Kornimate/medical-research-clean huggingface dataset:
ridaforolimus in treatment of sarcoma-succeed (sarcoma multi-center clinical evaluation of the efficacy of ridaforolimus)(8669-011 am6)

Conditions: Metastatic Soft-Tissue Sarcomas; Metastatic Bone Sarcomas

Summary: the purpose of this study is to determine whether maintenance therapy with oral ap23573 (ridaforolimus), by preventing and controlling tumor growth for a prolonged period of time in patients with metastatic soft-tissue or bone sarcomas responding to chemotherapy, will result in clinically significant improvement in progression-free survival as compared to oral placebo.


Eligibility criteria:
inclusion criteria: * confirmed diagnosis of metastatic soft-tissue or bone sarcoma * ongoing complete response, partial response, or stable disease (recist) after a minimum of 4 cycles (and maximum of 12 months) of any one first, second, or third line of prior cytotoxic chemotherapy for metastatic disease * eastern cooperative oncology group performance status of 0 or 1 * adequate organ and bone marrow function * completed prior chemotherapy with last dose received at least 3 and up to 12 weeks prior to randomization exclusion criteria: * prior therapy with rapamycin or rapamycin analogs * ongoing toxicity associated with prior anticancer therapy * another primary malignancy within the past three years * concomitant medications that induce or inhibit cyp3a * significant, uncontrolled cardiovascular disease
a trial to compare preoperative chemoradiation and surgery versus surgery alone in squamous cell carcinoma of oesophagus

Conditions: Esophageal Neoplasms

Summary: carcinoma of the esophagus is the among the most common cancers in indian population. while adenocarcinoma is more common in western countries, in india squamous cell carcinoma is the more frequent form. surgery is the standard treatment in resectable lesions, but survival is poor. adjuvant and neoadjuvant treatment therapy is used with an aim to improve the results. though few randomized trials have addressed the issue of neoadjuvant chemoradiotherapy, the methodology was inhomogeneous and the populations studied were different. the investigators will be conducting a randomized controlled trial in patients with squamous cell carcinoma of the esophagus. preoperative chemoradiation followed by surgery will be compared with surgery alone.


Eligibility criteria:
inclusion criteria: 1. age \< 65 years 2. squamous cell carcinoma 3. good performance status (eastern cooperative oncology group \[ecog\] grades 0, 1 and 2) 4. contrast enhanced computerized tomographic (cect) scan suggesting a potentially resectable lesion. the features of resectability assessed on cect scan will include - no evidence of infiltration of mediastinal structures such as the aorta (angle of contact \<900, no obliteration of the triangular fat space between the esophagus, aorta, and spine), and pericardium20, and no evidence of tracheobronchial fistula or tumor extension into the airway lumen. 5. no evidence of distant metastasis on cect. exclusion criteria: 1. patient refused consent for the study 2. comorbid conditions which would preclude oesophagectomy * poor performance status (ecog \> 2) * american society of anesthesiologists class iv 3. metastatic disease detected on evaluation 4. involvement of mediastinal structures except 5. carcinoma involving cervical esophagus 6. previous radiotherapy or chemotherapy

Keywords: esophagus squamous cell carcinoma neoadjuvant chemoradiation
nasal ventilation vs face mask

Conditions: Nasotracheal Intubation

Summary: nasotracheal intubation(nti) is commonly used in operations of the mouth, pharynx, larynx and also the neck. while these patients showed higher rates of difficult laryngoscopy. therefore, duration of apnoea is prolonged and re-oxygenation is inevitable.mask ventilation is the most fundamental technique in maintaining oxygenation, even when endotracheal intubation is failed. however, the most common complication of nti is epistaxis, removing the nasotracheal tube could make mask ventilation extremely difficult.so the investigatorsbelieve the ideal approach is ventilation through original nasotracheal tube.several techniques of supraglottic ventilations through endotracheal tubes have been reported.it remains uncertain whether supraglottic ventilation through inflated nasal rae endotracheal tube has similar efficiency as mask ventilation after general anesthesia induction. based on previous clinical experience, the investigators hypothesised that ventilations through inflated nasal rae endotracheal tube and through facemask were comparable in terms of tidal volume and airway pressure in anesthetized, apnoeic adults. forty patients were randomly assigned (sealed envelope method) to face mask（group a，n=20）or nasal ventilation(group b，n=20), for a: face mask ventilation followed by nasal ventilation and for b:nasal ventilation followed by face mask ventilation.measure the tidal volume and air leakage of face mask and nasal ventilation during pressure-controlled ventilation mode and volume-controlled mode, respectively.


Eligibility criteria:
inclusion criteria: * age between 18-55 years old * asa physical status i and ii * requiring general anesthesia with nasal intubation exclusion criteria: * respiratory disease，cardiovascular disease, cerebral vascular disease * anticipated difficult mask ventilation(age\>55 years old, obesity,bearded,edentulous,a history of snoring) * the need for emergency surgery * contraindications to nasal intubation * pregnancy * gastric-esophageal reflex or a full stomach

Keywords: face mask nasal ventilation
dysphagia and vfmi in cardiac patients

Conditions: Cardiac Disease

Summary: the proposed study seeks to determine the incidence of dysphagia and vocal fold mobility impairment (vfmi) in individuals undergoing cardiothoracic surgical procedures. it also seeks to determine the impact of postoperative swallowing impairment on health-related outcomes.

swallowing impairment and vfmi are common, yet often overlooked, complications of cardiac surgical procedures. the true incidence of both dysphagia and vfmi in this patient population is unclear due to a lack of rigorous study using instrumental assessment techniques and validated outcomes in all patents undergoing cardiac surgery. we therefore aimed to determine the incidence of dysphagia and vfmi in this patient population and to characterize impairment profiles related to swallowing safety and efficiency. we also aimed to assess the relative impact of vfmi and dysphagia on health-related outcomes such as length of hospital stay, pneumonia, sepsis, reintubation, and discharge status.

Eligibility criteria:
inclusion criteria: * adults aged 18 - 90 years old * undergoing planned or emergent cardiothoracic surgery via sternotomy and/or extended thoracotomy requiring cardiopulmonary bypass * willing to participate in post-operative swallowing evaluation testing exclusion criteria: * patients undergoing exclusively transcatheter valves * patients undergoing exclusively thoracic endovascular aortic repair procedures * the inability to achieve appropriate alertness and cognitive status following procedure will exclude one from completing the study. * participants must pass cognition, respiratory and physical abilities screening to ensure testing safety.

Keywords: dysphagia extubation cardiac intensive care unit (cicu) forced expiratory volume in one second (fev1) peak expiratory flow (pef)
corneal biomechanics study

Conditions: Myopia

Summary: the goal of the study is to investigate relationship between the corneal response to a temporary increase in intraocular pressure and corneal mechanical properties.

the preliminary theoretical study in which the corneal geometry at different intraocular pressure (iop) levels is investigated using a theoretical biomechanical cornea model found changes in both conventional refractive error (sphere and cylinder) and irregular astigmatism i.e. higher order aberrations (e.g. spherical aberration, trefoil and quadrafoil). this is due to the mechanical characteristics of the cornea determined largely by interaction between collagen fibrils organization and extrafibrillar matrix material properties. corneal geometry and the material properties are the two main factors that contribute to the changes in corneal aberrations with iop elevation. these aberration changes due to the variation of iop and the material properties of the cornea can be measured routinely with corneal topography systems (ur) and brillouin ocular scanner (mgh), respectively and can guide the investigators to study their impact on optical and biomechanical behaviors of the cornea.

Eligibility criteria:
inclusion criteria a person is eligible for inclusion in the study if he/she: * is an adult between the ages of 18 and 55. * is under 250 pounds. exclusion criteria a person will be excluded from the study if he/she: * is under the age of 18 or over the age of 55 yrs. * weighs more than 250 pounds. * has clinically significant dry eye. * has glaucoma. * has hypertension. * has prior cva. * has cardiovascular disease. * has lower extremity joint injury, damage, or replacement. * has baseline bradycardia. * has any orthopaedic injuries. * is pregnant. * has hiatal and ventral hernias. * has vertigo. * has acid reflux (gerd). * is undergoing myopia control treatment (e.g. atropinisation, ortho-k, bifocal contact lenses etc.). * has conditions or has undergone procedures resulting in significant corneal irregularity (e.g. keratoconus, corneal transplant, etc.). this does not include astigmatism and basic refractive errors. * has any ocular or systemic diseases that, in the opinion of the pi/si, would interfere with obtaining a measurement.
pk analysis of moxifloxacin in the treatment of cap

Conditions: Pneumonia

Summary: at the department of infectious diseases, aarhus denmark, moxifloxacin is used in the empirical treatment of severe community-acquired pneumonia (cap). this study was designed to determine the pharmacokinetics of moxifloxacin 400 mg/day to patients treated empirically for cap. to accomplish this aim, we established a pharmacokinetic population model. this approach was adopted with the dual purpose of assessing the potential efficacy of the drug and performing monte-carlo simulations to characterize the maximal mics for which recommended pharmacokinetic-pharmacodynamic (pk-pd) targets are obtained for pathogens commonly known to cause cap.

we determined the pharmacokinetic profile of moxifloxacin 400 mg/day in 18 patients treated empirically for community-acquired pneumonia. . moxifloxacin plasma concentrations were determined the day after therapy initiation using ultra high performance liquid chromatography. the moxifloxacin plasma concentration-time profiles were described with a one compartment model, using nonmem. peak drug concentrations (cmax) and 24-hour area under the free drug concentration-time curve values (fauc0-24) predicted for each patient were evaluated against epidemiological cut-off mic values for streptococcus pneumoniae, haemophilus influenzae and legionella pneumophilia. pk-pd targets adopted were cmax/mic ≥ 12.2 for all pathogens, fauc0-24/mic \> 34 for s. pneumoniae and fauc0-24/mic \> 75 for h. influenzae and l. pneumophilia. the same pk-pd estimates were used in the simulations of probability of target attainment (pta) versus mic.

Eligibility criteria:
inclusion criteria: * patients with community-acquired pneumonia, treated with moxifloxacin exclusion criteria: * under 18 years of age

Keywords: moxifloxacin pneumonia pharmacokinetics
a prospective randomized study comparing radiofrequency energy with cryoenergy

Conditions: Atrial Fibrillation Ablation

Summary: transvenous pulmonary vein (pv) isolation using radiofrequency energy is an effective treatment for atrial fibrillation (1-4). however, rare but potentially life threatening complications such as thromboembolism (5), pv stenosis (5-10), left atrium-oesophageal fistula (11) and inflammatory syndromes (12) have been described. in preliminary studies an alternate approach using cryoenergy induces less endothelial disruption/ thrombus formation (13), preserves the extra cellular matrix and creates lesions with well-delineated border zones (14). therefore, cryoenergy seems to be the ideal form of energy to safely perform pv isolation. we therefore hypothesise that in the setting of pv isolation for the treatment of atrial fibrillation (af) cryoenergy is less traumatic and therefore reduces systemic inflammatory responses compared to radiofrequency energy. 78 patients presenting with symptomatic intermittent or persistent af will be randomised to pv isolation with either radiofrequency (26 patients open irrigated tip, 26 patients closed irrigated tip) or cryoenergy (26 patients with cryoballoon). systemic markers of cell damage and inflammatory response (t-troponin, ck, ck-mb, vwf, pai-1, micro particles, platelet activation/overall function, crp, il-6, il-8, il-10, tnf alpha, procalcitonin) will be monitored before, during and 48h after the procedure. further endpoints include time to pv-isolation and procedure related complications. six month clinical follow-up will focus on freedom from af and cardiovascular events.


Eligibility criteria:
inclusion criteria: * age between 18 and 75 years * symptomatic drug refractory (more than 2 antiarrhythmic drugs) paroxysmal or persistent af * documentation of af on 12 lead ecg and/ or holter * left atrium of less than 55 mm * informed consent signed by the patient exclusion criteria: * previous ablation or operation for af * contra-indication for heart catheterisation * cardioversion for af during the 2 weeks before the procedure

Keywords: atrial fibrillation pulmonary veins ablation
a study of single-dose gabapentin in subjects with transient insomnia induced by a sleep phase advance

Conditions: Transient Insomnia

Summary: the purpose of this study is to assess the effect of gabapentin as compared to placebo on sleep, using subjective sleep measurements, in subjects with transient insomnia induced by a sleep phase advance.


Eligibility criteria:
inclusion criteria: * aged \>/= 18 years * females of child-bearing potential using medically-acceptable method of birth control \>/= 1 month prior to screening exclusion criteria: * current or recent history (within 2 years) of sleep disorder (excessive snoring, obstructive sleep apnea, chronic painful condition) * recreational drug use within past 30 days
impact of hyperoxia during cardiopulmonary

Conditions: Cardiac Complications

Summary: the hypothesis implies that this work is the use of hyperoxia during cardiopulmonary bypass by his heart preconditioning effect is associated with a lower incidence of cardiac arrhythmias (atrial fibrillation, tachycardia or ventricular fibrillation) and lesions of myocardial ischemia-reperfusion injury in cardiac surgery postoperative.


Eligibility criteria:
inclusion criteria: * major patient ≥ 18 years * patient operated cardiac surgery for myocardial revascularization (cabg) or surgical correction of valvular or combined surgery (cabg and valve disease) or ascending aortic surgery * signed consent * affiliation to social security exclusion criteria: * permanent atrial fibrillation * cordarone therapy, * pregnant woman * patient under guardianship or trusteeship or private public law * internal pacemaker * hypothermia, * patient refusal, * cardiac surgery without extracorporal circulation (ecc), * participation in another study.
evaluation of umeclidinium bromide in combination with fluticasone furoate in copd subjects with an asthmatic component

Conditions: Pulmonary Disease, Chronic Obstructive

Summary: the purpose of this study is to evaluate the dose-response of 4 doses of umeclidinium bromide in combination with fluticasone furoate compared with fluticasone furoate monotherapy in chronic obstructive pulmonary disease participants with an asthmatic component. the fluticasone furoate/umeclidinium bromide treatments will also be compared to the once-daily inhaled corticosteroid/long-acting beta agonist combination fluticasone furoate/vilanterol.


Eligibility criteria:
inclusion criteria: * 18 years of age or older * copd with evidence of an asthmatic component as demonstrated by spirometry, reversibility and current therapy at screening as follows: * post-bronchodilator morning (am) fev1 \>=50% and \<=80% of the predicted normal value at visit 1 * pre- and post-bronchodilator fev1/fvc ratio \<0.7. * demonstrated reversibility by \>=12% and \>=200 ml increase in fev1 following albuterol at visit 1. * a need for regular controller therapy (i.e., inhaled corticosteroids alone or in combination with a long-acting beta-agonist or leukotriene modifier, etc.) for a minimum of 12 weeks prior to visit 1. * outpatient subjects who are smokers or non-smokers. exclusion criteria: * history of life-threatening respiratory event within the last 5 years. * unresolved respiratory infection * recent severe copd or asthma exacerbation * risk factors for pneumonia * hospitalization for pneumonia within 3 months * concurrent respiratory disease other than chronic obstructive pulmonary disease or asthma. * other uncontrolled condition or disease state that, in the opinion of the investigator, would put the safety of the subject at risk through study participation or would confound the interpretation of the efficacy results if the condition/disease exacerbated during the study. * viral hepatitis or hiv * current or chronic history of liver disease, known hepatic or biliary abnormalities * drug or milk protein allergy * administration of prescription or over-the-counter medication that would significantly affect the course of copd or asthma, or interact with study drug * subjects with lung volume reduction surgery within 12 months prior to screening. * use of long-term oxygen therapy (ltot) * requirement for nebulized therapy * participation in the acute phase of a pulmonary rehabilitation program within 4 weeks * unstable or life-threatening cardiac disease * abnormal and clinically significant 12-lead electrocardiogram (ecg) finding * diseases preventing the use of anticholinergics

Keywords: gsk573719 asthma umec ff gsk2829332 persistent obstruction gw685698 fluticasone furoate copd umeclidinium bromide
reducing breast cancer recurrence with weight loss

Conditions: Breast Cancer; Overweight; Obesity

Summary: the purpose of the energy trial is to explore whether two different programs that are focused on weight management, through increased exercise and a healthy diet, are feasible, and have an impact on body weight, quality of life and fatigue. since obesity among breast cancer survivors is associated with recurrence and other co-morbidities, those will be assessed and their impact calculated. blood samples will be collected to enable analysis of potential mechanisms and differential response across subgroups.


Eligibility criteria:
inclusion criteria: * diagnosis of breast cancer (stages i (≥1 cm), stage ii, or stage iiia, b, c excluding distant metastasis) diagnosed between 6 months and 5 years earlier; after initial therapies are completed, diagnosed between six months and five years earlier * bmi between 25 to 45 kg/m2 * able to comply with all required study procedures and schedule exclusion criteria: * serious medical condition or psychiatric illness * inability to be moderately physically active * obesity of known endocrine origin (e.g., untreated hypothyroidism, pcos) * currently enrolled in a weight loss program * current use of weight loss medication or supplements * previous surgical procedures for weight reduction * planning weight loss surgery in the next 2 years. * 6+ months use of meds likely to cause weight gain or prevent weight loss * planned surgical procedure that can impact the conduct of the study * currently pregnant/breastfeeding * planning to become pregnant within the next 2 years * have plans to relocate from area within 2 years * family relative or close friend is a trial staff member or a study participant * any condition which in the opinion of the investigator makes the subject unsuitable for inclusion in this study

Keywords: overweight obese breast cancer survivors weight loss exercise physical activity
hypercapnic acute respiratory failure in the icu : the yeti study

Conditions: Intensive Care Unit Syndrome; Hypercapnia; Acute Respiratory Failure

Summary: hypercapnia is a frequent clinical situation defined as an elevation of the partial pressure of carbon dioxide (paco2) above 45 mmhg. several physiopathological parameters such as respiratory minute volume, dead space volume or co2 production influence the paco2. therefore, hypercapnia can affect the time of various diseases. available epidemiological data regarding hypercapnia are from studies investigating the efficacy of non-invasive ventilation (niv), with different population cohorts. however, their interpretation must be cautious given the heterogeneity in patient case-mix and results. then, whether hypercapnia is a common reason for intensive care unit (icu) admission, epidemiological data is scarce and heterogeneous. the aim of this study is to investigate the epidemiological, clinical determinants and outcomes of patients admitted to icu with hypercapnic respiratory failure.


Eligibility criteria:
inclusion criteria: * patients ≥18 years old presenting with at least of the following items : 1. respiratory rate ≥ 25/min, 2. paradoxical motion of the abdomen, 3. intercostal retraction and * a paco2 \> 45 cm h20 before icu admission or within the 12 hours following icu admission. exclusion criteria: * refusal to give informed consent, * pregnancy, * \< 18 years patient, * dying patient
weight loss effect on circulating liver enzymes

Conditions: Visceral Fat; Liver Dysfunction

Summary: to investigate weight loss effect with mild calorie restriction on circulating levels of liver enzymes in nondiabetic and overweight subjects with high visceral fat area \[visceral fat area (vfa) at l4 ≥ 100 cm²\].

a 12-week randomized, placebo-controlled study was conducted on 80 nondiabetic and overweight subjects with high vfa. the participants divided into two groups: 12-week mild calorie restriction (a 300 kcal/day intake reduction, n=40) or no treatment (control, n=40). the randomization was according to computer-generated block randomization (placebo:test = 1:1). before and after intervention period, venous blood samples were obtained from the subjects, and biochemical parameters including circulating liver enzymes were measured.

Eligibility criteria:
inclusion criteria: * able to give informed consent * 20-60 years old * males and females * overweight (25.0 kg/m²≤ bmi \<30 kg/m²) * absence of pregnancy or breast-feeding * stable body weight (body weight change \<1kg for 3 months before screening) * high visceral fat (vfa) at l4 (vfa at l4 ≥100 cm²) * without hypertension, type 2 diabetes, cardiovascular disease, or thyroid disease * no use medication affecting body weight, energy expenditure, or glucose control for the last 6 months exclusion criteria: * prior history of cushing syndrome or malignancy * prior history of liver disease including chronic viral hepatitis, autoimmune hepatitis, primary biliary cirrhosis, or drug-induced liver disease * excess alcohol intake (based on who standard) * history of intentional reduction in weight in the preceding 6 months

Keywords: high visceral fat liver enzymes aminotransferase mild calorie restriction