Kornimate/medical-research-clean huggingface dataset:
british randomised controlled trial of atrioventricular (av) and interventricular (vv) optimisation (bravo)

Conditions: Heart Failure

Summary: many patients who have cardiac resynchronisation therapy (a type of pacemaker) implanted for heart failure do not have the settings of their device optimised. the most widely available method for optimisation uses flow measured using cardiac ultrasound (echocardiography) to determine the optimal settings. however, this is not frequently performed because it is time consuming and requires two skilled operators. in this study the investigators will test a new non-invasive method for optimisation, which utilises pressure measurements (non-invasive blood pressure measured from the finger). is optimising av and vv delay using non-invasive haemodynamics at least equivalent, in terms of exercise capacity, to conventional echo optimisation.


Eligibility criteria:
inclusion criteria: * chronic heart failure due to systolic dysfunction * biventricular pacemaker implanted * give written informed consent exclusion criteria: * lung disease or any condition that would preclude them from walking on a treadmill

Keywords: heart failure cardiac resynchronisation therapy
hip fracture and covid-19

Conditions: SARS-CoV2 Infection; Hip Fractures; Surgery

Summary: hip fracture in the elderly is a worldwide public health issue and a medical challenge for early postoperative rehabilitation. more than 2 million people are treated annually with an annual incidence between 100 and 300/100,000 (usa, europe, china), resulting in a cost of billion dollars and a strain on most surgical facilities. in this context, an early surgical management of patient with fracture within the first 24-48h has been shown to reduce morbidity, length of hospital stay and mortality. during the covid-19 pandemics, a higher risk of 30-day mortality has been reported in patients with pre-operative sars-cov-2 infection diagnosed 0-2 weeks, 3-4 weeks and 5-6 weeks before surgery compared with patients who did not have a pre-operative sars-cov-2 infection. however, this risk seems to disappear in patients diagnosed with sars-cov-2 ≥ 7 weeks before surgery. these findings led to propose delayed elective surgery when the benefit-risk ratio was acceptable (cancer, cardiac surgeries). however, delaying surgery in covid-19 patients (with high risk of immune and thrombotic disorders) with hip fracture could be questionable as the risk related to covid-19 could be counteracted by the risk delayed surgery. for assessing the mortality risk related to hip fracture surgery associated with covid-19, we decided to use the french national hospital discharge records database for comparing the 30-day postoperative mortality in patients with hip fracture and with or without an hospitalization for sars-cov-2 infection in the 30 previous days before surgery.


Eligibility criteria:
inclusion criteria: * age \> 65 yars * hip fracture hospitalization * care code indicating a surgical procedure exclusion criteria: -patient with hip fracture hospitalization without a care code indicating a surgical procedure
clinical efficacy and safety evaluation of hcp1904-3 in essential hypertension patients

Conditions: Hypertension

Summary: the purpose of this study is to evaluate of efficacy and safety of hcp1904-3 and rld2001-1 alone in patients with essential hypertension inadequately controlled on rld2001-1 monotherapy.

a multi-center, randomized, double-blinded, active-controlled, parallel, phase iii study to evaluate the efficacy and safety of hcp1904-3 in essential hypertension patients

Eligibility criteria:
inclusion criteria: 1. patients over 19 years of age 2. patients who understands the process of clinical study and voluntarily signs a peer letter 3. visit1: a person whose blood pressure measured in visit1 corresponds to the following conditions * blood pressure medication taken patients: 130mmhg ≤ sitsbp\<180mmhg, sitdbp\<110mmhg * blood pressure medication free patients: 140mmhg ≤ sitsbp\<180mmhg, sitdbp\<110mmhg 4. visit2: 140mmhg ≤ sitsbp\<180mmhg, sitdbp\<110mmhg or if patients are in high risk group: 130mmhg ≤ sitsbp \<180mmhg, sit dbp \< 110mmhg exclusion criteria: 1. difference in mean value of blood pressure measured in both arms of more than 20mmhg in sitsbp or more than 10mmhg in sitdbp 2. orthostatic hypotension with symptoms within 3months of visit 1 3. secondary hypertensive patient or suspected to be 4. uncontrolled diabetes mellitus(hba1c \> 9%) or type i diabetes mellitus 5. active gout or hyperuricemia (uric acid ≥ 9mg/dl) 6. severe heart disease or severe neurovascular disease 7. severe or malignant retinopathy 8. clinically significant hematological finding 9. severe renal diseases (egfr\<30ml/min/1.73m2) 10. severe hepatopathy or active hepatopathy (ast or alt normal range ≥ 3 times) 11. hypokalemia or hyperkalemia(k\<3.5mmol/l or k ≥ 5.5mmol/l) 12. hyponatremia or hypernatremia(na\<135mmol/l or na ≥ 155mmol/l) 13. hypercalcemia 14. history of malignancy tumor 15. history of autoimmune disease 16. history of alcohol or drug abuse 17. positive to pregnancy test, nursing mother, intention on pregnancy 18. considered by investigator as not appropriate to participate in the clinical study with othe reason

Keywords: losartan chlorthalidone
fluid restriction in heart failure versus liberal fluid uptake

Conditions: Heart Failure

Summary: multi-centre open-label 1:1 randomized clinical trial in chronic heart failure patients on the effect of fluid restriction versus liberal fluid intake on quality of life.


Eligibility criteria:
inclusion criteria: * diagnosis of chronic hf with nyha class ii/iii according to the prevailing guidelines \> 6 months prior to randomization (1) * adult (age ≥ 18 years) exclusion criteria: * reversible cause of hf (thyroid disorders, severe anemia, vitamin deficiencies) * hospital admission for hf within 3 months of randomization * chronic hf with nyha class iv * hyponatremia at baseline (sodium \<130mmol/l) * changes in hf medical therapy in last 14 days prior to randomization * estimated glomerular filtration rate (egfr) of \< 30ml/min/1.73 m2 at baseline * scheduled cardiac surgery within 3 months of randomization * recent (within 3 months) coronary intervention (pci or cabg) or implantation of pacemaker device * comorbidity for which fluid restriction is advised by a different treating physician (e.g. nephrologist) * comorbidity with a life expectancy of less than 6 months * the treating clinician believes that participation in the domain would not be in the best interests of the patient * inability to provide informed consent
a non-interventional post-marketing surveillance study to evaluate the safety and efficacy of zeldox capsule

Conditions: Bipolar Disorder; Schizophrenia

Summary: this is a regulatory-required non-interventional pharmacovigilance study exploring the safety profile of ziprasidone hcl monohydrate 20mg, 40mg, 60mg, 80mg in the real world patient population, thus, safety (and/or efficacy) signals will be checked at every visit during the contracted study period until the maximum study end date, per the protocol, of april 2010.

all patients diagnosed with schizophrenia or acute manic or mixed episodes associated with bipolar disorder, with or without psychotic features will be included in the study.

Eligibility criteria:
inclusion criteria: * patients diagnosed with schizophrenia exclusion criteria: * patients who have known hypersensitivity to any ingredient of the product * patients who have had a recent acute myocardial infarction * patients who have uncompensated heart failure * patients who have conditions with a potential to increase qt interval (qt-interval prolongation or history of qt prolongation; congenital long qt syndrome; use with other drugs known to increase the qt interval; arrhythmias treated with class i and iii antiarrhythmic drugs)

Keywords: regulatory post-marketing surveillance regulatory pharmacovigilance ziprasidone
immunoregulation of periodontal disease

Conditions: Periodontal Disease

Summary: our design is to test in hospital practice a selection of immune parameters that could assess the pathophysiology and progression of periodontal lesions.

these parameters will be measured in 25 healthy volunteers and 25 moderate-to severe periodontal disese patients. phagocytes will be tested phenotypically and functionally, both ex vivo and in vitro.

Eligibility criteria:
inclusion criteria: * persons appearing spontaneously at the consultation of parodontologie for parodontale disease, * persons agreeing to undergo a sampling of blood intended for the search exclusion criteria: * presence of a chronic or pointed pathology, * an age 18-year-old subordinate or 65-year-old superior, * pregnant women,
biliary fistulas in surgery of liver echinococcosis

Conditions: Echinococcosis, Hepatic; Biliary Fistula

Summary: the objective of the study is to improving the results of surgical treatment of liver echinococcosis complicated by biliary fistula by optimizing diagnostic approaches to early verification of this complication and improving the tactical and technical aspects of its elimination.


Eligibility criteria:
inclusion criteria: * age under 18 years; * informed consent for inclusion in the study; * the presence of liver echinococcosis, for which conservative surgical treatment will be performed; * the presence of the entire spectrum of necessary preoperative diagnostic measures; * a full description of all stages of surgical intervention, indicating the type of intervention (open or laparoscopic surgery, location and size of the echinococcal cyst in the liver, type of antiparasitic treatment, presence or absence of a biliary fistula in the residual cavity, actions taken in relation to the fistula, the option of eliminating the residual cavity and drainage; * availability of objective data on the characteristics of the postoperative course, including dynamic indicators of the patient\&#39;s condition, temperature, amount and nature of discharge through the drainage, the time of drainage removal, the type of complications (if any) and the method of their treatment, the duration of the hospital period, data on the characteristics of the posthospital period up to 3 months of observation; * absence of concomitant pathology that may affect the outcome of the surgery. exclusion criteria: * age under 18 years; * refusal to participate in the study; * extrahepatic echinococcosis without liver damage; * absence of the full range of preoperative diagnostic data; * difficulties with objective analysis of the features of the performed surgical treatment; * incomplete data on monitoring the postoperative hospital and remote (up to 3 months) period; * the presence of concomitant pathology that may affect the outcome of the operation.

Keywords: echinococcosis of the liver biliary fistula conservative surgical treatment
a serosurvey study of hand, foot, and mouth disease in indonesia

Conditions: Hand, Foot and Mouth Disease

Summary: this study is a sero-survey study of infants aged 6 months to 71 months in bandung city and west bandung district. as initial data to find out how many children have been exposed to human enterovirus type 71 (hev-71) which causes hand, foot, and mouth disease (hfmd).

this study is a cross-sectional seroprevalence survey of ev-71, associated with hfmd, among children aged between 6 to 71 months in bandung, sampled from urban and rural primary health center in bandung, indonesia. this study was implemented by department of child health hasan sadikin general hospital/medical faculty universitas padjadjaran bandung, west java. age-stratified sample of 600 children aged 6-71 months will be conducted from these sites. samples testing includes routine blood counts, enzyme-linked immunosorbent assays (elisas) for enterovirus type 71 (ev71) igg and elisas for other hfmd-associated enteroviruses.

Eligibility criteria:
inclusion criteria: * children aged 6 months to 71 months. * the participant's parent/guardian receives an explanation and receives a letter of consent after the explanation (informed consent) and provided a documented informed consent by parents/legally accepted representative (lar) participants prior to the study procedures. * domicile in bandung and west bandung district for at least 6 months. exclusion criteria: * children with difficulty to withdraw the blood during blood collection * children with severe illness who require further treatment
a non-interventional, post-marketing study to describe outcome of nitisinone treatment in ht-1 patients

Conditions: Hereditary Tyrosinemia, Type I

Summary: this is a prospective, non-interventional, non-comparative, multicenter study to collect data on ht-1 patients in china treated with nitisinone in a routine clinical setting. no tests or examinations are mandated in the study.

this is a prospective, non-interventional, non-comparative, multicenter study to collect data on ht-1 patients in china treated with nitisinone in a routine clinical setting. no tests or examinations are mandated in the study, though the expectation is that most of the tests and examinations listed in the protocol will be performed in the context of routine clinical care and relevant data will be captured. at enrollment, data on patient treatment, medical and surgical history together with other patient characteristics will be captured.patients enrolled in the study will be followed for at least 1 year and for a maximum of 3.5 years. the study aims to enroll at least 15 ht-1 patients aged 0-18 years. if adult patients are enrolled the study population will be larger as all eligible patients will be invited to participate. however, the enrollment will close when the target of 15 patients aged 0-18 years has been reached.

Eligibility criteria:
inclusion criteria: 1. patients with a confirmed diagnosis of ht-1 treated with, or at enrollment prescribed, nitisinone treatment (product manufactured by sobi) in a routine clinical care setting. the decision to initiate treatment shall be made by the treating physician independently from the decision to include the patient in the study. 2. signed and dated informed consent provided by the patient, or the patient's legally authorized representative(s) for patients under the legal age, should be obtained before any study-related activities are undertaken. assent should be obtained from pediatric patients according to local regulations exclusion criteria: 1. enrollment in a concurrent clinical interventional study, or intake of an investigational medicinal product (imp), within three months prior to inclusion in this study

Keywords: rare diseases fumarylacetoacetate hydrolase (fah) deficiency liver failure drug treatment nitisinone observational research phase iv china pediatric patient
evaluation of the acceptability, appropriateness, and feasibility/usability of a metastatic breast-cancer specific prognostic calculator among clinicians

Conditions: Metastatic Breast Cancer; End of Life

Summary: i this qualitative study, investigators will conduct semi-structured interviews with clinicians that are involved in the care of patients with breast cancer to evaluate the acceptability, appropriateness, and feasibility/usability of a metastatic breast cancer-specific prognostic tool. these interviews will be conducted by the unc chai core and will continue until thematic saturation (estimated 10 participants). the investigators will code the qualitative data using emerging themes, guided by a well-established implementation science theory, the consolidated framework for implementation research (cfir). the information gained from these studies will inform an implementation approach to increase the usability and acceptability of a novel prognostic tool to assist oncologists in the prognosis of patients with metastatic breast cancer.

if this study is successful, investigators will implement an mbc-specific prognostic tool to help clinicians identify patients who are at high risk of death in the next 30 days. based on the input from clinicians in this proposal, as well as additional qualitative studies with patients and families, investigators will design an implementation protocol to inform how to use this tool in clinical practice. rather than simply publishing a prognostic tool that may not be adopted into practice, this project aims to ensure successful implementation of an evidence-based tool into the routine care of patients with mbc. doing so will serve as an important step towards identifying high-risk patients and connecting ort to ensure high-quality, patient-centered end-of-life care.

Eligibility criteria:
inclusion criteria: 1. verbal informed consent obtained to participate in the study. 2. subject is willing and able to comply with study procedures based on the judgement of the investigator or protocol designee. 3. physician, nurse practitioner, physician assistant, or nurse navigator 4. at least 6 months of experience in the clinical care of patients with metastatic breast cancer in the united states. exclusion criteria: * non-english speaking

Keywords: metastatic breast cancer prognostic tool end of life clinicians prognosis qualitative interview caregivers
effect of enhanced recovery after surgery (eras) on c-reactive and visceral proteins

Conditions: Gastric Cancer

Summary: the investigators designed a prospective randomized, controlled clinical trial then recruited 149 consecutive advanced gastric cancer patients. further divided into a eras group (n=73) and a conventional pathway group (n=76). surgical technique in both groups was same laparoscopic-assisted gastrectomy with d2 lymphadenectomy. compared outcomes included clinical parameters and serum indicators.

enhanced recovery after surgery combined with laparoscopic-assisted gastrectomy was successfully carried out in this study. recovery parameters such as the length of time to return to normal diet,mean hospital stay (d) were recorded.

Eligibility criteria:
inclusion criteria: 1. age 18-75 years old 2. diagnosis confirmed by the endoscopic biopsy and total-body ct scan 3. no history of the chronic renal disease ,chronic liver disease, cardiopulmonary dysfunction, asa score≦3 4. no neoadjuvant chemotherapy and radiotherapy 5. no digestive obstruction and distant metastasis exclusion criteria: 1. conversion to open gastrectomy 2. a large amount of bleeding leading(\>500ml) 3. patients withdrew their consent

Keywords: enhanced recovery after surgery laparoscopic gastrectomy advanced gastric cancer c-reactive,visceral proteins
valsartan in elderly isolated systolic hypertension study

Conditions: Aged; Systolic Hypertension

Summary: the aim of this study is to compare the incidence of cardiovascular events between two target systolic blood pressure levels, below 140 mmhg and below 150 mmhg under treatment with valsartan in elderly isolated systolic hypertensive patients in japan.

although antihypertensive therapy has been proven to reduce cardiovascular morbidity and mortality, it is unclear how much blood pressure should be decreased in elderly patients with hypertension. the valsartan in elderly isolated systolic hypertension (valish) study is a multicenter parallel-group study comparing the incidence of cardiovascular events between two target systolic blood pressure levels, below 140 mmhg and below 150 mmhg, under treatment with valsartan, an angiotensin ii receptor blocker, as an initial antihypertensive drug in elderly patients with isolated systolic hypertension. the number of patients to be recruited is 3,000 and the duration of follow-up is at least 2 years. this 3,000-patient trial was designed with a two-sided α level of 0.05 and 80% power to detect the difference in incidence of cardiovascular events between the target blood pressure levels based on estimation of the cardiovascular events ratio as 21.5/1,000 patient-years and 29.1/1,000 patient-years for the two blood pressure levels. the valish study, a large-scale investigator-initiated trial in japan, will determine whether age should be considered in setting target blood pressure in treatment of isolated systolic hypertension in elderly patients.

Eligibility criteria:
inclusion criteria: * outpatients aged over 70 years and less than 85 years, regardless of sex. * patients with stable seated systolic blood pressure of over 160 mmhg and diastolic blood pressure of less than 90 mmhg at two visits within 2 to 4 weeks. * previously untreated patients or patients who are on other therapy that can be converted to valsartan. exclusion criteria: * patients with secondary hypertension or malignant hypertension. * patients with seated systolic blood pressure of over 200 mmhg. * patients with seated diastolic blood pressure of over 90 mmhg. * patients with a history of cerebrovascular disorder or myocardial infarction within 6 months prior to enrolment in the study. * patients who underwent coronary arterioplasty within 6 months prior to enrolment in the study or patients who will undergo coronary arterioplasty within 6 months after entry. * patients with severe heart failure (nyha functional classification iii and iv). * patients with severe aortic stenosis or valvular disease. * patients with atrial fibrillation, atrial flutter, or serious arrhythmia. * patients with renal dysfunction with serum creatinine level of over 2 mg/dl. * patients with serious liver dysfunction. * patients with a history of hypersensitivity to valsartan. * other patients who are judged to be inappropriate for the study by the investigator or sub-investigator.

Keywords: isolated systolic hypertension valsartan target blood pressure
electronic recording of compliance with occlusion therapy for amblyopia

Conditions: Amblyopia

Summary: the purpose of this study was to determine whether compliance with occlusion therapy for amblyopia could be improved and, secondly, if risk factors for non-compliance could be identified.

non-compliance is a limiting factor for success of occlusion therapy for amblyopia (lazy eye) in childhood. it is responsible for approximately 1% of the adult population being unable to read with the amblyopic eye. the researchers used electronic monitoring of compliance to investigate predictors and a remedy for non-compliance. methods: in a prospective randomised controlled trial, compliance was measured for one week every three months during 30 months in newly diagnosed amblyopic children in the hague, frankfurt and leicester. the family's social-economic and ethnic background was assessed through a questionnaire. children were randomised to receive either an educational cartoon story explaining, without text, the rationale for treatment to the child with reward stickers and an information sheet, or a picture to colour. all received standard orthoptic care by a treating orthoptist, who was unaware of the randomisation. the electronic device and educational programme were distributed via home-visits by researchers. the primary outcome measure was percentage of compliance (realised/prescribed occlusion time). the secondary outcome measure was influence of social-economic, ethnic and clinical factors on compliance.

Eligibility criteria:
inclusion criteria: * all newly diagnosed amblyopic children with an inter-ocular difference in visual acuity of at least 0.2 logmar, strabismus and/or anisometropia or deprivation (e.g. cataract) exclusion criteria: * previous treatment for amblyopia * neurological disorder * medication * other eye disorder * decreased visual acuity caused by brain damage or trauma

Keywords: amblyopia occlusion therapy compliance risk factors