Kornimate/medical-research-clean huggingface dataset:
sentinel node detection in endometrial cancer: a consolidation study on detection rates of metastatic disease

Conditions: Sentinel Lymph Node; Endometrial Cancer; Lymphedema

Summary: evaluation of removal of sentinel lymph nodes only for detection of pelvic lymph node metastases in high risk and low risk endometrial cancer.

consecutive patients with- and low risk endometrial cancer will be approached for eligibility for inclusion in a study evaluating the detection rates of pelvic metastatic disease by detection and removal of sentinel lymph nodes only, i.e with no further lymphadenectomy. a re-staging will be performed in case of metastatic sentinel lymph nodes to guide adjuvant treatment. the detection rate will be evaluated from a non-inferiority perspective against the expected rate of nodal metastases based on detailed final histological data. adverse events related the intervention ( injection of tracer (icg) and removal of sentinel nodes), time for the intervention, and an objective evaluation of lymphatic complications (lymphoedema) will be performed in addition to the use of a validated lymphoedema qol questionnaire.

Eligibility criteria:
inclusion criteria: * women of age 18 years and older at the time of informed consent. * women with a pathologically proven endometrial carcinoma of any histologic subtype or grade, clinically stage i-ii planned for primary surgery * a uterine size allowing minimally invasive surgery * women must be able to understand and sign an informed consent in swedish language. * absence of any exclusion criteria exclusion criteria: * non consenting patients * ongoing pregnancy * inability to understand written and/or oral study information * who performance status or conditions contraindicating adjuvant oncological treatment (who iii or more) * previous lower limb lymphedema ( only for the lymphedema part of study) * evidence of locally advanced disease or intraabdominal/distant metastases at preoperative ct, mri or ultrasonography. * surgical contraindication to a laparoscopic approach or lymphadenectomy at surgeons discretion. * anesthesiologic contraindication to a laparoscopic approach at the anesthetist's discretion * allergy to iodine * patients with a known liver disease * patients with a bleeding disorder or mandatory antithrombotic treatment.
novel evaluation of aspirated follicular fluid

Conditions: Ovary Inflammation

Summary: a molecular study of follicular fluid aspirated from ovarian follicles during routine in vitro fertilization treatment, after the eggs were identified and separated.

ovarian stimulation is a routine part of in vitro fertilization treatment: this process involves an inflammatory response in the developing follicles. we still do not completely understand the complex interactions leading to the maturation of the egg and the multiple interactions of the egg with its supporting cells. in this study we will assess follicular fluid, letf over after the eggs were identified and separated, for the presence of inflammatory mediators, dendritic cells , vasorin and soluble flt1. the presence and quantification of these factors, as well as their correlation with the size of the aspirated follicle is the focus of this study.

Eligibility criteria:
inclusion criteria: * all women going through a fertility/ fertility preservation indicated egg retrieval in the in vitro fertilization (ivf) unit in 'meir medical center', * patients' informed consent exclusion criteria: * patients refusing to take part in the study
a study to assess safety and efficacy of prl3-zumab in patients with solid tumors

Conditions: Solid Tumor

Summary: this is a multi-center, phase 2, open-label, single dose level study of prl3-zumab monotherapy in patients with unresectable or metastatic solid tumor.

the study consists of a screening period (day - 14 to day -1), a treatment period during which visits will occur every 2 weeks, an end of treatment visit within 14 days of the decision to discontinue treatment for any reason, and a safety follow-up visit at 14 ± 4 days after the last dose of study treatment. prl3-zumab will be administered by intravenous (iv) infusion till patient meets any of the discontinuation criteria (progressive disease, clinically or per recist v1.1 and irecist, intolerable toxicity or withdrawal of consent). one cycle of treatment will be 4 weeks (2 infusions, 12 days ±2 days apart).

Eligibility criteria:
inclusion criteria: * patients with unresectable or metastatic solid tumors willing to provide signed informed consent. * histopathological diagnosis and metastatic status cancer at study entry. * must have received at least 1 prior line of systemic therapy for metastatic disease but no more than 3 prior lines of treatment for metastatic disease. * life expectancy of more than 6 months. * eastern cooperative oncology group (ecog) performance status (ps) score or less than 2. * adequate organ and hematological function. * measurable disease by recist v1.1 and irecist. exclusion criteria: * patient has known untreated or symptomatic central nervous system metastasis. * patient is receiving systemic glucocorticoids or other immunosuppressive treatments for autoimmune disease or any other medical condition. * patient has experienced a severe hypersensitivity reaction to another monoclonal antibody. * patient has received treatment with any systemic anti-cancer therapies within 3 weeks prior to starting study treatment. * patient has undergone radiotherapy ≤ 4 weeks prior to starting study treatment. * patient has received \> 3 lines of prior systemic chemotherapy for metastatic disease

Keywords: prl-3 tumor efficacy safety pharmacokinetics
pulse shortwave therapy in cervical osteoarthritis

Conditions: Cervical Osteoarthritis

Summary: the actipatch is an fda cleared pain therapy device that uses pulsed shortwaves to interrupt pain signals at the nerve. 200 patients will be randomized and divided into an actipatch treatment group and comparison analgesic drug therapy group . subjects will be assessed with the neck disability index (ndi) at baseline and at four weeks and vas scores will be recorded in order to determine the efficacy of the actipatch device compared to etoricoxib. cervical osteoarthritis causes chronic neck pain which could potentially be alleviated by the actipatch without the use of medication.

cervical osteoarthritis causes chronic pain in the neck due to the discs of the spine breaking down, losing fluid, and becoming stiffer over time. as obesity and age increase, the likelihood of cervical osteoarthritis increases as well. when the pain caused by the broken down discs becomes severe, it may result in a loss of mobility in the neck region. chronic neck pain has a serious impact on not only quality of life, but can also negatively affect a persons ability to lead a healthy active lifestyle. standard analgesic therapy it limited in efficacy and can result in serious adverse effects specially with long term use.

Eligibility criteria:
inclusion criteria: * chronic neck pain of \> 2 months * cervical osteoarthritis - radiological evidence * males \& females * age: 30-60 years exclusion criteria: * neck pain \<2 months * pregnancy * irreversible neck injury * congenital neurological/muscular diseases * osteo-articular disorders * auto-immune diseases * osteoporosis * hematological diseases (thalassemia/sickle cell anemia) * cancer * contra-indication to etoricoxib 60 mg * age \ 60 years
study evaluating estradiol/trimegestone in vasomotor symptoms (vms) in post-menopausal women.

Conditions: Postmenopause

Summary: the purpose of this study is to evaluate vasomotor symptoms (vms) control of the continuous regimen 17 b estradiol/trimegestone combination.


Eligibility criteria:
inclusion criteria: * generally healthy postmenopausal women 45 to 55 years of age inclusive, with at least 1 year of natural occurring amenorrhea, with vasomotor symptoms, with at least 4 hot flushes per day * intact uterus exclusion criteria: * known or suspected breast carcinoma or estrogen-dependent neoplasm * undiagnosed abnormal genital bleeding

Keywords: postmenopause
study of a novel interposition supraciliary implant in patients with open angle glaucoma

Conditions: Glaucoma, Open-Angle

Summary: the purpose of this study is to evaluate the safety and effectiveness of a novel interposition supraciliary implant as a stand-alone therapy for lowering intraocular pressure (iop) in patients with primary open angle glaucoma (poag) who have failed at least one class of topical medical therapy

68 patients will be included in this 5 years interventional study. all patients shall be indicated for glaucoma surgery alone (not combined with cataract), and will undergo incisional glaucoma therapy, including a novel simplified surgical technique allowing placement of an interposition supraciliary permanent device. several patient data like iop, visual capacity or associated pharmacological treatments will be recorded pre and post-operatively all along the follow-up. purpose is to ensure device safety, and verify iop and associated pharmacological treatment reduction after surgery, and evolution along follow-up.

Eligibility criteria:
inclusion criteria: * diagnosis of poag schafer 3 or 4 * medicated iop ≥ 21 exclusion criteria: * inflammatory, congenital, traumatic, neovascular, ice syndrome, angle closure and schaffer 1 and 2 glaucoma * non surgical interventional treatment (cyclophotocoagulation, ultrasounds, ...) * medical treatment having intraocular hypotensive effect
pie ii: pharmacological intervention in the elderly ii

Conditions: Diastolic Heart Failure; Heart Failure, Congestive

Summary: the purpose of this study is to examine whether spironolactone will improve exercise tolerance and quality of life in elderly patients with heart failure preserved ejection fraction (hfpef).

exercise intolerance due to hfpef is a major cause of disability among older americans. several lines of evidence suggest that aldosterone antagonism may improve exercise tolerance in hfpef. therefore, the primary aim of this study is to test the hypothesis that spironolactone will improve exercise tolerance and quality of life in elderly patients with isolated hfpef. a total of 72 participants aged 60 or older will be randomized to receive either spironolactone 25mg daily or a placebo.

Eligibility criteria:
inclusion criteria: * ambulatory * medically stable * ages 60 or older * diagnosis of diastolic heart failure exclusion criteria: * valvular heart disease * significant change in cardiac medication within the past 4 weeks * uncontrolled hypertension * recent or debilitating stroke * cancer or other noncardiovascular conditions with life expectancy less than 2 years * anemia * elevated serum potassium * renal insufficiency * psychiatric disease (uncontrolled major psychoses, depression, dementia, or personality disorder) * allergy to spironolactone; currently taking spironolactone or any aldosterone antagonist * plans to leave area within 1 year * refuses informed consent * failure to pass screening tests: pulmonary function, echocardiogram, or exercise * contra-indications to magnetic resonance imaging \[mri\] (indwelling metal-containing prosthesis; pacemaker or defibrillator; history of welding occupation; uncontrollable claustrophobia)
physician's evaluation of cyclosporine ophthalmic emulsion 0.05%

Conditions: Dry Eye Disease

Summary: the objective of this retrospective chart review is to evaluate the patient characteristics, treatment variations and efficacy of a second trial of cyclosporine ophthalmic emulsion 0.05% therapy in chronic dry eye patients who were initially treated with cyclosporine ophthalmic emulsion 0.05% but discontinued use after less than 12 weeks of treatment.


Eligibility criteria:
inclusion criteria: * adults \>16 years of age * dry eye patients * subject with history of less than 12 weeks of initial restasis® treatment * subject started second trial of restasis® treatment prior to june 1, 2008 * first day of second trial of restasis® started ≥ 4 weeks after the last day of previous restasis® treatment exclusion criteria: * patients with contact lens intolerance * patients with ocular rosacea
pilot study of minocycline in huntington's disease

Conditions: Huntington Disease

Summary: this study is being conducted to assess the impact of minocycline on the progression of symptoms of hd. the study will also assess whether it is reasonable to continue with further study of minocycline in hd. we will measure the effect of minocycline on hd by measuring the change in huntington's disease symptoms.

the domino study is a randomized, double-blind, multi-center, futility study of minocycline in patients with hd. subjects will be randomized (3:1) to one of the two study arms: (1) the group that receives active minocycline (100 mg po b.i.d.), and (2) the group that receives placebo. subjects will be enrolled over an approximate six-month period and remain on blinded study drug for 18 months. the primary analysis will involve a comparison of the change over time in tfc between the minocycline group and a fixed value determined from historical control data. a placebo group will also be included to facilitate blinding and to permit a descriptive assessment of the validity of the assumed change over time in historical controls.

Eligibility criteria:
inclusion criteria: * age 18 years or older * clinical features of hd and a confirmatory family history of hd; and/or genetically confirmed hd * independently walking and fully self-sufficient in activities of daily living (eating, dressing, bathing) * able to take medication (capsules) by mouth exclusion criteria: * history of known hypersensitivity or intolerability to minocycline or known allergy to any tetracycline * history of vestibular disease * subjects with underlying hematologic, hepatic or renal disease * history of systemic lupus erythematosus (sle)

Keywords: study of minocycline in huntington's disease
randomized anticoagulation trial in opcab (ratio)

Conditions: Ischemic Heart Disease

Summary: the ratio study is a multicenter, nationwide, randomized, controlled, single blinded, unfunded trial of n. 900 patients undergoing multivessel opcab (≥2 grafts). this study is designed to test in patients undergoing off-pump coronary artery bypass surgery the hypothesis that full (high dose, 300 u/kg) and half (low dose,150 u/kg) heparinization are not different in terms of thrombotic complications and major perioperative bleeding events (null hypothesis).

off-pump coronary artery bypass grafting (opcab) is an established alternative to on-pump coronary artery bypass grafting (cabg). opcab determines a pro-coagulant state potentially deleterious on grafts patency, that is not counterbalanced by the adverse effects of cardiopulmonary bypass on coagulation occurring in cabg, and that lasts as long as one month. therefore in opcab systemic heparinization is necessary to prevent thrombotic complications during transitory occlusion of coronary arteries and grafts. an internationally accepted standard intra-operative anticoagulation protocol for opcab has not yet been defined, and heparinization in opcab is a highly variable practice. the intraoperative anticoagulation regimen adopted in patients undergoing opcab may influence major postoperative outcomes, such as bleeding, transfusion requirements, inflammatory response, myocardial ischemia and grafts patency, but it has never been the object of large-scale randomized controlled trial (rct). the 2 most widespread intraoperative anticoagulation protocols in opcab are represented by full (300 u/kg) or half (150 u/kg) heparinization, with target act ranging from 200 sec to \>480 sec. patients enrolled in the study will be randomized to receive full or half heparinization in a 1:1 ratio using a randomization schedule blocked by site. randomization will take place in the operatory room by the anesthesiologist, and will be blinded to the surgeon.

Eligibility criteria:
inclusion criteria: consecutive patients electively undergoing multivessel opcab exclusion criteria: acute coronary syndrome, on-going double anti-platelets treatment (the second antiplatelet drug should be suspended 5 days before surgery), on-going intravenous heparin or sub-cutaneous low molecular weight heparin, known coagulopathy, documented liver disease, chronic renal failure (creatinine ≥ 2 mg/dl) or previous renal transplantation surgery, previous cardiac surgery.

Keywords: off-pump coronary artery bypass heparinization
effect of midazolam on inflammatory response and organ function in mechanically ventilated sepsis patients with different immune status

Conditions: Inflammatory Disorder of Immune System; Sepsis

Summary: icu patients always experience all kinds of pain, discomfort and sleep disturbance,especially the sepsis patients. appropriate sedation and analgesia is must,the newest sepsis guideline strongly recommend that mechanically ventilated sepsis patients need sedation therapy. recent studies show than immune dysfunction dose have an important effect on the occurrence and development of sepsis. when the body suffer from the pathogenic microorganism attacking and sepsis, it activate the systemic inflammatory response (sirs) and compensatory anti-inflammatory response syndrome (cars). when it is out of balance between sirs and cars, the inflammatory response, immune paralysis or immune dysfunction occurs and the mixed anti-inflammatory response syndrome (mars) exists, and then the multiple organ dysfunction. so, immune dysfunction is thought to be the key factors on the development of the sepsis. some studies show that the sedation drug such as midazolam, propofol, dexmedetomidine could suppress the inflammatory response effectively and then modulate the immune function. several recent studies show that midazolam has the immunoregulation effect and trend of suppress the inflammatory response, but the result is controversy, the possibly reason is the different immune status. now there is the guideline about the different immune status: the normal immune function means that the value of mhla-dr is more than 15000 monoclonal antibody; moderate-sever immune suppression means that the value of mhla-dr is in the range of 5000 and 15000 monoclonal antibody; the immune paralysis means that the value of mhla-dr is less than 5000 monoclonal antibody. the purpose of the study is to explore the effect of midazolam to inflammatory response and organ function at mechanically ventilated sepsis patients who have different immune status.


Eligibility criteria:
inclusion criteria: 1. mechanically ventilated icu patients, sedation is needed. 2. sepsis patients. 3. age 18-80 yrs 4. anticipated sedation duration is more than 3 days. 5. agreed to participate the study and assigned the informed consent. - exclusion criteria: 1. allergic to the benzodiazepine. 2. hepatic dysfunction(child-pugh is c level). 3. participated other study. 4. bad prognosis and possibly become the major reason of patients death, such as sever craniocerebral injury,cardiopulmonary resuscitation,advanced malignant tumor,etc. 5. history of immune system disease, immune treatment (including hormone ) or treatment that could affect immune function (including continuous renal replacement therapy,crrt). 6. alcoholic and drug abuse. 7. tendency for major mental disease or treatment of anti psychotics. 8. pregnant,lactation woman. 9. unwilling to assign the informed consent or bad compliance. -

Keywords: organ function sedation
glaucoma treatment by cyclo-coagulation using high intensity focused ultrasound (hifu)

Conditions: Glaucoma

Summary: the purpose of this study is to evaluate the effectiveness and the safety of the cyclocoagulation using high intensity focused ulatrsound with the eyeop1 device in glaucoma patients


Eligibility criteria:
inclusion criteria: * refractory glaucoma * iop \> 21 mm hg * no previous intraocular surgery or laser treatment during the 90 days before hifu day * age \> 18 years * informed consent sgned by the subject exclusion criteria: * normal tension glaucoma * glaucoma drainage device implanted and still present in the eye to be treated * history of ocular or retrobulbar tumor * ocular infection within 14 days prior to the hifu procedure * aphakic patient * ocular disease other than glaucoma that may affect assessment of visual and/or iop (choroidal hemorrhage or detachment, lens subluxation, thyroid ophthalmopathy, proliferative diabetic retinopathy, clinical significant macular edema) * pregnant or breast-feeding women, or lack of contraception use among women likely to have a child

Keywords: glaucoma cyclocoagulation hifu high intensity focused ultrasound
feedback reports and e-learning in primary care spirometry

Conditions: Respiratory Tract Diseases; Pulmonary Disease, Chronic Obstructive; Asthma

Summary: spirometry is a biomedical test to measure lung function in subject who (may) have a chronic respiratory condition. performing the test requires a certain level of training and experience from the health care professional who conducts the test, and sufficient cooperation of the patient. although the test is widely used in primary care in many countries, the quality of the test performance seems limited and needs improvement in order to avoid false-positive and false-negative test interpretations. in this study, the researchers investigated whether a combination of e-learning and bimonthly written performance feedback to family practice nurses and assistance regarding their spirometry tests improves the rate of adequate tests.


Eligibility criteria:
inclusion criteria for family practices: * collaboration with elkerliek hospital helmond through regional integrated care support service ('quartz') * purchased spirometer through this support service * have implemented spirometry as a part of routine patient care inclusion criteria for patients: * registered in one of the participating family practices * performed a spirometry test as a part of routine care during the observation period of the study exclusion criteria for patients: * age \< 10 years

Keywords: spirometry family practice randomized controlled trial feedback intervention studies
reduced intensity transplant in medically refractory systemic lupus erythematosus (sle) and systemic sclerosis (ssc)

Conditions: Systemic Lupus Erythematosus; Systemic Sclerosis

Summary: the purpose of this study is to determine if a reduced intensity (ri) (non-myeloablative) chemoimmunotherapy followed by allogeneic stem cell transplantation allosct (matched family donors and matched unrelated cord blood donors) will be well tolerated.

this is to test whether a reduced intensity will result in a high degree of mixed or complete donor chimerism and stabilization of autoimmune disease in a select group of patients with medically refractory sle or ssc.

Eligibility criteria:
inclusion criteria: * diffuse systemic sclerosis and variants as per acr criteria * medically refractory disease * adequate organ function - pulmonary function * renal function, cardiac function defined as: * sgot (ast) or sgpt (alt) \<5 x upper limit of normal * diagnosis of sle - medically refractory disease exclusion criteria: * karnofsky/lansky \<60%

Keywords: autoimmune disease reduced intensity transplant