Kornimate/medical-research-clean huggingface dataset:
the study of the bx velocity stent in the treatment of de novo artery lesions.

Conditions: Coronary Artery Disease

Summary: the main objective of this study is to assess the safety and effectiveness of the sirolimus-coated bx velocity™ stent in maintaining minimum lumen diameter in de novo native coronary artery lesions as compared to the uncoated bx velocity™ balloon-expandable stent. both stents are mounted on the raptor® stent delivery systems. the secondary objective is to assess cost-effectiveness expressed in incremental cost/life year gained or cost/quality adjusted life year gained at different time points (8 months, 1 year, 3 and 5 years).

this is a multicenter ,prospective, randomized double blind study. this study has a 2-arm design assessing the safety and effectiveness of the sirolimus-coated bx velocity™ stent to the uncoated bx velocity™ stent, both mounted on raptor® stent delivery systems. a total of 100 patients will be entered in the study and will be randomized on a 1:1 basis. patients who meet the eligibility criteria will be either randomized to treatment a or treatment b. neither the investigator nor the patient will know which stent will be implanted. patients will be followed at 30 days, 6, 9, and 12 months, and at 2, 3, 4 and 5 years post-procedure, with all patients undergoing repeat angiography at 8 months. additionally, medical costs associated with the index hospitalization and length of stay, and repeat hospitalizations and costs associated with other relevant medical resource use during the 5 years follow-up period will be collected and analyzed.

Eligibility criteria:
inclusion criteria: * diagnosis of angina pectoris as defined by canadian cardiovascular society classification (ccs i, ii, iii, iv) or unstable angina pectoris (braunwald classification b\&c, i-ii) or patients with documented silent ischemia; * single treatment of de novo lesion in a major coronary artery in patients with single or multi-vessel disease; patients with multiple lesions can be included only if the other lesions do not require treatment; * target vessel diameter at the lesion site is \>=2.50mm and \<=3.0mm in diameter (visual estimate); * target lesion is \>=15mm and \<=32mm in length (visual estimate); * target lesion stenosis is \>50% and \<100% (visual estimate); exclusion criteria: * patient has experienced a q-wave or non-q-wave myocardial infarction with documented total ck \>2 times normal within the preceding 24 hours and the ck and ck-mb enzymes remains above normal at the time of treatment; * has unstable angina classified as braunwald iii b or c and a i-ii-iii, or is having a peri infarction; * unprotected left main coronary disease with \>=50% stenosis; * significant (\>50%) stenoses proximal or distal to the target lesion that might require revascularization or impede runoff; * have an ostial target lesion; * angiographic evidence of thrombus within target lesion; * heavily calcified lesion which cannot be successfully predilated; * documented left ventricular ejection fraction \<=25%.
post-amputation survival following rehabilitation medium and long-term follow up study, a retrospective analysis.

Conditions: Amputation

Summary: this is a retrospective data analysis of patients who underwent lower limb amputation and rehabilitation and follow up. investigators analysed their survival outcomes in relation to various comorbidities i. e ischaemic heart disease, renal impairment, vascular interventions.

inclusion criteria: patients admitted for major dysvascular lower limb amputation, with complete follow-up record available. exclusion criteria: traumatic amputations, minor amputations, i.e. ray and toe amputation, and incomplete follow-up records.

Eligibility criteria:
inclusion criteria: patients admitted for major dysvascular lower limb amputation, with complete follow-up record available. exclusion criteria: exclusion criteria: traumatic amputations, minor amputations, i.e. ray and toe amputation, and incomplete follow-up records
comparison of liquid kaletra and low dose kaletra tablets

Conditions: HIV Infections

Summary: kaletra (a combination drug with lopinavir and ritonavir) is one of a few effective medications that are approved and available for young children who are hiv+. the liquid form is reported to have a very nasty taste and presents difficulties for the children who must take the medication twice a day and for their parents who must enforce the medication regimen. the children are often well into their teens before they weigh enough to be able to take the adult dose tablet (200mg/50mg). a new smaller dose tablet (100mg/25mg) is now available. however, it is not known if the liquid and tablet act the same in children. the purpose of this study is to switch children from the baseline treatment with the liquid to the study intervention treatment with 100mg/25mg tablet form of kaletra. the study will compare children pre-switch and post-switch in terms of how well their hiv is controlled . comparisons of parent and child satisfaction will also be made. eight to 10 hiv+ children currently well managed with a medications including liquid kaletra will be invited to switch from the liquid to the low dose kaletra tablet. the parent and/or child will complete a satisfaction survey for the liquid kaletra and lab values will be taken from the chart. at the time of the switch and 1, 3 and 6 months post switch blood tests will be drawn and the parent and/or child will complete the satisfaction survey. in addition, at the switch and 1 month post switch, a day will be spent in clinic with 5 blood draws to see how much of the drug is in the blood stream at different times after the medicine is taken.


Eligibility criteria:
inclusion criteria: * hiv+ children aged 3-18. * baseline treatment includes liquid kaletra * currently on a stable (on same regimen \> 3 months, viral load\< 5,000), highly active antiretroviral therapy (haart) regimen * able to take pills or willing to undergo pill training prior to enrollment * weight must be greater than or equal to 15kg exclusion criteria: * unable to swallow pills * concomitant treatment with rifampin or st. john's wort which have been shown to decrease plasma concentrations of lopinavir. * concurrent use of drugs primarily metabolized by cyp3a, which metabolizes ritonavir: astemizole, cisapride, dihydroergotamine, ergonovine, ergotamine, flecainide, lovastatin, methylergonovine, midazolam, pimozide, propafenone, simvastatin, terfenadine, triazolam * baseline treatment does not include kaletra

Keywords: hiv kaletra treatment experienced
exploratory study of ultrasound signs of native septic arthritis of the knee

Conditions: Ultrasound Therapy; Complications; Septic Arthritis; Knee Arthritis

Summary: primary objective: description of ultrasound abnormalities seen in native septic arthritis of the knee during each visit. primary endpoint: describe the ultrasound abnormalities observed on day 0, day 10, 6 weeks, 3 months, 6 months, during native septic arthritis of the knee.

secondary objectives: 1. search for poor prognostic factors in native septic arthritis of the knee. 2. to look for an association between initial sonographic factors and the use of joint lavage. 3. look for associations between sonographic signs and clinico-radio-biologic factors at each visit (d10, 6 weeks, 3 months and 6 months)

Eligibility criteria:
inclusion criteria: * male or female of legal age * bacteriologically proven native septic arthritis * meets the definition of septic arthritis: bacteriological documentation of joint puncture fluid-native articulation * free subject, without guardianship or trusteeship, or subordination * non-opposition of the patient after clear and fair information about the study exclusion criteria: * presence of material in the affected joint * arthritis with mycobacterium tuberculosis. * patients benefiting from a reinforced protection, namely: minors, pregnant and/or breast-feeding women, persons deprived of liberty by a judicial or administrative decision, adults under legal protection
combining non-invasive vagus nerve stimulation and robotic training in upper limb-impaired chronic stroke patients

Conditions: Stroke

Summary: previous studies suggested that both robot-assisted rehabilitation and non-invasive vagus nerve stimulation can improve upper limb function in chronic stroke patients. aim of present study is to explore whether the combination of these two approaches might enhance their positive effects on motor recovery. safety and efficacy of this combination will be assessed within a proof-of-principle, double-blinded, randomized, sham-controlled trial. transcutaneous vagus nerve stimulation (tvns) will be delivered at left ear, in order to improve the response to the following robot-assisted therapy. patients with both ischemic and hemorrhagic chronic stroke will be randomized to robot-assisted therapy associated with real or sham tvns, delivered for 10 working days. change in fugl-meyer has been chosen as primary outcome, while changes in several quantitative indicators of motor performance extracted by the robot as secondary outcomes.


Eligibility criteria:
inclusion criteria: * first-ever ischemic or hemorrhagic stroke at least 1 year earlier * hand function impairment * ability to give informed consent and comprehend instructions exclusion criteria: * previous surgical intervention on vagus nerve * low hearth rate (\< 60 bpm) * cognitive impairment or any substantial decrease in alertness, language reception, or attention that might interfere with understanding instructions for motor testing * apraxia * excessive pain in any joint of the paretic extremity * advanced liver, kidney, cardiac or pulmonary disease * history of significant alcohol or drug abuse * depression or use of neuropsychotropic drugs such as antidepressants or benzodiazepines * pregnant women

Keywords: ischemic stroke hemorrhagic chronic non-invasive vagus nerve stimulation robot-assisted rehabilitation
pulse steroids versus oral steroids in problematic hemangiomas of infancy

Conditions: Hemangiomas

Summary: the purpose of the study is to determine if pulse steroids are more efficacious and safer than the standard treatment with oral corticosteroids.

currently there is no prospective study in hemangioma patients answering critical questions such as: which type of steroid should be used,how much should we use and for how long. this study is an investigator blinded study with two arms:one arm is receiving standard treatment with daily oral corticosteroids and the other is receiving intravenous pulse corticosteroids daily for 3 days, monthly for 3 months. the main outcome of the study is assess the efficacy of each treament modality as the percentage improvement in the hemangioma's appearance. the secondary outcomes are the safety profiles of the two drugs and the changes in the angiogenesis markers as a result of treatment intervention.

Eligibility criteria:
inclusion criteria: * problematic facial hemangiomas (periorbital/facial hemangiomas with potential visual obstruction, large/dysfiguring hemangiomas) * 1-4 months of age * signed consent form exclusion criteria: * refusal to participate * age \> 4 months * complicated nonvisible hemangiomas * congenital heart disease
orelabrutinib combined with pemetrexed for relapsed/refractory central nervous system lymphoma

Conditions: Central Nervous System Lymphoma

Summary: this is a prospective single arm, phase ii clinical trial to observe the efficacy and safety of orelabrutinib combined with pemetrexed in the treatment for patients with relapsed/refractory central nervous system lymphoma.


Eligibility criteria:
inclusion criteria: 1. age between 18 to 75 years old (including 18 and 75) 2. diagnosed as diffuse large b-cell lymphoma; recurrence or progression of central nervous system disease confirmed by imaging ± tissue biopsy pathology or cerebrospinal fluid flow cytometry; secondary central nervous system lymphoma can also be admitted when the systemic disease is well controlled 3. having at least one measurable lesions 4. world health organization-eastern cooperative oncology group performance status (ecog) 0-2 ( ecog 3 due to tumors can be included after being fully assessed by the investigator) 5. life expectancy no less than 1 month 6. enough main organ function 7. pregnancy test within 7 days must be negative for women of childbearing period, and appropriate measures should be taken for contraception for women in childbearing period during the study and six months after this study 8. agreeing to sign the written informed consents exclusion criteria: 1. poor peripheral disease control of secondary central nervous system lymphoma 2. patients used pemetrexed or orelabrutinib in the past 3. active malignant tumor need be treated at the same time 4. other malignant tumor history 5. serious surgery and trauma less than two weeks 6. patients with active tuberculosis 7. systemic therapy for serious acute/chronic infection 8. congestive heart failure, uncontrolled coronary heart disease, arrhythmia and heart infarction less than 6 months 9. hiv-positive, aids patients and untreated active hepatitis 10. patients with a history of deep vein thrombosis or pulmonary embolism less than 12 months 11. patients with a history of mental illness or drug abuse 12. poor compliance during the trial and/or follow-up phase 13. allergies or people who are known to be allergic to any active ingredients, excipients, mouse-derived products or heterologous protein contained in this trial 14. researchers determine unsuited to participate in this trial

Keywords: central nervous system lymphoma btk inhibitor relapsed and refractory
clinical outcome of electrical transcutaneous auricular vagal stimulation in patients with stable symptomatic chronic heart failure

Conditions: Chronic Heart Failure

Summary: this study aims to investigate whether electrical vagus nerve stimulation in the auricle has an impact on the clinical presentation of heart failure. the device used, p-stim, is already successfully applied in pain therapy and angiology (peripheral arterial disease, pad) and will also be tested against a placebo in this study. in preliminary studies, acupuncture was shown to improve the 6-minute walking distance in heart failure patients (kristen et al., 2010). the investigators assume that acupuncture and p-stim have similar effects, and this study also aims to improve the 6-minute walking distance as its primary endpoint. additional endpoints include lvef (left ventricular ejection fraction), nyha classification, inflammatory markers (e.g., crp, pro-bnp), and patients' quality of life. study design: patients will be randomly assigned to either the placebo or the verum group. they will receive treatment for five weeks (with the device being replaced weekly) and undergo a follow-up examination after four weeks. at the beginning and during follow-up, left ventricular ejection fraction (measured by cardiac ultrasound), inflammatory markers in the blood, nyha classification, and quality of life (assessed by questionnaire) will be recorded. the primary endpoint, the 6-minute walking distance, will be measured at baseline, two weeks after the start of treatment, and at the follow-up examination.


Eligibility criteria:
inclusion criteria: * chronic heart failure * nyha classification ii-iii * stable medication since at least 1 months * lvef \<40% * patients must be able to understand study conditions * no exclusion criteria * signed informed consent 6.1.3 exclusion criteria * any electrical auricular vagal stimulation treatment within 6 months prior to base line visit * participation in another clinical trial within 3 months prior to base line visit * ventricular tachyarrhythmia within 1 month prior to base line visit * psoriasis vulgaris * hemophilia * cardiac pace makers

Keywords: auricular vagal stimulation chronic heart failure 6-minute walking test
an open, single-center, safety and efficacy study of conbercept in patients with very low vision secondary to wet age-related macular degeneration (wamd)

Conditions: Very Low Vision Secondary to Wet Age-related Macular Degeneration

Summary: this study is designed to evaluate the effect of conbercept therapy on visual acuity and anatomic outcomes and safety observed in subjects with very low vision secondary to wet age-related macular degeneration.


Eligibility criteria:
inclusion criteria: 1. patients give fully informed consent and are willing and able to comply with all study procedures. 2. in the study eye: there are primary or recurrent subfoveal or parafoveal active choroidal neovascularization (cnv) lesions secondary to wamd. the criterion of active cnv should meet at least one of following three conditions : * fresh bleeding; * neurosensory detachment showed on optical coherence tomography(oct); * leakage showed on fundus fluorescein angiography (ffa). 3. bcva in study eye \< 19 letters (approximately 20/400 snellen equivalent). exclusion criteria: 1. past or existing non-exudative amd in study eye decided by investigator that have affected macular detection or central vision; 2. subretinal hemorrhage in study eye and bleeding area ≥6 disc areas; 3. history of vitreous hemorrhage within last month; 4. the maximum diameter of scar and fibrosis area ≥500μm at subfoveal in study eye; 5. photodynamic therapy (pdt) or drug treatment of cnv within last 6 months in study eye, or anti-vascular endothelial growth factor (vegf) therapy in fellow eye within last month; 6. history of glaucoma in study eye; 7. aphakia (excluding artificial lens) in the study eye.
prospective multicenter registry on the endovascular treatment in critical limb threatening ischemia with below the knee lesions with wound, ischemia, and foot infection (wifi) assessment

Conditions: Chronic Limb-threatening Ischemia; Endovascular Therapy

Summary: this is a prospective multicenter clinical study that used wifi grading scores at different periods to evaluate the therapeutic value of endovascular therapy and this grading system for chronic limb-threatening ischemia.


Eligibility criteria:
inclusion criteria: 1. patients \> 18 years of age; 2. patients with chronic limb-threatening ischemia (clti); 3. patients with below-the-knee lesions undergoing endovascular treatment; 4. target limbs with certain wifi stage; 5. patients voluntary and capable of follow-up; 6. informed consent. definition of clti: a diagnosis of clti requires objectively documented atherosclerotic pad in association with ischemic rest pain or tissue loss (ulceration or gangrene). exclusion criteria: 1. contraindication for antiplatelet , anticoagulant or thrombolytic agent; 2. contrast agent allergy; 3. dysfunctional protein c, protein s, antithrombin ⅲ(at ⅲ) or refusal of blood transfusion; 4. complications affecting surgical safety; 5. major amputation was adopted to the target extremity; 6. the existence of aneurysm in the target vessels; 7. the existence of perforation, dissection or any other injury requiring intervention in the target vessels.
intraoperative contrast-enhanced ultrasound evaluation of blood flow at the time of surgical hip reduction for ddh

Conditions: Developmental Dysplasia of the Hip

Summary: this study evaluates the feasibility and utility of contrast-enhanced ultrasound to provide real-time assessment of blood flow to the femoral head in infants undergoing surgical reduction for developmental dysplasia of the hip.

for children presenting with late-diagnosed developmental dysplasia of the hip, a closed or open hip reduction followed by hip spica casting may be indicated if conservative treatment fails. although closed or open reduction and casting is largely successful for relocating a hip, iatrogenic avascular necrosis remains a major source of morbidity as a result of the surgical procedure. although recent evidence has demonstrated that postoperative gadolinium-enhanced magnetic resonance (mr) studies may be useful in assessing perfusion of the hip after surgery, these studies are not performed until after the cast is placed and they do not elucidate the specific intraoperative steps that increase risk for osteonecrosis. contrast-enhanced ultrasound (ceus) may be a reliable and effective alternative.

Eligibility criteria:
inclusion criteria: * males or females between 4 months and up to and including 24 months of age at the time of surgery. * diagnosed with ddh. * failed conservative treatment, or present with late-diagnosed ddh (where conservative treatment would not be appropriate to initiate at their age), and are undergoing closed or open reduction and spica casting. * informed consent (parental permission) exclusion criteria: * \> 24 months of age at the time of surgery. * subjects with ddh who are successfully treated with conservative measures and do not require surgical reduction. * previous open hip reduction of the affected side * children with known complex congenital heart disease or unstable cardiopulmonary conditions (as noted in the package labeling for lumason) including acute myocardial infarction, acute coronary artery syndromes, worsening or unstable congestive heart failure or serious ventricular arrhythmias will be excluded. * history of allergic reaction to lumason, sulfur hexafluoride, sulfur hexafluoride lipid microsphere components, or other ingredients in lumason (polyethylene glycol, distearoylphosphatidylcholine (dspc), dipalmitoylphosphatidylglycerol sodium (dppg-ns), palmitic acid).parental/guardian permission (informed consent) and if appropriate, child assent.

Keywords: contrast-enhanced ultrasound lumason developmental dysplasia of the hip (ddh) avascular necrosis
study of denosumab vs. zoledronic acid to treat bone metastases in men with hormone-refractory prostate cancer

Conditions: Bone Metastases

Summary: the purpose of this study is to determine if denosumab is non-inferior to zoledronic acid (zometa®) in the treatment of bone metastases in men with hormone-refractory prostate cancer


Eligibility criteria:
inclusion criteria: * men \>/= 18 years of age with histologically confirmed prostate cancer * radiographic evidence of at least one bone metastasis * failure of at least one hormonal therapy as evidenced by a rising psa * serum testosterone level of \<50 ng/dl * ecog ps 0, 1, or 2 * adequate organ function exclusion criteria: * current or prior iv bisphosphonate administration * current or prior oral bisphosphonates for bone mets * life expectancy of less than 6 months

Keywords: bone metastases hormone-refractory prostate cancer skeletal fractures compressions bisphosphonates