Kornimate/medical-research-clean huggingface dataset:
suture versus staples for wound closure in orthopaedic trauma surgery

Conditions: Lower Extremity Fracture

Summary: this pilot study is designed to assess the feasibility of comparing skin closure methods - sutures versus staples - and subsequent rates of surgical site infection following open reduction and internal fixation surgery for orthopaedic trauma injuries. the primary objectives are to determine if enrollment, randomization, and compliance are feasible and to refine data collection methods. patients =18 years of age with closed fractures of the tibial plateau, tibial pilon, patella, and distal femur presenting within 3 weeks of injury undergoing definitive treatment of their fracture will be approached for participation. if enrolled, they will be randomized to having their surgical wound closed with either nylon sutures or metallic staples. patient follow up will be standard of care besides answering promis surveys.


Eligibility criteria:
inclusion criteria: * adult patients 18-80 years old * tibial pilon, tibial plateau fractures, patella fractures, and distal femur fractures * incisions must be able to be approximated with subdermal sutures intraoperatively * english and spanish speaking patients only exclusion criteria: * open fractures * incarcerated patients * pregnant patients * patients who do not speak english or spanish * history of infection at surgical incision site at the time of definitive fixation * pre-existing skin condition associated with risk of infection (psoriasis, eczema) * unable to obtain consent from patient prior to surgery or from legally authorized representative (lar) prior to skin closure if the patient is unable to consent dur to their medical condition. * the absence of a subcutaneous closure during the index procedure
quantitative ablation of pulmonary vein vestibule in paroxysmal atrial fibrillation.

Conditions: Atrial Fibrillation; Arrythmia

Summary: the purpose of this trial is to explore the optimal ai value for isolating the pulmonary veins and achieving left ventricular apex and mitral isthmus block. patients with atrial fibrillation who are scheduled to undergo catheter ablation will be randomized to different groups, then every group receive circumferential pulmonary vein isolation with different ai values. the relevant indicators such as the proportion of pulmonary vein single-circle isolation, operation time, the incidence of complications, and the proportion of recurrence of atrial fibrillation and other atrial arrhythmias after 1 year were collected.

this is a prospective, single-center, randomized controlled trial. in this part,a total of 90 patients with paroxysmal atrial fibrillation who are scheduled for catheter ablation were randomly divided into 3 groups, 30 patients in each group. for the first group, the ai target value for the front wall and the top wall is 550, and the rear wall and the lower wall are 400. for the second group, the ai target values for the front wall and the top wall are 500, the rear wall and the lower wall are 350. for the third group, the ai target values for the front wall and top wall are 450, the rear wall and the lower wall are 300. the pressure value at each point is 5-15 g, and the distance between adjacent ablation points is less than 5 mm. the relevant indicators such as single-circle isolation rate of the pulmonary vein, operation time, the left atrial operation time, and the supplemental ablation site are recoded. the incidence of intraoperative and postoperative complications such as stroke, pericardial tamponade and steam pop during ablation are observed. dynamic electrocardiography is performed during the follow-up period to evaluate the proportion of sinus rhythm within 1 year.

Eligibility criteria:
inclusion criteria: 1. male and non-pregnant female subjects, 18≤age≤80. 2. receiving or able to tolerate anticoagulant therapy. 3. diagnosis of atrial fibrillation using an electrocardiogram or a dynamic electrocardiogram 4. the longest duration of atrial fibrillation episode is less than 7 days 5. patient is compliant and willing to complete clinical follow-up. exclusion criteria: 1. patients who have previously undergone catheter ablation of atrial fibrillation; 2. left ventricular ejection fraction \<35%; 3. pregnancy, planned pregnancy or lactating women; 4. left atrial appendage thrombosis was detected by transesophageal ultrasound or intracardiac ultrasound; 5. abnormal blood system or liver and kidney function; 6. combined with severe organic heart disease (including congenital heart disease, valvular heart disease, dilated cardiomyopathy, hypertrophic cardiomyopathy, and patients with myocardial infarction or coronary artery bypass grafting); 7. patients who are considered unsuitable for inclusion by the investigator.

Keywords: atrial fibrillation ablation index quantitative ablation
study of colchicine to treat and prevent recurrent pericarditis (first episode)

Conditions: Pericarditis; Recurrence

Summary: the purpose of the study is to determine whether colchicine is safe and effective in the treatment and prevention of recurrent pericarditis (first episode).

colchicine is safe and effective in the management of recurrent pericarditis after failure of conventional treatment. preliminary data have shown that it may be effective also in treatment of the first attack of recurrent pericarditis and the prevention of further recurrences. comparisons: the study will compare the safety and efficacy of colchicine in the treatment of the first attack of recurrent pericarditis and the secondary prevention of recurrences. colchicine will be used in addition to conventional treatment.

Eligibility criteria:
inclusion criteria: * patients with the first attack of recurrent pericarditis * age≥ 18 years * informed consent exclusion criteria: * suspected neoplastic, tuberculous, or purulent etiology * known severe liver disease and/or elevated transaminases \>1.5 times the upper limit of normality * serum creatinine \>2.5 mg/dl * serum creatine kinase (ck) over the upper limit of normality or known myopathy * known gastrointestinal or blood disease * pregnant or lactating women or women not protected by a contraception method * known hypersensibility to colchicine * treatment with colchicine at enrolment

Keywords: pericarditis recurrence therapeutics prevention colchicine
comparison of two different drug regimens for medical treatment of early pregnancy loss

Conditions: Abortion, Missed

Summary: the purpose of this study is to compare the safety and efficacy of a combination of two drugs (mifepristone and misoprostol) to only one of these drugs (misoprostol) in medical management of missed miscarriage up to 13+6 weeks of pregnancy (early pregnancy loss). the investigators aim to enroll 220 patients within two years which would be enough to determine the difference between these two treatments with confidence.

aim: to investigate the safety and efficacy of combination of mifepristone and misoprostol versus misoprostol alone in medical management of early pregnancy loss. primary objective: to test the hypothesis that the sequential combination of mifepristone and misoprostol is superior to misoprostol alone for the complete evacuation of uterus in patients diagnosed with early pregnancy loss. secondary objectives: to test the hypothesis that the addition of mifepristone reduces the need for further doses of misoprostol, duration of bleeding, complication rate and side effect frequency. the investigators will also evaluate if the addition of mifepristone improves patient satisfaction and quality of life. women with a diagnosis of early pregnancy loss that opt for medical treatment and sign an informed consent will be included. the participants will be randomized to two groups. first group will receive oral mifepristone (600 mg) and the second group will not. the remaining course of treatment will be the same for both groups including giving misoprostol (800 mcg vaginally) 48 hours after receiving mifepristone for the first group or immediately for the second group. 24 hours after receiving first dose of misoprostol, one more dose of misoprostol (also 800 mcg vaginally) will be given if no pregnancy tissue is lost. three weeks after medical treatment, primary and secondary outcomes will be assessed. in case of unsuccessful treatment (incomplete evacuation of uterus), surgical evacuation will be performed. 220 women will be randomized in a 1:1 ratio.

Eligibility criteria:
inclusion criteria: * women diagnosed with missed miscarriage in the first 13+6 weeks of pregnancy opting for medical management * age 18 years and older * intra-uterine pregnancy * hemodynamically stable patient * no signs of infection * no signs of incomplete miscarriage * willing and able to give informed consent exclusion criteria: * women opting for alternative methods of miscarriage management (expectant or surgical) * diagnosis of incomplete miscarriage * life threatening bleeding * hemodynamically unstable patient * contraindications to mifepristone or misoprostol use for example chronic adrenal failure, known hypersensitivity to either drug, haemorrhagic disorders and anticoagulant therapy, prosthetic heart valve or history of endocarditis, existing cardiovascular disease, severe asthma uncontrolled by therapy or inherited porphyria * previous participation in this trial * unable to give informed consent

Keywords: missed miscarriage mifepristone misoprostol medical management
study of immunotherapy to treat advanced prostate cancer

Conditions: Prostate Cancer

Summary: the purpose of the study is to determine if advanced prostate cancer patients that are treated with radiotherapy (rt) plus ipilimumab live longer that those treated with rt alone


Eligibility criteria:
for more information regarding bms clinical trial participation, please visit www.bmsstudyconnect.com. inclusion criteria: * advanced prostate cancer * at least 1 bone metastasis * testosterone \< 50 ng/dl * prior treatment with docetaxel exclusion criteria: * brain metastasis * autoimmune disease * known hiv, hep b, or hep c infection * more than 2 prior systemic anticancer regimens for prostate cancer * prior treatment on bms ca180227 for prostate cancer
frozen proquad administered concomitantly versus nonconcomitantly with other pediatric vaccines

Conditions: Measles; Mumps; Rubella; Varicella

Summary: this study will assess the safety and immunogenicity of proquad when administered concomitantly and nonconcomitantly with tripedia and comvax.


Eligibility criteria:
inclusion criteria: * in good health * negative clinical history of varicella, zoster, measles, mumps, rubella, diptheria, tetanus, pertussis, invasive hib disease and hepatitis b * had completed either a 2-dose primary series of pedvaxhib or comvax or any 3-dose primary series of a licensed hib vaccine * had received 2 or 3 doses of any hepatitis b vaccine or comvax prior to entry into trial exclusion criteria: * previous receipt of measles, mumps, rubella or varicella vaccine either alone or in combination * any immune impairment or deficiency * recent household, daycare or school exposure to invasive hib disease or hepatitis b * exposure to measles, mumps, rubella, varicella, or zoster in the 4 weeks prior to vaccination * vaccination with an inactive vaccine with in the past 14 days * vaccination with a live vaccine within the past 30 days * receipt of immune globulin, blood transfusion or blood-derived product in the past 3 months * recent history of fever or underlying medical problems
utility of presepsin in distinguishing between sepsis and sirs

Conditions: SIRS; Sepsis

Summary: this is an observational study to evaluate the diagnostic accuracy of presepsin levels to discriminate between sepsis and sirs upon presentation with critical illness compatible with either sepsis or systemic inflammatory response syndrome (sirs).


Eligibility criteria:
sepsis/sirs patients inclusion criteria: * male or female aged ≥ 21 years * appropriate clinical data to enable classification into sepsis or sirs * written informed consent by the patient or legally authorized representative * critical illness consistent with sirs or sepsis, to be enrolled within 18 hours of presentation exclusion criteria: * no informed consent * unacceptable risk imposed by extra blood sampling, such as by gross hemorrhage with a hematocrit \< 20% control inclusion criteria: * male or female aged ≥ 21 years * does not meet clinical criteria for sepsis or sirs * written informed consent by the patient or legally authorized representative exclusion criteria: * no informed consent * unacceptable risk imposed by extra blood sampling, such as by gross hemorrhage with a hematocrit \< 20% end stage renal disease inclusion criteria: * male or female aged ≥ 21 years * documented diagnosis of end stage renal disease currently undergoing dialysis * does not meet clinical criteria for sepsis or sirs * written informed consent by the patient or legally authorized representative exclusion criteria: * no informed consent * unacceptable risk imposed by extra blood sampling, such as by gross hemorrhage with a hematocrit \< 20%

Keywords: presepsin sepsis sirs
carecopd - copd home monitoring study

Conditions: Chronic Obstructive Pulmonary Disease

Summary: this is a pilot study to demonstrate early validation of objective home-monitoring of chronic obstructive pulmonary disease (copd) patients by combining accurate and relevant patient data of medication and lung function (lung impedance) through patient-facing devices.

the study goals are to demonstrate early validation of objective home-monitoring of copd patients using carecopd mature devices, paving way for follow-up work of care integration and larger studies. the data will consist of time-series airway obstruction parameters, medication quality, and symptoms data to detect correlations with exacerbation events. 50 copd patients (diagnosed gold 2- 3, c- d for moderate-severe, poorly controlled) will be monitored for 6 months. a successful outcome will be improved acute exacerbation of copd or aecopd detection of at least one day earlier than patient-reported assessment (copd assessment test or cat, modified medical research council or mmrc questionnaires) and false positives of \<20%.

Eligibility criteria:
inclusion criteria: patients who meet all of the following criteria are eligible for enrollment as study participants: * males and females over the age of 40 years. * physician-diagnosed copd classified as gold 2-3, c-d for at least 1 year. * using rescue medications at home delivered by a metered-dose inhaler or mdi. * speak, read, and understand english. * able to understand study requirements and comply with study procedures. * ability to operate a smartphone or tablet (for questionnaire and symptoms input). exclusion criteria: subjects who meet any of these criteria are not eligible for enrollment as study participants: * physically disabled such that they are incapable of performing forced oscillometry test (for airway impedance measurement) * physically disabled such that they are incapable of using metered-dose inhalers. * suffer from any visual, hearing, or cognitive impairment that cannot be corrected enough to operate the carecopd devices properly. mild/moderate vision loss and mild hearing loss may be included with appropriate corrective measures that do not affect the device usage. * suffering from serious uncontrolled medical conditions that may interfere with study conduct. * continuous home oxygen use for greater than 16 hours/day. * inability or unwillingness of the participant to give written informed consent. * individuals who are not yet adults (infants, children, teenagers) * pregnant women * prisoners
a registry study to observe clinical outcomes of participants with high-risk metastatic hormone-naïve prostate cancer in japan

Conditions: Prostatic Neoplasms

Summary: the purpose of this registry study is to longitudinally observe clinical outcomes and patient-reported outcomes (pro) for participants with high-risk metastatic hormone-naive prostate cancer (mhnpc) in the real-world setting in japan.


Eligibility criteria:
inclusion criteria: * documented diagnosis of metastatic, hormone-naïve prostate cancer (mhnpc) after 1 may 2019 * should have at least 2 of the 3 following high-risk factors: a gleason score of greater than or equal to (\>=) 8, at least 3-bone lesions, or the presence of visceral metastasis * willing to receive androgen-deprivation therapy (adt) containing regimens for high-risk metastatic, hormone-naïve prostate cancer (mhnpc) in the hospital which have the contract with sponsor for this study, or patient received a regimen containing adt for high-risk mhnpc * possess japanese nationality * each patient (or their legally acceptable representative) must sign an informed consent form (icf) indicating that he understands the purpose of, and procedures required for the study and is willing to participate in the study. for dead cases, the icf can be waived after approved by independent ethics committee/institutional review board (iec/irb) exclusion criteria: - has any other active malignancies
the usefulness of visuprime in cataract surgery

Conditions: Cataract

Summary: this is a multicentre, post-market, open label, randomized, placebo-controlled prospective study exploring the performance of visuprime in improving ocular surface homeostasis and reducing conjunctival bacterial load in patients receiving cataract surgery, as an addon treatment to postoperative standard terapy. the study will consist on 3 visits: visit 1 (day -3 from surgery), visit 2 (day 0, surgery), and visit 3 (day 7 from surgery). patients will be enrolled after having signed the informed consent form prior to any other study procedure and after inclusion/exclusion criteria check. at each visit all study procedures will be performed according to the clinical investigation plan requirements. patients will be enrolled at visit 1 and randomized with a 1:1 ratio to 2 groups: group a: patients receiving visuprime eyedrop bid from day -3 to week 1. after surgery, patients will be also given standard postoperative treatment consisting on unitdose desametasone eyedrop + levofloxacin eyedrop, both given four times daily (qid) from day 0 (after surgery) to the end of the study. group b: patients receiving placebo eyedrop (the vehicle of visuprime, i.e. isotonic buffered saline solution) bid from day -3 to week 1. after surgery, patients will be also given standard postoperative treatment consisting on unitdose desametasone eyedrop qid + levofloxacin eyedrop qid from day 0 to the end of the study.


Eligibility criteria:
inclusion criteria: * at least 18 years old patients, male and female * previous diagnosis of cataract requiring surgery * wishing to participate in the study and able to sign the icf * no topic ophthalmic medication, including lubricating eyedrops administration for at least 4 days before screening visit. exclusion criteria: * other clinically significant and uncontrolled pathologies that may interfere with study results (e.g.rheumatic disease) * previous participation on this study for the fellow eye * increased risk of complicated cataract surgery according to the investigator assessment (for example presence of dilation less than 6 mm, pupil decentration, pseudoexfoliation, areas of iris atrophy, sublussation or lussation of the lens, complete cataract, sac instability, iridodonesis, systemic disease limiting intraoperative patient cooperation) * coexisting corneal diseases * past or active conjunctivitis - any type * past ocular surface burns * keratinization of the eyelid margin * sjogren syndrome * history of corneal trauma * pregnant and lactating women * inability to self-administer study medications * know allergic sensitivity to any of the devices ingredients, or any other type of allergy * participation in a clinical trial during the 3 months prior to the beginning of the study.
precision medicine randomized clinical trial comparing molecular tumor board assisted care to usual care

Conditions: Non-Small Cell Lung Cancer

Summary: this trial will compare molecular tumor board (mtb) assisted care to usual care for patients who have newly diagnosed histologically or cytologically confirmed stage iib-iv non-small cell lung cancer (nsclc) and are planning to undergo treatment for their cancer.


Eligibility criteria:
inclusion criteria: * clinically suspected or histologically confirmed stage iib-iv nsclc who are planning to undergo treatment * no prior systemic therapies for nsclc, with the exception of adjuvant therapy for early stage nsclc. prior surgery and/or radiation is allowed. * ability to understand and the willingness to sign a written informed consent document. exclusion criteria: * uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with targeted therapy, in the opinion of the treating physician. * pregnancy

Keywords: molecular tumor board
a study to test the safety and efficacy of adding sitagliptin in patients with type 2 diabetes mellitus (mk0431-074)

Conditions: Type 2 Diabetes Mellitus

Summary: a study to assess the safety and efficacy of the addition of sitagliptin compared to placebo in patients with type 2 diabetes mellitus who have inadequate glycemic control on metformin.


Eligibility criteria:
inclusion criteria: * 18 - 78 years of age * currently on metformin monotherapy exclusion criteria: * history of type 1 diabetes mellitus or ketoacidosis * currently on a weight loss program and not in the maintenance phase or has started on a weight loss medication within the last 8 weeks * has undergone surgery requiring general anesthesia within the past 4 weeks or has planned major surgery * currently participating in a study or has participated in a study with or without an investigational compound or device within the past 12 weeks * history of active liver disease such as chronic active hepatitis b or c, cirrhosis or symptomatic gallbladder disease * hiv positive * pregnant, breast-feeding or planning to become pregnant during the study * user of recreational or illicit drugs or has a recent history (within the past year) of drug or alcohol abuse or dependence