Kornimate/medical-research-clean huggingface dataset:
phase iii clinical trial of npb-01maintenance therapy in patients with multifocal motor neuropathy.

Conditions: Multifocal Motor Neuropathy

Summary: patients diagnosed with multifocal motor neuropathy were confirmed based on the european federation of neurological societies/ peripheral. nerve society guideline. patients who meet all inclusion criteria and do not conflict with the exclusion criteria will receive npb-01 (intravenous immunoglobulin) 400mg/kg/day for five consecutive days. subsequently, patients receive npb-01 1g/kg every 3weeks and evaluate the medical research council（mrc） score and the guy's neurological disability scale（gnds） et al. as a safety endpoint, the safety of npb-01 will be investigated the occurrence of adverse events by one year after the start of the study treatment.


Eligibility criteria:
inclusion criteria: * 1. patients who need high-dose intravenous immunoglobulin（greater than or equal to 1g/kg） therapy. * 2. patients who continued treatment for mmn without addition or increase at 30 days before informed consent. * 3. patients who mrc score increased 1 stage in greater than or equal to 2 muscles and not decreased relative other muscles to before at after in high-dose intravenous immunoglobulin therapy. * 4. patients with greater than or equal to twenty years old at informed consent. exclusion criteria: * 1. patients treated with plasmapheresis at 3 months before informed consent. * 2. patients treated with rituximab or natalizumab at 6 months before informed consent. * 3. patients treated with interferon-beta at 6 months before informed consent. * 4. patients treated with high-dose intravenous immunoglobulin（greater than or equal to 1g/kg） at 8 weeks before informed consent. * 5. patients treated with intravenous immunoglobulin at 3 weeks before informed consent. * 6. patients with history of shock or hypersensitivity for npb-01. * 7. patients with iga deficiency. * 8. patients with malignancy. * 9. patients with impaired liver function. * 10. patients with impaired renal function. * 11. patients with cerebro- or cardiovascular disorders. * 12. patients with high risk of thromboembolism. * 13. patients with hemolytic/hemorrhagic anemia. * 14. patients with decreased cardiac function. * 15. patients with decreased platelet.

Keywords: ivig in multifocal motor neuropathy patients with multifocal motor neuropathy
left atrial appendage occlusion versus new oral anticoagulants for stroke prevention in patients with non-valvular atrial fibrillation

Conditions: Atrial Fibrillation

Summary: we will compare long-term effectiveness and safety in patients with atrial fibrillation treated with left atrial appendage occlusion versus new oral anticoagulants to prevent ischemic stroke from multicenter registry data

atrial fibrillation (af) is associated with a substantial risk of stroke and systemic embolism. vitamin k antagonists are highly effective in preventing stroke in patients with atrial fibrillation and high risk of ischemic stroke. however, their use is limited by a narrow therapeutic range, increased risk of intracranial hemorrhage, the need for continuous monitoring of inr, and drug or food interaction. new oral anticoagulants (noacs), the direct thrombin inhibitor and the factor xa inhibitor, have settled these limitations of warfarin therapy. in four pivotal phase 3 clinical trials and their meta-analysis, noacs have been shown to significantly reduce ischemic stroke, intracranial hemorrhage, and mortality, and had similar major bleeding as for warfarin in patients with non-valvular atrial fibrillation (nvaf). another new treatment strategy for prevention of stroke is left atrial appendage occlusion (laao). left atrial appendage has been considered to be an origin of thrombi more than 90% of cases. the concept that exclusion of laa from the circulation reduces the risk of stroke in patients with nvaf is therefore being tested in clinical studies. laao with watchman device and only aspirin were proved to be non-inferior to warfarin for ischemic stroke prevention or systemic embolism. and, laao reduced significantly cardiac death and hemorrhagic stroke compared to warfarin in a long-term follow up. up to date, there was no study to compare long-term clinical outcomes between laao and noacs, which are two new treatment strategies for stroke prevention in patients with nvaf.

Eligibility criteria:
inclusion criteria: 1. patients with atrial fibrillation, who laao or noac to prevent ischemic stroke or systemic embolism 2. patients with cha2ds2-vasc score \>1 exclusion criteria: 1. patients who failed to successfully implant laao 2. patients who receive new oral anticoagulant less than 6 months without clinical events 3. patients with mitral stenosis more than mild grade 4. patients with prosthetic heart valve

Keywords: anticoagulants atrial appendage stroke
effect of oral enteral nutrition in nasopharyngeal carcinoma survivors with swallowing disorders

Conditions: Dysphagia

Summary: this is a prospective multicenter study with patients with delayed dysphagia after radiotherapy. patients enrolled are randomly divided equally into the observation group and the control group. all patients receive conventional care, and the observation group received intermittent oro-esophageal tube feeding while the control group received nasogastric tube feeding for enteral nutrition support. baseline information (demographics, medical history, etc.), nutritional status at admission and after treatment, depression, dysphagia, and quality of life after treatment as well as adverse events are compared.

palliation to delayed dysphagia after radiotherapy for nasopharyngeal carcinoma continues to be a challenge. this is a prospective multicenter study with patients with delayed dysphagia after radiotherapy. patients enrolled are randomly divided equally into the observation group and the control group. all patients receive conventional care, and the observation group received intermittent oro-esophageal tube feeding while the control group received nasogastric tube feeding for enteral nutrition support. baseline information (demographics, medical history, etc.), nutritional status at admission and after treatment, depression, dysphagia, and quality of life after treatment as well as adverse events are compared.

Eligibility criteria:
inclusion criteria: * age between 30 and 65 years. * with the history of nasopharyngeal carcinoma and radiation therapy. * with dysphagia occurred at least three years after radiotherapy (confirmed by videofluoroscopic swallowing study), in need of and feasible for enteral nutrition support. * conscious and with stable vital signs; * willing to participate and sign the written informed consent form either personally or by a family member. exclusion criteria: * presence of other diseases that might cause dysphagia. * with distant metastasis of tumors, or complicated with severe systemic disorders or malignancies. * concurrent participation in other treatments that could interfere with the trial. * inability to cooperate with treatment due to aphasia, mental health issues, etc. * received tube feeding for enteral nutrition support within the past three years.
a pan-european study on minimally invasive versus open pancreatoduodenectomy in high-volume centers

Conditions: Pancreatic Neoplasms; Pancreas Cyst; Pancreas Cancer

Summary: rationale: minimally-invasive pancreatoduodenectomy (mipd), either laparoscopic or robot-assisted, has been suggested as a valuable alternative to open pancreatoduodenectomy (opd). the generalizability of the current literature is, however, unknown since randomized studies are lacking, and current data are published from few, very high volume centers and selection bias with a lack of case-matched series. international studies are lacking completely. objective: to compare outcomes of mipd versus open pancreatoduodenectomy (opd), in high-volume european pancreas centers (\>10 mipds per year, total \>20 pds per year). methods: a retrospective multicenter propensity-score matched cohort study including all consecutive patients who underwent mipd (or mi total pancreatectomy) between january 2012 and december 2016, for pancreatic head, bile duct, or duodenal cancer or cysts except chronic pancreatitis. predefined electronic case report forms will be disseminated amongst participating centers. participants are responsible for their own data collection. matching of mipd cases (collected from participating centers) to opd controls (extracted from dutch and german national registries) will be based on propensity scores determined by logistic regression including preoperative variables: year of surgery, demographics, bmi, asa, comorbidities, tumor size, tumor etiology (diagnosis), and multivisceral resection. primary outcome is 90-day major morbidity(clavien-dindo ≥ 3a). secondary outcomes are 90-day postoperative events including: pancreatic fistula, length of hospital stay, r0 (microscopically negative) resection margin, malignant lymph node ratio, days to adjuvant therapy and overall survival.


Eligibility criteria:
inclusion criteria: * indication for open or minimally invasive pancreatoduodenectomy * pancreatic head, bile duct, or duodenal cancer or cysts exclusion criteria: * chronic pancreatitis without suspected solid tumor.

Keywords: minimally invasive surgical procedures pancreas surgery pancreatoduodenectomy
efficacy of targeted memory reactivation for enhancing exposure therapy

Conditions: Claustrophobia; Obsessive-Compulsive Disorder; Arachnophobia

Summary: this study evaluates whether a scent applied during exposure therapy and during subsequent sleep will increase the durability of treatment effects for individuals with fear of spiders, contamination, and enclosed spaces.

newly acquired memories encoded during wakefulness are spontaneously re-activated during sleep, resulting in synaptic potentiation and strengthening of the re-activated traces. targeted memory reactivation (tmr) typically involves a period of initial learning in the presence of an olfactory or auditory contextual cue, coupled with later presentation of the cue during sleep to ostensibly facilitate memory reactivation and consolidation. numerous studies have found evidence of improved task performance subsequent to cue-induced neuronal replay, however application of tmr to treatment of naturally acquired, clinically significant fear has been limited. the present study will will provide a rigorous test of tmr's efficacy as an augmentative strategy for exposure therapy. it is hypothesized that participants who sleep in the presence of the same odor that they are exposed to during exposure therapy will exhibit reduced fear at follow up, relative to participants who sleep in the presence of a different odor, or a non-odorous control.

Eligibility criteria:
inclusion criteria: * marked anxiety in at least one fear domain (spiders, contamination, or enclosed spaces), as determined by the presence of both: 1. self-reported peak anxiety of at least 50 on a 100 point scale in response to two behavioral approach tasks 2. self-report measures meeting the following cutoffs for the target fear: * fear of spiders questionnaire ≥ 50 * obsessive-compulsive inventory-revised (washing subscale) ≥ 4 * claustrophobia screener ≥ 2 exclusion criteria: * diagnosed sleep disorder * current sleep medication usage * inability to differentiate two different odors from an indoor scent diffuser * current psychotherapy for fear of spiders, snakes, enclosed spaces, or contamination * current use of air fresheners, scented candles, or other items with odors related to those used in the study

Keywords: targeted memory reactivation memory consolidation exposure therapy sleep
2d-speckle tracking in pediatric renal chronic disease

Conditions: Chronic Renal Disease; Chronic Renal Insufficiency; Congenital Heart Disease

Summary: the speckle- kidney-ped is a multicentre observational controlled trial aiming to evaluate the 2d-speckle tracking in a population of 85 patients aged from 6 to 17 years old with a chronic renal disease and to compare the results to those of 85 age and gender-matched healthy subjects. the secondary objective is to assess the conventional echocardiographic parameters and the level of exercice capacity.

kidney disease and chronic kidney failure are one of the most common causes of chronic childhood disease. they are often complicated by cardiovascular disease, which can, in the long run, affect patients' prognosis. thus, mortality in children undergoing hemodialysis for end-stage kidney failure is related in more than 30% of cases to a cardiovascular complication. an annual cardiac assessment is recommended as part of the follow-up of these patients to assess the cardiac impact of kidney disease (high blood pressure, hyper-uremia, etc.). the use of conventional cardiological assessment parameters does not predict the cardiovascular prognosis of patients because the alteration of these parameters is greatly delayed in the course of the disease. 2d strain or "speckle tracking echocardiography" is a non-invasive ultrasound technique that allows for a more sensitive assessment of myocardial tissue damage and its early impairment has been shown as a factor of poor prognosis in other pediatric chronic pathology (neuromuscular disease, cardiotoxic exposure, etc.) as well as in adult chronic kidney failure. the speckle- kidney-ped trial is a multicentre observationnal controlled study. the main objective of this work is to asses the 2d strain ventricular function in children with kidney failure, to compare it with that of healthy children of 6 to 17 years old, and to correlate it with the cardio-renal severity of the disease in terms of level of kidney failure and aerobic physical fitness. the secondary objective is to assess, in this population, the level of exercice capacity and to compare it to the general population of children of the same age. a total of 180 children are recquired to observe a significant difference of 2,5% of the global strain value with a power of 90% and an alpha risk of 5%. the speckle- kidney-ped trial intends to improve the level of evidence for future guidelines on cardiologic survey and promotion of physical activity in this population

Eligibility criteria:
inclusion criteria: * patient aged 6 to 17 years old * patient with chronic renal disease (\>3 months) * patient with renal insufficiency (glomerular filtration rate \< 80ml/min/1,73m2) exclusion criteria: * patient with associated congenital heart disease * patient with uncontrolled arrythmia

Keywords: speckle-tracking exercice capacity cardiovascular prognosis
safety and tolerability of liraglutide in healthy male volunteers

Conditions: Diabetes; Healthy

Summary: this trial is conducted in europe. the aim of this trial is to assess the safety and tolerability (maximum tolerated dose) after five ascending single doses of nnc 90-1170 (liraglutide).


Eligibility criteria:
inclusion criteria: * male subjects of any ethnic origin * written informed consent obtained. (the subject must give signed informed consent before any trial-related activities. trial-related activities are any procedures that would not have been performed during the normal management of the subject) * good general health based on medical history, physical and laboratory examinations, incl. ecg (electrocardiogram) * body mass index within the range 20-27 kg/m\^2, inclusive exclusion criteria: * any clinically significant abnormal laboratory test results or clinically significant abnormal ecg * history of alcoholism or drug addiction; positive results in the plasma urine screens for illicit drug * alcohol intake within 48 hours of visit * hepatitis b surface antigen (hbsag), hepatitis c antibodies or hiv (human immunodeficiency virus) antibodies * history of significant drug allergy or drug hypersensitivity * smoke 5 cigarettes or more, or the equivalent per day and is unable to refrain from smoking during the 3 days prior to the dosing day and during the confinement period * subjects who drink more than 8 cups of tea/coffee per day
high-amylose barley (hiamba) in the regulation and prevention of type 2 diabetes

Conditions: Type 2 Diabetes

Summary: in a series of double-blinded randomized cross-over acute studies, the investigators want to study the effects of naturally produced high-amylose barley (lean-baking barley®) on the postprandial glucose-metabolism in subjects with and without type 2 diabetes (t2d).

the prevalence of t2d is increasing worldwide, primarily due to obesity, lack of physical activity and unhealthy diet. therefore, it is of great important to evolve dietary products that counteracts this development. barley has shown some beneficial effects on postprandial blood glucose compared with wheat. a lowering of the postprandial glucose level reduces the risk of developing t2d and helps in the regulation of a pre-existing diabetes. however, barley is traditionally not used in bread-making in denmark. the elevation of postprandial glucose also depends on how fast the dietary products are degraded in the gastrointestinal tract. the starch in barley consist of both fastly degraded amylopectin and slowly degraded amylose. slow degradation is expected to lower postprandial glucose. by natural breeding techniques it has been possible for the investigators collaborative partners at the universities of aarhus and copenhagen and plantcarb aps to make an natural organic high-amylose barley (lean-baking barley®). in a series of acute studies the investigators want to study the effects on the glycemic response to bread made with different flours (wheat, regular barley, lean-baking barley® in subjects with t2d. the investigators expect that lean-baking barley® positively affect the postprandial glucose-metabolism more than wheat and regular barley and hereby acutely improves the glycemic regulation for both subjects with and without t2d.

Eligibility criteria:
inclusion criteria for t2d group: * t2d defined by standard danish guidelines. * hba1c between 42-78 mmol/l. * treatment with drugs for hypertension and high cholesterol is allowed if the treatment dose is stable and does not demand changes during the study period. * participants are encouraged to maintain their present psychical activity level and their smoking and alcohol habits. exclusion criteria: * type 1 diabetes * insulin demanding t2d * use of weekly administrated glp-1 antagonist (e.g. ozempic, trulicity or byetta) * use of acarbose * significant cardiovascular, kidney, liver or endocrine comorbidity * significant psychiatric history * treatment with steroids * alcohol or drug abuse * pregnancy or breastfeeding * legally incompetent

Keywords: glycemic index postprandial barley high-amylose
a study to assess the prevention of bone-related events in patients with bone metastases from malignant solid tumors treated with jmt103 compared to zoledronic acid

Conditions: Imaging Examination Shows at Least One Site With Bone Metastases From Soild Tumors

Summary: this is a phase ⅲ, multicenter, randomized, double-blind, study to evaluate the efficacy and safety of jmt103 in patients with bone metastases from malignant solid tumors. the purpose of this study is to determine if jmt103 is non-inferior to zoledronic acid.


Eligibility criteria:
inclusion criteria: 1. age: older than 18 years; 2. breast cancer, prostate cancer, lung cancer and other solid tumors diagnosed by histological or cytological examination (prostate patients should also meet: castration-resistant prostate cancer with serum testosterone \<50 ng/dl or 1.7 nmol/l and serum psa progression after surgery or drug castration treatment); 3. patients with imaging studies showing at least one tumor bone metastasis; 4. with a good organ function; 5. expected survival of at least 6 months. exclusion criteria: 1. previous or ongoing osteomyelitis or osteonecrosis of the jaw; dental or oral surgery; acute dental or jaw disease requiring oral surgery; invasive dental procedures planned during the study; patients with pulpitis during the screening period; 2. radiotherapy or surgery for the bone metastases is planned during the study; 3. patients with brain metastasis or meningeal metastasis (patients with neurological symptoms should undergo mri/ct examination to exclude patients with brain metastasis); 4. patients with bone metabolic diseases \[e.g., paget's disease, cushing's syndrome, hyperprolactinemia, hyperthyroidism/hypothyroid (except for hypothyroidism with normal tsh, ft3, and ft4 after stable thyroid hormone replacement therapy, and subclinical hypothyroidism that does not need to be treated), hyper/hypoparathyroidism, etc.\]; 5. uncontrolled concurrent diseases, including but not limited to: uncontrolled diabetes mellitus (≥grade 3, nci-ctcae 5.0), symptomatic congestive heart failure, hypertension (bp\> 150/90 mmhg after standard therapy), unstable angina, arrhythmia requiring medical or instrumental treatment, history of myocardial infarction within 6 months, echocardiography with left ventricular ejection fraction \<50%; 6. treatment with anti-rankl antibody, bisphosphonates (except for bone scan purposes) within 6 months prior to the first dose; 7. patients considered by the investigator as unsuitable for this study (such as poor compliance, etc.).
glutamine effects in burn patients

Conditions: Drug Effect

Summary: the study is designed to evaluate the effect of parenteral glutamine supplementation on infection in burn patients.

despite improvements in prevention and management, burn injury continues to represent a major threat to the health and welfare of people worldwide in all age groups. even with early surgical intervention and aggressive antibiotic therapy, infectious complications are a major cause of death in severe burn injury, accounting for 75% of all deaths occurring after initial resuscitation. it is proposed that one source of these infections is a translocation of gram-negative bacteria from the gut. however, this mechanism of bacterial translocation through the gut wall remains a controversial mechanism of infection in humans. in animal studies, it has been demonstrated that glutamine supplementation can decrease gut-derived bacterial translocation and improve outcomes from burn injury. whether this holds true in humans has to be evaluated by additional studies. a recent study concluded that glutamine supplementation reduces gram-negative bacteremia in burned patients but viewed itself as preliminary and suggested that more clinical trials are warranted to corroborate the study outcome.

Eligibility criteria:
inclusion criteria: * age between 18-50 years. * total burn surface area of 20% - 60%. * expected length of stay in icu \> 48 hr. * admission within 72 hrs of burn injury. * any thermal injury such as flame burns. scald burns and contact burns. exclusion criteria: * burn patients with hepatic failure. * burn patient with severe renal failure (glomerular filtration rate (egfr \<50 ml/min). * patients with inborn errors of amino-acid metabolism (e.g., phenylketonuria). * burn patients with pre-existing severe cardiac, pulmonary diseases. * burn patients with diabetes mellitus or cancer. * patients with metabolic acidosis (ph\<7.35). * electric burns.