Kornimate/medical-research-clean huggingface dataset:
the approach open label study: a study of volanesorsen (formerly ionis-apociiirx) in participants with familial chylomicronemia syndrome

Conditions: Familial Chylomicronemia Syndrome; Lipoprotein Lipase Deficiency; Hyperlipoproteinemia Type 1

Summary: an open-label study of volanesorsen (isis 304801) administered subcutaneously to participants with fcs.

this is a multi-center, open-label study for fcs participants rolling over from the isis 304801-cs6 (nct02211209) index study, fcs participants rolling over from the isis 304801-cs16 (nct02300233) index study and treatment-naïve group. all participants were to receive volanesorsen 300 milligrams (mg) once per week for 52 weeks. participants were allowed dose adjustment/dose reduction based on monitoring rules. participants had the option of continuing dosing for an additional 52 weeks (france: up to an additional 104 weeks for a total of 156 weeks) until an expanded access program was approved and available in their country. participants who were not participating in an expanded access program were to enter a 13-week (france: 26-week) post-treatment evaluation period.

Eligibility criteria:
inclusion criteria: * must give written informed consent to participate in the study (signed and dated) and any authorization required by law. * able and willing to participate in a 65-week study. group 1 and 2: * satisfactory completion of isis 304801-cs6 (nct02211209) or isis 304801-cs16 (nct02300233) index studies with an acceptable safety profile, per sponsor and investigator judgment. group 3: * participants who did not participate in the cs6 or cs16 index studies and meet additional inclusion criteria of fcs may enroll in the study. * history of chylomicronemia. * a diagnosis of fcs (type 1 hyperlipoproteinemia.) * fasting triglycerides greater than or equal to (≥)750 milligrams per deciliter \[mg/dl\] (8.4 millimoles per liter \[mmol/l\]) at screening. exclusion criteria: * unwilling to comply with lifestyle requirements for the duration of the study. group 1 and 2: * have any new condition or worsening of existing condition which in the opinion of the investigator would make the participant unsuitable for enrollment, or could interfere with the participant participating in or completing the study. group 3: * diabetes mellitus if newly diagnosed or if hemoglobin a1c (hba1c)≥ 9.0%. * active pancreatitis within 4 weeks of screening. * acute coronary syndrome within 6 months of screening. * major surgery within 3 months of screening. * treatment with glybera therapy within 2 years of screening. * have any other conditions in the opinion of the investigator which could interfere with the participant participating in or completing the study.
reduction of physical inactivity facing the cancer

Conditions: Breast Cancer

Summary: study 1: the investigator hypothesizes that the level of knowledge about the benefits of physical activity, physical activity level and physical fatigue level observed in cancer patients, would influence their beliefs about physical activity and their intention to engage in ap.

study 2: because of a recent research, it is shown that a narrative message from a peer generates an identification, a sense of self-efficacy and intention to practice in sedentary patients with breast cancer. the investigator hypothesize that a promotional message about physical activity, issued by a self-determined peer (intrinsic motivation), compared to a non-self-determined peer (extrinsic motivation), generate higher scores of positive beliefs about physical activity and intention to engage in a physical activity program for sedentary patients. these promotional messages will be delivered through two videos, one featuring the self-determined pair, the other featuring the non-self-determined pair.

Eligibility criteria:
inclusion criteria: * ps 0-3 * patients with breast cancer undergoing chemotherapy treatment * neoadjuvant, adjuvant, metastatic, any histological type, any stage breast cancer * sedentary patients (physical activity score of dijon less than or equal to 20) exclusion criteria: * patients with ps greater than 3 * patients with cognitive disorders not allowing them to understand the questionnaires and study procedures
follow-on protocol of pitavastatin versus simvastatin in patients with hypercholesterolemia or dyslipidemia and coronary heart disease risk factors

Conditions: Hypercholesterolemia; Dyslipidemia; Coronary Heart Disease

Summary: this is a sixteen-week follow-on and 28 week single-blind extension study for patients who participated in study nk-104-304.

this is a sixteen-week, double-blind, active controlled, follow-on and 28 week single blind extension study for patients who participated in nk-104-304.

Eligibility criteria:
inclusion criteria: * completed nk-104-304 (nct 00309738) * hypercholesterolemia or combined dyslipidemia * 2 or more risk factors for coronary heart disease (chd) exclusion criteria: * withdrawn or terminated from nk-104-304 (00309738)

Keywords: hypercholesterolemia dyslipidemia chd pitavastatin simvastatin 2 or more risk factors for coronary heart disease combined dyslipidemia
the influence of perioperative administration of dexmedetomidine on inflammation response and postoperative recovery in patients undergoing robot or laparoscopic assisted gastrectomy

Conditions: Gastric Cancer; Gastrostomy

Summary: many studies have shown that inflammation has an important effect on the development, progression, and also response to treatment of tumors. dexmedetomidine is a potent and selective alpha 2 receptor agonist, known to have a sedative, analgesic and immune-controlling effect. the purpose of this study is to investigate the effect of dexmedetomidine during surgery on postoperative inflammatory response and surgical recovery in gastric cancer patients undergoing robot or laparoscopic gastrectomy.

* experimental group (dexmedetomidine group) continuous iv precedex™ using infusion pump (terufusion te-311, terumo, tokyo, japan) during surgery (from immediately after induction to before starting peritoneum closure) infusion rate 0.4μg/kg/hr * control group (normal saline group) continuous iv normal saline using infusion pump (terufusion te-311, terumo, tokyo, japan) during surgery infusion rate 0.4μg/kg/hr

Eligibility criteria:
inclusion criteria: * 1. 20-70 yrs old patients * 2. scheduled for robot or laparoscopic gastrectomy * 3. body weight under 90kg and bmi under 32 exclusion criteria: * 1. emergency operation * 2. reoperation * 3. co-operation with other surgery department * 4. co-operation with other organs (except cholecystectomy) * 5. patients with history of heart failure (unstable angina, congestive heart failure) * 6. patients with history of arrhythmia (specially av nodal block), ventricular conduction problem * 7. patients with history of uncontrolled hypertension (diastolic bp \>110mmhg), extremely bradycardia (hr \<45 bpm on ecg) * 8. patients with history of cerebrovascular disease (cerebral hemorrhage, cerebral ischemia * 9. patients who is steroid user * 10. patients who is beta blocker user * 11. patients with history of liver failure, renal failure, allergic to medicine * 12. patients with history of uncontrolled psychiatric disease (ptsd, anxiety, depression) * 13. patients who cannot read the consent form (examples: illiterate, foreigner) * 14. patients who withdraw the consent

Keywords: gastric cancer laparoscopic gastrectomy robotic gastrectomy
a blinded study to examine the ability of pf-610,355 to open the airways in asthmatic patients.

Conditions: Asthma

Summary: a study to determine the ability of different doses of pf-610,355 to open the airways in asthmatic patients by comparison with placebo and a marketed drug that also opens the airways in asthmatic patients.


Eligibility criteria:
inclusion criteria: * reversible asthmatic patients (\>15% increase in fev1 following 200ug salbutamol). * fev1 greater than or equal to 60% predicted * stable disease for at least the previous 3 months exclusion criteria: * subjects requiring rescue medication on greater than 2 occasions in the 72 hours prior to screening * subjects with a history of pulmonary disease other than asthma.
study to learn how the drug aflibercept works in in japanese patients with increased eye pressure that is caused by new blood vessels growing in the eye (neovascular glaucoma or nvg). safety of the drug and patients' tolerability of the drug injection is also studied

Conditions: Glaucoma, Neovascular

Summary: the researchers in this trial want to learn how the drug aflibercept works in in japanese patients with increased eye pressure that is caused by new blood vessels growing in the eye (neovascular glaucoma or nvg). they also want to find out how patient tolerate the application of the drug that is injected in the vitreous humor of the eye and if this will cause any medical problems during the trial (vitreous humor, also called vitreous body is the clear gel that fills the space between the lens and the retina of the eyeball).


Eligibility criteria:
inclusion criteria: * japanese men and women aged 20 years or older * patients diagnosed as having nvg (neovascular glaucoma) with neovascularization in the anterior segment (both iris and anterior chamber angle) * patients with iop (intraocular pressure) higher than 25 mmhg in the study eye due to anterior segment (both iris and anterior chamber angle) neovascularization exclusion criteria: * patients with angle-closure due to conditions other than nvg or complete angle-closure due to nvg * patients with a known or suspected ocular or peri-ocular infection * patients with severe intraocular inflammation in the study eye * women who are pregnant, suspected of being pregnant or lactating * patients with known allergy to aflibercept
socio-emotional development in preterm infants

Conditions: Preterm Infants

Summary: with advances in medicine and medical technology, premature infants born as early as 24 weeks of gestation and with birth weight less than 1000 grams are surviving today. preterms are born with immature biological systems. given their biological vulnerabilities, preterm infants are at risk for a variety of health and developmental problems. as a group, preterms show developmental delays in physical growth, motor skills, attention, social communicative skills, intelligence, language, academic performance, and later behavior problems. furthermore, research indicates that preterms are difficult social partners for their parents. despite biological insults and relational difficulties, research also shows that the development of premature infants appears to be facilitated by sensitive and responsive parenting. little attention, however, has been paid to understand the social risks faced by preterm infants. the proposed research, therefore, is designed to: 1. understand the extent to which neurophysiological risk may affect preterm infants' socioemotional development, 2. explore the role of maternal social support, sociopsychological stress, and perception of infant vulnerability in the socioemotional development of preterm infants varying in biological risk, 3. examine the role of social support in buffering stress in mothers of preterm infants, and 4. evaluate the role of maternal stress, coping, and support in preterm infants' socioemotional development. this study will include preterm infants recruited from the national taiwan university hospital at term and 12 months of corrected age. infants will be examined for physical growth, neurobehavioral development, and mother and infant interaction at term. the growth measures including weight, height and head circumference will be assessed. interaction between mother and infant will be investigated by observing the interaction between infants and their mothers in feeding and skin to skin contact conditions. mothers' psychosocial stress and social support will be obtained via questionnaires. it is expected that preterm infants' physical growth and neurobehavioral development as well as mothers' psychosocial stress and social support are associated with the quality of mother-infant interaction.


Eligibility criteria:
inclusion criteria: * preterm infants exclusion criteria: * significant congenital problems

Keywords: preterm infants
the metabolomics of anaphylaxis

Conditions: Patients With AERD Undergoing Aspirin Desensitization

Summary: metabolomics is the study of metabolic pathways and the unique biochemical molecules which result from the regulatory response to physiological stressors, disease processes, or drug therapy. by measuring changes in metabolite concentrations, the range of biochemical effects and therapeutic intervention can be determined. aspirin exacerbated respiratory disease (aerd) is a chronic inflammatory disease characterized by chronic rhinosinusitis, nasal polyposis, asthma, and airway reactivity to aspirin and/or other nonsteroidal anti-inflammatory drugs (nsaids). this reaction to aspirin during challenge/desensitization is equivalent to an allergic drug reaction however we are able to evaluate these specific reactions in a controlled, clinical environment. this population of patients undergoing aspirin desensitization is ideal for studying metabolomics as serial blood sampling can be performed in patients before, during a reaction, and after aspirin desensitization, thereby allowing each patient to serve as his or her own biological control. the investigator hopes that this study of metabolomics will allow for better methods of identifying anaphylaxis in the future.


Eligibility criteria:
inclusion criteria: * patients ages 18-75 with a history of aspirin anaphylaxis or a history of hypersensitivity reaction to aspirin and referred for a clinically indicated outpatient or inpatient aspirin desensitization procedure for aerd. exclusion criteria: * pregnancy/breastfeeding, possibility of poor compliance, unwilling to undergo aspirin desensitization.
platelet aggregation inhibition in children on clopidogrel (picolo)

Conditions: Congenital Heart Defects; Blood Platelet Disorders

Summary: picolo is a double blind placebo controlled phase ii dose ranging, dose escalating study in patients of blalock-taussig age categories (neonates and infants/toddlers), to determine the dose providing inhibition of platelet aggregation similar to adults.

there will be 3 blinded dose groups of 12 patients each (9 active, 3 placebo), central randomization, stratified by age (\< 1 month ;1 to 24 months). there will be a comparison of adp-induced platelet aggregation at steady state.

Eligibility criteria:
inclusion criteria: * neonates or infants/toddlers (up to 24 months) at risk for thrombosis (e.g., blalock-taussig shunt or any systemic to pulmonary artery shunt, kawasaki disease, vascular stent or any condition requiring antiplatelet therapy). exclusion criteria: * ongoing bleeding or increased risk of bleeding * weight \< 2 kg; gestational age \< 35 weeks * allergy to drugs * current or planned anticoagulant treatment * unable to receive drug enterically * platelet transfusion \< 7days * thrombocytopenia * hepatic or renal failure

Keywords: thrombosis platelet aggregation pediatrics
gemcitabine and cisplatin as first line combination therapy in patients with triple-negative mbc

Conditions: Metastatic Breast Cancer

Summary: primary objective of this study is to evaluate the efficacy of gemcitabine and cisplatin as first line therapy in patients with triple-negative mbc. 80 patients will be treated into this study.

triple-negative breast tumors could contribute to the poor prognosis comparing with luminal a breast cancer.fewer study has revealed that cisplatin-based therapy may be effective for this type breast cancer.

Eligibility criteria:
inclusion criteria: * give written informed consent prior to study, with understanding that the patient has the right to withdraw from the study at any time without prejudice * be female and ≥18 and ≤75 years of age * be ambulatory and have ecog performance stastus of ≤1 * have histological confirmed breast cancer,and the speciman confirmed er negative,pr negatiev, and her-2 negative by immunochemistry technich of fudan cancer hospital. * locally advanced or metastastic breast cancer who didn't receive first-line chemotherapy. no matter whether the patient has received anthracyclin or taxane treatment as neo-adjuvant or adjuvant treatment. * have at least one target lesion according to the recist criteria. exclusion criteria: * preganant or lactating women * advaced patient has received one or more chemotherapies * chemotherapy within four weeks preceding treatment start * ecog ≥ 2 * radiotherapy to the axial skeleton within the 4 weeks preceding study treatment start or insufficient recovery from the effects of prior radiotherapy * participation in any investigational drug study within 4 weeks preceeding treatment start * evidence of cns metastasis * history of another malignacy within the last five years except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix or a contralateral breast cancer * abnormal laboratory values: hemoglobin \< 8. 0g/dl, neutrophil\< 1.5×109/l, platelet\< 100×109/l. * serum creatine \> upper limit of normal (uln) * serum bilirubin \> uln * alt and ast \>5×uln * akp \>5×uln * serious uncontrolled intercurrence infection * life expectancy of less than 3 months

Keywords: metastatic breast cancer triple-negative breast cancer cisplatin chemotherapy
post-marketing clinical study of the lambre system for left auricle closure

Conditions: Atrial Fibrillation

Summary: atrial fibrillation (af) is responsible for 15-20% of ischaemic strokes. these events are often caused by thrombus formation in the left atrium. thromboembolic risk in af is primarily prevented by oral anticoagulation. however, this drug-based approach has a number of limitations, the most important of which are compliance problems and, above all, the risk of haemorrhagic complications, some of which are potentially serious. left atrial appendage closure is a therapeutic alternative for the prevention of cardioembolic risk in cases where anticoagulation is clearly contraindicated. the cnedimts opinion of 12 march 2019 defines that the lambre, lifetch prosthesis, a device for transcatheter closure of the left atrial appendage, is authorised for the prevention of thromboembolic events in patients with non-valvular atrial fibrillation at high risk of thromboembolic events with a cha2ds2-vasc score ≥ 4 and a formal and permanent contraindication to anticoagulants (validated by a multidisciplinary committee). lambre prosthesis in france are subject to a review of the results by the cnedimts committee. among the criteria analysed regarding the efficacy and safety of the device implantation, the result regarding the migration rate of the lambre device will be one of the criteria enabling the commission to decide on the appropriateness of the renewal of the registration.


Eligibility criteria:
inclusion criteria: * patient requiring a left atrial exclusion procedure according to the recommendations by the cnedimts and has using the lambre device * age ≥18 years * patient has been informed of the nature of the study and agrees to participate exclusion criteria: * minor patient * patient refusing to participate in the study or unable to give informed consent (patient under guardianship, curatorship or safeguard of justice)

Keywords: non-valvular atrial fibrillation atrial fibrillation lambre system
compare outcomes between two acellular dermal matrices

Conditions: Breast Cancer

Summary: this study will evaluate the performance of alloderm rtu medium (lifecell) vs. cortiva 1mm allograft dermis (rti surgical®, inc.). these are the thinnest versions of acellular dermal matrices (adm) offered by both vendors and can be used for post-mastectomy breast reconstruction. alloderm rtu medium has a thickness of 1.6±0.4 mm, while cortiva 1mm allograft dermis has a thickness of 1.0±0.2 mm. in the context of breast reconstruction, these adms are used in the same manner. they may be inserted with a tissue expander immediately after skin- or nipple-sparing mastectomy. the investigators will examine breast-reconstruction associated complication rates, pre- and post-operative patient reported outcomes using the breast q, and physician reimbursement as well as direct hospital costs. the endpoint will be either exchange of the tissue expander for a permanent breast implant or autologous flap, explantation due to patient preference, development of a complication, or less common reasons. the investigators propose that cortiva 1mm allograft dermis and alloderm rtu will have equivalent complication and patient reported outcome rates as well as physician reimbursement, but that direct hospital cost will be less with cortiva 1mm allograft dermis.


Eligibility criteria:
inclusion criteria: * sex: females * age: 22 to 70 years old * preoperative surgical plan: immediate placement subpectoral (subpectoral and postpectoral are synonymous) tissue expander with adm or immediate placement prepectoral tissue expander or implant with adm * mastectomy type: skin-sparing or nipple-sparing mastectomy with or without sentinel lymph node biopsy; may be unilateral or bilateral mastectomy * able to understand and willing to sign irb approved written informed consent document. exclusion criteria: -pregnant and/or breastfeeding.
longventkids study

Conditions: Prolonged Mechanical Ventilation in Pediatric Intensive Care Unit

Summary: scientific advances, population growth, lower mortality, and increasing complexity of diseases have boosted up the number of patients requiring prolonged breathing assistance with mechanical ventilators in the pediatric intensive care units (picu) in many parts of the developed world. previous studies also suggest that there is a small group of children who actually need such a high level of support for extended periods of time, utilizing a lot of human and technical resources. we defined children with prolonged mechanical ventilation (pmv) if they required supports with a breathing machine for more than 14 days. we propose an international point prevalence study of children requiring pmv in picu. we will conduct the study in multiple centers in several different regions, including north and south america, europe, and asian countries, with a strong relationship with local physician colleagues. practice for patients requiring pmv will be examined including the type and size of local picu, admission and discharge policies, and patient and treatment modalities administered to such patients, types of professionals looking after patients in pmv, types of health care. we anticipate a high variability in practices suggesting a need to further standardize the management of pmv.. specifically, as an immediate consequence, by comparing and understanding the differences in patient demographics, practice details among picus in regards to the background factors of local picus and their patients, practitioners will share their way of dealing with such patients. in that way, this study will support the need to generate guidelines and lead to patient care improvement in picus.


Eligibility criteria:
inclusion criteria: patients who are ventilated \>14 consecutive days (after 37 weeks postmenstrual post-conception age)\* * including for more than 6 hours per day including on inmv and niv duration * patient who have had and short interruptions (\<48hours) of ventilation during the weaning process as the same episode of ventilation can be included. * inmv can be administered through an endotracheal tube or a tracheostomy tube. * niv can be managed through a nasal, full-face, total facial mask, or helmet. * patient on hfnc will be included as on respiratory support if they have a proper or a nasal cannula (that allows \>=1 liters/kg/min (lpm) and \>4lpm). * we define nasal oxygen supply \<1 l/kg/min as non-niv practice. exclusion criteria: * age \>18 years * already included in this study * no consent if required * brain death * premature children not yet at 37 weeks gestational age.