Kornimate/medical-research-clean huggingface dataset:
to predict efficacy by detecting circulating endothelial cell subsets and blood perfusion parameters changes in vivo tumor in the phase ii/iii study of anlotinib in patients with advanced non-small cell lung cancer

Conditions: Non-small Cell Lung Cancer

Summary: 1. to reveal changes of peripheral markers and blood perfusion parameters in vivo tumor in the phase ii study of anlotinib in patients with advanced non-small cell lung cancer. 2. to clarify the meaning of peripheral markers and blood perfusion parameters in vivo tumor in predicting the effect of anti-angiogenic therapy.


Eligibility criteria:
inclusion criteria: 1. pathology diagnosed with advanced nsclc with measurable lesions; 2. have failed for 2 lines of chemotherapy; 3.18-70 years,ecog ps:0-2,life expectancy of more than 3 months; 4.other cytotoxic drugs,radiation therapy,or surgery≥4 weeks; 5.main organs function is normal; 6.women of childbearing age should take contraceptive measures during the study and within 6 months after end. exclusion criteria: 1. sclc(including mixed with nsclc); 2. the central cavity of squamous cell carcinoma and hemoptysis with nsclc; 3. patients failed to use the anti-tumor angiogenesis therapy; 4. patients have many influence factors toward oral medications ; 5. brain metastases patients accompanied by symptoms or symptom control for less than two months; 6. patients with severe and failed to controlled diseases,including: suboptimal blood pressure control;suffering from myocardial ischemia or above grade i myocardial infarction, arrhythmias and class i heart failure;activity or failure to control severe infections;liver disease such as cirrhosis, decompensated liver disease, chronic active hepatitis;poorly controlled diabetes (fbg\>10mmol/l);urine protein≥++,etc. 7. patients failed to heal wounds or fractures for long-term; 8. 4 weeks before enrollment, patients appeared nci ctc ae grading \>1 pulmonary hemorrhage; 4 weeks before enrollment, patients who appeared nci ctc ae grade\> 2 had other parts of the bleeding; patients have a tendency to bleed (e.g active peptic ulcer) or are receiving thrombolytic or anticoagulant therapy such as warfarin, heparin or its analogues; 9. patients occurred venous thromboembolic events within 6 months; 10. patients who have hiv-positive or organ transplantation.
effectiveness of multigrain supplementation among the rheumatoid arthritis patients

Conditions: Rheumatoid Arthritis

Summary: the objective of this study is to evaluate the effect of high fiber multigrain supplementation on the level of clinical disease severity measures, blood inflammatory molecules, and nutritional status changes in ra patients.

rheumatoid arthritis (ra) is a chronic inflammatory, autoimmune rheumatic disease, resulting in progressive joint inflammation and destruction. at present, there is no known cure for this disease. as a consequence of the potential side effects, many ra patients turn to other alternative remedies such as specialised diets and/or dietary supplements in a bid to relieve their symptoms. therefore, the current study aims to examine the effectiveness of high fiber multigrain supplementation on the level of clinical disease severity measures, blood inflammatory molecules, together with the nutritional status changes in ra patients, as compare with conventional drug treatments.

Eligibility criteria:
inclusion criteria: * ra patients according to the american college of rheumatology (acr) * moderate (das 28 = 3.2 - 5.1) and severe (das 28 \> 5.1) ra manifestation * chronological age: 21 years and above * stable ra patients who are receiving nsaids, glucocorticoids/dmards (for example leflunomide, methotrexate, sulfasalazine and hydroxychloroquine) for at least 3 months prior to entering the study * not taking antioxidant/antiinflammatory supplements (example of antioxidant: vitamin c, vitamin e, grape seed extract, garlic capsule, ginkgo biloba) (example of anti-inflammatory supplement: fish oil, curcumin extract, ginger extract, spirulina) exclusion criteria: * having liver (chronic liver failure, cirrhosis, all types of hepatitis), kidney (chronic kidney disease, haemodialysis) or haematological (anaemia, thalassemia, haemophilia) disorders * active gastric/duodenal ulcer * psychiatric disease/mental retardation (bipolar disorder, depression, schizophrenia) * cancer (all types), diabetes mellitus (type i and ii), uncontrolled hypertension (bp at 140/90 mmhg for the past 3 months), and endocrine disorders (cushing's disease, gigantism and hyperthyroidism). * alcohol and drug abuse (self-mentioned or as recorded in the medical card) * other autoimmune/inflammatory diseases (systemic lupus erythematosus, multiple sclerosis, gout, psoriasis, chronic inflammatory demyelinating polyneuropathy) * pregnancy/lactation * hormone replacement therapy (for at least 3 months prior to entering the study) * herbal remedies (any parts from the plants such as flowers, rhizome, seeds, roots, leaves, fruits, stems) * vegetarian patient (pure vegan) * gluten intolerance * participations from another supplementary program

Keywords: rheumatoid arthritis fiber multigrain
obturator block in lateral tumors of the bladder: does it have adverse effects on early postoperative mobilization?

Conditions: Obturator Nerve Block; Ultrasound Guided Nerve Block; Complications Neurological

Summary: investigation of delay in postoperative mobilization due to motor block and complications related to block in patients who underwent usg-assisted obturator nerve block with distal approach


Eligibility criteria:
inclusion criteria: * age between 18-75 * asa1, asa2, asa 3 physical status exclusion criteria: 1. the patient's refusal 2. active infection in the area to be blocked 3. kidney failure 4. liver failure 5. heart failure 6. bmi less than 18 and a bmi greater than 40
candesartan cilexetil in heart failure assessment of reduction in mortality and morbidity (charm added)

Conditions: Congestive Heart Failure

Summary: a study to evaluate the effect of atacand on patients with heart failure with depressed left ventricular function


Eligibility criteria:
inclusion criteria: * male or female aged 18 or above * congestive heart failure with symptoms for more than 4 weeks before starting study * provision of informed consent exclusion criteria: * current low blood pressure with symptoms * liver disease considered significant by the study doctor * pregnant or lactating females

Keywords: congestive heart failure atacand candesartan
natural history study of factor ix treatment and complications

Conditions: Factor IX Deficiency

Summary: this study will examine two groups of subjects with factor ix (fix) deficiency: 1) those with a current or history of inhibitors to fix, and; 2) groups of two or more affected brothers, with or without inhibitors. the overall goal is to characterize the study groups in terms of their medical history, their patterns of bleeding, their care, quality of life, and complications including the development of joint disease, inhibitory antibodies to fix, use of immune tolerance induction (iti) and outcome.

hemophilia b, fix deficiency, is the second most common type of hemophilia, occurring in about one in 25,000 male births. this disease is in some ways more complex than hemophilia a, and is less well understood. differences include a lower incidence and a greater risk of side effects to treatment, for example, allergic reactions and kidney disease. this study will examine two groups of subjects with fix deficiency - those with a current or history of inhibitors to fix, and groups of two or more affected brothers, with or without inhibitors. the overall goal is to characterize the study group in terms of their medical history, their patterns of bleeding, their care, quality of life, and complications including the development of inhibitory antibodies to fix, allergies, kidney, and joint disease.

Eligibility criteria:
inclusion criteria: 1. a consent approved by the appropriate institutional review board (irb)/independent ethics committee (iec) has been obtained from the subject or his legally acceptable representative 2. subject has fix deficiency and * is part of an affected brother pair/group that will also enroll; and/or * has a current or history of inhibitor, defined as \>0.6 bethesda units (bu) exclusion criteria: 1. subject has another congenital bleeding disorder 2. subject is a carrier of hemophilia b with factor level \>0.40 iu/ml

Keywords: hemophilia b hemophilia b with inhibitors
pain management using guided imagery for adolescents post-spinal fusion

Conditions: Pain; Scoliosis

Summary: surgery to correct scoliosis (spinal fusion)generates a severe pain intensity rending pain management a complex task. several studies have found out that pharmacological interventions alone were not enough to provide optimal pain management for these patients. the investigators developed a dvd on guided imagery, customized for teenagers, to help them cope better with their pain. the investigators believe that this type of intervention combined with their usual analgesic medication will help them to control their pain and foster rehabilitation.


Eligibility criteria:
inclusion criteria: * aged between 11 and 20 years old * have undergone a posterior/anterior arthrodesis surgery for idiopathic scoliosis * able to write and understand french * requires a computer or dvd player at home. exclusion criteria: * diagnosed with a moderate cognitive deficit or severe mental retardation

Keywords: pain scoliosis rehabilitation cognitive-behavioral interventions adolescents
precision medicine to predict the trajectory of liver cirrhosis: prospective cohort study

Conditions: Liver Cirrhosis; Metabolic Syndrome; Spleen; Fibrosis; Frailty

Summary: preventing decompensation is a key endpoint in the management of compensate cirrhosis patients. the known factors that increases the risk of decompensation include the presence of clinically significant portal hypertension (csph) and the control of primary etiology of cirrhosis. other factors which may influence the progression of cirrhosis included the presence of metabolic syndrome (diabetes mellitus and obesity), frailty, concomitant medications (statin, non-selective beta-blocker) were not well understood. investigators aim to perform a pilot, observational study to study various baseline factors in relation to the clinical outcome of cirrhosis patients in a prospective follow up.

all patient who fulfilled eligibility criteria will be consented and recruited. the study will last up to 3 years or up to 7 assessment and 7 visits all subjects will be followed every 6 monthly for study outcome from recruitment, biosamples (blood,urine and stool), elastography, quality of life questionnaire and frialty assessment were done at baseline. completion of sit to stand , handgrip and 6 minute walking test at baseline and visit 3.all visits will be follow up on study outcome (liver-related events ,metabolic related outcome and cardiovascular related outcomes.). during decompensation (decrease in liver function ) .collection of research leftover blood,urine and stool samples if applicable.

Eligibility criteria:
inclusion criteria: * aged 21 to 90 years with the diagnosis of liver cirrhosis (regardless of etiology) * consent to participate in the study exclusion criteria: * terminal malignancy. subjects with prognosis \< 3 months. * patient refusal or unable to commit to study follow-up

Keywords: liver cirrhosis metabolic syndrome cardiovascular events
evaluating an online mindfulness-based intervention for insomnia

Conditions: Insomnia, Primary

Summary: insomnia has significantly negative impact on work, quality of life, psycho-somatic health on individuals and imposes substantial economic burdens on society. mindfulness-based interventions (mbis) have shown its efficacy in the treatment of insomnia, however the effect of online mbis need more studies to verify. this study aims to compare the effectiveness of an online mbi named 'mindful living with insomnia (mlwi)' to online cbi-i for insomnia.

this will be an online based, randomized, controlled trial. investigators will recruit 1000 participants, and will randomize and allocate participants 1:1 to the 'mindful living with insomnia (mlwi)' group (n=500) and the 'cbt-i' group (n=500). the intervention will involve 12 sessions over 6 weeks course, 2 sessions a week and 0.5 hours per session. the primary outcome will be sleep quality assessed by the pittsburgh sleep quality index (psqi), severity of insomnia symptoms assessed by the insomnia severity index (isi), and sleep parameters recorded using mi smart band. the secondary outcomes include perceived stress, anxiety, depression, and mindfulness. outcomes will be evaluated at baseline, the end of the intervention period, and at a 3-month follow-up. analysis of covariance, regression analysis, χ2 test, t-test, pearson's correlations will be applied in data analysis.

Eligibility criteria:
inclusion criteria: 1. age between 18 and 59 years old 2. being able to read and write chinese 3. psqi exceeding 5 at screening 4. being able to access online services 5. willing to participate in the study exclusion criteria: 1. unable to communicate 2. with somatic disorders 3. with mental disorders except for insomnia disorder 4. being treated with pharmacotherapy 5. significant current mindfulness practices (\>15 minutes/ day)

Keywords: insomnia mindfulness-based intervention cognitive behavioral therapy for insomnia online
sunitinib as second-line treatment in advanced biliary tract carcinoma

Conditions: Advanced Biliary Tract Adenocarcinoma

Summary: the purpose of this study is to determine whether sunitinib as second-line treatment in advanced biliary tract carcinoma

phase ii study of sunitinib as second-line treatment in advanced biliary tract carcinoma: multicenter, multinational study

Eligibility criteria:
inclusion criteria: 1. age ≥ 18 2. histologically or cytologically confirmed adenocarcinoma of biliary tract 3. unresectable or metastatic 4. ecog performance status of 0\~2 5. measurable or evaluable lesion per recist criteria 6. adequate marrow, hepatic, renal and cardiac functions 7. one prior treatment of cytotoxic chemotherapy (including adjuvant treatment within 12 months) 8. provision of a signed written informed consent exclusion criteria: 1. severe co-morbid illness and/or active infections 2. pregnant or lactating women 3. active cns metastases not controllable with radiotherapy or corticosteroids 4. known history of hypersensitivity to study drugs

Keywords: advanced biliary tract carcinoma sunitinib
adherence to cied implantation guidelines and cardiac rehabilitation

Conditions: Left Ventricular Systolic Dysfunction; Myocardial Infarction

Summary: there are limited data on how the guideline indications for icd implantation are applied in clinical practice across europe. moreover, the impact of "time-dependence" of some indications to implantation on the guidelines adherence is still unknown. objective of the present observational study is the evaluation of the adherence to the scientific guidelines in patients with a time-dependent indication to icd/crt-d implantation admitted to an in-hospital cardiac rehabilitation program.

current guidelines recommend icd implantation in patients at high risk of sudden cardiac death with either ischemic or non-ischemic heart disease. however, implantation rate of cardiac implantable electrical devices (cied), especially icd, crt and crt-d, is lower than expected and do not reflect guideline indications. several factors may justify the differences in icd implantation rates across europe and the gap between daily clinical practice and guidelines: economic restrictions, poor guidelines awareness, especially among referring cardiologists and general practitioners, and different guidelines adherence. the impact of "time-dependence" of some indications to cied implantation on the guidelines adherence is still unknown. objective of the present observational study will be the evaluation of the adherence to the scientific guidelines in patients with a time-dependent indication to icd/crt-d implantation admitted to an in-hospital cardiac rehabilitation program. this is a prospective, multicenter, observational study performed in 6 cardiac rehabilitation facilities.

Eligibility criteria:
inclusion criteria: * admission to an in-hospital cardiac rehabilitation program because of a recent index event; * provision of signed and dated informed consent form; * age ≥ 18 years. * nyha ii-iii class at the admittance in the cardiac rehabilitation facility; * lvef ≤ 40% at echocardiography at the admittance in the cardiac rehabilitation facility; * presence of a time-dependent indication to an icd/crt-d implantation: * \<3 month of optimal medical therapy; * \<40 days from the index myocardial infarction in patients with acute coronary syndrome; * 3 months from the revascularization procedure in patients with surgery; * \<3 months in patients with a de-novo heart failure episode of no ischemic etiology. * patients who have already received an icd/crt-d for primary prevention before the admittance in the cardiac rehabilitation facility, despite a time-dependent indication to an icd/crt-d implantation; * indication to icd-crt-d implantation for primary prevention. exclusion criteria: * inability to give informed consent (diminished understanding or comprehension); * age \< 18 years; * nyha class i or iv during the cardiac rehabilitation in-hospital stay; * lvef \> 40% at echocardiography performed at the admittance in the cardiac rehabilitation facility * absence of a time-dependent indication to an icd/crt-d implantation; * indication to icd-crt-d implantation for secondary prevention.
r2 in the treatment of follicular lymphoma

Conditions: Follicular Lymphoma

Summary: lenalidomide based immunotherapy in the treatment of fl

lenalidomide based immunotherapy efficacy related molecular biomarker in follicular lymphoma

Eligibility criteria:
inclusion criteria: patients diagnose as de novo or relapse refractory fl grade 1-3a . no history of stem cell transplantation. written informed consent. exclusion criteria: chemotherapy or large field radiotherapy within 3 weeks prior to entering the study. clinically significant active infection. impaired liver, renal or other organ function not caused by lymphoma, which will interfere with the treatment schedule. any significant medical or psychiatric condition that might prevent the patient from complying with all study procedures. subject has ≥grade 2 peripheral neuropathy or grade 1 with pain within 14 days before enrollment. patients who are pregnant or breast-feeding. hiv infection.
sleep/wake state assessment with non-invasive earbuds

Conditions: Hypersomnolence

Summary: this study is a within subject's assessment of whether a novel wearable technology, nextsense electroencephalography earbuds (eegbuds), is able to detect differences in onset to sleep from wake versus in-laboratory, gold-standard electroencephalography (eeg) utilized as part of a standard four trial maintenance of wakefulness test (mwt) at medicated baseline versus free of prescribed medications for promoting wake (random order).

detection of "sleepiness" has for more than four decades relied upon methods that acquire the electroencephalogram (eeg) from multiple surface electrodes applied to the scalp and hardware that amplifies and stores information on a central processing unit (cpu). there are substantial limitations to this methodology beyond the fact that it is time, labor, and cost intensive. such procedures restrict a subject's freedom of movement and necessitate that patients are monitored by trained staff in an accredited laboratory which levies substantial time and financial burdens upon patients and families. finally, the test-re-test reliability and utility of testing paradigms reliant solely on an eeg 'signature' to detect statistically meaningful - let alone clinically meaningful - changes is dubious, and has come under increased scrutiny. this study will assess whether novel wearable technology (nextsense eegbuds and/or ellcie healthy glasses) are able to detect differences in onset to sleep in patients diagnosed as having one of the central disorders of hypersomnolence (e.g., narcolepsy type 1 or type 2, or idiopathic hypersomnia) while using their prescribed wake promoting medication(s) versus while they are not medicated, and how it's sensitivity compares to differences as detected by the standard mwt. the two study visits will occur within 16 days of one another.

Eligibility criteria:
inclusion criteria: * adults ages 18-60 years of age previously diagnosed with narcolepsy type i (nt1), narcolepsy type 2 (nt2), or idiopathic hypersomnia (ih). * requiring daily wake promoting medication(s) continuously for 3 months for diagnosed nt1, nt2 or ih with symptomatic improvement on treatment documented by standard subjective or objective tools. exclusion criteria: * presence of a diagnosed or suspected co-morbid sleep-related breathing disorder, parasomnia, or other sleep-related movement disorder. * unstable psychiatric disorder (e.g., acute psychosis, acute suicidal ideation or major depressive episode, active substance abuse/dependence). * history of malignancy (active or in remission for \< 2 years) or active infectious disease at time of screening. * inability to safely tolerate wearing earbuds due to recent injury, skin breakdown, or infection. * uncorrected near visual acuity no worse than 20/50. * any other condition which may affect the outcome of this study or safety of the participant as determined by the principal investigator.

Keywords: narcolepsy type 1 narcolepsy type 2 idiopathic hypersomnia
effects of nt-0796 in obese participants at risk of cardiovascular disease

Conditions: Cardiovascular Diseases

Summary: this trial is a randomized, double-blind (sponsor-open), placebo-controlled study to assess the effect of nt-0796 on inflammation in obese participants at risk of cardiovascular disease. participants will be admitted to an in-patient clinical research unit on day -1 and will be discharged on day 30. the trial will include a 7-day out-patient safety follow-up period following the last dose of study treatment. for the first approximately 20 participants effect of food will be evaluated on the pharmacokinetics of nt-0796. mri's will be conducted in a subset of participants.

the goal of this clinical trial is to evaluate the effects of nt-0796 on inflammation in obese participants at risk of cardiovascular disease, evaluate the effects of nt-0796 on body weight and composition, to see how safe nt-0796 is, and how well it is tolerated and to measure the blood levels of nt-0796, with and without food.

Eligibility criteria:
inclusion criteria: 1. male or female aged 18 years or older. 2. body mass index (bmi) ≥30 and ≤40 kg/m2 at screening. 3. presence of 1 or more of the following risk factors for atherosclerotic cardiovascular disease: * history of controlled hypertension * history of hypercholesterolemia * history of high-density lipoprotein levels * controlled type 1 or type 2 diabetes mellitus exclusion criteria: 1. history of stroke with residual neurological deficit within 2 years or transient ischemic attack within 6 months 2. history of acute coronary syndrome (acs) 3. stable angina. 4. diagnosis of congestive heart failure 5. evidence of past or current infection with hepatitis b or hepatitis c