Kornimate/medical-research-clean huggingface dataset:
ohana: optimizing cross-cultural care

Conditions: Cultural Competence

Summary: increasing globalisation and international migration have led to greater cultural diversity in western societies, including healthcare settings. hospitals and healthcare environments have become meeting places for individuals from different cultural backgrounds. this diversity presents significant opportunities for improving healthcare, but also introduces complex challenges related to communication, trust and mutual understanding between healthcare professionals and patients. in this context, the concept of culturally competent care, i.e. the ability of healthcare professionals to provide respectful and appropriate care to patients by taking into account their cultural beliefs, values and practices, emerges as a crucial approach to address the specific needs of patients from different cultures. the concept of cultural competence was first introduced by cross, who defines it as a set of behaviours, attitudes and policies that, when integrated into an organisation or among professionals, enable them to operate effectively in intercultural contexts.

although there is preliminary evidence on the benefits of cultural concordance, the literature is still scarce and fragmented. in particular, there is a lack of in-depth studies on the subjective experiences of the main actors involved. for healthcare professionals, cultural concordance could be a valuable resource, but also a source of additional stress or pressure, especially if perceived as a task requiring cultural or linguistic competence that is not always adequately supported. for patients, the experience of being cared for by a professional from the same culture might enhance a sense of trust and comfort, but also generate unrealistic expectations or influence perceptions of quality of care. exploring the lived experiences of healthcare professionals and patients in a context of cultural concordance is essential to understanding perceived benefits, criticisms and areas for improvement. this multicentre study, coordinated by the gemelli hospital in italy in collaboration with several italian hospitals , aims to explore cultural concordance in a variety of healthcare settings, providing an in-depth understanding of the potentials and criticisms of cultural concordance in hospital settings

Eligibility criteria:
inclusion criteria: * all nurses or caregivers involved in the concordance system cultural will be included, with direct experience in caring for foreign patients * all foreign patients admitted to hospital who speak a language other than the main language of the host country and who have been involved in the concordance system cultural will be included exclusion criteria: * all patients with severe cognitive conditions that prevent participation and nurses or caregivers who do not work closely with assigned patients will be excluded.
effects of vagus nerve stimulation on central pain sensitivity & parasympathetic function in knee osteoarthritis

Conditions: Knee Osteoarthritis; Central Pain Syndrome

Summary: the goal of this clinical trial is to test the feasibility and effectiveness of transcutaneous vagus nerve stimulation (tvns) to the ear on pain and autonomic function in people with knee osteoarthritis (oa). the main questions it aims to answer are: 1) whether tvns is feasible to be used in people with knee oa; 2) whether tvns demonstrates the trend in improving knee pain; and 3) whether tvns has physiological effects on autonomic function (e.g., parasympathetic function) and pain perception in the central nervous system such as brain (i.e., central pain mechanisms). participants will be asked to complete a battery of self-reported questionnaires about their demographic and behavioral information, ethnicity, pain, sleep, psychological/emotional symptoms. subsequently, participants will complete baseline assessment where investigators will assess their knee pain severity, central pain sensitivity, and heart rate variability (a measurement for autonomic function). then participants will receive a 60-minute tvns. investigators will redo the same assessment as baseline assessment after tvns intervention to see the degree of knee pain, central pain sensitivity, and autonomic function changes. at the end of the study, investigators will assess their satisfaction level with the tvns intervention and the feasibility of the intervention (e.g., completion rate, side effects).


Eligibility criteria:
inclusion criteria: * chronic knee pain consistent with a clinical osteoarthritis diagnosis, which does not require radiographic evidence (age ≥ 45 years, activity-related knee pain, and no knee morning stiffness lasting \>30 minutes) * knee pain ≥ 3 months * average pain intensity ≥ 4 on a scale from 0 to 10 * knee pain as the chief complaint * able to understand english exclusion criteria: * current skin disease of the left ear interfering with the application of the auricular electrode for stimulation(eczema, urticarial lesion, skin infection, external otitis, etc.) * auditory canal not adapted to the application of the ear electrode * known history of cardiac rhythm disturbances or atrioventricular block \> 1st degree, conduction disturbances * recurrent vagal syncope * history of vagotomy * use of other medical devices electrically active (pacemaker, transcutaneous electrical nerve stimulation, etc) * serious and uncontrolled concomitant disease, including cardiovascular, nervous system, pulmonary, renal, hepatic, endocrine, gastrointestinal, epileptic disease or malignant diseases * pregnant or breastfeeding woman * numbness or sensation loss on the body sites for pain measurements (i.e., the wrist, knee, the forearm) * any intervention procedures for knee pain in the past 3 months * age less than 45 years old
feasibility of a minimally invasive thoracoscopic ultrasound for localization of pulmonary nodules

Conditions: Lung Cancer

Summary: the ex-vivo lung will be evaluated by xltf-uc180 for localization of the tumor. the ultrasound probe will be put on the lung surface in several different directions to obtain the cross section with maximum diameter. the ultrasound image with size measurement of the tumor will be recorded using an ultrasound scanner (eu-y0008, olympus medicalsystems corp., tokyo, japan). next, the bronchial stump of the specimen will be opened and a small sized endotracheal tube will be inserted to inflate and deflate the lung. after inflation of the lung, the tumor will be evaluated by xltf-uc180 to see the difference in ultrasound images between deflated and inflated lung. after ultrasound evaluation, the specimen will be delivered directly to the pathology laboratory and the actual tumor size and histological diagnosis will be determined. in addition, we will evaluate the differences between us image and pathological morphology using he slides of lung tumor. we will work together with the surgical team to confirm sign off of specimens.

this is a single center clinical trial. forty patients (sufficient for an initial evaluation) scheduled for a lobectomy or an anatomical segmental resection for malignant lung tumors will be enrolled in the study. after lung resection, the lung will be placed on a surgical table in a similar position to the in-vivo situation in the image guided therapeutic operating room (gtx-or) within toronto general hospital. the lung will be evaluated by xltf-uc180 for localization of the tumor. the ultrasound probe will be put on the lung surface in several different directions to obtain the cross section with maximum diameter. the ultrasound image with size measurement of the tumor will be recorded using an ultrasound scanner (eu-y0008, olympus medicalsystems corp., tokyo, japan). next, the bronchial stump of the specimen will be opened and a small sized endotracheal tube will be inserted to inflate and deflate the lung. after inflation of the lung, the tumor will be evaluated by xltf-uc180 to see the difference in ultrasound images between deflated and inflated lung. after ultrasound evaluation, the specimen will be delivered directory to the pathology laboratory and the actual tumor size and histological diagnosis will be determined. in addition, we will evaluate the differences between us image and pathological morphology using hemotoxylin and eosin (he) slides of lung tumor. we will work together with the surgical team to confirm sign off of specimens.

Eligibility criteria:
inclusion criteria: * any patients scheduled for lobectomy of anatomical segmental resection for malignant lung tumors. * 18 years of age and older exclusion criteria: * any patients with inability to give informed consent

Keywords: lung cancer
pleural irrigation with a novel devise.

Conditions: Pleural Effusion Disorder

Summary: single-arm pilot trial of the use of intrapleural saline irrigation to treat retained pleural infections for patients with contraindications to standard of care intrapleural enzymatic therapy.


Eligibility criteria:
inclusion criteria: * retained pleural effusion identified via bedside ultrasound within the first 24 hours after chest tube insertion * patient is contraindicated from receiving intrapleural enzymatic therapy within the first 24 hours after chest tube insertion exclusion criteria: * non-infectious cause of pleural fluid analysis findings listed above identified (e.g. malignancy) * post-procedural empyema or complicated parapneumonic effusion
a study, performed in subjects with post traumatic-post surgical ,venus insufficiency and diabetic hard to heal/chronic wounds, to evaluate the safety and efficacy of polyheal-2 versus polyheal in once daily regimen

Conditions: Surgical Wound Dehiscence

Summary: this is a double-blind , randomized, controlled, two-arm study aiming to evaluate the safety and efficacy of polyheal-2 vs polyheal, in once daily application as compared to historical control. the study will enroll adult subjects with post traumatic/post surgical, venus insufficiency and diabetic hard to heal wounds who meet the entrance criteria which will be followed for 12 weeks.

subjects will undergo screenibg period of up to two weeks. following to eligibilidy confirmation subjects will be randomized into one of the two treatment groups and treated with study device once daily for 4 weeks. continuation of study device for additional period is based on wound healing progression and under investigator's discretion. subjects will be followed up weekly following to 4 weeks of active treatment for additional 8 weeks untol week 12.

Eligibility criteria:
inclusion criteria: * hard to heal/chronic post traumatic post surgical ,venus insufficiency and diabetic wound refractory to healing at least 4 weeks prior to study treatment (one or more target wound/s will be eligible per each subject to be treated by the same agent) * subjects who are able to read, understand, and sign the informed consent form. in case of compromised mental capacity, approval and signature of a legal guardian is required. exclusion criteria: * presence of a systemic infection or significant local infection with copious purulent drainage, fluids drainage, gangrene, or cellulites, or necrosis at the target wound site, as well as nonviable tissue, sinus tracts or tunnels that cannot be removed by debridement. * wounds with exposed bones, tendons or ligaments * wounds with exposed orthopedic implants * wounds with exposed breast prostheses * uncontrolled diabetes with hba1c \>11% * subjects with bmi greater than 35kg/m2 * woman who are pregnant or nursing, or of childbearing potential and are not using adequate contraception * participation in another clinical drug/device trial within 30 days prior to the screening visit or during this study
a physiological study on downregulation of egf-receptors in the skin by topical exposition with egf

Conditions: Plaque Psoriasis

Summary: investigation of egf-receptor downregulation by topical egf (dermal cream) exposition.


Eligibility criteria:
inclusion criteria: * informed consent * mild to moderate psoriasis (all types) with active plaques on both body sides accessible for biopsy and self product application * egfr immunohistochemistry score \> 5 * male * age 18-60 years exclusion criteria: * systemic psoriasis treatment 3 months prior and during the study * local psoriasis treatment on the investigational sites in the last 30 days or during the study * known hypersensitivity or allergy to the egf containing product (newskin) and/or to vaseline/10% salicylic acid and/or to local anaesthetics of the amid type * known or suspected non-compliance to study protocol coagulopathy or treatment with anticoagulants * history of malignant disease other clinically relevant concomitant disease state participation in another investigational drug study in the last 30 days
dietary interventions in prediabetes

Conditions: Impaired Fasting Glucose; Pre Diabetes; Liver Fat

Summary: assessment of glucose metabolism and liver fat after 12 week dietary intervention in pre diabetes subjects. subjects will be randomized to either high fat (olive oil supplemented),high carb/high fiber (beans supplemented) and high carb/low fiber diets. glucose metabolism will be assessed by labeled oral glucose tolerance test and liver fat by magnetic resonance spectroscopy pre randomization and at 8 and 12 week after starting dietary intervention.


Eligibility criteria:
inclusion criteria: * impaired fasting glucose(100-125 mg/dl) * hba1c 5.7-6.4 % * bmi 26-40 kg/sq.m exclusion criteria: * mrs contraindication * pregnant women * liver disease
a prospective observational study of the expectations and physiological effects of fluid bolus therapy

Conditions: Hypovolemia; Sepsis; Post-operative Hypovolemia; Fluid Therapy

Summary: this prospective observational study aims to (i) asses intensive care doctors trigger for and the expected physiological response to a fluid bolus and (ii) evaluate the patient's actual physiological response to a single fluid bolus at one hour post-bolus for 100 adult patients admitted to the intensive care unit will be included in the study.

intensive care unit patients often receive a fluid bolus during their icu-stay. icu doctors use a variety of clinical triggers when deciding whether or not to give a fluid bolus. however, the type of physiological triggers used and their correlation to the anticipated physiological response of the patient to an administered fluid bolus is not entirely clear. the investigators will perform a prospective observational study to evaluate the triggers for, expected physiological and actual physiological response to fluid bolus therapy in the intensive care unit. specifically, the investigators will assess which of the the physiological trigger(s) intensive care doctors use when deciding to give a fluid bolus; the expected physiological response to the fluid bolus by intensive care doctors; and, to what degree the patients actual physiological response 1 hour after a fluid bolus correlate with expectations. this study will involve a survey of icu physicians to determine the physiological trigger and expectations and a medical audit to ascertain the physiological response to a fluid bolus. the investigators will evaluate a single fluid bolus in 100 separate intensive care unit patients.

Eligibility criteria:
inclusion criteria: * patients admitted to the intensive care unit and prescribed a fluid bolus. exclusion criteria: * the intensive care physician declines to participate. * expected survival \< 24h

Keywords: fluid therapy
effect of non-surgical periodontal treatment on cardiovascular risk markers

Conditions: Coronary Heart Disease; Periodontitis

Summary: the research question was to investigate whether non-surgical periodontal therapy could reduce cardiovascular risk markers in coronary heart disease (chd) patients.

chd patients or non-chd with or without periodontitis were included. they were provided with non-surgical periodontal therapy (nspt). periodontal parameters and cardiovascular risk markers were measured at baseline and 3 months and 6 months after nspt.

Eligibility criteria:
inclusion criteria: * non-chd or chd (at least 50% diameter stenosis in at least one coronary artery and clinically stable with absence of any potentially confounding inflammatory conditions for at least 6 months) * had at least 14 natural teeth excluding third molars exclusion criteria: * received anticoagulant drugs * had chronic conditions (e.g. diabetes mellitus, rheumatoid arthritis, malignancy, autoimmune disease) or acute conditions (e.g. trauma, surgery) or medications known to affect systemic inflammatory markers (e.g. antibiotics, immunosuppressive, contraceptives) within 3 months * pregnancy or lactation * presence or history of other infections * periodontal treatment within 6 months * tooth extractions within 2 months prior to the study.

Keywords: coronary heart disease, peridontitis,
magnetic resonance imaging (mri) in asymptomatic patients with juvenile idiopathic arthritis (jia)

Conditions: Juvenile Idiopathic Arthritis

Summary: juvenile idiopathic arthritis (jia) may progress asymptomatically leading to joint destruction despite treatment. the aim of the observational study is to describe patients with silent arthritis comparing symptoms, clinical findings with results of ultrasound and magnetic resonance imaging (mri).


Eligibility criteria:
inclusion criteria: * children without symptoms or with only mild joints swelling or with only minimal limited range of motion exclusion criteria: * patients with manifest arthritis

Keywords: jia
a study of vortioxetine (lu aa21004) in comparison to agomelatine in adults suffering from major depression with inadequate response to previous medication

Conditions: Major Depressive Disorder

Summary: the objective of the present study is to evaluate whether vortioxetine (10 or 20 mg/day) is at least as effective as agomelatine (25 to 50 mg/day) in patients with depressive symptoms that showed inadequate response to serotonin reuptake inhibitors (sri) antidepressants.


Eligibility criteria:
inclusion criteria: * the patient is being treated with a serotonin reuptake inhibitor (sri) antidepressant (monotherapy) that was prescribed to treat major depressive episode (dsm-iv-tr criteria) * the response to the current sri treatment is inadequate and patient agrees to discontinue the current sri at the baseline * montgomery åsberg depression rating scale (madrs) total score ≥22 at the screening visit and baseline * the patient, if a woman, must: agree not to try to become pregnant during the study, and use adequate, highly effective contraception exclusion criteria: * the patient has any current axis i disorders (dsm-iv criteria) other than major depressive disorder (mdd), general anxiety disorder (gad) and social anxiety disorder (sad) * the patient is at significant risk of suicide * the patient is currently receiving formal psychotherapy or other psychoactive medications other protocol-defined inclusion and exclusion criteria may apply.

Keywords: depression multimodal antidepressant
evaluation of a new treatment for migraine attacks

Conditions: Migraine

Summary: the purpose of this study is to evaluate the efficacy of a novel therapy for treatment of migraine, pain reduction and relief of associated symptoms during ongoing migraine attacks, and presence of a preventive effect post treatment.


Eligibility criteria:
inclusion criteria: * female or male subjects, in otherwise good health, 20 to 55 years of age * subjects who meet the ichd-2 (2nd edition of the international headache classification) criteria for migraine headache * subjects with a minimum of 1 migraine attack per month * attack duration of 4 to 72 hours * normal attack intensity of at least 4 on a 0-10 vas-scale exclusion criteria: * completed heart surgery * cardiovascular disease * vascular damage on neck vessels * disease other than migraine of the csn * severe disease of vital body organs * severe psychiatric disorders * more than 6 migraine attacks per month
effects of different assisted mechanical ventilation in acute lung injury/acute respiratory distress syndrome (ali/ards) patients: pressure support ventilation (psv), neurally adjusted ventilatory assist (nava) and controlled by patient

Conditions: ALI/ARDS Patients

Summary: the investigators' aim is to study the effect of pressure support ventilation versus neurally adjusted assist (nava) and controlled by patient in mechanically ventilated ali/ards subjects.

in this study, psv is compared with nava and assisted mechanically ventilation controlled by patient through a button. inclusion criteria are: assisted mechanically ventilated ali/ards patients.

Eligibility criteria:
inclusion criteria: * ali/ards patients exclusion criteria: * haemodynamic instability * barotrauma * copd
benchmarking trial between france and australia comparing management of primary rectal cancer beyond tme (total mesorectum excision) and locally recurrent rectal cancer

Conditions: Rectal Cancer

Summary: the incidence of rectal cancers is at 15,000 new cases per year in france of which 10 to 15% are locally advanced (t4bnxm0) at the moment of diagnosis. the rate of invaded resection margins (r1) for these locally advanced and fixed rectal tumours varies from 10 to 20%. the invasion of the resection margins triples the risk of local recurrence. in the absence of surgical treatment, the 5-year survival rate for patients having had pelvic recurrence of rectal cancer is lower than 4% whereas it varies from 35 to 40% in cases of curative resection. the care and management of locally advanced and fixed rectal tumours and pelvic recurrence of rectal cancer constitutes, therefore, in the absence of recommendation, a difficult therapeutic problem with great variability in the methods of care and management around the world. these variations in practice can be explained by structural and organizational differences, as well as cultural dissimilarities. with regards to the organization of its healthcare system, australia is shown to be a leader as regards the care and management of locally advanced and fixed rectal tumours and pelvic recurrence of rectal cancer.

this research project rests on the comparison between two contrasting countries with regards to the care management of prc-btme (primary rectal cancer beyond total mesorectum excision planes) and lrrc (locally recurrent rectal cancer), france and australia. regarding its healthcare system for patients with prc-btme and lrrc, australia equipped itself with a veritable policy of centralisation and clinical pathway, appearing as an international referent country in this surgical field. the main hypotheses of research are that these differences rest on individual and collective representation of disease, organisations, structures, clinical pathway and care management. benchmarking of clinical practices is a process that consists of a structured comparison and the sharing of good practices of clinical care; it is based on a quality of care assessment and allows to fit into an approach of continuous improvement of this quality of care.

Eligibility criteria:
inclusion criteria: * patients operable and/or capable of receiving a radiotherapy and/or a chemotherapy * patients in care in the french and australian centres participating in the study exclusion criteria: * patients suffering from primitive rectal cancer at a stage inferior to t4b * patients suffering from primitive locally-advanced metastatic rectal cancer (t4nxm1) * patients suffering from recurrence of metastatic rectal cancer * patients having been refused a surgical procedure because of one or multiple comorbidities

Keywords: locally advanced rectal cancer fixed primary rectal cancer pelvic recurrence benchmarking france australia