Kornimate/medical-research-clean huggingface dataset:
a study to learn more about the safety of damoctocog-alfa-pegol when used in routine medical care in korean participants with hemophilia a

Conditions: Hemophilia A; Prophylaxis of Bleeding; Treatment of Bleeding

Summary: in this study, researchers will observe and study the data from participants with hemophilia a who receive damoctocog alfa pegol as prescribed by their doctors. participants will not receive any advice or changes to their healthcare during the study. hemophilia a is a genetic bleeding disorder. it is caused by the lack of a protein called clotting factor 8 (fviii) that helps blood to clot properly. lack of fviii can result in excessive blood loss or bleeding inside the body after being injured or having surgery. the study drug, damoctocog alfa pegol, can be used to prevent or treat bleeding episodes by replacing missing fviii in the body of people with hemophilia a. it is already approved for people with hemophilia a who are at least 12 years old and have previously used other hemophilia a treatments. through this study, researchers want to learn more about its safety in a real-world setting. the participants will receive damoctocog alfa pegol as prescribed by their doctors during routine practice according to the approved product information. the main purpose of this study is to learn more about how safe damoctocog alfa pegol is in korean participants with hemophilia a who previously used other hemophilia a treatments. to do this, researchers will collect information about any medical problems participants have during their treatment. data will be collected from december 2023 to march 2026 and cover a period of about 8 months for each participant. data will come from participants' health records and information collected during their routine clinic visits. in this study, only available data from routine care will be collected. no visits or tests are required as part of this study.


Eligibility criteria:
inclusion criteria: * ≥12 years of age with hemophilia a * previously treated with fviii concentrate(s) (plasma derived or recombinant) * patients who have been treated with jivi (damoctocog alfa pegol) and those for whom the decision to initiate treatment with jivi was made as per physician's routine treatment practice with any kind of treatment modality (on-demand, prophylaxis, etc.) * written informed consent from subject or legal representative; assent from subject when appropriate exclusion criteria: * contraindication according to the local authorized indication (including known hypersensitivity to the drug substance or any of its components (e.g., mouse or hamster protein)) * patients participating in an investigational program with interventions outside of routine clinical practice * patients with any other diagnosis of bleeding/coagulation disorder other than hemophilia a * patients on immune tolerance induction treatment at the time of enrollment
evaluation of persistence of anti-meningococcal bactericidal antibodies among adolescents who previously received menacwy conjugate vaccine

Conditions: Meningococcal Meningitis

Summary: the primary objective is to evaluate the persistence of bactericidal antibodies in adolescents previously enrolled in the v59p13 study who received either novartis menacwy conjugate vaccine or commercially available menacwy conjugate vaccine. the study will also enroll age-matched subjects who have never received any other meningococcal vaccine (naïve subjects) to serve as an additional control group.


Eligibility criteria:
inclusion criteria: subjects enrolled in v59p13: * healthy subjects who have completed the v59p13 study. naïve subjects: * healthy subjects aged-matched with subjects who had completed the v59p13 trial.(currently 16-23 years old). exclusion criteria: subjects who had completed the v59p13 study: * who received any meningococcal vaccine after the v59p13 trial; * who have had previous confirmed or suspected disease caused by n. meningitidis; * who have had household contact with and/or intimate exposure to an individual with culture-proven n. meningitidis (serogroups a, c, w135, or y); * subjects with any serious, acute or chronic progressive disease. naïve subjects: * who previously received any meningococcal vaccine; * who have had previous confirmed or suspected disease caused by n. meningitidis; * who have had household contact with and/or intimate exposure to an individual with culture-proven n. meningitidis (serogroups a, c, w135, or y); * subjects with any serious, acute or chronic progressive disease.

Keywords: meningococcal acwy conjugate vaccine meningitis adolescents persistence
a cohort study of conversion from aranesp® to nesp® for the treatment of anemia in dialysis patients

Conditions: Anemia; End Stage Renal Failure on Dialysis

Summary: this is a prospective single-arm open-labeled cohort study on dialysis patients of the conversion from aranesp® to nesp® for the treatment of anemia. the primary outcome of the study is the haemoglobin level after conversion to nesp® after 6 months. secondary outcomes include the variability in haemoglobin level, average weekly dose of erythropoietin, safety profile of nesp®, patients' subjective assessment of fatigue and injection pain after the conversion.

currently in hong kong, aranesp®, manufactured by amgen® is the only available darbepoetin alpha licensed. nesp®, a darbepoetin alpha agent manufactured by kirin®, will be replacing aranesp®.it is important to evaluate the therapeutic equivalence of the two agents, and its efficacy, tolerability and safety profile in the treatment of anemia in dialysis patients. moreover, a new maximum preparation of nesp 120® microgram will be available to replace the aranesp® 100 microgram prefilled syringe at the same cost. this larger darbepoetin alpha preparation may allow extension of dosing intervals. this may subsequently allow cost saving and better convenience to medical staff and patients. the objectives of this project are: 1. to investigate the effectiveness of nesp® in the achieving a stable anemia control in chronic dialysis patients with the same dose conversion from aranesp® 2. to investigate the effectiveness of increasing the dosing interval of nesp® (but maintaining the same total dose) in sustaining a stable anemia control in chronic dialysis patients 3. to explore the possibility of cost saving in administering a larger dose nesp® but at an extended interval patients will be divided into 3 groups. group a. same dose conversion group • patients on stable low dose aranesp® (on 20mcg preparations or on 40mcg every 2 weeks or less) will be converted to the same dose of nesp® group b. attempt extension of dosing interval with higher dose of nesp® preparations • patients on stable dose of aranesp® will be converted to higher dose preparation of nesp® (40 or 120 mcg preparations) with extended dosing intervals. group c. attempt dosage saving with 120 mcg preparation • patients on aranesp® 100mcg will be switched to the nesp® 120mcg preparation with slight increase in dosing interval

Eligibility criteria:
inclusion criteria: * adult chinese patients (age greater than or equal to 18) * on long-term dialysis for at least 3 months * on aranesp® treatment for at least 3 months * stable hemoglobin level within the range of 9 to12 g/dl, on the same stable dose of aranesp® within the past 2 months. * minimum weekly kt/v of 1.7 for peritoneal dialysis patients and 1.2 per haemodialysis session for haemodialysis patients * able to give informed consent exclusion criteria: presence of * thalassaemia * haematological diseases * severe hyperparathyroidism (pth \>90 pmol/l) * iron, vitamin b12 or folate deficiency * uncontrolled malignancy * active blood loss or hemolysis
laparoscopic appendectomy performed by junior surgeons: impact of 3d visualization on surgical outcome

Conditions: Appendicolith; Appendicitis; Appendicitis With Perforation; Appendicitis Peritonitis; Appendiceal Abscess; Appendicitis Acute

Summary: laparoscopy has revolutionized the approach to a number of surgical problems causing a re-evaluation of several clinical strategies. now it has become the standard treatment for majority of ailments including symptomatic gall stone disease, appendicitis, gerd (gastroesophageal reflux disease), morbid obesity and colorectal disease. all these developments aim at minimizing perioperative morbidities, providing rapid postoperative recovery and enhancing patient's safety profile. one of the major limitations of conventional laparoscopy is lack of depth perception. introduction of 3d imaging, has removed many of these technical obstacles. in 1993, becker et al., reported that a 3d display might improve laparoscopic skills. since then, many researchers have demonstrated benefit of 3d imaging . starting from this, we can theorize an impact of 3d technologies on surgeon's learning curves. this concern is recently being demonstrated in experimental and clinical setting with improvement of hand-eye coordination, better laparoscopic skills and less time to learn surgical procedure. usually junior surgeons (js) start their activities with cholecystectomy and appendectomy but, despite an amount of literature regarding the first procedure, there is a 'black hole' regarding the use of 3d imaging in laparoscopic appendectomy (la). the investigators decided to investigate the impact of 3d visualization on surgeons' and surgical outcome during laparoscopic appendectomy (la) performed by junior surgeons (js). operative details and clinical aspect are both take in account in order to looking for any advantages or concerns conferred on js in performing la.


Eligibility criteria:
inclusion criteria: * all adult patients scheduled to undergo laparoscopic appendectomy. ages eligible for study: \>18 sexes eligible for study: all exclusion criteria: * patients who decline to join the study * patients under 18 years old * patients with contraindication to undergo laparoscopic surgery. * patients without appendicular disease found at laparoscopy (such as complicated inflammatory bowel disease, tumor, complicated diverticula, gynecological disorder) * patients undergoing open appendectomy

Keywords: 3d laparoscopy
effect of phosphate binders on markers of vascular health in chronic kidney disease stages 3 and 4

Conditions: Chronic Kidney Disease

Summary: chronic kidney disease (ckd) patients often have high levels of a substance called fibroblast growth factor-23 (fgf-23), a phosphorus excreting hormone, which has been related to heart disease. as kidney function declines, less phosphorus is removed by the kidneys and as a result phosphorus accumulates in the blood. in response to elevated phosphorus levels, more fgf-23 is released to help facilitate the excretion of extra phosphorus into the urine. in addition to effects on fgf-23, increased phosphorus levels can lead to calcification (hardening) of the blood vessels in the ckd population. phosphate binding medicines are used in ckd patients to lower the amount of phosphorus absorbed by the stomach and intestines after eating meals and snacks. in patients with ckd, studies have shown that phosphate binders can lower fgf-23 levels in the blood. lowering fgf-23 levels in ckd patients may also lower substances in the blood that cause calcification of blood vessels in the ckd population. this study is being done to determine if using phosphate binders, either sevelamer carbonate or calcium acetate, in the earlier stages kidney disease (before dialysis) can decrease fgf-23 and biomarkers (substances in the blood) associated with hardening of the blood vessels and heart disease.


Eligibility criteria:
inclusion criteria: * males or females ≥ 18 years of age at start of screening * ckd stage 3 or 4 defined by an egfr 15 - 60 ml/min/1.73m2 * not expected to start dialysis for 8 months * serum intact pth \< 500 pg/ml during screening period * on a stable ace inhibitor/arb regimen for 30 days prior to screening exclusion criteria: * history of any of the following diseases: congestive heart failure, mi within the last 6 months, cerebrovascular accident, significant valvular disease, malignancy * currently receiving erythropoiesis stimulating agent or iv iron therapy * history of inflammatory/autoimmune disease * history of polycystic kidney disease * hiv positive or aids * pregnant or breastfeeding * receiving activated vitamin d analogs, nutritional vitamin d agents \> 2,000 iu/day, or calcimimetics with in the last 3 months * significant gi disorder * proteinuria \>3.5 g/24 hours

Keywords: chronic kidney disease phosphate binder sevelamer carbonate calcium acetate vascular calcification endothelial dysfunction
effects of functional electrical stimulation and inspiratory muscle training in heart failure patients

Conditions: Heart Failure

Summary: the purpose of this study is to assess the effects of functional electrical stimulation associated with inspiratory muscle training on functional capacity and quality of life in heart failure patients.

the aim of this study is to assess the effects of the functional electrical stimulation (fes) associated with inspiratory muscle training (imt) on functional capacity and quality of life in patients with heart failure (hf). a randomized clinical trial with 60 hf patients (functional class ii-iv) will be randomly assigned to the fes, imt, imt associated with fes or control group. fes will be applied at 15 hz, 0.4 ms pulse width, 10-s contraction time, 50-s resting time and maximum tolerable intensity, 3 sessions per week, for 12 weeks. the imt will also be performed for 12 weeks, 5 sessions per week, with an intensity of 30% of maximal inspiratory pressure. acute and chronic effects of interventions on functional capacity, quality of life, peripheral muscle strength, pulmonary function, respiratory muscle strength and endurance, endothelial function, autonomic control and oxidative stress will be analyzed in these patients.

Eligibility criteria:
inclusion criteria: * patients with stable heart failure and new york heart association (nyha) class ii-iv * aged 30-70 years * left ventricular ejection fraction less than 35% determined by echocardiography and optimized pharmacological treatment (unchanged 1 month prior to study) exclusion criteria: * patients with unstable heart failure * nyha class i * unstable angina pectoris and ventricular arrhythmia * implanted cardiac pacemaker * acute pulmonary diseases * chronic renal failure or dialysis * acute myocardial infarction 3 months before the inclusion in the study * acute inflammatory diseases * peripheral vascular disease * neurologic disease * musculoskeletal pathologies * malignancies or being an active smoker

Keywords: heart failure electric stimulation breathing exercises
cpsta system cadlad study

Conditions: Coronary Artery Disease

Summary: this study is primarily designed to collect resting phase signals from eligible subjects using the phase signal recorder (psr) prior to coronary angiography to machine learn and test an algorithm for detecting the presence of significant coronary artery disease in symptomatic adult patient.

this clinical protocol is primarily designed to collect resting phase signals from eligible subjects using the phase signal recorder (psr) prior to coronary angiography to machine learn and test an algorithm for detecting the presence of significant coronary artery disease in symptomatic adult patient. in addition to this primary objective, machine-learned algorithms will be developed and tested to report the left ventricular ejection fraction and to identify the location of significant coronary artery disease. the performance of the machine-learned algorithm will be evaluated using a comparative paired trial design. in this study, the physician will not be provided the results of analysis performed and, accordingly, the results of the analyses will not be used to guide treatment decisions for the patient.

Eligibility criteria:
inclusion criteria: 1. age ≥21 years of age at the time of screening 2. meets criteria for coronary angiography 3. scheduled to undergo cardiac catheterization with coronary angiography 4. ability to understand the requirements of the study and to provide written informed consent exclusion criteria: 1. prior documented myocardial infarction (mi) 2. prior coronary artery bypass grafting (cabg) or previous coronary interventions (pci) 3. indication for invasive coronary angiography other than to assess for obstructive cad (e.g., arrhythmia, cardiomyopathy, valvular abnormality) 4. previous heart valve replacement 5. previous sustained or paroxysmal atrial or ventricular arrhythmia 6. infiltrative myocardial disease (amyloid, sarcoid, right ventricular dysplasia) 7. presence of cardiac implantable electronic device (cied), including implantable cardioverter defibrillator (icd), pacemaker (pm), implantable loop recorders and other monitors 8. implantable neuro-stimulators 9. congenital heart disease 10. pregnancy (breast feeding) 11. currently taking any type ia, ic or iii antiarrhythmic 12. any history of amiodarone therapy 13. clinically significant chest deformity (e.g., pectus excavatum or pectus carnitatum) 14. breast implants 15. neuromuscular disease if the condition results in tremor or muscle fasciculations

Keywords: coronary angiography ventricular ejection fraction coronary artery disease
guided internet-delivered acceptance and commitment therapy for chronic pain patients

Conditions: Chronic Pain

Summary: the aim of this study was to investigate if guided internet-delivered acceptance and commitment therapy (act)would help chronic pain patients.

the present study investigates internet-delivered act for persons with chronic pain. the use of internet as a delivery format for interventions could be a way of overcome many barriers (financial obstacles, reluctance to seek treatment and paucity of clinicians trained in act) that hinder persons with chronic pain to seek or receive adequate help. persons were randomized to either treatment for 7 weeks or to a control group who were invited to participate in a moderated online discussion forum. follow up data was collected six months after the treatment.

Eligibility criteria:
inclusion criteria: * that participants had undergone medical investigation (within one year) * had regular access to the internet * had functional impairment caused by chronic pain * had internet access exclusion criteria: * ongoing medical investigations or treatment that could interfere with participation in the study, such as planned surgery and suffering from acute physical or psychological conditions * not fluent in the swedish language

Keywords: internetdelivered cbt chronic pain acceptance and commitment therapy mindfulness guided self help
diagnosis of epithelial ovarian cancer using ovarian cancer score (ocs) test

Conditions: Epithelial Ovarian Cancer; Adnexal Mass

Summary: the study is designed to confirm the performance of the 3d medicines corporation ocs test in diagnosis of epithelial ovarian cancer in patients with adnexal mass. to this end, blood samples from female patients with adnexal mass required surgical resection from four centers are obtained and analysis in the study.


Eligibility criteria:
inclusion criteria: * a) ≥ 18 years of age; * b) patients with adnexal masses; * c) sign the informed consent form; * d) adnexal mass that requires excision; exclusion criteria: * a) history of chemoradiotherapy; * b) history of malignancy; * c) pregnancy; * d) adnexal mass not require surgical excision; * e) the adnexal mass has been diagnosed as malignant before surgery, and the number of cases enrolled in a single institution exceeds 50; * f) blood ca125 value greater than 1000 u/ml at initial treatment.

Keywords: early diagnosis ovarian cancer ocs test
the impact of oral nutritional supplements on the nutritional status of elderly patients

Conditions: Nutrition Disorders in Old Age; Nutritional Supplement Toxicity; Elderly Infection

Summary: the study compares nutritional status of two groups elderly patient aged 65 and more. one group of the patients received nutritional support (nutridrink multi fibre) for 14 days. nutritional status of the patients were compared 2 months after the start of the intervention.

the aim of the study was to compare nutritional status of two groups of elderly patients (\> 65 years old). total of 120 patients were randomly assigned into two groups. one group received normal diet whereas the second group received 300 kcal nutritional support (nutridrink multi fibre 2x100 ml) between meals for 14 days. two months after start of the intervention following examinations were performed: * functional status of the patient (barthel's scale, mmse scale) * nutritional status based on: weight, height, bmi; mini nutritional assessment, plasma concentration of prealbumin, albumin, transferrin, total lymphocyte count. the clinical status of the patient was evaluated based on clinical data on different organ infections. in addition costs of supplementary nutrition were taken into consideration.

Eligibility criteria:
inclusion criteria: * age \> 65 and general status which enables compliance with study requirements * barthel's scale (barthel scale = barthel adl index - an ordinal scale used to measure performance in activities of daily living) points 21-100 * mmse (mini mental state examination) points 24-30 * no use of laxatives exclusion criteria: * lack of consent * neoplasms * previous enteral nutrition * barthel's scale 0-20 * mmse points 0-23 * bmi \> 25 * laxatives

Keywords: nutritional status nutridrink elderly nutrition
bifeprunox extension to extension study in patients with schizophrenia

Conditions: Schizophrenia

Summary: the purpose of this study is to provide access to bifeprunox for patients, who have completed previous studies with bifeprunox, and require continued treatment with bifeprunox, other treatment not being adequate. a further purpose is to investigate the safety and side-effects of bifeprunox during long-term treatment.

this is a non-controlled, open-label, flexible-dose, international multi-centre extension study. the patient population consists of male and female patients with schizophrenia, who have completed open-label bifeprunox studies 10206 or 10265, and require continued treatment with bifeprunox, other treatments not being feasible as judged by the investigator.

Eligibility criteria:
inclusion criteria: * patients, suffering from schizophrenia, having completed studies 10206 or 10265 * otherwise healthy * female patients of non-childbearing potential, or non-pregnant, not breast-feeding women using adequate contraception * the patient must be in need of treatment with bifeprunox (that is, the switch to another compound is not feasible) exclusion criteria: * current axis i primary psychiatric diagnosis other than schizophrenia * significant risk of suicide and/or violent behaviour * other psychiatric, neurological or behavioural disorders that may interfere with study conduct * substance or alcohol abuse, current cannabis dependence * clinically significant physical illness

Keywords: open-label flexible-dose extension safety study