Kornimate/medical-research-clean huggingface dataset:
dual epicardial endocardial persistent atrial fibrillation(af) study (staged deep)

Conditions: Atrial Fibrillation

Summary: the purpose of this study is to assess the safety and technical feasibility of treating subjects with persistent atrial fibrillation or longstanding persistent atrial fibrillation in a minimally invasive thoracoscopic ablation procedure utilizing the atricure bipolar system, with mapping and additional lesion creation/ gap closure (as needed) provided by currently approved catheter technology, when the epicardial and endocardial phases are performed in a staged manner within 1-10 days apart, during the same hospitalization.

the purpose of this clinical investigation is to evaluate how safe a less invasive cardiac surgery using the atricure bipolar system in conjunction with a catheter ablation procedure performed approximately 1-10 days after, in treating atrial fibrillation, and how effective is this staged procedure. the atricure bipolar system will be used to perform the less invasive cardiac surgery and a standard electrophysiology catheter, currently available, will be used to perform the catheter ablation procedure. this surgical procedure is considered less invasive because it is done through tiny surgical punctures on the sides of the chest near the ribs instead of one large surgical incision of the breast bone to completely open the chest and access the heart, and it also avoids the need for the heart-lung bypass machine.

Eligibility criteria:
inclusion criteria: * age \> 18 year * patients with symptomatic persistent or longstanding persistent af refractory to a minimum of one class i or iii antiarrhythmic drug (aad). * patients with failed catheter ablation attempts are eligible if the patients are symptomatic with persistent or longstanding persistent af. (catheter ablation procedure must be more than 3 months prior to index procedure) * life expectancy of at least two years * patient will and able to provide informed consent * patient is willing and able to attend the scheduled follow-up visits exclusion criteria: * prior cardiothoracic surgery * patient has nyha (new york heart association) class iv heart failure * evidence of underlying structural heart disease requiring surgical treatment * surgical procedure within the 30 days prior to the index procedure * ejection fraction \< 30% * measured left atrial diameter \> 6.0 cm * renal failure * stroke within previous 6 months * known carotid artery stenosis greater than 80% * evidence of significant active infection or endocarditis * pregnant woman or women desiring to become pregnant in the next 24 months * presence of thrombus in the left atrium determined by echocardiography * history of blood dyscrasia * contraindication to anticoagulation, based on investigator's opinion * mural thrombus or tumor * moderate to severe copd

Keywords: persistent af longstanding persistent af ablation catheter ablation
prospective pecutaneous coronary intervention registry

Conditions: Coronary Artery Disease; Percutaneous Coronary Intervention

Summary: coronary artery disease is the most important cause of death worldwide. treatment option for coronary artery disease is medical treatment, percutaneous coronary intervention, or coronary artery bypass surgery. among them, the field of percutaneous coronary intervention is rapidly developing with regard to the improvement of devices, techniques, or medical treatment, leading to reduce mortality or morbidity. until now, numerous previous studies related to the risk factors of coronary artery disease and the prognosis of patients have been conducted. however, the field of percutaneous coronary intervention is rapidly evolving, and treatment strategies are constantly being updated. therefore, the current study sought to identify the long-term prognosis and related risk factors of patients with coronary artery disease who underwent percutaneous coronary intervention.


Eligibility criteria:
inclusion criteria: * patients who have undergone or are scheduled to undergo coronary angiography and percutaneous coronary intervention. exclusion criteria: * patients who did not consent to the research
clinical and functional results after total elbow arthroplasty

Conditions: Elbow Fracture; Elbow Arthropathy; Elbow Osteoarthritis

Summary: analysis of clinical and functional outcomes after a total elbow arthrosplasty, all indications combined, with a minimum follow up of 24 months the hypothesis is that there a significant improvement after an elbow replacement, no matter what the surgery indication is


Eligibility criteria:
inclusion criteria: * total elbow arthroplasty, all indication combined exclusion criteria: * less than 24 months of follow up * revision of total elbow arthroplasty
kids intestinal dysfunction in congenital heart disease: the kind heart study

Conditions: Congenital Disease

Summary: approximately 40,000 infants are born each year in the united states with congenital heart defects (chd), and heart defects are the leading cause of birth defect-related deaths in the united states. while advances in surgical treatment, cardiac bypass, and post-operative management have improved mortality for children born with heart defects, these children continue to have significant morbidity related to post-operative malnutrition, multiple organ dysfunction (mods), and sepsis. proposed mechanisms for post-operative sepsis and mods is via loss of intestinal epithelial barrier function (ebf) or intestinal micro biome diversity. the purpose of this multi-center observational cohort study is to understand the extent to which practice variation for routine post-operative care might worsen intestinal barrier dysfunction and reduce diversity of the intestinal microbiome for infants undergoing surgical correction of left sided cardiac obstructive defects. we will enroll 80 children with left sided obstructive congenital cardiac lesions across several us congenital cardiac centers to obtain clinical data and biological specimens. we will leverage existing differences in nutritional and antibiotic strategies at these centers to better understand how intestinal barrier function and the intestinal microbiome may contribute to post-operative multiple organ dysfunction syndrome.


Eligibility criteria:
inclusion criteria: * pre-operative diagnosis of left sided obstructive congenital cardiac defect exclusion criteria: * corrected gestational age \< 37 weeks at time of surgery * short bowel syndrome * intestinal graft vs. host disease * inflammatory bowel disease (ulcerative colitis, or crohn's disease) * candidate for intestinal transplant * history of necrotizing enterocolitis (nec) * previous randomization into this study

Keywords: heart multiple organ dysfunction syndrome pediatric critical care congenital heart disease
tcp regimen in newly diagnosed mcd:a prospective, single-center, single-arm, phase-ii pilot trial

Conditions: Multicentric Castleman Disease

Summary: to explore the effectiveness and safety of thalidomide, cyclophosphamide and prednisone (tcp regimen) in newly diagnosed multicentric castleman's disease (mcd) patients.

this is a single center, open-labeled , single arm, phase-ii pilot study which aims to evaluate the efficacy and safety of thalidomide, cyclophosphamide and prednisone (tcp regimen) in newly diagnosed multicentric castleman's disease (mcd) patients.there would be two phases of the study. the treatment and the response evaluation phase will last from the time of enrollment up to 24 months (evaluation will be carried out every 3 months). the follow-up phase to assess for progression of disease will last from 24 months (2 years) to 4 years after enrollment (evaluation will be carried out every 12 months).the total study duration will be 4 years after the last patient starts study medication.

Eligibility criteria:
* inclusion criteria: * ≥18 years, all race/ethnic groups in china； * newly diagnosed and previously untreated (patients are allowed to have received oral prednisone for up to 1 week before enrollment) symptomatic mcd patients (symptomatic disease is defined by the presence of clinical symptoms with the nci-ctcae grading ≥1 that are attributable to the disease, and for which treatment is indicated); * eastern cooperative oncology group (ecog) performance status ≤2; * clinical laboratory values meeting these criteria at screening: absolute neutrophil count ≥ 1•0 x 109/l, platelets ≥ 50 x 109/l, alanine aminotransferase (alt) within 2•5 x upper limit of normal (uln); total bilirubin within 2•5 x uln; estimated glomerular filtration rate (according to mdrd formula) \<15ml/min; * women of childbearing potential must agree to use birth control measures during the study and for at least 3 months after receiving the last dose of study agent, and must have a negative pregnancy test at screening period. men must agree to use birth control measures during the study and for at least 3 months after receiving the last dose of study agent; * informed consent must be signed. * exclusion criteria: * age under 18 years; * ecog (eastern cooperative oncology group) status above 2; * immunosuppressive or anti-neoplastic drugs within the last 3 months; * serious diseases including malignancy; * plan to have babies within 1 year after enrollment (for women and men), or pregnancy / breast-feeding (for women); * known hypersensitivity to study agents; * active infection requiring systemic treatment; * other severe concurrent disease (eg. uncontrolled diabetes, symptomatic coronary heart disease) that is likely to interfere with study procedures or results, or that in the opinion of the investigator would constitute a hazard for participating in this study; * unwilling or unable to provide informed consent; * unwilling to return for follow-up at pumch.

Keywords: multicentric castleman's disease thalidomide, cyclophosphamide and prednisone (tcp regimen) efficacy safety
efficacy and safety of alxn1840 administered for 48 weeks versus standard of care in participants with wilson disease

Conditions: Wilson Disease

Summary: the study will evaluate the efficacy and safety of alxn1840 (formerly called wtx101) administered for 48 weeks compared to standard of care (soc) in wilson disease (wd) participants aged 12 and older in the primary evaluation period. in addition, efficacy and safety will be evaluated during an optional 60-month extension period.

the study consists of 2 cohorts. cohort 1: participants who have received soc therapy for \> 28 days and cohort 2: participants who are treatment-naïve or who have received soc therapy for ≤ 28 days. all enrolled participants were randomized by cohort in a 2:1 ratio to treatment with alxn1840 or soc (either as continued therapy in cohort 1 or as continued or initial therapy in cohort 2).

Eligibility criteria:
key inclusion criteria: * established diagnosis of wd by leipzig-score ≥ 4 * female participants of childbearing potential, if heterosexually active, must be willing to follow protocol-specified guidance for highly effective contraception starting at least 6 weeks before the day 1 visit and continuing through 28 days after the last dose of either alxn1840 or soc * male participants, if heterosexually active, must be willing to follow protocol-specified guidance for highly effective contraception beginning at day 1 visit and continuing through 90 days after last dose of either alxn1840 or soc key exclusion criteria: * decompensated hepatic cirrhosis * meld score \> 13 * modified nazer score \> 7 * clinically significant gastrointestinal bleed within past 3 months * alanine aminotransferase \> 2 x upper limit of normal (uln) for participants treated for \> 28 days with wd therapy (cohort 1) * alanine aminotransferase \> 5 x uln for treatment-naïve participants or participants who have been treated for ≤ 28 days (cohort 2) * marked neurological disease requiring either nasogastric feeding or intensive inpatient medical care * hemoglobin \< 9 grams/deciliter * history of seizure activity within 6 months prior to informed consent * pregnant (or women who are planning to become pregnant) or breastfeeding women * active infection with hepatitis b virus (positive hepatitis b surface antigen) or c virus or seropositivity for human immunodeficiency virus (hiv) * previous treatment with tetrathiomolybdate * participants with end-stage renal disease on dialysis (chronic kidney disease stage 5) or creatinine clearance \< 30 milliliter/minute

Keywords: wilson disease alxn1840 copper
safety and efficacy of agn 203818 for pain associated with fibromyalgia syndrome

Conditions: Fibromyalgia

Summary: this study will explore the safety and effectiveness of different doses of agn 203818 in treating the pain associated with fibromyalgia syndrome. the study is being conducted in 2 parts. part a enrolled 211 pts dosed with either 3, 20, 60 mg bid agn 203818 or placebo over 4 week treatment duration. part b will enroll 440 pts and dose with either 20, 100, 160 mg bid agn 203818 or placebo over 12 week treatment duration.


Eligibility criteria:
inclusion criteria: * diagnosis of fibromyalgia syndrome * moderate or severe pain associated with fibromyalgia exclusion criteria: * any other uncontrolled disease * pregnant or nursing females
clinical efficacy and safety of autologous cultured keratinocyte cell on severe burn wood

Conditions: Burn Wound

Summary: the efficacy and safety of autologous cultured keratinocyte cell on severe burn wound.


Eligibility criteria:
inclusion criteria: * age : 1\~70 years * more than 30% tbsa of second degree burn or more than 10% tbsa of third degree burn * must provide signed informed consent prior to participation in any study-related procedures exclusion criteria: * have a pyogenic infection * part of the facial cosmetic surgery cost * hypersensitivity reactions in patients with bovine proteins * hypersensitivity reactions in patients with gentamycin * pregnancy or lactation

Keywords: keratinocyte cell severe burn wound
implications of wearing a fat suit

Conditions: Feeding Behaviors

Summary: this study examined how wearing a fat suit might lead individuals to experience the negative effects of weight based stigmatization, including psychological, behavioral, and physiological consequences. it also aimed to test using the fat suit as a possible intervention tactic to reduce weight stigma.

the goal of this study was to understand how embodying a stigmatized domain might elicit the same consequences investigators see in victims of weight stigma. participants were randomly assigned to either manipulate their weight through wearing a fat suit prosthesis or to a control condition where they wore the same clothing that was on the fat suit but in their own size. outcome variables were cortisol reactivity, psychological well-being, and food and drink consumption. additionally, this study tested whether wearing the fat suit might serve as an effective weight stigma reduction effort.

Eligibility criteria:
inclusion criteria: * participants had to be registered in the ucla department of psychology subject pool. exclusion criteria: * no specific exclusion criteria.

Keywords: weight stigma cortisol reactivity eating behavior
protein intake plus neuromuscular electrical stimulation on muscle mass in hospitalized elderly

Conditions: Atrophy, Muscular

Summary: this study aims to investigate the effects of supplementation of protein plus sessions of electrostimulation on muscle mass, length of hospital stay, readmission and mortality of hospitalized elderly.

hospitalized elderly people show malnutrition, physical inactivity, and pronounced systemic inflammation which may be exacerbated the catabolic state and promote drastic muscle wasting during the hospitalization and, thus increasing the length of stay, morbidity, and mortality. therefore, the aim of this study is to investigate the effects of supplementation of protein plus sessions of electrostimulation on muscle mass, length of hospital stay, readmission, and mortality of hospitalized elderly.

Eligibility criteria:
inclusion criteria: * both sex; * 65 years and older; * hospital stay less than 48 hours; exclusion criteria: * cancer in the last 5 years; * delirium; * cognitive deficit that impossibility the patient to read and sign the informed consent form; * neurological disease; * neurodegenerative muscular disease; * impossibility to receive the intervention.
cost-effectiveness of two forms of dots in a demonstration area of the dots strategy in colombia

Conditions: Tuberculosis, Pulmonary

Summary: * tuberculosis ( tb ) remains a major global public health problems and actions to ensure the diagnosis and complete treatment of all cases is the priority for the control of this disease. despite the availability of effective anti-tuberculosis medications, there are still high levels of nonadherence to treatment. the nonadherence increases the morbidity and mortality of patients, decreases the cure rate, increases the community transmission and the increase of chronically ill patients enables the emergence of multi - drug resistant and increases treatment costs. * despite the knowledge about different forms of cost-effective delivery of dot (directly observed treatment), recognition of the need to establish the dot strategy related to the context from local studies, in colombia and in cali we hadn't had made studies similar than this one that establish the cost and results of the current dot delivery strategy and to identify other ways to improve adherence and cure rate for the tb patients at reasonable cost for both: health services and families * therefore, this research aims to compare the cost -effectiveness of current dot delivery method with an alternative extra- institutional delivery of anti -tb treatment in urban areas of cali. a cost-effectiveness study was conducted from the institutional and familiar perspective with prospective information collection.

we compared two strategies for anti- tb treatment delivery: one institutional in which patients went to health institutions to receive treatment and other extra- institutional in which the medication was delivered in the place of choice for treating patients. measuring the effectiveness ( compliance and cure ) was made from a controlled clinical trial , randomized , partially blinded . the measurement of family and institutional costs , direct and indirect , will be based on the activities.

Eligibility criteria:
inclusion criteria: * male and female (non-pregnant) * 15 years of age and older * living in urban area (cali) * new diagnosed patients (tb) * in conditions to give survey information * patients without hemoptysis and special conditions like: hepatic disease, renal failure, diabetes, hypertension, hiv/aids and negative test for pulmonary tuberculosis exclusion criteria: * not written informed consent

Keywords: tuberculosis adherence, medication patient compliance
is sjögren's syndrome associated with meibomian gland dysfunction ?

Conditions: Sjögren's Syndrome; Meibomian Gland Dysfunction

Summary: the investigators hypothesize that the dry eye caused by ss may include the evaporative type, resulting from the mgd. furthermore, the investigators hypothesize that both pss and sss are associated with mgd.to test our hypothesis, we conducted a prospective clinical study in patients with ss (both pss and sss) and mgd, and the normal population all subjects were matched for both age and gender and assessed for tear function and ocular surface signs and symptoms.


Eligibility criteria:
inclusion criteria: * all the subjects are female and age between 50-60 years * patients with primary ss fulfilled the criteria established by the european study group * patients with sle and ra met the criteria set by the american college of rheumatology exclusion criteria: * the control history of autoimmune disease

Keywords: sjögren's syndrome meibomian gland dysfunction dry eye disease
valproic acid with methylprenisonlone for the treatment of acute gvhd

Conditions: Peripheral Blood Stem Cell Transplantation; aGVHD

Summary: agvhd remains as complication in patients after allogeneic stem cell transplantation. methylprednisolone at 1\~2mg/kg is considered as standard first-line treatment. in recent lab study, we demonstrated that valproic acid (vpa) as histone deacetylase inhibitor can inhibit cd4+ th1 and th17 cells and control the agvdh in mice model while preserve the gvl effects. in this study, we tested the hypothesis that adding vpa to standard dose steroid treatment may improve the outcome of agvhd.

to evaluate the complete response rate of vpa+methylpednisolone in patients with grade ii-iv agvhd after allogenetic stem cell transplantation.

Eligibility criteria:
inclusion criteria: * grade ii-iv agvhd * no previous history of allergy to valproic acid * no active and severe infection exclusion criteria: * inclusion in other clinical trial * gvhd prophylaxis with valproic acid * severe organ dysfunction: heart, lung, liver and kidney

Keywords: agvhd valproic acid
analysis of respiratory mechanics in patients with rheumatoid arthritis

Conditions: Rheumatoid Arthritis

Summary: rheumatoid arthritis (ra) is an autoimmune disease of unknown etiology characterized by peripheral polyarthritis, symmetric, which leads to joint destruction and deformity. it is estimated that the ra reaches about 0.5% of the population. according to data from datasus, was responsible for 26,671 hospitalizations, 229 deaths and cost exceeding r$ 20 million in 2005-2007. the main bodily changes are related to joint problems, however, systemic manifestations are also found in organs such as lung and heart. although cardiovascular diseases are the most responsible of the deaths ar, pulmonary complications are common and account for 10% to 15% of all mortality. anaya and colleagues point out that the pulmonary involvement contributes significant morbidity and mortality in these patients. although pulmonary involvement is a frequent manifestation in ra, the prevalence and nature of rheumatoid lung disease has not yet been precisely established. several lung disorders such as interstitial pulmonary fibrosis, pulmonary nodules and bronchiolitis may ocorrer1. laitinen et al point out that studies of lung function appear to be a valuable helper for radiography in the evaluation of pulmonary involvement in connective tissue diseases. previous studies indicate that patients with ra have an increased incidence of abnormal lung function, according to assessments including spirometry, lung volume tests and diffusion capacity of carbon monoxide. thus, the main objective of this study is to analyze the respiratory mechanics of patients with ra. specific objectives were to seek to understand whether a relationship exists between duration of rheumatoid disease and lung function in these patients. for this, the investigators used 18 subjects in the control group, free of pulmonary disease and / or heart, all nonsmokers. in the ra group, a total of 72 patients divided into 4 groups of 18 volunteers each, classified according to disease duration (0-5 years, 6-10 years, 11-15 years and\> or = 16 years). it is noteworthy that all patients in the ra group will also be non-smokers, since it is already known in the literature that smoking impairs lung function. all individuals will perform the function test with a trained technician and qualified to function. the examinations will be conducted: forced oscillation technique and spirometry, in that order.


Eligibility criteria:
inclusion criteria: * volunteers with rheumatoid arthritis for patients group; * volunteers without any respiratory disease for the control group. exclusion criteria: smokers

Keywords: rheumatoid arthritis respiratory mechanics time of disease