Kornimate/medical-research-clean huggingface dataset:
multicenter, randomized, open-label, parallel-group study to compare mlsg15 + kw-0761 to mlsg15

Conditions: Adult T-cell Leukemia-Lymphoma

Summary: this is a multicenter, randomized, open-label, parallel-group study to compare mlsg15 + kw-0761 to mlsg15 in subjects with ccr4-positive adult t-cell leukemia-lymphoma (untreated primary disease). the primary variable is an efficacy of kw-0761 used as an add-on therapy to mlsg15 as measured in terms of complete response rate (cr/cru) in the best overall response assessment for antitumor effect. the secondary variables include response rate (cr/cru/pr) in the best overall response assessment for antitumor effect, complete or response rates by lesion site in the best overall response assessment for antitumor effect, progression-free survival and overall survival. the safety and pharmacokinetic profiles of kw-0761 will be also determined.


Eligibility criteria:
inclusion criteria: * subjects who have been positive for serum anti-human t-cell lymphotropic virus type i antibody * subjects with hematologically or pathohistologically confirmed as peripheral lymphoid tumor which surface antigen analysis has identified to be of t-cell origin * subjects who have been classified into acute subtype, the lymphoma subtype or chronic subtype with poor prognostic factors * subjects who have been positive for ccr4 by ccr4 expression analysis * subjects who have never been treated for adult t-cell leukemia-lymphoma * subjects who have presented enlarged lymph nodes, tumor nodules in extranodal organs, abnormal lymphocytes in peripheral blood or cutaneous lesions * subjects with a performance status of 0 to 2 * subjects who have been negative for hbs antigen and anti-hcv antibody * subjects who have given written voluntary informed consent to participate in the study exclusion criteria: * subjects who are scheduled for transplant therapy such as hematopoietic stem-cell transplantation * subjects who had myocardial infarction within 12 months before study enrollment or who have cardiac disease that may worsen during treatment with doxorubicin * subjects who have been positive for anti-hiv antibody * subjects with active multiple cancer * subjects with a history of allergic reactions to therapeutic antibodies * subjects who require emergency radiotherapy for treating the symptoms caused by bulky masses or who may require such radiotherapy after the start of the study * subjects who are pregnant, lactating or of childbearing potential, or who are planning to have children
construction and application of a self-care behavior intervention scheme for chronic heart failure patients based on interaction model of client health behavior

Conditions: Chronic Heart Failure; Self-care; Health Education

Summary: the purpose of this study, which will last for 3 months, is to investigate the effect of the intervention based on the interaction model of health behavior on patients' disease perception, heart failure self-care level, quality of life and service satisfaction. if you have any questions or difficulties, you can withdraw from this study at any time, which will not affect your treatment and care; the purpose of this study is to improve your level of self-care, prevent your readmission to the hospital, and do not harm your physical and mental health, nor negatively affect the patient's relationship with care; your participation in the study and the personal data in the study are confidential, and any public report on the results of this study will not disclose your personal identity.


Eligibility criteria:
inclusion criteria: * patients diagnosed with chf according to the new york heart association (nyha) functional classification of ii-iii. * age ≥ 18 years, stable condition, clear consciousness, normal language and written expression abilities, no communication barriers, able to understand and accurately complete questionnaires. * informed consent and voluntary participation. exclusion criteria: * -patients with complications such as renal or hepatic insufficiency, a history of mental disorders, or currently experiencing mental disorders, or critically ill.
finding gab in the treatment of heart failure in assiut university hospital

Conditions: Heart Failure With Reduced Ejection Fraction

Summary: analyze the epidemiology and outcome of all patients with heart failure with reduced ejection fraction (hfref) presented to asyut university hospital (auh) and to identify factors associated with mortality and all-cause hospitalization at a duration of 6 months follow-up.

heart failure (hf) is nowadays an important health problem and associated with high use of resources and healthcare cost, but the prevalence of heart failure is increasing due to better care and treatment of hf and to the aging of the population. epidemiology of hf is changing and shifting towards a higher prevalence of patients with hf with preserved ejection fraction. moreover, the outcome of hf is grim. the mortality rate is high and hospitalizations are frequent and associated with worse outcomes. the majority of studies that analyzed hf outcomes have focused on hf hospitalizations. however, in patients with hf, all-cause hospitalizations can affect up to 23-58% of the patients at 1-year follow-up and non-cardiovascular hospitalizations are associated with risk of subsequent mortality similar to cardiovascular hospitalizations. despite the evidence that all-cause hospitalizations are detrimental in hf patients, few studies have analyzed whether the factors associated with all-cause and hf-hospitalizations are different in hf patients. however, the characteristics and outcome of hf patients are not well described in developing countries like egypt. documenting patients' characteristics and the outcome might improve management of comorbidities associated with heart failure patients in egypt as well as the disease outcome, however, characteristics and outcome of hf patients are not well described in developing countries like egypt. documenting patients' characteristics and the outcome might improve management of comorbidities associated with heart failure patients in egypt as well as the disease outcome, however, characteristics and outcome of hf patients are not well described in developing countries like egypt. documenting patients' characteristics and the outcome might improve management of comorbidities associated with heart failure patients in egypt as well as the disease outcome however, characteristics and outcome of hf patients are not well described in developing countries like egypt. documenting patients' characteristics and the outcome might improve the management of comorbidities associated with heart failure patients in egypt as well as the disease outcome

Eligibility criteria:
inclusion criteria: - all patients \> 18 years of age with left ventricular ejection fraction (lvef) \< 40 % with symptoms and signs of heart failure (according to esc guidelines of acute and chronic heart failure 2016). exclusion criteria: * patients more than 80 years old
robot therapy for rehabilitation of hand movement after stroke

Conditions: Stroke; Movement Disorders; Hemiparesis

Summary: a study will be performed where individuals with chronic stroke will be randomly assigned to receive 2 different dosages of robotic hand therapy. one group will receive 12 sessions of robot-assisted repetitive movement practice in the hexorr robot over a 4-5 week period. a second group will receive 24 sessions of hexorr therapy over a 8-10 week period.

the overall goal of the proposed work is to improve hand function after stroke. adequate hand function is critical to a functional upper limb, and is often resistant to conventional therapeutic interventions. many stroke survivors have residual ability to flex the fingers, but extension is often limited and impeded by increased passive stiffness in flexors, involuntary activation of flexors and inability to activate extensors. the rationale for this approach stems from the growing evidence that neuro-rehabilitation after stroke may be enhanced via the application of motor learning strategies within the context of repetitive movement practice. the key therapeutic aspects of these strategies are high repetition, volitional effort, and successful completion of tasks to prevent frustration. while these represent promising therapeutic strategies, they are limited to mildly impaired subjects who already have enough control of finger extension to tolerate high repetitions of grasp/release tasks without succumbing to fatigue and/or frustration. there is a very large population of stroke patients who don't fall into this category and often must rely on compensatory strategies. in these patients, repetitive task practice facilitated by a robotic device may be more effective than unassisted task practice.

Eligibility criteria:
inclusion criteria: 1. a diagnosis of stroke more than 6 months prior to randomization 2. presence of voluntary hand activity indicated by a score of at least 1 on the finger mass extension/grasp release item of the fugl-meyer test of motor function 3. adequate cognitive status, as determined by mini-mental status examination score \>24 exclusion criteria: 1. were under the influence of oral or injected antispasticity medications during the study 2. had mcp and ip passive extension limit \> 30 degrees from full extension 3. had pain that interfered with daily activities 4. had excessive tone in the fingers and thumb as determined by ashworth scores \>=3 5. had severe sensory loss or hemispatial neglect as determined by clinical exam.

Keywords: robotic therapy finger hand
accuracy of 3-dimensional printed implant cast versus conventional stone cast for edentulous mandibular arch

Conditions: Prosthesis Durability

Summary: this study will be conducted to compare between accuracy of 3d printed implant cast produced from digital impression and conventional stone cast produced from conventional splinted open tray impression for edentulous mandibular arch with four implants.


Eligibility criteria:
inclusion criteria: * • patients were healthy and free from all systemic diseases that affect osseointegration or bone resorption around the implant as recorded from medical and dental history. * patients were free from all oral pathological conditions and any remaining roots which were verified by pre-operative panoramic radiograph. * patients with u shaped arch, flat mandibular alveolar ridge covered with even compressibility healthy mucosa and gingival thickness of about 2mm verified by dual scan of cone beam computed tomography (cbct) during treatment planning. fig.(1) * adequate residual alveolar bone quality d2 bone type in the anterior and premolar regions according to the misch bone density classification scheme (850 to1250 housefield units) confirmed by cbct. * angel's class i maxillomandibular relation with moderate inter- arch space (20 mm) confirmed through tentative jaw relationship, and restorative space of at least 15 mm determined by putty index technique * patients complain from poor retentive mandibular denture seeking for alternative fixed options. * patient who is motivated, agreed with the follow-up visits and willing to return for follow-up appointments. exclusion criteria: * • patient with absolute contraindications that interfere with surgical placement and osseointegration of implants as uncontrolled diabetes mellitus, generalized osteoporosis, recent myocardial infarction, patient with radiotherapy. * patient with relative contraindication such as un controlled diabetes mellitus, moderate smoking and alcoholism, patient with tmj disorder and heavy smokers for more than10 cigarettes per day. * patient with local contra indication as insufficient bone quality, localized lesion in canine area and premolar area, unfavourable position of the lower alveolar or mental nerve, bone defects as verified by cone beam ct. * uncooperative patient.
image-guided thermal ablation vs. lobectomy for solitary papillary thyroid microcarcinoma

Conditions: Papillary Thyroid Cancer

Summary: to evaluate the clinical outcomes of image-guided thermal ablation versus thyroid lobectomy for the treatment of papillary thyroid microcarcinoma


Eligibility criteria:
inclusion criteria: 1. solitary papillary thyroid carcinoma confirmed by fine-needle aspiration or core-needle biopsy; 2. largest diameter ≤10 mm; 3. no evidence of extrathyroidal extension( no signs of unsmooth thyroid capsule or involvement of the perithyroidal tissue) on ultrasound; 4. no evidence of cervical lymph node metastasis on us or neck ct; 5. no distant metastasis on chest ct; 6. no history of neck irradiation. exclusion criteria: * (1)aggressive subtype of papillary thyroid microcarcinoma confirmed by biopsy(1); (2)multiple tumors; (3) incomplete data or lost follow-up
assessment of lumen expansion after thrombus extraction in primary percutaneous coronary intervention

Conditions: Acute ST Elevation Myocardial Infarction

Summary: to use ivus to assess (1) culprit plaque morphology and thrombus burden in patients with st-elevation myocardial infarction; (2) the efficacy of thrombus removal with an aspiration catheter in 40 patients during primary pci.

primary pci has become the preferred therapy for st-elevation acute myocardial infarction. the tapas trial data suggests that widespread adoption of manual thrombus aspiration may improve clinical outcomes for patients undergoing primary pci. little data exists on the degree to which thrombus is removed during thrombectomy and how much thrombus remains with the potential for distal embolisation during stent deployment. the mechanism of lumen enlargement after thrombus aspiration is also unknown. since angiography only provides an outline image of the vascular lumen, such questions cannot be adequately addressed by this modality alone. the aim of this study is to use ivus to assess (1) culprit plaque morphology and thrombus burden in patients with st-elevation myocardial infarction; (2) the efficacy of thrombus removal with an aspiration catheter during primary pci. hypotheses in this study we will assess 40 patients with stemi. primary pci will be performed according to our hospital standard working protocol with thrombus aspiration and balloon dilatation of the culprit lesion if necessary prior to stent deployment. ivus imaging will be undertaken prior to, and following, passage of the aspirations catheter to assess (1) initial and (2) residual thrombus volume. a third and final ivus imaging run will be performed after stenting of the culprit lesion. ivus analysis will be performed off-line to assess the lumen enlargement and volume of residual thrombus at each stage. all studies will be undertaken with the approval of the local clinical research ethics. aspirated material will be collected and analyzed. clinical markers such as troponin release and left ventricular function will be assessed.

Eligibility criteria:
inclusion criteria: 1. patients 18-75 years old with myocardial infarction with st-segment elevation 2. symptoms of myocardial ischemia lasting more than 30 minutes 3. onset of symptoms within 12 hours of hospital presentation 4. st-segment elevation of more than 0.1 mv in two or more leads on the ecg exclusion criteria: 1. inability to obtain informed consent 2. use of fibrinolytic drug within 12 hours of presentation 3. comorbidity with anticipated life expectancy of \< 6 months 4. cardiogenic shock on presentation 5. major bleeding diathesis 6. history of aspirin and clopidogrel intolerance 7. critical left main stem lesions 8. severe calcfic disease precluding safe passage of the imaging catheter 9. culprit lesion within saphenous vein grafts -

Keywords: acute mi primary percutaneous coronary intervention thrombus aspiration, ivus
cardiac allograft rejection gene expression observational (cargo) ii study

Conditions: Graft Rejection; Heart Disease

Summary: the cardiac allograft rejection gene expression observational (cargo) ii study is designed to provide independent evidence of the clinical performance of the non-invasive allomap test. sensitive detection of cardiac allograft rejection and dysfunction is the basis for successful recipient management. the cargo ii study will assess the correlation between the presence or absence of acute cellular rejection as determined by examination of endomyocardial biopsy specimens with results from the allomap test. of 17 participating transplant centers, 4 are in north america and 13 are in europe.


Eligibility criteria:
inclusion criteria: * new and existing allograft recipients * all patients (age ≥ 18years) receiving post-transplant care at the enrolling centers exclusion criteria: * concurrent enrollment in a double-blind drug trial (immunosuppressive drugs).

Keywords: allograft rejection biopsy gene expression cardiology heart transplant
a trial of mb-6 for reduction of neutropenia induced by chemotherapy in patients with stage iii colorectal cancer.

Conditions: Stage III Colorectal Cancer; Neutropenia

Summary: this is a randomized, double-blind, placebo-controlled multi-center phaseⅲstudy to evaluate efficacy and safety of oxaliplatin-based chemotherapy plus mb-6(320 mg/capsule, 6 capsules tid) in patients with stage 3 colorectal cancer who underwent surgical excision of their primary tumor.

the investigational new drug, mb-6, in the proposed clinical trial is to be used as an adjuvant therapy for metastatic colorectal cancer patients. all of six extracts have been used in human with a long history, and many literatures reported the medicinal use either individually or as ingredients of formulations. mb-6 may provide its therapeutic benefits via inhibition of tumor induction or enhancing the efficacy of chemotherapy in colorectal cancer.

Eligibility criteria:
inclusion criteria: 1. men or women 20 years of age or older. 2. histologically or cytologically confirmed stage 3 colorectal adenocarcinoma. 3. complete resection of the primary tumor without gross or microscopic evidence of residual disease. 4. no more than 8 weeks have elapsed from the time of surgery and have recovered from the effects. 5. eastern cooperative oncology group performance status (ecog ps) \< 2 at the time of screening. 6. hematological function: anc≥1500/mm3, hemoglobin ≥9.0 g/dl, platelet count ≥100000/mm3. 7. kidney function:serum creatinine \<2 mg/dl. 8. liver function: ast ≤3 times uln, alt ≤3 times uln, total bilirubin ≤2 times uln. 9. ability to understand and the willingness to sign a written informed consent document according to institutional guidelines. 10. men and women of childbearing potential must agree to employ adequate contraception during the study period. exclusion criteria: 1. history of second primary malignancies except for adequately treated basal cell carcinoma of the skin or carcinoma in situ of the cervix. 2. systemic chemotherapy, immune therapy or experimental or approved antibodies/proteins (e.g. bevacizumab) administered after surgery and prior to randomization. 3. concurrent treatment with any other anticancer therapy. 4. radiotherapy ≤14 days prior to randomization. 5. any unresolved toxicity \> ctc (common toxicity criteria) grade 1 from previous anti-cancer therapy (including radiotherapy) except haematological toxicity and alopecia. 6. patients with congestive heart failure, epilepsy, or other significant medical conditions as judged by the investigator. 7. contraindications to folfox chemotherapy: peripheral neuropathy nci ctc \>1, liver failure, uncontrolled coronary heart disease, myocardial infarction within the previous 6 months before randomization. 8. patient of child-bearing potential is evidently pregnant or is breast feeding.

Keywords: stage iii colorectal cancer grade 4 neutropenia mb-6
cincalcet and vascular arterial stiffness among peritoneal dialysis patients with secondary hyperparathyroidism

Conditions: Hyperparathyroidism; Arterial Stiffness

Summary: active parathyroid glands among renal dialysis patients contribute to calcified and hardened blood vessels. such damage to the blood vessels, in turn, takes a significant toll in terms of cardiovascular disease. calcimimetics has been suggested to lower the risk of vascular calcification. role of cinacalcet was demonstrated in animal model but human data are lacking. the investigators designed an open label pilot study to evaluate the effect of cinacalcet in 20 peritoneal dialysis patients with inadequately controlled secondary hyperparathyroidism despite standard treatment. the primary outcome is the aortic pulse wave velocity at 26 and 52 months after cinacalcet treatment.

mineral metabolism disturbance and hyperparathyroidism contribute to arterial stiffness and vascular calcification. the vascular damage, in turn, contributes to significant cardiovascular morbidity and mortality of end-stage renal disease patients. calcimimetics has been suggested to lower the risk of vascular calcification. role of cinacalcet was demonstrated in animal model but human data are lacking. we design an open label pilot study to evaluate the effect of cinacalcet in 20 peritoneal dialysis patients with inadequately controlled secondary hyperparathyroidism despite standard treatment. the primary outcome is the aortic pulse wave velocity at 26 and 52 months after cinacalcet treatment.

Eligibility criteria:
inclusion criteria: * plasma parathyroid hormone level of at least 300 pg/ml (31.8 pmol/l) * aged 18 or older on peritoneal dialysis for at least three months * willingness to give written consent and comply with the study protocol exclusion criteria: * evidence of cancer, active infection or diseases with limited life expectancy * diseases known to cause hypercalcaemia * adjusted serum calcium level below 2.1 mmol/l (8.4 mg/dl) after correction for albumin * participation in another interventional study within last 30 days of randomization * history of a psychological illness or condition that would interfere with the patient's ability to understand the requirement of the study and/or comply with the study procedures * patients receiving drugs with a narrow therapeutic index and metabolized by cytochrome p-450 2d6 (which is inhibited by cinacalcet): flecainide, thioridazine and most tricyclic antidepressants

Keywords: hyperparathyroidism pulse wave velocity end-stage renal disease arterial stiffness
promoting informed decision making through advance care planning

Conditions: Dementia; Neurodegenerative Diseases

Summary: the purpose of this study is to evaluate the application of a best-practice advance care planning (acp) model for individuals living with dementia in a sample of nursing homes in northern ireland


Eligibility criteria:
inclusion criteria: 1. family caregivers * family caregivers of a resident who does not have decision making capacity to participate in acp discussion * individuals identified by the nursing home manager as the family member who possess power of attorney for personal care and/or viewed by the nursing home staff as most involved in the care of the resident who does not have decision making capacity. 2. health care professionals nursing home managers, registered nursing staff and gps who: * are employed, or in the case of gps, care for residents, in the six nursing homes that were part of the intervention group * were familiar with the intervention to discuss its strengths and weaknesses in an interview * are able to speak english as they are required to participate in interviews. exclusion criteria: * family caregivers and health care professionals who are unable to communicate through written and spoken english. * family caregivers who has a family resident considered to have the ability to participate in acp discussions.

Keywords: dementia decision-making communication advance care planning