Kornimate/medical-research-clean huggingface dataset:
marginprobe, a device for intraoperative assessment of margin status in breast conservation surgery

Conditions: Breast Cancer

Summary: the purpose of this study is to show that addition of device use to a routine breast cancer tumor excision procedure is beneficial and assists the surgeon in correctly determining the extent of excision.

the study is a prospective, multi-center, randomized, double arm study demonstrating the effectiveness of the device in adjunctive use for locating the tissue for additional excision following primary specimen excision. one arm is a "standard of care" (soc) control group and the other arm a "device+soc" group.in the "device +soc" group the surgeon will use the marginprobe device on the tissue specimen removed during the surgical procedure.the surgeon will use the results derived from the device and other routine assessments to decide if it is necessary to remove some additional breast tissue.

Eligibility criteria:
inclusion criteria: 1. women histologically diagnosed with carcinoma of the breast 2. women with non-palpable malignant lesions, requiring image guided localization. 3. undergoing lumpectomy (partial mastectomy) procedure. 4. age 18 years or more 5. signed icf exclusion criteria: 1. multicentric disease (histologically diagnosed cancer in two different quadrants of the breast) 2. bilateral disease (diagnosed cancer in both breasts) 3. neoadjuvant systemic therapy 4. previous radiation in the operated breast 5. prior surgical procedure in the same breast 6. implants in the operated breast 7. pregnancy 8. lactation 9. participating in any other investigational study for either drug or device which can influence collection of valid data under this study.

Keywords: idc, dcis, ilc
comparison of ocular findings in patients between surgical and natural menopause

Conditions: Menopause Surgical; Macula Edema; Visual Acuity Reduced Transiently

Summary: it is aimed to compare the ocular findings in patients with natural and surgical menopause.

to compare the parameters such as fundus examination, macular thickness, visual acuity and lens opacities among female patients diagnosed with menopause between the ages of 40-65.the criteria for exclusion from the study are the presence of a history of illness, drug use, smoking and alcohol use.inclusion criteria were female patients who were in menopause and who did not use any medications. for surgical menopause, the uterus and ovaries were surgically removed at least 3 months ago.

Eligibility criteria:
inclusion criteria: * newly diagnosed menopause (natural or surgical menopause( at least 3 months after surgery), * no history of illness(diabetes,heart disease,kidney disease etc.) * not smoking * did not use alcohol * have not use any medication * age between 45-65 years * bmi between 20-25 kg/m exclusion criteria: * smoking or alchohol consumption * age before 45 and after 65 years * have chronic disease * using any medication * have not diagnosed menopause * bmi greater than 30 kg/m

Keywords: menopause eye disease macular changes
efficacy of early tracheostomy to reduce incidence of ventilator acquired pneumonia (vap)

Conditions: Respiratory Insufficiency

Summary: the study aims to assess early (one to three days after intubation) tracheostomy effectiveness in terms of reduction in ventilator associated pneumonia (vap) incidence.

tracheostomy is an essential and irreplaceable procedure for critically ill patients requiring mechanical ventilatory support and adequate airway control. the therapeutical choice of performing a tracheostomy is supported by a number of clinical benefits, such as less use of drugs for sedation, fewer days of mechanical ventilation and hence shorter intensive care unit (icu) length of stay, as well as better resource rationalization. actually there is no agreement on the best timing for tracheostomy. the aim of this study is to verify if an early tracheostomy (one to three days after intubation) increases ventilator associated pneumonia-free days. secondary endpoints are: increase of ventilator free-days and mortality reduction.

Eligibility criteria:
inclusion criteria: * oro/nasotracheal intubation for less than three days * simplified acute physiology score (saps ii) between 35 and 65 upon admission to intensive care unit (icu) exclusion criteria: * oro/nasotracheal intubation \> three days * age \< 18 years * previous otolaryngologic or maxillofacial procedures * brain injury patients with intracranial pressure \> 20 mmhg without pharmacological treatment (or intracranial pressure \> 15 mmhg under specific pharmacological treatment) and with cerebral perfusion pressure \< 60 mmhg * pregnancy * ventilator associated pneumonia, hospital acquired pneumonia, community acquired pneumonia diagnosis before randomization * infection in the tracheostomic area * acute worsening of chronic obstructive pulmonary disease (copd) * pre-existing malignancies in the tracheostomic area * immunosuppressed and/or immunodepressed patients: * leukocytes \< 1000/microliters * neutrophils \< 500/microliters * aids * long-term steroid treatment (daily dose \> 0.5 mg/kg for more than 30 days) * patients already enrolled in other trials

Keywords: tracheostomy tracheostomy timing ventilator associated pneumonia mechanical ventilation
monitoring of arrhythmias and hrv in patients with heart failure treated with the crt pacemaker renewal tr2

Conditions: Congestive Heart Failure

Summary: the objective of this study is to evaluate the prevalence of sustained ventricular and supraventricular rhythm disorders in patients implanted with a contak renewal tr2 ventricular resynchronization therapy (crt) device


Eligibility criteria:
inclusion criteria: * moderate or severe chronic heart failure, defined by the presence of nyha class iii or iv symptoms, intra/interventricular synchronization disorder evaluated by echocardiography and/or doppler tissue imaging (dti, yu's method22), ejection fraction (ef) ≤ 40 %, if previous history of myocardial infarction, mi must be \> 60 days from the date of inclusion, estimated life expectancy \> 6 months in the case of concomitant disease, age ≥ 18 years, optimal drug treatment of chronic heart failure (according to sfc\* recommendations). exclusion criteria: * conventional indication for treatment by implantable defibrillator upon inclusion, cardiac transplant envisaged within 6 months, unexplained syncope, mi \< 60 days before inclusion, non compliance to drug treatment for chronic heart failure, any coronary pathology which may be treated by revascularisation.
effects of cerebrolysin on level of consciousness and brain metabolism in disorder of consciousness after stroke: single center randomized controlled study

Conditions: Stroke

Summary: the purpose of this study was to determine the effect of stroke on post-stroke level of consciousness through a double-blind, placebo-controlled, randomized study design. and brain 18f-fdg pet was used to reveal the mechanism of recovery after cerebrolysin administration. thirty patients with chronic stroke patients with minimal consciousness (mcs) or vegetative human (vs) level of consciousness disorder in the revised coma recovery scale were enrolled. thirty patients were randomly divided into a cerebrolysin group and a placebo group.


Eligibility criteria:
inclusion criteria: * ischemic or hemorrhagic stroke patients * stroke with ct or mri diagnosis * chronic patients with more than 3 months of stroke onset * patients with vegetative status or minimal consciousness (coma recovery scale -revised: crs-r) * age: 19 to 90 years old * a person who voluntarily consents to the clinical trial in writing by the principal or legal representative exclusion criteria: * in case of contraindications, including allergies to cerebrolysin * patients with contraindications to pet * progressive or unstable stroke * in case of accompanying serious neurogenic disease * major depressive disorder, schizophrenia, bipolar disorder, dementia, and other serious psychiatric diseases. * history of alcohol or other drug addiction within 3 years of onset * in case of accompanying serious liver, kidney, heart, or respiratory disease * if you have the following medical abnormalities (total serum bilirubin\> 4 mg/dl, alkaline phosphatase\> 250 u/l, sgot/ast\> 150 u/l, sgpt/alt\> 150 u/l, or creatinine) \> 3.5 mg/dl) * in case of having a medical disease that is less than 1 year old * during pregnancy or lactation * participating in other therapeutic research
the effect of selective laser trabeculoplasty (slt) on ocular rigidity

Conditions: Glaucoma

Summary: the purpose of this study is to examine the influence of selective laser trabeculoplasty (slt) on ocular rigidity in glaucoma patients.

ocular rigidity (corneal hysteresis and corneal resistance factor) is measured with the ocular response analyzer (reichert) before and 4 weeks after slt (q-switched 532 nm frequency doubled neodymium yttrium aluminium garnet laser with a spot size of 400 µm and a 3-ns pulse duration). the trabecular meshwork is treated with 100 spots over 360° and an energy of 0,8 mj. the purpose is to examine if selective laser trabeculoplasty changes ocular rigidity.

Eligibility criteria:
inclusion criteria: glaucoma patients (primary open angle glaucoma, ocular hypertension) over the age of 18 who need further iop reduction to control their glaucoma exclusion criteria: other forms of glaucoma (angle closure, secondary glaucoma, congenital, juvenile), acute psychosis, epilepsy

Keywords: glaucoma, selective laser trabeculoplasty, ocular rigidity
optimizing the care pathway of febrile children via capillary c-reactive protein assay in primary care

Conditions: Fever

Summary: fever is the leading reason for outpatient consultations among children aged 2 to 9 years. the main concern in fever is severe bacterial infection, particularly for younger children. history and clinical examination do not always differentiate viral infections from bacterial infection. in 20% of febrile children, no infectious focus is found after examination and additional tests are necessary. the first one is measuring c-reactive protein (crp). the results are obtained in several hours on an outpatient basis, causing long delays before starting treatment and often requiring telephone calls or further consultations. emergency room use is constantly increasing, generating growing tensions within healthcare facilities, yet a large number of visits are avoidable. among children visiting the pediatric emergency room, parents reported being referred by their primary care physician in approximately 20% of cases for children aged 1 to 5 years and in 30% of cases for children under one year old. the use of capillary medical device to measure crp in primary care could reduce this referral rate and help relieve overcrowding in emergency rooms, as well as unscheduled consultation centers and medical analysis laboratories. this would result in a streamlined care pathway, saving time for both physicians and patients, as well as reducing the cost of care for the healthcare system.


Eligibility criteria:
inclusion criteria: * the patient must be a member or beneficiary of a health insurance plan * children consulting primary health institutes with fever (temperature ≥ 38°c) requiring crp testing: * fever \> 12h in infants aged 3 to 6 months * fever ≥ 5 days in children over 6 months of age * fever \>12h regardless of age, and at the time of consultation, the doctor is concerned about the child's general condition, the tolerance of the fever, or doubts about a bacterial focus (e.g. suspicion of pneumopathy, appendicitis, etc.). * no severity criteria necessitating immediate hospitalization * no bacterial infection whose diagnosis is exclusively clinical or identified by other means (e.g. purulent aom, bacterial angina identified by rdt, etc.). * child whose parents and child have been informed about the study, and at least one parent has given consent for their child's participation in the study. * enrolment of the child according to their capacity of discernment (for children aged 12 and over, enrolment is essential). * child affiliated to or benefiting from a health insurance scheme exclusion criteria: * the subject is participating in a category 1 interventional study, or a study with drug or medical device * premature infants under one year of age * immunosuppression * insulation * chronic infection * malignant pathology * autoimmune pathology * sickle cell disease * child with a central catheter

Keywords: c-reactive protein
surgical stages of liver cirrhosis in patients with hepatocellular carcinoma

Conditions: Hepatocellular Carcinoma; Liver Cirrhosis

Summary: the investigators intend to perform a prospective, multicenter study to establish a set of clinical criteria for surgical stages of liver cirrhosis, which can be implemented to guide the surgical treatment of hepatocellular carcinoma (hcc).

hcc is the fifth most common malignancy in the world and ranks the third leading cause of tumor-related mortality. in china, more than 80% of hcc patients are accompanied by liver cirrhosis. varied degrees of cirrhosis not only play an important role in selecting appropriate operative interventions for hcc patients, but are closely associated with tumor recurrence and long-term survival as well. therefore, evaluating cirrhotic severity is essential for individualizing surgical modalities and predicting outcomes for patients with hcc. in recent years, investigators' group has proposed to stage the severity of liver cirrhosis through intraoperative liver morphological changes and preoperative cirrhotic severity scoring (tj-css) model. although the morphological classification of liver cirrhosis is of guiding significance for surgeons to determine the extent of hepatectomy, this method has some defects, such as subjectivity, lack of specific quantitative indicators and so on. based on this, investigators propose to evaluate the severity of liver cirrhosis by measuring liver stiffness directly by shaw hardmeter. therefore, this prospective, multicenter clinical study intends to modify and perfect the preoperative cirrhotic severity scoring (tj-css) and direct measurement of liver stiffness (dms) grade established in the early period, so as to build a set of clinical standards for surgical liver cirrhosis classification, which can be used to guide the surgical treatment of hcc.

Eligibility criteria:
inclusion criteria: 1. male or female, 18 to 75 years of age, inclusive. 2. patients who are clinically diagnosed as hepatocellular carcinoma and confirmed by postoperative pathology. 3. the liver function grade was child-pugh class a or class b, which can be restored to child-pugh class a within a short period of medical treatment. 4. patients who undergo open surgery. 5. patients have not been accompanied by serious physical diseases of heart, lung, brain, etc., and can generally tolerable for surgery. 6. ability to understand and the willingness to sign a written informed consent document. exclusion criteria: 1. patients with tumors that oppress the main portal vein or main portal vein thrombus. 2. patients that are accompanied with cavernous degeneration of portal vein. 3. patients with hypersplenism caused by diseases of the blood system. 4. patients suffer from serious acute and chronic diseases. 5. patients with severe infectious diseases. 6. patients with hiv-infectious or other aids-related disease. 7. patients are drug abusers or have any psychological or mental conditions that potentially lead to poor study compliance. 8. patients have any condition that in the judgement of the investigators would make the subject inappropriate for entry into this study.
safety and efficacy of collagenase clostridium histolyticum after prior intralesional prp for peyronie's disease

Conditions: Peyronie Disease; Sexual Dysfunctions, Psychological; Genital Diseases, Male

Summary: the purpose of this study is to learn about the safety and side effects of intralesional collagenase clostridium histolyticum (cch) injected into the peyronies disease (pd) plaque after receiving prior treatment with intralesional platelet rich plasma (prp) injections.


Eligibility criteria:
inclusion criteria: 1. be able to provide written informed consent 2. have a diagnosis of pd with evidence of stable disease as determined by the investigator 3. patient must have palpable penile plaque 4. penile curvature deformity of \>30° to \<90° 5. agree to comply with all study related tests/procedures. 6. prior intralesional platelet rich plasma treatment within the past 18 months and desire secondary treatment of penile curvature exclusion criteria: 1. previous penile surgery of any kind (except circumcision and condyloma removal), such as penile lengthening, penile cancer surgery, penile plication, grafting, penile prosthesis. 2. previous intralesional injection therapy with cch for pd within six months. patients with failed therapy greater than six months ago may be included. 3. previous history of priapism or penile fracture 4. pd characterized by a ventral plaque 5. severe erectile dysfunction as characterized with an iief score ≤ 12 6. hour-glass deformity 7. unwilling to participate 8. medically unfit for sexual intercourse as deemed by the principal investigator 9. patients scheduled to undergo an elective medical procedure during the investigation timeframe that will interfere with autologous prp injection therapy. 10. have a serious comorbid illness/condition/behavior that, in the opinion of the investigator, may compromise the safety or compliance of the subject or preclude successful completion of the study.
testosterone pellets plus vitamin d and e versus vitamin d and e alone for the treatment of peyronie's disease

Conditions: Peyronie's Disease

Summary: two recent studies have identified low levels of serum testosterone in association with peyronie's disease (pd), with a significant correlation noted between severity of testosterone deficiency and severity of curvature. the study hypothesis is to determine whether treatment with testosterone may help men with pd and penile curvature.


Eligibility criteria:
inclusion criteria: * acquired penile curvature of \> 30 degrees and \< 90 degrees associated with palpable penile plaque on physical examination * onset of curvature within 18 months prior to signing consent form * serum tt \< 500 ng/dl at the screening visit exclusion criteria: * prior history of treatment for pd that includes intra-lesional injections, topical creams, or surgery * prior treatment with oral therapy at least 2 weeks prior to signing consent form (e.g. potaba, vitamin e, colchicines) will be acceptable for inclusion * prior history of treatment for testosterone deficiency * presence of dense calcified plaque by us or plain radiograph * taking the medication coumadin * hypersensitivity to testosterone, stearic acid, or polyvinyl pyrolidone (the constituents of testopel) * unable to achieve adequate erection with penile injection to access degree of curvature * undergone definitive treatment for prostate cancer, bladder cancer, or other pelvic malignancies including surgery, external beam radiation therapy, brachytherapy, cryotherapy. * prior history of prostate cancer, hematologic disorders, chronic liver disease including cirrhosis and hepatitis c, disorders affecting the immune system, including infection with human immunodeficiency virus, or psychiatric disorders including major depression, schizophrenia, bipolar disease * history of cerebrovascular accident, history of deep venous thrombosis within the past 5 years or history of untreated or severe sleep apnea * psa \> 4.0 ng/dl at the screening visit, unless prostate cancer has been excluded to the investigator's satisfaction * clinically significant abnormal lab results that would put the subject at increased risk or compromise the integrity of the study data, in the opinion of the investigator * received any other investigational drug within 30 days

Keywords: low testosterone penile curvature
effect of head rotation on efficacy of face mask ventilation in anesthetized obese (bmi ≥ 35) adults

Conditions: Noninvasive Ventilation

Summary: mask ventilation is fundamental to airway management at the start of surgical procedures requiring general anesthesia. for general anesthesia, medications are provided that affect the entire body and lead to a loss of consciousness. medical professionals perform mask ventilation by placing a plastic mask over a subjects mouth and nose to provide enough oxygen for the placement of a breathing tube. in this study, we expect that a 45 degree rotation of the head will increase the efficiency of mask ventilation.

mask ventilation is a foundation of airway management after the initial induction of anesthesia. it allows for adequate oxygenation of the patient to buy enough time for intubation, during which the patient is not ventilated. however, in some patients mask ventilation may be difficult - older than 55 years, heavier (bmi \> 26 kg/m\^2), with no teeth, having a beard or sleep apnea. inadequate ventilation, if not corrected, can result in decreasing oxygen saturation to dangerous levels - which could lead to devastating complications. as a result, the efficacy of mask ventilation is of critical importance to patient safety after the induction of anesthesia. a recent study proposed that mask ventilation could be improved simply by turning a patient's head. the study showed that rotating a patient's head to a 45 degree angle significantly improved mask ventilation when compared with the head placed in a neutral position. however, this study was done in patients with a bmi lass than 35. as such, the effects of head rotation on the efficacy of mask ventilation has not been studied in patients with a bmi of 35 and greater. obesity (bmi ≥ 30 kg/m\^2) affects almost 40% of us adults and is one of the most prevalent health concerns in our society. it is a predictor of difficult mask ventilation because it is associated with increased upper airway obstruction, decreased airway patency, and decreased lung volumes such as functional residual capacity (frc). if previous findings in regard to the effects of 45 degree head rotation on the efficacy of ventilation hold true in the obese patient, then this study will show that head rotation could be used as a simple way to improve the efficacy of mask ventilation for patients with a bmi of 35 and above.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years * asa physical status classification i-iii * body mass index (bmi) ≥ 35 kg/m\^2 exclusion criteria: * inability to obtain written informed consent * pregnant or breastfeeding * limited head rotation or neck extension * subjects with expected or history difficult intubation * large beard * orogastric (og)/nasogastric (ng) tube * gastroesophageal reflux disease (gerd)

Keywords: face mask obesity anesthetized adult ventilation head rotation