Kornimate/medical-research-clean huggingface dataset:
interferon gamma release assays (igra) testing versus tuberculin skin test in renal transplant recipients

Conditions: Latent Tuberculosis Infection

Summary: interferon gamma release assays (igra) have been shown to be more specific and sensitive for the detection of tuberculosis (latent or active infection) than the tuberculin skin test (tst) in immunocompetent individuals. however, very little data are available concerning the relative performance of igra and tst in immunosuppressed individuals from other causes than hiv. the investigators hypothesize that igras would be more sensitive and specific than the tst in a group of renal transplant recipients under chronic immunosuppressive treatment for detecting latent tuberculosis infection.

in a recent study (triverio pa et al. "interferon-gamma release assays versus tuberculin skin testing for detection of latent tuberculosis in haemodialysis patients". nephrol dial transplant 2009; 24: 1952-6), the investigators had compared 2 igras (t-spot.tb and quantiferon gold) with the tst and shown that one igra was clearly more sensitive than the tst but that both tests had a very low sensitivity for detecting prior tb. this study applies the same protocol to renal transplant recipients undergoing routine annual check-up visits: questionnaire with detailed collection of risk factors for latent tuberculosis infection (ltbi), history of prior contact with tuberculosis (tb), bcg (bacille of calmette and guerin vaccine), prior tb or ltbi, treatment for tb or ltbi, analysis of chest x-ray for signs of prior tb, on-going treatment, level of immunosuppression (cd4 lymphocytes), simultaneous blood sampling for t-spot.tb and quantiferon gold, and tuberculin skin testing.

Eligibility criteria:
inclusion criteria: * prior renal transplantation; * age \> 18; * stable clinical condition exclusion criteria: * hypersensitivity to tuberculin skin testing

Keywords: tuberculosis latent tuberculosis infection immunosuppression renal transplant recipient
legion™ primary safety and efficacy

Conditions: Osteo Arthritis Knee; Total Knee Replacement

Summary: this study will look at the health results of using the legion™ primary knee system over a period of ten (10) years. this type of surgery uses an artificial knee made of plastic and metal. this study will enter subjects who suffer from a variety of conditions that have caused at least one of their knees to become nonfunctional. you are being asked to participate in the study because you have significant problems with your knee(s) and your study surgeon has determined that your knee(s) must be surgically replaced to improve your condition. if you decided to participate in this study, you will be one of approximately one hundred thirty-eight (138) subjects in the study.

this is a prospective, consecutive series, multi-center clinical study of the legion™ total knee system. the study design was selected to assess the safety and effectiveness profile of the legion™ total knee system in subjects with degenerative knee disease requiring primary total knee replacement. subjects meeting the entrance criteria specified in this protocol will be approached to participate in the study and enrolled sequentially. any consenting subjects meeting the inclusion criteria are not to be excluded unless they do not consent to participate. a nonrandomized, consecutive series of up to 138 subjects will be enrolled at a maximum of 8 research sites, with an expectation of 18 subjects (up to a maximum of 28 subjects) to be enrolled at each site. when 138 subjects are enrolled from all sites, enrollment will be stopped, regardless of the number contributed from each site. sites will be selected for participation in the study at the discretion of smith \& nephew. follow-up clinical assessments will be at operative/discharge, 3 months, 1 year, 2 years, 3 years, 5 years, 7 years and 10 years. each subject will receive a standard radiographic evaluation at discharge that will be used for baseline analysis. additional radiographic analysis will be performed at operative/discharge, 3 months, 1 year, 2 years, 3 years, 5 years, 7 years and 10 years.

Eligibility criteria:
inclusion criteria: subjects must meet all of the inclusion criteria: * subject is a candidate for the legion™ primary knee system according to the instructions for use * subject is of legal age and skeletally mature * subject is willing to sign and date an ethics-approved consent form and participate in the study * subject is willing to be available for ten-year follow-up postoperatively. exclusion criteria: subjects must not meet any of the exclusion criteria: * subject with immunosuppressive disorders * subject has grossly insufficient femoral or tibial bone stock * subject has an active localized or systemic infection * subject is pregnant * subject psychological or neurological conditions that would impair the subject's ability or willingness to restrict activities or follow medical advice during the course of this study * subject is a prisoner.

Keywords: legion™ primary tka osteoarthritis of knee
differentiation hhd from hcm (early-myo-hhd)

Conditions: Hypertrophic Cardiomyopathy; Hypertensive Heart Disease

Summary: differentiating hypertrophic cardiomyopathy (hcm) from hypertensive heart disease (hhd) unavoidably encounters diagnostic challenges especially in patient of suspected hcm with history of hypertension. diverse and overlapping forms of hcm can often lead to ambiguity when diagnosis is based on a single genetic or morphological index. the investigators have deduced a integrated formula based on cardiac magnetic resonance (cmr) imaging and established a differentiating flow-chart between hcm and hhd, the investigators aim to identify their method in the current multi-center trial.

both hypertrophic cardiomyopathy (hcm) and hypertensive heart disease (hhd) present left ventricular hypertrophy (lvh), but the prognosis varies. nevertheless, the feasibility of distinguishing these two conditions is limited by the fact that overlapping lvh and diverse forms of hcm can often lead to diagnostic ambiguity when diagnosis is based on a single morphological index. diagnosis is more difficult in a patient with a history of hypertension and with left ventricular wall thickness between 11 and 15 mm. it also puzzles the situation when hypertrophy without outflow-track obstruction was found in hypertensive subjects which might not be explained solely by the history of hypertension. the investigators have deduced an integrated formula based on cardiac magnetic resonance (cmr) imaging and established a differentiating flow-chart between hcm and hhd. in this study, the investigators aim to explore the applicability of the quantifying scheme for distinguishing hcm from hhd in the multi-center trial.

Eligibility criteria:
inclusion criteria: 1. control group: (1) absence of known systemic diseases; (2)normal examinations（normal findings in both echocardiography and cmr）. 2. hypertrophic cardiomyopathy: 1) genetic determination of a pathogenic mutation or 2) left ventricular hypertrophy (lvh) (end-diastolic wall thickness \>15 mm) with resting left ventricular outflow tract obstruction or 3) hypertrophy in a recognizable pattern, i.e., ventricular bulge in apical-variant hcm; of note, patients with documented hcm were divided into subgroups based on whether concomitant with hypertension or left ventricular outflow tract (lvot) obstruction. 3. hypertensive heart disease: (1) long durations of uncontrolled hypertension (systolic blood pressure≥150 mm hg or diastolic blood pressure ≥90 mm hg); echocardiography: left ventricular wall thickness in diastolic \>11mm; absence of other cardiac or systemic diseases; (2) left ventricular mass/body surface area \>115 g/m2 (male) or \>95 g/m2 (female). exclusion criteria: 1. documented coronary artery disease: previous history or cag\>50%; 2. nyha ⅳ level; 3. severe aortic valve stenosis; 4. standard metallic contraindications to cmr; 5. systemic diseases or infiltrative cardiomyopathy; 6. septal ablation for drug-refractory hypertrophic obstructive cardiomyopathy.

Keywords: hypertrophic cardiomyopathy hypertensive heart disease cardiac magnetic resonance
cardiac tumors in children

Conditions: Congenital Heart Disease

Summary: the purpose of this study is to define the natural history of untreated cardiac tumors, study the pathology of primary cardiac tumors, review the surgical treatment and results of primary cardiac tumors and to determine the prognosis for these tumors.

primary cardiac tumors in children are extremely rare. benign tumors are typically myxomas, lipomas, and rhabdomyomas, while malignant tumors are typically angiosarcomas and rhabdomyosarcomas. due to the rarity of these tumors, it is difficult to gather meaningful information regarding their natural history, pathology and treatment. the primary aims are to define the natural history of untreated cardiac tumors, study the pathology of primary cardiac tumors, review the surgical treatment and results of primary cardiac tumors and to determine the prognosis for these tumors. the secondary aims are to discover patterns and consistencies among primary cardiac tumors and to define the best treatment options for these patients. the study will be conducted through a retrospective chart review of about 70 patients.

Eligibility criteria:
inclusion criteria: * patients in the congenital surgery database * children who have been treated for a primary cardiac tumor

Keywords: pediatric health cardiac cardiac tumor children
impact of a virtual diabetes self-care and education program on diabetes-related outcomes in latinos with t2 diabetes

Conditions: Type 2 Diabetes Mellitus

Summary: the goal of this study is to evaluate the impact of a comprehensive diabetes education and management program based on frequent communication with patients using teleconsultation, text messaging, and phone calls on diabetes related outcomes in latino patients with type 2 diabetes. the investigators hypothesize that the decline in hemoglobin a1c value between the baseline and the six-month visit will be at least 0.5 percent greater in the intervention group than in the control group.

in this study participants will be followed for a period of 9 months. the control group will receive usual care during this period of time. while, the intervention group will be part of a diabetes education and management program lasting 6 months via a smartphone participants will receive. the 6 month intervention will be followed by a 3 month observation period.

Eligibility criteria:
inclusion criteria: * have physician-diagnosed type 2 diabetes * be self-identified as hispanic or latino * an a1c value between 8-14% within the last three months. * demonstrate the ability, either alone or with the help of a family member that will be with the patient at least once a week, to use the technology that will be used during the teleconsultations exclusion criteria: * severe diabetes related chronic complications such as chronic renal failure, blindness, amputations, stroke, etc. * concomitant chronic illnesses that would affect their participation in the program, i.e. cancer, debilitating diseases, etc. * any other condition that would affect participant's basic mental health skills * type 1 diabetes or gestational diabetes * patients with abnormal hemoglobin, anemia or any condition that may affect red blood cell turnover. any of these conditions may be detected through participants' history or through the laboratory report at study screening * signs or symptoms of metabolic decompensation (polyuria, polydypsia, polyphagia, unexplained weight loss, blurry vision, lethargy, etc.)

Keywords: type 2 diabetes mellitus telehealth hispanics latinos self-care mobile health mhealth
treatment of giardia lamblia infections in children

Conditions: GIARDIASIS

Summary: this study investigates the efficacy and safety of rectally administered metronidazole for pediatric giardia lamblia infection, as well as the acceptance of this treatment regimen by patients/caregivers. the investigators hypothesize that rectal metronidazole is non-inferior to single-dose of oral tinidazole and will cure at least 72% of patients, a well as will be tolerated as good as tinidazole.

approximately 180 children (age 6 months to 10 years) whose clinical symptoms could be explained by giardiasis and whose fecal samples will test positive for the presence of g.lamblia in uusimaa laboratory (huslab) will be recruited. the study will be performed as an open-label trial. patients will be randomized during primary visits alternately into two groups by random allocation to receive either of the two study drugs. patients from group 1 will be treated with a standard regimen of oral tinidazole (fasigyn) at a single dose of 50 mg/kg, maximum 2 g/dose. patients from group 2 will be given rectal metronidazole (flagyl) 500 mg/dose for children weighing 10-14,9 kg, 1000 mg/dose for those weighing 15-29,9 kg and 1500 mg/dose for those weighing 30-44,9 kg. suppositories will not be halved. patients will be given 1 dose/day for 3 days. the first dose of metronidazole will be administered during the primary clinical visit and 2 additional doses will be provided to the parents for home administration. fecal samples will be collected from the study patients on day 7-10 post-treatment and will be analyzed in huslab for the presence of g.lamblia antigen by enzyme immunoassay (eia). early collection of samples on day 7-10 will help to avoid the risk of tests being positive due to reinfection. if any of the patients will not clear the infection by day 10, he/she will be invited to a second visit and re-treated. patients from group 1 will be re-treated by rectal metronidazole and patients from group 2 by oral tinidazole, thus performing a cross-over. follow-up stool samples will be collected. criteria for clinical cure will be resolution of symptoms by day 10 and microbiological cure will be defined as negative g.lamblia antigen test from fecal samples collected on day 7-10 post-treatment.

Eligibility criteria:
inclusion criteria: * clinical symptoms could be explained by giardiasis and * fecal samples will test positive for the presence of g.lamblia in uusimaa laboratory (huslab) exclusion criteria: * age \ 10 years * weight \<9.5 kg * the absence of symptoms * co-infection with another pathogen, which may cause giardiasis-like symptoms
long-term results of a randomized trial comparing banded-versus-standard laparoscopic roux-en-y gastric bypass

Conditions: Morbid Obesity

Summary: the purpose of the study is comparatively analyze the advantages and disadvantages of banded versus unbanded laparoscopic roux-en-y gastric bypass (rygb). the outcome variables of the general study included morbidity, maximal weight loss, and late weight regain.

obesity is a public health problem that has grown exponentially worldwide. bariatric surgery has been recognized as the most effective treatment for morbid obesity. however, the debate about the best surgical procedure is still considerable. among a wide range of operations that have been used for morbid obesity, roux-en-y gastric bypass (rygb) has shown an appropriate risk/benefit balance and has achieved a high degree of acceptance in america. the weight loss pattern in rygb is characteristic and includes significant eight loss during the first 2 years after surgery, followed by some weight regain after the second or third postoperative year. to prevent this some authors suggest the placement of a premeasured band or ring around the gastric reservoir, adjacent to the gastroenterostomy. this procedure has been called banded rygb.

Eligibility criteria:
inclusion criteria: * body mass index of 40-55 kg/m2 * agreed to participate in this study with informed consent signed

Keywords: morbid obesity obesity surgery gastric bypass banded gastric bypass
effect of remote ischemic preconditioning on lung injury after pulmonary resection

Conditions: Lung Neoplasms

Summary: the purpose of this study is to determine whether ischemic preconditioning reduces lung injury in patients undergoing pulmonary resection.

remote ischemic preconditioning is an intervention in which brief ischemia of one tissue or organ protects remote organs from a sustained episode of ischemia. it is known that one-lung ventilation in patients undergoing pulmonary resection, which may cause acute lung injury. the investigators did a single-blinded randomised controlled study to establish whether remote ischemic preconditioning reduces lung injury in these patients.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of pulmonary carcinoma * must be received pulmonary lobectomy exclusion criteria: * cardiac disease categorized as nyha classes ii-iv * preoperative severe impairment of respiratory function (arterial oxygen tension (pao2) \<60 mmhg or fev1\<50% predicted), * pre-existing coagulopathy or thrombocytopenia * prior receipt of chemotherapy or radiation therapy or immunotherapy * systemic or local active infections (either clinically defined or suggested by evidence such as elevated c-reactive protein levels, leukocytosis, or a body temperature\>38℃) * peripheral vascular disease affecting the upper limbs * administration of vitamins, nonsteroidal anti-inflammatory agent or corticosteroid within 3 months.

Keywords: remote ischemic preconditioning lung injury pulmonary resection
optim dasatinib (optimized tyrosine kinase inhibitors monotherapy)

Conditions: Chronic Myelogenous Leukemia, BCR/ABL Positive

Summary: this protocol is a multicentric interventional phase ii study from the french cml intergroup (filmc). the core of the protocol is to explore the efficacy and safety of an optimization strategy consisting in the modulation of the dasatinib daily dose according to the results of repeated plasmatic levels of dasatinib. the objective of this strategy is to improve the overall results of the treatment of early cp-cml in order to avoid the development of resistance and bcr-abl tyrosine kinase mutations. the study will be conducted in selected filmc and canadian centers. the study is sponsored by the hôpitaux de versailles and supported by bristol-myers squibb. the dasatinib treatment will be provided by bristol-myers squibb until marketing authorization is granted in that indication.


Eligibility criteria:
inclusion criteria: 1. male or female patient ≥ 18 years 2. ecog performance status score 0-2 3. philadelphia chromosome positive newly diagnosed (≤ 3 months) cp-cml 4. patients not previously treated except with hydroxyurea or imatinib (less than 4 weeks for imatinib) 5. signed written inform consent 6. adequate hepatic function defined as: total bilirubin ≤ 2.0 times the institutional uln; alt and ast ≤ 2.5 times the institutional upper limit of normal (uln). 7. adequate renal function defined as serum creatinine ≤ 3 times the institutional uln. 8. women of childbearing potential (wocbp) must be using an adequate method of contraception. exclusion criteria: 1. patients with bcr-abl positive, philadelphia negative cml 2. patient previously treated with a tyrosine kinase inhibitor (tki) except with imatinib during less than 4 weeks. 3. pregnancy 4. active malignancy 5. uncontrolled or significant cardiovascular disease 6. patients with qtc \> 450 ms 7. significant bleeding disorder unrelated to cml 8. concurrent severe diseases which exclude the administration of therapy
quadratus lumborum vs caudal epidural block for perioperative analgesia in pediatric patients for upper abdominal surgeries

Conditions: Post Operative Pain, Acute

Summary: compare between the analgesic effect of the ultrasound-guided quadratus lumborum block and single caudal epidural injection in pediatric patients undergoing surgeries with supraumbilical incisions.


Eligibility criteria:
inclusion criteria: * any pediatric patient aged from 2 to 8 years undergoing abdominal surgery with supraumbilical umbilical incision exclusion criteria: * parents refusal to participate in the study, * previous history of allergy to local anesthetics * hemodynamic instability * coagulopathy,
a multiple dose study of abt-555 in subjects with relapsing forms of multiple sclerosis

Conditions: Multiple Sclerosis

Summary: this study seeks to evaluate the safety, tolerability, pharmacokinetics (pk) and immunogenicity of abt-555 in participants with relapsing forms of multiple sclerosis (rfms).


Eligibility criteria:
inclusion criteria: * currently receiving one of the following ms medications for at least 3 months: beta-interferon (any formulation including the pegylated form), glatiramer acetate (copaxone®, others), teriflunomide (aubagio®), fingolimod (gilenya®), or dimethyl fumarate (tecfidera®); or * has not been treated with an ms immunotherapy for the past 6 months (12 months if they previously received cyclophosphamide or alemtuzumab); or * treatment naïve with established ms diagnosis per criteria by a neurologist. * diagnosis of relapsing-remitting ms (rrms) or secondary progressive ms (spms) according to revised mcdonald criteria * baseline expanded disability status scale (edss) between 0 and 6.0, inclusive. * brain mri scan at screening that did not show evidence of overt vascular lesions, masses, mass effect or other abnormalities other than those compatible with ms, which would preclude the participant from undergoing a lumbar puncture/spinal tap for csf collection exclusion criteria: * diagnosis of primary progressive ms. * anticipated maintenance immunomodulator change, either agent or dose * an ms relapse that occurred within the 30 days prior to randomization and/or the participant has not stabilized from a previous relapse prior to randomization * participants for whom mri is contraindicated * participants who have claustrophobia that cannot be medically managed or are unable to lie still for 1 hour or more for the imaging procedures * findings on brain mri scan indicating any clinically significant brain abnormality other than ms * contraindication for lumbar puncture

Keywords: relapsing-remitting secondary progressive relapsing forms
a multiple dose study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of romosozumab (amg 785)

Conditions: Postmenopausal; Osteopenia

Summary: the primary objective of this study was to assess the safety, tolerability, and immunogenicity potential of romosozumab following multiple subcutaneous (sc) administrations in healthy men and postmenopausal women with low bone mass.


Eligibility criteria:
inclusion criteria: * healthy males and females between 45 to 80 years of age * postmenopausal females * low bone mineral density, defined by bone mineral density (bmd) t-scores between -1.0 and -2.5, inclusive, for the lumbar spine \[l1-l4\] or total evaluable vertebrae \[if fewer than l1-l4\] or total hip) * 25-hydroxyvitamin d ≥ 20 ng/ml * weight ≤ 98 kg (216 lb) and/or height ≤ 196 cm (77 in) exclusion criteria: * osteoporosis defined by bone mineral density (bmd) t-scores \< -2.5 for the lumbar spine (l1-l4) or total evaluable vertebrae (if fewer than l1-l4) or total hip * diagnosed with any condition that would affect bone metabolism * previous exposure to amg 785