mteb/BIRCO-ClinicalTrial-Test huggingface dataset:
Back pain is one of the most common of all symptoms. It is also a great cause of days lost from work and visits to health care providers. This study will develop and evaluate an approach to low back pain that allows subjects to talk with each other and with health professionals via an Internet discussion group. Results we will look at include health behaviors, such as exercise; health status, such as pain and disability; and health care use, such as number of visits to doctors and other health care providers. Anyone 18 years old or older who lives in the United States and has ongoing Internet access can take part in the study. All subjects must have back pain and meet the eligibility criteria listed below. This study will develop and evaluate in a randomized trial a low back pain intervention that allows subjects to talk with each other and with health professionals via an Internet discussion group. The intervention consists of a book and a videotape and is based on interaction with other participants in the program and health professionals through a closed password protected moderated Internet discussion group. Outcome measures include health behaviors, such as exercise; health status, such as pain and disability; and health care use, such as number of visits to doctors and other health care providers. Patients will be randomized either to the treatment group and followed for 6, 12, 18, and 24 months with the intervention.
To determine whether the regular administration of the beta-blocker drug propranolol to people who had had at least one documented myocardial infarction would result in a significant reduction of mortality from all causes over the follow-up period. Eligible volunteer patients were recruited to participate in a double-blind clinical trial within 21 days after the onset of the acute event. One-half of the patients were randomly assigned to a beta-blocking drug (propranolol) and one-half to a placebo. The trial also evaluated the effect of propranolol on incidences of coronary heart disease mortality, sudden cardiac death, and nonfatal myocardial infarction plus coronary heart disease mortality in persons with documented previous myocardial infarction. BACKGROUND: Survivors of a documented myocardial infarction are recognized as having a high risk of dying relative to the general population. Serious arrhythmias, occurring with or without evidence of new infarction, are a common cause of death in this population. Theoretically, an agent which (1) can block the sympathetic nervous activity thought to be involved in precipitating sudden death and (2) has non-neurogenic antiarrhythmic properties would be of value to people with coronary heart disease. Propranolol, like other beta- blocking agents, has these as well as other properties and therefore might be expected to prevent or retard complications of coronary heart disease such as serious arrhythmias. This would be reflected in a decrease in mortality due to coronary heart disease.
To test the feasibility and the efficacy of nutritional interventions in the primary prevention of hypertension in individuals predisposed to the development of hypertension; specifically, to test the hypothesis that reduction of weight and/or decreased sodium intake in obese individuals, or decreased sodium intake with or without increased potassium intake (in men and women, regardless of weight) would prevent the elevation of blood pressure and the incidence of hypertension. BACKGROUND: The nature of essential hypertension as a mass public health problem throughout the United States, and internationally as well, is recognized generally. Prevalence estimates exceed l5 percent in most adult populations. Further, the results of the Hypertension Detection and Follow-up Program (HDFP) demonstrated the efficacy of antihypertensive therapy even at the 90-l05 mmHg level, which comprises 72 percent of the total hypertensive population. The Joint National Committee on the Detection, Evaluation and Treatment of High Blood Pressure recommended treatment of mild hypertension by pharmacologic or non-pharmacologic therapy to the lowest diastolic pressure consistent with safety and tolerance. The recommendation was consonant with the goal blood pressure guidelines for those with baseline pressures from 90-99 mmHg. Hence, there appeared to be a growing consensus that reduction of blood pressure to levels as low as 80 mmHg might be desirable for optimal cardiovascular health. The Joint National Committee further recommended that, in young patients with uncomplicated mild hypertension, the benefits from pharmacologic therapy must be weighed against the cost, inconvenience, and possible side effects.
It is unknown if obesity contributes to the development of heart disease in African American men and women. This study was created to determine whether there is a relationship between sex and body size and the incidence of heart disease in African American men and women. Researchers will attempt to associate obesity with the presence of heart disease risk factors. Risk factors that will be studied include; total body fat, body fat distribution, fat content of the blood (triglyceride concentration, low density lipoproteins [LDL], and high density lipoproteins [HDL]), how fast fat is removed from the blood, and how well insulin works in the body. Scientific studies have shown that obesity and increased levels of fat content in the blood are important risk factors for heart disease in Caucasian women. However, similar studies in African American women have failed to show the same correlation. In fact, it appears that African American women in all three body weight groupings, nonobese, overweight, and obese experience high death rates due to heart disease. In addition, prior research has shown that obese African American men tend to have elevated levels of fat in the blood while African American women have normal blood fat levels. Therefore, if high levels of triglycerides (fat found in the blood) are not seen in non-diabetic obese African American women, it cannot be considered a risk factor in this population.
The African-American Antiplatelet Stroke Prevention Study is designed to prevent recurrent strokes by administration of aspirin or ticlopidine. The study also provides community information on reducing risk of stroke and recognizing the symptoms of stroke. The study involves more than 50 participating hospitals located throughout the United States. Study medication is provided free of charge, and a transportation stipend is available for those in need. Stroke is one of the important diseases that disproportionately affects African-Americans. African-American men and women are about 2 times more likely than whites to die of cerebrovascular disease or experience stroke. Scientific information about the efficacy and safety of stroke preventatives in this group is much needed, yet African-Americans and other minorities have been underrepresented in biomedical research studies. Preliminary data collected from nonwhite, predominantly African-American patients, suggest that ticlopidine is more effective than aspirin in the secondary prevention of stroke and death for these patients and that the risk of serious adverse events is lower. This is a multicenter, randomized, double-blind clinical trial of ticlopidine hydrochloride (500mg/day) and aspirin (650mg/day) in African-American patients with recent non-cardioembolic ischemic stroke. The primary purpose of the study is to compare the efficacy of ticlopidine and aspirin in the prevention of the outcome endpoints recurrent stroke, vascular death, and myocardial infarction in these African-American patients. Adverse experiences will be studied to further our understanding of the safety of these medications in this group.
To conduct longitudinal and cross-sectional studies of risk factors for coronary heart disease and hypertension in school age children and adults who had been examined in previous screens. BACKGROUND: Longitudinal studies of coronary risk factors beginning in subjects at adult age have shown that hypertension, hypercholesterolemia, and obesity are related to the risk of coronary artery disease and stroke. The Framingham Study has shown, in adults over 30 years of age, a positive association between risk of cardiovascular disease and low density lipoprotein cholesterol, elevated systolic blood pressure and diabetes, and a negative association with high density lipoprotein cholesterol. In 1971 when the Muscatine Heart Study was initiated, there was preliminary evidence that these processes began in childhood. It was noted that children's lipids, blood pressures, and body size maintained a degree of rank order over time, suggesting that those with high levels were likely to become adults with high levels. Whether elevated levels in children of the accepted adult coronary risk factors were predictive of future cardiovascular disease morbidity and mortality remained an important unanswered question. No data were available which directly linked overt cardiovascular disease to childhood measures of risk factors. The Muscatine study followed children from their school age years into middle age. This study, for the first time, directly related multiple observations of levels and profiles of change in coronary risk factors during childhood to levels of these risk factors measured at ages when the levels had established predictive significance for the development of premature atherosclerotic heart disease.
This is a prospective study of the environmental and genetic factors that influence the development of cardiovascular disease (CVD) in African American men and women. The cohort is an expansion of the Jackson, Mississippi site of the Atherosclerosis Risk in Communities (ARIC) study and is a partnership among two minority institutions (Jackson State University and Tougaloo College), one majority institution in Jackson, Mississippi (the University of Mississippi Medical Center), the National Institutes of Health (NIH) National Center on Minority Health and Health Disparities (NCMHD), and the National Heart, Lung, and Blood Institute (NHLBI). BACKGROUND: Heart disease and stroke remain the first and third leading killers of all Americans, with a disproportionate share of the burden borne by African Americans. Cardiovascular and total mortality are known to be higher among African Americans than among white Americans, but reasons for these differences remain unknown. In addition, well-documented declines in CVD and coronary disease mortality in the past three decades have not been shared equally between blacks and whites. Age-adjusted death rates were identical in both groups in 1980, but by 1994 the rate among African Americans was 14% higher than in whites. The race difference in magnitude of coronary heart disease (CHD) mortality is greater in women than men and higher in middle age, such that CHD deaths tend to occur in blacks about 5 years earlier than in whites.
To determine whether differences in the activity of the renin-angiotensin and bradykinin systems are involved in the pathogenesis of blood pressure variation in African Americans. BACKGROUND: Each year, more than 40,000 new patients require treatment for end stage renal disease, a condition which is 4-fold higher among African Americans than Caucasians. Trials of angiotensin converting enzyme inhibitors (ACEIs) in Caucasians support a role of the renin-angiotensin system in the pathogenesis of glomerulosclerosis. Yet, despite the high prevalence of nephropathy among African Americans, Blacks have been under-represented in studies in ACEIs. Data from our laboratory suggest that the renal effects of ACEI may differ in African Americans. African Americans are resistant to the anti-hypertensive effects of ACEI and, thus, may be resistant to the renoprotective effects as well. The ACE deletion allele, a variant associated with increased ACE activity and progression of renal diseases, is increased in frequency in African Americans, while the frequency of the Ang AT1 receptor C allele, a variant associated with antihypertensive responsiveness to ACEI is decreased. Moreover, African Americans exhibit decreased sensitivity to Ang I and increased sensitivity to bradykinin. Taken together, these data suggest the hypothesis that ACE activity is increased in African Americans, leading to decreased bradykinin levels ( and receptor sensitization) and increased tissue Ang II (and receptor desensitization). DESIGN NARRATIVE: The study tests the hypothesis that ACE activity is increased in African Americans, leading to decreased bradykinin levels (and receptor sensitization) and increased tissue Ang II (and receptor desensitization).
Beta-blocker medications have been shown to improve heart function and prolong the lives of patients with chronic heart failure (CHF). Some people with advanced CHF have difficulty taking beta-blocker medications due to troublesome side effects, such as low blood pressure and/or low heart rate, severe tiredness, dizziness, or shortness of breath. In other words, they have difficulty tolerating beta-blocker medications. The purpose of this study is to determine if enoximone can improve a patient's ability to tolerate a beta-blocker medication. Over the last decade, it has become evident that certain beta-blocking agents (beta-blockers) exert a favorable effect on the natural history of mild to moderate chronic heart failure (CHF), including reducing mortality and hospitalization rate. However, as heart failure becomes more severe, beta-blockers become difficult to administer because of myocardial depression leading to hemodynamic intolerance. A recent clinical study demonstrated that subjects who could not tolerate the beta-blocker metoprolol experienced improved tolerability when low-dose, oral enoximone was administered prior to the introduction of metoprolol and during ongoing treatment. This study will investigate the hypotheses that by stabilizing subjects on enoximone first, advanced CHF subjects who are intolerant of beta-blockade will be able to 1) tolerate the effects of beta-blocker therapy, and 2) have clinical benefit that is due to the combination of both enoximone and extended-release metoprolol succinate (ER metoprolol).
This clinical trial compares two psychological treatments for back pain. The primary objective is to examine the incremental efficacy of a patient-centered and tailored self-management treatment approach, Tailored Cognitive-Behavior Therapy (TCBT), for persons with chronic musculoskeletal pain. TCBT will be compared with a Standard Cognitive- Behavior Therapy (SCBT) condition. The hypothesis is that TCBT will be associated with improved outcomes following treatment. Outcome will be assessed by multiple standardized measures of key domains of the chronic pain experience. Secondary objectives are to examine the process of successful self-management treatment.
Patients with end-stage renal failure have a markedly higher mortality because of cardiovascular events in comparison with the normal population. Disorders in the calcium metabolism, such as calcification of the vessel walls, occur very frequently. There are indications that calcium channel blockers are capable of lowering the cardiovascular mortality in patients with end-stage renal failure. It is intended to carry out a prospective, randomized, double-blind, placebo-controlled, multicenter study in order to find out if the calcium channel blocker amlodipine is able to reduce the mortality of patients with end-stage renal failure. The investigation will be carried out after suitable explanation and written informed consent in 356 patients aged between 18 and 90 years with end-stage renal failure and chronic haemodialysis treatment. The patients will be randomized to either treatment with amlodipine 10 mg/day or placebo. The occurrence of events will be documented and evaluated prospectively over a period of 30 months. Trial protocol for ADAM Study 1.1 General Data: 1. Title of the Study: Influence of Amlodipine on the Mortality of Patients with End-Stage Renal Failure (abbreviated title: ADAM [Amlodipine and Dialysis Patients, Action on Mortality]) 2. Study Directors: Prof. Dr. med. Martin Tepel, Charite University of Berlin, Campus Benjamin Franklin, Medizinische Klinik IV, Hindenburgdamm 30, 12200 Berlin, Germany. Tel. : +49-30 8445 2305, Fax: +49-30 8445 4235, e-mail: Martin.Tepel@charite.de Statistics: PD Dr. rer.
Various guidelines recommended angiotensin converting enzyme (ACE) inhibitors or angiotensin Ⅱ receptor-1 blockers (ARBs) for hypertensive patients with diabetes on the basis of the cardiac- and reno-protective effects of these drugs. However, these recommendations could not be extrapolated to Japanese patients, because Japan has been known as a country with a low incidence of coronary artery disease and a high incidence of cerebrovascular disease. Furthermore, calcium channel blockers (CCBs) also were protective against renal function as well as ACE inhibitors in Japanese diabetic hypertensive patients. This study will test whether ARBs or CCBs are superior in treating Japanese diabetic hypertensive patients.
The purpose of this study is to investigate whether high-dose angiotensin II receptor blocker (ARB) monotherapy or combination therapy with ARB and calcium channel blockers is more effective in reducing the incidence of cardiovascular events in Japanese elderly high-risk hypertensive patients not adequately controlled by standard dose ARB alone. Hypertension is one of the major risk factors of cardiovascular diseases. It is also important for elderly hypertensive patients to strictly reduce their blood pressures to prevent cardiovascular events. Although angiotensin II receptor blockers (ARBs) are increasingly used in antihypertensive treatment recently, few studies have been performed in Japan to assess the difference between high-dose ARB monotherapy and combination therapy of ARB with calcium channel blocker (CCB) in prevention of cardiovascular diseases for patients whose blood pressure is not well controlled by ARB monotherapy. OSCAR-study is a multicenter, active-controlled, 2-arm parallel group comparison, prospective randomized open blinded end-point (PROBE) design study. The dose administered is olmesartan medoxomil 20mg/day as ARB monotherapy in the 'Step 1' period. If the blood pressure is not adequately controlled and treatment is well tolerated then the dose is changed to olmesartan medoxomil 40mg/day in the high-dose ARB monotherapy group, or olmesartan medoxomil 20mg/day and a CCB in the combination therapy group in the 'Step 2' period. At least 500 patients will be enrolled in each group, and the follow-up duration will be 3 years.
Although ACE Inhibitors and Angiotensin Receptor Blockers are effective blood pressure lowering agents, the exact mechanisms by which these agents lower BP are still not fully understood. This study aims to compare the blood pressure and hormonal responses (plasma renin activity and aldosterone) to the ACE inhibitor enalapril and ARB candesartan in individuals with mild essential hypertension.
The objective of study is to compare the anti-ischemic efficacy and safety profiles of once daily amlodipine or isosorbide-5-mononitrate in the treatment of stable asymptomatic and symptomatic myocardial ischemia
The KYOTO HEART Study is to assess the add-on effect of valsartan, an Angiotensin-Receptor Blocker, on top of the conventional treatment in high risk patients in Japan with hypertension in terms of the morbidity and mortality. Although many reports show that ACE inhibitors and angiotensin II receptor blockers (ARB) are superior for prevention of cardiovascular events, previous data are not enough for the patients who have more than one risk factor and for anti-atherosclerotic effects of ARB. In Japan, there were only a few large-scale trials for cardiovascular disease prevention, and it has not been clarified whether the evidence in Western countries could be unqualifiedly applied to Japanese patients as a long-range strategy. The KYOTO HEART Study is to assess the add-on effect of valsartan, an Angiotensin-Receptor Blocker, on top of the conventional treatment in high risk patients with hypertension in terms of the morbidity and mortality.
The study is designed to see if stress heart imaging can be used as a screening exam in patients with diabetes and risk factors of developing of coronary artery disease and experiencing future cardiac events.
The causes of pediatric pain are often not the same for every child. Most children who visit a cardiology specialist with complaints of chest or other somatic pain have no known medical diagnosis to explain their symptoms. These children and their families often leave with no explanation for the child's distress. This early study will ask parents and children specific questions related to the stress in their lives, their emotional well-being and the children's physical functioning. The investigators want children who experience chest and other somatic pain, and those who do not, to be in their study so that they can look at both groups. The investigators hope to use these answers to better inform cardiologists who often work with children with non-cardiac pain and, in turn, help them to better serve their patients. Ultimately, the investigators hope that the answers they get will provide answers to these families. They also hope to use the results of this study to put together a short screener for the cardiologist to give to pediatric patients with complaints of chest or other somatic pain to help the cardiologists better understand their patients' symptoms. The current investigation will address some similar factors considered in prior research, but will considerably extend our understanding of how psychological, familial, and environmental factors influence noncardiac chest pain. In this investigation, a number of variables that have not been considered in prior research in this area will be included.
BACKGROUND: Although much has been written about the influence of local opinion leaders on clinical practice, there have been few controlled studies of their effect, and almost none have attempted to change prescribing in the community for chronic conditions such as congestive heart failure (CHF) or ischemic heart disease (IHD). These two conditions are common and there is very good evidence about how to best prevent morbidity and mortality - and very good evidence that quality of care is, in general, suboptimal. Practice audits have demonstrated that about half of eligible CHF patients are prescribed ACE inhibitors (and fewer still reaching appropriate target doses) and less than one-third of patients with established IHD are prescribed statins (with many fewer reaching recommended cholesterol targets). It is apparent that interventions to improve quality of prescribing are urgently needed. HYPOTHESIS: An intervention that consists of patient-specific one-page evidence summaries, generated and then endorsed by local opinion leaders, will be able to change prescribing practices of community-based primary care physicians. DESIGN: A single centre randomized controlled trial comparing an opinion leader intervention to usual care. Based on random allocation of all physicians in one large Canadian health region, patients with CHF or IHD (not receiving ACE inhibitors or statins, respectively) recruited from community pharmacies will be allocated to intervention or usual care. The primary outcome is improvement in prescription of proven efficacious therapies for CHF (ACE inhibitors) or IHD (statins) within 6 months of the intervention.
To investigate the clinical benefits of Docetaxel or alternating AC-Docetaxel in comparison with standard AC for metastatic breast cancer power to detect a 50% increase in median TTF at 0.025 one-sided alpha in AC vs. D and AC vs. AC-D. Results: 441pts (146 in AC, 147 in D, 148 in AC-D) were randomized between 01/99 and 05/03. Major grade 3-4 toxicities were neutropenia (26/45/46% for AC/D/AC-D), febrile neutropenia (3/4/6%), nausea/vomiting (3/3/4%). There was no toxic death. One grade 4 diarrhea in AC-D and 1 secondary leukemia (APL) in D were reported. Response (CR/PR) rates were 30, 41, and 35% for AC, D, and AC-D respectively. Median TTF (AC, D, and AC-D) are 6.4, 6.4, and 6.7 months (p =.255 for AC vs. D, p =.275 for AC vs. AC-D), and median overall survival are 22.4, 25.7, and 25.0 months (p=.092 for AC vs. D, p=.076 for AC vs. AC-D). The same difference was shown by the adjusted Cox model. Conclusions: No benefit was demonstrated in D and AC-D over AC in TTF, however, D and AC-D tended to be superior to AC in response rate and overall survival. Survival benefit of front-line docetaxel should be re-evaluated by further long follow-up.
To test whether ivabradine when given in combination with atenolol is able to improve the exercise tolerance of patients with stable angina pectoris
We wish to see if the drug rosiglitazone, currently used in the treatment of type 2 diabetes, could be used as a new treatment for angina when compared with placebo in overweight subjects who do not have overt diabetes. The drug will be given for 3 months and the subjects will be have their angina tested, by way of exercise testing, angina quality of life questionnaire and 24-hour ECG monitoring before and after using the drug. Chronic stable angina is a common manifestation of ischaemic heart disease. Current mechanical therapies (percutaneous coronary intervention and coronary artery bypass grafting) and pharmacological therapies (nitrates, calcium channel blockers, betablockers and potassium channel activators) main actions are to treat the end product of ischaemic heart disease on chronic stable angina, i.e. the flow limiting stenosis. We postulate that by treating insulin resistance, an upstream factor in the pathogenesis of ischaemic heart disease, we will improve angina by in turn improving endothelial function. We will attempt to demonstrate this by way of full bruce protocol exercise tolerance test, Seattle Angina Questionnaire and 24 hour ST segment analysis before and after treatment with the insulin sensitiser rosiglitazone for three months.
Osteoporosis or "thinning of the bones" affects in 1 in 4 Canadian women and 1 in 8 Canadian men. Moreover, while the rates of osteoporosis among Canadians are stabilizing, worldwide the number of people afflicted with osteoporosis continues to rise. The most serious complication of osteoporosis is a broken bone or fracture. Fractures due to osteoporosis can result in long hospital stays, dependence on others, and premature death. While there are several medications that prevent osteoporosis they all have side effects. For example, postmenopausal women who take hormone replacement therapy (HRT) are at increased risk of breast cancer and heart disease. In addition, drugs to prevent osteoporosis are expensive and not available worldwide. Therefore, it is essential that researchers continue to identify and test new medications for the prevention of osteoporosis. The purpose of the research is to determine if nitrates, a group of drugs that are widely available, inexpensive, and commonly used to treat chest pain or angina, can prevent osteoporosis in women. If the researchers find that nitrates prevent osteoporosis, a widely available, inexpensive treatment for osteoporosis prevention that does not have any long term side effects would have been identified. This will improve the health of patients with osteoporosis worldwide. This proposal consists of two studies. The objective of the first study is to determine which of isosorbide mononitrate (ISMO) at 20 mg/day or nitroglycerin ointment (NTG) at 15 mg/day results in fewer headaches.
The purpose of this study is to compare the clinical effectiveness of two types of chiropractic spinal manipulation to conservative medical care for patients at least 55 years old with sub-acute or chronic LBP. Despite the high prevalence of LBP and the associated economic costs, disability, and lost productivity, and despite the development of several treatment guidelines, one of which recommends chiropractic spinal manipulation for some subgroups of patients with back pain, the management of LBP remains controversial and highly variable across professions and geographic regions. Although one recent publication describes the design of chiropractic and exercise for seniors with low back or neck pain, no published studies, to our knowledge, have assessed the effectiveness of chiropractic manipulation compared to medical care for older adults with sub-acute or chronic low back pain.
This is a randomized, double blind, placebo-controlled study, clinical trail designed to evaluate the efficacy safety and superiority of intravenous boluses of isosorbide dinitrate for the relief of acute anginal pain episodes in acute coronary syndrome patients in comparison with the usual manner of S/L isosorbide dinitrate . Analgesia is an important element in the management of ACS patients. Pain contributes to the heightened sympathetic activity that is particularly prominent during periods of acute STEMI, NSTEMI and unstable angina and consequentially causes elevation of tissue oxygen demand. Control of cardiac pain is typically accomplished with a combination of oxygen, analgesic (e.g. morphine) beta blockers agents and primarily nitrates. Sublingual nitrates are currently the guidelines recommended preparation for instant relief of brief episodes of pain. In patients with prolonged periods of waxing and waning chest pain, drip of intravenous nitrates may be of benefit in controlling of symptoms and correcting ischemia. Intravenous nitrates are also indicated for the treatment of acute decompensated CHF patients with pulmonary edema, nevertheless the current treatment for these patients edema is repeated intravenous boluses of and not sublingual isosorbide dinitrate, followed by continuous drip. Although there is no hard data on intravenous high-dose nitrates for the relief of acute anginal pain episodes, our clinical impression with this method is excellent. Intravenous boluses of isosorbide dinitrate in a hospital setting provides immediate, accurate (bioavailability ) and is an easily controlled modality for providing nitrates.
As a pulmonary hypertension center, we have created a database that prospectively tracks patients with different forms of secondary pulmonary hypertension. Records include genetic analysis, and clinical and hemodynamic profiles.
African American women have higher rates of obesity than women of any other racial or ethnic group in the United States. Obesity can have many causes, including genetic and environmental factors. This study will examine how neighborhood environments influence the occurrence of obesity among African American women. Obesity, which leads to higher rates of diabetes, cancer, and heart disease, is an increasingly important public health problem. In 2000, over 78% of African American women were overweight, and over 50% were obese. Several factors can contribute to obesity, including genetics, diet, and environmental factors. Individuals who live in an environment in which it is difficult to maintain an active lifestyle are more prone to obesity. The Black Women's Health Study (BWHS) is an extensive long-term study that is gathering data from women across the country to examine the occurrence of various diseases among African American women. Using BWHS study data and specific information on participants' neighborhoods, including street layout and the presence of sidewalks, this study will determine if neighborhood environments influence the prevalence of obesity among African American women. This study will use already-collected data on physical activity and body mass index of BWHS study participants who live in New York, Los Angeles, and Chicago; there are no additional study visits specifically for this study. A transportation and urban planning expert will compile data regarding the pedestrian environment of neighborhoods in all three cities, including the nature and density of land use, proximity to parks, presence of sidewalks, speed and volume of traffic, and street structure.
The overall aim of the project is to evaluate diagnosis and treatment of chest pain originating from the musculoskeletal system. Specifically, we wish to investigate prevalence and character of such chest pain in a population of patients with acute chest pain, admitted to a university hospital based acute chest pain clinic, and undergoing evaluation of acute coronary syndrome (Part 1). Then, to test a manually-based treatment protocol to patients with diagnosed musculoskeletal chest pain in a randomized clinical trial (Part 2). The specific purpose of this study (Part 1) is to determine the exact number of patients with acute chest pain origination from the musculoskeletal system, and to describe their cardiac status with respect to ischemic heart disease. Further, we wish to evaluate the decision making process of the chiropractor. Acute chest pain is a common reason for hospital admission. The focus of diagnosis is of course pain of cardiac origin including myocardial infarction and/or other ischemic heart disease; however, in up to 50% of cases the aetiology may be non-cardiac. Differential diagnoses include primarily pulmonary, gastrointestinal, psychosocial, or musculoskeletal problems, and musculoskeletal problems may account for around 20% of the total number of admissions in acute chest pain clinics. Thus the musculoskeletal system is a recognized possible source of pain in patients with chest pain even though a confident diagnosis of musculoskeletal chest pain can be difficult to establish since no gold standard exists to verify this diagnosis.
Prader-Willi syndrome (PWS) is a rare genetic disorder that affects about 1 in 14,000 people in the United States. As the most commonly identified genetic cause of obesity, PWS is often confused with Early-onset Morbid Obesity (EMO). Individuals with EMO show some signs of PWS, but clinically do not have PWS. The purpose of this study is to evaluate the clinical features and genetic basis of PWS and EMO, and to determine how these conditions affect a person throughout a lifetime. PWS is a complex neurobehavioral syndrome. Clinical features include obesity, increased appetite, low muscle tone, cognitive impairment, distinct behavioral features, hypogonadism, and neonatal failure-to-thrive. It is the most commonly recognized genetic cause of obesity; however, many obese children do not in fact have PWS. These individuals are therefore diagnosed with EMO, a condition that shares features with PWS. The development of new advances and strategies for treating PWS and EMO requires a thorough understanding of the conditions at both the clinical and molecular levels. One goal of this study is to collect long-term data on individuals with PWS and EMO in order to gain a better understanding of the natural progression of the conditions, from the neonatal period well into adulthood. Specific to PWS, this study will establish a genotype-phenotype correlation among the different sub-types and will evaluate the effects of growth hormone treatment on disease progression.
The purpose of this study is to determine the efficacy and effectiveness of calcium channel blockers and adenosine in the treatment of Supraventricular Tachycardia. Paroxysmal Supraventricular Tachycardia (SVT) is a common cardiac emergency encountered in the Emergency Department. Both Calcium Channel Blockers (CCB) and Adenosine have been using in the Management of SVT. Objective This study compared the efficacy and effectiveness between slow Infusion of Calcium Channel Blockers (either Verapamil or Diltiazem) and bolus intravenous Adenosine in termination of SVT. Methodology This was a prospective, randomised, controlled clinical trial comparing the efficacy and effects of intravenous adenosine with slow infusion of calcium channel blockers (verapamil or diltiazem) in patients presenting with SVT to an Emergency Department. The study was approved by the hospital’s Ethics Committee. Patients of at least 10 years of age, who presented to the Emergency Department of the Singapore General Hospital with regular narrow complex tachycardia and an electrocardiographic(ECG) diagnosis of SVT that was not converted by vagal manoeuvres (Valsava manoeuvre or carotid sinus massage or both) and who were in SVT at the time of doctor attendance were included in the study. The exclusion criteria were as follows: - Patients with signs of impaired cerebral perfusion (e.g. altered mental state) or acute pulmonary oedema - Patients with a subsequent diagnosis of arrhythmias other than SVT (i.e.
The estimated recurrence rate of primary spontaneous pneumothorax is 23-50% after the first episode, and the optimal treatment remains unknown. In the recently published British Thoracic Society (BTS) guidelines, simple aspiration is recommended as first line treatment for all primary pneumothoraces requiring intervention. However, the 1 year recurrence rate of this procedure was as high as 25-30%, making it inappropriate as a standard of care. Intrapleural instillation of a chemical irritant (chemical pleurodesis) is an effective way to shorten the duration of air leaks and reduce the rates of recurrent spontaneous pneumothorax in surgical and non-surgical patients. Many chemical irritants (tetracycline, talc, and minocycline) have been used to decrease the rate of recurrence in spontaneous pneumothorax. Tetracycline, which was the most commonly used irritant, is no longer available. Talc insufflation of the pleural cavity is safe and effective for primary spontaneous pneumothorax. However, it should be applied either with surgical or medical thoracoscopy. Minocycline, a derivative of tetracycline, is as effective as tetracycline in inducing pleural fibrosis in rabbits. In the previous studies, we have shown that additional minocycline pleurodesis is a safe and convenient procedure to decrease the rates of ipsilateral recurrence after thoracoscopic treatment of primary spontaneous pneumothorax. In the present study, additional minocycline pleurodesis will be randomly administered in patients with first episode of primary spontaneous pneumothorax after simple aspiration to test if it can reduce the rate of recurrence.
AMB-220-E is an international, multicenter, open-label study examining the long-term safety of ambrisentan (BSF 208075) in subjects who have previously completed Myogen study NCT00046319, "A Phase II, Randomized, Double-Blind, Dose-Controlled, Dose-Ranging, Multicenter Study of BSF 208075 Evaluating Exercise Capacity in Subjects with Moderate to Severe Pulmonary Arterial Hypertension".
The purpose of this study is to investigate which combination therapy is more effective in reducing the incidence of cardiovascular events in Japanese elderly high-risk hypertensive patients: AT1 subtype angiotensin II receptor antagonist/calcium channel blocker or AT1 subtype angiotensin II receptor antagonist/low dose diuretic. Recently, antihypertensive combination therapies have been recommended by various guidelines because of their additive effects. Combination therapies of AT1 subtype angiotensin II receptor antagonist and calcium channel blocker or low dose diuretic have shown pharmacological benefit. However, reduction of cardiovascular events and safety profile of these combination therapies under same level of antihypertensive target have not been investigated yet. In this study, primary objective is to compare two combination therapies when antihypertensive target is 140/90mmHg in elderly hypertensive patients with high cardiovascular risk. Further study details as provided by COLM-Study data center Primary Outcomes: A composite of fatal and non-fatal cardiovascular events: Sudden death (death of endogenous origin within 24 hours after acute onset); Cerebrovascular events (new occurrence or recurrence of a cerebral infarction, cerebral hemorrhage, subarachnoid hemorrhage or transient ischemic attack); Coronary events (new occurrence or recurrence of a myocardial infarction, coronary revascularization[PCI or CABG], hospitalization for angina pectoris, hospitalization for heart failure); Renal dysfunction (doubling of serum creatinine and creatinine ≥2.0 mg/dl, end stage renal disease) Secondary Outcomes: All deaths; Death from cardiovascular events; Effects on glucose metabolism(fasting plasma glucose, postprandial glucose, new onset of diabetes mellitus); Incidence of primary outcomes events; New occurrence of atrial fibrillation; Safety; Proportion of the subjects who withdrew from the allocated treatment
Acute chest pain is a common cause of hospital admission. Active approaches are directed towards diagnosis and treatment of potentially life threatening conditions, especially acute coronary syndrome and coronary artery disease. However, a considerable number of patients may have chest pain caused by biomechanical dysfunction of muscles and joints of the chest wall or the cervical and thoracic spine (20%). The diagnostic approaches and treatment options for this group of patients are scarce and there is a lack of formal clinical studies and validated outcome measures addressing the effect of manual treatment approaches. Objective: This single blind randomized clinical trial investigates whether chiropractic treatment can reduce pain and improve function in a population of patients with acute, musculoskeletal chest pain when compared to advice directed towards promoting self-management. Methods: Among patients admitted to a chest pain clinic in a university hospital under suspicion of acute coronary syndrome, 120 patients with an episode of acute chest pain of musculoskeletal origin are included in the study. All patients have completed the chest pain clinic diagnostic procedures, and acute coronary syndrome and other obvious reasons for chest pain have been excluded. After completion of the study evaluation program, the patients are randomized into one of two groups: A) advice promoting self-management and individual instructions focusing on posture and muscle stretch; B) a course of chiropractic therapy of up to ten treatment sessions focusing on high velocity, low amplitude manipulation of the cervical and thoracic spine together with a choice of mobilisation and soft tissue techniques.
The purpose of the study is to determine for how long sildenafil potentiates the blood pressure reduction that occurs with glyceryl trinitrate in men with angina. By producing a mediator known as cGMP, nitric oxide (NO) potently dilates blood vessels. Nitrates, such as glyceryl trinitrate (GTN), are drugs that release NO (NO donors) and are widely used in the treatment and prevention of angina. Sildenafil is an effective treatment for male penile erectile dysfunction that inhibits the breakdown cGMP. When given alone it causes modest reductions in BP in healthy people and patients with cardiovascular disease. By their synergistic actions, co-administration of NO donors with sildenafil can result in large reductions in BP in patients with angina, a population at increased risk of developing erectile dysfunction. As a result, it is recommended that the two drugs not be co-administered within 24 hours of one another. Previous studies have defined the effect of nitrates at 60 min after administration of sildenafil, the time of likely maximum interaction. However, emergency medicine physicians would value evidence of a balance of risks from which to make a personal clinical judgement about when they might consider giving GTN in a patient presenting with a severe episode of angina who has recently received sildenafil. Evidence on which to base such a judgement is currently not available. However, we have recently completed a study, showing that the interaction of GTN (0.4 mg spray) after sildenafil (100 mg) lasts less than 4 hours in healthy subjects.
EGF104578 is two-part study (Pilot part/Randomized part).Pilot part is designed to find the optimal (best) doses of lapatinib and paclitaxel when given together,Randomized part is designed to evaluate the overall survival in patients receiving lapatinib and paclitaxel compared to patients receiving only paclitaxel.
The purpose of this study is to determine whether a brief counseling intervention initiated in the chest pain observation unit has a significant impact upon the health attitudes (readiness to change) and cardiovascular risk-related behaviors (diet, exercise, and smoking) of emergency department patients. Increasingly, emergency department patients for whom a non-ischemic etiology of ACS symptoms cannot be identified undergo further evaluation to rule out myocardial ischemia and appraisal of cardiovascular risk factors (CRFs) in chest pain observation units (CPOUs). CPOU admission may represent a "teachable moment," but there has been little research on the effectiveness of brief, practical interventions for cardiovascular risk reduction in this population, despite the fact that the vast majority of these patients have at least one modifiable CRF and many do not receive regular primary care follow-up. The purpose of this study is to determine whether a brief counseling intervention initiated in the CPOU has a significant impact upon health attitudes (readiness to change) and cardiovascular risk-related behaviors (diet, exercise, and smoking). Based on the Health Belief Model (HBM), the intervention is designed to provide patients with tailored information on their cardiovascular risk, to negotiate goals for change, and to build problem-solving skills. All participants who are admitted to the CPOU for evaluation of ACS symptoms will be randomized to brief intervention (face-to-face counseling in the CPOU, coupled with telephone counseling at 4 weeks) or to minimal intervention (booklet with general information on CRFs) after a negative initial troponin measurement.
The purpose of this study is to collect information on the long-term side effects of treatment for Hodgkin Lymphoma. We hope to study about 500-800 survivors of Hodgkin Lymphoma. We plan to use the findings from this study to better understand Hodgkin Lymphoma survivors' health and quality of life.
All Patients between 18 and 65 years are asked 6 month after investigation for chest pain or palpitation at Cardiological Out-patient Clinic, Molde Hospital, about if they still have symptoms of chest pain or palpitation. If they still have some of the symptoms they are invited to participate in a coping course to learn a better way to deal with their symptoms. The coping course consist of three sessions of cognitive behaviour therapy.
This is a pilot study analyzing the effect of sildenafil therapy on digital ulcers in systemic sclerosis. We want to analyze ulcer healing by measuring the size of digital ulcers and their count and analyze the effect of sildenafil on angiography. INVESTIGATOR: Dr. Gabriela Riemekasten Anke Praast Prof. G. R. Burmester Prof. Falk Hiepe OBJECTIVES: Sildenafil is a very potent drug in the treatment of digital ulcers secondary to Raynaud´s phenomenon in patients with connective tissue diseases. Probably, sildenafil has a disease-modifying capability improving different signs of a disturbed regulation of vascular tone in connective tissue diseases. Sildenafil can be used over a long period without significant side effects in scleroderma patients and improves disease severity, life quality, and prognosis of patients with connective tissue diseases and secondary Raynaud`s phenomenon. SUBJECTS and CENTERS: We want to study 10-15 patients with digital ulcers secondary to connective tissue diseases and which are refractory to other drugs, such as calcium channel blockers or iloprost. In this pilot study, patients are treated only in the Charité University Hospital. INCLUSION/EXCLUSION CRITERIA 1 . Digital gangrene, ulcers in patients with severe secondary Raynaud`s phenomenon 2. Stable therapy with vasoactive drugs, such as calcium channel blockers, angiotensin inhibitors/AT II receptor antagonists or pentoxifyllin 4 weeks before and during the treatment with sildenafil. 3. Unchanged immunosuppressive therapy 3 months before treatment with sildenafil 4.