Kornimate/medical-research-clean huggingface dataset:
risedronate in osteopenic postmenopausal women

Conditions: Osteoporosis

Summary: the primary objective of this study is to compare risedronate 35 mg and placebo with respect to the percent change at 12 months for distal radius trabecular bone volume (bv/tv) in osteopenic postmenopausal women, as measured by three-dimensional peripheral quantitative computed tomography (3d pqct). the secondary objectives are to compare the percent change from screening/baseline between the 2 treatment groups for the following measurements: * bone mineral density of the lumbar spine, femoral neck, femoral trochanter, and total proximal femur using a dual energy x-ray absorptiometry (dxa) scan at 12 and 24 months; * 3d pqct analysis of distal radius and distal tibia bone microarchitecture data at 6, 12, and 24 months; and * bone turnover markers (btms) of: * fasting serum carboxyterminal cross linking telopeptide of type 1 bone collagen (ctx 1); * serum aminoterminal propeptide of type 1 procollagen (pinp); and * urine n-telopeptide cross-links (ntx) at 3, 6, 12, and 24 months.


Eligibility criteria:
inclusion criteria: * osteopenic, postmenopausal women, between 55 and 75 years of age with a body mass index (bmi) \< 30 kg/m² exclusion criteria: * clinical or radiological evidence of osteoporosis * severe renal impairment * serum 5-hydroxy vitamin d level \< 15 ng/ml * history of recent primary hyperparathyroidism or recent thyroid disorder * history of any generalized bone disease * current use of glucocorticoids, estrogens, progestins, calcium supplements \> 1 g/day, vitamin d supplements \> 800 iu/day, parathyroid hormone (pth), or any bisphosphonate for \> 1 month at any time within the past 6 months. the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Keywords: postmenopausal
f-bevar vs open surgery for complex abdominal aortic aneurysm

Conditions: Aneurysm Aortic; Vascular Diseases

Summary: the aim of the present study was to investigate outcomes of a propensity matched series of patients treated with f-bevar and open surgery repair for complex abdominal aortic aneurysm in two aortic high-volume centres.

this retrospective study analyzes the long-term outcomes of a propensity-matched cohort of patients with complex abdominal aortic aneurysm prospectively collected between january 2010 and june 2016 from the aortic center of lille (lille, france) and the unit of vascular surgery of policlinic gemelli (rome, italy). patients were observed with regular postoperative appointments. the long-term imaging follow-up consisted in a yearly computed tomography angiography in the f-bevar group; and yearly abdominal ultrasound examination and 5-year computed tomography angiography were performed in the open surgery repair group. in case of abnormal renal function (egfr\<60 ml/min/1.73 m2), the patient underwent computed tomography without contrast associated to a contrast-enhanced ultrasound examination in both groups. laboratory data with evaluation of renal function by estimated glomerular filtration rate (egfr), were completed at three, six, and 12 months, and yearly thereafter. survival assessment was completed after general partitioner's, patients' or patient siblings' contact by phone.

Eligibility criteria:
inclusion criteria: * juxtarenal abdominal aortic aneurysms * pararenal abdominal aortic aneurysms * suprarenal abdominal aortic aneurysms * type iv thoracoabdominal aneurysms exclusion criteria: * extent i to iii thoracoabdominal aneurysms * ruptured o symptomatic aneurysms * dissections or connective tissue disorder aneurysms.

Keywords: f-bevar open surgery complex abdominal aortic aneurysm
anti-obesity effect of pediococcus pentosaceus lp28

Conditions: Obesity

Summary: this study is designed to evaluate efficacy of pediococcus pentosaceus lp28 in reducing body fat and body weight in subjects with bmi 25-30 kg/m2.


Eligibility criteria:
inclusion criteria: * bmi 25-30 kg/m2 exclusion criteria: * taking medicines or functional food that may affect body weight or body fat * pregnant or nursing a child * participation in any clinical trial within 90 days of the commencement of the trial * renal or hepatic dysfunction * heart disease
tetranectin as a novel obesity-associated adipokine for regulating lipid accumulation

Conditions: Obesity; Metabolic Syndrome

Summary: adipose tissue is strongly correlated to obesity and diabetes which are two major problems in the worldwide. adipose tissue is involved in modulating glucose and energy metabolism locally and systemically by secreting factors, called adipocytokines. tetranectin (tn), a novel adipocytokine, is secreted by adipose tissues. tn may regulate the glucose/energy homeostasis to affect lipid accumulation.the role of tn in adipocytes with or without tn on regulation of adipose tissue growth and lipid metabolism is valuable to be studied. materials and methods: secreted proteins from human adipocyte culture medium were deciphered using 2-d polyacrylamide gel electrophoresis and determined by lc/ms with maldi-tof analysis of proteins. adipose tissues were obtained from the breast of 15 women undergoing mastectomy. serum samples from 200 normal healthy people and 54 breast cancer patients were assigned to either a lean or obese group according to the body mass index. the tn protein concentration was measured in the culture medium of stromal-vascular fraction (svf)-derived adipocytes from healthy humans, breast cancer patients, pigs and also from 3t3-l1 cells. associations between plasma tn and other biomarkers were assessed with pearson's correlations and multivariable linear regression.

adipose tissues were obtained from the breast of breast cancer patients with 0 to 1 progression stage. all participants gave permission and the study was approved by the ethics committee of national taiwan university hospital as no. 9461701203. from 2012 to 2013 in national taiwan university hospital, a cross-sectional sampling of 21 to 78 -year old people included women and men who were living in taiwan. blood samples were collected after an overnight fasting. serum was separated by centrifugation and stored at -80 ℃ until analysis. plasma triglyceride (tg), high density lipoprotein (hdl), low density lipoprotein (ldl), cholesterol, glucose and insulin were measured. fasting serum samples were obtained from 193 randomly selected persons having health check-ups. to investigate the relationship among tn and breast cancer, fasting serum samples also obtained from 54 randomly selected breast cancer patients who were 25 to 59 years old with elected surgery for breast cancer stage 0 and 1.

Eligibility criteria:
inclusion criteria: 1. must be above age 20 years old. 2. subjects must sign the written informed consent form. 3. must have residual fat after surgery. 4. clinical diagnosis of liposuction and tumor resection. exclusion criteria: 1. terminal cancer. 2. subjects have no fat tissue after surgery. 3. pregnant subjects.

Keywords: adipokine, tetranectin, lipid metabolism, body mass index
comparison of goal-directed algorithms of hemodynamic therapy after combined valve repair

Conditions: Valvular Heart Disease

Summary: valvular repair and repair surgery is rapidly progressing yet rather challenging aspect of current cardiosurgical practice. several approaches were introduced into the clinical practice to alleviate systemic inflammatory response induced by cardiopulmonary bypass and organ-specific injury including meticulous haemodynamic monitoring, pharmacological heart preconditioning, systemic use of anti-inflammatory agents, prevention of coagulopathy, and induced topical and systemic hypothermia. an in-depth monitoring of haemodynamics, oxygen transport, and vascular permeability is of a great clinical value to control the efficacy of these approaches. therefore, the aim of this study was to compare two algorithms of goal-directed therapy aimed to achieve a postoperative haemodynamic optimization in combined valve repair surgery.

forty-three adult patients scheduled for elective two valve replacement/repair were enrolled into randomised single-centre study. all interventions were performed in cardiosurgical department of city hospital #1 (arkhangelsk, russian federation) by the same surgical team. three patients were excluded from the analysis; two - due to protocol violation and one - due to inadequate surgical correction diagnosed by intraoperative transoesophageal echocardiography. day before surgery patients were asked for informed consent and randomized in two groups. in the first group postoperative haemodynamic optimization was targeted on parameters provided by pulmonary artery catheter (the pac-group, n = 20): pulmonary arterial occlusion pressure, cardiac index (lifescope monitor, nihon kohden, japan) and hemoglobin blood level. in the second group haemodynamics was managed using parameters given by transpulmonary thermodilution (the complex-group), that included cardiac index, global end-diastolic volume index, extravascular lung water index, continuous central venous oxygen saturation, and oxygen delivery index as measured with picco2 monitor (pulsion medical systems, munich, germany. in addition, mean arterial pressure, heart rate, and hemoglobin concentration were included into both pac- and picco2-driven protocols.

Eligibility criteria:
inclusion criteria: * two valve repair / replacements * age above 18 * informed consent exclusion criteria: * pulmonary hypertension * insulin-dependent diabetes mellitus * severe atherosclerosis of femoral arteries * severe respiratory failure * pregnancy

Keywords: valve repair postoperative period goal-directed therapy pulmonary artery catheter transpulmonary thermodilution central venous oxygen saturation
arsenic trioxide and thalidomide in the treatment of refractory multiple myeloma

Conditions: Multiple Myeloma

Summary: in this trial, we plan to evaluate further the role of arsenic trioxide in the treatment of patients with refractory multiple myeloma. arsenic trioxide will be used in combination with thalidomide. although both drugs have a similar mechanism of action, it is likely that the mechanisms may be additive or synergistic. since neither drug produces much myelosuppression, this combination regimen should be tolerable in patients with compromised marrow function due to involvement with myeloma and/or previous cytotoxic chemotherapy

upon determination of eligibility, patients will be receive: * arsenic trioxide + thalidomide

Eligibility criteria:
inclusion criteria: to be included in this study, you must meet the following criteria: * confirmed diagnosis of multiple myeloma * received at least one previous chemotherapy regimen at most 3 previous * thalidomide with or without dexamethasone without chemotherapy will not factor in to total number of regimens. * age at least 18 years years * able to perform activities of daily living with minimal assistance * life expectancy more than 3 months * adequate bone marrow, liver and kidney function * must give written informed consent in order to participate. exclusion criteria: you cannot participate in this study if any of the following apply to you: * women pregnant or lactating. * pre-existing moderate neuropathy * patients with significant underlying cardiac dysfunction * uncontrolled hypercalcemia * active serious infections not controlled by antibiotics * history of grand mal seizures (other than infantile febrile seizures) * receiving other medications that prolong the qt interval. please note: there are additional inclusion/exclusion criteria. the study center will determine if you meet all of the criteria. if you do not qualify for the trial, study personnel will explain the reasons. if you do qualify, study personnel will explain the trial in detail and answer any questions you may have.
via respimat® inhaled bi 1744 cl compared to moxifloxacin and placebo in healthy male and female volunteers

Conditions: Healthy

Summary: study to investigate the effect of bi 1744 cl on the qt/qtc interval of the ecg (electrocardiogram) in comparison to placebo


Eligibility criteria:
inclusion criteria: all participants in the study will be healthy males or females, ranging from 21 to 50 years of age, with a body mass index (bmi) be within 18.5 to 29.9 kg/m2 (bmi calculation: weight in kilograms divided by the square of height in meters). in accordance with good clinical practice and the local legislation all volunteers will have given their written informed consent prior to admission to the study exclusion criteria: * any finding of the medical examination (including blood pressure, pulse rate and ecg) deviating from normal and of clinical relevance * gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders, clinically relevant electrolyte disturbances * diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders * history of orthostatic hypotension, fainting spells or blackouts * chronic or clinically relevant acute infections * history of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator * intake of drugs with a long half-life (\> 24:00 hours) within at least one month or less than ten half-lives of the respective drug before enrolment in the study or during the study * use of any drugs which might influence the results of the trial up to 7 days prior to enrolment in the study or during the study * participation in another trial with an investigational drug (within two months prior to administration or during the trial) * smoker (\> 10 cigarettes or \> 3 cigars of \> 3 pipes/day) * inability to refrain from smoking on trial days * alcohol abuse (\> 60 g/day for males and \> 20 g/day for females) * drug abuse * blood donation (\> 100 ml within four weeks prior to administration or during the trial) * any laboratory value outside the reference range if indicative of underlying disease or poor health * excessive physical activities within the last week before the trial or during the trial * hypersensitivity to treatment medication, moxifloxacin and/or related drugs of these classes * previous tendon disease related to quinolone treatment * congenital or documented acquired qt- prolongation, previous history of symptomatic arrhythmias * pulse rate at screening of \> 80 bpm or \< 45 bpm * any screening ecg value outside of the reference range of clinical relevance including, but not limited to pr (pulse rate) interval \> 220 ms, qrs interval \> 115 ms, qtcb \> 450 ms, or qt (uncorrected) \> 470 ms for female subjects: * pregnancy * positive pregnancy test * no adequate contraception (adequate contraception e.g. sterilisation, intrauterine-pressure, oral contraceptives) * inability to maintain this adequate contraception during the whole study period * lactation period
use of intrapyloric botulinum injections in children

Conditions: Vomiting; Feeding Disorders; Gastroparesis

Summary: this study aims to evaluate the effect of intrapyloric botulinum toxin in children with feeding disorders.

chronic vomiting and feeding difficulties are common in young children and have a negative physical and psychosocial impact for patients and families. currently there is no straightforward treatment algorithm for these issues, and management often involves multiple medication trials and procedures. intrapyloric botulinum toxin injection has been proposed as a treatment for nausea and vomiting in adults, but there is minimal prior research on use in children and no prior research on use in children with feeding disorders. the aims of this study are: (1) to determine the efficacy of intrapyloric botulinum toxin injection for reducing gastrointestinal symptoms in children, (2) to determine the efficacy of intrapyloric botulinum injections for improving feeding outcomes in children, and (3) to define predictors of response to intrapyloric botulinum toxin injection.

Eligibility criteria:
inclusion criteria: * patients with chronic nausea, vomiting, or feeding intolerance undergoing upper endoscopy with or without intrapyloric botulinum injections. * age between 30 days and 18 years. exclusion criteria: * significant uncontrolled inflammation on upper or lower endoscopy * known inflammatory bowel disease * uncontrolled thyroid disease * current opioid use

Keywords: botulinum toxin
analgesic efficacy of pre-operative oral pregabalin in dacryocystorhinostomy surgery

Conditions: Dacryocystitis

Summary: this study is conducted to evaluate the effects of preoperative oral pregabalin on postoperative pain and analgesic requirements in patients undergoing dcr surgery. the primary outcome is to compare pain scores by visual analogue scale (vas). secondary outcomes are the time of first analgesic request, the total analgesic requirements during the postoperative 24 hours, the incidence of ponv, in addition to effect on hemodynamic parameters between the two groups.

external dacryocystorhinostomy (dcr) is still considered the golden standard for lacrimal surgery. it is a bypass technique which creates an anastomosis between the lacrimal sac and the nasal mucosa through a bony ostium via an external skin incision. external dcr can be completed under either local or general anesthesia. it is a painful surgical procedure that involves intra- and extra-ocular dissection, with a high prevalence post-operative nausea and vomiting (ponv). so, it is necessary to ensure a stress-free peri-operative period with adequate pain relief and a low incidence of ponv after dcr surgery. pregabalin is a lipophilic gamma-amino-butyric acid (gaba) analogue that binds to the voltage-gated calcium channels. it reduces the excitability of the dorsal horn neurons after tissue damage. it has anticonvulsant, anxiolytic and sleep-modulating properties. it was shown to be effective in several models of neuropathic pain, incisional injury, and inflammatory injury. preoperative administration of pregabalin is supposed to be a promising technique of enhancing postoperative pain control and reduction in postoperative opioid consumption. this study is a prospective randomized double-blind clinical trial included 100 asa i and ii patients of both sex with age between 18 and 65 years old, who are planned for elective dcr surgery under general anesthesia in mansoura university ophthalmology center. informed written consent is obtained from all subjects in the study after ensuring confidentiality. details of the anesthetic technique and the study protocol are clarified to the entire involved cases. patients are randomly assigned to two equal groups according to computer-generated randomization schedule. a prospective analysis of the collected data is performed using the statistical package for the social sciences (spss) program for windows (version 22). all data are considered statistically significant if p value is ≤ 0.05.

Eligibility criteria:
inclusion criteria: * american society of anesthesiology (asa) i and ii patients. * scheduled for dcr surgery. exclusion criteria: * patient' refusal of consent. * mental, psychological or neurological disorders. * patients with history of drug or alcohol abuse. * history of know sensitivity to the used drugs. * bleeding or coagulation diathesis. * obese patients (body mass index (bmi) \< 35). * pregnancy and lactation.

Keywords: pregabalin dacryocystorhinostomy analgesia
predictors of early success from circumferential compression stitch meniscal repairs

Conditions: Knee Medial Meniscus Tears; Meniscus Lesion; Meniscus; Rupture, Bucket Handle; Meniscus Disorder

Summary: this is a retrospective study of meniscal tear repairs at least one-year post repair status. all patients were treated with ceterix novostitch devices. the primary objectives of this study are to assess the clinical repair success rate via reoperation and pros at greater than 12 months.

the study is a retrospective, non-randomized, single-group assignment, open-label study of repairs of meniscal tears status post repair. the following clinical efficacy endpoints will be evaluated at greater than 12 months: * reoperation rate * validated patient-reported outcomes measures * contribution of the following retrospective covariates on failure and outcomes when available: type of tear, location of tear (lateral versus medial), chronicity of symptoms, nature of tear (degenerative versus traumatic), length of tear, patient age, patient gender, length of rehabilitation protocol, performance of trephination, inclusion of biologic enhancement, meniscal repair alone versus meniscal repair combined with acl reconstruction.

Eligibility criteria:
inclusion criteria: * able and willing to give consent by voluntarily providing written informed consent in accordance with governing institutional review board (irb)/independent ethics committee (iec) requirements, local regulations, and health insurance portability and accountability act (hipaa) authorization (or equivalent if locally applicable) * in the opinion of the investigator are able to comply with study-required follow-up exclusion criteria: * post-operative interval \<1year * concurrent bony fractures * post-operative reinjury (except the meniscus) * pre-operative arthritis grade 3 or higher on modified outerbridge * knee surgery prior to meniscus repair surgery * any kind of infection

Keywords: lateral meniscus tear medial meniscus tear