Kornimate/medical-research-clean huggingface dataset:
transcatheter aortic valve replacement for pure severe aortic valve regurgitation

Conditions: Aortic Valve Regurgitation

Summary: the purpose of this multicenter, prospective and observational registry is to evaluate the safety and efficacy of tavr for treatment of pure severe aortic valve regurgitation. baseline characteristics, procedural and clinical data will be collected

pure native aortic valve regurgitation (navr) is a multifactorial valvular disease, with a prevalence of moderate or severe navr ranging from 0.5% to 2.7%. patients with severe navr have a poor prognosis, conservative management has a 1-year mortality rate of more than 20%. currently, surgical aortic valve replacement (savr) is the recommended treatment strategy for patients with navr. however, data showed that only 20% of patients with severe navr and left-ventricular ejection fraction (lvef) of 30-50% undergo savr, while only 3% of those with an lvef below 30% receive savr. therefore, a less invasive surgical alternative therapy is needed for high surgical-risk patients from savr. transcatheter aortic valve replacement (tavr) is now considered the first-choice treatment for elderly patients with aortic stenosis, regardless of surgical risk. recently, it has also been used to treat patients with navr in an "off-label" setting. the latest european guidelines suggest that tavr may be considered in experienced centers for selected patients with ar who are not eligible for savr. however, the role of tavr in patients with severe navr is still debatable. current studies on this topic are limited by their retrospective design and small sample sizes. dedicated devices for aortic regurgitation, such as the jenavalve, have shown promising results in terms of technical success and short-term outcomes. however, tavr for patients with navr using on-label devices has a relatively high rate of pacemaker implantation. additionally, the dedicated device was designed only for tricuspid valve anatomy, making tavr with off-label devices the main invasive strategy for high-surgical risk patients with bicuspid valves. it's worth noting that the dedicated device is not yet commercially available worldwide. therefore, further investigation into tavr using off-label devices for navr patients, including those with bicuspid and tricuspid valves, is necessary. the objective of this study was to evaluate the safety and efficacy of tavr in patients with navr in a real-world setting.

Eligibility criteria:
inclusion criteria: * 1. patients diagnosed with severe aortic valve regurgitation undergo evaluation by the heart team and are eligible for tavr therapy. * 2. patients who understand the purpose of this study, agree to participate in the trial and sign the informed consent form exclusion criteria: * 1. patients who cannot provide informed consent * 2. patients who are treated with tavr for aortic stenosis * 3. patients who are participating in other clinical trials

Keywords: aortic valve regurgitation tavr real-word
comparison of metformin and pioglitazone effects on adipokines concentrations in newly diagnosed type 2 diabetes patients

Conditions: Type 2 Diabetes Mellitus

Summary: oral hypoglycemic agents encompass the mainstay of treatment in the majority of patients with type 2 diabetes. thiazolidinediones (such a pioglitazone) and biguanides (such as metformin), are two major groups of hypoglycemic medications that while function via different pathways, are both effective in short- and long-term glycemic control . these medications diminish or at least delay long term micro- and macrovascular complications associated with prolonged insulin resistance although at different rates. the mechanisms by which this aim is achieved, nevertheless, remains largely unclear. with adipokines playing a key role in development of both insulin resistance and atherosclerosis, oral hypoglycemic agents might regulate these substances by direct and indirect routes.


Eligibility criteria:
inclusion criteria: * newly diagnosed type 2 diabetes patients based on american diabetes association criteria (2011) for diagnosis of diabetes exclusion criteria: * previous intake of oral hypoglycemic agents for treatment of diabetes or other hyperglycemia associated conditions * intake of glucocorticoids in the past one year * major illnesses of heart, lung, kidney, and liver.

Keywords: adipokines leptin chemerin omentin metformin type 2 diabetes mellitus
cyclic deep brain stimulation in essential tremor

Conditions: Essential Tremor

Summary: the aim of the study is to prove the efficacy and safety of cyclical deep brain stimulation (dbs) in patients with essential tremor, and demonstrate non-inferiority of cyclical dbs on tremor control when compared to continuous stimulation.

this study is a prospective, randomized, double-blind cross-over trials. patients will be randomized into two groups in a cross-over fashion to have either continuous or cyclical stimulation for a total of three months. following this, the trial will be unblinded and open-label follow up will continue for another nine months. device use as per standard practice continues after the end of the trial. if the hypothesis is proven correct, this will provide proof of concept that cyclical stimulation for the treatment of essential tremor results in improved battery life, reduced number of operations for battery changes, reduction in stimulation side-effects and enhancing quality of life.

Eligibility criteria:
inclusion criteria: 1. participant is at least 18 years of age 2. participant has confirmed diagnosis of medically-refractory essential tremor 3. participant meets criteria for implantation of dbs system 4. participant understands the study requirements and treatments procedures and provides informed consent before any study-specific tests or procedures are performed exclusion criteria: 1. participant meets any contraindications for implantation of dbs system 2. participant is undergoing or has had previous thalamic stimulation either in a research trial or with a permanent implant 3. participant is unwilling or unable to comply with all study required follow-up evaluations

Keywords: essential tremor deep brain stimulation
formative research - developing a family-based obesity prevention intervention in the canadian context

Conditions: Obesity

Summary: this formative research shows that parents of preschool-aged children are enthusiastic about learning general parenting skills, such as discipline strategies, but that they are less interested in information on child nutrition and physical activity needs. to capitalize on this enthusiasm, dr. haines developed parents and tots together (ptt), an intervention that embeds strategies to improve children's nutrition and activity behaviours within an existing general skills parenting program. results from the investigators feasibility trial with 16 boston-area parents show that ptt is feasible for implementation and is extremely well-received by parents. results are also encouraging with respect to changing parent feeding behaviours and children's nutrition and activity behaviours. what is not known is whether this program is feasible and contextually appropriate for canadian families. thus, the next step in this research program, and the overall goal of this study, is to assess parents and tots together (ptt), a family-based intervention to prevent obesity among children 3 to 5 years of age, within the canadian context. to achieve this goal, the investigators will conduct a pilot trial of the ptt program with 60 families recruited through ontario early years centres (oeyc). the investigators will randomize 30 families to the 3-month ptt intervention and 30 to a control condition. the investigators primary objective is to implement and test the feasibility and acceptability of ptt among families with preschool children so appropriate revisions can be made to adapt it to a canadian context. the investigators secondary objective is to compare the following outcomes among intervention versus control participants: 1. parent weight-related behaviours (i.e., parent physical activity, intake of sugar-sweetened beverages, and television/video viewing, as well as responsiveness to child satiety cues). 2. general parenting behaviours (i.e., use of positive discipline strategies). 3. child weight-related behaviours (i.e., sleep duration, physical activity, intake of sugar-sweetened beverages, television/video viewing). 4. nutritional risk score based on a screening tool for preschoolers. 5. child change in body mass index (bmi), standardized to age and gender.


Eligibility criteria:
inclusion criteria: * we will consider eligible all parents who have a child age 2-5 years. exclusion criteria: * we will exclude: 1) any families who plan to move out of the area during the 9-month study period; and 2) children with severe health conditions that would prohibit them from participating in study activities.
prediction of everolimus-induced interstitial lung disease

Conditions: Breast Neoplasms

Summary: the investigators will determine which factors are predictive for the development and severity of everolimus-induced interstitial lung disease and will develop a prediction model based on these risk factors.

in this study the investigators will prospectively investigate pulmonary adverse events during treatment with everolimus. the investigators will distinguish the following everolimus-induced pulmonary adverse events: pulmonary infection, everolimus-induced airway disease and everolimus-induced interstitial lung disease (ild). the investigators will investigate the predictive value of pneumoproteins, everolimus exposure, pulmonary function tests, four distinct radiological patterns, baseline patient characteristics and the development of skin toxicity or oral mucositis for the development and severity of everolimus-induced ild.

Eligibility criteria:
inclusion criteria: * adult women with metastatic or locally advanced breast cancer not amenable to curative treatment by surgery or radiotherapy. * histological or cytological confirmation of estrogen-receptor positive (er+) breast cancer * postmenopausal women * radiological or clinical evidence of recurrence or progression on last systemic therapy prior to enrollment * resistance to treatment with a non-steroidal aromatase inhibitor * serum platelets ≥ 100x10e9/l * everolimus dose adjustment is recommended for patients with hepatic impairment (child-pugh a/b/c) * performance status ecog 0 - 2 (karnofsky index: 60 - 100) exclusion criteria: * patients with a her2-overexpressing tumor * known hypersensitivity to mtor inhibitors, e.g. sirolimus (rapamycin). * patients with a known history of hiv seropositivity or hepatitis b or c * uncontrolled diabetes mellitus * impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of study drugs (e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome) * patients being treated with drugs recognized as being strong inhibitors or inducers of the isoenzyme cyp3a

Keywords: breast neoplasms everolimus interstitial lung disease pneumonitis
pandemic triage score in patients with known or suspected severe acute respiratory syndrome (sars) coronavirus (cov) 2 infection

Conditions: SARS-CoV-2 Acute Respiratory Disease; Covid19

Summary: during this pandemic period, the goal of the health care system is to optimize the use of intensive care services for patients infected with sars-cov-2, given the frequency of complications that can lead to high mortality. when patients with suspected or confirmed covid-19 are admitted to hospital, whether or not they are symptomatic, there is currently no method to predict who will progress to complications requiring the use of intensive measures in 24-48 hours.

the body undergoes a systemic adaptation response to severe illness. elevated cortisol and systemic inflammation are two key responses. along with hypotension, this triad can lead to end-organ failure and death in critical illness. in critical illness, serum cortisol is dissociated from its tissular activity. we have developed a formula that calculates tissular action of cortisol called the cortisol index. it correlates in chronic ambulatory illness, and acute illness such as myocardial infarction (manuscript pending). elevated neutrophil to lymphocyte ration (nlr) is a marker of systemic inflammation and predictor of mortality on admission to the emergency department. we have confirmed this in a retrospective and prospective study (manuscript pending, data available upon request). the purpose of this study is to evaluate a triage score (stc-19) based on patients' biological state at the time of diagnosis, to objectively determine which patients are most likely to require intensive medical services within 24-48 hours of presentation of the emergency department.

Eligibility criteria:
inclusion criteria: * patient with clinical signs of cov-2-sars infection * complete blood count test and systolic blood pressure available at the time of diagnosis * informed of the study. exclusion criteria: * women beyond the 1st trimester of pregnancy * persons under-the-age-of or legally-denied medical decision-making capacity by a judicial or administrative decision, * persons of full age who are subject to a legal protection measure, * persons unable to consent, * persons who are not members of or beneficiaries of a social welfare program administered by the republic of france * patient's refusal to participate in the study.
shoulder fracture interview study

Conditions: Proximal Humerus Fracture (Shoulder Fracture)

Summary: shoulder fractures are painful injuries and are the third most common fracture in adults. more and more people are having these injuries each year. problems such as pain, swelling and lack of movement and strength can last for many months and some people never get back to their previous levels of ability with the injured arm. information that is given to people following this injury can be very difficult to understand. to improve the information that is given to people following a shoulder fracture, it is necessary to understand what it is like to live with a shoulder fracture and what is important to people recovering from this injury. this study will interview people who have had a shoulder fracture at around one month and around 4-6 months after their injury. these people will be identified from a physiotherapy waiting list. the interviews will explore people's views on their injury, their recovery and how their needs and priorities change over time.

previous studies have shown that the written information provided to people after a shoulder fracture is varied and complex, and is written by experts without any apparent input from patients. appropriate information provided at the right time may lead to improved outcomes for patients after a shoulder fracture, which may mean improvements in pain levels and function. appropriate information may help to increase patients empowerment, which is their ability to use information provided to enable them to make informed decisions regarding their health care and to take a proactive approach in their recovery following an injury such as a shoulder fracture. to ensure that information is accessible and appropriate, it is necessary to understand the experience of living with a shoulder fracture and what is important to those who have sustained this injury. this study intends to hear the views of people who have had a shoulder fracture both early on (around one month after injury) and later in their recovery (4-6 months after injury). it aims to explore the differing needs and experiences of people at different time points after injury and how their views on recovery change over time. this may lead to further work on information provision, which may help improve outcomes by providing the right (accessible) information to the right people in the right way at the right time.

Eligibility criteria:
inclusion criteria: - aged 18 years or over have sustained a proximal humerus fracture and been referred from east lancashire hospitals nhs trust fracture clinic to outpatient physiotherapy able and willing to provide written informed consent, as deemed by the chief investigator exclusion criteria: - does not meet inclusion criteria
effect of low-dose pegintron on alt normalization in japanese patients with chronic hepatitis c (study p04508)(completed)

Conditions: Hepatitis C, Chronic; Hepatitis C

Summary: in patients with chronic hepatitis c, the ultimate treatment goal is the improvement of liver histology and inhibition of progression to liver cirrhosis and hepatocellular carcinoma (hcc). these effects are reported to be correlated with sustained alt improvement. therefore, the aim of this study is to determine if a low-dose (0.25, 0.5, or 1.0 mcg/kg sc qw) pegintron monotherapy administered for 12 weeks will result in alt normalization in japanese patients with chronic hepatitis c.


Eligibility criteria:
inclusion criteria: patients with chronic hepatitis c patients (chc) who met all of the following criteria: * at least 20 years of age and willing to sign an informed consent * patients who can practice contraception * patients who are classified either as relapsers or non-responders. * weight between 45 and 100 kg * patients willing to be hospitalized for 3 days after the start of treatment * patients with positive hcv-rna * serum alt level: over 60 iu/l, equal to or less than 150 iu/l * neutrophil count: equal to or more than 1,200 /mm\^3 * platelet count：equal to or more than 100,000/mm\^3 exclusion criteria: * patients with conditions which would interfere with the evaluation of therapeutic efficacy of the study drug and patients for whom assurance of safety is a concern were excluded from the study.

Keywords: alanine transaminase
effects of relaxation training and stimulus control in chronic insomnia patients

Conditions: Chronic Insomnia

Summary: the study aims to validate the effect of relaxation training and stimulus control on reducing hyperarousal states and improving maladaptive sleep behaviors.

relaxation training typically includes techniques such as breathing exercises, muscle relaxation, and mindfulness meditation to help patients reduce levels of physical and psychological tension, promote relaxation, and create favorable conditions for sleep onset. stimulus control aims to break the negative association between the bed and insomnia, and rebuild a positive association between the bed and sleep.

Eligibility criteria:
inclusion criteria: 1. meet the diagnostic criteria for insomnia disorder according to dsm-5. 2. pittsburgh sleep quality index (psqi) total score \> 5. 3. age ≥ 18 years, with at least a middle school education level. 4. anxiety symptoms meeting hama ≥ 14. 5. "self-developed 8-item questionnaire on maladaptive sleep behaviors" used to assess "maladaptive sleep behaviors." 6. voluntarily participate in this study and sign an informed consent form. exclusion criteria: 1. individuals with severe physical illnesses or severe mental disorders, at risk of suicide. 2. clinically diagnosed or suspected sleep-related breathing disorders, restless leg syndrome, and sleep-wake rhythm disorders, as well as shift workers. 3. pregnant or lactating women. 4. currently undergoing any psychological therapy.

Keywords: chronic insomnia sleep restriction stimulus control sleep hygiene education
a prospective, non-randomized pivotal clinical investigation to demonstrate the safety and performance of the truecross single-use microcatheter

Conditions: Coronary Artery Disease Obliterative; Chronic Total Occlusion (CTO)

Summary: the trial is a pivotal clinical investigation, which is a prospective, non-randomized pivotal clinical investigation to demonstrate the safety and performance of the truecross single-use microcatheter.

the objective of this clinical investigation is to evaluate the performance and safety of the truecross single-use microcatheter in patients requiring a pci procedure as well as the related clinical benefits. the study will include 59 subjects suffering from coronary artery disease requiring a percutaneous coronary intervention. enrollment duration will be 4 months or so without follow-up. it is a single-arm trial.in the uneventual case of a potential dropout (serious protocol deviation or procedure interruption unrelated to the catheter), subjects will be replaced to reach 59 evaluable subjects for the per protocol population.

Eligibility criteria:
inclusion criteria: i. subjects who are \>25 years of age. ii. subjects who are able/willing to provide a written informed consent prior to participating in the clinical investigation. iii. the subject is male or, if female, is either not of childbearing potential or must use effective contraception during participation in this clinical investigation. iv. subject suffering from coronary artery disease requiring percutaneous coronary angiography and/or intervention. v. lesions classified as ctos, meaning, timi 0 flow within the occluded segment and angiographic or clinical evidence or high likelihood of an occlusion duration \> 3 months vi. reference vessel diameter ≥2 mm. exclusion criteria: i. coronary angiography and/or intervention contraindications. ii. subjects with severe arrhythmia. iii. subjects with severe systemic infection. iv. subjects with severe coagulation disorder. v. subjects with severe heart failure, unstable decompensated heart failure, congestive heart failure, or dyspnea who are unable to lie supine on the examination table for angiography. vi. subjects with prior coronary artery spams or prior heart valve replacement. vii. currently participating in an investigational drug or another device clinical investigation that has not completed the primary endpoint or that clinically interferes with the current clinical investigation endpoints.

Keywords: microcatheter, cto, coronary artery disease, pci
the water-blueberry study

Conditions: Cardiovascular Disease

Summary: we will study the effect of supplementation of 1 l blueberry juice to participants with at least one elevated cardiovasculat risk factor.

participants with at leat one elevated cardiovacsular risk factor, as defined as systolic blood pressure between 140 and 165 mmhg, diastolic blood pressure between 90 and 105 mmhg, low density lipoprotein (ldl) cholesterol ≥3.4 mmol/l, total/high density lipoprotein (hdl) cholesterol ratio \>4 or smoking a minimum of 3 cigarettes daily. subjects were randomized to two groups, where the blueberry group were supplemented with 1 l blueberry juice per day for four weeks. the control group consumed an equal amount of water. clinical markers, as well as biomarkers of antioxidant status, oxidative stress status and inflammation were measured in blood samples before amd after the intervention period.

Eligibility criteria:
inclusion criteria: * 30-70 years for men and 45-70 years or at least 12 months postmenopausal for women * at least one elevated cardiovascular risk factor, defined as systolic blood pressure between 140 and 165 mmhg, diastolic blood pressure between 90 and 105 mmhg, low density lipoprotein (ldl) cholesterol ≥3.4 mmol/l, total/high density lipoprotein (hdl) cholesterol ratio \>4 or smoking a minimum of 3 cigarettes daily. exclusion criteria: * clinically recognized chronic diseases as impaired renal function, diabetes mellitus, cardiovascular disease, liver or gastrointestinal disease or cancer within the last 5 years * use of lipid-lowering drugs, diuretics or hormone replacement therapy for women * subjects with a body-mass index ≥31 * with a alcohol consumption above 3 units/day for men and 1 unit/day for women * blood donation within the last six months

Keywords: cardiovascular disease blueberruy antioxidants oxidative stress inflammation