Kornimate/medical-research-clean huggingface dataset:
resection of the primary tumor vs. systemic treatment alone for patients with small intestinal neuroendocrine tumors and unresectable metastases: a europe-wide study

Conditions: Neuroendocrine (NE) Tumors; Metastasis; Bowel Obstruction

Summary: when possible, surgery to completely remove small intestinal neuroendocrine tumors (sinets) is always recommended. however, in cases where the tumor has spread and cannot be cured completely, it is unclear whether a surgical removal of the primary tumor only is reasonable. in this situation, current guidelines from the european neuroendocrine tumor society (enets) recommend surgery only for patients who have symptoms like intestinal blockage or bleeding, or are at risk of such complications. for patients without symptoms, it is still unclear whether removing the main tumor improves overall outcomes and prevents future problems. studies evaluating this type of surgery on survival show conflicting results. these studies often do not separate patients with symptoms from those without, and they overlook other important factors like the amount of cancer in the liver and nearby tissues. due to these uncertainties, the rarity of sinets and many factors that can affect outcomes, like age, overall health, or other current treatments, conducting a high-quality study to answer this question is challenging. to address this, the present europe-wide study is being planned. this study aims to determine if resecting the main tumor improves the 10-year overall survival and reduces risks like intestinal blockages or blood flow issues compared to no surgery in patients without symptoms. the study will also assess other outcomes, such as how long patients stay free from disease progression, the risks of surgery, and prognostic factors for long-term survival. this international collaboration among neuroendocrine tumor referral centers will provide robust evidence to guide clinical practice and update treatment guidelines for sinets.


Eligibility criteria:
inclusion criteria: - all patients with sinet and non-curative metastatic disease between 01.01.2005 and 31.12.2019 will be included. exclusion criteria: - all patients with sinet g3, resectable metastatic disease and/or non-resectable primary tumor at initial diagnosis will be excluded. furthermore, symptomatic patients (small intestinal obstruction, bleeding) or when imaging suggests that obstruction will probably occur (bowel dilatation, mesenteric fibrosis) at initial diagnosis will be excluded. patients with diarrhea, flushing, or abdominal pain will not be excluded. patients with a documented rejection for a further use of their data for scientific purposes will also be excluded.
immunogenicity & safety of bio farma's measles-rubella (mr) vaccine in indonesian infants (bridging study)

Conditions: Congenital Rubella Infection; Measles

Summary: thus study is a clinical trial for measles and rubella vaccine that will be used inindonesian national program of immunization. the study design will be randomized, observer blind, prospective intervention study.

the objectives of the study are: * to assess the protectivity rate of bio farma's measles/rubella (mr) vaccine in infants * to describe antibody response to measles and rubella after 1 dose of bio farma's mr vaccine as a primary dose in infants * to assess the safety of bio farma's measles/rubella (mr) vaccine in infants * to evaluate immunogenicity and safety one dose of bio farma's mr vaccine compare to registered mr vaccine. * to evaluate immunogenicity and safety in three consecutive batches of bio farma's mr vaccine in infants .

Eligibility criteria:
inclusion criteria: 1. healthy infants, 9-12 months 2. parents have been informed properly regarding the study and signed the informed consent form 3. parents will commit themselves to comply with the instructions of the investigator and the schedule of the trial. exclusion criteria: 1. subject concomitantly enrolled or scheduled to be enrolled in another trial. 2. evolving mild, moderate or severe illness, especially infectious diseases or fever (axillary temperature \> 37.5 centigrade). 3. known history of allergy to neomycin, kanamycin or erythromycin or any component of the vaccines. 4. history of immunodeficiency disorder or disorders like hiv infection, leukemia, lymphoma, or generalized malignancy that can alter immune response. 5. subjects who have previously received any measles and/or rubella containing vaccines. 6. subjects who had a clinical history of measles/rubella infection. 7. subjects who has received in the previous 3 months a treatment likely to alter the immune response (intravenous immunoglobulin, blood-derived products or long term corticosteroidtherapy (\> 2 weeks). 8. any abnormality or chronic disease which according to the investigator might interfere with the assessment of the trial objectives. 9. subject already immunized with any vaccine within 4 weeks prior vaccination.

Keywords: vaccine measles rubella bio farma
pyrotinib, trastuzumab, pertuzumab and nab-paclitaxel as neoadjuvant therapy in her2-positive breast cancer

Conditions: Breast Cancer Invasive

Summary: this study aims to evaluate the efficacy and safety of pyrotinib in combination with trastuzumab, pertuzumab and nab-paclitaxel as neoadjuvant therapy in early stage or locally advanced her2-positive breast cancer.

the study evaluate the pathological complete response rate, event-free survival, disease-free survival, overall survival and safety of pyrotinib in combination with trastuzumab, pertuzumab and nab-paclitaxel as neoadjuvant therapy in early stage or locally advanced her2-positive breast cancer. patients will receive 4 cycles of pyrotinib in combination with trastuzumab, pertuzumab and nab-paclitaxel or 4 cycles of trastuzumab, pertuzumab and nab-paclitaxel as neoadjuvant therapy, then undergo surgery, then receive adjuvant chemotherapy and targeted therapy according to pathologic response and physician's choice.

Eligibility criteria:
inclusion criteria: * with signed consent * histologically confirmed invasive breast carcinoma with a primary tumor size of no less than (≥) 2 centimeters (cm) by standard local assessment technique * breast cancer stage at presentation: stage ii-iii * her2-positive breast cancer defined as 3+ score by immunohistochemistry in \> 10 percent (%) of immunoreactive cells or her2 gene amplification by in situ hybridization * known hormone receptor status (estrogen receptor and/or progesterone receptor) * eastern cooperative oncology group performance status equal to or less than (\<=) 1 * baseline left ventricular ejection fracture \>= 50% measured by echocardiography * willing to use highly effective form of nonhormonal contraception while on study and for 7 months after end of study treatment for female with fertility or male * willing to obey the study protocol exclusion criteria: * stage iv disease * previous anti-cancer therapy or radiotherapy for any malignancy * history of other malignancy within 5 years prior to screening, except for appropriately-treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, ,stage i uterine cancer or thyroid papillary microcarcinoma * concurrent anti-cancer treatment in another investigational trial, including hormone therapy, bisphosphonate therapy, or immunotherapy * major surgical procedure unrelated to breast cancer within 4 weeks prior to randomization or from which the participant has not fully recovered * serious cardiac illness or medical condition * other concurrent serious diseases that may interfere with planned treatment, including severe pulmonary conditions/illness * any abnormalities in liver, kidney or hematologic function laboratory tests immediately prior to randomization * sensitivity to any of the study medications, any of the ingredients or excipients of these medications, or benzyl alcohol * not able to swallow the drug * pregnant or lactating * positive serum or urine pregnancy test or above mentioned tests cannot be achieved for women with fertility

Keywords: her2-positive stage ii-iii
a safety/efficacy study of intracoronary integrilin to improve balloon angioplasty outcomes for the treatment of heart attacks

Conditions: ST-Elevation Myocardial Infarction

Summary: the main purpose of this research study is to try to improve the results of the standard treatment for heart attacks. normally, heart attack patients get a fast dose and a slow dose of eptifibatide in the emergency room, shortly after arriving. this drug is usually given through a vein in the arm. however, eptifibatide can also be injected directly into the heart's blood supply just before angioplasty, a common procedure to unblock a blood vessel in the heart. this new way of giving the drug is being studying.

the primary objective of the ic-titan study is to demonstrate that an ic bolus of eptifibatide added to an upstream double-bolus and infusion regimen of eptifibatide administered intravenously and initiated early in the er will result in significant additional clot resolution in vivo when compared with an ic injection of placebo (saline). the primary endpoint chosen to evaluate this hypothesis is the improvement in percent diameter stenosis of the culprit artery following the ic bolus administration of eptifibatide vs. ic placebo (saline) as assessed with quantitative coronary angiography (qca).

Eligibility criteria:
inclusion criteria: clinical * patients (men or women) at least 18 years of age and * presenting with ischemic chest discomfort \>20 minutes and \<6 hours of duration suggestive of acute myocardial infarction and: ecg * st elevation \>1mm (\>0.1mv) in two contiguous limb leads or \>2mm (\>0.2mv) in two contiguous precordial leads exclusion criteria: clinical * maximal systolic blood pressure \<80 mmhg after initial fluid and/or pressor resuscitation * uncontrolled hypertension (sbp\>180 or dbp \>110) at time of enrollment * ventricular fibrillation or ventricular tachycardia requiring dc cardioversion * sinus bradycardia (hr \<50/min), third degree or advanced second degree heart block. * known pregnancy * new or suspected new left bundle branch block biochemical * known thrombocytopenia (platelet count \<100,000) * known severe renal insufficiency (creatinine \>4.0 mg/dl) increased bleeding risk * active or recent (\<1 year) bleeding or gastrointestinal hemorrhage * major surgery \<1 month * known coagulopathy, platelet disorder or history of thrombocytopenia: if a patient is known to be on chronic warfarin therapy, the international normalized ratio (inr) must be known to be \<1.6 in order for the patient to be included * known neoplasm * any history of hemorrhagic cerebrovascular disorder or active intracranial pathology medications * administration of a fibrinolytic agent within 7 days * known allergy or contraindication to eptifibatide or aspirin or heparin * treatment with another gp iib/iiia inhibitor within 7 days

Keywords: eptifibatide integrilin st-elevation myocardial infarction acute myocardial infarction
the role of indocyanine green (icg) fluorescence imaging on anastomotic leak in robotic colorectal surgery

Conditions: Colon Neoplasms; Rectal Neoplasms; Inflammatory Bowel Disease; Diverticular Disease

Summary: in colorectal surgery, anastomotic leak and its septic consequences still remain as the most concerning complications resulting in substantial morbidity and mortality. a common determining factor for assessing the viability of a bowel anastomosis is adequate arterial perfusion to ensure sufficient local tissue oxygenation. intraoperative near-infrared fluorescence (inif) imaging using indocyanine green (icg) dye is a novel technique which allows the surgeon to choose the point of transection at an optimally perfused area before creating a bowel anastomosis. recently, the inif imaging system has been installed on the robotic systems and this helps identify intravascular nif signals in real time. although reports from several case series and retrospective cohorts have described the feasibility and safety of this imaging system during robotic colorectal surgery, to date, no studies have addressed more systematically the outcomes of this technique in robotic surgery. considering the limitations of these reports, investigators aim to conduct a prospective randomized trial to compare robotic procedures with or without inif imaging in patients undergoing colorectal surgery.


Eligibility criteria:
inclusion criteria: * subject is able to give informed consent for participation in the study * subject is willing and able to comply with the study procedures * subject is diagnosed with colon/rectal neoplasia, inflammatory bowel disease, diverticular disease requiring surgical excision * subject is scheduled for robotic colon or rectal resection * a negative pregnancy test for women of childbearing potential prior to surgery exclusion criteria: * subjects present with bowel obstruction or perforation * subject undergo emergency surgery * subject with asa iv, v * history of allergy or hypersensitivity against indocyanine green * pregnant or breast-feeding women * subject has uremia (serum creatinine \>2.5 mg/dl) * subject is undergoing palliative surgery or who is terminally ill * subject who is unable to discontinue warfarin anticoagulation 5 days before surgery * subject taking phenobarbital, phenylbutazone, primidone, phenytoin, haloperidol, nitrofurantoin, probenecid

Keywords: colorectal disease robotic surgery indocyanine green fluorescence imaging anastomotic leak short-term outcomes
a study of mircera in patients with kidney disease who are not on dialysis

Conditions: Renal Tubular Acidosis, Distal, With Hemolytic Anemia

Summary: this open-label, non-randomized, retrospective-prospective, non-interventional study will evaluate the efficacy and safety of mircera in patients with stage iii-iv chronic kidney disease (ckd) not on dialysis. patients will receive open-label treatment with mircera for 12 months at a dose to be determined by the investigator.


Eligibility criteria:
inclusion criteria: * patients with stage ii-iv ckd not on dialysis, including renal transplant patients, who are receiving erythropoiesis-stimulating agent (esa) treatment or are esa-naive * patients who will not require dialysis within 12 months after the start of mircera therapy * patients whose life expectancy is greater than 12 months after mircera initiation * patients \>/= 18 years and \</= 75 years of age * patients who are female and of childbearing potential must be using effective contraception methods * patients with no contra-indications to esa treatment (for example, hypersensitivity, non-controlled hypertension and others according to the local smpc) * patients who have given written informed consent where local regulations allow or require it exclusion criteria: * patients with stage i-ii or stage v ckd * poorly controlled hypertension * active malignant disease
is there an immediate effect on pectoralis minor length after performing a prone scapular retraction exercise

Conditions: Pectoralis Minor Length

Summary: the goal of this clinical trial is to test normal participants. the main question it aims to answer is: • do the participant's pectoralis minor muscles change length immediately after performing an exercise that recruits the scapular retractor muscles? participants will have their pectoralis minor muscle measured, then perform an exercise recruiting the scapular retractor muscles, and then have their pectoralis muscle measured again.

the participants will have their standing height measured in centimeters with a tape measure fixed against a wall. participants will then step away from the wall and will be asked to stand in their normal resting position. a mark will be placed on the most medial-inferior aspect of the coracoid process and a second mark on the anterior-inferior edge of the third rib, one index finger's width lateral to the sternum. a caliper will then be used to measure the distance between these marks as the participant holds a normal exhalation. participants will then lay prone on a treatment plinth with a small towel roll under their forehead. the participants will form both fists and place them on the plinth just superior to their head, with bilateral thumbs up and the ulnar side of the hands resting on the plinth, and their arms relaxed so their elbows remain on the plinth. the participants will then lift their elbows off the plinth as high as possible while keeping their hands on the plinth. the participants will repeat this motion for 10 repetitions, performing three sets of this exercise with 30 seconds of rest in between each set. after the third set, the participants will stand up and a second caliper will be used to once again measure pm length by the same tester using the same marks. this will conclude the testing procedure and the participant's involvement in the study.

Eligibility criteria:
inclusion criteria: * 18 years of age or older. at least 130 degrees of shoulder elevation. none of the exclusion criteria. exclusion criteria: * current shoulder pathology and or pain, prior shoulder surgery, any neurological impairment, any upper quarter deformity, a fracture of the upper extremity, or systemic inflammatory disease.

Keywords: pectoralis minor reciprocal inhibition
dermal substitute and topical negative pressure in burns

Conditions: Burns

Summary: the purpose of this study is to determine whether a treatment of full thickness wounds by the dermal substitute matriderm, split skin graft and vac treatment will improve scar quality, demonstrated by a significant increase of skin elasticity parameters after 3 months. additionally, an increase of the take of graft and improvement of scar assessment scale, scar colour/pigmentation and time to complete wound closure, is expected.

the standard therapy for full thickness wounds is transplantation with a split thickness skin graft. however, scars usually develop as a result of this therapy. previous research has demonstrated an improvement of scar quality if a dermal substitute was applied in combination with a split skin graft in reconstructive wounds, but not so much in burn wounds. one of the problems in burn wounds was the retarded outgrowth of the skin graft when a dermal substitute was applied in a one step procedure with the graft. since then, application of topical negative pressure has demonstrated that the take and outgrowth of a skin graft can be improved by this technique. it now seems feasible to combine these two technologies in order to improve the quality of healing of burn wounds in the acute phase of healing. aim of the study is to investigate if application of a dermal substitute in combination with topical negative pressure can improve the quality of the scar in burn wounds.

Eligibility criteria:
inclusion criteria: * patients \>=18 yrs with acute burns/trauma wounds that require skin grafting * minimal study wound surface 10 cm2 * maximal study wound surface 300 cm2 * maximal tbsa 15% full thickness wounds * informed consent exclusion criteria: * patients with wounds without adequate possibility to apply vac * immunocompromised patients * infected wounds * pregnant patients * patients who are expected (according to the responsible medical doctor) to be non-compliant to the study protocol. this includes patients with severe cognitive dysfunction/impairment and severe psychiatric disorders (e.g. borderline or depression).

Keywords: matriderm dermal matrix vac therapy split skin graft burns scar quality
does etanercept influence tweak modulation of inflammation during inflammatory rheumatisms (psoriatic arthritis and rheumatoid arthritis)?

Conditions: Inflammatory Rheumatism; Psoriatic Arthritis; Rheumatoid Arthritis

Summary: tweak (tnf weakly inducer of apoptosis) is a type ii-transmembrane protein, member of the tnf ligand superfamily that can be cleaved to function as a soluble cytokine. depending on target cell type, tweak triggers multiple cellular responses ranging from modulation of inflammation to cell death when it binds to its main receptor, fn 14. our team has been the first to describe pro-inflammatory effects of tweak during central nervous system inflammation. various data support the possibility that tweak produced by synovial macrophages may contribute to chronic synovitis in animal models and in humans. in psoriatic arthritis (psoa), anti-tnf therapy has been successful concording with the key role of tnf in the pathogenesis of this disease and the generation by psoriatic patients of neutralizing anti-tnf autoantibodies referred as "beneficial autoimmunity to pro-inflammatory mediators". in 2010, van kuijk et al. have described a high expression of tweak in the inflammatory synovial of psoa and rheumatoid arthritis (ra) patients before and after anti-tnf therapy. the role of tnf-alpha in the regulation of tweak expression remains unclear.


Eligibility criteria:
inclusion criteria: * · group rhpso : * fill(perform) the criteria caspar of the rheumatism psoriasic (taylor w, on 2006) * rheumatoid absence of factor and antibody anti-ccp(anti-post office account) (cyclic citrulline peptide) in the serum * indication established to begin a treatment with etanercept · group pr * fill(perform) the criteria of the acr (american college of rheumatology) for pr (revised in 1987) (arneth fc, on 1988) * presence of antibody anti-ccp(anti-post office account) in the serum * indication established to begin a treatment with etanercept exclusion criteria: * minors(miners) * pregnant or breast-feeding women * adults under guardianship * nobody staying in a sanitary or social establishment * persons in emergency situation and/or not beneficiaries of a national insurance scheme * private persons of freedom * arthritis or not labelled polyarthritis * contraindication established in the treatment(processing) by etanercept * puvathérapie or cyclosporine or high dose of corticosteroid therapy (except intra-articular infiltration) or other anti-tnf treatment(processing) in two months preceding the inclusion
physical status of osa patients

Conditions: Obstructive Sleep Apnea Syndrome

Summary: to investigate the differences in postural stability, anxiety/depression, and quality of life of the patients according to the severity of obstructive sleep apnea syndrome.


Eligibility criteria:
inclusion criteria: * age \> 18 years old. * getting a diagnosis of osas with polysomnography. * agree to participate in the study. exclusion criteria: * having respiratory system disease (copd, asthma, bronchiectasis, lung cancer, etc.). * sedative, hypnotic drug intake. use of medical supplements such as diazepam. * hypothyroidism, acromegaly. * diagnosis of a psychiatric illness. * uncontrolled arrhythmia causing symptoms or hemodynamic impairment. * pulmonary edema. pregnancy.