Kornimate/medical-research-clean huggingface dataset:
evaluation of the impact of pulsed field ablation on autonomic nervous system modulation in paroxysmal atrial fibrillation

Conditions: Atrial Fibrillation (AF); Paroxysmal AF

Summary: the objective of this clinical trial is to evaluate the impact of pulse field (pf) energy, both alone and in combination with radiofrequency (rf) energy, on vagal modulation during point-by-point pulmonary vein isolation (pvi) in patients with paroxysmal atrial fibrillation (paf). the effect of pf energy on ganglionated plexi (gp) will be assessed using heart rate variability (hrv) as a surrogate marker. participants will be randomized into three groups: the pf-only group and the hybrid group (pf posterior/rf anterior) as the experimental arms, and the rf-only group as the control arm. hrv will be measured before and 24 hours after the pvi procedure. additionally, cardio and neuro biomarkers (troponin and s100b) will be measured pre-procedure and 20 minutes post-ablation. all participants will be followed for 12 months, with 24-hour holter-ecg evaluations scheduled at 3, 6, and 12 months after the initial ablation procedure.


Eligibility criteria:
inclusion criteria: * symptomatic paroxysmal atrial fibrillation (af) that terminates spontaneously or with intervention within 7 days of onset * age range: 18-70 years * willing and capable of providing informed consent * able and willing to comply with all pre-, post-, and follow-up testing and requirements exclusion criteria: * previously diagnosed persistent af (\&gt; 7 days in duration) * previous la ablation * previous cardiac surgery * myocardial infarction within the previous 3 months * severely compromised left ventricular ejection fraction (lvef\&lt;40%) * presence of implanted pacemaker or implantable cardioverter-defibrillator (icd) or other implanted metal cardiac device that may interfere with the pulsed electric field energy * acute illness, active systemic infection, or sepsis * presence of intracardiac thrombus, myxoma, tumor, interatrial baffle or patch or other abnormality that precludes catheter introduction or manipulation. * severe mitral regurgitation * woman who are pregnant, lactating, or who are planning to become pregnant during the course of the clinical investigation

Keywords: vagal modulation ganglionated plexi pulsed field dual-energy focal ablation paroxysmal atrial fibrillation heart rate variability pulmonary vein isolation
anesthetic effects in mitochondrial disease

Conditions: Mitochondrial Disease

Summary: summary. at the present, the investigators do not have the perfect anesthetic for mitochondrial patients. when possible, consideration should be given to the use of local anesthetics in small amounts. when a general anesthetic is necessary, they each carry significant risks and have been associated with poor outcomes. at present it is not possible to eliminate one group as less safe than others. what is clear is that these patients must be monitored more closely than other patients. the advent of the bispectral index (bis) monitor may allow us to monitor their depth of anesthesia more closely and thus expose these patients only to the minimum amount of drug necessary to carry out the surgical procedure. purpose. the investigators hypothesize that specific mitochondrial diseases, in particular those that decrease complex i function, make certain children hypersensitive to volatile anesthetics. these same patients may be at increased risk for adverse outcomes following general anesthesia. the specific aims of this application are: 1. determine which molecular defects in mitochondrial function lead to alter sensitivity to the va sevoflurane. 2. establish the relative safety of sevoflurane in treatment of patients with mitochondrial disease. the investigators plan to monitor patients with mitochondrial disease using expanded measures of cardiovascular stability and measurements of brain electrical activity while slowly inducing general anesthesia. the investigators will use those measurements to limit the amount of anesthetic these patients receive in an attempt to minimize their risk. in addition, the investigators will correlate their sensitivity to the type of mitochondrial defect so that the investigators may be able to predict which patients are likely to have an increased sensitivity.


Eligibility criteria:
inclusion criteria: * patients presenting to the operating room for muscle biopsy as part of their diagnostic workup for possible mitochondrial disease. exclusion criteria: * patients more than 16 years of age. * patients with concurrent acute infectious disease. * patients not tolerating a slow induction for emotional reasons. * initial bis measurement of less than 95. * documented pulmonary disease.

Keywords: mitochondrial disease sevoflurane mitochondrial disease and sevoflurane sensitivity
pro- and anti-inflammatory cytokines in pcos

Conditions: Reproductive Age; PCOS (Polycystic Ovary Syndrome)

Summary: the study will involve measurements and comparisons of the concentrations of pro-inflammatory cytokines: il-6, tnf-α, il-18, as well as anti-inflammatory cytokine il-4 in women with polycystic ovary syndrome (pcos) and insulin resistance, women with polycystic ovary syndrome without carbohydrate metabolism disorders, and women without pcos (control group).

polycystic ovary syndrome (pcos) is the most common endocrinopathy among women of reproductive age, which, in addition to menstrual disorders and infertility due to anovulation, is characterized by insulin resistance (ir). the metabolic disturbances associated with pcos contribute to a higher incidence of cardiovascular diseases and endometrial cancer prior to menopause. the severity of ir in women with pcos is linked to abdominal obesity. there is an urgent need to identify more precise and universal markers of insulin resistance than the homa-ir index or glucose tolerance tests, which are intended to identify existing disorders rather than predispositions. additionally, there is a need to investigate the balance of pro-inflammatory and anti-inflammatory parameters in pcos and their relationship with insulin resistance, which is responsible for the development of adverse health complications. the objective of this study is to measure and compare the concentrations of pro-inflammatory cytokines: il-6, tnf-α, il-18, and the anti-inflammatory cytokine il-4 in women with polycystic ovary syndrome (pcos) and insulin resistance, women with polycystic ovary syndrome without carbohydrate metabolism disorders, and women without pcos (control group). tests will be conducted using immunoenzymatic methods (elisa) and the erba xl biochemical analyzer. the concentrations of the substances under investigation will be measured and compared among the three study groups. statistical analysis will be performed using spss statistics software.

Eligibility criteria:
inclusion criteria: * women aged 18-45 years exclusion criteria: * previous removal of at least one ovary * treated diabetes of any type * diagnosed and treated metabolic diseases * diagnosed and treated autoimmune diseases * diagnosed and treated autoinflammatory diseases

Keywords: menstrual disorders chronic inflammation insulin resistance metabolic syndrome polycystic ovary syndrome
correction of exercise-induced desaturation by acute oxygen supply and exercise responses in copd

Conditions: Chronic Obstructive Pulmonary Disease; Oxygen/Therapeutic Use

Summary: in the literature, the effects of acute oxygen administration on exercise tolerance and related symptoms have often appeared to be contradictory. some investigations have reported benefits from acute oxygen supply during exertion, including increased exercise performance, reduced dyspnea, and better cardiorespiratory adaptations, whereas other studies have reported no improvement. recently, we advanced then the hypothesis that some patients would be non-responders and even worsen under oxygen treatment. the preliminary results confirmed our hypothesis since we demonstrated that while 56% of the patients were improved with supplemental oxygen, 16% were non-responders and 28% were negative-responders (decreased performance and increased dyspnea during endurance exercise with supplemental oxygen). however, this was a pilot study offering preliminary insights and tentative conclusions that must be confirmed in a larger case series. the aims of this retrospective study was : 1. to confirm on cohorte and with clinical test (the 6-minute walking test - 6wt) the deleterious responses to acute oxygen supplementation in ltot (long terme oxygenotherapy treatment) and non-ltot patients who exhibit exercise desaturation. 2. to identify the predictive factors among the clinical data (i.e., anthropometric, spirometric and gazometric data) and/or functional data recorded during rehabilitation program

during this study, a retrospective data collection will be carried out using the informations contained in the medical folders of patients admitted in our centers for pulmonary rehabiliation program. we will select patients who meet the following criteria: a) patients having two 6wt early in their program b) who desaturate (spo2 \<90% for 3 consecutive min) during the first 6wt and who will have been properly corrected with a supply of oxygen during the second walk test. the analyzed parameters will be distance and dyspnea during the tests

Eligibility criteria:
inclusion criteria: * obstructive airflow limitation defined by fev1/cvf \< 70% and fev1 \< 80 % * patients with or without long terme oxygenotherapy * patients exhibited during the first test, an exercise-induced desaturation, defined by sao2 \< 90% for 3 consecutive minutes during the 6-minute walking test in the air condition for non-ltot or with the flow normally recommended during exercise for ltot patients (i.e., flow rate of rest + 1l/min) * patients with no desaturation during the test with oxygen supply exclusion criteria:
desmopressin for bedwetting in children with scd

Conditions: Nocturnal Enuresis; Anemia, Sickle Cell

Summary: this study assesses if using the medication desmopressin will decrease nightime bedwetting in children with sickle cell disease.

night time bedwetting is a common complication of sickle cell disease, and affects up to 30 % of children. desmopressin is an oral medication that increases water reabsorption in the kidneys. studies have shown that it is effective in decreasing bedwetting episodes in children without sickle cell disease. chronic sickling episodes causing damage to the kidneys could cause permanent damage and may make this treatment ineffective in sickle cell disease. this trial will inform pediatric sickle cell doctors if desmopressin is an appropriate treatment for bed wetting in the investigators patients. this study expanded upon a previously terminated study which had separately registered (nct02636387, id: 2014-3768).

Eligibility criteria:
inclusion criteria: 1. patients with hemoglobin ss, sc, sb0thal or sb+thal 2. patients with at least two episodes of primary nocturnal enuresis per week or four episodes over the two weeks prior to enrollment. 3. patients with secondary enuresis who have been evaluated and cleared by a pediatric urologist as not having other etiologies of enuresis (e.g. overactive detrusor activity, a genitourinary anatomic abnormality) exclusion criteria: 1. patients with developmental delay or neurologic dysfunction secondary to stroke. 2. patients with hypertension or underlying renal disease. 3. patients with genitourinary anatomic abnormalities. any prior renal ultrasound showing normal genitourinary anatomy is sufficient to clear a patient for the study. 4. patients with daytime urinary incontinence 5. patients with glucosuria on urinalysis. 6. patients with secondary nocturnal enuresis who have not been evaluated by a pediatric urologist to rule out other etiologies of enuresis. 7. patients who are pregnant. 8. patients receiving another medicine for nocturnal enuresis (e.g. imipramine).
study for evaluation of efficacy and safety of sh l 749 to indolent b-cell non-hodgkin's lymphoma

Conditions: Non-Hodgkin's Lymphoma; Lymphoma, B-Cell; Lymphoma, Low-Grade

Summary: the purpose of this study is to investigate the antitumor effect and safety of the product for relapsed or refractory indolent b-cell non-hodgkin's lymphomas.

the study has previously been posted by schering ag, germany. schering ag, germany has been renamed to bayer schering pharma ag, germany.bayer schering pharma ag, germany is the sponsor of the trial.

Eligibility criteria:
inclusion criteria: * platelet counts of \>/= 100,000/mm3 * absolute neutrophil counts of \>/= 1,200/mm3 * bone marrow involvement \< 25% exclusion criteria: * patients who received hematopoietic stem cell transplantation, including bone marrow transplantation, peripheral blood stem cell transplantation, etc. * patients presenting with marked bone marrow hypocellularity (any suspected bone marrow hypocellularity should be confirmed by bone marrow biopsy) * patients with previous myocardial infarction within the past 1 year, with heart disease that requires treatment or with pulmonary dysfunction * patients with serious concomitant diseases (cardiac failure, renal failure, etc.)

Keywords: antigen cd20
oral contraceptives and subantimicrobial doxycycline: effect on endometrial matrix metalloproteinases

Conditions: Breakthrough Bleeding

Summary: the purpose of this study is to compare the effects (good and bad) of subantimicrobial dose doxycycline on the irregular bleeding women experience when taking continuous oral contraceptive pills. this research is being done because currently, there is no effective treatment for this condition. findings from this study could help to decrease the side effects of birth control pills and decrease unplanned pregnancies.

continuous oral contraceptive administration entails women taking hormonally active pills for 28 days without a seven day placebo week to avoid hormonal withdrawal bleeding. unfortunately, with continuous administration, timed, regular bleeding can be replace by irregular, unscheduled bleeding, which often leads to dissatisfaction, discontinuation and the possibility of unplanned pregnancy. matrix metalloproteinases, a group of zinc-dependant proteases, are hypothesized to play a role in endometrial degradation. the purpose of this study is to describe the expression of matrix metalloproteinases in endometrial biopsy specimens collected 1) prior to initiating oral contraceptives 2) while taking cyclic oral contraceptive 3) while taking continuous oral contraceptives and 4) while taking continuous oral contraceptives along with sub-antimicrobial doxycycline.

Eligibility criteria:
inclusion criteria: * women between the ages 18 and 45 who are ovulatory as demonstrated by a pre-treatment progesterone (p) greater than or equal to 3.0 ng/ml prior to oral contraceptive use exclusion criteria: * women with any absolute contraindications to ethinyl estradiol and levonorgestrel; * women who are pregnant or breastfeeding * use of oral contraceptives, patch, ring, intrauterine or implantable hormonal contraception within 4-weeks; * medroxyprogesterone acetate use within six months; * current use of drugs that interfere with sex steroid metabolism.

Keywords: continuous oral contraceptives matrix metalloproteinase expression
study evaluating persistence of anti-hbs antibodies in uraemic patients receiving henogen's hbv vaccine, or fendrix™

Conditions: Hepatitis B

Summary: the current extension study will assess the persistence of anti-hbs antibodies at months 12, 24 and 36 after primary vaccination with henogen's hbv vaccine or fendrix™. this protocol posting deals with the objectives \& outcome measures of the extension phase at months 12, 24 and 36. the objectives \& outcome measures of the primary phase are presented in a separate protocol posting (nct00291941).

subjects who received complete full vaccination with henogen hbv adjuvanted vaccine or fendrix™ will participate in this persistence study for three long-term time points (12, 24 and 36 months after the first dose of primary vaccination). blood sampling will be done at each time point to measure immune persistence.

Eligibility criteria:
inclusion criteria: * written informed consent obtained from the subject/ from the parent/ guardian of the subject. * subjects who completed the full course of primary vaccination. exclusion criteria: * immunosuppression caused by the administration of parenteral steroids or chemotherapy. * any confirmed or suspected human immunodeficiency virus (hiv) infection.

Keywords: dialysis pre-dialysis hepatitis b vaccine vaccine
comparative study of the wearing satisfaction of two soft contact lens designs.

Conditions: Myopia

Summary: to evaluate the wearing satisfaction of a new design of the purevision soft contact lenses.


Eligibility criteria:
inclusion criteria: * subject is myopic * subjects who wear soft contact lenses that are exchanged at least biweekly at the time consent is obtained. exclusion criteria: * systemic disease affecting ocular health * using pharmaceuticals that may affect the function of the eyes or lenses. * subject possessing corneal infiltrate or corneal ulcers.
erector spina plane block and radiofrequency treatmen

Conditions: Back Pain; Block; Pain, Muscle

Summary: esp is the deepest back muscle originating from the transverse processes of the vertebrae. blocks applied to this region are effective for a longer time and in the broader area than those applied to superficial muscles. recently, pulsed radiofrequency treatments have also been performed in myofascial pain, and successful results have been obtained. the investigators aim to investigate whether there is a difference between these two applications in terms of treatment efficacy.

trigger point injections and erector spina planus muscle (esp) blocks are used to treat back pain related to myofascial pain syndrome. esp is the deepest back muscle originating from the transverse processes of the vertebrae. blocks applied to this region are effective for a longer time and in the broader area than those applied to superficial muscles. recently, pulsed radiofrequency treatments have also been performed in myofascial pain, and successful results have been obtained. deep and superficial back muscles, transverse processes of the vertebrae, costume, and pleural movement are identified by ultrasonographic examination. the investigators perform the intervention through the transverse processes. the investigators give 20 ccs of fluid (bupivacaine, steroids, saline). the patients to whom the investigators apply pulsed radiofrequency complete the procedure by giving 20 ccs of fluid after the radiofrequency application on the transverse processes and during the procedure, using 10 cm, 21 gauge radiofrequency needles with an active tip of 10 mm. the radiofrequency wave is applied at 2 hz, ten milliseconds, and 55 volts for 5+5 for 10 minutes. the investigators aim to investigate whether there is a difference between these two applications in terms of treatment efficacy. for this reason, the visual pain scale of each patient will be recorded before the procedure, the second week after the procedure, and the first month. the centrality of pain scale will be applied to these patients at the controls. the correlation between the results of this scale, which evaluates the emotional and physical state of the patients, and the post-treatment pain scales will be evaluated.

Eligibility criteria:
inclusion criteria: * myofascial pain * normal thoracic examination exclusion criteria: * additional cardiac disease * lung disease * malignancy
suture fixation versus tension band wiring of simple displaced olecranon fractures

Conditions: Olecranon Fracture

Summary: simple displaced olecranon fractures are most often treated with tension band wiring. this is an effective treatment, but the risk of subsequent re-operation is high. the investigators propose open reduction and internal fixation with a strong suture, thus reducing the risk of re-operation significantly.

background olecranon fractures are frequent with an incidence of 11.5 per 100.000 people per year. olecranon fractures are classified according to the mayo classification in three groups. type 1a and b are treated conservatively, while comminute fractures of type mayo 2b and 3b are treated with plate osteosynthesis. the most common type is a simple two part fracture, mayo type 2a, which represents 74% of all olecranon fractures. the typical treatment of mayo type 2a fractures is osteosynthesis using k-wires and tension band wiring. this provides adequate fracture healing and good functional results. the use of plate osteosynthesis for mayo type 2a fractures does not provide functional or health economic benefits compared with operation with tension band wiring. common for both techniques is a high risk of re-operation due to delayed healing of the surgical wound, and complications arising from the implanted material. recently, new techniques for mayo type 2a fractures have been described, in which no metal is implanted. osteosynthesis is achieved with strong sutures. these techniques have been shown to reduce the high risk of complications leading to re-operation without effecting the functional outcome or fracture healing rate. hypothesis the investigators hypothesize that suture fixation of mayo type 2a fractures will decrease the risk of re-operation and provide equal functional outcome compared with tension band wiring. design prospective, randomized multicenter study

Eligibility criteria:
inclusion criteria: * olecranon fracture, mayo type 2a exclusion criteria: * bilateral upper extremity fracture * open fracture * neurovascular affection * injury to ligament, dislocation or subluxation * additional upper extremity fracture * pathological fracture * previous elbow issue * fracture more than 14 days old * substance abuse * medical contraindication for surgery * previous fracture to the same elbow
thoratec heartmate ii left ventricular assist system (lvas) for destination therapy

Conditions: Heart Failure, Congestive; Ventricular Dysfunction; Cardiomyopathies

Summary: the purpose of this study is to determine the safety and effectiveness of the thoratec heartmate ii left ventricular assist system (lvas) as destination therapy in end-stage heart failure patients who do not qualify for cardiac transplantation. the destination therapy indication for use was approved by fda on january 20, 2010 (ref. pma p060040/s005).

the heartmate ii is a high speed, electric, axial flow, rotary blood pump. the pump drains blood from the left ventricular apex via a rigid inlet cannula and ejects into the aortic root via an outflow cannula joined to the aorta with an end to side anastomosis. power and control of the pump are delivered through a percutaneous cable from the pump to the belt-worn system driver. the destination therapy trial is a prospective, randomized, unblinded, non-inferiority evaluation of the heartmate ii lvas, compared to the heartmate xve.

Eligibility criteria:
inclusion criteria: the following are general criteria; more specific conditions are included in the study protocol: * subjects with advanced heart failure symptoms (nyha class iiib or iv) who are: * on optimal medical management and are failing to respond; or * in class iii or class iv heart failure and dependent on iabp and/or inotropes; or * treated with ace inhibitors or beta-blockers and found to be intolerant. * ineligible for cardiac transplant * vo2max \<=14 ml/kg/min * lvef \<=25% exclusion criteria: the following are general criteria; more specific conditions are included in the study protocol: * evidence of, or risk factors for end-organ dysfunction that would make lvas implantation futile * existence of factors that would adversely affect patient survival or function of the lvas * intolerance to anticoagulant or antiplatelet therapies. * existence of any ongoing mechanical circulatory support other than intra-aortic balloon counterpulsation. * participation in any other clinical investigation that is likely to confound study results or affect study outcome

Keywords: heart-assist devices