Kornimate/medical-research-clean huggingface dataset:
alpps versus pve/pl

Conditions: Colorectal Cancer; Liver Metastases

Summary: study title comparison of two different models of liver growth stimulation in advanced colorectal liver metastatic disease, (ligro trial) enabling liver resection methodology scandinavian multiple center randomized registry based clinical trial study duration the planned duration of study participation for an individual subject from inclusion to follow-up are 3 years primary investigator: per sandstrom (linköping) number of subjects 100 patients randomized in a 1:1 randomization diagnosis and main inclusion criteria patients with colorectal liver metastasis requiring liver resection, but are not resectable in one step because of a future liver remnant/standardized total liver volume of \< 30 % extrahepatic metastatic disease is not an exclusion criteria if they can be addressed surgically in the future overall goal to evaluate if the alpps approach is superior to pve in enabling patients, primarily unresectable due to inadequate flr, to be resected and reach an r0 situation with an acceptable level of complications and perioperative mortality. to evaluate if the alpps approach increases the growth rate of the liver compared to portal embolization or portal ligation leading to a shorter treatment period. in addition the investigators aim to study if alpps may reach these goals without detectable or improved differences in tumor activity (pfs and os), but with a shorter recovery and a higher proportion of patients reaching r0. hypothesis a higher proportion of patients can be resected with alpps counted as rate resected compared to the previously established methods with portal ligation or embolization. this increased resection rate will not reduce the r0 rate, or increase the rate of clavien grade 4 complication or higher (h0). the alpps approach will increase the growth rate compared to portal embolization/ligation measured one week after the primary intervention.


Eligibility criteria:
inclusion criteria: 1. by liver tumor board found accepted for inclusion 2. patients with a tumor burden of colorectal liver metastasis 3. signed informed content 4. colorectal liver metastatic disease with an estimated flr/stlv of \<30% 5. primary tumor and any extrahepatic disease possible to resect in patients with liver first approach or after resection of primary tumor. exclusion criteria: 1. cirrhosis 2. significant comorbidity rendering subjects unsuitable for major surgery 3. progressive disease after preoperative oncological treatment 4. age\<18 years

Keywords: cancer, colorectal hepatectomy portal vein embolization two-stage
trends in cohabitation status, academic achievement and socio-economic indicators after mild traumatic brain injury

Conditions: Mild Traumatic Brain Injury; Concussion, Mild; Academic Achievement; Specific Academic or Work Inhibition; Marriage; Marital Status; Income; Education; Socioeconomic Status; Sickness Absence

Summary: mild traumatic brain injury (mtbi) accounts for 70-90% of all diagnosed traumatic brain injuries (tbi) affecting approximately 50-300 per 100.000 individuals annually. persistent post-concussion symptoms are reported in 15-80% of hospital admitted and outpatient treated populations, affecting labour market attachment, academic achievement, income, socio-economic status, social interactions, home management, leisure activities and cohabitation status. the association between mtbi and long-term trends in cohabitation status, income, academic achievement and socio-economic status has not been thoroughly explored. previous studies focus on children's academic performance after severe tbi and only few studies include early adulthood and patients with mtbi. trends in divorce rates are frequently conducted on severe injuries or populations consisting of veterans. additionally, all studies have failed to apply a national register based design. aim the aim of the study is to examine the long-term associations between mtbi and trends in cohabitation status, academic achievement and socio-economic status between pre-injury rates and observed rates at 5 years post-injury. the hypothesis was that by 5 years mtbi would be associated with increased odds of marital breakdown, decreasing academic achievement, decreasing income, decreasing socio-economic status compared to the general population in denmark. methods: the study is a national register based cohort study with 5 years follow-up of patients with mild traumatic brain injury from 2008 - 2012 in denmark. population: patients between 18-60 years diagnosed with concussion (icd-10 s06.0) were extracted from the danish national patient register between (2003-2007). patients with major neurological injuries and previous concussions at the index date and 5 years before the index date (1998-2007) were excluded. patients who were not resident in denmark 5 years before and during the inclusion period were also excluded (1998-2007). data will be retrieved from several national databases, including: the danish national patient register, danish civil registration system (crs), the danish education registers, the income statistics register and the employment classification module (akm). one control of the general population were matched for each case on sex, age and municipality. outcome measures are: cohabitation status, education, income and socio-economic status.


Eligibility criteria:
inclusion criteria: * concussion (icd-10 s06.0) (primary diagnosis)(2003-2007) exclusion criteria: * major neurological injuries and previous concussions (1998-2007) * not resident in denmark (1998-2007)
perfexion registration using cbct

Conditions: Brain Metastases

Summary: measuring precision radiation delivery through cone-beam computed tomography (cbct) and intra-fraction motion management (ifmm) incorporated on a gammaknife unit via the leksell coordinate frame (lcf) and relocatable mask system (rms) immobilization devices.

: brain metastases are reported to occur in 20% to 40% of all patients with cancer. treatment options for brain metastases include surgical resection, particularly in lesions causing significant mass effect, whole brain radiation (wbrt) and radiosurgery (srs). due to concerns of neurocognitive toxicity following wbrt, there is growing use of srs, particularly in patients with limited brain metastases and controlled extracranial disease. radiosurgery delivers a high dose of radiation to a defined intracranial target through precise targeting with a sharp dose fall off at the target boundaries and minimal damage to surrounding tissue. to date, precision radiation delivery has been facilitated through the leksell coordinate frame (lcf), fixated to the patient's skull through 4 pins. a relocatable mask system (rms), consisting of a patient specific head rest and mask was developed to enable minimally-invasive fractioned radiosurgery. a cone-beam computed tomography (cbct) image guidance and intra-fraction motion management (ifmm) system was previously developed in-house in order to measure and address setup uncertainties on gamma knife. the in-house prototype has been integrated into a commercially available gammaknife device with cbct guidance. the installation of this device will enable volumetric guidance for all patients treated in either a single or multiple session on gammaknife perfexion. this study is designed to have 2 arms, a and b. both arm a (using the leksell coordinate frame) and arm b (using the relocatable mask) are undergoing standard of care treatment on gammaknife perfexion for srs. cbct is part of standard of care for arm b. however, cbct imaging is considered as part of study treatment for arm a. pre and post treatment images will be acquired of the patient treated on perfexion gamma knife using the leksell coordinate frame in order to aid in analyzing the imaging metrics of the image guided perfexion unit.

Eligibility criteria:
inclusion criteria: 1. at least 18 years old 2. ability to provide informed consent 3. any patient receiving single or multi-fraction stereotactic radiosurgery on the perfexion gamma knife with image-guidance exclusion criteria: 1. age \< 18 years old.

Keywords: advanced cancer imaging study stereotactic radiosurgery gammaknife cone-beam computed tomography (cbct)
subthalamic nucleus connectivity in parkinson's disease with ultra-high field magnetic resonance imaging

Conditions: Parkinson Disease

Summary: the purpose of this study is to investigate the segregation of the subthalamic nucleus into its motor and non-motor regions in patients with parkinson's disease and healthy controls with the aid of ultra-high field magnetic resonance imaging.


Eligibility criteria:
inclusion criteria: both groups: * mental competence group 1: * parkinson's disease patients scheduled for deep brain stimulation surgery group 2: * age and gender matched volunteers exclusion criteria: both groups: * head injury * stroke * other neurological diseases other than parkinson's disease * metallic prostheses or pacemaker in the subject's body or other contra indications for mri group 1: * inability to abstain from dopaminergic drug use group 2: * parkinson's disease * use of medication affecting the central nervous system

Keywords: parkinson disease subthalamic nucleus ultrahigh field magnetic resonance imaging functional connectivity structural connectivity
application of s26e for diabetic foot ulcer healing

Conditions: Diabetic Foot; Neuropathic Foot Ulcer; Chronic Diabetic Ulcer of Left Foot (Diagnosis); Chronic Diabetic Foot Ulcer of Right Foot

Summary: a randomized, controlled open-label, parallel group study to examine the effectiveness of a local application of the kalahari melon (citrullus lanatus) seed oil for the healing of non-infected diabetic foot ulcers.

this is a randomized, controlled open-label, parallel group study of 12 weeks duration aimed to examine the effectiveness of a local application of the kalahari melon (citrullus lanatus) seed oil (s26e) for the healing of non-infected chronic (\>12 weeks) diabetic foot ulcers. the s26e is a natural extract rich in unsaturated (such as linoleic, oleic, palmitic and static) fatty acids which have shown promise in the promotion of wound healing by modulating the migration and functional properties of inflammatory cells in wound cites as well as the production of inflammatory cytokines. the safety of topical s26e application on human skin has been clinically demonstrated. eligible participants will be adults patients with diabetes mellitus (dm) type 1 or 2 and chronic (persistent for \>12 weeks after initial presentation) neuropathic or neuroischaemic non-infected diabetic foot ulcers. following recruitment and randomization (on a 1:1 ratio) eligible patients will attend the study site on weekly intervals. after a run-in period of 2 weeks (visits 1-2) during which all participants will receive the optimal standard-of-care for neuropathic/neuroischaemic diabetic ulcers (incl. optimization of glycemic control, off-loading, local debridement as needed, atraumatic surface scrubbing, saline washing and sterile dressing) eligibility will be reassessed. participants who will continue in the study will receive standard of care (control group) or standard of care plus daily local s26e application on ulcer (intervention group) (visits 3-12). after visit 12 the application of s26e will be terminated and all participants will receive an additional follow up visit 4 weeks later (final visit). efficacy end-points will be assessed at the end of the of 12 weeks of observation (visit 12)

Eligibility criteria:
inclusion criteria: * type 1 or type 2 diabetes mellitus * body mass index \<40 kg/m2 * glycated hemoglobin (hba1c) \<10% * presence of a diabetic foot ulcer with the following features i) owing to chronic peripheral sensorimotor diabetic neuropathy, with or without peripheral arterial disease (critical ischemia excluded as indexed by an ankle-brachial index \ 12 weeks iii) already following an adequate off-loading method exclusion criteria: * presence of clinical signs of infection * inability or refusal to follow off-loading methods * ulcer surface area decline by \>15% during the run-in period * malignant disease (non-melanoma skin malignancy and healed thyroid malignancies excluded) * acute charcot arthropathy * serious chronic hepatic (child-pugh b or c), renal (stage 4-5 ckd) or heart (nyha 3-4) disease * known hypersensitivity to the product or its contents * any random glucose measurement \>350 mg/dl during the run-in period
identification of emt indicators in healthy and periodontally diseased gingival samples

Conditions: Chronic Periodontitis

Summary: the current study focuses on the localization and quantitative assessment of growth factors and cytokines related to the emt process found in the human gingival tissue samples taken from periodontally diseased individuals compared to other samples taken from healthy individuals. through this investigation the correlation between the severity of the disease and the amount of these factors will be studied aiming to alleviation of the high prevalence of periodontal diseases among the egyptian population.

in a case control human study the existence and the amount of the indicators and cytokines for emt in the gingival tissue samples taken from the periodontitis patients will be investigated and compared to those in healthy individuals using histopathology and real time pcr to reveal the role of these factors in periodontal disease incidence in humans. total of 36 participants will be recruited in this study the participants will be divided according to their periodontal status into four groups (healthy, mild, moderate and severe periodontitis) 9 patients in each group. the periodontal screening of patients will be done using mouth mirror and graduated williams's periodontal probe for the following: * gingival status will be assessed by using gingival index * periodontal pocket depth. * clinical attachment loss. * radiographic examination using panoramic technique. screening criteria for chronic periodontitis was the presence of at least 5 sites with 4 mm horizontal alveolar bone loss on radiographs. gingival tissue samples will be harvested during periodontal surgery and extraction of the periodontally hopeless tooth for the periodontitis patients and during the premolar extraction (orthodontic ttt) or third molar extraction for the healthy controls. the dissected gingival samples will be washed in saline solution and fixed in 4% buffered formalin for 48 hours, dehydrated in ascending grades of ethyl alcohol, cleared in xylene and embedded in paraffin and will be subjected to the following:. 1. sections of 4-5 µm in thickness will be obtained, deparaffinized, rehydrated and subjected to histological staining and histomorphometric analysis. 2. real time- pcr for tgf-b1 ,vimenten , e-cadherin .

Eligibility criteria:
inclusion criteria: * inclusion criteria for healthy group: * absence of any clinical sign of gingival inflammation * probing depth ≤3 mm * no clinical attachment loss. inclusion criteria for periodontitis group: * generalized presence of clinical signs of gingival inflammation * generalized probing depth ≥4 mm * generalized clinical attachment loss of ≥2 mm. exclusion criteria: * • patients with any systemic disease, * smokers * pregnant or lactating women, * cervical/proximal/subgingival caries or restorations, * periodontal or antimicrobial therapy within 3 months before sampling.
contribution of erector spina plane block to analgesia for myofascial pain syndrome

Conditions: Trigger Point; Myofascial Pain

Summary: myofascial pain syndrome is a common chronic disease characterized by pain and tenderness in one or more muscle groups. it is characterized by myofascial trigger points that are felt as a band or a nodule harder than normal consistency located in the muscle. myofascial trigger points are developes as a result of muscle injury ; this can be acute trauma caused by sport injury, accident, or chronic muscle overuse by repetitive occupational activities, emotional stress or poor posture. trigger point injection is the application of low dose local anesthetic drug into the trigger point.its main purpose is to weaken the trigger point caused by muscle spasm.however, it may reduce pain partially or have a short duration of action, so it may need to be repeated several times at regular intervals.trigger point injection can reach trigger points in superficial muscles with the erector spina plane block technique, more effective and long-term pain treatment can be achieved by reaching deeper trigger points. with this hypothesis, we aimed to investigate the contribution of the erector spina plane block to trigger point injection in the treatment of myofascial pain.

myofascial pain syndrome is a common chronic disease characterized by pain and tenderness in one or more muscle groups. it is characterized by myofascial trigger points that are felt as a band or a nodule harder than normal consistency located in the muscle. myofascial trigger points are developes as a result of muscle injury ; this can be acute trauma caused by sport injury, accident, or chronic muscle overuse by repetitive occupational activities, emotional stress or poor posture. trigger point injection is the application of low dose local anesthetic drug into the trigger point.its main purpose is to weaken the trigger point caused by muscle spasm.however, it may reduce pain partially or have a short duration of action, so it may need to be repeated several times at regular intervals.trigger point injection can reach trigger points in superficial muscles with the erector spina plane block technique, more effective and long-term pain treatment can be achieved by reaching deeper trigger points. with this hypothesis, we aimed to investigate the contribution of the erector spina plane block to trigger point injection in the treatment of myofascial pain.

Eligibility criteria:
inclusion criteria: clinical diagnosis of myofascial pain exclusion criteria: cervical radiculopathy fibromyalgia

Keywords: trigger point , erector spinae plane block , ultrasonography
safety, reactogenicity & immunogenicity study to evaluate a booster dose of gsk biologicals' hib-menc given with priorix™ in toddlers (13-14 m) primed with 3 doses of hib and menc-crm197

Conditions: Haemophilus Influenzae Type b; Neisseria Meningitidis

Summary: the purpose of this study is to evaluate the safety, reactogenicity and immunogenicity of a booster dose of the candidate hib-menc conjugate vaccine given concomitantly with measles, mumps and rubella (mmr) vaccine, versus hib-menc only and mmr only, when given to healthy subjects aged 13 to 14 months who were primed with 3 doses of hib (as part of a dtpa -containing vaccine) and menc-crm197.

this multicenter study is open with respect to the treatment allocation, but double-blind with respect to the hib-menc-tt lots (3 lots). hib-menc-tt and priorix™, when given separately, serve as active controls. two blood samples are taken: before and one month after vaccination. additional vaccines are offered at study end in order to complete the vaccine schedule recommended in spain

Eligibility criteria:
inclusion criteria: * healthy male or female between, and including, 13 and 14 months of age. * previously completed 3-dose primary vaccination with a menc-crm197 vaccine, and hib (given as part of a combined dtpa-containing vaccine) with at least 6 months between the administration of the third doses and the study entry. exclusion criteria: * use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the study vaccine, or planned use during the study period. * previous vaccination against or history of h. influenzae type b (hib) and/or meningococcal serogroup c disease and/or measles, mumps or rubella or known exposure to measles, mumps or rubella within 30 days prior to the start of the present study. * any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (hiv) infection. * a family history of congenital or hereditary immunodeficiency. * history of any neurologic disorders or seizures. * history of allergic disease or reactions likely to be exacerbated by any component of the vaccine including neomycine
application to predict neonatal apnea with bradycardia

Conditions: Apnea Neonatal; Bradycardia Neonatal

Summary: this purpose of this study is to reduce or stop apneas and bradycardias in pre-term infants, before they occur using gentle stimulation.

this will be a randomized cross-over trial that will use additional ecg leads connected to a novel device and laptop to determine the accuracy and efficacy of an algorithm to predict, detect, and interrupt episodes of bradycardia for two 4-hour periods. there will be a 4-hour period without vibro-tactile stimulation and a 4-hour period with vibro-tactile stimulation when episodes are predicted or detected.

Eligibility criteria:
inclusion criteria: * documented episodes of apnea with bradycardia over the previous 24 hours. * off ventilatory support/ncpap for \> 48 hours prior to study entry * gestational age \< 32 0/7 weeks' gestation at birth * parents/legal guardians have provided consent for enrollment exclusion criteria: * a major malformation or a neuromuscular condition that affects respiration or causes apnea, or terminal illness or decision to withhold or limit support.
sleep for stroke management and recovery trial

Conditions: Ischemic Stroke; Sleep Apnea; Sleep Apnea, Obstructive; Stroke; CPAP; Telemedicine; Home Sleep Apnea Test; Randomized Clinical Trial; Multicenter Trial

Summary: the purpose of this study is to determine whether treatment of obstructive sleep apnea (osa) with positive airway pressure starting shortly after acute ischemic stroke (1) reduces recurrent stroke, acute coronary syndrome, and all-cause mortality 6 months after the event, and (2) improves stroke outcomes at 3 months in patients who experienced an ischemic stroke.

sleep smart has a prospective, randomized, open-label, blinded-endpoint (probe) design. it is a multi-site, parallel-group superiority trial that compares 6 months of osa treatment to usual care. the study includes two trials: a prevention study with an embedded recovery trial. 3062 subjects will be randomized over 5 years at 110 sites within the ninds-funded strokenet clinical trials network.

Eligibility criteria:
current inclusion criteria, as of 6/28/2024: 1. ischemic stroke within the prior 7 days. 2. nih stroke scale score ≥1 at the time of enrollment previous inclusion criteria, prior to 6/28/2024: 1. ischemic stroke or tia with abcd ≥4, within prior 14 days. exclusion criteria (for entire time period): 1. pre-event inability to perform all of own basic adls 2. unable to obtain informed consent from subject or legally authorized representative 3. incarcerated 4. known pregnancy 5. current mechanical ventilation (can enroll later if this resolves) or tracheostomy 6. current use of positive airway pressure, or use within one month prior to stroke 7. anatomical or dermatologic anomaly that makes use of cpap interface unfeasible 8. severe bullous lung disease 9. history of prior spontaneous pneumothorax or current pneumothorax 10. hypotension requiring current treatment with pressors (can enroll later if this resolves) 11. other specific medical circumstances that conceivably, in the opinion of the site pi, could render the patient at risk of harm from use of cpap 12. massive epistaxis or previous history of massive epistaxis 13. cranial surgery or head trauma within the past 6 months, with known or possible csf leak or pneumocephalus 14. recent hemicraniectomy or suboccipital craniectomy (i.e. those whose bone has not yet been replaced), or any other recent bone removal procedure for relief of intracranial pressure 15. current receipt of oxygen supplementation \>4 liters per minute 16. current contact, droplet, respiratory/airborne precautions