Kornimate/medical-research-clean huggingface dataset:
oral tonapofylline (bg9928) in patients with heart failure and renal insufficiency

Conditions: Renal Insufficiency; Heart Failure

Summary: the main purpose of this study is to determine the safety and tolerability of tonapofylline (bg9928) when given at different doses to patients with heart failure and renal insufficiency. this study will also explore: * disease related quality-of-life * exercise capacity * renal function * concomitant medications


Eligibility criteria:
inclusion criteria: * 18 years of age or older * diagnosis of heart failure requiring hospitalization \>1 and ≤12 months prior to screening * nyha class iii or iv at the time of screening * renal insufficiency as defined by egfr ≥20 and ≤70 ml/min/1.73 m2 * negative pregnancy test exclusion criteria: * history of an allergic reaction to any xanthine-containing compound. * history of seizure * history of stroke * serious systemic infection * sustained systolic blood pressure \>170 or \<90 mmhg * myocardial infarction within 30 days of day 1 * hemodynamically destabilizing arrhythmia within 30 days of day 1 * uncorrected hemodynamically significant primary valvular disease * known obstructive or restrictive cardiomyopathy * cardiac surgery within 60 days prior to day 1 * likely to undergo cardiac transplantation, device implantation, or other cardiac surgery within next three months * evidence of malignancy within 6 months prior to day 1. * participation in any other investigational study of drugs or devices within 30 days prior to day 1. * receiving aminophylline, theophylline, pentoxifylline, dyphylline or adenosine * presence of any clinically significant condition that might interfere with optimal safe participation in this study

Keywords: heart failure renal insufficiency congestive heart failure
the βig-h3 protein: a new marker in pancreatic adenocarcinoma (bighpanc)

Conditions: Pancreas Adenocarcinoma

Summary: the primary objective of this trial is to evaluate the correlation between the intensity of the protein big-h3 expression at tumoural microenvironment and the tnm/uicc staging (from i to iv) of pancreatic adenocarcinoma lesion.

the pancreatic adenocarcinoma is the most common pancreatic cancer. currently, it represents the fourth cause of death by cancer in france. the diagnosis is often realized when the disease is at an advanced stage because of its delayed clinical expression. only 20% of the patients are diagnosed at a stage enabling a tumour resection. scientists discovered a protein playing a key role: the βig-h3 protein. in mouse models, this protein is present in several stages of the tumorigenesis. a mutation of the gene kras leads to the development of panin (pancreatic intraepithelial neoplasia) type precancerous lesions. the βig-h3 protein is early and highly expressed in the stroma around these lesions and in the pancreatic adenocarcinoma stroma. moreover, studies showed that protein neutralization leads to a tumour size reduction by increasing the cd8+anti-tumor activity. this protein is detected in the blood serum of patients suffering from a pancreatic adenocarcinoma. so, this protein which is secreted by the extracellular matrix could be a predictive marker for the pancreatic adenocarcinoma. in this prospective, multicentric non-interventional study, it is anticipated to recruit 80 patients (20 per tnm/uicc stage). included patients will undergo two samples: a blood sample (5 ml) and a tumour sample (surgical exeresis piece or tumour tissue obtained for the initial diagnosis). in case of relapse, new samples will be performed.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years at the day of consenting to the study * patient with a potential pancreatic adenocarcinoma whatever the tnm/uicc stage * systematic treatment not initiated * signed and dated informed consent document. exclusion criteria: * pregnant or breastfeeding woman * geographical, social or psychiatric reason preventing the patient from completing the study follow-up

Keywords: pancreatic adenocarcinoma βig-h3 pronostic marker
the femtosecond laser in residency training (flirt) pilot study

Conditions: Cataract; Intraocular Lens Implantation

Summary: this pilot study aims to primarily assess the rate of complication of anterior vitrectomy for patients undergoing femtosecond laser-assisted (fla) cataract extraction and intraocular lens placement (ceiol) compared to manual ceiol, when performed by resident physicians under direct attending supervision. in this pilot study, the investigators aim to assess what the incidence of anterior vitrectomy is for each group, in order to better understand the sample size needed to assess whether there is a difference between these two groups. secondarily, it will gather preliminary data on safety and refractive outcomes for patients undergoing these interventions.


Eligibility criteria:
inclusion criteria: * patients of the los angeles county + university of southern california medical center (lac+usc) who are 40 years or older with visually significant cataracts asking for surgical intervention. * cataract must be visually and clinically significant on examination as determined by the resident surgeon and the attending physician. exclusion criteria: * age less than 40 * visual acuity 20/30 or better with refraction in the study eye * any previous ocular surgery * patient request for monovision or for correction at near at the expense of distance * patient and physician decision to use an iol implant other than monofocal iol * corneal pathology (e.g. fuch's dystrophy, corneal opacity or scar, corneal ectasia) * posterior or anterior capsular plaque * posterior polar cataract * white cataract * subluxated lens, weak zonules, or phacodonesis * pseudoexfoliation syndrome * failure of preoperative pupillary dilatation (\< 6 mm dilation) * history of uveitis * history of retinal detachment * untreated or active proliferative diabetic retinopathy * untreated or active diabetic macular edema * ocular diseases that may affect visual acuity or the operation (including and not limited to macular degeneration, retinitis pigmentosa, macular hole, advanced or end-stage glaucoma) * neurological or systemic diseases that may affect visual acuity or the safety of the operation
eating behavior, food craving and relation to excessive weight gain in patients submitted to liver transplantation

Conditions: Eating Behavior; Liver Transplant

Summary: excessive weight gain, obesity and metabolic syndrome are highly prevalent in patients undergoing liver transplantation. traditional methods of assessing dietary intake have failed to demonstrate an association between these problems and dietary intake. patients with an indication for transplantation due to ethanolic cirrhosis, ex-smokers and those with a previous history of overweight were identified as being at greater risk for overweight and metabolic syndrome, and these factors may be related to the change in eating behavior after the operation. objective: to evaluate the eating behavior, the occurrence of food craving and relation to weight gain, overweight and obesity after liver transplantation. method: this is a cross-sectional study in which adult and elderly patients in follow-up at the hepatic transplant outpatient clinic of the alpha institute of gastroenterology of the federal university of minas gerais were evaluated for eating behavior and food craving. the evaluation of the eating behavior was performed with the help of the three factor eating questionnaire-r21 (tfeq-r21), translated version and validated for portuguese. food craving questionnaires state (fcq-s) and trait (fcq-t) and the brazilian inventory of foods related to craving (fci-br) were used in the translated and validated versions for portuguese. demographic, lifestyle, clinical and anthropometric variables of the evaluated patients were obtained through electronic medical records. weight gain was assessed by the difference between the current weight and the first post-transplant outpatient weight.


Eligibility criteria:
inclusion criteria: * patients who undergone liver transplantation * at least 18 years of age * patients regularly followed up at the bias fortes outpatient clinic * patients who agreed to participate in the study exclusion criteria: * patients who were unable to write and who did not have an accompanying person present as a literate person * pregnant or nursing women

Keywords: eating behavior excessive weight food craving liver transplantation obesity weight gain
efficacy of iv lidocaine at alleviating pain associated with propofol infusion in pediatric patients undergoing sedation

Conditions: Pain

Summary: this protocol describes a double-blind, placebo-controlled trial intended to demonstrate the effectiveness of lidocaine at reducing pain associated wiht propofol infusion for short-term deep sedation in children. patients will be randomized to receive either placebo (saline) or one of two dosing regimens of iv lidocaine prior to initiating propofol infusion. the efficacy of the differing lidocaine doses will be compared to determine the minimum dose required to safely achieve alleviation of pain. we hypothesize that premedicating with lidocaine will significantly decrease pain experienced by pediatric patients receiving propofol for outpatient sedation.


Eligibility criteria:
inclusion criteria: * scheduled for painless diagnostic procedures * are asa i or asa ii exclusion criteria: * have an indwelling central venous catheter * have received an analgesic or sedative medication in the previous four hours prior to enrollment * have an underlying chronic disorder that would impact on their ability to express distress when in painful or otherwise anxiety-provoking situations * known hypersensitivity to lidocaine or any component of the formulation * hypersensitivity to another local anesthetic of the amide type * adam-stokes syndrome * severe degrees of sa, av, or intraventricular heart block * allergy to corn-related products * contraindication to propofol

Keywords: pain propofol lidocaine sedation pediatric
rapid intravenous infusion of mannitol results in a dipper-type change in stroke volume variation in patients undergoing major neurosurgery

Conditions: Craniotomy

Summary: the purpose of this study is to observe the variation of hemodynamics、lactic acid、base excess、peripheral vascular resistance and do2 through flotrac™/vigileo™ system after rapid infusion mannitol in neurosurgery.the hemodynamic changes after mannitol infusion are shown in figure 1. hr (fig. 1a) and systolic bp (figure 1b) significantly increased between 0 min and 10 min (p = 0.041) and between -10 min and 10 min (p = 0.073), respectively; these two variables decreased steadily and returned to the baseline. diastolic bp (fig. 1b) showed no significant change after mannitol infusion (p = 0.102). cvp (fig. 1c) significantly increased between -20 min and 0 min (p \< 0.001) and constantly decreased after 0 min, which remained below the baseline between 30 min and 60 min. ci (fig. 1d) and svi (fig. 1e) showed a significant persistent increase between -20 min to 0 min (p \< 0.001) and between -20 min and 10 min (p \< 0.001), respectively. svv exhibited a dipper-type change shown as a significant decrease between -20 min and 0 min and a significant increase between 0 min and 60 min (p \< 0.001), which returned to the baseline after 20 min.


Eligibility criteria:
inclusion criteria: * the inclusion criteria were: being aged between 16 and 70 years; * with a body mass index of 18-25 kg/m2; * with a physical status classified as asa class i or ii; * and scheduled for elective craniotomy exclusion criteria: * any patient would be excluded from this study if the patient had complicating serious coagulopathy, hepatorenal insufficiency, aortic regurgitation, or cardiac arrhythmia; * had a previous history of intra-aortic balloon counterpulsation; * exhibited systolic blood pressure (sbp) ≥160 mmhg, diastolic blood pressure (dbp) ≥100 mmhg, or heart rate ≥ 100 bpm on operating room admission; * or rejected to participate in this study.
to assess the effectiveness of three distinct mechanical assisted sputum evacuation apparatuses in the treatment of patients with mechanical ventilation-induced atelectasis

Conditions: Mechanical Ventilation; Atelectasis

Summary: retention of airway secretions is a common clinical problem in patients with mechanical ventilation. effective removal of airway secretions requires a balance between the production and removal of airway secretions through the mucociliary transport system. effective removal of airway secretions is the basic measure to maintain airway patency and normal alveolar ventilation and oxygenation. at present, a variety of mechanical assisted expectoration devices have been used to remove airway secretions in critically ill patients, including the metaneb® system(metaneb), high frequency chest wall oscillation(hfcwo) and (cycloid vibration therapy)cvt. however, there is still a lack of sufficient evidence to evaluate the clinical efficacy of these three different mechanical assisted expectoration devices in airway management of patients with mechanical ventilation. this study aims to observe the clinical efficacy of three different mechanical assisted sputum evacuation devices in airway management of patients with mechanical ventilation atelectasis, and to provide a basis for optimizing the airway management scheme of patients with mechanical ventilation.


Eligibility criteria:
inclusion criteria: * ≥18 years old. * patients who were diagnosed as obstructed airway secretion clearance and required mechanical sputum evacuation in sir run run shaw hospital, zhejiang university school of medicine. among them, patients using cvt were included in the cvt cohort, patients using metaneb were included in the metaneb cohort, and patients using high-frequency chest wall oscillation (hfcwo) were included in the high-frequency chest wall oscillation (hfcwo) cohort. * voluntarily participated in this study and signed the informed consent. if the subjects were unable to read and sign the informed consent form due to incapacity or other reasons, their guardians were required to act for them during the informed consent process and sign the informed consent form. if the subjects were unable to read the informed consent form (e.g., illiterate subjects), witnesses were required to witness the informed consent process and sign the informed consent. * invasive mechanical ventilation ≥48 hours. * atelectasis was confirmed by chest ct, chest x-ray or lung ultrasound. exclusion criteria: * bmi≥40kg/m2. * severe spinal and thoracic deformity. * known or suspected diaphragmatic dysfunction such as phrenic nerve rupture, neuromuscular disease, etc. * untreated tension pneumothorax. * active bleeding in the lung. * severe hemodynamic instability (increased dose of vasoactive drugs within 2 hours or map≤65mmhg). * severe other organ dysfunction was expected to result in short-term death (7 days) or palliative treatment. * other reasons considered by the medical team not suitable for treatment. * pregnancy status.
investigation of heylo, a novel app driven digital supporting ostomy product

Conditions: Ileostomy - Stoma; Colostomy Stoma

Summary: people with intestinal stomas can have, despite development of better ostomy products, problems with leakage which influence their quality of life negatively. to overcome this, coloplast has developed a new supporting ostomy product called heylo™, which has an adhesive sensor layer that should be placed underneath the baseplate. the sensor layer consists of an electronic sensor system that continuously detects moisture and output leakage underneath the baseplate. a transmitter connected to the sensor layer continuously evaluates the incoming information and sends a status to a smartphone software application, which based on a predefined flow decides which information to deliver to the user about the baseplate status. the overall aim of this clinical investigation is to evaluate the benefits of the new supporting product, heylo compared to standard of care.

the investigational device - heylo, is already ce-marked. the investigation is an open-labelled, randomized cross-over trial with two test periods evaluating heylo and standard of care. in total 144 subjects having an ileostomy or an colostomy will be included and randomized.

Eligibility criteria:
inclusion criteria: * has given written consent to participate by signing the informed consent signature form. * is at least 18 years of age and has full legal capacity. * has an ileostomy or colostomy with consistent liquid/mushy fecal output (5-7 bristol scale\*) * is able to use one of the five test products (i.e. ø40, ø50, ø60, ø70, ø80 mm). * has experienced leakage\*\* under the baseplate at least three times within the last fourteen days. \*\*leakage defined as output seeping under the baseplate" * has worry about leakage to "some degree, high degree, or very high degree" (on a five-point likert scale: very low degree/not at all, low degree, some degree, high degree, very high degree) * is willing to refrain from use of ostomy paste. * has a smartphone compatible with the heylo™ application * is able to follow study procedures for 4 months (assessed by investigator or delegate) exclusion criteria: * is participating in other clinical investigations or has previously participated in this investigation * is pregnant or breastfeeding * has known hypersensitivity towards any of the products used in the investigation * is using/ has a pacemaker
im ketorolac vs cambia for the acute treatment of severe migraine

Conditions: Migraine Headache

Summary: this research will be conducted to see if the oral drug cambia is as effective in relieving severe migraine headaches as the injectable drug ketorolac.

the treatment of severe migraine often requires a patient office visit or treatment in the er or urgent care setting. this is due to the minimal efficacy of po treatments once migraine is severe, and therefore the need for parenteral treatments. im ketorolac is one mainstay of parenteral treatment. there is an unmet need for effective at-home treatment regimens for severe migraine. despite fda approval of cambia for acute migraine treatment, insurance is reticent to cover the treatment due to higher cost in comparison to generic diclofenac tablets, despite superior efficacy of cambia in comparison to generic diclofenac tablets (diener, cephalalgia 2006). one objective of this study would be to provide rationale to justify the insurance coverage of this treatment in comparison to generic tablets, because at home treatment is less costly than office visit or emergency department visit to receive im ketorolac. a previous study of cambia demonstrated that this formulation of diclofenac potassium for oral solution is effective in reducing pain intensity within 30 minutes, which may be related to the 15-minute tmax associated with this formulation. the rapid-onset benefits were sustained through 24 hours post-treatment (lipton, cephalalgia 2010)

Eligibility criteria:
inclusion criteria: * patients who meet ihs criteria for migraine * age 18 to 65 * at least 2 migraine attacks per month * able to give written consent * willing to complete the entire course of the study * current headache duration greater than or equal to 36 hours exclusion criteria: * pregnant or nursing * significant medical or psychiatric disease * history of gastritis, gastric ulcer, gi bleed * renal insufficiency * hepatic insufficiency * history of opioid dependence within the last 10 years or currently * any current or prior use of diclofenac potassium powder for oral solution (cambia) * past allergic reaction to diclofenac or other nsaids

Keywords: severe migraine headache
neurologic complications in peripheral regional anesthesia - an evaluation based on a standardized protocol

Conditions: Anesthesia, Conduction; Nerve Block; Adverse Effects

Summary: to evaluate the incidence of neurologic complications as a consequence of peripheral regional anesthesia, all patients receiving peripheral nerve blocks will be evaluated according to a standardized protocol screening pain, motoric and sensory function recovering to defined periods, and according to a study protocol defining the items.

neurologic complications as an adverse effect occur in all types of regional anesthesia. reviewing the literature, the incidence spreads from 0.02 up to 3 percent. the incidence remains unclear because of different types of definitions, too. in this study, we evaluate all patients receiving peripheral regional anesthesia 24 hours after block performance according to a standardized study protocol. in case of any conspicuousness concerning motoric or sensory function or pain, the patient will be evaluated again after 48 hours. further on, in case of neurologic dysfunction, periods of investigation will be after 3 days, 1 week, 2 weeks, 1 month, 3 months, 6 months and 1 year. this study includes the definition for nerve damage concerning motoric and sensory neural function and pain. the patients will be recruited among all patients from our hospital receiving continuous peripheral regional anesthesia.

Eligibility criteria:
inclusion criteria: * all patients receiving peripheral regional anesthesia exclusion criteria: * missing agreement

Keywords: peripheral regional anesthesia nerve damage adverse effects neurologic complication neuropathy
role of strontium ranelate in proximal femur fragility fractures.

Conditions: Fragility Fracture; Femur; Fracture, Pertrochanteric; Clinical Trial

Summary: this study is being conducted with the aim of comparing the time to bone healing after surgery for fragility fractures of proximal femur between patients receiving strontium ranelate and placebo. patients recruited are of 60 years of age and above. bone healing will be assessed on clinical parameters when patient is able to ambulate full weight bearing without pain and on xray images using rush score. moreover dexa scan will be performed pre-operatively and at 3 months postoperatively. the findings of this study will help in setting up guidelines for treatment of fragility proximal femur fractures in our population as there is still paucity of literature on effectiveness of strontium ranelate from our part of the world.


Eligibility criteria:
inclusion criteria: * all patients with age =/\> 60 years with proximal femur fracture including per-trochanteric, sub-trochanteric and neck of femur fractures amnebale to orif. * orif will include hip cannulated screws, dynamic hip screw and intra-medullary nails. exclusion criteria: * patients with metabolic bone diseases. * patients with pathological fractures like tumor, osteopetrosis etc. * patients with prior ischemic heart diseases and underwent pci or cabg