Kornimate/medical-research-clean huggingface dataset:
investigation of cancer cell extravasation through mrna analysis of organ-specific endothelial cells and microfluidics

Conditions: Breast Cancer Metastatic

Summary: the project aims at unraveling the role of organ-specific endothelia mediating the preferential metastasisation of breast cancer cells to bone by using a multi-faceted approach, integrating microfluidics and transcriptomic profiling. based on a recently study published by the investigators \[jeon et al., pnas 2015\], it can be hypothesized that phenotypic differences at the level of organ-specific endothelial cells are able to drive the preferential extravasation of breast cancer cells to specific sites. hence, the transcriptional profile of primary organ-specific endothelial cells derived from healthy patients (i.e. non-affected by breast cancer) will be analyzed to identify phenotypic differences between organ-specific populations of endothelial cells. these analyses will allow to identify potential target genes involved in the organ-specific extravasation of cancer cells (i.e. genes differentially expressed by endothelia of preferential and non-preferential metastasisation sites). the selected genes will be silenced and the effect of gene silencing will be evaluated through microfluidic in vitro organ-specific 3d models designed to study cancer cell extravasation.

in particular, the main aim of the study will be to highlight differences between bone and skeletal muscle microenvironments, which are respectively preferential and non-preferential metastasisation sites for breast cancer cells, in order to identify specific pathways driving breast cancer cells extravasation. to this purpose, differences in the transcriptional profile of ecs derived from bone and muscle endothelium will be investigated. these analyses will be used to select target genes differentially expressed by bone- and muscle-specific ecs. then, ecs obtained from bone and muscle endothelium will be respectively used to mimic bone and muscle microvessel environments in microfluidic in vitro 3d models allowing for the study of breast cancer cell extravasation. the genes selected according to the results of the transcriptomic analysis (e.g. genes expressed in ecs derived from bone endothelium, but not expressed in ecs derived from muscle endothelium) will be silenced and the effect of gene silencing will be evaluated monitoring breast cancer cell extravasation in order to verify the involvement of the selected genes in this process.

Eligibility criteria:
inclusion criteria: * age between 18-65 years * patients undergoing cruciate ligament surgery or hip arthroplasty * subscription of informed consent exclusion criteria: - hiv, hcv, hbv, tpha viral

Keywords: organ specific endothelium microfluidics cancer cell extravasation
gene delivery clinical trial of srp-9003 (bidridistrogene xeboparvovec) for participants with limb-girdle muscular dystrophy, type 2e (lgmd2e) (beta-sarcoglycan deficiency)

Conditions: Limb-Girdle Muscular Dystrophy, Type 2E

Summary: the proposed clinical trial is the first-in-human, single-center, open-label, gene delivery study of srp-9003 (bidridistrogene xeboparvovec) in participants with lgmd2e.


Eligibility criteria:
inclusion criteria * males or females of any ethnic group * β-sg deoxyribonucleic acid (dna) gene mutations at both alleles * weakness demonstrated based on history of difficulty in running, jumping and climbing stairs * a 100 meter walk/run (mwr) test result: ≥40 % of predicted for age-, height-, gender-, and weight-matched healthy controls at the screening visit exclusion criteria * active viral infection based on clinical observations * cardiac magnetic resonance imaging (mri) determined left ventricular ejection fraction (lvef) \<40% * serological evidence of human immunodeficiency virus (hiv), hepatitis b, or hepatitis c infection * diagnosis of (or ongoing treatment for) an autoimmune disease * abnormal laboratory values considered clinically significant * concomitant illness or requirement for chronic drug treatment that, in the opinion of the principal investigator, creates unnecessary risks for gene transfer. other inclusion/exclusion criteria apply.

Keywords: limb girdle muscular dystrophy lgmd2e beta-sarcoglycan gene transfer adeno-associated virus lgmdr4
intra-nasal mechanical stimulation (inmest) as a treatment of keratoconjunctivitis sicca (dry eye syndrome)

Conditions: Keratoconjunctivitis Sicca (KCS)

Summary: the purpose of the study is to evaluate how treatment with intra-nasal mechanical stimulation (inmest) in the nasal cavity in patients with keratoconjunctivitis sicca can relieve these symtoms.


Eligibility criteria:
inclusion criteria: * ocular surface disease index, osdi \> 12 points. * non-invasive breakup time, nibut \< 11 seconds. exclusion criteria: * ocular surface disease index, osdi \< 12 points. * non-invasive breakup time, nibut \> 11 seconds.
a study to evaluate the safety, pharmacokinetics and pharmacodynamics of amg 557 in subjects with systemic lupus erythematosus

Conditions: Systemic Lupus Erythematosus

Summary: this is a multicenter, randomized, double-blind, placebo-controlled, sequential rising single-dose study in which approximately 56 subjects with sle will be enrolled in 7 dosing cohorts


Eligibility criteria:
inclusion criteria: * diagnosis of sle with positive ana * stable disease with no change in sle therapy within the previous 30 days * bmi from 18 to 38 kg/m2 exclusion criteria: * have had signs or symptoms of a viral, bacterial or fungal infection within 30 days of study randomization * evidence of renal disease or liver disease * any history of granulomatous disease including autoimmune granulomatous vasculitis and sarcoidosis * prior administration of any other biologic that primarily targets the immune system
a study to compare efficacy and safety of ct-p55 and cosentyx in patients with moderate to severe psoriasis

Conditions: Plaque Psoriasis

Summary: the goal of this phase 3 clinical trial is to compare efficacy and safety of ct-p55 with cosentyx in patients with moderate to severe plaque psoriasis

ct-p55 is a recombinant humanized monoclonal antibody containing the active ingredient secukinumab. ct-p55 is a drug product being developed by celltrion, inc. and being compared to both the eu-approved cosentyx®. in this study, efficacy and safety of ct-p55 will be evaluated in patients with moderate to severe chronic plaque psoriasis.

Eligibility criteria:
inclusion criteria: - patient has had a diagnosis of chronic plaque psoriasis for at least 24 weeks. exclusion criteria: * patient diagnosed with forms of psoriasis other than chronic plaque-type or medication-induced psoriasis. * patient who has previously received secukinumab or any other biologic drug directly targeting interleukin-17 or the il-17 receptor. * patient who has allergies to any of the excipients of study drug or materials of device or any other murine and human proteins, or patient with a hypersensitivity to immunoglobulin products.
a study of orforglipron (ly3502970) in participants with obesity or overweight and at least one weight-related comorbidity

Conditions: Obesity; Overweight

Summary: the main purpose of this study is to see how orforglipron, compared with placebo, helps reduce body weight in participants with obesity or with overweight and at least one other related health condition (excluding type 2 diabetes). this trial is part of the master protocol study j2a-mc-gzpo. participation in the study will last about 18 months.


Eligibility criteria:
inclusion criteria: * have body mass index (bmi) ≥30 kilograms per square meter (kg/m2) or bmi ≥25.0 kg/m2 and at least 1 of the following weight-related comorbidities at screening: * hypertension * dyslipidemia * obstructive sleep apnea, or * cardiovascular disease * have a history of at least one unsuccessful dietary effort to lose body weight exclusion criteria: * have type 1 diabetes, type 2 diabetes, or any other types of diabetes * have an unstable body weight within 90 days prior to screening * have new york heart association functional classification iv congestive heart failure or an acute cardiovascular condition within 90 days prior to screening * have acute or chronic hepatitis or pancreatitis * are taking other medications or alternative remedies to manage weight loss
kyphoplasty with structured titanium spheres

Conditions: Vertebral Fracture

Summary: the aim of the trial is to study efficacy and safety of kyphoplasty technique with porous titanium microspheres in patients with type a vertebral body fracture (according to magerl classification).

randomized controlled open trial with p.r.o.b.e. design (prospective randomized open, blinded end-point) objective: the aim of the trial is to study efficacy and safety of kyphoplasty technique with porous titanium microspheres in patients with type a vertebral body fracture (according to magerl classification). all consecutive eligible patients, belonging to the neurosurgery unit of a.r.n.a.s. civico hospital, in palermo, will be included in the pilot study: 10 patients will be recruited for the treatment arm and 10 patients for the control arm. * patients aged between 18 and 80 years. * diagnosis of vertebral body fracture, type a (according to magerl classification) in particular a.1, a.2 and a.3.1. * absence of ligamentous structures lesion and / or invasion of the spinal canal, confirmed by rx tc and nmr. * refusal to sign informed consent, * diagnosis different from those established by inclusion criteria. * age under 18 years. * age over 80 years. * presence of ligamentous structures lesion and / or invasion of the spinal canal confirmed by rx, tc and nmr. for each patient will be evaluated: * spine rx * ct of the spinal layer (or spine ct) * spine mri * roland morris disability (for the assessment of low back pain) * eq-5d (health questionnaire) * denis work scale (for the assessment of working conditions) * vas (for pain assessment) * the statistical analysis will be performed using the spss software vers. 12.0 (spss inc., chicago, il, united states). the study data will be collected pursuant to and for the purposes of articles 13 and 23 of the d. l.gs. n. 196/2003. the study will be performed according to the rules established by the principles of good clinical practice (as per ministerial decree of 07/15/97) and according to the principles gathered in the helsinki declaration (52 nd wma general assembly version, edimburgh, scotland, october 2000 ). the clinical practices are performed according to the most recent recommendations of the world medical assembly (declaration of helsinki, 1964, and subsequent amendments).

Eligibility criteria:
inclusion criteria: * magerl type a thoracolumbar fracture with no neurological deficits * age\>18yy and \< 80yy * no ligament lesions exclusion criteria: * age \ 80yy * ligament lesions * refusal to sign informed consent

Keywords: kyphoplasty ebm titanium microsphere vertebral fracture
energy intake and energy deficit in obese adolescents

Conditions: Pediatric Obesity

Summary: the aim of the present study is to compare the effect of two weight loss interventions inducing the same energy deficit but one based on exercise and one using dietary restriction, on appetite control in obese adolescents. investigator hypothesis that daily energy intake and hunger will be increased in the dietary restriction group but not in response to the exercise program.

the present study will compare the nutritional responses to two 4-month weight loss programs inducing the same energy deficit in obese adolescents, one based on exercise and the other one using dietary restriction. after a first 4-month phase stabilizing the adolescents' daily energy intake and expenditure, half of the sample with increase their physical activity to induce a 10% increase of their daily energy expenditure (maintaining the same energy intake) while the other half will stick with the same physical activity program but reduce their daily intake to match for the same 10% energy deficit. before, at the end and 4 months after the intervention, investigator will assess the adolescents' energy intake and appetite control by measuring: ad libitum energy intake, appetite feelings throughout the day, food preferences, food reward. but also all the potential underneath mechanisms based on gastro-peptides and adipokines. finally, sleep metabolism will be assessed using polysomnography as a potential link between weight loss and appetite control. body composition, quality of life, aerobic capacities and resting metabolic rate will also be measured at each time point.

Eligibility criteria:
inclusion criteria: * bmi percentile \> 97th percentile according to the french curves. * ages 12-16 years old * signed consent form * being registered in the national social security system * no contraindication to physical activity exclusion criteria: * previous surgical interventions that is considered as non-compatible with the study. * diabetes * weight loss during the last 6 months * cardiovascular disease or risks

Keywords: appetite control obesity adolescents physical activity
femur transtrochanteric fractures treated with dynamic hip screw and calcium sulfate scaffold.

Conditions: Proximal Femur Fracture

Summary: this is a randomised prospective comparison study to evaluate the incidence of cut - out failure of the dynamic hip screw implant alone compared to the dynamic hip screw adding calcium sulfate through the cervical canal before placing the sliding screw for improvement of the implant stability integration and bone healing.

transtrochanteric fractures are a frequent entity, mainly in patients over 65 years old, with low bone density. most of these fractures of the proximal femur are treated effectively with internal fixation with dynamic hip screw (dhs), nonetheless a conditional factor in the treatment success its in the fracture stability and in the osteoporosis severity. there is controversy in the treatment decision in patients with osteoporosis and an unstable fracture added the risk of peri-prosthetic infection or increased bleeding during surgery means that the decision to place a dhs versus a prosthesis is debated. this study represents the first comparison of closed reduction and internal fixation with dhs using calcium sulfate graft versus conventional dhs procedure.

Eligibility criteria:
inclusion criteria: * patients between 65 and 80 years old * patients classified as 31a1.3 and all 31a2 by the orthopaedic trauma association classification system. exclusion criteria: * patients with stable hip fractures * participants who do not accept the randomization process * patients who do not complete follow-up during the study

Keywords: dynamic hip screw dhs hip fracture
neuroprotection with n-acetyl cysteine for patients with progressive multiple sclerosis

Conditions: Multiple Sclerosis; Multiple Sclerosis, Primary Progressive; Multiple Sclerosis, Secondary Progressive

Summary: this study evaluates the effectiveness of n-acetyl cysteine (nac) in the treatment of progressive multiple sclerosis. half of the patients will receive nac, while the other half will receive a placebo.


Eligibility criteria:
inclusion criteria: * - 40-70 (inclusive) years in age, * meet 2017 mcdonald criteria (thompson 2018), * patients with primary or secondary progressive ms (thompson 2018), * at least 2 years since progressive symptom onset, * evidence of clinical changes over the previous 2 years unrelated to relapses: increased edss or 20% slowing on 25-foot walk, change of ambulatory support, cognitive change documented on cognitive testing. progression defined by patients in terms of ambulation perimeter or type of support to ambulate are acceptable if aforementioned physician-based measure changes are not available. * edss score 3.0 to 7.0 (inclusive), * can be on a stable disease-modifying treatment initiated \> 3 months prior to screening, * can be on stable doses of dalfampridine initiated at least one month before screening. exclusion criteria: * - ms relapses in the previous 6 months * oral glucocorticosteroid treatment within the prior 3 months * patient with issues undergoing mri scans * pregnancy or breastfeeding * women of child-bearing potential not able to utilize an effective form of contraception for the duration of the study * history of bleeding disorders * active gastrointestinal ulcers * abnormal liver function testing (aminotransferase (ast) or alanine aminotransferase (alt) \>2 times upper limit of normal) * current treatment for active malignancy or metastatic malignancy treated in the past year * alcohol or substance use disorder * allergy to nac * planned surgery or move within 15 months * use of medications/supplements with antioxidant properties (including over-the-counter nac)
prehab for lung and esophageal cancer

Conditions: Neoplasm of Lung; Neoplasms; Exercise; Surgery

Summary: research indicates that individuals diagnosed with lung or esophageal cancer who enter treatment with higher functional capacities, improved body composition, and better nutrition status tend to experience better outcomes and a higher quality of life. the primary objective of a prehabilitation health coaching program is to enhance the overall health and well-being of patients before they undergo major surgery.this personalized 8-week program encompasses elements such as nutrition, smoking cessation, sleep hygiene, and movement, equipping participants with the knowledge and tools needed to adopt healthier lifestyles.

the purpose of this study is to explore the implementation, feasibility and effectiveness of a community-based prehabilitation health coaching program, including nutrition, smoking cessation, sleep hygiene and movement for individuals scheduled to undergo surgery for lung or esophageal cancer.. participants will have the option to engage in a one-on-one prehabilitation health coaching program tailored to their needs, led by a qualified exercise professional (qep). the personalized prehabilitation plan will encompass 4-6 in-person or virtual meetings before surgery, including a structured movement plan, education on smoking cessation, sleep quality, stress reduction, mindfulness, and nutrition. post-surgery, the qep will provide support through counselling and scheduled sessions for a month after surgery and include one session while the patient is in hospital. this research adopts a repeated measure, mixed-methods approach. participants will undergo three clinical assessments at different stages: baseline, pre-surgery, and 4-6 weeks post-surgery. the findings from this study will guide future grant applications aimed at funding larger studies and the implementation of prehabilitation as part of standard of care in lung and esophageal cancer patients in nova scotia. central to the research endeavor is the driving question: "how can a community-based prehabilitation program be successfully implemented in the community, and can it lead to improved functional outcomes in patients undergoing surgery for lung or esophageal cancer?" this overarching question provides the study with its core focus and serves as a guiding force throughout the research process.

Eligibility criteria:
inclusion criteria: * diagnosed with lung or esophageal cancer * scheduled to receive surgical intervention in minimum 2-weeks * surgeon approval * able to read and write in english * \>18 years of age exclusion criteria: * not able to provide informed consent
logotherapy counseling programme for palliative care patients with chronic sorrow

Conditions: Palliative Care; Cancer

Summary: the purpose of this study is to evaluate the effectiveness of logotherapy counseling program on chronic sorrow, meaning of life and dignity of palliative care patients.

palliative care patients experience psychosocial and spiritual problems such as depressed mood, fear of metastasis, uncertainty, lack of pleasure, fear of suffering, and chronic sorrow. logotherapy is a meaning-centered intervention helping the individual to discover the meaning of life and increasing the spiritual well-being and quality of life of the individual. in this study, the effect of logotherapy counseling program on dignity, chronic sorrow and meaning of life of palliative care patients will be evaluated. in this study, the participants will be randomized in a single blind manner (participant) to either intervention (8 session-4 week logotherapy) or control (routine care) groups.

Eligibility criteria:
inclusion criteria: hospitalized patients due to advanced cancer patients informed of cancer diagnosis at least 1 month patients reporting to have chronic sorrow patients with palliative performance scale score at least 50% patients having life expectancy more than 6 months patients who volunteered to participate in the study and signed written informed consent exclusion criteria: clinically diagnosed mental disorder patients with palliative performance scale score \< 40%

Keywords: logotherapy nursing meaning in life chronic sorrow dignity
investigation of metabolic risk in korean adults

Conditions: Cardiovascular Disease

Summary: a cohort study with korean adults to investigate biomarkers in prediction of cardiometabolic and other diseases

this is a prospective cohort study with korean adults to investigate biomarkers in prediction of cardiometabolic and other diseases

Eligibility criteria:
inclusion criteria: * healthy adults without chronic diseases * diabetic patients who are well controlled with oral antidiabetic agents * hypertensive patients who are well controlled with oral antihypertensive agents * dyslipidemic patients who are well controlled with oral lipid-lowering agents exclusion criteria: * malignancy * chronic wasting disease * long-term steroid use
octa changes in choroidal neovascularization in high myopia

Conditions: Myopic Choroidal Neovascularisation

Summary: to analyze the ability of optical coherence tomography angiography ( oct-a ) to detect the presence of myopic choroidal neovascularization and to describe the structural features of myopic cnv..

to analyze the ability of optical coherence tomography angiography ( oct-a ) to detect the presence of myopic choroidal neovascularization and to describe the structural features of myopic cnv.. regarding the size , shape , core , margin , appearance , and activity of cnv..

Eligibility criteria:
inclusion criteria: * all patients with high myopia ( \> -6 d or axial length \> 26.5 mm ) with fundoscopic changes consistent with cnvm , with clear media are subjected to octa exclusion criteria: * patients with treated cnvs , or with other causes of cnvs including : neovascular amd , idiopathic cnv , traumatic , inflammatory , neoplastic , degenerative ..
ino - a retrospective study of uk patients with leukaemia

Conditions: Precursor Cell Lymphoblastic Leukemia-Lymphoma

Summary: the purpose of this study is to describe the demographics and clinical characteristics, treatment pathway, and effectiveness and safety of inotuzumab ozogamicin in patients with relapsed/refractory b-cell acute lymphoblastic leukaemia treated with inotuzumab ozogamicin in the real-world.


Eligibility criteria:
inclusion criteria: * patients with relapsed/refractory all. * patients who initiated ino between 1st of june 2016 and date of data collection. * patients who accessed ino treatment via nhs commissioning, via the cup, or via private purchase. * patient aged ≥18 years old at initiation of ino treatment exclusion criteria: * patients initiated on treatment with ino at a different hospital than the ones selected in this study. * patients with \<3 months of follow-up since index date, unless death occurs \<3 months from index date.