Kornimate/medical-research-clean huggingface dataset:
bacteriological setting before prosthesis implantation with one stage surgery in prosthetic joint infection

Conditions: Prosthetic Joint Infection

Summary: chronic prosthetic joint infection (pji) is a devastating complication of arthroplasty and its treatment continues to fuel the debate on how to manage it appropriately. one stage and two stage exchange surgery both are the conventional surgical procedures for chronic pji commonly used to date. two stage surgery disadvantages (major surgery, anesthesia and nosocomial risks, functional impairment between surgeries and a high socio-economic coast) encouraged many surgical teams to adopt one stage exchange surgery which provides equivalent or better outcomes. however one stage surgery encounters a major conceptual difficulty when it comes to implant the new prosthesis in a surgical site microbiologically undetermined and potentially contaminated. investigators suppose the new prosthesis is implanted in a contaminated setting regardless of bacteria type and antibiotic therapy duration before arthroplasty. the total lack of data answering this question motivated the conception of this prospective study in order to describe the microbiological setting where is implanted the new prosthesis with one stage exchange surgery after surgical excision and antibiotic therapy initiation in chronic pji.

study duration: two weeks. recruitment period: 18 months. maximal duration of data collection: two weeks. investigator center: monocenter study. mean patient inclusion per year: 70 patients per year.

Eligibility criteria:
inclusion criteria: * patient consent * aged over 18 years * pji documented preoperatively by joint fluid culture according to musculoskeletal infection society definition * monoarticular pji * pji management validated at the weekly cross-disciplinary conciliation meeting * pji treated with one stage surgery and intravenous antibiotherapy adjusted to preoperative aspiration results. exclusion criteria: * patient who does not meet eligibility criteria * negative preoperative aspiration culture * pji du to fungi * patient lawfully deprived of his liberty * patient insured under social security scheme

Keywords: prosthesis joint infection perioperative samples
caudal block & hip fracture surgery in anticoagulated patient

Conditions: Hip Fractures; Anticoagulants and Bleeding Disorders

Summary: hip fractures are common in elderly patients, and require surgery. many elderly patients take anticoagulants for vasculopathy treatment. anticoagulation precludes the use of neuraxial anesthesia because of the risk of epidural bleeding. caudal anesthesia may be a safe and effective technique in anticoagulated emergency surgical patients. quantitative analysis of prospective clinical data. evaluation of caudal anesthesia efficacy for hip fracture surgery. analysis of perioperative outcome, and postoperative course.

hip or femoral neck fractures are common in elderly patients. these fractures require surgical repair. many elderly patients take regular anticoagulant therapy for vasculopathy. anticoagulation precludes the use of spinal or epidural anesthesia because of the risk of epidural bleeding. caudal anesthesia is another form of neuraxial anesthesia that may be safe and effective for hip fracture surgery in anticoagulated elderly patients. quantitative analysis of prospective clinical data. it is an evaluation of caudal anesthesia efficacy for hip fracture surgery. this is an analysis of intraoperative analgesia, perioperative outcome, postoperative course, and complications.

Eligibility criteria:
inclusion criteria: * patients with fractured hip or femoral neck who undergo surgical repair exclusion criteria: * patients who refuse surgical repair

Keywords: caudal anesthesia
a study evaluating the safety, tolerance and anti-tumor activity of hbm1020 in subjects with advanced solid tumors

Conditions: Advanced Solid Tumor

Summary: this is a study to evaluate the safety and tolerability of the study drug hbm1020 which contains two parts. part 1 will enroll solid tumor participants and part 2 will enroll renal cell carcinoma (rcc) and colorectal adenocarcinoma (crc).

this is a study to evaluate the safety and tolerability of the study drug hbm1020, and to determine the maximum tolerated dose and/or recommended phase 2 study dose of hbm1020. the study will also look at the anti-tumor activity of hbm1020.the study consists of 2 parts. in part 1, patients are enrolled into different cohort doses in order to identify the appropriate recommended phase 2 dose (rp2d) or maximum tolerated dose (mtd). in part 2, participants with metastatic/unresectable rcc, crc will receive the mtd and/or rp2d established in part 1 of the study. in part 1 and part 2, participants will be administered treatment every 3 weeks.

Eligibility criteria:
inclusion criteria: 1. willingness to sign a written informed consent document. 2. male or female subject aged ≥18 years old at the time of screening. 3. histologically or cytologically confirmed advanced solid tumors or recurrent and progressed since last antitumor therapy for which no alternative, curative standard therapy exists. 4. adequate organ and bone marrow function. exclusion criteria: 1. prior used anti-b7h7 monoclonal antibodies (mab) or anti-kir3dl3 monoclonal antibodies (mab). 2. any systemic anti-cancer therapy within 4 weeks prior to first dose of investigational medicinal product (imp), or immunosuppressive medications within 2 weeks before the first dose of investigational medicinal product (imp). 3. not yet recovered from surgery or (immune-related) toxicity related with previous treatment. 4. with clinically significant congenital or acquired cardiovascular diseases. 5. with severe or uncontrolled systemic diseases, including uncontrolled hypertension, uncontrolled diabetes mellitus, active bleeding diatheses, or active infection including hepatitis b, hepatitis c, autoimmune disease and human immunodeficiency virus. 6. presence of other active invasive cancers other than the one treated in this study within 5 years prior to screening, except appropriately treated basal cell carcinoma of the skin, or in situ carcinoma of uterine cervix, or other local tumors considered cured by local treatment. 7. major surgery (excluding placement of vascular access) within 4 weeks of first dose of study drug. 8. previously untreated brain metastases. 9. pregnant or breastfeeding women.

Keywords: advanced solid tumors
efficacy and safety of ginsenoside-rd for acute ischemic stroke

Conditions: Ischemic Stroke

Summary: the purpose of this phase 3 study is to validate the efficacy and safety of ginsenoside-rd for acute ischemic stroke.

a phase ⅲ randomized, double-blind, placebo-controlled, multicenter study was conducted to examine the efficacy and safety of ginsenoside-rd in patients with acute ischemic stroke. stroke patients were randomized equally to receive a 14-day infusion of placebo or ginsenoside-rd 20mg. primary end points were nihss scores at 15 days. secondary end points were nihss scores and the barthel index at 8 days, the barthel index and the modified rankin scale at 15 days and 90 days. the safety end points included serious and nonserious adverse events, laboratory values and vital signs. analysis was by intention to treat.

Eligibility criteria:
inclusion criteria: * between 18 to 75 years * the first episode * from onset to admission within 72 hours * nihss scores:5\~22 exclusion criteria: * had other intracranial pathologies (e.g., tumor, infection) * had a neurologic or psychiatric disease * had a coexisting condition that limited their life expectancy * had significant drug or alcohol misuse * had high-grade carotid artery stenosis for which surgery was planned * were pregnant or nursing * participated in a clinical trial with an investigational drug or device within the past 3 months * were unlikely to be available for follow-up

Keywords: randomized trial ischemic stroke ginsenoside-rd
a study of neorecormon (epoetin beta) in patients with renal anemia.

Conditions: Anemia

Summary: this study will determine whether 8 weekly monitoring of hemoglobin and iron parameters in the correction phase of neorecormon therapy in patients with renal anemia is as safe and effective as 4 weekly monitoring. patients with chronic kidney disease will receive neorecormon at a dose aimed at achieving and maintaining a hb level of 110-130g/l. they will be randomized into one of two schedules for monitoring hemoglobin levels and iron parameters, either 4 weekly or 8 weekly. the anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 inidividuals.


Eligibility criteria:
inclusion criteria: * adult patients, 18-80 years of age; * stage 3-4 chronic kidney disease (egfr 15-60ml/min); * hb \ =20%, and ferritin \>=100 mcg/l at screening. exclusion criteria: * anticipating to go on renal replacement therapy; * anticipating a living related-donor kidney transplant, or a prior recipient of a kidney transplant; * uncontrolled hypertension; * congestive heart failure; * active bleeding or red blood cell transfusions in 8 weeks prior to screening; systematic hematological disease.
a simulation-based intervention for caregivers of children with seizures

Conditions: Dependency on Medications Prescribed for Patient; Types of Seizures and Epileptic Syndromes

Summary: caregivers of children with seizures receiving simulation based seizure management teaching in addition to the traditional seizure teaching will report more confidence with seizure management and demonstrate a higher level of performance with seizure management.


Eligibility criteria:
inclusion criteria * clinical diagnosis of seizure disorder * dependence on a anti-seizure medication exclusion criteria * no dependence on rescue medication

Keywords: seizure caregivers family centered care learning modality
effect of physician attire on patients' preference of physician

Conditions: Malignant Neoplasms of Independent (Primary) Multiple Sites

Summary: the goal of this research study is to learn about the effects of a doctor's characteristics on participant's preference for a doctor. researchers also want to learn about how a doctor's characteristics affect participant's options about professionalism and compassion.

if participant agrees to take part in this study, participant will be asked to complete 7 questionnaires. these questionnaires ask about participant's gender, date of birth, ethnicity, marital status, level of education, religion, and information about the disease and treatments participant received. participant will also be asked about any symptoms participant may be having, how much trust participant has in the medical profession in general, how participant feels about the disease, any depression or anxiety participant may have, and participant's level of hopefulness. these questionnaires should take about 6 minutes to complete. participant will be shown 2 videos (each 3 minutes long) and then participant will complete questions about each video. participant will be asked to rate the doctors participant saw on their professionalism and their compassion. caregivers will be required to leave the room or stay silent while the participant is watching the videos. the total time to watch the videos and complete the second set of questionnaires should be about 7 minutes. finally, participant will be asked to complete 3 questionnaires about participant's overall preference for a doctor. these questionnaires will take about 5 minutes to complete. length of study participation: participation in this study is complete after participant answers the final questionnaires. overall, this study should take about 30 minutes to complete. this is an investigational study. up to 108 participants will be enrolled in this study. all will take part at md anderson.

Eligibility criteria:
inclusion criteria: 1. advanced cancer diagnosis (locally advanced, recurrent or metastatic disease). 2. patients presenting as follow-ups only at the outpatient supportive care center. 3. age \>/= 18 years-old 4. english speaking exclusion criteria: 1. altered cognition (as assessed routinely in the supportive care clinic using the memorial delirium assessment scale (mdas), with a score of \>/= 7/30). 2. patients suffering from a severe psychiatric disorder or condition that would significantly interfere with study participation. 3. patients with hearing and/or visual impairments.

Keywords: malignant neoplasms of independent (primary) multiple sites advanced cancer videos questionnaires surveys
optimal time for tenofovir treatment of anti-hepatitis b virus (hbv) during the pregnancy

Conditions: Hepatitis B, Chronic

Summary: to determine the optimal time for the tenofovir treatment of anti-hepatitis b virus (hbv) during the pregnancy among women with chronic hbv infection and high hbv dna load. this is a randomized, open-label, three-arms, parallel-controlled clinical trial. pregnant women with high hbv load and normal liver function will be treated with tenofovir during the middle or late stage of pregnancy, started from 24th gestational week, 28th gestational week and 32th gestational week through 1 month postpartum, respectively. the hbv dna load at 40th gestational week of mothers, the intrauterine hbv infection rate of infants will be compared across the three groups.

tenofovir disoproxil fumarate is a american food and drug administration (fda) pregnancy class b drug. to determine the optimal time for the tenofovir treatment during the pregnancy among women with chronic hbv infection and high hbv dna load. pregnant women with high hbv dna load and normal liver function at second trimester will be randomized into three treatment groups at the 20th week of gestation and treated with tenofovir from 24 weeks, 28 weeks and 32 weeks to 1 month postpartum, respectively. the blood will be drawn at 24 weeks, 28 weeks, 32 weeks, 36 weeks and the delivery, respectively and the hbv dna load and liver functions will be tested. the status of hbv infection for infants will be observed at 1st month, 7th month and 12th month after the babies were delivered. the hbv dna load at 40th gestational week of mothers, the intrauterine hbv infection rate of infants and safety outcomes will be compared across the three groups.

Eligibility criteria:
inclusion criteria: * women between 20 and 40 years old * have had hbsag positive in serum greater than 6 months * hbv dna load\>10\*\*6 iu/ml * gestation week\<24 weeks * normal liver function * able to comprehend and willing to sign the informed consent form exclusion criteria: * combined with following infections: hepatitis a virus (hav), hepatitis c virus (hcv), hepatitis d virus (hdv), hepatitis e virus (hev) and human immunodeficiency virus (hiv) * got antiviral treatments before 24 weeks of gestation * got immunosuppressor treatment and/or steroids * got diagnosis of cirrhosis,hepatocellular carcinoma or severe hepatitis b * got serious obstetric complications * got evidence of fetal deformity diagnosed by four-dimensional color doppler ultrasound examination * biological father of infant had hbv infection

Keywords: vertical infection transmission tenofovir
a dose-ranging study to evaluate albuterol and hydrofluoroalkane in subjects ages 12 and older with persistent asthma

Conditions: Asthma

Summary: this study is examining how well a dry powder inhaler (dpi) of albuterol medication works to help adult and adolescent subjects 12 years of age and older with persistent asthma to improve lung function.


Eligibility criteria:
inclusion criteria: * must provide written informed consent, * be between 12 years of age and older, * male or female, females of non-child bearing potential or using reliable contraception * asthma for at least 6 months, fev1 (forced expiratory volume in 1 second) between 50-80% of predicted value, and reversibility greater than or equal to 15% following 180 mcg albuterol * stable low dose of inhaled corticosteroids * non-smoker, 12 months smoking-free and \<=10-pack years history * otherwise healthy * other criteria apply exclusion criteria: * pregnant * allergic to albuterol or severe milk protein allergy * must not be on another trial for 30days. * other criteria apply
expanded study of the highlife 28mm trans-septal trans-catheter mitral valve in patients with moderate-severe or severe mitral regurgitation and at high surgical risk

Conditions: Mitral Regurgitation

Summary: to evaluate the safety and performance of the highlife 28mm transcatheter, trans-septal mitral valve in patients with moderate-severe or severe mitral regurgitation who are at high risk for surgical treatment.


Eligibility criteria:
inclusion criteria: * 1. age ≥ 18 years 2. moderate-severe or severe mitral regurgitation (≥ 3+) 3. patient has new york heart association (nyha) functional class ii, iii or ambulatory iv 4. patient is under guideline directed medical therapy, as reviewed and confirmed by the local multidisciplinary heart team, for at least one month 5. patient is high-risk for open-heart surgery based on the assessment of the multidisciplinary heart team using standard scoring systems and consideration of co-morbidities, frailty, and disability 6. patient meets the anatomical criteria for highlife valve 7. patient is willing to participate in the study and provides signed informed consent exclusion criteria: 1. any stroke/tia within 30 days 2. severe symptomatic carotid stenosis (\> 70% by non-invasive imaging) 3. active infections requiring antibiotic therapy 4. active ulcer or gastro-intestinal bleeding in the past 3 months 5. history of bleeding diathesis, coagulopathy or refusal of future blood transfusion 6. patients in whom tee is not feasible 7. patients who are pregnant or lactating, or plan to get pregnant in the next 12 months. 8. patient is unable to comply with the follow-up schedule and assessments 9. participation in another clinical investigation at the time of inclusion 10. patient has known allergies to the device components or contrast medium 11. patient cannot tolerate anticoagulation or antiplatelet therapy 12. patients with a life expectancy of less than 12 months due to non-cardiac conditions 13. patient had permanent pacemaker, or similar device with implantable cardiac leads (i.e. resynchronization therapy) within the last 3 months -
evaluation of safety and efficacy of lumason in pediatric echocardiography

Conditions: Heart Disease

Summary: safety and efficacy study in pediatric subjects aged 9 to 17 years of age with suboptimal lv ebd on non-contrast 2d echocardiography. imaging modalities that are used throughout the study in pediatric subjects represented those utilized in routine clinical practice in adults.

this was a phase iii, multicenter, open-label study that was to be conducted at approximately 7-12 sites in the united states, canada and europe in pediatric patients with suboptimal lv ebd on non-contrast 2d transthoracic echocardiography. it was estimated that 92 patients were to be enrolled to provide 73 evaluable patients. three cardiologists unaffiliated with enrolling centers (blinded readers), blinded to the patient's identity and clinical profile were to independently evaluate the echocardiograms. the efficacy analysis was primarily based on the blinded reader evaluations. imaging modalities that are used throughout the study in pediatric subjects represented those utilized in routine clinical practice in adults. one of the sites participating in this study was to be asked to consent a subset of patients for additional blood sampling for analysis of sf6 concentration in blood from a total of 6 patients (3 males and 3 females) in the age group 9 up to 12 years of age and 6 patients (3 males and 3 females) in the age of \>12 up to and including 17 years. the current study was designed to assess the efficacy of lumason-enhanced echocardiography in pediatric patients.

Eligibility criteria:
inclusion criteria: * provide written informed consent from parent(s) or legal guardian * provide assent when required according to local regulations * suspected of having cardiac disease or undergoing evaluation of cardiac anatomy for congenital heart disease * undergone a previous transthoracic echocardiogram within one month prior to enrollment resulting in suboptimal left ventricular endocardial border defined as ≥ 2 contiguous segments in any given view that cannot be visualized. exclusion criteria: * children \< 9 years of age * previously enrolled in the study * administered any other contrast agent either intravascularly or orally within 48 hours of lumason administration * known right-to-left, bidirectional or transient cardiac shunt (ruled out with agitated saline study performed before administration of lumason) * known hypersensitivity to one or more of the ingredients of the investigational product * received an investigational compound within 30 days before enrolling into this study * pregnant or lactating female * determined by investigator to be unsuitable for the study
efficacy and safety of omt on asthmatics

Conditions: Asthma

Summary: this is a pilot study in which the objective is to determine the feasibility of a randomized clinical trial investigating the safety and efficacy of omt as an adjunctive treatment for patients with mild to moderate asthma compared to the same patient population without the use of omt. omt may be able to correct anatomical dysfunctions that contribute to increased symptoms in asthmatic patients. omt's effect on asthma will be demonstrated by symptomatology reporting, frequency of medication use, and pulmonary function tests.

asthma is a leading cause of activity limitation and healthcare burden in the united states of america. the asthmatic population is in need of treatments that target reducing asthma symptoms, reduce the need for medication, and improve lung functionality. as of today, there are not many studies investigating the efficacy and safety of osteopathic manipulative treatment (omt) on asthmatic patients. this is a pilot study in which the objective is to determine the feasibility of a randomized clinical trial investigating the safety and efficacy of omt as an adjunctive treatment for patients with mild to moderate asthma compared to the same patient population without the use of omt. subjects will be randomized into either a control group or an intervention group where omt will be used in conjunction with standard asthmatic treatment. subjective and objective measurements will be taken including the asthma control test (act) questionnaire, peak flow, spirometry, pulse oximetry, and chest/diaphragmatic excursion measurements. measurements will be compared from baseline, before the first treatment and at the follow-up visit after the final treatment.

Eligibility criteria:
inclusion criteria: * clinically diagnosed with mild to moderate asthma (episodic symptoms included were airflow obstruction or airway hyper-responsiveness, and airflow obstruction that was at least partially reversible (based upon an increase in fev1 or greater than or equal to 12% from baseline or by an increase of at least 10% of predicted fev1 after inhalation of a short-acting bronchodilator) exclusion criteria: * pneumonia * copd as a primary diagnosis * pulmonary fibrosis * smoking history * inability to perform pulmonary function tests * history of recent myocardial infarction or heart disease * unable to respond to the questionnaire * unable to provide informed consent * pregnant * using muscle relaxants * any contraindications to omt such as: known bone metastases, severe osteoporosis, osteomyelitis, or fracture

Keywords: omt