Kornimate/medical-research-clean huggingface dataset:
collaborative research group for necrotizing enterocolitis

Conditions: Prematurity; Necrotizing Enterocolitis

Summary: this proposal will test the hypothesis that synthesis and catabolism of epidermal growth factor (egf), the genotype of the egf gene, and the microbiome interact to influence egf expression in infants at risk for necrotizing enterocolitis (nec).

* preterm infants will receive a six hour intravenous infusion of \[5,5,5-2h3\]leucine (2h3) through an existing intravenous line (iv) to measure egf synthesis rate. * two blood samples will be obtained, one prior to the start of infusion, and one during the infusion. the enrichment of the stable isotope labeled leucine will be measured in the plasma from these samples; dna will be extracted from the residual cell pellets. the egf and egf receptor genes will be sequenced. * saliva and urine will be obtained for 5 days following infusion to measure egf and the rate of incorporation of leucine into egf using liquid chromatography (lc)/mass spectroscopy (ms)/ms technology, as well as enzyme-linked immunosorbent assay (elisa) . saliva will be obtained by a q tip swab and urine and stool obtained from the diaper. * stool will be obtained every 3 to 7 days through 5 weeks to evaluate inflammatory markers and the microbiome. * if breastfeeding, a single sample of mother's milk will be obtained for measurement of egf after adequate volumes for infant feeds are achieved.

Eligibility criteria:
inclusion criteria: * gestation 32 weeks or less * 1 week of age or less * intravenous line in place for clinical purposes exclusion criteria: * imminent death * active infection * pre-existing diagnosis of nec * fluid or electrolyte imbalance

Keywords: newborn necrotizing enterocolitis genetics growth factors metabolism
flashforward emdr treatment for patients with an icd

Conditions: Anxiety and Fear

Summary: the goal of this randomized controlled trial is to test whether flashforward (ff) emdr alone is effective in reducing anxiety symptoms in patients with an implantable cardioverter defibrillator (icd). participants will fill out several questionnaires to asses their level of anxiety, depression symptoms and quality of life before, during and after treatment.

patients with an implantable cardioverter defibrillator (icd) are at risk of ventricular arrhythmias (va). the icd is a device that can treat va by antitachycardia pacing or icd shocks. since icd shocks are painful and unpredictable, patients with an icd can suffer from anxiety symptoms. eye movement desensitization and reprocessing treatment (emdr) is an effective treatment to enhance the process of traumatic events. in addition, this treatment has also shown to be able to reduce anxiety symptoms. emdr treatment according to standard protocol starts with flashback (fb) procedure and may be followed by the flashforward (ff) procedure. the fb procedure focusses on events that happened in the past, while the ff procedure aims to reduce fear evoked by images of imagined future adverse events. so far, it is not clear whether the fb procedure is always necessary for the emdr treatment to be effective. moving straight towards application of the ff procedure (without first applying the fb procedure), may save treatment time and costs. therefore, the main objective in this study is to test whether flashforward (ff) emdr alone is effective in reducing anxiety symptoms in icd patients. this will be tested with a pilot randomized controlled trial with a three-arm repeated measures design. subjects will either receive ff emdr, fb emdr or no emdr during the study. to measure their heart focussed anxiety, subjects will fill out the cardiac anxiety questionnaire (caq) before, during and after treatment or waiting period.

Eligibility criteria:
inclusion criteria: * subjects have an icd; * subjects have clinical anxiety symptoms related to their icd. exclusion criteria: * insufficient knowledge on dutch or english language; * severe psychiatric disorders that warrant (other) psychiatric first, such as suicidality or psychotic disorders

Keywords: emdr flashforward anxiety icd
efficacy and safety of bupropion hydrobromide in adolescents and children with major depressive disorder

Conditions: Major Depressive Disorder

Summary: double-blind, placebo-controlled, multicenter study of efficacy and safety

* the primary efficacy endpoint is the mean change from baseline to eot in total cdrs-r (raw) score. * the secondary efficacy endpoints include: * proportion of subjects characterized as responders at eot (≥40% improvement from baseline total cdrs-r raw score) * proportion of subjects characterized as in remission at eot (total cdrs-r raw score \<29) * mean change from baseline to eot in cgi-c. safety endpoints include: * incidence of aes * change from baseline to eot in vital signs (blood pressure and radial pulse rate), blood and urine laboratory panel, and ecg * treatment discontinuation due to aes * suicidality as assessed by the c-ssrs score * change from baseline to eot in sleep as assessed by the sleep subscale of the cdrs-r.

Eligibility criteria:
inclusion criteria: * male or female outpatients aged ≥7 to \<18 years (at screening visit 1). * provide assent (subject) and written informed consent (parent/legal representative) and health insurance portability and accountability act (hipaa) for study participation (at screening visit 1). * meet diagnostic criteria for mdd as defined in the dsm iv-tr5 at screening visits 1 and 1a (k-sads-pl; see appendix 17.2). * current depressive episode of at least 4 weeks' duration as noted in the subject's history (screening visit 1). * total cdrs-r raw score ≥45 at both the screening and baseline visits (visits 1 and 2) (see appendix 17.3). * cgi-s score of ≥4 at the baseline visit (visit 2) (see appendix 17.4). exclusion criteria: * are unable to swallow medications without difficulty * have known hypersensitivity to bupropion hydrobromide * are pregnant or planning to get pregnant or are lactating * women of childbearing age unable to use at least one method of effective contraception for the duration of the study * previous history of attempted suicide * are unable to understand and communicate effectively with parent, investigator, and study coordinator * are at immediate risk of requiring hospitalization, in the investigator's opinion * have current seizure disorder or history of seizures or head trauma * have history or presence of clinically significant medical conditions or clinically important laboratory abnormalities * have ecg or physical examination abnormality at screening * have body weight less than the 3rd percentile or greater than the 97th percentile for age.

Keywords: able to swallow medications without difficulty bupropion hydrobromide
tobradex ophthalmic suspension versus tobramycin 0.3%/dexamethasone 0.05% ophthalmic suspension

Conditions: Ocular Inflammation Associated With Blepharaconjunctivitis

Summary: the purpose of this study is to describe the differences in efficacy between tobradex ophthalmic suspension and tobramycin 0.3%/dexamethasone 0.05% ophthalmic suspension in the treatment of ocular inflammation and infection associated with blepharaconjunctivitis


Eligibility criteria:
inclusion criteria: * ocular inflammation associated with blepharaconjunctivitis exclusion criteria: * ocular allergy * ocular disorders that would preclude safe administration of test article

Keywords: ocular inflammation blepharaconjunctivitis
prolotherapy for the treatment of plantar fasciitis

Conditions: Plantar Fasciitis

Summary: the purpose of this study is to demonstrate that prolotherapy in conjunction with a physiotherapy program looking at reinforcing calf muscle and muscle of the plantar fascia, relieves pain and improves function of people suffering of plantar fasciitis, an inflammation of the plantar fascia, after basic treatment failure.


Eligibility criteria:
inclusion criteria: * have a diagnosis of plantar fasciitis * experience pain in the plantar fascia for more than 6 months * be capable to understand and execute physiotherapy exercises exclusion criteria: * previous operation of the plantar fascia * deformation of the foot (congenital or acquired) * presence or suspicion of infection of the skin at the site where the injection will occur * history of systemic diseases capable of inducing pain or sensitivity to the feet (seronegative arthritis, diabetes, fibromyalgia, etc.) * abnormal coagulation * allergy to lidocaine and/or marcaine * pregnancy * lumbar, hip or knee pain
kinesiophobia, pain, functional status and self-efficacy in patients with knee osteoarthritis

Conditions: Knee Osteoarthritis

Summary: objective: the aim of this study is to examine the relationship between kinesiophobia, pain, functional status and self efficacy in patients with knee osteoarthritis.

material and methods: the study was performed on 72 individuals diagnosed with stage 2 and stage 3 knee osteoarthritis according to the kellgren lawrence classification. the tampa scale for kinesiophobia (tsk) was used to evaluate kinesiophobia, and the visual analogue scale (vas) was used to assess pain. the western ontario and mcmaster universities arthritis index (womac) was used to asses the functional status. self efficacy was assessed using the arthritis self efficacy scale (ases).

Eligibility criteria:
inclusion criteria: * being between the ages of 40-85 and diagnosed with stage 2-3 bilateral knee osteoarthritis according to kellgren lawrence classification. exclusion criteria: * with a history of lower extremity surgery and a major trauma, orthopedic knee injuries such as tendinopathy, bursitis, ligament and meniscus injuries, a neurological or cardiopulmonary disease that may affect the evaluations, and any other joint in the lower limb that may cause reflected pain in the knee, individuals who had inflammatory rheumatic disease such as gout, rheumatoid arthritis, have participated in physical therapy and rehabilitation program in the last 6 months and who have been given knee injections

Keywords: knee osteoarthritis kinesiophobia pain functional status self efficacy
dose escalation and expansion study of hm97662 in advanced or metastatic solid tumors

Conditions: Advanced or Metastatic Solid Tumors

Summary: this is a phase1 study to assess the safety, pk, pd and efficacy of hm97662, ezh1/2 dual inhibitor, in solid tumors. the study is comprised of dose-escalation part followed by randomized dose-ranging part and dose-expansion part. dose-escalation part is planned with a 3+3 dose-escalation design and is to establish the mtd or rd for randomized dose-ranging part. dose-ranging part is designed mainly to further evaluate safety and preliminary efficacy of hm97662 monotherapy in subjects with specific genomic alterations to more precisely determine the potential rp2d that are to be tested in a dose-expansion part. dose-expansion part is designed to assess the potential efficacy of hm97662 monotherapy when administered at the rp2d to subjects in indication-specific expansion cohorts.


Eligibility criteria:
inclusion criteria: * histologically and/or cytologically confirmed advanced or metastatic solid tumor who have failed/are intolerant to standard therapy. * patients for dose-escalation part must have evaluable or measurable disease at baseline and the patients for randomized dose-ranging and dose-expansion part must have at least one measurable lesion at baseline by ct or mri per response evaluation criteria in solid tumor (recist v1.1). * eastern cooperative oncology group (ecog) performance status of 0 or 1. * life expectancy ≥ 3 months before starting hm97662. * adequate renal function. * adequate hematologic function. * adequate liver function. * males or females aged ≥ 18 years (or country's legal age of majority if the legal age was \> 18 years) at the time of informed consent. * for dose-ranging part, documentation of an alteration in at least one of the genes of the swi/snf complex in tumor tissue (archival or newly obtained). exclusion criteria: * prior exposure to valemetostat or other ezh1/2 dual inhibitor. * known brain metastases that are untreated, symptomatic, or require therapy to control symptoms. * patients currently taking medications that are known strong cyp3a inhibitors and strong or moderate cyp3a inducers. * any prior treatment-related (i.e. chemotherapy, immunotherapy, radiotherapy) clinically significant toxicities that have not resolved to grade ≤ 1 per ctcae version 5.0 or prior treatment-related toxicities that are clinically unstable and clinically significant at time of enrollment. * major surgery within 4 weeks before the first dose of study drug treatment in cycle 1. * females who are pregnant or breastfeeding. * patients who have undergone an organ transplant.
tendoshock-2010 combination therapy for athletic tendinopathies

Conditions: Tendinopathy; Epicondylitis

Summary: athletic tendinopathies of the upper and lower extremity are often therapeutically challenging. colour and power-doppler-ultrasound visualizes pathological neovessels in painful tendons, which are associated with pain-mediating nerve fibres in such tendinopathies. these neovessels are represented by an increased capillary blood flow at the point of pain. painful eccentric training reduces pain and improves function in achilles tendinopathy substantially (evidence level ib). shock wave therapy in combination with eccentric training is superior to eccentric training alone (evidence level ib). long-term results suggest a collagen induction and reduced pain following topical glyceryl trinitrate (no) (evidence level ib). colour- and power-doppler-guided sclerosing therapy using polidocanol reduces pain, improves function and may lead to tendon remodelling (evidence level ib). pain-restricted sport beyond pain level 5/10 during therapy is recommended (evidence level ib). 3x10min of cryotherapy reduce pain and capillary blood flow (evidence level ib). the role of proprioceptive training in tendinopathy has to be determined in future randomized-controlled trials (evidence level ii). the investigators thought to evaluate the combination of the aforementioned individually successfully therapeutic options in athletes to shorten the recovery period and return to play interval.

interventions: combined power-doppler-guided sclerosing therapy using polidocanol (0.5%, 2ml) in 6-8 week intervals combined with extracorporeal focused shockwave therapy (storz duolith 2000impulses 0.25mj/mm2) every 6-8weeks plus painful daily eccentric training plus daily topical no

Eligibility criteria:
inclusion criteria: * painful tendons at the achilles tendon (both insertional and mid-portion tendinopathy) * patella tendinopathy * elbow tendinopathy * informed consent exclusion criteria: * no informed consent * no painful tendons * allergy against polidocanol * current treatment with marcumar

Keywords: achilles tendon patella allergy necrosis infection
prospective study on dextenza® safety and efficacy following concomitant migs and cataract surgery

Conditions: Glaucoma; Cataract

Summary: in this study, the investigators are comparing dexamethasone ophthalmic insert (dextenza®) to the current standard of care, prednisolone acetate 1% eye drops, in a glaucoma population receiving both cataract and minimally-invasive glaucoma surgery (migs). dextenza® and prednisolone acetate 1% drops are both steroids used to control inflammation after eye surgery. dextenza®'s method of delivery differs by offering a sustained release of steroid that does not necessitate postoperative anti-inflammatory eye drops. the investigators hypothesize that dextenza® will be as safe as prednisolone acetate 1% drops and as effective at controlling postoperative inflammation following concomitant cataract-migs in a glaucoma population. the investigators also hypothesize that dextenza® will be preferred by patients over prednisolone acetate 1% drops.

glaucoma and cataract surgery patients face an outsize postoperative burden. in addition to taking frequent anti-inflammatory eye drops, they often continue their glaucoma medications. this can cause patient confusion and nonadherence, potentially leading to poor healing, slower recovery period, and/or cystoid macular edema. dextenza®, as a sustained release anti-inflammatory insert, could help preclude adherence difficulties and increase comfort by reducing eye drop load. however, glaucoma surgeons may hesitate to adopt dextenza® due to concerns regarding safety with respect to elevated intraocular pressure. this prospective study will address those concerns directly, providing timely and high-quality clinical evidence comparing dextenza® to standard-of-care steroid eye drops. for physicians and patients, the results of this study will prove immediately useful for therapeutic decision-making.

Eligibility criteria:
inclusion criteria: * cataract surgery candidate and glaucoma present in at least one eye. * minimally-invasive glaucoma surgery candidate in that same eye. defined by having ocular hypertension requiring a medication, or as by having mild, moderate, or severe glaucoma that is sufficiently stable and appropriate for operation. exclusion criteria: * maintains regular use (daily or more) of systemic or ocular steroids at time of enrollment * maintains regular use (daily or more) of systemic or ocular nonsteroidal anti-inflammatory drugs at time of enrollment * anterior chamber cells present at time of enrollment * recent febrile illness that precludes or delays participation for 3 months * pregnancy or lactation * known allergy to dexamethasone * known allergy to prednisolone * treatment with another investigational drug within the last 20 years * current recreational drug use * preexisting ocular pathology likely to confound the visual acuity or comfort endpoints including but not limited to: severe corneal scarring, ocular surface disease, diabetic retinopathy, or macular edema * corneal or retinal procedures (laser or incisional) during the study period and 6 months prior

Keywords: migs, minimally invasive glaucoma surgery
mid-hdf randomized controlled study on outcome

Conditions: End Stage Renal Disease

Summary: the purpose of this study is to determine whether mid-dilution hemodiafiltration is effective in the reduction of the crude mortality risk in patients who have been undergoing renal replacement treatment for less than 1 year. patients will be randomized since the beginning of the study in two groups: standard hf dialysis and mid-dilution hdf.

it is a matter of fact that in the last decades the chronic kidney disease (ckd) population has widely changed. in italy, for example, more than 50% of the incident dialysis patients are more than 70 year old, with diabetic and hypertension being the major underlying diseases; moreover a great percentage of the patients starts dialysis with a burden of at least 1-2 comorbidities \[1\]. online hemodiafiltration (online hdf) has been recently associated with better patient survival in comparison with standard hemodialysis in two large trials \[2,3\]; the overall relative risk of mortality was found to be approximately 33% lower in patients treated with online hdf \[2,3\]. these impressive results were not obtained anyway on the whole population, but in a sub-group analysis. a strong correlation was found between the total convective volume obtained and the mortality risk reduction; hdf was found to be significantly better than standard hemodialysis when a total convective volume of 19-22 l/session (in 4 hours sessions of post-dilution hdf) was achieved. these results support the importance of the "adequate convective dose" concept in order to improve the patient outcomes especially in frail patients, as recently demonstrated by a large randomised control trial, the mpo study \[4\], comparing high flux versus low flux dialysis in patients with plasma albumin levels equal to or less than 4 gr/dl ( as a marker of patient comorbidities) and, in a post hoc analysis, in diabetic patients \[4\]. mid-dilution hdf is a variant of classical hdf combining simultaneous pre- and post.-dilution in order to maximise middle and large solutes removal. the milestone study would aim to fully demonstrate for mid-dilution hdf the significant mortality risk reduction observed in the recent mentioned studies.

Eligibility criteria:
inclusion criteria: * on a thrice/week rrt for at least 3 months * dialysis vintage \> 3 months * signed informed consent * blood flow \> 300 ml/min exclusion criteria: * on waiting list for living-donor transplant * residual diuresis \> 500 ml/day * inability, as judget by the investigator, to follow or understand the protocol instructions * active neoplastic disease * single needle treatment * patients with expectancy life lower than 6 months * inclusion to other studies * pregnancy

Keywords: dialysis mortality cardiovascular stability inflammation quality of life
the effects of yoga and motor control exercises in patients with chronic neck pain

Conditions: Chronic Neck Pain

Summary: identification of the effects of yoga and motor control exercises on pain intensity, pain sensitivity, function, and pain cognition in individuals with neck pain.

patients participating in the study were divided into two parallel groups. the patients in the motor control exercise group were instructed to perform motor control exercises, which consist of strengthening of the deep cervical flexors, deep cervical extensors, and axioscapular muscles; stretching exercises; postural correction exercises, and patients in the yoga group were instructed to perform a yoga program, which consists of breathing, relaxation, and flexibility exercises.

Eligibility criteria:
inclusion criteria: * non-specific neck pain * must be pain at least 3 months exclusion criteria: * history of any cervical spine surgery * presence of neurological deficit * having been diagnosed with cardiovascular or systemic diseases that would prevent him/her from taking exercise training. * inflammatory, infectious, or tumoral disease of the vertebra * severe/progressive scoliosis, spinal stenosis, spondylolisthesis * had been diagnosed with a neurological disease * were currently pregnant.

Keywords: neck pain exercise cognition yoga motor control function
st-2; a non-invasive fibrosis marker for chronic hepatitis b

Conditions: Sequela of Chronic Liver Disease

Summary: il-33 is a recently identified number of the il-1 family. hepatic over-expression of il-33 has been recently linked to liver fibrosis. st-2 exerts pro-inflammatory effects of il-33. we aimed to determine ability of st2 to predict fibrosis in chronic hepatitis b.

st-2 is an il-1 receptor family member and exists in both a membrane-bound isoform and a soluble (sst2) isoform. it has a functional ligand (interleukin-33) and via st-2/il-33 inflammation and immunity is regulated. hepatic over-expression of il-33 has been recently linked to liver fibrosis. st-2 exerts pro-inflammatory effects of il-33. we aimed to determine ability of st2 to predict fibrosis in chronic hepatitis b.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of chronic hepatitis b or liver cirrhosis exclusion criteria: * accompanying chronic inflammatory disease

Keywords: st-2, il-33, prediction, fibrosis, hepatitis b