Kornimate/medical-research-clean huggingface dataset:
post-marketing surveillance (usage results study) of rixubis in adult and pediatric patients with haemophilia b in south korea

Conditions: Hemophilia B

Summary: primary: to characterize the safety of rixubis when used under normal clinical care in south korea. secondary: to describe hemostatic effectiveness in subjects receiving rixubis under normal clinical care in south korea.


Eligibility criteria:
inclusion criteria: 1. participants with congenital hemophilia b (fix level ≤5%) 2. participant or the participant's legally authorized representative has provided signed informed consent. 3. participant is indicated for treatment according to the rixubis korean product leaflet. exclusion criteria: 1. participants with known hypersensitivity or presence of any contraindication to rixubis or its excipients including hamster protein 2. participants with disseminated intravascular coagulation (dic) 3. participants with signs of fibrinolysis
effectiveness of two interventions in patients with low educational level with diabetes to reduce inequalities in self-care behavior

Conditions: Diabetes Mellitus Type 2

Summary: the purpose of this cluster randomized trial is to determine whether an intervention implemented in a general surgery, based in improving patient-provider communication, results in a better diabetes self-management in patients with lower educational level. a secondary objective is to assess whether telephone reinforcement enhances the effect of such intervention.


Eligibility criteria:
inclusion criteria: * diagnosis of dm2, * over 18 years, * low educational level (no college to gbs or eso), * inadequate glycemic control (glycosylated hemoglobin levels above 7%) exclusion criteria: * physical or mental condition that prevents the completion of the intervention - complications arising from severe dm2 altering routine medical monitoring.

Keywords: diabetes mellitus type 2; primary care, healthcare inequalities; diabetes self-management, quality of diabetes care
effect of acupuncture on quiescent crohn's disease

Conditions: Inflammatory Bowel Diseases; Crohn Disease

Summary: to observe the clinical effect of acupuncture on quiescent crohn's disease

to observe the effect of acupuncture on maintaining remission of quiescent crohn's disease

Eligibility criteria:
inclusion criteria: 1. aged 16-70; 2. patients with disease in remission: cdai \<150 and at least one of the following: serum c-reactive protein \<5mg/l, fecal calprotectin \<50μg/g or no ulcers on endoscopy; 3. patients with more than 2 disease relapses in the past year; 4. patients were not taking medication or were only taking one or more of the following drugs: \[prednisone ≤15mg/d, azathioprine (≤1mg/kg/d), methotrexate (≤15mg/w) or mesalazine (≤4g/d)\] and prednisone was used for at least 1 month, while azathioprine, methotrexate or mesalazine was used for at least 3 months; 5. those who did not use anti-tnf alpha and other agents within 3 months before entering the study; 6. those who have never experienced acupuncture; 7. patients signing informed consent. exclusion criteria: 1. patients who are recently pregnant or in pregnancy or lactation; 2. patients with serious organic diseases; 3. patients diagnosed as psychosis; 4. patients who take antibiotics, probiotics, traditional chinese medicine and other drugs at the same time, or who suffer from multiple diseases and need to take other drugs for a long time, and may affect the observation of the efficacy of this trial; 5. severe skin diseases (such as erythema nodosum, pyoderma gangrenosum, etc.), eye diseases (such as iritis, uveitis, etc.), thromboembolic diseases and other serious extraintestinal manifestations; 6. there are serious intestinal fistula, abdominal abscess, intestinal stenosis and obstruction, perianal abscess, gastrointestinal hemorrhage, intestinal perforation and other complications; 7. patients with short bowel syndrome who have undergone abdominal or gastrointestinal surgery in the past half a year; 8. there are skin diseases or defects in the selected area of acupuncture and moxibustion that cannot be performed.

Keywords: acupuncture crohn's disease
a prospective clinical study to evaluate the safety and effectiveness of pulmonary vein isolation plus box isolation of fibrotic areas with the globe® pulsed field system for treating patients with symptomatic paroxysmal or persistent atrial fibrillation

Conditions: Paroxysmal Atrial Fibrillation (PAF); Persistent Atrial Fibrillation

Summary: the study will evaluate the safety and 12-month effectiveness of the pulmonary vein isolation plus box isolation of fibrotic areas (bifa) ablation strategy with the globe pulsed field system (globe pf system) for the treatment of atrial fibrillation.


Eligibility criteria:
key inclusion criteria: * a diagnosis of recurrent symptomatic paroxysmal or persistent af * failure or intolerance of at least one antiarrhythmic drug (aad) class i or iii key exclusion criteria: * long-standing persistent af (sustained \>12 months) * atrial fibrillation secondary to a reversible cause or of non-cardiac origin * history of thromboembolic events within the past six months * myocardial infarction (mi)/percutaneous coronary intervention (pci) within the last three months * any cardiac surgery within the previous six months * prior left atrial ablation or surgical procedure * presence of an implanted cardiac device * body mass index (bmi) \>40 kg/m\^2 * left ventricular ejection fraction (lvef) \<35% * anterior-posterior left atrial (la) diameter \>55mm

Keywords: pulsed field ablation
a spanish medical record review of adults with relapsed or refractory cd30+ malignancies when re-treated with brentuximab-vedotin

Conditions: Hodgkin Disease; Lymphoma, T-Cell, Cutaneous

Summary: participants in the study are adults with cd30-positive malignancies which include classical hodgkin lymphoma (chl), cutaneous t-cell lymphoma (ctcl): mycosis fungoides (mf) or primarily cutaneous anaplastic large cell lymphoma (pcalcl), or systemic anaplastic large cell lymphoma (salcl). the main aims of the study are as follows: * to learn about the response rates of participants with relapsed or refractory cd30+ malignancies when re-treated with bv. * to check for side effects from re-treatment with bv. the study will take place in approximately 30 hospitals in spain. the study doctors will review each participant's medical record at least 6 months after finishing the last dose of re-treatment with bv. this study is about collecting existing information only; participants will not receive treatment or need to visit a study doctor during this study.

this is an observational, non-interventional, retrospective study in participants with r/r cd30 positive chl, ctcl (mf and pcalcl) and salcl who have previously achieved a cr or pr with bv treatment and subsequently experienced disease progression were administered bv retreatment. this study will assess the effectiveness and safety of bv retreatment in the spanish population in real-world clinical practice. the study will enroll approximately 35 participants. the data will be collected and recorded from the medical record of participants and also recorded in electronic case report forms (e-crfs). all the participants will be assigned to a single observational cohort: • participants with cd30-positive lymphoma this multi-center trial will be conducted in spain. the overall duration of the study will be approximately 24 months (12 months for medical chart review and 12 until publication submission).

Eligibility criteria:
inclusion criteria: 1. histologically confirmed chl, ctcl (mf and pcalcl) or salcl with cd30 positive. 2. previously treated with bv containing regimen, with evidence of objective response (determined by having achieved cr or pr), and subsequent disease progression or relapse after discontinuing treatment bv retreatment. 3. participants with data of disease relapse or progression greater than or equal to (\>=) 6 months since the last dose of the first treatment with bv. 4. participant with data available at the participating site since diagnosis of chl, ctcl (mf and pcalcl) or salcl. 5. having received at least, two doses of bv as retreatment and having follow up information available at the site for a minimum period of six months or until death. exclusion criteria: there are no exclusion criteria for this study.

Keywords: drug therapy
multiparametric mri for assessment of changes of renal hemodynamics after fistula closure in kidney transplant patients

Conditions: Kidney Transplantation

Summary: assessment of changes of renal hemodynamics by multiparametric mri after closure of avf access.


Eligibility criteria:
inclusion criteria: * written informed consent * age \> 18 years * patients wishing to close the fistula and planned for surgical fistula closure * egfr ckd epi ≥ 45 ml/min/1.73m2 at one year post transplantation * stable egfr within the past 6 months * controlled blood pressure exclusion criteria: * kidney transplantation \< 12 months before fistula closure * proteinuria \> 500mg/d * presence of donor specific antibodies * rejection within the past 6 months * bk virus replication within the past 3 months * cardiac pacemaker, which is not compatible with mri * claustrophobia
ablative fractional lasers to treat peri-orbital rhytides

Conditions: Peri-orbital Rhytides

Summary: ablative fractional lasers were introduced for treating facial rhytides in an attempt to achieve results comparable to traditional ablative resurfacing but with fewer side effects. however, there is conflicting evidence on how well this goal has generally been achieved as well as on the comparative value of fractional co2 and er:yag lasers. the present study compares these modalities in a randomized controlled blinded split-face study design: 28 patients were enrolled and completed the entire study. patients were randomly assigned to receive a single treatment on each side of the peri-orbital region, one with a fractional co2 and one with a fractional er:yag laser. the evaluation included fitzpatrick wrinkle score, profilometric measurement of wrinkle depth (both before and 3 months after treatment) as well as assessment of side effects and patient satisfaction (1, 3, 6 days and 3 months after treatment).


Eligibility criteria:
inclusion criteria: * age 40-55 * mild to moderate peri-orbital rhytides exclusion criteria: * unrealistic expectations * inability to meet follow-up criteria * fitzpatrick skin phototype \>iii * coagulation disorders or anti-coagulant treatment * allergy to lidocaine or tetracaine * oral isotretinoin within the last 6 months * any active skin disease within the treatment areas (e. g., cancer, autoimmune disease) * synthetic implants in the treatment area * facial cosmetic procedures affecting the treatment area within the last 6 months * photosensitizing medications (e. g., tetracycline, gold) * history of keloid formation * pregnancy

Keywords: skin aging laser surgery fractional photothermolysis comparative study ablative fractional treatment of peri-orbital rhytides
the heart rhythm twins study

Conditions: Premature Atrial Complex; Premature Ventricular Contraction

Summary: premature atrial contractions (pacs) and premature ventricular contractions (pvcs) are observed in the majority of individuals monitored for more than a few hours. although the clinical course of pacs and pvcs is usually benign, it has been described that high pac or pvc frequency causes various comorbidities and worsens outcomes in different patient groups. for example, pacs can initiate episodes of atrial fibrillation, and pac count is highly specific in predicting diagnosis of incident atrial fibrillation. increasing pvc frequencies are an important predictor of incident heart failure. while conventional wisdom dictates that common environmental exposures determine pac and pvc frequencies, this has not born out in rigorous studies. whether pac and pvc frequencies may have genetic underpinnings remains unknown. comparisons between identical twins and fraternal twins can provide estimates of heritability. fraternal twins are an ideal control because, like identical twins, they share a womb, have the same birthday, and their environment while growing up are as similar as between identical twins. however, while identical twins share approximately 100% of the same inherited dna, fraternal twins share, on average, about 50%. by monitoring identical and fraternal twins with portable electrocardiograms (ecgs), we will be able to count the pacs and pvcs over a consecutive timespan to describe the familial aggregation of these complexes. this, to our knowledge, would be the first study to compare pac and pvc frequencies in identical and same-sex fraternal twins, providing the first assessment of how genetical inheritance may influence cardiac ectopy burdens.


Eligibility criteria:
inclusion criteria: * identical or same-sex fraternal sets of twins * english-speaking exclusion criteria: * pregnancy * current anti-arrhythmic medication use (including beta blockers) * diagnosis of congenital heart disease * diagnosis of persistent or permanent atrial fibrillation * prior cardiac ablation

Keywords: twin
effect of transcutaneous auricular vagal nerve stimulation on chronic constipation

Conditions: Chronic Constipation

Summary: the worldwide prevalence of chronic constipation (cc) is 15%, and women are more likely to develop the disease than men. cc have a significant impact on quality of life and increase the burden of national health insurance. the conventional medication treatments are primarily symptom-specific and have limited efficacy. previous small sample study had shown the therapeutic potential of transcutaneous auricular vagus nerve stimulation (tavns) for irritable bowel syndrome with constipation (ibs-c). the aim of this study was to investigate whether tavns could improve defecation condition and constipation symptoms in patients with cc.


Eligibility criteria:
inclusion criteria: 1. fc or ibs-c patients aged 18-75 years who meet the diagnostic criteria for rome iv; 2. complete spontaneous bowel movements (csbms) per week \< 3; 3. no constipation medication used for at least 2 weeks prior to enrollment, not participated in clinical trials in the past three months, and no abnormal colonoscopy within the past 12 months in those with alarm symptoms. exclusion criteria: 1. have cognitive impairment, psychiatric disorders, or conditions that may affect patient cooperation; 2. have a cardiac pacemaker implantation or other electronically implanted devices; 3. prior tavns treatment; 4. history of colorectal surgery, except for simple appendectomy; 5. severe cardiovascular, hepatic, or renal disease; 6. known malignancy; 7. secondary constipation caused by medications and other diseases; 8. pregnant or lactating women; 9. refusal to sign an informed consent.

Keywords: constipation
evaluation of serial troponin and cardiac multimarkers at the point of care in the emergency department

Conditions: Acute Myocardial Infarction; Chest Pain; Acute Coronary Syndrome

Summary: this is a multi-center study to assess the diagnostic accuracy of the troponin i assay in the biosite triage cardio3 panel at the point-of-care (poc) in adults presenting to the emergency department with possible acute myocardial infarction (ami).


Eligibility criteria:
inclusion criteria: * 18 years of age or older at time of enrollment * presenting to the ed within 6 hours from onset of chest discomfort (pain, pressure, tightness, etc) consistent with a possible diagnosis of ami or acs and with an initial ecg non-diagnostic for injury (or injury equivalent resulting in emergent reperfusion therapy). (note: subjects who have chest discomfort that is episodic or stuttering in nature may be included if the ed presentation is within 6 hours of symptom onset.) * experiencing at least 30 minutes of chest pain or other anginal equivalent symptoms. (note: subjects who have symptoms of shorter duration due to pharmacologic intervention may be included.) exclusion criteria: * patient (or legal representative) unable or unwilling to provide written informed consent. * patient unwilling or unlikely to comply with study procedures, including protocol-specified blood sampling or telephone follow-up at 30 days and 6 months. * vulnerable populations as deemed inappropriate for study by site principal investigator. * st-elevation or other ecg criteria that result that is diagnostic for ami and results in patient being sent for percutaneous coronary interventions (pci) or being treated with thrombolytics6. * pulmonary edema requiring cpap, bipap, or mechanical ventilation * tachyarrhythmias (svt, v-tach, rapid atrial fib) * end stage renal disease on hemodialysis * cardiac arrest prior to arrival * implantable defibrillator firing prior to arrival * hemodynamically unstable patients * trauma injury to the chest
single incision versus conventional laparoscopic appendectomy

Conditions: Acute Appendicitis

Summary: this is a randomized prospective study comparing single incision versus conventional laparoscopic appendectomy for management of acute appendicitis.


Eligibility criteria:
inclusion criteria: * acute appendicitis exclusion criteria: * perforation with peritonitis * lower abdominal scar * contraindications to laparoscopy
single-shot tap block vs continuous tap block

Conditions: Postoperative Pain

Summary: the purpose of this study is to determine whether continuous transversus abdominis plane (tap) block is superior to single shot tap for postoperative pain after laparoscopic donor nephrectomy

this study is a randomized, prospective, double blind study comparing single shot versus continuous transversus abdominis plane (tap) block for postoperative analgesia after laparoscopic live donor nephrectomy. good pain control after surgery has been shown to decrease complications. to address the problem of postoperative pain control in donor nephrectomy patients,the study investigators began performing transversus abdominis plane (tap) blocks. the tap block involves injection of local anesthetic between the abdominal muscle planes (internal oblique muscle and transversus abdominis muscle), to block the somatic nerves that supply sensation to the skin, muscles, and parietal peritoneum of the anterior abdominal wall. prior reports of tap blocks have shown that it provides good analgesia for postoperative pain after abdominal surgery. however because the duration of postoperative pain exceeds that of the single shot tap block, the investigators hypothesized that by placing a catheter through which a continuous infusion of local anesthetic could be delivered, investigators could provide analgesia throughout the postoperative period. the study investigators also hypothesized that improved analgesia would decrease the need for opioid pain medications, hence decreasing the side effects associated with opioid use. this study is designed to test our hypothesis that placing a tap catheter is superior to single shot tap, because it provides a longer duration of analgesia and decreases narcotic use.

Eligibility criteria:
inclusion criteria: * healthy subject undergoing laparoscopic live donor nephrectomy * (asa) american society of anesthesiologists class 1 or 2 * age 18 or older, male or female * desires tap block for postoperative pain control exclusion criteria: * any contraindication for tap block - single or continuous * history of substance abuse * any physical, mental or medical conditions which, in the opinion of the investigators, may confound quantifying postoperative pain resulting from surgery. * known allergy or other contraindications to the study medications (ropivacaine, normal saline, hydromorphone, oxycodone and acetaminophen)

Keywords: transversus abdominis plane block
study evaluating the safety and efficacy of megf0444a in combination with carboplatin, paclitaxel and bevacizumab in patients with advanced or recurrent non-squamous non-small cell lung cancer who have not received prior chemotherapy for advanced disease (nile)

Conditions: Non-Squamous Non-Small Cell Lung Cancer

Summary: this is a phase ii, multicenter, randomized, double-blind, placebo-controlled trial designed to evaluate the efficacy and safety of megf0444a combined with paclitaxel + carboplatin + bevacizumab therapy in patients with histologically or cytologically documented inoperable, locally advanced, metastatic (stage iv), or recurrent non-squamous nsclc.


Eligibility criteria:
inclusion criteria: * histologically or cytologically documented inoperable (stage iv) or recurrent non-squamous non-small cell lung cancer (nsclc). diagnoses of non-squamous nsclc that are based on sputum cytology alone are not acceptable. mixed tumors should be categorized according to the predominant cell type. * ecog performance status of 0 or 1 * life expectancy \>12 weeks * measurable disease, as defined by recist 1.1 * adequate hematologic and end organ function exclusion criteria: * prior therapy (including chemotherapy, antibody therapy, tyrosine kinase inhibitors,radiotherapy, immunotherapy, hormonal therapy or investigational therapy) before day 1 of cycle 1 for the treatment of stage iv or recurrent nsclc. patients who received prior adjuvant chemotherapy or radiotherapy for nsclc are not excluded if the time interval from completion of adjuvant therapy until disease progression is \> 12 months. * treatment with any other investigational agent or participation in another clinical trial with therapeutic intent within 28 days prior to enrollment * malignancies other than nsclc within 5 years prior to randomization, except for adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, localized prostate cancer treated surgically with curative intent, ductal carcinoma in situ treated surgically with curative intent * pregnant and lactating women * active infection requiring iv antibiotics bevacizumab-specific exclusions: * histologically or cytologically documented inoperable, locally advanced, mixed non-small cell and small cell tumors or mixed adenosquamous carcinomas with a predominant squamous component * evidence of tumor invading major blood vessels on imaging * evidence of central nervous system (cns) metastases * history of stroke or transient ischemic attacks (tias) within 6 months prior to day 1 * significant vascular disease within 6 months prior to day 1 * major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to day 1