolic disorders or a past history of these conditions, associated with previous estrogen use * vaginal infection * use of exogenous corticosteroids or sex hormones within 8 weeks of starting active treatment in study * use of vaginal, oral or vulvar homeopathic preparations within seven days of starting active treatment in study * history of treatment with diethylstilbestrol