Kornimate/medical-research-clean huggingface dataset:
adaptive platform trial for personnalisation of sepsis treatment in children and adults: a multi-national, treatable traits-guided, adaptive, bayesian basket trial

Conditions: Sepsis

Summary: palette is a perpetual adaptive platform to efficiently study sepsis interventions within 'treatable traits' in all-ages patients enabling prompt evaluation of pandemic treatments. treatable traits, therapeutic targets identified by phenotypes or endotypes (defined by biological mechanism or by treatment response) through validated biomarkers (measurable characteristic reflecting normal or pathogenic processes, or treatment responses), may include multi-omics, cellular, immune, metabolic, endocrine features, or intelligent algorithms. palette bayesian adaptive design enables parallel investigations of multiple interventions for sepsis, and quick inclusion of pandemic pathogens. palette's new conceptual model will respond to the challenges of standard approaches, i.e. series of sepsis trials, each investigating one or two interventions, expensive, time consuming, and inappropriate in pandemic context.


Eligibility criteria:
inclusion criteria: * all genders patients aged \>37 weeks corrected gestational age with sepsis as per sepsis-3 definition for adults, and as per the phoenix sepsis for children * documented or suspected infection * a sequential organ failure assessment (sofa) score ≥2 for adults, and phoenix sepsis score of ≥2 for children. domain specific additional inclusion criteria : 1. hyper or hypo inflammation based * for adults on, respectively: beta, delta and gamma sub-phenotypes, and/or circulating levels of il-6 \> 100pg/ml, and lymphocytes counts \< 1.0 × 109/l and/or hla-dr \<5,000 hla-dr receptors/monocytes * for children on: the podium (+specific criteria for children) 2. corticosteroids domain corticosteroids responses based on the combination of glucocorticoid-induced 1 glcci1) aa and nuclear factor (nf)-kb1 di genotypes. 3. coagulation domain * hypercoagulation state defined as a sic score ≥4 points and neutrophils side fluorescence light (neut-sfl) \>66 arbitrary units (patients with disseminated intravascular coagulopathy, dic) or neut-sfl ≤66 au (septic coagulopathy) * hypofibrinolytic state defined as sic score ≥4 points and decreased plasminogen level \<1.2 nm. exclusion criteria: * refused to consent participating in the study * pregnancy * any condition for which patient's primary physician will consider inappropriate enrolling patient in the study * previous enrollment in the study. * additional domain specific exclusion criteria relevant to specific interventions, i.e. tocilizumab, baricitinib, anakinra, hydrocortisone, fludrocortisone, unfractioned heparin, tinzaparin, human recombinant thrombomodulin, sivelestat, fresh frozen plasma, according to the "base de données publiques des medicaments" patients can be included in multiple domains.

Keywords: sepsis platform trial
effectiveness of online visit compared with in-person clinic visit on weight loss

Conditions: Obesity; Overweight

Summary: online visit and online counseling via telemedicine technology is a new service for obese people who wish to lose weight but because of their active lifestyle and time limitation cannot come to clinic. the purpose of this study was to examine the efficacy this technology-based intervention on weight loss in obese and overweight female adults.


Eligibility criteria:
inclusion criteria: * must be female * must be 18-45 years of age. * must have body mass index (bmi) between 27-35 kg/ m². * must be able to have moderate exercise. * must be interested to have weight loss. * have access to the internet via broad- band adsl or mobile 4g exclusion criteria: * pregnancy or lactation during the previous 6 months, or planned pregnancy in the next six months. * taking medications that could affect metabolism or change body weight. * report heart problems, chest pain, and cancer within the last five years. * smoking * menopause * diagnosis of any chronic disease such as fatty liver, cancer, chemo/radio therapy, heart disease, immune compromised conditions, abnormal thyroid hormone level.

Keywords: weight loss diet online visit clinic visit
intraoperative indocyanine green laser angiography; postoperative outcomes for autologous tissue flaps

Conditions: Breast Cancer

Summary: the purpose of this study is to identify and compare complication rates between autologous breast reconstruction techniques with and without the inclusion on intraoperative indocyanine green (icg) angiography.

icg-angiography is a real-time visualization of tissue perfusion using intravenous fluorescence. it allows the surgeon a tool for intraoperatively assessment of tissue perfusion of the autologous flap, providing a basis for trimming of hypo perfused areas. the study evaluates the effect of inclusion of this technique by examine postoperative outcomes retrospectively. this is done by differentiation between major and minor complications to evaluate the greatest gains of the intervention.

Eligibility criteria:
inclusion criteria: * eligible patients over the age of 18 years * deemed suitable for breast reconstruction with the latissimus dorsi (ld) myocutaneous flap, muscle sparring ld flap or transverse rectus abdominal muscle (tram) flap exclusion criteria: * patients with recurrence of breast cancer * smoking 4 weeks prior of operation * not able to read and understand danish

Keywords: breast reconstruction autologous tissue flaps indocyanine green angiography breast cancer
an intravenous infusion study of rhigm22 in patients with multiple sclerosis immediately following a relapse

Conditions: Multiple Sclerosis, Acute Relapsing

Summary: this is a phase 1, multi-center, double-blind, randomized, placebo-controlled, dose-escalation study in subjects with relapsing multiple sclerosis (ms). the primary outcome will be the safety and tolerability of a single dose of rhigm22 in relapsing ms subjects.


Eligibility criteria:
inclusion criteria: * males or females (18-70 years of age; \< 104 kg) * capable of giving informed consent * meet diagnostic criteria for ms, as defined by revised (2010) mcdonald criteria * present with a clinical acute relapse defined as a new or worsening neurological symptoms attributable to ms preceded by a stable or improving neurological state of at least 30 days, not associated with fever or infection, lasting at least 24 hours and accompanied by an objective physical (neurological) exam finding as confirmed by the investigator * has at least one new, identifiable, measurable and active lesion on mri (gd+) meeting the criteria of the imaging charter. exclusion criteria: * certain specified co-morbidities (including pregnancy) * taking certain proscribed medications * a medical regimen that has changed in the month prior to screening * inability to undergo requisite mri evaluations * drug or alcohol abuse * any other reason for which, in the opinion of the investigator, the subject should not participate in the study.
audit of hip fractures surgically managed

Conditions: Hip Fractures

Summary: investigators are reviewing the the charts and medical records of participants who were operated at our institute from 2010 onward for hip fractures. checking their outcomes (postoperative complications, length of hospital stay and mortality) and studying their background characteristics and potential associated factors.

this retrospective study is a cohort with multiple exposures and groups. from this nested case control will be analysed as well.

Eligibility criteria:
inclusion criteria: * all patients, regardless of gender, commodities and age * hip fractures which were managed surgically. * operated at our institute. exclusion criteria: * participants with incomplete data or missing information in either the primary exposure or the outcome of interest. * participants with pathological fracture, open fractures, poly-trauma or revision surgeries.
motorized movement therapy & pulmonary functions in down syndrome

Conditions: Pulmonary Functions; Down Syndrome

Summary: to investigate the effects of the addition of motorized movement therapy versus conventional chest physiotherapy alone on pulmonary functions, exercise capacity, and endurance in children with down syndrome

to investigate the effects of the addition of motorized movement therapy versus conventional chest physiotherapy alone on pulmonary functions, exercise capacity, and endurance in children with down syndrome (ds). methods: this randomized controlled study included 40 children (24 boys \& 16 girls) with ds. their ages ranged from 9 to 13 years. the control group received conventional chest physical therapy program, three sessions per week for 12 weeks. the study group received an aerobic exercise regimen using a motorized movement therapy device 3 times /week in addition to the same traditional program used with the control group. pulmonary function tests, and six-minutes walking test were measured at baseline, after 18 sessions and after 36 sessions of treatment.

Eligibility criteria:
inclusion criteria: * ability to walk independently * no involvement in any physical rehabilitation program or sports activity * ability to understand and follow orders exclusion criteria: * children suffering from obesity * severe visual and/or auditory impairment * congenital heart disease * children with musculoskeletal disorders
scaffold in emilia romagna and in the magic network

Conditions: Coronary Artery Disease

Summary: the prospective study will investigate the clinical performance and long-term safety of scaffold implantation in a real world regional setting. the protocol includes two different networks. the first network includes all cath-labs in the emilia-romagna region (sherpa). the second includes the centers partecipating into the magic retrospective study. both networks joined into the prospective sherpa-magic project. investigators from both networks agreed in indications and strategy implanatation described by the protocol. in each center, after irb approval, the patients will be enrolled according to established criteria.

coronary stents are the default devices for the treatment of coronary artery disease in percutaneous coronary intervention (pci) according to existing guidelines. however, thrombosis and restenosis are still the main limitations of current permanent metallic stents. in contrast to bare metal stents (bmss), drug eluting stents (dess) have a reduced restenosis rate due to the presence of antiproliferative agents in the coating layer of the stent surface and reduced rate of repeat revascularisation. however, late and very late stent thrombosis remains the limitation of des in spite of prolonged dual antiplatelet therapy. bioabsorbable scaffolds have been introduced to overcome limitations of permanent metallic stents. the aim of this observational prospective study is to investigate the clinical performance and long-term safety of scaffold in a real world regional setting. the investigators agreed in the following preferential/optimal indications: * complete revascularization in patients with age \<65 years * revascularization of long lesions (\>24 mm), especially located in left anterior descending * spontaneous coronary dissection the investigators agreed in the following strategy implantation: * mandatory predilatation * sizing 1:1 * to avoid vessel with reference vessel diameter \ 3.8 mm * to avoid vessel with severe calcifications * mandatory postdilation with non compliant balloon ≥0.5 the scaffold diameter the study organization is based on: data safety monitoring board (dsmb) all adverse events will be reported to the dsmb and reviewed on an on-going basis throughout the subject enrolment and follow-up period to ensure the safety of subjects enrolled in this study. the dsmb may request additional information as needed. core laboratory analysis all coronary artery angiographies and percutaneous coronary interventions will be reviewed by an indipendent core-lab. the core-lab will perform quantitative coronary analysis and assessment of the agreement between implantation technique in each case and established criteria

Eligibility criteria:
inclusion criteria: * subjects \>18 years * sign of the patients informed consent * implanation of at least one scaffold exclusion criteria: * inability to garantuee at least one year follow-up * inabiliuty to garantuee at least one year compliance to dual antiplatelet regimen
study of tak-733 in combination with alisertib in adult patients with advanced nonhematologic malignancies

Conditions: Advanced Nonhematologic Malignancies

Summary: this is a multicenter, open-label, phase 1b study of tak-733 in combination with alisertib in adult patients with advanced nonhematologic malignancies


Eligibility criteria:
inclusion criteria: * male or female patients 18 years or older * patients must have a diagnosis of a solid tumor malignancy for which standard, curative, or life-prolonging treatment does not exist or is no longer effective * radiographically or clinically evaluable tumor * eastern cooperative oncology group (ecog) performance status 0 to 1 * female patients who are post menopausal for at least 1 year, surgically sterile, or agree to practice 2 effective methods of contraception through 30 days after the last dose of study drug or agree to abstain from heterosexual intercourse * male patients who agree to practice effective barrier contraception through 4 months after the last dose of alisertib or agree to abstain from heterosexual intercourse * voluntary written consent * clinical laboratory values as specified in the protocol exclusion criteria: * female patients who are breastfeeding and lactating or pregnant * serious medical or psychiatric illness or laboratory abnormality that could, in the investigator's opinion, potentially interfere with the completion of treatment according to the protocol * treatment with any investigational products within 28 days before the first dose of study drug * prior treatment with aurora a-targeted agents, including alisertib * prior treatment with mek inhibitors, including tak-733 * prior treatment with braf inhibitors * systemic anticancer therapy within 21 days before the first dose * prior biologic or immunotherapy within 28 days before the first dose * major surgery or serious infection within 14 days before the first dose * life-threatening illness unrelated to cancer * known active infection with human immunodeficiency virus (hiv), hepatitis b virus, or hepatitis c * cardiac condition as specified in study protocol or severe cns, pulmonary, renal or hepatic disease * known gi conditions or gi procedure that could interfere with the oral absorption or tolerance of study drugs * history of uncontrolled sleep apnea syndrome or other conditions that could result in excessive daytime sleepiness * history of ongoing or a newly diagnosed eye abnormality * symptomatic brain metastases please note that there are additional inclusion and exclusion criteria. the study center will determine if you meet all of the criteria. site personnel will explain the trial in detail and answer any question you may have if you do qualify for the study. you can then decide whether or not you wish to participate. if you do not qualify for the trial, site personnel will explain the reasons

Keywords: tak-733, alisertib, mln8237, oral mek inhibitor, oral aurora a kinase inhibitor
cardiopulmonary responses to 6-minute stepper test in bronchiectasis versus healthy controls

Conditions: Bronchiectasis Adult; Healthy Controls Group - Age and Sex-matched

Summary: individuals with bronchiectasis exhibit productive cough and recurrent lung infections as well as reduced exercise capacity, physical activity level, and respiratory and peripheral muscle strength. 6-minute walk test (6mwt) is often used to assess exercise capacity in chronic lung diseases. 6mwt is recommended to be performed along a flat corridor, at least 30 m long, with low pedestrian traffic, on a hard surface. to overcome technical limitations during 6mwt, 6-minute stepper test (6mst) has been proposed to assess exercise capacity. another test that provides information about exercise capacity is the 1-minute sit-to-stand test (1sts). to our knowledge, there is limited information about different exercise tests including 6mst and 1sts and cardiopulmonary responses to these tests in individuals with bronchiectasis. therefore, this study aims to compare the responses to the 6mst between individuals with bronchiectasis and healthy controls and to investigate the relationships among 6mst, 6mwt, and 1sts responses and muscle strength.


Eligibility criteria:
bronchiectasis group - inclusion criteria for the study: * being 18 years of age and older, * having a clinically stable bronchiectasis, * to cooperate with the tests to be performed, * not having a cardiovascular disease, orthopedic or neurological problem that may affect the tests, * being willing to participate in the study. bronchiectasis group - exclusion criteria: * being in an acute exacerbation period, * having a cardiovascular, orthopedic or neurological problem that may affect the tests, * not being willing to participate in the study. control group - inclusion criteria for the study: * being 18 years of age and older, * to cooperate with the tests to be performed, * not having a cardiovascular, orthopedic or neurological problem that may affect the tests, * being willing to participate in the study. control group - exclusion criteria: - individuals with any known internal disease and those who do not volunteer to participate in the study will not be included in the study.

Keywords: bronchiectasis exercise capacity
influence of high vitamin c dose on lactate during and after extracorporeal circulation

Conditions: Hyperlactatemia; Cardiac Disease; Bypass Complication; Valve Disease, Heart; Vitamin C

Summary: the aim of our study is to find out whether high doses of vitamin c before cardiopulmonary bypass and during the first 24 hours after that have and impact of lowering the incidence of hyperlactatemia.


Eligibility criteria:
inclusion criteria: * \> 18 years old patients with cardiac disease needing surgery (coronary bypass, valve replacement) exclusion criteria: * dementia * kidney stones * dialysis * haemochromatosis * thalassemias * g-6-p deficiency

Keywords: cardiac surgery cardiopulmonary bypass hyperlactatemia vitamin c
prognostic significance of the uncertain resection in nsclc

Conditions: Non Small Cell Lung Cancer; Residual; State

Summary: the concept of residual tumor classification proposed by the union for international cancer control (uicc) was used to assess the completeness of surgical resection, and non-small cell lung cancer (nsclc) patients with incomplete resection were more likely to occur recurrence, leading to significantly poor survival. but this r classification only refers to the surgical margin and neglects other factors associated with surgical quality, such as the extent of lymph node dissection (lnd). therefore, the international association for the study of lung cancer (iaslc) proposed the definition of uncertain resection \[r(un)\], which includes the suboptimal extent of lnd. however, the clinical significance of r(un) is still controversial. on the one hand, some researches demonstrated that r(un) had definite prognostic significance, with r(un) survival stratifying between r0 and r1. on the other hand, some studies indicated that in early-stage nsclc, the suboptimal extent of lnd had no impact on survival, and the concept of r(un) might be insignificant in these patients. even in those studies supporting the prognostic significance of r(un), which kind of patients is suitable for r(un) was still unclear. thus, the investigators explore the impact of the r(un) on the long-term survival of patients with nsclc using a large cohort in china, to identify those patients who could really benefit from the lnd required by the r0 classification proposed by iaslc.


Eligibility criteria:
inclusion criteria: 1. primary non-small cell lung cancer 2. with pulmonary resection exclusion criteria: 1. sublobar resection 2. r1/r2 3. positive highest mediastinal lymph nodes 4. operative death

Keywords: non-small cell lung cancer lymphadenectomy r stage
healthy eating and active lifestyle (heal): breast cancer program outcomes

Conditions: Breast Cancer

Summary: the goal of this single-group prospective study is to examine the impact of the healthy eating and active lifestyle (heal) breast cancer program on participants' perceived stress, biometrics, basic labs, lifestyle behaviors, self-efficacy, mental health, and quality of life. participants will participate in an 8-week program of 90-minute virtual sessions each week to decrease risk of cancer recurrence. program participants can choose to participate in the research study which will include data collection (surveys, biometrics, basic labs). the data collection will occur at four timepoints - baseline prior to program start, post-program, 3 month follow-up, and 6 month follow-up.

the study will include 45 subjects recruited from adventhealth medical group in the heal breast cancer program that consent to participate in the research study. the research study will include data collection along with the program participation. patients who decline participation in the research study are able to participate in the heal breast cancer program. the program sessions will be conducted virtually via zoom by dr. amber orman, a breast cancer physician board certified in radiation oncology and lifestyle medicine. there are eight program sessions, one per week, each lasting 90-minutes. the survey package includes nine questionnaires and is expected to take 60 minutes to complete.

Eligibility criteria:
inclusion criteria: 1. adult ≥ 18 years old 2. diagnosis of breast cancer 3. enrolled in the heal: breast cancer program 4. able to speak, read, and understand english fluently 5. willing and able to provide informed consent 6. willing and able to comply with all study procedures and requirements for the duration of the study exclusion criteria: 1. not willing or able to provide informed consent 2. not willing or able to comply with all study procedures and requirements for the duration of the study
assessment of the psychological, cognitive and social resources of applicants for huntington's disease and presymptomatic genetic testing

Conditions: Presymptomatic Huntington Disease

Summary: the purpose of this study is to assess the psychological, cognitive and social resources of applicants for huntington's disease and presymptomatic testing.


Eligibility criteria:
inclusion criteria: * applicants for huntington's disease and presymptomatic testing * aged 18 years and above * huntington disease family member * subject gave its written consent exclusion criteria: * no national health insurance affiliation * being under guardianship * meeting brain mri exclusion criteria (pacemakers, aneurysm clips, artificial heart valves, ear implants, metal fragments or foreign objects in the eyes, skin, or body, renal failure, hypersensitivity of gadolinium) or refusing mri. * patient with movement disorder