Kornimate/medical-research-clean huggingface dataset:
nutritional care and head growth in preterm infants

Conditions: Prematurity; Extreme; Growth Retardation

Summary: as extremely low birth weight infants are high-risk patients, the study aimed to compare neonatal care, nutritional strategy and postnatal growth of these infants in two european neonatal units. a retrospective study included extremely low birth weight infants born in lyon, france or in stockholm, sweden. data on morbidity, treatments, care practices, macro-nutrient intakes and postnatal growth were collected to determine risk factors of extra uterine growth restriction at discharge. by comparing postnatal growth in elbw infants hospitalized in two european neonatal intensive care units with different nutritional and extra nutritional care,our objective was to evaluate the role of nutrition in this population of preterm infants.

in a retrospective study, all elbw infants (birth weight under 1000 g) with a gestational age between 23 and 28 weeks were included if they were admitted during the first 24 hours of life and stayed for at least seven weeks in two european units (lyon, france, and stockholm, sweden). parenteral and enteral nutrition policies were detailed and protein and energy intakes were collected.growth assessment postnatal growth was precisely evaluated and compared in the two groups of infants. body weight, crown-heel length and head circumference were measured in both units at birth and until discharge. we calculated z-scores and changes in z-scores between birth and 36 weeks post-conceptional age (delta z-score) for body weight, hc, and crown-to-heel length using olsen's references. intra-uterine growth restriction was defined as a birth weight below or equal to minus two standard deviations. extra-uterine growth restriction was defined as a z-score loss above or equal one standard deviation between birth and 36 weeks pca. i

Eligibility criteria:
inclusion criteria: * birth weight under 1000 grams * gestational age (ga) between 23 and 28 weeks * born in 2012 * admitted during the first 24 hours of life * stayed in one of the two studied units for at least 7 weeks before transfer to the referring hospital, discharge to home or death. exclusion criteria: * neonates with congenital anomalies

Keywords: growth small for gestational age prematurity breastfeeding fortification parenteral nutrition nutrition
clinical trial to compare tapp (transabdominal preperitoneal) vs tep (totally extraperitoneal) y approach for women's inguinal hernia on an outpatient basis

Conditions: Inguinal Hernia

Summary: open prospective randomised clinical trial enrolling women who suffer from inguinal or femoral hernia, to evaluate if tep approach is superior to tapp concerning postoperative development, principally postoperative pain, with no increase of recurrent hernia at the one-year follow-up visit.

randomised phase iv clinical trial enrolling women suffering from inguinal hernia in virgen del rocío university hospital influence area, from march 2019 to march 2021. the aim of the study is to conclusively stablish whether there is real and significant benefit in using tep approach over tapp, in an outpatient basis, concerning postoperative evolution. secondary objectives are the assessment of postoperative pain, using vas (visual analogic scale), of both techniques, and evaluation of hernia recurrence during the first postoperative year the individuals will be assigned to each group according to simple random sampling.

Eligibility criteria:
inclusion criteria: * inguinofemoral hernia, ehs (european hernia society) classification. * patient over 18 years old. * signed informed consent form. * female * meeting of outpatient discharge criteria, determined by aldrete´s test exclusion criteria: * loss of domain. * abdominal skin grafts. * previous preperitoneal (open or laparoscopic) prosthetic mesh. * incarcerated hernia. * previous complications such as infection, fistulae... * not candidate for ambulatory surgery * pregnancy or desire for pregnancy in the first postoperative year

Keywords: woman inguinal hernia tapp tep outpatient surgery ambulatory surgery
personalized crt - mpp post approval study

Conditions: Heart Failure

Summary: the purpose of this post-approval study (pas) is to evaluate the effectiveness of mpp to improve crt response in the non-responder patient population when used in "real-world" clinical practice, following commercial release. this evaluation is based on the clinical composite score which summarizes the proportions and frequencies of crt non-responder patients who are "improved", "unchanged" or "worsened" after receiving mpp therapy. patients will be followed for the duration of the pas. this study is required by fda as a condition of approval of the mpp feature and is integrated within the product surveillance registry (psr).

medtronic market-released cardiac resynchronization therapy (crt) quadripolar (quad) systems approved for commercial release with the multiple point pacing (mpp) feature were eligible to contribute to the post-approval study (pas) objectives. products with mpp capabilities receiving appropriate license or regulatory approval during the conduct of the pas were included and contributed to the pas objectives upon commercial release. crt is an established pacing therapy for patients with heart failure (hf). crt provides atrial- synchronized biventricular (biv) pacing using standard pacing technology combined with a special third lead that is implanted via the coronary sinus and positioned in a cardiac vein to sense and/or pace the left ventricle (lv). following a sensed atrial contraction or atrial paced event, both ventricles are stimulated to synchronize their contraction. the mpp feature is designed to allow a second lv pace to occur in lv only or biv pace configurations. in the lv only pace configuration, the lv paces occur simultaneously or sequentially (lv- lv), as applicable by product. when bi-v pacing is enabled, the rv pace can be delivered either before or after the lv paces, with the order determined by the programmed ventricular pacing configuration. the mpp pas was a global, prospective, observational multi-center study. patients implanted with an eligible crt quad system were enrolled and followed in the product surveillance registry per the expected standard of care practices of their care provider.

Eligibility criteria:
inclusion criteria: * patient or legally authorized representative provides written authorization and/or consent per institution and geographical requirements * patient has or is intended to receive or be treated with an eligible crt device * patient within 30 days of therapy received at the time of their initial psr platform enrollment exclusion criteria: * patient who is, or is expected to be inaccessible for follow-up * patient with exclusion criteria required by local law * patient is currently enrolled in or plans to enroll in any concurrent drug and/or device study that may confound results
hetrombopag or placebo in treatment-naive severe aplastic anemia

Conditions: Severe Aplastic Anemia

Summary: this is a multicenter, randomized, placebo-control, phase iii study to investigate hetrombopag in subjects with severe aa who are treated naive. 180 treated naive patients with saa will be enrolled in the study. the primary objective of the study will be the rate of complete hematologic response at six months.


Eligibility criteria:
inclusion criteria: 1.15 years to 75 years (weight greater than 50 kg if age \< 18 years old). 2.severe aplastic anemia characterized by bone marrow cell proliferation less than 25 percent (if ≥25% but \<50%, the remaining hematopoietic cells should be \<30%) and at least two of the following: absolute neutrophil count \<0.5×109/l; platelet count \<20×109/l; absolute reticulocyte count \<20×109/l. 3.unsuitable or unwilling to perform hematopoietic stem cell transplantation (hsct). 4.signed informed consent. exclusion criteria: 1. diagnosis of whole blood cell reduction due to other causes or bone marrow hypoproliferative diseases. 2. subjects who have previously received immunosuppressive therapy with mycophenolate mofetil, sirolimus, high dose cyclophosphamide (≥45mg/kg/d), alemtuzumab, etc；or have treated with thrombopoietin receptor agonist (eg, eltrombopag, romiplostim, rhtpo, etc.) prior to randomization. 3. previous history of hematopoietic stem cell transplantation. 4. subjects who is known or suspected of contraindications or hypersensitivity to hetrombopag's api (active pharmaceutical ingredient). 5. evidence of clonal cytogenetic abnormalities at the time of screening. 6. bleeding and/or infection not adequately responding to appropriate therapy. 7. any laboratory or clinical evidence for hiv infection. any clinical history for hepatitis c infection; chronic hepatitis b infection; or any evidence for active hepatitis at the time of subjects screening. 8. alt\> 2.5 x upper limit of normal (uln), ast\> 2.5 x upper limit of normal (uln) dbli\> 1.5 x upper limit of normal (uln), scr\> upper limit of normal (uln). 9. subjects with uncontrolled hypertension (\>180/100mmhg), severe arrhythmia (such as complete left bundle branch block, qt interval prolongation (bazetts formula), torsade ventricular tachycardia, etc.), unstable angina, pulmonary hypertension at the time of screening. 10. subjects diagnosed with cirrhosis or portal hypertension. 11. subjects with malignant solid tumors of any organ system within 5 years prior to screening, with or without treatment, metastasis or recurrence, except for local cutaneous basal cell carcinoma; subjects with hematological tumors found previously or during screening. 12. subjects with deep vein thrombosis, myocardial infarction, stroke or peripheral arterial embolization within 12 months prior to randomization. 13. female subjects who are nursing or pregnant. 14. subjects cannot comply with effective contraception. 15. subjects have participated in other clinical trial within the 3 months prior to study entry.

Keywords: saa
adding vertical correction to scapular recognition on patients with frozen shoulder

Conditions: Frozen Shoulder

Summary: objective: to study the effect of adding a continual vertical downward correction to dynamic scapular recognition exercise on scapular dyskinesis and shoulder pain and disability in patients with frozen shoulder. design: a double-blinded randomized controlled study setting: out-patient clinic subjects: sixty-seven subjects with unilateral frozen shoulder interventions: participants were distributed into two groups. the intervention group performed the dynamic scapular recognition exercise and continual vertical downward correction using rigid taping with 50%-75% tension. the control group performed a similar dynamic scapular recognition exercise using a wireless biofeedback system and placebo taping. a scapular dyskinesis test with caliper was utilized to measure scapular dyskinesis, a digital inclinometer was utilized to evaluate the scapular upward rotation and shoulder roms, and the shoulder pain and disability index (spadi) was utilized to evaluate the shoulder pain and disability.


Eligibility criteria:
inclusion criteria: * the existence of a unilateral frozen shoulder with incapability of the participant to raise the arm more than 100 degrees in the plane of the scapula. * aa restriction in both passive and active shoulder rom * the existence of pain that affects performing activities of daily living\[19\] exclusion criteria: * the presence of any shoulder problem contraindicated for performing exercises to the shoulder joint, such as active inflammatory disease, cancer, active infection, recent subluxations or dislocations, fractures, and surgeries nearby the shoulder region. furthermore, the patient was excluded if he/she had no signs of scapular dyskinesis.
phase i dose escalation study of vs-4718 in subjects with metastatic non-hematologic malignancies

Conditions: Non Hematologic Cancers; Metastatic Cancer

Summary: this is a phase i, open-label, multicenter, dose-escalation trial of vs-4718, a focal adhesion kinase inhibitor, in subjects with metastatic non-hematologic malignancies. this clinical study is comprised of 2 parts: part 1 (dose escalation) and part 2 (expansion). the purpose of this study is to evaluate the safety (including the recommended phase ii dose), pharmacokinetics (the amount of vs-4718 in your blood) and the anti-cancer activity of vs-4718. the pharmacodynamic effects (genes or proteins that may predict or show how your body may respond to vs-4718) will also be examined in tumor biopsies and blood samples.


Eligibility criteria:
inclusion criteria: * age ≥ 18 years. * histopathologically confirmed diagnosis of a metastatic non-hematologic malignancy. * ecog (eastern cooperative oncology group) performance status of ≤ 2 * adequate renal function * adequate hepatic function (total bilirubin ≤ 1.5x uln (upper limit of normal) for the institution; ast \[aspartate transaminase\] and alt \[alanine transaminase\] ≤ 3x uln, or ≤ 5x uln if due to liver involvement by tumor). * adequate bone marrow function (hemoglobin ≥ 9.0 g/dl; unsupported platelets ≥ 100 x10 9 cells/l; absolute neutrophil count ≥ 1.5x10 9 cells/l * corrected qt interval (qtc) \< 470 ms * subjects must have at least one tumor lesion that is suitable for repeat biopsy, and must agree to two tumor biopsies (pre- and post- treatment). * willing and able to participate in the trial and comply with all trial requirements. exclusion criteria: * gastrointestinal (gi) condition which could interfere with the swallowing or absorption of study medication. * uncontrolled or severe concurrent medical condition (including uncontrolled brain metastases). * history of upper gastrointestinal bleeding, ulceration, or perforation within 12 months. * known history of stroke or cerebrovascular accident within 6 months. * subjects being actively treated for a secondary malignancy.

Keywords: focal adhesion kinase inhibitor fak inhibitor cancer stem cells csc
smart-phone application to promote medication adherence in adolescents and young adults (aya) with cancer

Conditions: Neoplasms

Summary: to explore use of a smart-phone medication reminder application to promote adherence to oral medications by aya with cancer.

non-adherence to oral medications is a prevalent problem in adolescents and young adults (aya) with cancer that may impact both survival and quality of life while on treatment. the purpose of this study is to explore use of a smart-phone medication reminder application to promote adherence to oral medications by aya with cancer. the study's primary aim is to explore the feasibility and acceptability of using a smart-phone medication reminder application to promote adherence to oral medications by aya with cancer as well as to characterize application use. secondary aims include: 1) to obtain initial estimates of intervention effect- measured by pre-intervention to post-intervention differences in perceived behavioral control for adherence, intention to adhere, and adherence behavior - to inform design of a future trial powered to detect a clinically significant effect of smart-phone medication reminder application use on adherence to oral medications; and 2) to examine the relationships among perceived behavioral control for adherence, intention to adhere, and adherence behavior. a pre-post single group design will be used. data will be collected weekly for 4 weeks before introduction of the intervention and for 8 weeks following introduction of the intervention. analytic approaches will include descriptive statistics and generalized estimating equation (gee) modeling.

Eligibility criteria:
inclusion criteria: 1)15-29 year olds receiving treatment for any type of cancer, either primary or recurrent/relapsed disease. 2) patient has completed at least one month of therapy 3)patient is expected to remain on therapy for 3 month duration of study 4) patient has an iphone, ipad, or itouch running ios 4.0 or later 5) patient is willing to use a smart-phone medication reminder application- exclusion criteria: 1)patients who are unable to speak/read/write english as required for use of smart-phone medication reminder application and completion of study measures.

Keywords: neoplasms adolescent young adult medication adherence
a study to assess beta-lactam in the treatment of hospitalized patients with bacterial pneumonia

Conditions: Pneumonia, Bacterial

Summary: this study will assess the efficacy and safety of intravenous beta-lactam, in comparison with ceftriaxone, in hospitalized patients with community-acquired pneumonia not caused by legionella. the anticipated time on study treatment is 3-12 months and the target sample size is 100-500 individuals.


Eligibility criteria:
inclusion criteria: * male or female patients at least 18 years of age; * hospitalization with community-acquired pneumonia or development of pneumonia within 48 hours of being hospitalized for another reason; * fever; * new or increased productive cough; * chest pain, shortness of breath, or rapid breathing. exclusion criteria: * requiring intubation or ventilation; * nursing home or extended care within 60 days before study; * concomitant bacterial infection requiring antibiotics; * long-term immunosuppressive therapy.
association of plasma n-terminal pro-brain natriuretic peptide levels with the burden of coronary artery disease

Conditions: Chronic Coronary Syndrome; Chronic Coronary Total Occlusion; Coronary Arterial Disease (CAD); Stable Chronic Angina; NT-pro-BNP

Summary: this study aim to investigate the association between plasma nt-probnp levels and the presence, extent and severity of stenosis in patients with suspected coronary artery disease.

the investigators prospectively measured plasma nt-probnp levels in consecutive patients referred to the center for elective diagnostic coronary angiography due to symptoms or signs of coronary artery disease over a two- year period. patients with conditions known to elevate nt-probnp levels, including heart failure, severe valvular disease, atrial fibrillation, severe chronic kidney disease (egfr \< 30 ml/min), prior coronary artery bypass grafting, or age over 80 years, were excluded.

Eligibility criteria:
inclusion criteria: * patient referred for elective coronary angiography due to suspected cad. * nt-probnp measurement during hospitalization exclusion criteria: * heart failure * severe valvular disease * atrial fibrillation * severe chronic kidney disease (egfr \< 30 ml/min) * prior coronary artery bypass grafting * age over 80 years

Keywords: nt-pro-bnp coronary arterial disease (cad) chronic coronary syndrome (ccs)
peripheral endothelial function in asthmatic patients

Conditions: Endothelial Function

Summary: the aim of the study is to assess the peripheral endothelial function in adult asthmatic patients and the relationship between the peripheral endothelial function and the pulmonary function.

the primary criteria is the peripheral endothelial function that will be assessed by the measure of flow-mediated dilation (reactive hyperemia-peripheral artery tone index). the pulmonary function will be assessed by the measures of the fev1, the forced vital capacity (fvc) and the expiratory flow between 25% and 75% (fef25-75%). the relationship between these parameters of the pulmonary function and the peripheral endothelial function will be analyzed. in addition, a relationship between peripheral endothelial function and the level of asthma control (asthma control test (act)), the cardiovascular risk factors (score index) and the treatment for asthma (controllers) will be also assessed.

Eligibility criteria:
inclusion criteria: * all patients must have a clear-cut history of asthma at the time of enrolment into the trial (eventually confirmed in the past and documented by an increased hyperresponsiveness to methacholine; or a bronchodilator reversibility to a beta-2-adrenergic drug). exclusion criteria: * patients with unstable asthma * patients with a significant acute disease other than asthma. a significant disease is defined as a disease which, in the opinion of the investigator, may influence the results of the trial. * pregnant or nursing women.

Keywords: asthma, endothelial function
genetic testing of noonan subjects previously treated with norditropin®. an extension to trial ghnoo-1658

Conditions: Genetic Disorder; Noonan Syndrome

Summary: this trial is conducted in europe. the aim of this trial is to obtain the ptpn11 mutation status and investigate the impact of the ptpn11 mutation status on the effect of somatropin (norditropin®) by use of data obtained in the ghnoo-1658 trial.


Eligibility criteria:
inclusion criteria: * participation in the ghnoo-1658 trial * subject has completed genetic testing of ptpn11 mutation
phase 2b study evaluating safety and efficacy of otx-tp compared to timolol drops in the treatment of subjects with open angle glaucoma or ocular hypertension

Conditions: Glaucoma; Ocular Hypertension

Summary: to evaluate the safety and iop lowering efficacy of otx-tp, a sustained release travoprost drug product, placed in the canaliculus of the eyelid compared to timolol maleate ophthalmic solution, 0.5% in the treatment of subjects with open angle glaucoma or ocular hypertension. the study is designed to assess clinically meaningful response to treatment and is not powered to measure any efficacy endpoints with statistical significance.


Eligibility criteria:
inclusion criteria: * subject must have a documented diagnosis of ocular hypertension, open angle glaucoma (with or without pseudoexfoliation or pigment dispersion component). * subject has a mean baseline iop following washout in at least 1 eye (the same eye) of ≥ 24mmhg at hour 0 (t0) at baseline visit 1 and baseline visit 2 (day 1) * subject has a mean baseline iop following washout in at least 1 eye (the same eye) of: ≥ 22mmhg at (t0 + 4h) and (t0 + 8h) at baseline visit 1 (note: the same eye must meet the iop eligibility criteria at all 4 baseline assessments) * washout iop must be ≤ 34mmhg in each eye at all time points at the baseline visit 1 and baseline visit 2 (day 1) exclusion criteria: * subject with any form of glaucoma other than open angle glaucoma (with or without a pigment dispersion or pseudoexfoliation component). * subject with mean baseline iop \>34 mmhg in either eye at any time point during the baseline visits 1 or 2 (day 1). * subject with a bcva worse than 0.6 logmar (20/80 snellen) in either eye as measured using an etdrs chart. * subject with a known or suspected allergy and/or hypersensitivity to travoprost, timolol, fluorescein or to any component of the study products.
magnesium, partenium, andrographis, co-enzyme q10 and riboflavin (pacr) in migraine prophylaxis

Conditions: Migraine Disorders

Summary: migraine is a highly disabling disorder that affects hundreds of millions of people around the world. yet, a little number of prophylactic treatments are available still now. the limited number of available drugs leads to a wide use of nutraceutical compounds in migraine therapy. to improve the efficacy, some of these nutraceuticals were combined. so far, we do not know if these combinations are really more effective than the single compounds alone, or an anti-synergic effect could be present because of a reciprocal antagonism of effects. for this reason, we decided to test the efficacy of a fixed combination of magnesium, partenium, andrographis, co-enzyme q10 and riboflavin (pacr) as prophylactic treatment for migraine in a randomized controlled double blind study.


Eligibility criteria:
inclusion criteria: * diagnosis of migraine (with or without aura) * both genders * age between 18 and 65 y.o. * more than 1 year of migraine history * no other headache conditions * a migraine frequency between 2 and 8 per month exclusion criteria: * prophylactic treatments in the last 3 months * pregnancy or lactation * other medical conditions that requires a daily drug assumption * intolerance or allergic reactions to some of compounds of the product.