Kornimate/medical-research-clean huggingface dataset:
a new biomarker for the non-invasive diagnosis of rejection after heart transplantation

Conditions: Heart Transplant Rejection

Summary: this study is a prospective, observational multi-center cohort study. the study will consist of patients undergoing heart transplantation. the main purpose is to test a new biomarker for rejection against the gold-standard, the endomyocardial biopsy (emb). 80 patients will be included, both children and adults.

the primary objective is a comparison of an the established, invasive diagnostic test, the endomyocardial biopsy (emb) against a new, non-invasive test. the new test is the measurement of donor-derived cell-free dna (dd-cfdna) circulating in the blood stream of the recipient, quantified by droplet digital pcr (polymerase-chain reaction) after targeted multiplex preamplification. sensitivity is calculated with emb as the gold standard. the patients will be followed during one year post-transplantation with simultaneous blood samples and emb. the patients will further be followed clinically for 5 years. a suitable cut-off for the ratio of dd-cfdna will be calculated using receiver operating characteristic (roc) analysis. secondary objectives are description of patient outcomes with respect to organ function, quality of life and adverse events. secondary objectives are the calculation of the costs related to the transplantation process as well as to the follow-up with emb. a simulation will be done with respect to possible savings achieved if the new biomarker could be implemented. the study consists of two cohorts: all adult recipients of heart transplantation at sahlgrenska university hospital (one of two center conducting heart transplantation in sweden): regional study. the other cohort consists of all children undergoing heart transplantation in sweden:national study. patients will undergo transplantation at sahlgrenska university hospital in gothenburg as well as at skåne university hospital in lund. follow-up with blood samples and emb of these patients will be in gothenburg, lund and at karolinska university hospital in stockholm.

Eligibility criteria:
inclusion criteria: 1. patient on waiting list for heart transplantation 2. signed informed consent exclusion criteria: 1. follow-up outside sweden

Keywords: diagnosis economics cell-free dna digital droplet pcr heart failure
argon plasma coagulation vs hemoclipping for bleeding peptic ulcers

Conditions: Bleeding Peptic Ulcer

Summary: endoscopic treatment is recommended for initial hemostasis in nonvariceal upper gastrointestinal bleeding. however, the additional hemostatic efficacy of argon plasma coagulation (apc) has not been widely investigated. we designed a randomized trial comparing apc plus injection therapy vs hemoclipping plus injection therapy for peptic ulcer bleeding.

【goals and background 】 endoscopic treatment is recommended for initial hemostasis in nonvariceal upper gastrointestinal bleeding. many endoscopic devices have been demonstrated to be effective in the hemostasis of bleeding ulcers. however, the additional hemostatic efficacy of argon plasma coagulation (apc) after endoscopic injection therapy has not been widely investigated. 【study】 from feb. 2012 to april 2016, consecutive patients with high-risk bleeding ulcers, characterized by active bleeding, non-bleeding visible vessels and adherent clots, were admitted to our hospital. they prospectively randomly underwent either apc therapy plus distilled water injection or hemoclipping plus distilled water injection. pantoprazole infusion was conducted during the fasting period after endoscopy and orally for 8 weeks to encourage ulcer healing. episodes of rebleeding were retreated with endoscopic combination therapy. patients who did not benefit from retreatment underwent emergency surgery or arterial embolization.

Eligibility criteria:
inclusion criteria: ． high-risk peptic ulcer bleeding. high-risk bleeding ulcers were defined as participants with stigmata of a bleeding visible vessels (eg, spurting, oozing), a non-bleeding visible vessels (nbvv) or adherent clot.4 a nbvv at endoscopy was defined as a raised red, red-blue or pale hemispheric vessel protruding from the ulcer bed, without active bleeding. an adherent clot was defined as an overlying blood clot that was resistant to vigorous irrigation. exclusion criteria: * the presence of another possible bleeding site (eg, gastroesophageal varix, gastric cancer, reflux esophagitis) * coexistence of actively severe ill diseases (eg, septic shock, stroke, myocardial infarction, surgical abdomen) * treatment with an anticoagulant (eg, warfarin) * pregnancy * the presence of operated stomach * refusal to participate in the study

Keywords: argon plasma coagulation hemoclipping distilled water injection
risk for short-term adverse events in older users in the emergency department

Conditions: Old Age; Medical Care; Survey

Summary: the study evaluates the performance criteria of abnormal prisma-7 score, length of stay in emergency department and in hospital, and hospital admission in older emergency department users.

in quebec, canada, the "program of research on integration of services for the maintenance of autonomy" (prisma-7) is the ministry of health and social services' reference tool for the frailty assessment of older emergency department users. this tool has been initially developed and validated to assess disabilities in older community dwellers with the aim to quickly identify older individuals at risk for disabilities and who should undergo a comprehensive assessment. prisma-7 has a high sensitivity for identifying frailty in older community dwellers but its performance criteria for this goal has never been examined in older emergency department users. recently, a systematic review underscored that prisma-7 has all characteristics for being a usable clinical tool in emergency department because it is a brief (i.e., \<5 min), simple and multidimensionality assessment. prisma-7 is composed of 7 questions assessing health and functionality of older adults and stratifies risk for disability in two levels: low versus high. prisma-7 is a prognostic tool for disabilities.

Eligibility criteria:
inclusion criteria: * being enrolled in the er2 study( emergency room evaluation and recommendation) * having a score test of prisma 7( program of research on integration of services for the maintenances of autonomy) at emergency. exclusion criteria: * never being enrolled in the er2 study( emergency room evaluation and recommendation) * never having a score test of prisma 7( program of research on integration of services for the maintenance of autonomy) at emergency

Keywords: emergency, old patients , survey questionnaire
clottriever® thrombectomy system use-result survey in japan

Conditions: Deep Vein Thrombosis

Summary: the objective of this survey is to determine the safety and efficacy of the clottriever thrombectomy system under daily clinical practice after marketing approval in japan. this device was designated as a subject of use results evaluation at the time of application for manufacturing and marketing approval.


Eligibility criteria:
this is an all-comers survey of all patients treated with clottriever® thrombectomy system in japan.
reuptake of an e-learning programme in general practice

Conditions: Education; Dementia

Summary: the evaluate the use and diffusion of an e-learning programme in diagnostic evaluation of dementia among general practitioners (gps) in denmark. the hypothesis are: 1. the gps do not use the guided instructions 2. the gps using the programme are more frequently younger gps. 3. gps working in rural areas will use the programme more frequently

in a period from november 2006 to may 2007 all log files of those gps who log on to the e-learning programme are kept by the danish medical association. they are handed over to the principal investigator in an anonymous form.

Eligibility criteria:
gps stopping working as gps in study period

Keywords: heading health plan implementation computer-assisted instruction general practice dementia
clinical and molecular findings in patients with cervical/supraclavicular metastasis from non-small-cell lung cancer (nsclc)

Conditions: Lung Cancer Metastatic

Summary: despite the availability of highly effective endoscopy-based and computed tomography (ct)-based biopsy procedures, up to 50% of patients with advanced lung cancer potentially eligible for targeted therapies or immunotherapy do not have access to a diagnosis or to a thorough molecular profiling for different reasons. enlarged and/or positron emission tomography (pet) positive cervical/supraclavicular lymph nodes (csls) are ideal targets for a minimally invasive diagnosis of lung cancer through a percutaneous ultrasound-guided biopsy (us-nab). however, the prevalence of metastatic involvement of csls in patients with advanced lung cancer was never specifically assessed. furthermore, the possible association of malignant csls involvement with molecular status was never investigated, unlike what was done for several other metastatic sites.


Eligibility criteria:
inclusion criteria: * age \>18 years at the time of the procedure; * suspected advanced, treatment naïve non-squamous nsclc ; * indication to biopsy for diagnosis and/or molecular profiling; * written informed consent to the study participation. exclusion criteria: * patients with known non-squamous nsclc sent for re-biopsy after first or second line treatment; * inability to stop anticoagulant or antiplatelet therapy before the procedure (except acetylsalicylic acid 100 mg/day); * platelet count \<50.000 per μl; * inability or unwillingness to provide a written informed consent.
antibiotics in free flaps reconstructions

Conditions: Postoperative Infection

Summary: the purpose of this study is to monitor and compare peri-operative problems and outcomes of reconstructive surgery with microvascular free flaps in the head and neck region between groups of patients treated with perioperative antibiotics and a group of patients without antibiotics.

study design and patient recruitment all clinical investigations have been conducted according to the principles expressed in the declaration of helsinki. patient consent was written. any patient who required reconstructive surgery for oncological reasons within the oral cavity with microvascular free flaps was eligible. patients receiving preoperative neoadjuvant or previous adjuvant radiation therapy in their medical history were not included in this study as the protocols available are not comparable in doses and effect on the irradiated tissue.14 a prospective study was initiated from july of 2007 to june 2012. all patients were prospectively evaluated. postoperative care the investigators standard regimen was to keep the patient sedated for one night on the intensive care unit and then transfer to the surgical ward. the specific intravenous antibiotic therapy was started 30 minutes before the operation and administered for 10 days. data analysis recorded parameters included: age, sex, preoperative medical history, american society of anesthesiologists classification of preoperative status 15, diagnosis, stage of disease, defect localisation, type of microvascular free flap, choice of recipient vessels, flap success, rate and number of operative revisions, primary or secondary reconstruction, type of previous treatment (radiation or surgery), type of previous neck dissection (if any), microvascular complications, the total operative time, wound healing disturbances subdivided into dehiscence and infection at the neck, region of reconstruction, or donor site, and prophylactic antibiotic agent, if used. infection was defined as a purulent discharge at the wounds. descriptive statistics for quantitative variables are given as the mean ± standard deviation. the data were analyzed with the "statistical package for the social sciences" software (ibm® spss® statistics for windows, version 22.0; ibm corp., armonk, ny, usa). figures are generated with spss and microsoft® office excel (microsoft excel for windows, release 11.0, 2003, microsoft corporation, redmond, wa, usa). multiple linear regression analyses were used to determine factors independently associated with the dependent variable wound infection or wound healing disturbances. 95% confidence intervals (95% ci) are also given. differences were considered to be statistically significant for a two-sided p-value of less than 0.05.

Eligibility criteria:
inclusion criteria: * any patient who required reconstructive surgery for oncological reasons within the oral cavity with microvascular free flaps. exclusion criteria: * healthy humans. * patients receiving preoperative neoadjuvant or previous adjuvant radiation therapy in their medical history.
effect of neoadjuvant or adjuvant systemic therapy on breast cancers, bone marrow cancer cells, and circulating cancer cells

Conditions: Breast Neoplasms

Summary: the main purpose of this study is to compare genetic markers present on tumor cells before and after chemotherapy.

in this study, the investigators propose that persistent disseminated tumor cells (dtc) present after systemic therapy represent a unique subpopulation of all dtc, are predictors of a poor response to systemic therapy and correlate with poor clinical outcome. the investigators hypothesize that systemic therapy-resistant dtc can be identified by their expression of a unique constellation of tumor marker proteins which may be similar to those expressed by breast cancer stem cells. in this research, the investigators' specific aims are : 1) to characterize tumor markers expressed by dtc which are present after systemic therapy, 2) to compare the expression of these markers to that on dtc detected prior to systemic therapy, 3) to correlate expression of the defined tumor markers on dtc with clinical outcome of breast cancer patients to identify those markers that are predictive of disease recurrence, 4) to utilize biomarkers identified in specific aims 1 and 2 to isolate purified dtc for further molecular analysis.

Eligibility criteria:
inclusion criteria: * recently diagnosed with clinical stage ii, iii, or iv breast cancer * planning to undergo neoadjuvant or adjuvant systemic therapy; patients who have already completed neoadjuvant systemic therapy are also eligible * must be \>= 18 years of age * if female, must not be pregnant * must not have hepatitis b, c, or hiv * must be willing and able to sign informed consent document

Keywords: breast cancer neoadjuvant
the schmitz-hinkelbein method. a new technique for cpr in space.

Conditions: Cardiac Arrest

Summary: the risk of a severe medical event during long-duration spaceflight is significant and can endanger both the whole mission and crew. there is a certain risk for a cardiac arrest in space requiring cardiopulmonary resuscitation (cpr). so far, 5 known techniques to perform cpr in microgravity have been reported. the aim of the present study was to describe and gather data for two new cpr techniques useful in microgravity.

the risk of a severe medical event during long-duration spaceflight is significant and can endanger both the whole mission and crew. there is a certain risk for a cardiac arrest in space requiring cardiopulmonary resuscitation (cpr). so far, 5 known techniques to perform cpr in microgravity have been reported. the aim of the present study was to describe and gather data for two new cpr techniques useful in microgravity. the investigators conducted a randomized controlled manikin trial and asked 15 participants with valid diving-license to resuscitate a manikin in two different techniques of cpr in a free-floating position underwater. the first technique, (schmitz-hinkelbein-method) is similar to conventional cpr, with the patient in a supine position on the performer's knees for stabilization. the second technique (hinkelbein-schmitz-method) is similar to the first, but chest compressions are conducted with the elbow.

Eligibility criteria:
inclusion criteria: * valid diving-license(ssi - open water diver (owd), cmas \*, padi open water diver, iso 24801-2 (autonomous diver), naui scuba diver or equal license * german emt-qualification exclusion criteria: * any acute or chronic ent illness/injury * no valid diving/emt license

Keywords: cardiopulmonary resuscitation cpr
the effect of omega-3 polyunsaturated fatty acids in the treatment and prevention of relapse of bipolar disorder

Conditions: Bipolar Disorder

Summary: the whole study will be divided into two major parts: (a) a 12-week, double-blind, randomized controlled, parallel n-3 fatty acids adjunctive therapy study in 30 bipolar disorder patients with mild to moderate depression. (b) a double-blind, randomized controlled, parallel n-3 fatty acid add-on prophylactic study in 31 patients with stable bipolar disorder.

part of the study will be a 12-week parallel-group placebo-controlled double-blind randomized n-3 fatty acids add-on combination therapy trial. a total of 30 patients in the acute depression stage of bipolar disorder will be collected from outpatient clinics and randomly assigned to receive n-3 fatty acids or placebo. t-test (or mann-whitney u-test) will be used to evaluate the differences in the severity of depressive and manic symptoms between the two groups across the study points. the second part of the study will be a 6-month add-on prophylactic trial with parallel-group, double-blind random allocation to n-3 fatty acids or placebo groups. a total of 31 patients with stable bipolar disorder recruited by newspaper advertisements will be recruited and randomly assigned to receive n-3 fatty acids or a placebo. kaplan-meier survival analysis will be used to evaluate the differences in the recurrence rate of bipolar depression between the two groups. also, t-test (or mann-whitney u-test) will be used to evaluate the differences in the severity of depressive and manic symptoms between the two groups across the study points. the 2 separate studies will be conducted after approval from the human trials committee.

Eligibility criteria:
inclusion criteria: 1. dsm-iv criteria for bipolar disorder. 2. age being age 18-65. 3. capacity and willingness to give written informed consent. 4. routine biochemical parameters within normal range. exclusion criteria: 1. presence of any major medical illnesses. 2. recent or past history of other dsm-iv axis i diagnoses such as psychotic disorders, organic mental disorders, substance abuse, substance dependence and anxiety disorder; acute psychotic state or strong suicidal attempts; and dsm-iv axis-ii diagnoses, including borderline and antisocial personality disorder.
bi-pap vs sham bi-pap on pulmonary function in morbidly obese patients after bariatric surgery

Conditions: Atelectasis; Pulmonary Infection; Chronic Obstructive Pulmonary Disease (COPD); Pulmonary Disease; Hypoxemic Respiratory Failure; Hypoxemia; Morbid Obesity

Summary: the effect of biphasic positive airway pressure (bi-pap) at individualized pressures on the postoperative pulmonary recovery of morbidly obese patients (mop) undergoing open bariatric surgery (obs) and possible placebo device-related effects (sham-bi-pap) were investigated.

in the present study the effect of bi-pap on the postoperative respiratory function and related complications of mop undergoing obs through a randomized sham-controlled design was investigated. bi-pap was applied at individualized pressures in order to optimize respiratory support and sham bi-pap was also used in order to neutralize possible placebo device related effect and researcher related bias. the investigators hypothesized that the use of bi-pap at individualized pressures in mop undergoing obs, ameliorates postoperative respiratory function as well as diminishes related pulmonary complications, postoperative pain and duration of hospitalization. primary endpoints were the difference in pre- and postoperative measurements of certain pulmonary function parameters (forced expiratory volume at one second (fev1), forced vital capacity (fvc), peak expiratory flow rate (pefr) and oxygen saturation by pulse oximetry (spo2) and the incidence of certain pulmonary complications postoperatively (hypoxemia, atelectasis, lower respiratory tract infections). secondary endpoints were postoperative pain and days of hospitalization.

Eligibility criteria:
inclusion criteria: * all patients have been morbidly obese (bmi\> 40kg/m2) for at least 10 years * all patients had unsuccessfully tried to lose weight by other non-invasive means. * all patients enrolled were continuous positive airway pressure (cpap) and bi-pap naïve and had no knowledge about the bi-pap apparatus prior to enrollment * all patients underwent obs (gastroplasty by mason or gastric bypass) by the same operating team * all patients were treated with the same standard anesthetic protocol exclusion criteria: * cardiovascular and pulmonary disease not related to obesity status * chronic renal disease * patients who were initially enrolled but did not use the allocated device (bi-pap or sham bi-pap) for at least 12 h daily were also excluded at a later point.

Keywords: bi-pap bipap morbid obesity anesthesia bariatric surgery sham bi-pap sham bipap postoperative complications
intraoperative hypotension and post-anesthesia care unit recovery

Conditions: Post-induction Hypotension; Post Anesthesia Recovery; Hypotension; Intraoperative Hypotension

Summary: the underlying causative mechanism that leads to intraoperative hypotension (ioh) may vary depending on the stage of anesthesia and surgery, which determines different ioh types. naturally, the incidence and severity of ioh types will differ, as will the incidence and severity of postoperative complications.

background the underlying causative mechanism that leads to intraoperative hypotension (ioh) may vary depending on the stage of anesthesia and surgery, which determines different ioh types. naturally, the incidence and severity of ioh types will differ, as will the incidence and severity of postoperative complications. methods the investigators conducted a data-based observational study that included 4776 patients. post-induction hypotension (pioh) is defined as a decrease during the first 20 min after anesthesia induction and maintenance intraoperative hypotension (mioh) when there is a decrease of blood pressure 20th min after induction, with or without pioh.

Eligibility criteria:
inclusion criteria: * 18 years and older * underwent elective surgery * received general anesthesia * planned overnight stay in the hospital after surgery exclusion criteria: * under 18 years of age * cardiac surgery * transplant surgery * preoperatively receiving vasoactive drugs * patients with mechanical circulatory support * pediatric surgery * patients from icu * patients with scheduled postoperative icu admissions

Keywords: complication intraoperative hypotension pacu outcomes pacu recovery hypotension