Kornimate/medical-research-clean huggingface dataset:
camrelizumab and chemotherapy combined with endoscopic surgery for recurrent nasopharyngeal carcinoma

Conditions: Recurrent Nasopharyngeal Carcinoma

Summary: to explore the effect of camrelizumab and chemotherapy combining with endoscopic surgery in the treatment of recurrent nasopharyngeal carcinoma.


Eligibility criteria:
inclusion criteria: * pathologically confirmed recurrent nasopharyngeal carcinoma * american joint committee on cancer recurrent rt2(recurrent t2)(including deep parapharyngeal space), recurrent t3, recurrent t4 which can be surgically removed * age ≥18 years old * informed consent signed * with or without lymph node metastasis, which can be surgically removed * no massive hemorrhage risk recently * no distant metastasis * ≥6 months from initial radiotherapy to recurrence * radical radiation only once * sufficient organ function * eastern cooperative oncology group score 0-2 exclusion criteria: * with a history of allergic to platinum drugs and similar compounds * evidence of distant metastasis or radiation encephalopathy or leptomeningeal disease (lmd) * have received radioactive seed implantation in the treatment area * suffer from uncontrolled disease which could interfere with treatment * suffered from another malignant tumor or multiple primary tumors at the same time within 5 years (excluding fully treated basal cell or squamous cell skin cancer, cervical cancer in situ, etc.) * the patient has surgical contraindications: such as severe cardiopulmonary disease, coagulation dysfunction and so on * the patients have autoimmune diseases * the patient is using immunosuppressive agents or systemic glucocorticoid to achieve the purpose of immunosuppression (dose\>10mg/day prednisone or other), and continues to use it within 2 weeks before the first administration * severe allergic reaction to other monoclonal antibodies * previously received pd-1 monoclonal antibody, ctla-4 monoclonal antibody (or any other antibody that acts on t cell co-stimulation or checkpoint pathway) treatment * live vaccines have been inoculated within 4 weeks before the first administration or during the study period * the patient has any situation that may hinder study compliance or the safety during the study period * existence of serious neurological or psychiatric diseases, such as dementia and seizures * uncontrolled active infection * pregnant or breastfeeding women * those who have no personal freedom and independent capacity for civil conduct * there are other situations that are not suitable for entry into the study

Keywords: endoscopic surgery inductive chemotherapy
a clinical trail of demethylation drug combined with chemotherapy in intermediate-risk aml

Conditions: Leukemia, Myeloid

Summary: it is often impossible to find therapeutic target in intermediate-risk aml, so it is very important to select appropriate chemotherapy protocol to eliminate minimal residual disease (mrd) in these aml patients. recent studies demonstrated that leukemia microenvironment is the shelter nich for leukemia stem cells and the essential reason for impossibly eliminating mrd. demethylation drug not only prove the effect of chemotherapy, but also change leukemia microenvironment through epigenetics modification. both of them will result in eliminating mrd in patients with aml. the investigators designed a multicenter randomized control clinical trail to evaluate the effect of demethylation drug combined with chemotherapy in aml patients with intermediate-risk factors after hematological complete remission. efficacy will be evaluated through mrd detected by flow cytometry every 1 month. continuous negative mrd indicates a good prognosis. the patients with continuous negative mrd can select auto-hsct or consolidation chemotherapy, those with continuous positive mrd should be considered as candidates of allo-hsct. overall survival and relapse free survival will be recorded after follow-up every 3 months. it will provide a basis for precision therapy and a new way for designing a novel protocol for intermediate-risk aml. this clinical trail will benefit to the aml patients with intermediate-risk factors.


Eligibility criteria:
inclusion criteria: * aml patients with normal heart, lung, liver and renal function, or without serious infection. ecog score is below 2 exclusion criteria: * aml patients with abnormal heart, lung, liver and renal function, or with serious infection. ecog score is over 2

Keywords: acute myeloid leukemia intermediate-risk demethylation drug complete remission
long-term physical training in chronic obstructive pulmonary disease

Conditions: Pulmonary Disease, Chronic Obstructive

Summary: several impairing factors contribute to physical limitation in chronic obstructive pulmonary disease (copd) as deconditioning, muscle dysfunction and physical inactivity. the available literature clearly indicates that these therapeutic targets benefit from exercise training in patients with copd and, currently, the key point is not whether patients should or not exercise, but which is the specific contribution of each exercise modality to this population. about this topic, the characteristics of a physical training program to be offered to patients have been a point discussed among researchers in this field, although recently the high-intensity training has been recognized as superior in comparison to the low-intensity training. literature also indicates that, in order to change the sedentary lifestyle of patients with copd, long-term training programs are indicated. however, a doubt still remains: if long-term programs are one of the key points to reduce physical inactivity, it is not yet clear whether it is necessary to include high-intensity exercises in that long-term program. if the duration is the only factor influencing the outcomes of the program, thus the intensity of training could be reduced, increasing the adherence of patients to the protocol. based on this hypothesis, the aim of this study is to compare the effects of two physical training protocols in a long-term rehabilitation program (6 months) in patients with copd: a high-intensity protocol (based on endurance and resistive training) and a low-intensity protocol (based on callisthenic and breathing exercises training). it is expected that the results of this study contribute to the scientific literature by demonstrating whether low- and high-intensity training contribute equally to change the sedentary lifestyle of patients after a long-term exercise program.


Eligibility criteria:
inclusion criteria: * chronic obstructive pulmonary disease (copd) diagnosis according to global initiative for chronic obstructive lung disease(gold)criteria * clinical stability (i.e. absence of acute exacerbation in the last 3 months) * absence of any unstable/severe cardiac,osteoarticular or neuromuscular disorders which could limit physical activities in daily life * non participation in pulmonary rehabilitation in the last year exclusion criteria: * being unable to attend the outpatient clinic three times per week * inability to understand or cooperate with the assessment methods

Keywords: motor activity exercise rehabilitation
clinical study to determine safety and effectiveness of keepasleep device in simple snorers.

Conditions: Snoring; Sleep Apnea Syndromes

Summary: study to demonstrate the safety and effectiveness of a new oral enhanced airway device to treat simple snoring.

the keepasleep airway device is a novel and unique buccopharyngeal airway device to enhance breathing during sleep. this method has not been described in the medical literature and has been successful in limited testing. this clinical trial is to determine the safety and effectiveness of the keepasleep device utilizing 30 subjects with simple snoring. each subject will serve as his/her own control. the device augments airflow into the posterior pharynx to minimize airway collapse,tissue vibration, and consequent snoring.the device passes through the retromaxillary space and requires that the subject be absent their wisdom teeth.

Eligibility criteria:
inclusion criteria:- 18 yrs. of age or greater * generally good health * intact dentition / absent upper and lower wisdom teeth ( by extraction or lack of development ) * simple snoring( documented by observer) or mild sleep apnea rdi \< 15 ( documented by polysomnogram) * subject must have a concerned observer to assess of sleep and snoring behavior during trial period exclusion criteria:- presence of wisdom teeth (third molars) * active oral disease * acute illness * bmi (body mass index) \> 30
early nutrition and neurological development of very preterm infants

Conditions: Infant, Premature, Diseases; Infant Nutrition Disorders; Development; Delayed, Mental

Summary: the main goal of this study is to determine the association between: * the quantity of mother's milk and duration of breastfeeding * the intake of polyunsaturated fatty acids and iron during hospitalization and the development of preterm infants born with a ga \< 32 weeks.


Eligibility criteria:
inclusion criteria: * infants with a gestational age \< 32 weeks already included in the epipage2 study * agreement of parents exclusion criteria: * death during hospitalisation

Keywords: pufa iron neurological development premature infant
pk study of pregabalin glars tablet 150mg and ir formulation after multiple dosing under fed condition in healthy male subjects

Conditions: Healthy

Summary: the purpose of this clinical trial is to compare the pharmacokinetic characteristics of gla5pr glars tablet 150mg and lyrica capsule 75mg. gla5pr glars tablet 150mg is a new formulation which is made by gl pharm tech. glars(geometrically long absorption regulated system) is new solution to sustained absorption by extending the absorption site. to overcome the shortcomings of the currently existing sustained release drug delivery technologies the investigators have recently developed a novel drug delivery system to enable a drug to be dissolved irrespective of the surrounding environment and further absorbed up to colon. the investigators coined this "geometrically long absorption regulated system(glars)".

basically, this system is a triple-layered tablet, comprised of upper and lower layers that swell and draw a sufficient amount of water, plus a highly water - soluble middle layer that rapidly draw water into the tablet core simultaneously. the water drawn into the tablet (about 3 to 4 times the weight of the tablet itself) functions as an additional media which enables additional and later drug release out of the dosage form. this serves to overcome the shortage of surrounding media that has been reported to be one of the key reasons for mal-absorption of a drug in colon. as the middle layer induces a rapid water draw into the tablet core, the penetrated water also diffuses to the upper and lower layers, which makes the tablet to rapidly swell and controls drug release. at virtually the same time, the swollen upper and lower layers form to surround a lateral side of the middle layer, which can, in turn, further control drug release. this relatively rigid swollen matrix structure makes drug release not affected by surrounding mechanical flux, which can provide relatively consistent in vivo drug release irrespective of degree of gastrointestinal motility.

Eligibility criteria:
inclusion criteria: * 20\~45 years old, healthy adult male subject * ≥ 50kg(body weight) and ideal body weight ≤ ±20% exclusion criteria: * alt or ast \> 1.25(upper normal range) * total bilirubin \> 1.5 (upper normal range)

Keywords: pregabalin, glars
effects of l-carnitine on gastric emptying in children with drug resistant epilepsy on ketogenic diet

Conditions: Ketogenic Diet

Summary: this study was conducted on thirty children aged from12 months to 18 years newly diagnosed with drug resistant epilepsy and following up at pediatric nutrition and neurology outpatient clinics assigned randomly into 2 groups, group1: patients who started ketogenic diet with l-carnitine and group2: patients who started ketogenic diet only.


Eligibility criteria:
inclusion criteria: * all infants and children aged from 12 months to 18 years old newly diagnosed with drug resistant epilepsy and were assigned to start kd. exclusion criteria: * patients with intolerance or non-compliance to ketogenic diet therapy. * patients for epilepsy surgery or vagal nerve stimulation. * children with history of previous abdominal operations. * children with history of gi diseases affecting gi motility before starting kd. * children with tube feeding or feeding gastrostomy or jejunostomy.
a clinical study that will measure how well sep-363856 works and how safe it is in adults with generalized anxiety disorder

Conditions: Generalized Anxiety Disorder

Summary: a clinical study that will meaure how well sep-363856 works and how safe it is in adults with generalized anixety disorder. this study will be accepting both male and female subjects between the ages of 18 years and 65 years old. the study will be held in approximately 50 global study centers and approximately 15 additional centers for a separate japan population. participation in the study can be up to approximately 12 weeks.

this is a multicenter, randomized, double-blind, parallel-group, flexible dose, outpatient study evaluating the efficacy and safety of sep-363856 flexibly dosed (50 - 75 mg/day) versus placebo over an 8-week treatment period in subjects with gad. this study is projected to randomize approximately 434 subjects to 2 treatment groups (sep-363856 \[50 - 75 mg/day\] or placebo) in a 1:1 ratio. approximately 30 additional subjects (n = 15 per treatment group) are projected to enroll in the japan cohort. treatment assignment will be stratified by country. study drug will be taken at approximately the same time each evening at bedtime .

Eligibility criteria:
inclusion criteria: (list is not all inclusive) * male or female subject between 18 to 65 years of age. * subject meets dsm-5 criteria for a diagnosis of generalized anxiety disorder. * subject must be willing and able to comply with the study procedures and visit schedule and must be able to understand and follow verbal and written instructions. exclusion criteria: (list is not all inclusive) * subject has dsm-5-based diagnosis of any disorder other than generalized anxiety disorder that was the primary focus of treatment within 12 months before screening. * subjects who report an inadequate response to more than 3 antidepressant treatments * subject is at significant risk of harming self or others based on investigator's judgment. * subject has any clinically significant unstable medical condition or any clinically significant chronic disease that in the opinion of the investigator, would limit the subject's ability to complete and/or participate in the study. * female subject who is pregnant, lactating, or plans to get pregnant during the study.

Keywords: generalized anxiety disorder
two-dimensional shear-wave elastography evaluate esophageal varices bleeding risk of liver cirrhosis

Conditions: Liver Cirrhosis; Esophageal Varices; Liver Stiffness

Summary: the purpose of this retrospective study was to investigate the diagnostic performance of 2d-swe for predicting the presence of esophageal varices and high-risk varices in patients with liver cirrhosis.

variceal bleeding is a fatal complication in patients with liver cirrhosis. a screening esophagogastroduodenoscopy (egd) is recommended in all patients with cirrhosis to identify those patients at risk of variceal bleeding. however, this technique is invasive, uncomfortable and costly. moreover, with the development of noninvasive technology for early diagnosis of liver cirrhosis, half of these patients will not develop varices within 10 years and therefore will undergo unnecessary egd screening. thus, the need for noninvasive screening methods for varices in patients with cirrhosis is urgent. 2d-swe is a promising new type of shear wave-based ultrasound technique for measuring ls. the shear waves are generated directly within the tissue by acoustic radiation force impulse, allowing the measurement of stiffness in patients with ascites. in addition, the ls values can be obtained on the basis of anatomic information to avoid major vessels and control major measurement bias. 2d-swe has been reported to have high reliability and reproducibility in assessing liver stiffness. several studies compared te with 2d-swe in predicting fibrosis stages and portal hypertension, which suggested that 2d-swe has a higher technical success rate and a better diagnostic value for portal hypertension than te.the purpose of this retrospective study was to investigate the diagnostic performance of 2d-swe for predicting the presence of esophageal varices and high-risk varices in patients with liver cirrhosis.

Eligibility criteria:
inclusion criteria: * cirrhosis were diagnosed by liver biopsy, ct and ultrasound before enrolled * age was 16-80 exclusion criteria: * with bleeding history * with evl history, brto or tips history * with nsbb history * with ascites * with splenectomy or splenic embolism, history * with liver cancer

Keywords: liver cirrhosis esophageal varices liver stiffness spleen stiffness
the effect of hyperoxia on ventilation during recovery from general anesthesia

Conditions: Ventilatory Depression; Postoperative Respiratory Failure

Summary: in this randomized-controlled trial the investigators will examine the effect of oxygen supplementation on the recovery of breathing for 90 minutes in the immediate post-anesthesia period starting from extubation of the trachea.

in a pilot randomized-controlled trial (nct04723433) the investigators found that hyperoxia, compared with standard o2 supplementation, enhanced ventilation, as estimated by the fraction of time at a transcutaneous pco2 (tcpco2) \> 45 mmhg. more specifically, patients treated with hyperoxia (o2 titrated to: spo2 \> 96%, n=10; liberal o2) for 90 minutes post-anesthesia, spent 61.2% of the time at tcpco2 \> 45 mmhg, compared with 80.6% of the time in those receiving standard o2 supplementation (o2 titrated to: spo2 between 90-94%, n=9; conservative o2 - between-group difference of 19.4% (95% ci: -18.7% to 57.6%), ancova adjusted p = 0.140\]. results were consistent across the 90-min monitoring period. with an observed effect size of 0.73, it was estimated that 30 participants per group are required, to demonstrate this difference with a power of 80% at a two-sided alpha of 5%. in the present confirmative randomized controlled trial, the investigators plan to estimate and compare the cumulative segment of time during which the transcutaneous partial pressure of carbon dioxide will exceed an upper limit of 45 mmhg (i.e., tcpco2 \> 45 mmhg) for the 90-min-long post-anesthesia period, between the conventional (titrated to an oxygen saturation \> 96%) and the conservative (titrated to o2 saturation 90-94%) o2 supplementation interventions. hypothesis: conservative use of o2 (titrated to an spo2: 90 - 94%), will be associated with more hypoventilation (i.e., more time spent with an tcpco2 \> 45 mmhg) during recovery from general anesthesia, compared to liberal o2 supplementation (spo2 \> 96%).

Eligibility criteria:
inclusion criteria: * american society of anesthesiologists (asa) physical status i-iii * body mass index (bmi) less than 40 kg/m2 * scheduled to undergo robotic-assisted radical laparoscopic nephrectomy or prostatectomy. exclusion criteria: * patients with a diagnosis of chronic obstructive pulmonary disorder (copd), severe neurological, cardiopulmonary, psychiatric, or untreated thyroid disorder * chronic pain condition that is being treated with opioids * patients with a hematocrit lower than 30% at the end of surgery, or those with an excessive blood loss, requiring transfusion of blood products during surgery.
a feasibility study of supplemental oxygen to improve pulmonary hypertension in people with intradialytic hypoxemia

Conditions: Pulmonary Hypertension

Summary: the purpose of this study is to assess the feasibility of supplemental oxygen delivery during hemodialysis in people with pulmonary hypertension and intradialytic hypoxemia.


Eligibility criteria:
inclusion criteria: * adults ≥18 years * receiving monday-wednesday-friday or tuesday-thursday-saturday hemodialysis * screened positive for pulmonary hypertension (defined by tricuspid regurgitant velocity \[trv\] \>2.5 m/s on echocardiography) and intradialytic hypoxemia (defined by spending ≥1/3 treatment with o2 saturation \<90%) or hypoxemia for ≥10% of the treatment if associated with a desaturation event (≥4% decline in o2 saturation to \<88% for ≥10 seconds) during enrollment in the ph-eskd study (pro00108710). exclusion criteria: * daily supplemental oxygen use * inability to provide informed consent
evaluation of the effect of combined music on sleep disorder

Conditions: Sleep Disorder

Summary: the results of this study will provide an affordable, safe and scientific treatment for patients with sleep disorders, so that patients can improve their sleep quality at home.

the population suffered from sleep disorders is raising year by year, it has increased much social costs and medical burdens, especially the spread of the covid-19 epidemic has made it even worse recently. although many studies in the past few years have found that the use of non-invasive music therapy (such as five-element music, music combined with binaural beats) can effectively improve sleep quality, however, there is a lack of rigorous study design and measurement tools (scientific instrument examination). to explore the effects of short-term sleep quality in patients with sleep disorders after receiving five-element music therapy or binaural beats, and further explore the combination of the above two music therapies to verify its effectiveness in improving long-term sleep quality. the first year study was a randomized single-blind trial. 60 patients with sleep disorders were randomly assigned to the five-element music group and binaural beats group for two consecutive nights treatment to verify their short-term effects and assess the differences between them; the second year study was a randomized controlled trial , 60 patients with sleep disorders were randomly assigned to the five-element music combined with binaural beats group and the control group for four-week follow-up treatment to verify their long-term results and evaluate the feasibility of home treatment. the main results were measured with meridian energy examination and polysomnography. other secondary results include sleep-related questionnaires (including pittsburgh sleep quality index, epworth sleepiness scale, berlin questionnaire, hospital anxiety and depression scale).

Eligibility criteria:
inclusion criteria: * sleep disorder * psqi score \> 5 exclusion criteria: * using tranquilizers or taking drugs or foods (such as coffee or refreshing drinks) * severe cardiopulmonary disease (heart failure or cardiopulmonary failure) or cancer * kidney dialysis patients * patients with cardiac rhythm regulators or built-in hearing aids * pregnant women and women who are still breastfeeding