Kornimate/medical-research-clean huggingface dataset:
danish pragmatic randomized trial to evaluate the effect of heartlogic-guided management on heart failure outcomes

Conditions: Heart Failure

Summary: the purpose of the study is to assess the impact of heartlogic-guided management on clinical outcomes among patients implanted with an eligible cardiac device.

the study is a pragmatic, registry-based, randomized controlled trial. eligible patients in denmark will be randomized 1:1 to either heartlogic-guided management or usual care. during the trial, patients in the heartlogic arm will be contacted by the study team in case of any heartlogic alerts for evaluation and treatment decisions. there will be no mandatory in-person visits scheduled in the trial. heartlogic alerts will be managed according to a prespecified management guide. trial data besides device-related data will be retrieved from the danish nationwide health registries including baseline information and endpoint data. the control group will receive usual hf care in the danish health system without the involvement of the study team. the study will comply with the standards of the consort statement and the principles of the declaration of helsinki.

Eligibility criteria:
inclusion criteria: 1. implanted with a crt-d or icd device that has heartlogic capability and ability to change heartlogic enablement per randomization 2. age ≥18 years 3. compliant with remote monitoring and not listed in the latitude™ remote monitoring system as "not monitored" exclusion criteria: there are no specific exclusion criteria for the trial.

Keywords: pragmatic heart disease icd crt-d pacemaker registry heartlogic
a phase 2 study of opc-262 in patients with type 2 diabetes

Conditions: Diabetes, Type 2

Summary: a multicenter, randomized, double-blind, placebo-controlled, group-comparison study to investigate the safety and efficacy of opc-262 in patients with type 2 diabetes


Eligibility criteria:
inclusion criteria: * type 2 diabetes patients with hba1c above 7.0% and below 10% * patients who are capable of giving informed consent * patients who are able to take contraceptive measures to avoid pregnancy of the patient or the patient's partner exclusion criteria: * patients with type1 diabetes mellitus, patients with diabetes mellitus or impaired glucose tolerance (igt) due to other specified mechanism or diseases, and patients with gestational diabetes mellitus * patients with a medical history of diabetes coma * patients with poorly-controlled hypertension * patients with heart failure * patients with a complication of active hepatitis or hepatic cirrhosis * patients undergoing treatment of glomeruler diseases other than diabetic nephropathy * patients with a history or complication of malignant tumor
effectiveness of an eight week online mediterranean based diet

Conditions: Obesity

Summary: this research is examining whether an 8-week online nutritional programming based on a mediterranean diet can achieve meaningful increase intake of a mediterranean based diet and improvements in measures of body weight and laboratory measures of oxidative stress, a risk marker for cardiovascular disease. this study will also examine whether weekly short support and communication from a medical assistant (ma) in a primary care setting in addition to the online program will result in better program adherence and have a positive impact on health.

eligible participants will be identified by primary care providers or their staff at clinical outpatient site(s). study is 3-arm randomized control trial where participants will be randomized to 1) control group (ctl)-will not receive access to online program nor intervention for first 12 weeks; 2) gffy-1-will receive access to online program without ma intervention 3) gffy-2-will receive access to online program and ma intervention with weekly phone call. the core of the intervention is an 8-week mediterranean diet and behavioral online program called "go! foods for you (gffy)" which is offered on the cleveland clinic's 360.5.com website. the research will last for 24 weeks. questionnaire data and biometric measurements will be collected at pre and post intervention (0-8 weeks) and at followup (12 and 24 weeks). regardless of randomization, participants will be asked to provide their weight every week and an activity log at the end of each week of the program. a urine sample to measure f2-isoprostane will be collected at week 0 and 12 for gffy-2 and ctl groups. a preparatory phase requiring the involvement of mas to provide weekly support to participants is necessary to test process and communication with mas. enrollment of 10-20 volunteers for the preparatory phase is desired. data collected during this phase will not be part of study analysis. to test data collection process, we may ask a few participants to complete baseline questionnaire only.

Eligibility criteria:
inclusion criteria: * body mass index (bmi) of 25 or greater. * age 18 to 70 years old. * patient of a participating internal medicine or family medicine primary care provider at a cleveland clinic family health center. * registered on the cleveland clinic's electric medical records, my chart. exclusion criteria: * women who are pregnant or planning to be pregnant in the next 6 months. * no easy internet and email access at place of residence. * no access to a scale at place of residence for weekly weight measurement. * sudden unintentional weight loss or weight gain in the past 3 months due to medical illness * currently involved in a weight loss program * unwilling to be in the wait-list control group where participant will not have access to the program for 3 months * unwilling to log onto the internet on a regular basis for the duration of the study (3-4 months)

Keywords: bmi weight loss nutrition diet mediterranean diet online program web-based program oxidative stress f2 isoprostanes
effects of walking and respiratory muscle training on pulmonary function and functional exercise capacity in pd

Conditions: Parkinson Disease

Summary: the purpose of this randomised and controlled study is to investigate the effects of walking training combined with respiratory muscle training on pulmonary function, respiratory muscle strength, and functional exercise capacity.

although respiratory dysfunction has been recognized as a cause of morbidity and mortality in patients with parkinson's disease (pd), most of the patients were not aware of their respiratory problems due to restriction in their activities. respiratory dysfunction in patients with pd has not been well characterized. however, there are many studies showing restrictive or obstructive type respiratory disorders and decreased respiratory muscle strength in the literature. ineffective cough due to decreased respiratory muscle strength may cause to secretion retention and secondary infections in pd patients who have severe symptoms. therefore, the assessment and rehabilitation of these respiratory problems is important in pd patients treatment. there are studies in the literature showing that respiratory muscle training is effective in pd. walking difficulty is seen as a common problem in pd. typically, walking is slow despite adequate levodopa therapy. it is known that exercise capacity may be affected by respiratory impairment, walking difficulties and personal exercise habits in patients with pd. respiratory and walking problems lead to limitation of physical activity in pd, which leads to a decrease in exercise capacity. in a recently published article reported that walking is a good example of exercise. although walking training is important for pd patients, there is no studies what happens to pulmonary function and functional exercise capacity when walking training is combined with respiratory muscle training in patients with parkinson's disease. therefore, this study planned to investigate the effects of walking and respiratory muscle training on pulmonary function and functional exercise capacity in pd.

Eligibility criteria:
inclusion criteria: * have been diagnosed according with pd to the clinical criteria of the united kingdom parkinson's disease society brain bank diagnostic criteria * being in phase 1-3 according to the hoehn-yahr (h-y) scale, * being under anti-parkinson's treatment, and * being in the "on"period. exclusion criteria: * • dyskinesia, (which may be obstacles to the tests), * chronic respiratory disease, * dementia, * co-operation difficulty, * cognitive impairment (mini-mental test score \<24), and * other neurologic, cardiovascular or musculoskeletal problems that impede walking.

Keywords: walking training respiratory muscle training pulmonary function functional capacity
behavioral approaches to reducing diabetes distress and improving glycemic control

Conditions: Type 1 Diabetes; Diabetes Distress

Summary: this study is comparing three programs to reduce diabetes distress (the worries and concerns that people with diabetes may experience as they struggle to keep blood glucose levels in range) in adults with type 1 diabetes. about a third of participants will take part in the tunedin program, about a third will take part in the fixit program, and about a third in the streamline program.

diabetes distress (dd) is the personal, often hidden side of diabetes: it reflects the unique emotional burdens and strains that individuals with diabetes may experience as they struggle to keep blood glucose levels within range. when high, dd can have a major, negative impact on disease management and glycemic control. high dd is characterized by frustration, feeling overwhelmed, and feeling hopeless and discouraged by the unceasing demands of diabetes. dd is also linked to an individual's beliefs, expectations, current life situation, and personal and social resources. the proposed study is a three-arm, 12-month randomized comparison trial to test the added value of a dd-targeted (tunedin) intervention vs. a unified dd and management intervention (fixit), relative to a traditional, educational/behavioral-management intervention (streamline). each of the three programs (arms) will follow a separate, standardized protocol. all participants will receive three months of intervention with nine months of follow-up.

Eligibility criteria:
inclusion criteria: * adult patients with type 1 diabetes (confirmed by clinical history and/or anti-glutamic acid decarboxylase\] antibody testing) on intensive insulin treatment; * diagnosis of type 1 diabetes for at least 12 months that occurred at or below age 40; * have a recent hba1c of 7.5% or higher; * not have started to use any new (to the participant) diabetes device (such as an insulin pump or continuous glucose monitor) in the past 6 months; * internet access through a computer or smart phone; * ability to speak/read english. exclusion criteria: * no documented psychosis, blindness, dementia, active dialysis, substance abuse, amputations, or severe functional deficits, or recent major surgery or hospitalization in the past year.
the effect and safety of plum-blossom needle for tourette syndrome

Conditions: Tourette Syndrome

Summary: to evaluate the effect and safety of plum-blossom needle for tourette syndrome.

this is a randomized, controlled trial with two parallel arms. a total of 60 patients will be randomly allocated into the plum-blossom needle group (n=30) and the habit reversal training (hrt) group (n=30). 12-week treatment will be given to all patients of each group, follow-up will be made at the 12th week after treatment. the primary outcome measure will be the mean change from baseline in the total tic score on the yale global tic severity scale (ygtss) at the 12th week. secondary outcome measures will include the mean changes in score of ygtss, ts clinical global impression scale (cgi) and the children and adolescents' quality of life scale from baseline at other time. safety will also be evaluated.

Eligibility criteria:
inclusion criteria: 1. meeting the diagnostic criteria of the diagnostic and statistical manual of mental disorders of the american psychiatric association (dsm-iv) for ts. 2. aged 7 to 18. 3. agree to participate in the trial and sign written informed consent by both guardians and subjects. exclusion criteria: 1. having severe problem in heart, liver or kidney, or having hyperthyroidism. 2. after evaluated by psychiatrists based on the kiddie-sads-present and lifetime version, those who are associated with co-morbid conditions such as mental retardation, pervasive developmental disorder, schizophrenia, mania episode, bipolar disorder, anxiety and depression and specific learning disorder will be excluded. 3. tics symptoms caused by some drugs. 4. currently receiving any other form of pharmacological or non-pharmacological treatment for their tourette syndrome. 5. patients with a history of psychotropic substance or alcohol use during the 3 months preceding screening. 6. patients with a history of nonresponsiveness to hrt or participating in another clinical trial.

Keywords: acupuncture plum-blossom needle tourette syndrome randomized controlled trial
lymphedema surveillance study

Conditions: Breast Cancer; Lymphedema

Summary: this study is being done to find out how many women develop lymphedema after an axillary lymph node dissection. the investigators also want to look for reasons why some women get lymphedema and others don't. specifically, the investigators want to do tests on the breast tissue that is removed at the time of surgery to see if they can identify inflammation in the breast tissue, which may increase a woman's risk for lymphedema. the investigators will also ask the patient to answer questions to see how much their quality of life is affected by lymphedema, and whether this study can help women by detecting lymphedema earlier.


Eligibility criteria:
inclusion criteria: * female breast cancer patients over the age of 18 * patients consenting for unilateral axillary lymph node dissection (alnd) (prior history of sentinel lymph node biopsy allowed if \<6 months from consent) * patients consenting for unilateral sentinel lymph node biopsy (slnb) and possible alnd are eligible for initial entry into the study, but will become ineligible if alnd is not performed * initially consented patients, treated with slnb alone, who were originally considered ineligible to continue on study, will be approached for re-enrollment * patients who self-identify as black or white consenting for unilateral alnd or possible alnd will be approached for enrollment onto translational study (cohort 3) exclusion criteria: * male breast cancer patients * patients consenting for bilateral axillary surgery * patients with prior history of surgical excision of one or more axillary lymph nodes or slnb, performed \>6 months from date of consent * patients with prior history of alnd * patients with no breast surgery performed at msk

Keywords: lymphedema surveillance program axillary lymph node dissection 16-220
prevention of events with angiotensin-converting enzyme inhibitor therapy (peace)

Conditions: Cardiovascular Diseases; Coronary Disease; Heart Diseases; Myocardial Infarction; Myocardial Ischemia

Summary: to determine whether the addition of angiotensin converting enzyme (ace) inhibitor to standard therapy in patients with known coronary artery disease and preserved left ventricular function will prevent cardiovascular mortality and reduce the risk of myocardial infarction.

background: individuals with coronary artery disease are at heightened risk for major cardiovascular events. with current advances, a larger segment of our population is manifesting coronary artery disease at a more advanced age. the majority of these individuals have preserved left ventricular function. prior studies with converting enzyme inhibitor (cei) therapy in patients with depressed ejection fraction have demonstrated that their long-term administration leads to improved survival and reduced risk of myocardial infarction over and above conventional therapy. there is sufficient rationale and experience to indicate that these benefits will apply to the larger group of individuals with coronary artery disease and preserved left ventricular function and therefore have even broader public health implications. a definitive trial is needed to assess the capacity of cei therapy to prevent mortality and reduce the risk of myocardial infarction in patients with coronary disease and preserved left ventricular function. the initiative was proposed by the former clinical trials branch staff and given concept clearance at the may 1994 national heart, lung, and blood advisory council. the request for proposals was released in october 1994. design narrative: a multicenter, randomized clinical trial. there are approximately 180 centers in the united states, canada, puerto rico, and italy. patients are randomly assigned to treatment groups in which the addition of the angiotensin-converting enzyme (ace) inhibitor trandolapril is compared to standard therapy. the primary endpoint includes a reduction in the incidence of cardiovascular death, nonfatal myocardial infarction, or the need for coronary revascularization (ptca or cabg) in coronary artery disease patients with left ventricular ejection fraction of 40 percent or more. secondary endpoints include the incidence of hospitalization for the management of either unstable angina, congestive heart failure, stroke, or cardiac arrhythmia. recruitment started in november 1996 and ended in june 2000 with a minimum follow-up of five years.

Eligibility criteria:
men and women patients at least 50 years of age with coronary heart disease documented by angiography and a left ventricular ejection fraction of 40 percent or more.
preoperative serum albumin and duration of intraoperative hypotension on postoperative acute kidney injury

Conditions: Acute Kidney Injury

Summary: acute kidney injury is one of major adverse postoperative complications. research about postoperative acute kidney injury conclude that low preoperative albumin and intraoperative hypotension is associated to postoperative acute kidney injury. however, due to ethic issue and nonlinear realtionship between these factors and postoperative acute kidney injury, the exact threshold of these two risk factors were not be able to identified. the research tried to locate the exact threshold with implementation of penalized splines by generalized additive model.


Eligibility criteria:
inclusion criteria: adult non-cardiac, non-obsteric, non- kidney elective surgery patients exclusion criteria: patients aged \<18 y emergency surgeries without arterial blood pressure cardiac surgeries obstetric surgeries kidney surgeries under local infiltration or mac first sbp \<100 mmhg
screening for gdm in women with pcos and controls

Conditions: Polycystic Ovary Syndrome; Gestational Diabetes Mellitus

Summary: women with polycystic ovary syndrome (pcos) are often insulin resistant. during pregnancy, insulin sensitivity decreases. the investigators examine glucose metabolism during oral glucose tolerance test and the incidense of gestational diabetes mellitus in a prospective cohort of pregnant women with pcos and controls.


Eligibility criteria:
inclusion criteria: * pregnancy achieved during 2010-2012 * residents of the municipality of odense exclusion criteria: * moving from odense during pregnancy

Keywords: pcos gdm ogtt glucose metabolism
non-invasive chromosomal examination of trisomy study

Conditions: Trisomy 21

Summary: the purpose of this blinded, multi-center, prospective, case-controlled study is to compare the ariosa harmony™ prenatal test for trisomy 21 detection with a standard first-trimester prenatal screening test consisting of serum screening (papp-a,free beta-hcg \[β-hcg\] or total hcg) and a nuchal translucency (nt) measurement (i.e. combined first trimester screening) in a general screened population. the performance characteristics of these two test modalities will be assessed relative to the clinical reference standard of genetic analysis of the fetus or phenotypic characterization and genetic analysis of the newborn.


Eligibility criteria:
inclusion criteria: 1. subject is at least 18 years old and can provide informed consent. 2. subject is planning a hospital delivery. 3. subject has a singleton pregnancy with a documented gestational age between 10 weeks, 0 days, and 14 weeks, 2 days, inclusive, at the time of the study blood sample collection. 4. subject is planning to undergo combined first trimester prenatal screening that includes nt measurement, and when indicated, serum screening with total or free β-hcg and papp-a. exclusion criteria: 1. subject has known aneuploidy. 2. subject has active or history of malignancy requiring major surgery and/or systemic chemotherapy. 3. subject has a twin demise at any gestational age. twin demise includes any reductions, spontaneous or elective, after sonographic identification of a second (or more) gestational sac. any clinical, sonographic, or other testing that suggests twin demise would serve as an exclusion criterion.

Keywords: pregnancy fetal aneuploidy trisomy 21 down syndrome prenatal screening non-invasive prenatal testing first trimester combined screening nuchal translucency papp-a hcg cell free dna cf dna dna performance characteristics of non-invasive first trimester screening harmony prenatal test
radiation exposure in spine intervention under angiography

Conditions: Low Back Pain

Summary: evaluate radiation exposure and procedure times for continuous fluoroscopic monitoring during lumbar esi

the purpose of this prospective study was to evaluate radiation exposure and procedure times for fluoroscopic monitoring during lumbar esi with analyzing the differences among operators (experienced staff and trainee) and among different method for esi.

Eligibility criteria:
inclusion criteria: * suspected of having radiculopathic low back pain exclusion criteria: * angiography is contraindicated