Kornimate/medical-research-clean huggingface dataset:
safety and efficacy of gx-188e dna therapeutic vaccine administered by electroporation after observation

Conditions: Cervical Intraepithelial Neoplasia 3

Summary: this study is to follow up on the change of immune response by measuring hpv type 16/18 e6 and e7 specific t cell response and lesion condition in subjects who have administered in dna-based therapeutic vaccine.

this is a follow-up study to investigate the change of immunogenicity and lesion condition in subjects with cervical intraepithelial neoplasia (cin) 3 who have enrolled and participated gx-188e phase ii trial(gx-188e_cin3_p2). subjects will make visits 7 times for about three years from the last visit of gx-188e phase 2 trial (gx-188e_cin3_p2). the endpoints are to evaluate the change of immune response, involved lesion and infection status compared to that of the final visit in phase 2 trial (gx-188e_cin3_p2).

Eligibility criteria:
inclusion criteria: * those who voluntarily signed informed consent form * the subjects who have participated in phase ii trial(gx-188e_cin3_p2) exclusion criteria: * the subjects who didn't receive gx-188e dna vaccine during phase ii trial (gx-188e_cin3_p2) * the subjects, it is difficult to participate in this study continuously * any other ineligible condition at the discretion of the investigator that would be ineligible to participate the study

Keywords: phase 2 follow up cervical intraepithelial neoplasia adult safety efficacy
adherence to computer-assisted maxillofacial reconstructions

Conditions: Maxillofacial Abnormalities; Computer-assisted Surgery; Virtual Surgical Planning

Summary: the study was approved by the local ethics committee and was conducted in compliance with the world medical association declaration of helsinki on medical research. a total of 335 patients who underwent oral and maxillofacial reconstruction were recorded from jan 2014 to jun 2020. reconstruction with computer-assisted surgery ( cas), which included, virtual surgical planning, computer-aided design-computer-aided manufacturing (cad-cam) surgical guides/templates and pre-bent plates on 3d printed models. reasons for tissue defect were oncologic, osteoradionecrosis, trauma and osteoporosis. patients undergoing dental implant placement and orthognathic surgery were excluded. finally, 136 patients were selected and the reasons for partial or abandon surgical plan performance were described and analyzed.

computer-aided design

Eligibility criteria:
inclusion criteria: 1. maxillofacial reconstruction with cas, including virtual surgical planning, cad-cam surgical guides/templates and pre-bent plates on 3d printed models. 2. reasons for reconstruction were oncologic, osteoradionecrosis, trauma and osteoporosis. exclusion criteria: 1. patients undergoing computer-assisted implant surgery were excluded. 2. patients undergoing computer-assisted orthognathic surgery were excluded.

Keywords: computer-assisted surgery treatment adherence and compliance patient-specific modelling
a double-blind study of controlled release oros hydromorphone compared to placebo in patients with chronic osteoarthritis (oa) pain

Conditions: Chronic Pain

Summary: to evaluate the efficacy of oros hydromorphone in reducing moderate to severe chronic pain in patients with osteoarthritis (oa) pain


Eligibility criteria:
inclusion criteria * primary clinic diagnosis of osteoarthritis pain of the hip or of the knee for at least 6 months * patients required daily opioid medication to treat their chronic osteoarthritis pain exclusion criteria * joint replacement of the hip or of the knee that is the primary source of osteoarthritis pain * history drug or alcohol abuse * fibromyalgia * patients who have major depression or anxiety * women who are pregnant or breast feeding

Keywords: oa chronic pain osteoarthritis oa pain osteoarthritis pain pain hip pain knee pain joint pain
effect of diltiazem on coronary artery ectasia

Conditions: Coronary Artery Ectasia

Summary: coronary artery ectasia (cae) has been defined as localized or diffuse dilatation of epicardial coronary arteries more than 1.5 fold of adjacent normal segments. isolated cae constitutes minor portion of the total cae cases, with an incidence of 0.1% to 0.79% in which coronary artery stenosis or severe valvular heart diseases are not present. cae represents not only an anatomical variant but also a clinical constellation of coronary artery disease (cad) like association with myocardial ischemia and acute coronary syndromes. patients with cae without significant coronary narrowing may still present with angina pectoris, positive stress tests, or acute coronary syndromes. impaired epicardial and microvascular perfusion were demonstrated in ectatic coronary arteries. myocardial blush grading (mbg) technique has been utilized in various conditions such as acute myocardial infarction, coronary artery ectasia, syndrome x and idiopathic dilated cardiomyopathy to evaluate myocardial perfusion. there is still no consensus for management of cae. previously improvement of coronary flow has been demonstrated by mibefradil in patients with slow coronary flow. a new trial is needed to explore the effect of calcium channel blockers (ccb) in isolated cae. diltiazem improves myocardial perfusion by blocking calcium channels in coronary arteries. this agent has been widely used in coronary catheter labs to prevent and treat no-reflow. the current study with prospective design was therefore set up to assess whether epicardial flow and tissue level perfusion would be improved by diltiazem in myocardial regions subtended by the ectatic coronary arteries among patients with isolated cae.


Eligibility criteria:
inclusion criteria: patients with isolated coronary artery ectasia at least 1 major epicardial coronary artery exclusion criteria: patients with known allergy to diltiazem acute coronary syndrome left ventricular systolic dysfunction significant valvular heart disease heart failure systolic blood pressure \ i) severe liver or kidney failure significant coronary artery stenosis and patients on treatment with calcium channel blockers were excluded
ultrasound-enhanced delivery of chemotherapy to patients with liver metastasis from breast- and colorectal cancer

Conditions: Colorectal Neoplasms; Breast Neoplasms

Summary: the aim of this clinical trial is to investigate whether the therapeutic response of chemotherapy can be improved by focused ultrasound and microbubbles. patients with liver metastases from breast cancer and colorectal cancer will be included. computer tomography (ct) will be performed as a baseline scan before treatment start. two metastases in each patients liver will be preselected and randomized to either "target lesion" to be treated or "control lesion" to serve as internal control. the patients will receive conventional treatment with chemotherapy according to national guidelines. after intravenous chemotherapy infusion the patients will receive the experimental treatment. the target lesion will get focused ultrasound (fus). simultaneously repeated bolus-doses of microbubbles will be administered intravenously. the investigators will measure the difference in response between fus- treated and -untreated lesions on the post-treatment ct scan.


Eligibility criteria:
inclusion criteria: * histologically verified breast carcinoma or colorectal carcinoma * 2 or multiple liver metastases * considered eligible by a consulting oncologist for first line treatment with chemotherapy in the group of taxanes (patients with breast cancer) or the combination regimen folfiri (patients with colorectal carcinoma) * signed informed consent and expected cooperation of the patients for the treatment and follow up must be obtained and documented according to ich gcp, and national/local regulations exclusion criteria: * known contraindications for ultrasound contrast-enhancement agent sonovue® (bracco) * hematological bleeding status before experimental treatment: hb \< 8g/dl, trc \< 80 x109/l, aptt˃ 45s, inr ˃ 1,5 * considered eligible for surgical removal of liver metastases * pregnancy

Keywords: contrast agent br sonovue ultrasonic therapy neoplasm metastasis liver microbubbles
a prospective, randomized trial of intravenous pulse versus sequential steroid therapy for patients with graves' orbitopathy

Conditions: Graves' Ophthalmopathy

Summary: this study was designed to compare the efficacy and safety of 4.5g iv mp administered in 12 weeks and 4 weeks.


Eligibility criteria:
inclusion criteria: * patients should meet the criteria of either a or b and together with c, d and e to include into the study. a. lid retraction with any one of the following: i) thyroid dysfunction ii) proptosis iii) optic nerve involvement iv) extraocular muscle involvement b. thyroid dysfunction with any one of the following: i) proptosis ii) optic nerve involvement iii) extraocular muscle involvement c. exclude cases with such ophthalmological signs caused by other diseases. d. moderate to severe patients defined by eugogo. e. clinical activity score (cas)≥3/7 f. normal function of heart, liver and kidney. exclusion criteria: * orbital decompression surgery needed immediately * history of chronic recurrent or active infection * history of peptic ulcer * patients with a history of chronic liver disease or liver disorders； alt or ast above 2.5 times upper limit of normal * history of hiv, hepatitis c or hepatitis b positive * cardiovascular or cerebrovascular disease clinically significant * uncontrolled diabetes mellitus * use of corticosteroids during 12 weeks before to inclusion period * pregnant patient or patient who is planning to become pregnant during the study
a study to define the distribution of type of hypertension in asia by blood pressure monitoring at home (asia bp@home)

Conditions: Hypertension

Summary: blood pressure variability (bpv) is being increasingly recognized as an important influence on hypertension outcomes as well as a risk factor for other cardiovascular (cv) events. however, in asia there is a current lack of awareness of bpv and its significance on patient outcomes. furthermore, there is ongoing debate on the role of home blood pressure (hbp) monitoring in managing hypertension patients and uncertainty on how best to integrate it into clinical practice. therefore, we conduct asia bp@home study to assess hbp control status in each asian country and develop an asian consensus and asia-specific treatment for hypertension.

blood pressure variability (bpv) is being increasingly recognized as an important influence on hypertension outcomes as well as a risk factor for other cardiovascular (cv) events. however, in asia there is a current lack of awareness of bpv and its significance on patient outcomes. furthermore, there is ongoing debate on the role of home blood pressure (hbp) monitoring in managing hypertension patients and uncertainty on how best to integrate it into clinical practice. the main purpose of this study is to: * assess hbp control status in each asian country * develop an asian consensus and asia-specific treatment for hypertension * improve the management of hypertension in asia by encouraging patients to monitor hbp

Eligibility criteria:
inclusion criteria: 1. age \>= 20 years 2. subjects with stable medication (\> 3 months) diagnosed as hypertension 3. asian 4. subjects have been thoroughly informed about this registry and signed an informed consent form. exclusion criteria: -

Keywords: blood pressure monitoring, home asia
outpatient biofeedback in addition to home pelvic floor muscle exercises

Conditions: Urinary Incontinence, Stress

Summary: to test whether biofeedback (bf) added to pelvic floor muscle training (pfmt) promotes additional benefits over pfmt alone in the stress urinary incontinence (sui) treatment.

introduction: the aim of this study was to test the hypothesis that outpatient bf added to home pfmt results in increased frequency of home exercises sets per month performed by the patients and objective cure rate after 3 months of supervised training. secondarily, to investigate other subjective and objective clinical parameters in the groups that received or not bf together with pfmt after 3 months of supervised training, and in a longer term of 9-month follow-up. method: 72 incontinent women were randomized to the: bf group (outpatient bf + home pfmt) or pfmt group (outpatient pfmt + home pfmt). assessments: baseline after 3 months of supervised treatment and at 9-month follow-up (after 6 additional months of home pfmt without supervision). primary outcomes: adherence - monthly exercises sets performed (exercise diary) and objective cure of sui (pad test) after 3 months. secondary outcomes: urinary symptoms, muscle function, quality of life, adhesion and subject cure at the two time-points.

Eligibility criteria:
inclusion criteria: * sui and mixed urinary incontinence with predominant symptoms of sui with ≥ 2 g of leakage measured by pad test exclusion criteria: * younger than 18 years old * chronic degenerative diseases * pelvic organ prolapse greater than stage i by pop-q * neurologic or psychiatric diseases * previously undergone pelvic floor re-education programs and/or previous pelvic floor surgeries

Keywords: urinary incontinence, stress pelvic floor exercise patient compliance
comparison of nutritional screening tools in liver cirrhosis patients

Conditions: Malnutrition; Cirrhosis, Liver

Summary: this study compares two nutritional screening questionnaires in cirrhotic patients. all patients will be assessed with both questionnaires, besides a complete nutritional assessment.

disease-related malnutrition is a health problem with high prevalence and associated costs. poor nutritional status has an unfavorable effect on clinical outcomes in terms of complications, post-transplant survival and mortality in relation to the liver, in addition to a decrease in quality of life. the same complications of liver disease, such as hypoalbuminemia or ascites, make it difficult to assess malnutrition in cirrhotic patients. the use of screening tools defines the first step in the prevention and treatment of patients at risk of malnutrition or overt malnutrition. the use of screening tools to detect malnutrition upon admission to hospital improves the identification of malnourished patients by 50-80%, early treatment of patients can reduce hospital stay. it has been observed that nutritional interventions, after assessment of nutritional risk, appear to prevent complications and improve quality of life and survival rate in cirrhotic patients. due to changes in body composition in cirrhotic patients (i.e. ascites), the most common questionnaires for screening for malnutrition (e.g. must, nrs-2002), which use anthropometric measures, have not been validated in cirrhosis and are therefore not considered suitable for malnutrition screening. on the contrary, in recent years two specific nutritional screening tools have been developed for cirrhotic patients, the royal free hospital nutritional prioritizing tool (rfh-npt) and the liver disease undernutrition screening tool (ldust). both questionnaires, however, require further validation against clinical outcomes in cirrhotic patients. this study will use two screening tools for malnutrition risk (rfh-npt and ldust), to compare their validity in detecting malnutrition risk in patients with liver cirrhosis. these tools will be validated by performing a nutritional assessment with the new diagnostic criteria of malnutrition promoted by the global leadership initiative on malnutrition. sarcopenia can occur in malnourished cirrhotic patients, so it will be of interest to know what the possible prevalence may be in the sample of patients studied. the use of the screening questionnaire sarc-f will allow an assessment of the prevalence of risk of sarcopenia. situations such as malnutrition or sarcopenia can have an impact on the patient's health-related quality of life, so this parameter will be assessed using the chronic liver disease questionnaire.

Eligibility criteria:
inclusion criteria: * patients diagnosed with liver cirrhosis. exclusion criteria: * patients with cognitive impairment or major psychiatric disorder. * lack of consent from the patient for inclusion in the study. * any patient who is not suitable based on the researcher's own judgement.

Keywords: malnutrition liver cirrhosis sarcopenia quality of life
pharmacokinetics and safety of evogliptin in subjects with hepatic dysfunction

Conditions: Liver Dysfunction

Summary: the objective of the study is to compare the pharmacokinetics profiles and safety of evogliptin in patients wit hepatic dysfunction versus healthy volunteers after single oral dose of evogliptin

when the future evogliptin be administered to liver dysfunction patients, to investgate whether dose adjustment is necessary.

Eligibility criteria:
inclusion criteria: \ * at least 6 months with chronic liver disease (regardless of cause hepatic dysfunction) * child-pugh a or b \ * subject has the following conditions: age ± 5 years, bmi ± 20%, same sex of each matched hepatic dysfunction subject exclusion criteria: \ * child-pugh c * history of liver transplant \ * history of chronic liver disorders * pregnant or lactating women

Keywords: diabetes mellitus, type ii
mechanisms and reversibility of heart failure associated with diabetes

Conditions: Type 2 Diabetes

Summary: patients with diabetes have a higher incidence of heart failure and worse outcomes than normoglycaemic subjects. basic science research has suggested many mechanisms for this observation including endothelial dysfunction, abnormal calcium handling, fibrosis and activation of the renin-angiotensin-aldosterone system (raas), but clinical data are lacking. in this study the investigators will investigate the relationship between diabetes and heart failure by exploring the correlation between microvascular dysfunction and cardiac magnetic resonance (cmr) markers of left ventricular (lv) hypertrophy, cardiac dysfunction and fibrosis. the investigators also propose to see if this relationship is independent of blood pressure and markers of raas activity. this could have important clinical ramifications in type 2 diabetes by increasing the indications for treatment with raas inhibition or making a case for lower blood pressure targets.


Eligibility criteria:
inclusion criteria: * type 2 diabetes exclusion criteria: * known cardiac or renal disease * uncontrolled hypertension * treatment with acei/arb * treatment with insulin * contraindication to cmr
total dose infusion of ferumoxytol(1020mg) in 15 minutes for iron deficiency anemia

Conditions: Iron Deficiency Anemia

Summary: the aim of the study is to recruit 30 patients who have been referred to auerach hematology oncology assoc. for the treatment of iron defeciency anemia with iv iron (ferumoxytol 1020 mg) administered via infusion pump over 15 minutes. to ascertain acute safety and tolerability of ferumoxytol during immediate post dosing observation period. assess additional safety profile and laboratory assessment at follow up visit and interim telephone follow up.

ferumoxytol, a modified iron dextran, which allows the rapid administration of iv iron without free iron release, was approved for a 510 mg injection to be administered in not less than 17 seconds. although this represents a felicitous treatment for patients who come frequently, such as dialysis and chemotherapy patients, multiple publications suggest that full dose replacement is usually at the 1000 mg level. no studies extant are available with this dosing schedule for ferumoxytol. in this trial, iron deficient patients with hemoglobin levels of \<11.0 grams per deciliter will be consented to received 1020 mg (two 510 mg vials) of ferumoxytol in 15 minutes. vital signs will be performed at 5, 10, 15, 30 and 60 minutes. followup phone calls for any clinical adverse events will be made at 24-48 hours and one week after administration. at four weeks follow-up hematologic and serologic (iron parameters) will be made along with a physician visit.

Eligibility criteria:
inclusion criteria: * iron deficiency anemia intolerant of or failure to respond to oral iron or condition where oral iron is known to be ineffective or harmful. * subject must be able to be contacted at 24-48 hours after dose and come for followup at four weeks. * subject must be capable of understanding informed consent * no other form of iron may be taken within four weeks of consent or for four weeks after treatment exclusion criteria: * history of hypersensitivity to ferumoxytol. * imminent dialysis. * anemia due to other etiology. * parenteral iron within 4 weeks of consent. * pregnancy. * erythropoiesis stimulating agent within 30 days of consent. * other illness that would interfere with participation or understanding of trial. * major surgery planned within four weeks of consent.

Keywords: intravenous iron ferumoxytol iron deficiency anemia treatment of iron deficiency intolerance of or ineffectiveness of oral iron
register of cardiovascular complications among people living with hiv

Conditions: HIV; Cardiovascular Diseases

Summary: the register of cardiovascular complications among people living with hiv (recovih) is a single hospital registry of adults living with hiv, with one or more other cardiovascular risk factor, who undergo cardiac examination at the cardiac center of the saint antoine hospital. recovih is an observational and prospective, monocentric (institutional) registry, with anonymized cardiac, biochemical and associated data collection.

this hospital-based cardiac registry maintains data from all non-opposing adults living with hiv, with one or more other cardiac risk factor, who undergo complete cardiac examination at the cardiac center at the saint antoine hospital. recovih registry: the focus of this hospital-based cardiac registry is on clinical care, particularly on risk stratification, of adults living with hiv. the register was designed to evaluate echocardiographic, coronarographic, and blood pressure abnormalities among people living with hiv (plwh). the primary goal of this single hospital registry is the improvement of patient care, especially risk stratification, by medical audit-type evaluation of cardiac tests and outcomes. recovih data and research: cardiac, biochemical, and associated data collected by this single hospital registry are also used as a source of data for some types of research. this research is particularly timely and relevant as currently little scientific evidence exists describing optimal cardiac care, and risk stratification, for adults living with hiv. the primary goal of research using recovih data is the quantification of morphologic and functional cardiac abnormalities and blood pressure abnormalities. the secondary research goal is the identification and description of key aspects of the relationship between hiv, cardiovascular diseases (cvd), and cvd risk factors. exploration of this complex relationship may help identify and describe the impact of chronic hiv related infection and inflammation, antiretroviral use (arv), and individual health risks on the development and course of morphologic and functional cardiac abnormalities and blood pressure levels.

Eligibility criteria:
inclusion criteria: * 18 years of age or older * known hiv-1 seropositivity for minimum of six months (confirmed by elisa and western blot) * underwent complete cardiac examination (echocardiography, ischemia test, ambulatory blood pressure monitoring) between 2005 and 2010 at the cardiac center in the saint antoine university hospital in paris, france * presenting a minimum of two cardiovascular risk factors (hiv and a minimum of one other) according to the affssaps 2005 and morlat report 2013. * willing and able to give informed consent to participate in the study exclusion criteria : * refusal to give or sign informed consent * not associated with a social security regime (no health insurance)

Keywords: functional cardiac abnormality morphologic cardiac abnormality blood pressure abnormality