mteb/BIRCO-ClinicalTrial-Test huggingface dataset:
This Post-Marketing Observational Study (PMOS) was conducted to assess the effectiveness of adalimumab on reducing synovitis (inflammation of the synovial membrane, which lines movable synovial joints, such as shoulders, elbows, wrists, knees, and hips) in adult participants with Rheumatoid Arthritis (RA) in Egypt. B-mode ultrasonography data was collected from participants receiving adalimumab treatment who had not been treated with any other anti-tumor necrosis factor (anti-TNF) therapy in the past. This study was a prospective, observational, single arm, multicenter study. Participants were treated with adalimumab in accordance with usual clinical care practices and local marketing authorization requirements. A total of 5 visits were planned: Baseline (Visit 1), Visits 2, 3, 4 and 5 (Week 13). The time interval between the baseline visit and the second visit was approximately 2-3 weeks, with a window of one week. Additional study objectives were to investigate the rate of RA progression via changes in the B-mode ultrasonography assessment score over time as well as changes in the number of joints with erosion over time. The study was terminated due to low enrollment.
The study compares the efficacy and safety of modified release prednisone versus immediate release prednisone in patients suffering from polymyalgia rheumatica. The study consists of a screening phase, followed by a 4 week double-blind phase. During the double-blind phase, the patients will be randomised in a 1:1 ratio to either Lodotra® or immediate release prednisone (prednisone IR) plus respective placebo. After completion of the double-blind phase, patients will be re-randomised in a 1:1 ratio to open-label Lodotra® or prednisone IR for 48 weeks. During the open-label phase, the dose of study medication will be tapered based on titration criteria.
The primary objective of this study is to obtain implant survivorship and clinical outcomes data for commercially available Persona fixed bearing knee implants used in total knee arthroplasty. The assessment will include implant survivorship and clinical performance measured by pain and function, quality of life data, radiographic parameters and survivorship. The study design is a prospective, multicenter, study of the commercially available Persona fixed bearing knee implants. The study will require each site to obtain Institutional Review Board (IRB) approval prior to study enrollment. All potential study subjects will be required to participate in the Informed Consent Process. All study subjects will undergo preoperative clinical evaluations prior to their total knee arthroplasty. The post-operative clinical and radiographic evaluations will be conducted at 6 weeks, 6 months, 1 year, 2, 3, 4, and 5 years.
We aimed to investigate if adiponectin facilitates diagnosis of ARF by analyzing adiponectin levels in acute and convalescent periods of the acute rheumatic fever and by comparing results with that of healthy control group; also by comparatively examining levels of adiponectin in ARF cases who had different clinical findings at presentation. In addition, we aimed to investigate its role in the pathogenesis of ARF by evaluating correlations with cytokines such as TNF-α, IL-6 and IL-8 and acute phase reactants. Totally, 33 children (age range: 5 - 17 years; 15 male and 18 female) were enrolled to the study who were diagnosed as ARF at the Pediatric Cardiology Department, Medical Faculty, Eskişehir Osmangazi University. The study protocol was approved by Ethics Committee of Medical Faculty, Eskişehir Osmangazi University (Decision No. 41 dated June 4, 2008). Parents of study participants were informed about the aim and the method of the study and written consents were obtained. For the study subjects, diagnosis of ARF was made according to the Modified Jones criteria (4) and appropriate treatment was started. Patients were divided into three groups by clinical findings. Group 1 included patients with only chorea, while patients with arthritis and carditis were involved in Group 2 and patients with only carditis were included in the Group 3. A group with only arthritis was not established since the patients with isolated arthritis are usually followed up at primary and secondary healthcare facilities rather than referring those patients to our tertiary healthcare center.
For post-menopausal women diagnosed with hormone-receptor positive breast cancer tumors, aromatase inhibitors (AIs) are the standard adjuvant hormone treatment to prolong disease-free survival and time-to-recurrence. Unfortunately, joint pain/stiffness/achiness (arthralgia) is a common side-effect of AIs. This "proof-of-concept" study explores how an evidence-based physical activity (PA) program- the Arthritis Foundation's Walk with Ease (WWE) program- can be adapted for breast cancer survivors on AI therapy to: 1) Help them maintain or achieve recommended levels of PA, 2) reduce their joint pain/stiffness/achiness, and 3) thereby enable them to remain on AI therapy as prescribed.
1.0 BACKGROUND AND HYPOTHESES 1.1 Osteoarthritis is a continuous and entirely physiologic adaptive process that occurs in every joint. These include the replication of cells that produce matrix, enzymes, protease inhibitors, cytokines, and other peptides. Along with the synthesis of new tissue there is a release of breakdown products into the synovial fluid. Enzymes and phagocytes are required to clear these breakdown products. Normal tissue turnover involves synthesis and breakdown in well-regulated balance. In the degenerative state this balance is upset producing inflammation-derived alterations to the synovium, cartilage, capsule, tendons, and bone. Common causes of such alterations include increased loading, physical stress, and traumatic injury to the joint. 1.2 The rationale for the use of corticosteroids in temporomandibular joint therapy is that they inhibit prostaglandin synthesis and decrease the activity of collagenase and other enzymes that degrade the articular cartilage. Platelet rich plasma is a novel therapeutic agent that has several potential advantages over corticosteroids for the treatment of degenerative pathology of the temporomandibular joint. Platelet rich plasma has been shown to have anti-inflammatory, analgesic, and anti-bacterial properties. It also restores intra-articular hyaluronic acid, increases glycosaminoglycan condrocyte synthesis, balances joint angiogenesis, and provides a scaffold for stem cell migration. Autologous platelet rich plasma injections for treatment of knee cartilage degenerative lesions and osteoarthritis have shown longer efficacy than hyaluronic acid injections in reducing pain and recovering articular function.
Researchers at the Hospital for Special Surgery are trying to learn more about post-operative rheumatoid arthritis flare (RA). This study hopes to understand RA flare after total joint replacement surgery and what the result of flaring is for patients over the next year. We will ask patients about their RA, whether it has gotten worse, and whether they are able to work with the physical therapist. During the course of this study, we'll be collecting questionnaires, and we'll be drawing blood to better understand what's going on with RA and with a patient's recuperation from their joint replacement. We want to understand whether a flare of RA might affect the outcome of a patient's joint replacement. We believe this study might show us how to better manage patients with rheumatoid arthritis following a joint replacement. If RA patients who flare are unable to participate in physical therapy and do worse after one year after a total hip replacement, more effective treatment could be developed. The study will also help us to identify early factors that may influence long-term outcomes of joint replacements in RA patients. The condition to be studied is worsening (flare) of rheumatoid arthritis (RA) in patients who have undergone arthroplasty. RA patients undergoing arthroplasty most often have severe, erosive disease. If the rate of flare approaches the estimated 26% rate suggested in a previous study for RA patients after arthroplasty (Johnson ACR 2011), this could be of significance in regards to their long term arthroplasty and disease outcomes.
Rheumatic fever (RF) is an autoimmune disease that is mediated by the cellular and humoral immune response that follows an untreated pharyngeal Streptococcus pyogenes infection. The most serious complication is rheumatic heart disease (RHD), one of the most common problems facing children and young adults worldwide, which leads to chronic valvular lesions. It is estimated that 60% of all acute rheumatic fever cases will develop RHD. The pathogenesis of RHD is complex with both environmental and genetic factors contributing to its etiology. The investigators know little about the genetic etiology, cellular events and modifiers of progression of RHD, and there exists a wide range of disease severity and progression to severe valve pathology. Thus, the investigators will study the genetics of RHD in Rwanda, a country with a very high incidence of RHD, using a combination of next-generation targeted exome capture, transcriptomics, and expressed quantitative trait loci (eQTL) analysis. There are an estimated 2.4 million children between 5 and 14 years of age affected by RF and/or RHD in developing countries of the world, approximately one million of whom live in sub-Saharan Africa (>40%) (1). A systematic review of prevalence studies found exceptionally high rates of RHD in sub-Saharan Africa, with the highest level found at 30.4 cases per 1000 children in Mozambique (2,3,4,5). At present, no specific treatment for rheumatic heart disease exists other than for its complications, including heart failure, atrial fibrillation, ischemic embolic events, and infective endocarditis.
Aldosterone and its target the mineralocorticoid receptor are implied in development of cardiovascular disease such as arterial high blood pressure or cardiac failure. Serum aldosterone level is insufficient to know if the mineralocorticoid receptor is activated or not. The aim of this study is to identify biomarkers of mineralocorticoid receptor activity. The first "candidate biomarker" is Neutrophil gelatinase-associated lipocalin (NGAL) or "lipocalin" which being measured in blood or in the urine. According to scientific knowledge's evolution, others biomarkers could be tested later thanks to the blood or urinary samples taken during study. This study is broken up into 5 groups: The first is a pre-analytical study to determinate optimum conditions for lipocalin samples. The second focuses on intra-individual variations of lipocalin levels in blood and urine. The third determinate the normal values of lipocalin in blood and urine. Fourthly, we study the role of renal function on serum and urines lipocalin levels. Fifthly, we study the role of anti-aldosterone treatment on patients who suffer of primary hyperaldosteronism.
The study will evaluate the radiographs (x-rays) of 100 patients with a TriFIT total hip at 2 weeks, 3 months, 6 months, 12 months, and yearly following surgery to see if there has been any movement or wear in the hip stem over the course of the study. The study will also record clinical data on each patient using various functional tests and questionnaires at the same intervals. The present study will prospectively recruit 100 patients scheduled for elective total hip replacement with Corin's TriFIT Hip System at the Ottawa Hospital - General Campus. As part of their clinical care, patients routinely undergo a clinical examination and have had radiographs taken at 2 weeks, 3 months, 6 months, 12 months, and yearly following surgery. Using specialized software, radiographs from each interval will be examined to assess femoral stem migration and joint wear patterns. Femoral stem migration will be assessed using computer-assisted software. The study will also assess the rate of implant failure during the first two post-operative years. Clinical assessments and questionnaires will also be completed during each of the follow-up intervals.
The purpose of this study is to investigate whether there are genetic differences between patients with rheumatic heart disease and members of the general population. The investigators will micro-array genotype approximately 300,000 single nucleotide polymorphisms (SNP) using DNA samples from patients with rheumatic heart disease (cases) from New Caledonia and Fiji, and members of the general population (controls) from New Caledonia, Vanuatu and Fiji. The investigators will perform standard quality control checks on the SNP data using measures such as call rate, heterozygosity, duplication and relatedness, and exclude variants on the basis of deviation from Hardy-Weinberg equilibrium and minor allele frequency. We will also impute variants not present on the micro-array with reference to the latest release of 1000 Genomes data and whole-genome sequence data from sixty Melanesian individuals from New Caledonia from the phenotypic extremes in this study. The investigators will conduct a discovery analysis in using a genome-wide association study approach focusing on Oceanic cases and controls from the Francophone nations of New Caledonia and Vanuatu. This analysis will be corrected for bias due to population stratification using the Linear Mixed Model (LMM) and consider additive, dominant and recessive genetic models. The investigators will then perform LMM association testing for variants with P-value in the discovery analysis less than 1x10^-5 in Oceanic cases and controls from Fiji and combine the association statistics by fixed-effects meta-analysis. The investigators will consider variants with significant effects in the same direction in discovery and replication analyses with combined P-value less than 1x10^-8 to have replicated.
While there has been progress in juvenile idiopathic arthritis (JIA) management, there is no cure. Despite receiving standard of care, many children live with pain. Thus, it is not surprising that families turn to complementary and alternative medicines (CAM) therapies, including massage therapy (MT). Little is known about the efficacy of MT in JIA. In this project, a massage therapist will teach parents how to provide a massage to their child with JIA at bedtime, at home. The feasibility of establishing a home MT program for children with JIA will be evaluated. In addition, the effects of MT on JIA will be examined. This proposal is relevant to JIA families, who ask questions on MT to professionals of the JIA clinic. Beyond providing education to JIA families, this project demonstrates the team approach to JIA management. Team members will include a pediatric rheumatology nurse and a massage therapist. While research breakthroughs have led to improved outcomes, many patients with JIA live with pain. There is an association between daily fluctuations in JIA symptoms (pain, stiffness and fatigue), and worse mood and stressful events, supporting the utility of daily diaries to analyze JIA symptoms. Sleep disturbances have been demonstrated in JIA and are linked to the pain experience. Ultimately, pain impacts on HRQoL. JIA families explore complementary and alternative medicines such as MT, in addition to using conventional medicines, to help manage the daily JIA symptoms.
The investigators will include patients attending outpatient clinic in the area of Orthopedics and Traumatology of our hospital with a diagnosis of unilateral Patellofemoral Pain Syndrome. Inclusion criteria are: age between fifteen and thirty-five years, presenting unilateral PFPS with six months of evolution, presenting anterior or retro knee pain that presents itself when undergoing two or more of the following activities: squatting, running, kneeling, jumping, or climbing stairs; physically active patients, with at least thirty minutes of physical activity at least three times per week. Exclusion criteria include patients with previous knee surgeries, chronic pain with more than one year of evolution, pregnancy or suspected pregnancy, application of intra-articular steroids in the three months prior to their evaluation, patients with meniscal injuries, ligament or intra-articular knee structures, degenerative diseases such as diabetes, rheumatoid arthritis, OA of the knee, hip or ankle, history of dislocation or subluxation of patella, Osgood Schlatter syndrome and patellar tendinitis or quadriceps. The investigators will divide patients into two groups. The control group will receive treatment with acetaminophen and physical therapy rehabilitation, closed chain exercises and stretches at home intended for the strengthening of quadriceps, abductors and internal rotators of the hip for the duration of six weeks. The experimental treatment group will receive the above plus the application of the technique NUCAP Medical Upper Knee Spider ® Kinesio taping on the affected knee.
Rheumatic heart disease remains a major challenge in low and middle income countries. Early detection of clinically silent valvular lesions by screening echocardiography allows timely implementation of secondary antibiotic prevention, and may prevent progression of disease to severe valvular damage and heart failure. The objective of the study is to assess the prevalence of rheumatic heart disease among schoolchildren in Arequipa, Peru. Subsequently, the investigators will evaluate progression of disease in children with early stages of subclinical rheumatic heart disease. The investigators will perform a population-based observational survey for rheumatic heart disease using portable echocardiography among schoolchildren aged 5 to 16 years from randomly selected public and private schools. Rheumatic heart disease will be documented both according to the modified World Health Organization definition and the echocardiographic criteria suggested by the World Heart Federation. Background Rheumatic fever complicated by rheumatic heart disease continues to be a major contributor to morbidity and premature death in low- and middle-income countries where it accounts for up to a quarter of a million deaths every year. Rheumatic fever results from an autoimmune response to groups A streptococcal pharyngitis and may progress to rheumatic heart disease with cumulative exposure. Data on prevalence of rheumatic heart disease in Latin America is scarce and ranges from 1.3/1000 as assessed by cardiac auscultation to 4.1/1000 as assessed by echocardiography. Secondary antibiotic prevention and inclusion of patients with rheumatic heart disease in a registry with close follow-up has been demonstrated to reduce the cardiovascular sequelae associated with disease progression.
The purpose of this study is to determine whether daily treatment with Streptococcus Salivarius BLIS K-12 prevents streptococcal throat infection in children that have had an episode of rheumatic fever. Children diagnosed with Rheumatic fever are currently given preventive streptococcal treatment with either monthly IM (intramuscular injection) Penicillin or daily oral Penicillin. This preventive treatment is recommended for years until the child is 20 y old or even later. The compliance rate for this treatment declines significantly with time (the injections are painful) and even with good adherence the prevention is not complete. In the last few years a new product licensed as "BLIS K-12" has been developed and approved by FDA as GRAS (generally recognized as safe) status from 2011. This probiotic treatment prevents the pathogenic Strep A from adhering to the throat of the child thus preventing the infection. This kind of prevention is better for the long run for the patient and for the surrounding, It is better tolerated, is effective even if a dose is skipped or missed is not painful and is tasty to the children. So the investigators assumption is that giving this product to children instead of Penicillin either orally or intramuscularlly will be better tolerated thus give a better protection profile with much less side effects. The investigators will be giving BLIS K-12 to those children on the trial on a daily basis for 6 autumn-winter months instead of Penicillin and will monitor the children by monthly throat swabs.
Neutrophils emerge as key immune cells in the initiation and perpetuation of immune responses in autoimmune diseases. They display marked abnormalities in phenotype and function in various autoimmune diseases, including systemic vasculitis, systemic lupus erythematosus (SLE) and rheumatoid arthritis (RA). These neutrophils are characterised by an extended life span, increased capacity to produce reactive oxygen species, active gene expression and release of extracellular traps. Consequently, there is a need for better understanding of neutrophil phenotype and functions in these conditions, as well as for identifying molecules capable of specifically manipulating neutrophil function. The investigators have recently discovered that interferon lambdas (IFN-λs), also known as interleukin 28 (IL28) and interleukin 29 (IL29), class II cytokines with previously studied anti-viral biological functions, specifically suppress neutrophil infiltration and interleukin-1β production and thereby, halt and reverse the development of collagen induced arthritis (CIA). The investigators propose to further investigate the cellular and molecular mechanisms behind this suppression and examine the translational potential of the investigators' finding by examining the IFN-λ receptor expression and function in neutrophils isolated from the blood of healthy donors and rheumatic patients (early rheumatoid arthritis and vasculitis). Expression of Interferon lambda receptor 1 (IFNLR1)/interleukin 28 Receptor Alpha (IL28RA) in human neutrophils. Neutrophils will be isolated from freshly drawn human blood with subsequent removal of red blood cells with dextran and/or magnetic-activated cell sorting (MACS).
Objective:To present an extremely rare site of occurrence of endometriotic cyst in the layers of Broad Ligament. Patient:A 32 yrs.old woman,married 4 yrs.,presented to OB-GY Dept.with acute,gnawing pain in lower abdomen and history of sub-fertility.Diagnostic Laparoscopy and pelvic ultrasound were performed in emergency.Oblong cyst structure,41x21x23mm in the left adnexa,away from ovary and uterus was identified and excised by Four Port laparoscopic interventional surgery. Endometriosis is the second most common finding in the pelvis of females in their reproductive age, frequently associated with primary infertility. Endometrioma, within layers of broad ligament has been reported, but only in four cases, so far. Contributing factors in the etiopathogenesis of endometriosis and endometriomas are retrograde menstrual flow, metaplasia, genetic predisposition, lymphatic/ vascular distribution, immune dysfunction and environmental influences. Etiopathogenesis of endometriosis is still poorly understood, the main theories being embryonic, migratory and immunologic. Embryonic theories suggest that endometriosis develops from the remnants of wolffian ducts or the Mullerian ducts or may develop from the metaplasia of the peritoneal or the ovarian tissue. Migratory theories suggest transportation of endometrial tissue to distant places via fallopian tubes or, lymphovascular structure and subsequent implantation as the cause of endometriosis. Immunologic theory implies that altered immune response may help in ectopic endometrial implantation. However, all these mechanisms may act synergistically and not in exclusion of each other.
This is a single-centered trial of a group A streptococcal (GAS) vaccine, StreptAnova™. The study is designed to assess safety and immunogenicity of three doses (0, 1, 6 months) of one dosage (600 µg protein) in healthy adults 18 through 50 years of age. This is a single-centered trial of a group A streptococcal (GAS) vaccine, StreptAnova™, to be performed in Canada. It will be randomized, observer-blinded, and comparator controlled. The study is designed to assess safety and immunogenicity of three doses (0, 1, 6 months) of one dosage (600 µg protein) in healthy adults 18 through 50 years of age. A comparator vaccine is included at 2:1 ratio (StreptAnova™ to comparator). Assignment to StreptAnova™ or comparator vaccine will be both randomized and observer-blinded. Three (3) 0.6 mL doses (600 µg protein) of StreptAnova™ or 0.5 mL doses of comparator will be administered on days 0, 30 and 180 (N= 30 StreptAnova™, 15 comparator); each subject will receive three doses of the same treatment. Forty-five subjects will be enrolled. At each vaccine dose, detailed safety data will be collected from the first 15 randomized subjects until seven days after administration and used to determine whether to proceed to immunizing the 30 remaining subjects. Detailed safety data will be collected from the remaining 30 randomized subjects until seven days after administration and used to determine whether to proceed to immunizing the first 15 randomized subjects at the next dose.
The main purpose of this study is to learn if adding the investigational drug RO7009789 (anti-CD40) to nab-paclitaxel and gemcitabine both before surgery and after surgery is safe, feasible, and beneficial to patients with pancreatic cancer. This study also intends to look at blood and tissue samples to help doctors better understand the role of the immune system in fighting cancer.
Evaluate efficacy, safety and tolerability of tofacitinib in pediatric JIA patients. This is a randomized withdrawal, double blind, placebo controlled study of pediatric subjects (2 to <18 years of age) with JIA. The primary objective is to compare the efficacy of tofacitinib versus placebo for the treatment of signs and symptoms of JIA at Week 26 of the double blind phase as measured by the percentage of subjects with disease flare (according to PRCSG/PRINTO Disease Flare criteria) after Week 18 of the open label run in phase.All eligible subjects enrolled in the study will initially receive open label tofacitinib for 18 weeks (run in phase). At the end of the 18 week run in phase, only subjects who achieve at least a JIA ACR 30 response will be randomized to the 26 week double blind, placebo controlled phase. Subjects who do not achieve a JIA ACR 30 response at this time point will be discontinued from the study. In addition, subjects who experience a single episode of disease flare at any time during the study (including the open label run in and double blind phase) will also be discontinued from the study. All subjects participating in this study, including those discontinued from the study, will have the option, if eligible (based on inclusion and exclusion criteria), of enrolling in the tofacitinib JIA long term extension study (A3921145).
Exercise is effective at reducing pain while improving physical function. However we do not know if exercise can boost resilience in the workplace, to allow people with osteoarthritis to work as long as they desire. Previous research shows that exercise holds the most promise for helping people enjoy their work because it reduces sick time, reduces pain, and improves productivity. However, little work has examined the effect of exercise for people with arthritis in the workplace. The purpose of the study is to investigate whether exercise improves resilience in the workplace, mobility, fitness, strength, and pain in comparison to no exercise in those with knee and/or hip osteoarthritis. The Canadian workforce is aging. The most prevalent age group is 50-54 years and most of these Canadians will aim to continue working over the next 10 years. However, the impact of arthritis on aging Canadians compromises their ability to continue working. By 2031, over 2 million Canadians aged 45 to 64 years will have arthritis. We aim to boost the ability of older adults with the most common arthritis, osteoarthritis (OA), to engage in the workforce for as long as they desire. Identifying strategies to promote productivity among older workers with knee and hip OA will be of great public health significance in the coming decades. However, we face two challenges. First, obesity among sedentary workers is a risk for worsening knee and hip OA.
The purpose of this study is to evaluate treatment retention in psoriatic arthritis participants with STELARA or tumor necrosis factor alpha inhibitor (TNFi) therapies in relation to effectiveness, safety, benefit/risk and to examine clinical response. This is a prospective, observational, cohort study to collect data on adult participants who have a confirmed diagnosis of psoriatic arthritis (PsA) and are starting STELARA or TNFi as a first, second, or third line of biologic disease-modifying antirheumatic drug (bDMARD) therapy. Approximately 1,400 paticipants will be enrolled into this study, with 700 participants who are receiving STELARA at study entry and 700 participants who are receiving a TNFi therapy at study entry. Recruitment into the study will continue for 2 years, with a 3-year follow-up period. For each participant, the follow-up period will continue for a maximum of 3 years (36 months) after inclusion into the study. Participants will primarily be asessed for parameters of treatment retention, clinical response, effectiveness and safety over an observational period of 36 months.
To determine the long-term efficacy of the combination therapy of phentermine and fenfluramine in conjunction with diet, exercise, and behavior modification in the treatment of simple, moderate obesity. BACKGROUND: Obesity is a problem of significant public health concern both in this and other western countries. One reason is that it is a risk factor for cardiovascular disease, most notably hypertension. For example, in the Framingham study it was found that relative body weight, weight change during observation, and skin fold thickness were related to existing blood pressure levels and to the subsequent rate of development of hypertension. Additionally, for previously normotensive individuals, the risk of developing hypertension was proportional to the degree of overweight. Obesity is also a major risk factor for type II diabetes mellitus. On the other hand, some overweight individuals are physically healthy but suffer from the psychosocial consequences of their condition so that losing weight would be desirable for them as well as for individuals more at risk for physical illness. Like essential hypertension, obesity is not only a chronic condition for many individuals but it is also a heterogeneous condition with many underlying causes and interacting factors. It is generally difficult to treat because it is a chronic problem, success comes slowly, and physicians in practice generally understand the condition rather poorly and do not manage it well. Results from studies of caloric restriction, behavior modification and medication have often been disappointing both to the subjects and their physicians.
RATIONALE: Radioactive iodine may be effective in reducing the rate of recurrence of liver cancer after surgery to remove the tumor. It is not yet known if radioactive iodine is more effective than no further treatment after surgery. PURPOSE: Randomized phase III trial to determine the effectiveness of radioactive iodine in treating patients who have undergone surgery for liver cancer. OBJECTIVES: - Compare the effect of adjuvant hepatic intra-arterial iodine I 131 lipiodol vs observation in terms of rate of recurrence and overall survival of patients with curatively resected hepatocellular carcinoma. OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center. Patients are randomized to 1 of 2 treatment arms. - Arm I: Within 4-6 weeks after prior resection, patients receive adjuvant hepatic intra-arterial iodine I 131 lipiodol once. - Arm II: After prior resection, patients undergo observation. Patients are followed monthly for 1 year and then every 3 months thereafter. PROJECTED ACCRUAL: A minimum of 300 patients (150 per treatment arm) will be accrued for this study.
This phase II trial is studying how well decitabine works in treating patients with metastatic papillary thyroid cancer or follicular thyroid cancer that has stopped responding to radioactive iodine. Iodine I 131 (radioactive iodine) kills thyroid cancer cells. Metastatic thyroid cancer cells can lose the ability to be treated with radioactive iodine. Decitabine may help thyroid cancer cells regain the ability to respond to treatment with radioactive iodine. PRIMARY OBJECTIVE: I. Determine whether decitabine can restore iodine I 131 (131I) uptake in patients with metastatic papillary thyroid or follicular thyroid cancer lesions that are undetectable by low-dose iodine 131I scanning. SECONDARY OBJECTIVES: I. Determine the efficacy of 131I therapy, administered after restoration of 131I uptake by decitabine, in these patients. II. Determine the effect of decitabine on clinical and molecular markers of thyroid cancer cell differentiation in these patients. III. Determine the safety and tolerability of decitabine in patients undergoing thyroid hormone withdrawal-induced hypothyroidism and 131I therapy. OUTLINE: This is an open-label, multicenter study. Patients receive decitabine intravenous (IV) over 1 hour on days 1-5 and 8-12 of weeks 1 and 2 (course 1). On week 3, patients undergo iodine I 131 (131I) scanning using thyrotropin alfa injections. Patients whose scan does not demonstrate iodine uptake continue suppressive thyroid hormone therapy but receive no further study therapy. These patients undergo study follow up.
The thyroid cells take up iodine, and radioactive iodine is commonly used to irradiate residual thyroid tissue and thyroid cancer following surgical removal of the thyroid gland (thyroidectomy). A whole body radioactive iodine scanning is usually carried out after thyroidectomy to assess the amount of thyroid tissue left behind at surgery (that might still contain cancer), and to evaluate the presence of iodine avid lesions elsewhere in the body (that might be cancer metastases). A large dose of radioactive iodine is often given, still the optimal iodine dose to ablate the thyroid remnant after surgery is not known. In this study, two radioactive iodine doses are compared in the ablation of the thyroid remnant, a smaller (1110 MBq) dose and a larger (3700 MBq) dose. The study participants are randomly allocated using a 1:1 ratio to receive either the smaller or the larger radioactive iodine dose. These treatments are compared for safety, adverse effects, and the need for subsequent repeat treatments. The individual absorbed radiation doses are measured. The study hypothesis is that fewer repeat radioiodine treatments might be needed after the larger dose, but the larger dose might be associated with a higher frequency of adverse events. The study participants are randomly allocated to receive either a 1110 MBq or a 3700 MBq dose of radioiodine (131I) approximately 5 weeks after thyroidectomy.
The trials in this protocol deals with the effect of pretreatment with rhTSH on radioiodine treatment of thyroid size and function, in patients with nontoxic and toxic nodular goiter. It is an introduction of a novel principle, based on prospective, randomized double blind investigations. Attached to this, we investigate the acute effects of rhTSH on thyroid size (measured by ultrasonography), both in healthy individuals and in patients with nontoxic nodular goiter. Thus, the investigations are divided into 4 categories listed below: 1. Prospective randomized double blind study of pretreatment with 0.3 mg recombinant human TSH for the effect of radioiodine in nontoxic multinodular goiter. 2. Prospective randomized double blind study of the pretreatment with 0.3 mg recombinant human TSH for the effect of radioiodine on thyroid size and function in patients with a very large (>100 ml) nontoxic or toxic goiter. 3. Does administration of 0.9 mg recombinant human TSH affect thyroid function and volume in healthy individuals? A randomized double-blind cross-over trial. 4. Does administration of 0.3 mg recombinant human TSH affect thyroid function and volume in healthy individuals and in patients with multinodular non-toxic goiter? A randomized double-blind cross-over trial. As a final note we investigate, in a pilot-study; 5. The influence of rhTSH on thyroid radioiodine uptake in patients with hyperthyroidism treated with continuous block-replacement therapy.
Aim: In a phase II pilot study encompassing 20 patients with Graves’ disease to evaluate the effect of rituximab: 1. Biochemically as assessed by markers of disease activity ( free T4, free T3, TSH, TSH-receptor antibodies, anti-TPO) Background Rituximab is a chimeric murine/human anti-CD20 monoclonal antibody which was originally introduced in the clinic years ago for the treatment of malignant lymphomas. The antibody is an IgG1 kappa immunoglobulin containing murine light-and heavy chain variable region sequences and human constant region sequences. The Fab domain of rituximab binds to the CD20 antigen on B lymphocytes. Possible mechanisms of cell lysis include complement-dependent cytotoxicity, antibody-dependent cellular cytotoxicity, and induction of apoptosis. The mechanism(s) behind the favourable response of rituximab in autoimmune cytopenias are unsettled. A depletion of peripheral blood B cells occurs after just one antibody infusion. Accordingly, it has been proposed that opsonized CD20+ B cells inhibit and saturate macrophage Fc-receptor function and thereby clearance of IgG-coated blood cells by reticuloendothelial cells. Suppression of auto reactive B-cell clones may be another potential mechanism. Most recently several studies have shown that rituximab– also is very effective in the treatment of various autoimmune cytopenias and autoimmune diseases - idiopathic thrombocytopenic purpura (ITP), warm and cold autoimmune haemolytic anemias, autoimmune neutropenia, pure red cell aplasia, Wegener’s granulomatosis, systemic lupus erythematosus, membranous glomerulonephritis, and rheumatoid arthritis - , including disorders which have been considered to be primarily diseases elicited by aberrant T-cell responses, e.g., rheumatoid arthritis.
Background: The use of radioactive iodine (131I) therapy as the definite cure of hyperthyroidism is widespread. According to a survey on the management of Graves' disease, thirty per cent of physicians prefer to render their patients euthyroid by antithyroid drugs (ATD) prior to 131I therapy. This strategy is presumably chosen to avoid 131I induced 'thyroid storm', which, however, is rarely encountered. Several studies have consistently shown that patients who are treated with ATD prior to 131I therapy have an increased risk of treatment failure. Mostly, patients with Graves' disease have been studied, while other studies were addressed also toxic nodular goiter. Thus, it is generally accepted that ATD have 'radioprotective' properties, although this view is almost exclusively based on retrospective data and is still under debate. Indeed, this dogma was recently challenged by two randomized trials in Graves' disease, none of which showed such an adverse effect of methimazole pretreatment. It cannot be excluded that the earlier results may have been under influence of selection bias, a source of error almost unavoidable in retrospective studies. Whether ATD is radioprotective also when used in the post 131I period has also been debated. In the early period 131I therapy following a transient rise in the thyroid hormones is seen which may give rise to discomfort in some patients. The continuous use of ATD during 131I therapy, possibly in combination with levothyroxine (BRT: block-replacement therapy), leads to more stable levels of the thyroid hormones.
Background: The use of radioactive iodine (131I) therapy as the definite cure of hyperthyroidism is widespread. According to a survey on the management of Graves’ disease, thirty per cent of physicians prefer to render their patients euthyroid by antithyroid drugs (ATD) prior to 131I therapy. This strategy is presumably chosen to avoid 131I induced ‘thyroid storm’, which, however, is rarely encountered. Several studies have consistently shown that patients who are treated with ATD prior to 131I therapy have an increased risk of treatment failure. Mostly, patients with Graves’ disease have been studied, while other studies were addressed also toxic nodular goiter. Thus, it is generally accepted that ATD have ‘radioprotective’ properties, although this view is almost exclusively based on retrospective data and is still under debate (13). Indeed, this dogma was recently challenged by two randomized trials in Graves’ disease, none of which showed such an adverse effect of methimazole pretreatment. It cannot be excluded that the earlier results may have been under influence of selection bias, a source of error almost unavoidable in retrospective studies. Whether ATD is radioprotective also when used in the post 131I period has also been debated. In the early period 131I therapy following a transient rise in the thyroid hormones is seen which may give rise to discomfort in some patients.
To evaluate the short-term effects of structured lipids on appetite regulation. Background Obesity is a major health problem worldwide, and it is a risk factor for several chronic disorders. Even small changes in energy intake, leading to a positive balance may lead to weight gain over time. Thus, slight modifications in food intake, such as the inclusion of foods that effect energy balance, may prevent weight gain and even facilitate weight loss. Replacing dietary fat with low-calorie fat (LCF), such as modified triglycerides with medium and long chained PUFA.may be an efficient way to reduce body fat. Bray et al. (2002) has shown a sustained weight loss of ~6 kg over a 9 month period where one-third of a fat-reduced diet (25% fat) was replaced by olestra. This weight loss can not solely be explained by the decreased caloric content of olestra. Thus, inhibition of appetite leading to lower food intake, may be a potential mechanism of the observed weight loss. A reduced absorption of LCF leaves undigested fatty acids in the middle and lower intestine, which may generate increased feelings of satiety and decrease caloric intake due to regulating peptides and hormones such (CCK, GLP-1, etc.). In addition, intraduodenal fatty acids may also promote distension of the stomach and distension of the intestine, which are well-known gastrointestinal signals controlling mechanisms for food intake.
This is a randomized intervention that examines the effect of culturally adapted weight loss program in African American (AA) females age 40-65. Evidence suggests that AA women are more successful with weight loss programs that are culturally tailored (Karanja, et al, 2002). Take HEED is a combination of 2 interventions, Therapeutic Lifestyle Changes Diet (TLC) from ATP-III and the CHANGE exercise program, which have shown success independently in previous clinical trials with AAs. Project/study objective(s), This is a randomized intervention that examines the effect of culturally adapted weight loss program in African American (AA) females age 40-65. Evidence suggests that AA women are more successful with weight loss programs that are culturally tailored (Karanja, et al, 2002). Take HEED is a combination of 2 interventions, Therapeutic Lifestyle Changes Diet (TLC) from ATP-III and the CHANGE exercise program, which have shown success independently in previous clinical trials with AAs. Methods, The 21 month program (6 months active intervention and 15 months maintenance) is provided by a Nurse matched with the study participants for race, age, and gender. Take HEED uses behavior change strategies (Prochaska et al 1992) which have been modified to include spirituality, AA cultural materials and examples woven into the lesson plans, and sustained peer support. The diet has been modified to include calorie reductions, increased fruit/ vegetable and calcium intake, incorporation of AA ethnic recipes.
This project will compare the efficacy and safety of 2 methods of disease modification in the treatment of active moderate and severe thyroid orbitopathy. A prospective, randomized, double-blind, parallel, controlled multidisciplinary clinical trial involving Singapore National Eye Centre, National University Hospital, Changi General Hospital, Tan Tock Seng Hospital and University of British Columbia Orbital Services, Singapore Eye Research Institute, Singapore General Hospital Endocrinology and Radiology Departments and Tan Tock Seng Hospital Rheumatology Department is planned. The SingHealth-SGH High Field MR Research Laboratory will be involved in the MR imaging of the trial patients. Patients who satisfy the inclusion and exclusion criteria will be asked to participate in this trial. After informed consent (Appendix B) is obtained, each patient will be randomized into one of two treatment arms: 1) Intravenous high-dose pulsed methylprednisolone (1 gram infusion over 1 hour per day with a total of 3 doses over 3 days; 4 cycles at 6 weekly intervals) and oral placebo and 2) Intravenous high-dose pulsed methylprednisolone (same dose) plus oral methotrexate 7.5 mg per week for 2 weeks, increased to 10 mg per week for another 2 weeks then 12.5 mg per week for 5 months (total 6 months of methotrexate treatment). Depending on patient response, the dose can be further increased by 2.5mg per week every 4 weeks to a maximum of 20 mg per week.
The purpose of this project is to examine the impact of sleeping pills and waking up in the middle of the night on walking balance and cognitive function, to identify risk factors for falls in older adults. A significant percentage of falls, approximately 33 to 52 percent, occur during the nighttime and morning hours when people are normally sleeping; therefore, it is possible that sleep and sleeping medication related impairments in balance may contribute to this risk. Awakening from sleep is well documented to impair cognitive performance in young adults. This phenomenon, called sleep inertia, has been reported to impair performance just as much as one night of total sleep deprivation, suggesting that there are significant functional consequences to sleep inertia. However, whether walking stability is impaired by sleep inertia is unknown. If sleep inertia impairs walking stability, it could be an important but currently unrecognized risk factor for falls in older adults. Also, the impact of aging on sleep inertia-related impairments in cognitive performance is unknown. Sleeping medication use is higher in older than younger adults, and is a risk factor for falls. Current evidence suggests that sleeping medications impair walking stability and cognitive performance in young and older adults during wakefulness; however, no study has examined walking stability and cognitive performance of young and older adults upon awakening from sleep at night after taking a hypnotic (sleeping medication).
Thyroidectomy is an operation that is commonly performed. After an operation a pressure dressing by Hypafix is usually used due to the belief that it will help to reduce complications such as post-operative bleeding or haematoma. However, the practice is uncomfortable to patients and makes it hard to detect early haematomas. We carried out a prospective randomised study to study the role of pressure dressing after thyroid surgery by evaluating the amount of fluids collected in the operative bed by ultrasonography compared with normal dressing. Thyroidectomy is an operation that is commonly performed. In Department of Otolaryngology, Khonkaen University was performed this operation about 200 cases per years. After an operation a pressure dressing by Hypafix is usually used due to the belief that it will help to reduce complications such as post-operative bleeding or haematoma. However, the practice is uncomfortable to patients and makes it hard to detect early haematomas. We carried out a prospective randomised study to study the role of pressure dressing after thyroid surgery by evaluating the amount of fluids collected in the operative bed by ultrasonography compared with normal dressing.