Kornimate/medical-research-clean huggingface dataset:
angiodefender versus brachial artery ultrasound imaging

Conditions: Cardiovascular Diseases

Summary: the objective of this study is to demonstrate that the investigational device, angiodefender, is comparable to the established procedure referred to as 'brachial artery ultrasound imaging' in their abilities to quantify flow-mediated vasodilation of the brachial artery.


Eligibility criteria:
inclusion criteria: * ecog 0-2 exclusion criteria: 1. body mass index (bmi) \>50 kg/m2 2. mid-upper arm circumference of arm selected for fmd testing \ 40 cm 3. sinus arrhythmia (rr intervals vary by \>50%), atrial fibrillation, atrial flutter, multifocal atrial tachycardia, frequent (\>1 per 10-sec strip) premature atrial or ventricular contractions (isolated, non-isolated, or alternating), documented by 12-lead ecg with rhythm strip at the time of subject screening. 4. clinical signs and/or symptoms of active viral or bacterial infections 5. resting tremor or inability to remain still for the duration of ad and baui testing 6. systolic blood pressure (sbp) at rest of \>170 mmhg or diastolic blood pressure (dbp) at rest of ≥110 mmhg. 7. previous intolerable adverse reaction(s) to vascular testing using an upper extremity occlusive pneumatic cuff

Keywords: physiology
placental removal method and uterine massage on preventing postpartum hemorrhage

Conditions: Postpartum Hemorrhage; Cesarean Section Complications; Uterine Atony

Summary: postpartum hemorrhage is the leading cause of maternal deaths in all over the world, especially in developing and underdeveloped countries. medical and surgical methods exist for management of bleeding. there are two surgical techniques for removal of the placenta on cesarean delivery, which are called manual removal and controlled cord traction. in manual removal group, the duration of surgery time might be shorter theoretically. nevertheless, there are studies showing that manual removal of the placenta may increase postpartum endometritis and postpartum hemorrhage. the optimal method for removal of the placenta during the cesarean delivery remains uncertain (1). it is a known fact that uterine massage after vaginal birth lowers the risk of postpartum hemorrhage (2) however, there is no study on how effective uterine massage is during cesarean delivery. in 2018, saccone and colleagues wanted to publish a meta-analysis on the role of uterine massage in reducing postpartum bleeding during cesarean delivery, but when they examined the literature on the subject, they could not find a study which included only the group that gave birth by cesarean section and was free from bias. in the same publication, it was mentioned that it was necessary to investigate the effectiveness of uterine massage, which is a cost-free method that can reduce maternal morbidity in underdeveloped countries where maternal deaths due to postpartum bleeding are high, in cesarean section. (3)

in this study, data of patients who underwent emergency cesarean delivery in the department of obstetrics and gynecology, ankara etlik city hospital, will be collected the parameters to be examined in the research are as follows: 1. patients' postoperative 30th minute, 1st and 2nd hour systolic blood pressure, diastolic blood pressure, pulse rate, shock indexes 2. volume of diuresis at postoperative first six hours 3. hemoglobin and hematocrit values at preoperatively and 2nd, 6th, 24th hours postoperatively. 4. duration of the surgery. 5. need for additional dose of uterotonics 6. need for surgical methods to manage postpartum bleeding 7. duration of hospital stay the sample size of this study was calculated with the gpower3.1 computer program. the total number of samples with 90% power and 95% confidence interval was calculated as 338 patients. the number of volunteers to participate in our study is planned to be 360 in total, 60 volunteers for each group, across 6 groups. results will be considered statistically significant for p\< 0,05.

Eligibility criteria:
inclusion criteria: * live singleton pregnancy of 37 0/7 weeks or more * without history of previous uterine atony * no comorbidities * no gestational hypertension or gestational diabetes mellitus exclusion criteria: * in utero fetal death * multiple gestation * history of uterine atony * vaginal birth * previous history of cesarean delivery

Keywords: postpartum atony uterine massage hemorrhage placenta cesarean
the effect of colon cancer on muscle gene expression, body composition, muscle function, and muscle metabolism

Conditions: Cachexia; Cancer

Summary: rationale: cancer cachexia is a complex metabolic syndrome characterized by clinically relevant loss of muscle mass with or without loss of fat mass. to determine how treatment methods can be most effective, full insight in changes in gene expression, body composition, muscle function and muscle metabolism are of great importance. objective: main aim of the study is to investigate the differences in gene expression, body composition, muscle function and muscle metabolism in colon cancer patients compared to controls. study design: observational study study population: 40 colon cancer patients undergoing a tumor resection (30 primary tumor and 10 liver metastases) and 15 control patients undergoing an inguinal hernia repair (♂, 10) or an abdominal hysterectomy (♀, 5). main study parameters/endpoints: primary study parameter will be gene expression (transcriptomic and polymerase chain reaction analyses of muscle biopsies). secondary parameters will be body composition (determined in available ct scans and bio impedance analysis and with dexa), muscle function parameters (grip and knee flexion/extension strength and measured in a biopsy), metabolic markers (measured in fat and muscle biopsies), biochemical markers (measured in blood/serum) and gene expression of fat biopsies. nature and extent of the burden and risks associated with participation, benefit and group relatedness: the investigators expect no additional risk for the subjects due to the proposed measurements. biopsies will be taken during the planned operation and therefore is not expected to cause a significant increase in burden for the patient. all other measurements are non-invasive, observational measurements with no risk of any harmful side effects.


Eligibility criteria:
inclusion criteria: * cc patients: in order to be eligible to participate in this study, a subject must meet all of the following inclusion criteria: * diagnosed with primary colon cancer (30) or liver metastases due to colon cancer(10) * eligible for a primary tumor or liver metastases resection procedure * controls: * eligible for an inguinal hernia repair (♂, 10) or an abdominal hysterectomy (♀, 5) exclusion criteria: * cc patients: a potential subject who meets any of the following criteria will be excluded from participation in this study: * having had chemotherapy or an operational procedure of the abdomen in the past 6 months * suffering from malabsorption * controls: * having had treatment for previous or current tumors
management of the pda trial

Conditions: Infant, Premature; Patent Ductus Arteriosus; Infant, Newborn, Diseases; Patent Ductus Arteriosus After Premature Birth

Summary: estimate the risks and benefits of active treatment versus expectant management of a symptomatic patent ductus arteriosus (spda) in premature infants.

this is a pragmatic randomized multicenter, effectiveness study comparing active treatment of a symptomatic patent ductus arteriosus (spda) to expectant management. we hypothesize in premature infants with a spda, expectant management reduces the incidence proportion of death or bpd by 10% (from 50% to 40%) when compared to active treatment. participants with a spda allocated to the active treatment arm will receive intravenous administration of indomethacin or ibuprofen (depending on center preference). the decision to ligate will be left to the clinical team. participants with a spda allocated to the expectant management arm will receive supportive care at the clinical team's discretion and will receive indomethacin/ibuprofen or ligation if the infant develops cardiopulmonary compromise. the decision to ligate will be left to the clinical team. the primary endpoint for the study will be death or bpd (as assessed by the physiologic definition) at 36 weeks postmenstrual age (pma).

Eligibility criteria:
inclusion criteria: * postnatal age 48 hours -21 days * infant 22 0/7 to 28 6/7 weeks gestation at birth * spda, as defined as: 1. mild, moderate, or severe clinical criteria with small or moderate size pda on echocardiogram 2. mild or moderate clinical criteria with large pda on echocardiogram exclusion criteria: * cardiopulmonary compromise * known congenital heart disease (besides atrial septal defect or ventricular septal defect) * known pulmonary malformation (e.g. congenital lobar emphysema, congenital pulmonary adenomatous malformation) * any condition which, in the opinion of the investigator, would preclude enrollment
interferon toxicities in melanoma treatment

Conditions: Stage III Melanoma

Summary: the primary objective of this study is to quantify and compare the prevalence of adverse events (aes) in patients with stage iii melanoma before and after initiation of interferon (ifn) therapy in a real-world setting. a secondary objective is to quantify annual costs and resource utilization before and after ifn initiation among patients with stage iii melanoma in a real-world setting.


Eligibility criteria:
inclusion criteria: * patients with a pharmacy claim for ifn between 1/1/2007 and 12/31/2011. the date of the first observed claim will be defined as the index date * patients with a melanoma diagnosis based on two medical claims prior to the index date * patients with a procedure code for melanoma-related lymph node dissection before the index date * patients ≥ 18 years of age on or before the index date * patients with continuous benefit enrollment for at least 180 days before and after the index date exclusion criteria: * patients with diagnosis of any other (primary) cancer during the 180-day pre-index period (excepting skin cancers and hematologic malignancies) * patients with diagnosis of a secondary cancer during the 180-day pre-index period or on the index date (excepting lymph node metastasis to a site common for melanoma or an improbable site for any other primary cancer) * patients who received systemic chemotherapy during the pre- or post-index period
study of lym-x-sorb™ to improve fatty acid and choline status in children with cf and pi

Conditions: Cystic Fibrosis; Pancreatic Insufficiency

Summary: the purpose of this phase ii research study is to evaluate the effectiveness of the next generation lym-x-sorb™ in improving the essential fatty acid (efa) and choline status for children and adolescents with cystic fibrosis (cf) and pancreatic insufficiency (pi).

fat malabsorption is common in individuals with cystic fibrosis (cf) and pancreatic insufficiency (pi). this places them at risk for caloric, essential fatty acid, and choline deficiency, which may in turn, lead to growth failure and a poorer clinical course. the purpose of this research study is to find whether or not taking lym-x-sorb™ over an 18-month period, every day, will correct the problem people with cf and pi have with absorbing fat and choline. participation will help cf doctors and other healthcare professionals learn more about the potential benefits of lym-x-sorb™ to children and adolescents with cf and pi. these benefits may include better absorption of fat, better choline status, better growth in height, weight, muscle and bone, better lungs, and improvement of health status. the study will enroll a total of 78 participants from children's hospital of philadelphia (chop) and from several other cystic fibrosis centers. one half of the participants will be randomly picked to receive the active powder with the lym-x-sorb™ supplement and one half will receive a placebo (with no active supplement).

Eligibility criteria:
inclusion criteria: * diagnosed as having cystic fibrosis (cf) with pancreatic insufficiency (pi) * subjects aged 6 to 17 years of age * in usual state of good health * family and subject commitment to the 18-month study protocol * fecal elastase \< 15µg/g stool exclusion criteria: * forced expiratory volume at one second, % predicted (fev1) \< 40% predicted * other chronic health conditions that may affect gi absorption, growth, dietary intake, nutritional status * liver disease, lung transplant, celiac disease, allergy/intolerance to wheat/gluten, pregnant * participation in another cf nutrition-related intervention study * regular intake of fatty acids (i.e., fish oils) or choline nutritional supplements * home parenteral lipid administration (i.e., intralipids)

Keywords: cystic fibrosis pancreatic insufficiency lym-x-sorb™ lxs
high flow nasal oxygen for children with cystic fibrosis presenting with respiratory failure - a randomized controlled study

Conditions: Cystic Fibrosis

Summary: respiratory exacerbations are frequent among cystic fibrosis patients and supplemental oxygen is usually required. we will compare a new high flow nasal cannula system with venturi masks for oxygen supplementation to patients with cf hospitalized for respiratory exacerbation.

introduction: cystic fibrosis (cf) is a genetic disease that leads to chronic lung infections and recurrent respiratory exacerbations. supplemental oxygen is usually required during respiratory exacerbations. recently, a new high flow nasal cannula system that provides flows up to 40l/min at 100% humidification was developed and tested in neonates and children, providing greater comfort to the patient. the main hypothesis of the study is that this method has advantages for oxygen supplementation to patients with cf hospitalized for respiratory exacerbation. methods: 40 patients with cf aged 6 to 18 years will be randomized to receive supplemental oxygen via nasal cannula or venturi masks during hospitalization for respiratory exacerbation. main outcomes will be the duration of hospitalization and oxygen supplementation, viscosity and transportability of sputum and personal impressions of patients regarding the method of oxygen administration (questionnaire). spirometry and venous blood gas analysis will be performed after the second hospital day, and sputum samples will be obtained in the first and third day of hospitalization. clinical treatment (antibiotics, etc) will be defined by the medical team of the institution, not involved in the study. expected results: the use of high flow nasal cannula will result in significantly less time of supplemental oxygen, with increased comfort for patients, without significant differences in the levels of paco2. sputum samples obtained from the patients treated with the high flow nasal cannula will have lower viscosity and higher transportability as compared to those obtained from patients treated with venturi mask.

Eligibility criteria:
inclusion criteria: * established diagnosis of cystic fibrosis * age between 6 and 17 years * ability to perform lung function testing * hospital admission due to acute pulmonary exacerbation in the last 12h * regular use of pulmozyme * need for high fio2 defined as more than 2 liters per minute in the nasal cannula or need of a venturi mask exclusion criteria: * recent admission (less than 30 days) * recent or current atelectasis (less than 3 months) * hemoptysis or pneumothorax * need for a bronchoscopy during admission * need for non-invasive ventilation for more than 2 hours/day

Keywords: cystic fibrosis oxygen respiratory failure
effects of low-flow anesthesia on hemodynamic parameters and oxygenation in morbidly obese patients

Conditions: Morbid Obesity; Hemodynamic Instability; Bariatric Surgery Candidate

Summary: low-flow anesthesia has been used for years with positive results, but its effects on hemodynamic parameters and oxygenation are not clearly known in high-risk morbidly obese patients who are prone to pulmonary dysfunction related to the obesity. therefore, this prospective randomized study aimed to compare the effects of low-flow (0.75 l/min) and normal-flow (1.5 l/min) anesthesia on hemodynamic parameters and oxygenation in morbidly obese patients undergoing laparoscopic bariatric surgery.

low-flow anesthesia has several potential benefits. it improves the flow dynamics of the inhaled air, increase mucociliary clearance, maintain body temperature, reduce fluid loss, result in savings of up to 75% and reduce greenhouse gas emissions and reduce treatment costs (10 - 13). however, it is necessary to examine whether the reduction of fresh gas flow affects the quality and safety of anesthesia management, especially during high-risk operations such as laparoscopic bariatric surgery. low-flow anesthesia has been used for years with positive results, but its effects on hemodynamic parameters and oxygenation are not clearly known in high-risk morbidly obese patients who are prone to pulmonary dysfunction related to the obesity. therefore, this prospective randomized study aimed to compare the effects of low-flow (0.75 l/min) and normal-flow (1.5 l/min) anesthesia on hemodynamic parameters and oxygenation in morbidly obese patients undergoing laparoscopic bariatric surgery.

Eligibility criteria:
inclusion criteria: * morbidly obese patients with american society of anesthesiology (asa) scores of iii-iv, * aged 18-65 years old, * bmi\>40 exclusion criteria: * pregnant * uncontrolled diabetes mellitus, * cardiovascular disease, * pulmonary disease, * cerebrovascular disease, * drug and alcohol addiction.

Keywords: morbidly obese patients bariatric surgery arterial blood analysis
intubrite versus macintosh for endotracheal intubation in out of hospital cardiac arrest

Conditions: Intubation Complication; Cardiopulmonary Arrest

Summary: a randomized, parallel, non-blinded trial in a single emergency mdeical service in poland within a group of 34 ground ambulances crews, comparing time and first pass success (fps) for endotracheal intubation (eti) in dl using the intubrite® (int) and macintosh laryngoscope (mcl) during cardiopulmonary resuscitation (cpr). intubations will be performed using int and mcl based on an intention-to-treat analysis. the fps time of the eti attempt will be analysed. first attempt success will be counted.

investigators designed a prospective observational study to compare int (intubrite®, llc; vista, ca, usa) and mcl for eti performed by paramedics in ohca without an emergency physician on the scene. the main goal was to determine whether int is superior to using an mcl laryngoscope during a tracheal intubation attempt in nontraumatic ohca, in terms of time and effectiveness. the time of intubation was measured using an electronic stopwatch. time measurement began when the paramedic held the selected laryngoscope and declared their readiness to perform the procedure. the effectiveness of the first eti attempt for instrumental airway management for nontraumatic adult ohca and end-tidal carbon dioxide monitoring was used to confirm correct device placement in all patients. the degree difficulty of intubation attempts for all of the patients included in the study. a long-term survival and a cost-effectiveness analysis were not included within this trial. the investigators will collect case report forms (crfs) from patients after ohca within a 40-month period. the average professional experience of the paramedics in instrumental airway management will be noted (dl and lma). the primary outcome is the fps time of the eti attempt performed by the paramedics. the success rate on the first intubation attempt will be counted.

Eligibility criteria:
inclusion criteria: * patients in cardiac arrest , requiring cardiopulmonary resuscitation exclusion criteria: * suspected difficult intubation
evaluation of regional lung mechanics in obese patients undergoing laparoscopic surgery

Conditions: Obesity; Mechanical Ventilation Pressure High; Intraoperative Respiratory Injury

Summary: this study will evaluate what is the impact of laparoscopy and trendelenburg position on lung regional ventilation distribution in obese patients, focusing on the differences between the different phases of surgery.

electrical impedance tomography (eit) is a non invasive monitoring technique that allows to evaluate the regional distribution of ventilation. eit has been used in different contexts, such as acute respiratory failure or intraoperative ventilation settings. obesity, by increasing intrabdominal pressure, may reduce functional residual capacity after anesthesia and therefore require a more aggressive intraoperative ventilatory setting. in addition, laparoscopy, by increasing the volume of the abdomen, further pushes the diaphragm and increase the probability of lung collapse. the aim of the current study is to describe the effect of 1) anesthesia and of 2) laparoscopy and trendelenburg position on regional ventilation distribution. moreover, the investigators will evaluate if the best ventilatory parameters set after anesthesia induction are confirmed also when the condition changes (i.e. during pneumoperitoneum and trendellenburg). finally, the investigators will explore if the different parameters which can be provided by eit agree in suggesting the best level of positive-end expiratory pressure in both moments of surgery.

Eligibility criteria:
inclusion criteria: * age 18-90 years * body mass index \> 30 kg/m2 * major surgery * predicted duration of surgery \> 2 hours * predicted presence of invasive arterial pressure monitoring exclusion criteria: * emergency surgery * refuse to participate from patient * presence of implantable cardiac device or pacemaker * thoracic wounds * thoracic surgery

Keywords: eit obesity laparoscopy
evaluation of the onset of action in highly active ms (magnify)

Conditions: Multiple Sclerosis

Summary: the main purpose of the study was to determine the onset of mavenclad® action by frequent magnetic resonance imaging (mri) assessment of the combined unique active (cua) lesions in participants with highly active relapsing multiple sclerosis (ms).


Eligibility criteria:
inclusion criteria: * highly active rms as defined by: * one relapse in the previous year and at least 1 t1 gadolinium (gd)+ lesion or 9 or more t2 lesions, while on therapy with other disease modifying drugs (dmds) * two or more relapses in the previous year, whether on dmd treatment or not. * expanded disability status scale (edss) score less than equals to (\<=) 5.0. * other protocol defined inclusion criteria could apply. exclusion criteria: * previous exposure to drugs such as fingolimod, natalizumab, alemtuzumab, mitoxantrone and ocrelizumab. * positive hepatitis c or hepatitis b surface antigen test and/or hepatits b core antibody test for immunoglobulin g (igg) and/or immunoglobulin m (igm). * current or previous history of immune deficiency disorders including a positive human immunodeficiency virus (hiv) result. * currently receiving immunosuppressive or myelosuppressive therapy with, for example, monoclonal antibodies, methotrexate, cyclophosphamide, cyclosporine or azathioprine, or chronic use of corticosteroids. * history of tuberculosis , presence of active tuberculosis, or latent tuberculosis * evidence or suspect of progressive multifocal leukoencephalopathy (pml) in magnetic resonance imaging (mri). * active malignancy or history of malignancy. * other protocol defined exclusion criteria could apply.

Keywords: multiple sclerosis mavenclad ® cladribine