Kornimate/medical-research-clean huggingface dataset:
a randomized, double-blind, placebo-controlled phase 3 study of the effects of ferric citrate in subjects with end stage renal disease

Conditions: Hyperphosphatemia; End Stage Renal Disease; ESRD

Summary: the purpose of the study is to determine the effect and optimum dose and evaluate the safety of ferric citrate, administered three times daily (tid) immediately after meals for a total daily dose of 4 or 6 grams for 56 days, on serum phosphate (po4) levels in subjects with end stage renal disease (esrd).


Eligibility criteria:
inclusion criteria: * age\>18 years and has a diagnosis of esrd * on a three-times per week hemodialysis regimen * on a stable dose of a phosphate-binding agent for at least one month prior to study entry. * if on vitamin d supplementation or calcitriol, must be on a stable dose for at least one month prior to study entry. * hct \>= 20% * serum ca level of 8 mg/dl to 10.5 mg/dl exclusion criteria: * is pregnant or lactating * clinically significant gi disorder * has tertiary hyperparathyroidism or is immediately post-operative from a parathyroidectomy (within the first 3 months post-op or the plasma ca is \<7 mg/dl) * ferritin\>800 ng/ml * unstable medical condition unsuitable for the study in the opinion of investigator * has been treated with an investigational agent within 30 days of enrollment * has a history of documented iron allergy or hemochromatosis

Keywords: kidney diseases kidney failure, chronic hyperphosphatemia urologic diseases renal insufficiency, chronic renal insufficiency phosphorus metabolism disorders
a reliability and validity study of urdu version of western ontario and macmaster osteoarthritis index

Conditions: Knee Osteoarthritis

Summary: the aim of the study is to translate and culturally adapt western ontario and macmaster osteoarthritis index into urdu language and to investigate its reliability and validity pakistani population with primary knee osteoarthritis while assessing its correlation with lequesne index.

as per preceding commendation, western ontario and macmaster osteoarthritis index will be translated into urdu language from its english version and adapted culturally in pakistan. among primary knee osteoarthritis population, western ontario and macmaster osteoarthritis index will be distributed among 87 patients recruited by convenience sampling technique under the pre-defined inclusion and exclusion criteria after signing consents forms. for testing inter-observer reliability and intra-observer reliability of western ontario and macmaster osteoarthritis index and lequesne index will be administrated by two observers, on the same day, with a time interval of 2 hours between 1st and 2nd conduction. as for the 3rd conduction, it will be carried out after seven days by the first observer, for intra-observer assessment. statistical package of social sciences software version 24 will be used for the purpose of data entry and analysis. internal consistency will be assessed by using an intra-class correlation coefficient. the western ontario and macmaster osteoarthritis index will be evaluated for content validity, construct validity, criterion validity and responsiveness

Eligibility criteria:
inclusion criteria: * male and female patients * age above 40 years * participants with primary knee osteoarthritis * patients willing to participate. exclusion criteria: * history or presence of ; * rheumatic diseases,severe articulation inflammation and cardiac disease. * participants with secondary knee osteoarthritis.

Keywords: western ontario and macmaster osteoarthritis index urdu version reliability validity knee osteoarthritis lequesne index
social medical progression of coronary heart disease with associated psychosocial comorbidity -interval rehabilitation.

Conditions: Cardiovascular Events

Summary: the purpose of the study is to verfiy the hypothesis if a short intensive psychocardiological interval-intervention, combined with a structured follow up, decreases the rate of disability retirements caused by psychosocial co-morbidity of patients with coronary heart disease.

the purpose of the study is to verfiy the hypothesis if a short intensive psychocardiological interval intervention, combined with a structured follow up, decreases the rate of disability retirements caused by psychosocial co-morbidity of patients with coronary heart disease.

Eligibility criteria:
inclusion criteria: * coronary heart disease * disease-related psychosocial morbidity * not a disability retirements * insured with the german rheinland pension (deutsche rentenversicherung rheinland) * sufficient language skills * age 18-58 exclusion criteria: * acute cardiac decompensation * consuming the underlying disease * psychotic disorder * acute suicidality * pregnancy

Keywords: psychocardiological interval intervention disability pension risk profile mental comorbidity
eeg - guided anesthetic care and postoperative delirium

Conditions: Delirium; Emergence Delirium; Anesthesia, General; Electroencephalography; Laparoscopy; Surgical Procedures, Operative

Summary: the study is a prospective, double blinded, randomized and controlled parallel trial to investigate the effect of the anesthetic care guided by eeg monitor (sedline) on postoperative delirium. emodipod = electroencephalography monitoring to decrease the incidence of postoperative delirium

to investigate the impact of the anesthetic care guided by eeg monitor (sedline) on (1) the incidence of delirium in post-anesthesia care unit (pacu) and within the first five days after laparoscopic surgery and (2) the incidence of in-hospital complications and 30-day mortality in adult patients after laparoscopic surgery.

Eligibility criteria:
inclusion criteria: 1. age ≥ 50 years; 2. asa physical score i-iii 3. scheduled to undergo elective laparoscopic surgeries under general anesthesia with endotracheal intubation; 4. extubation expected after surgery; 5. scheduled to stay in hospital for \> 3 days after surgery. exclusion criteria: 1. refuse to participate; 2. emergent surgery; 3. trauma patients; 4. preoperative cognitive impairment characterized by mini-mental state examination (mmse) of 23 or less; 5. preoperative history of stroke, schizophrenia, major depression, parkinson's disease, epilepsy, or dementia; 6. inability to communicate in the preoperative period due to illiteracy, language difficulties, or significant hearing or visual impairment; 7. inability to complete mmse and delirium survey; 8. severe cardiac disease including low-output cardiac failure defined as a preoperative left ventricular ejection fraction \< 30%, or arrhythmia with pacemaker or aicd placement; 9. severe hepatic dysfunction being evaluated for liver transplantation or with a child- pugh class c classification; 10. severe renal dysfunction requiring renal replacement therapy before surgery; 11. those with preoperative asa classification of 4 or who are unlikely to survive for more than 3 days after surgery.

Keywords: electroencephalography spectral edge frequency patient state index anesthesia laparoscopic surgery postoperative delirium emergence delirium
maternal and neonatal outcomes following exposure to benzodiazepines during pregnancy

Conditions: Pregnancy Related; Benzodiazepines Causing Adverse Effects in Therapeutic Use; Congenital Anomaly

Summary: this is a nationwide cohort study to assess maternal and neonatal outcomes following exposure to benzodiazepines during pregnancy.

benzodiazepines are widely used in pregnant women; however, their safety on congenital malformations in a real-world setting is still uncertain. we aimed to assess the association between benzodiazepine use in early pregnancy and the risk of congenital malformations. we will conduct a retrospective nationwide cohort study using the health insurance review and assessment (hira) database of south korea, which covers the entire south korean population.

Eligibility criteria:
inclusion criteria: * pregnancies with live birth, 2011-2018 * pregnancies linked to liveborn infants * pregnancies aged 20-45 years at delivery exclusion criteria: * pregnancies with a chromosomal abnormality * pregnancies with exposure to known teratogenic drugs (e.g. antineoplastic agent, warfarin, lithium, isotretinoin, misoprostol, thalidomide) during the first trimester * pregnancies with no benzodiazepine prescription during the first trimester, but with at least one benzodiazepine prescription during the 3 months before the pregnancy onset
salvage cryotherapy for recurrent prostate cancer after radiation therapy

Conditions: Prostate Cancer; Cryotherapy; Recurrent Prostate Cancer

Summary: the main objective of this project is to establish a shared comprehensive and systematic protocol for a multicenter prospective registry of patients undergoing salvage cryoablation of the prostate (scap). our study hypothesis is that scap constitutes an effective and safe approach to treat local prostate cancer recurrence after brachytherapy or external beam radiation therapy (ebrt).

salvage cryoablation of the prostate has been proposed as an alternative to salvage radical prostatectomy, as it has a potentially lower risk of morbidity and equal efficacy. a recent systematic review assessed a total of 32 studies of scap (5.513 patients). the overwhelming majority of patients (93%) received whole-gland scap. the adjusted pooled analysis for 2-year bcr-free survival for scap was 67.49% (95% ci: 61.68-72.81%), and for 5-year bcr-free survival was 50.25% (95% ci: 44.10-56.40%). nevertheless, the evidence base relating to the use of scap is poor, with significant uncertainties relating to long-term oncological outcomes. one of the main limitations when these studies are analyzed is the lack of information about the histopathology both before starting treatment and at the time of recurrence after cryotherapy. the vast majority only refer to biochemical-free survival as end point, thus limiting interpretation of real oncological performance of this technique. furthermore, side effects vary widely from study to study and there are uncertainties about the real morbidity associated to cryotherapy in the salvage setting. due to this lack of evidence, the eau 2021 guidelines recommend that scap should only be performed in selected patients in experienced centres as part of a clinical trial or well-designed prospective cohort study.

Eligibility criteria:
inclusion criteria: * patients with local recurrence (with histological confirmation) after treatment with radiotherapy or brachytherapy without evidence of distant involvement evaluated with pet/psma (if not available then fluciclovine pet/ct or choline pet/ct must be performed). * life expectancy \>10 years * prostate volume \< 100cc * psa\<10 ng/ml * mpmri + fusion/systematic biopsy ≤ct3a without affecting the bladder neck or the membranous urethra exclusion criteria: * patients with clinically confirmed distant metastasis * any previous major rectal surgery * clinically significant lower urinary tract or rectal anomalies * existing urethral, rectal, or bladder fistulae

Keywords: psma/pet-ct
discover workshop programme for care experienced young people

Conditions: Mental Health Issue; Emotional Stress; Emotional Regulation

Summary: the nhs discover team has secured 2-year funding from the maudsley charity to tailor the workshop programme the investigators deliver in school sixth forms to meet the specific needs of care experienced young people. the investigators are planning to complete a pilot of this adapted workshop programme within medway children's social services to explore its feasibility, accessibility, acceptability and early-stage efficacy within this population of adolescents. investigators from the discover team will recruit young people aged 16-19yrs who are currently known to the medway care leavers 16+ teams. the study will be conducted at medway local authority sites, with the option of some stages being completed remotely via microsoft teams if needed in the context of the ongoing covid-19 pandemic.


Eligibility criteria:
inclusion criteria: participants who are eligible to take part in this discover research project will be: * young people aged 16-19 years who have experience of being in care and are currently under one of the medway children's social care, care leavers 16+ teams. this means that they are either currently a looked after young person or a care leaver (i.e. they are no longer looked after but they remain under the care of a medway care leavers team). * able to work within a group setting over the course of a day workshop. * able to communicate and read in english. exclusion criteria: the investigators will not be able to recruit young people to the project if they are: * acutely psychotic or actively suicidal. * currently taking part in other research project(s). * under the influence of alcohol or any other substances during discover programme meetings - this is essential as a safety consideration for all participants and staff. struggles with alcohol/substance use in themselves are not necessarily grounds for exclusion; the investigators will discuss with the allocated member of the young person's care leavers 16+ team on a case-by-case basis where relevant. * unable to communicate and read in english - as the investigators are at an early stage in developing this discover workshop programme for care experienced young people, these young people must be excluded at this time. however, the investigators are eager to review this criterion in future to enhance the accessibility of the intervention, once the initial feasibility and acceptability of the workshop programme has been established.

Keywords: care leavers looked after children psychological intervention workshop programme adaptation cognitive behaviour therapy acceptance and commitment therapy
a study of lenvatinib in combination with pembrolizumab in korean patients

Conditions: Endometrial Neoplasms; Endometrium; Carcinoma; Renal Cell Carcinoma

Summary: the purpose of this study is to collect and evaluate the following information in relation to the safety and the efficacy of lenvatinib in lenvatinib/pembrolizumab combination therapy in the post marketing setting: (1) serious adverse events and serious adverse drug reactions (2) unexpected adverse events and adverse drug reactions not reflected in the approved product package insert of lenvatinib in lenvatinib/pembrolizumab combination therapy (3) known adverse drug reactions (4) non-serious adverse drug reactions (5) other safety and efficacy related information.


Eligibility criteria:
inclusion criteria: 1. greater than (\>) 18 years 2. considered by the treating physician for lenvatinib/pembolizumab combination therapy for the approved indications in korea, prior to study 3. provided written consent for use of personal medical information for the study purpose 4. meets the approved indication and none of the contraindications for lenvatinib/pembrolizumab combination therapy in korea, as confirmed by the treating physician exclusion criteria: 1. currently receiving lenvatinib and pembrolizumab as part of a clinical trial

Keywords: lenvatinib pembrolizumab
copeptin for prediction of treatment response in children with monosymptomatic nocturnal enuresis (men).

Conditions: Nocturnal Enuresis

Summary: monosymptomatic nocturnal enuresis (men) is a common problem in children, affecting 7-10% of all 7 year olds. men is often leading to psychosocial problems because of its burden and stigmatism. the only available medical treatment option is the vasopressin analogum desmopressin®. however, according to the literature, only one third of patients shows a good treatment response, defined as more than 90% of reduced bed wetting. furthermore, treatment with desmopressin® may lead to psychosocial problems, high costs and potentially dangerous side effects like water intoxication and hypertension. copeptin, mirroring arginine vasopressin (avp), has been shown to be significantly lower in patients with men compared to controls and lower in patients with severe bed wetting compared to patients with only slight bed wetting.


Eligibility criteria:
inclusion criteria: * children at the age between 5 and 16 years * diagnosis of monosymptomatic nocturnal enuresis * completion of uroflowmetry and bladder sonography if possible * completion of home recording charts of bed wetting episodes if possible * willingness to use desmopressin® treatment exclusion criteria: * children with daytime enuresis * children with lower urinary tract symptoms and infection * children with structural abnormalities of the urinary tract * children with chronic illness, esp. renal failure, hypertension, congenital heart disease, diabetes mellitus and diabetes insipidus.

Keywords: children desmopressin copeptin
machine learning to reduce hypertension treatment clinical inertia

Conditions: Hypertension

Summary: among individuals with an uncontrolled bp at the current visit, the objective of this study is to compare clinical management of hypertension with and without information from a machine learning algorithm on whether a patient will have uncontrolled blood pressure at their next follow up visit through a case-vignette study.

among adults with uncontrolled blood pressure (bp) at a clinic visit, clinical inertia is common. clinical inertia is defined as a failure of providers to initiate or intensify treatment (i.e., adding medication or increasing dosage) when guidelines indicate doing so. prior studies report that clinicians intensify antihypertensive medication treatment in less than 20% of visits where intensification would have been clinically recommended. thus, patients who have uncontrolled bp may not receive timely therapy to control their bp. to address this issue, the investigators will use a randomized design to test the hypothesis that clinicians will be more likely to intensify the hypertensive regimen and/or assess nonadherence for patients with uncontrolled bp at the current visit when presented with information that a patient is predicted to have uncontrolled bp at the next visit by a machine learning algorithm.

Eligibility criteria:
inclusion criteria: practicing primary care clinicians who see patients (i.e., internal medicine, family medicine, attending physicians, nurse practitioners) will be eligible to participate - exclusion criteria: -

Keywords: uncontrolled blood pressure antihypertensive medication hypertension treatment clinical inertia machine learning
evaluation of a navigator-nurse care team on the management of high blood pressure and cardiovascular disease risk

Conditions: Hypertension

Summary: the purpose of this trial is to study the effect of a patient navigator-nurse team in improving the management of hypertension and other cardiovascular disease risk factors in a health care system taking care of a vulnerable, mostly latino population.

this study represents one phase of a large partnership grant with the colorado health outcomes program of the university of colorado at denver health sciences center (ucdhsc) and denver health and hospital authority (dh). the overarching goal of latinos using cardio health actions to reduce risk (luchar) is to improve the primary and secondary prevention of cardiovascular disease (cvd) in hispanics through a comprehensive research program aimed at (1) increasing awareness of cvd risk in the hispanic community and increasing participation of high risk hispanics in the health care system, (2) developing more effective models of care delivery for high risk patients in a health system, and (3) identifying markers that will more effectively identify hispanic patients at high risk of cvd than current approaches based on traditional risk factors. this trial has been designed to assess the effectiveness of a quality improvement project which focuses on the hypertensive multiracial underserved population within the denver health system. in addition, we are hoping at study end to have developed and validate this project as an efficient and sustainable approach to improving blood pressure control and controlling cardiovascular risk factors, especially in the vulnerable patient population served at denver health. the objective of this quality improvement program is to conduct a randomized, primary care-based, efficacy trial evaluating the effectiveness of a patient navigator-nurse disease management intervention for treating hypertension and its associated cardiovascular risk factors using information obtained in earlier phases of the luchar grant: i.e., algorithms, risk factor profiles, and qualitative data from focus groups and interviews. the study is designed to test the hypothesis that a patient navigator-nurse assisted intervention will improve blood pressure (bp) in vulnerable hypertensive patients, compared with usual clinical care.

Eligibility criteria:
inclusion criteria: * active patients from the target adult health clinic * identified with a diagnosis of hypertension * uncontrolled hypertension (2 of 3 last bp measurements above target bp range; target bp is defined at 140/90 or 130/80 mm hg for people with diabetes or kidney disease) exclusion criteria: * pregnant or breastfeeding * end-stage kidney disease requiring dialysis * co-morbid illness with life expectancy less than 12 months * institutionalized individuals because of the potentially confounding factors due to severe co-morbidity or other medical conditions

Keywords: high blood pressure cardiovascular