Kornimate/medical-research-clean huggingface dataset:
comparison of two formulations of biphasic insulin aspart 70

Conditions: Diabetes; Healthy

Summary: this trial is conducted in europe. the aim of this trial is to compare two formulations of biphasic insulin aspart 70 and characterise the pharmacokinetics of biphasic insulin aspart 50 and biphasic insulin aspart 70 in healthy male subjects.

each subject participated in three treatment periods, and were randomly assigned to each of the six treatment sequences in varying order

Eligibility criteria:
inclusion criteria: * caucasian * considered generally healthy upon completion of medical history and physical examination as judged by the investigator * body mass index (bmi) between 19-27 kg/m\^2 * fasting plasma glucose between 3.8-6.0 mmol/l exclusion criteria: * participation in any other clinical trial involving other investigational products within the last three months * clinically significant abnormal haematology or biochemistry screening tests, as judged by the investigator * any serious systemic infectious disease that occurred in the 4 weeks prior to the first dose of test drug
the long-term effect of marine omega-3 fatty acid supplementation in renal transplantation

Conditions: Kidney Transplantation

Summary: this is a long-term intervention study on the effects of marine n-3 pufas in renal transplantation. our hypothesis is that patients treated with marine n-3 pufa supplementation will have less decline in kidney transplant function compared to patients treated with placebo.

the study is designed as a randomized, double blind, placebo controlled, multi-center trial of 174 renal transplant recipients. patients will be randomized to oral supplementation of marine n-3 pufa 2.5 g / day or control in a 1:1 fashion. the primary endpoint is change in estimated glomerular filtration rate after 156 weeks in the treatment group compared with the control group. secondary endpoints include the following variables: proteinuria, plasma inflammatory biomarkers, blood pressure, resting heart rate, fasting serum glucose / hba1c, lipid and lipoprotein concentrations, number of graft rejections and graft losses, and number of cardiovascular events and deaths. patients from akershus university hospital will also participate in a sub-study, where renal graft biopsies will be performed to assess the degree of fibrosis and chronic allograft damage index (cadi) and markers of fibrosis.

Eligibility criteria:
inclusion criteria: * renal transplant recipients over 18 years of age. * stable renal graft function, defined as egfr \>30 ml/min at the last 2 visits. * 6-60 months post-transplantation at randomization. * signed informed consent. exclusion criteria: * women of childbearing potential who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for up to 4 weeks after the last dose of study drug. * women who are pregnant or breastfeeding. * patients who participate in a clinical trial with other investigational drugs. * patients with a history of an allergic reaction or significant sensitivity to fish, seafood and the study drug omacor or drugs or dietary supplements similar to the study drug. * any reason why, in the opinion of the principal investigator, the patient should not participate - e.g. history of repeated non-adherence to prescribed treatment, repeated non-attendance to clinic visits, cognitive impairment that prevents understanding the nature of this study, etc.

Keywords: kidney transplantation renal transplantation omega-3 fatty acids marine n-3 fatty acids fatty acids inflammation interstitial fibrosis glomerular filtration rate renal function allograft function proteinuria blood pressure heart rate variability lipids blood glucose body mass index fatty acid composition gas chromatography interventional study allograft biopsy kidney biopsy
stimulation of acupuncture points by athermic laser therapy for the prevention of chemotherapy induced nausea and vomiting in children

Conditions: Children; Chemotherapy-induced Nausea and Vomiting; Malignant Tumor

Summary: poor control of chemotherapy-induced nausea and vomiting has a major clinical and psychological impact in patients treated with chemotherapy. metabolic, nutritional and mechanical complications, as well as psychological repercussions, complicate the therapeutic management of the patient and can lead to poor compliance, a deterioration in the general condition or even prolongation of hospitalizations and a delay in the implementation of chemotherapy cures. the control of induced chemo- and radio-induced nausea and vomiting rests above all on their prevention. at present and in most centers, the prevention of nausea and vomiting in the pediatric onco-hematology department of the chu de nice is based exclusively on drug treatments, according to a protocol established according to the emetogenic risk of the chemotherapy received. we propose a study evaluating the effectiveness of the stimulation of acupuncture points by low frequency laser therapy associated with antiemetics in the management of chemotherapy induced nausea and vomiting in patients of 2 to 20 years followed in the service of analgesics. pediatric onco-hematology.


Eligibility criteria:
inclusion criteria: * diagnosis of malignant pathology with indication of chemotherapy with moderate to severe emetogenic potential * indication of at least three identical chemotherapy cures * age between 2 and 20 years * prescription of an anti emetic protocol * karnosky / lansky index\> 60% exclusion criteria: * proven laser contraindication * vomiting in the 24 hours before starting treatment * presenting a brain lesion responsible for nausea and vomiting * pelvic abdominal irradiation the week before the start of treatment * treatment with benzodiazepines or opioids the week before treatment * pregnant women
responsiveness of the german version of the neck disability index (ndi-g)

Conditions: Neck Pain Chronic

Summary: this study evaluates if the german version of the ndi is sensitive to change over time.

chronic neck pain patients will be asked to participate in the study. the participants are asked to fill out the ndi at the beginning of the study and after seven weeks. additionally the participants will fill out the pgic.

Eligibility criteria:
inclusion criteria: * chronic neck pain * over 18 years old * informed consent * able to speak, write and read german. exclusion criteria: * any problems that may exclude manual therapy treatment of the cervical spine e.g fractures
use of ultrasound in the initial management of patients in shock in the nancy emergency department

Conditions: Shock

Summary: context: shock is a serious pathology where diagnostic and therapeutic speed determines the prognosis, ultrasound can be a valuable aid for the emergency physician to differentiate the different types of shock and allow appropriate treatment. hypothesis: what are the uses of ultrasound in the initial diagnostic and therapeutic management of patients in shock at the emergency department of nancy? main outcome: describe the use of ultrasound in the initial diagnostic and therapeutic management of patients in shock at the nancy emergency department secondary outcome: study the contribution of the use of different ultrasound techniques in the initial diagnostic and therapeutic management of patients depending on the type of shock state


Eligibility criteria:
inclusion criteria: * age ≥ 18 years old * shock (map \< 65 mmhg + lactate ≥ 2 mmol/l) * admission to the nancy ed between 01/01/2023 and 12/31/2023 * icd-10 output coding: r57: shock, not elsewhere classified; r570: cardiogenic shock; r571: hypovolemic shock; r572: septic shock; r578: other shocks; r579: shock, unspecified; t794: traumatic shock; t782: anaphylactic shock, unspecified; or diagnosis of entry into intensive care including the word "shock" exclusion criteria: * age \< 18 years old * absence of shock * no passage through the nancy ed * patient whose initial treatment was carried out in another emergency department * state of shock occurring after going to the emergency department

Keywords: shock ultrasound emergency department
acupuncture treatment in adults undergoing diagnostic ogd : a double-blind placebo controlled randomized trial

Conditions: Anxiety

Summary: to find out how the application of acupuncture needles to the proposed acupuncture points: heart 7 (ht 7) and pericardium 6 (pc 6) for reducing anxiety during esophago-gastro-duodenoscopy (egd)

acupuncture is being used as one part of chinese medicine for more than 2,500 years in treating diseases. recent functional magnetic resonance imaging demonstrated that acupuncture can suppress the "pain" area in the brain so as to reduce the pain that felt by human subjects. western medicine proposed the acupuncture mechanisms as to "provoke the release of endogenous substances" from central nervous system so in reducing pain. many studies had been done using acupuncture in reducing pain for post-operation period, however, most of them were not very systematic and even some of them are leak of control group. furthermore, to our knowledge, the use of acupuncture for reducing anxiety during egd has not been previously investigated.

Eligibility criteria:
inclusion criteria: * 18-70 undergoing elective unsedatant diagnostic egd * belonging to american society of anesthesia (asa) classes 1 to 2 exclusion criteria: * history of gastrectomy, esophagectomy, whipple's operation and other gastrointestinal operations * asa class 3 to 4 * pregnancy * allergy to acupuncture needles * request sedation * previous experiences of egd

Keywords: acupuncture, endoscopy
facial demodicosis and ocular demodicosis

Conditions: Demodex Infestation; Rosacea; Blepharitis; Meibomian Gland Dysfunction; Pityriasis Folliculorum

Summary: to understand the association between facial demodicosis and ocular demodicosis, we plan to enroll patients with facial demodicosis, ocular demodicosis, or both, in order to analyze their clinical presentations, the density of demodex infestation over facial skin and eyelashes, and possible risk factors of the two diagnoses.

although facial demodicosis and ocular demodicosis are described in a variety of clinical presentations, the association between the two diagnoses is not clearly identified. clinically, we plan to enroll 120 patients with facial demodicosis, ocular demodicosis. we will obtain their basic information, medical history, medication, and lifestyle. we will evaluate their clinical features. we will also perform quantitative tests including direct microscopic examination and cilia epilation test: 1. direct microscopic examination: on glabella and bilateral cheeks, follicular contents in the 1-cm × 1-cm area will be squeezed out. the contents are transferred onto a glass slide, covered with mineral oil and a cover slide, and examined under the microscope. 2. epilation: four (4) non-adjacent cilia will be pulled from each upper eyelid and examined under the microscope. the total demodex counts are recorded. we will analyze the clinical presentations, the density of demodex infestation, and possible risk factors of the two diagnoses.

Eligibility criteria:
inclusion criteria: patient with a diagnosis of facial demodicosis or ocular demodicosis. a. facial demodicosis defined as both 1 and 2: 1. clinical presentation of facial skin matches any of the followings: 1. pityriasis folliculorum. 2. papulopustular lesion. 3. rosacea. 2. demodex infestation detected by direct microscopic examination ≥ 5 mites/cm2. b. ocular demodicosis defined as both 3 and 4: 3. clinical presentation of ocular region matches any of the followings: 1. chronic blepharitis. 2. eyelash abnormalities: trichiasis, distichiasis, madarosis. 3. meibomian gland dysfunction. 4. recurrent chalazion. 5. ocular rosacea. 4. demodex infestation detected by cilia epilation test ≥ 1 mite/eyelid. exclusion criteria: 1. usage of oral ivermectin, topical ivermectin or topical tea tree oil in the past 1 month. 2. patient who cannot tolerate direct microscopic examination or cilia epilation test.

Keywords: demodex facial demodicosis ocular demodicosis direct microscopic examination rosacea blepharitis meibomian gland dysfunction pityriasis folliculorum
ic-8 apthera iol new enrollment post approval study

Conditions: Cataract; Presbyopia; Posterior Capsule Opacification

Summary: the purpose of this study is to verify the post-market safety of the ic-8 apthera iol after the treatment of posterior capsular opacification (pco), an expected complication related to ic-8 apthera iol implantation.

prospective, multi-center, single-group, non-randomized new enrollment post approval study to assess the post-market safety of the ic-8 apthera iol after nd:yag laser capsulotomy following sufficient surgeon training of the sponsor-recommended standardized nd:yag laser capsulotomy technique. all subjects will undergo approximately 6 study visits and will be followed 24 months post ic-8 apthera iol implantation. there is one study group: subjects previously implanted with the ic-8 apthera iol and who have developed posterior capsular opacification (pco) which requires treatment with nd:yag laser capsulotomy.

Eligibility criteria:
inclusion criteria: * 22 years of age or older, any race and any gender; * posterior capsule opacification (pco) requiring treatment in the ic-8 apthera iol eye * able to comprehend and have signed a statement of informed consent; * availability, willingness, ability and sufficient cognitive awareness to comply with examination procedures and study visits; * clear intraocular media in both eyes; * preoperative corneal astigmatism ≤1.5 d in the ic-8 apthera iol eye prior to ic-8 apthera implantation; * prior ic-8 apthera iol implantation in one eye and a monofocal/monofocal toric iol in the other eye in accordance with the directions for use (dfu) for each iol. exclusion criteria: * pharmacologically dilated pupil size less than 7.0 mm in the ic-8 apthera iol eye; * irregular astigmatism in either eye; * history of retinal disease; * active or recurrent anterior segment pathology; * presence of ocular abnormalities; * diagnosis of dry eye in which patients are unable to maintain eye comfort or adequate vision even with dry eye treatment; * previous corneal or intraocular surgery, except cataract surgery; * history of ocular trauma or ocular conditions expected to require retinal laser treatment or other surgical intervention; * acute, chronic or uncontrolled systemic disease that would, in the opinion of the investigator, confound the outcomes of the study; * patient is pregnant, plans to become pregnant, is lactating or has another condition associated with hormonal fluctuation that could lead to refractive changes and dry eye; * concurrent participation or participation in any clinical trial up to 30 days prior to the first visit in the study. * subjects who plan to be traveling, relocating or otherwise unavailable to attend any of the visits
efficacy and safety of efinaconazole 10% solution in the treatment of onychomycosis in diabetic patients

Conditions: Onychomycosis

Summary: onychomycosis, a common pathology of the toenails, is even more prevalent among diabetic subjects. nearly 26 million americans suffer from diabetes, and approximately one-third of subjects with diabetes have toenail onychomycosis. numerous studies have addressed the efficacy and safety of both topical and oral antifungal treatment options for onychomycosis in diabetic subjects. however, no study to date has specifically addressed the efficacy and safety of efinaconazole among diabetic subjects. the objective of this noncomparative, uncontrolled study is to determine the efficacy of topical efinaconazole 10% for toenail onychomycosis among subjects with diabetes mellitus. specific indicators to measure efficacy of treatment will be the mycological cure rate, complete cure rate, and treatment success. furthermore, an additional goal of the study is to gain knowledge of safety in the setting of a cohort of diabetic subjects


Eligibility criteria:
inclusion criteria: * clinical diagnosis of onychomycosis confirmed through positive koh stain or positive mycologic culture findings. * involvement of at minimum 20% of the target great toenail. exclusion criteria: * diagnosis of a nondermatophyte fungus infection, diagnosis of proximal subungual onychomycosis, diagnosis of superficial white onychomycosis * diagnosis of peripheral arterial disease or anatomic abnormalities of the target toenail * inability to follow through with all requisite office visits * routine use of a systemic corticosteroid, routine use of a systemic immunomodulator, or history of systemic antifungals within the prior five years. * active interdigital tinea pedis refractory to topical antifungal treatments * known hypersensitivity to efinaconazole * use, within the month preceding screening, of: topical antifungal agents, topical anti-inflammatory agents to the toes * any history of oral systemic antifungal with known activity against dermatophytes
efficacy and necessity of anti-inflammatory drops after laser peripheral iridotomy

Conditions: Glaucoma, Closed-Angle; Glaucoma, Narrow-Angle; Glaucoma, Angle-Closure

Summary: the purpose of this study is to evaluate the efficacy and need for prescribing anti-inflammatory topical drops to patients undergoing laser peripheral iridotomy.

primary closed angle glaucoma is responsible to almost half glaucoma related blindness around the world. laser peripheral iridotomy (lpi) is a common and simple treatment used for both treatment and prevention of acute angle closure event. anti-inflammatory drops are commonly prescribed to patients undergoing lpi in order to prevent or reduce post-treatment discomfort. however, to date, there are no specific guidelines for post lpi anti-inflammatory treatment, nor sufficient clinical evidence regarding the efficacy of such treatment. in the current study, the investigators aim to evaluate the effect of topical steroids and non-steroidal anti-inflammatory drugs (nsaids) on post lpi symptoms and inflammation markers.

Eligibility criteria:
inclusion criteria: * diagnosis of primary narrow/closed angle by gonioscopy * able to give consent * ability to attend follow-up visits exclusion criteria: * corneal disease preventing sufficient evaluation of the angle * secondary closed angle (e.g. uveitis related) * pregnant women * previous eye surgery other than laser refractive correction

Keywords: laser peripheral iridotomy topical anti-inflammatory drops
blended mindfulness-based intervention for persistent depression

Conditions: Persistent Depressive Disorder

Summary: we plan to share all ipd but not any personal information.


Eligibility criteria:
inclusion criteria: 1. a current diagnosis of major depression as assessed by structured clinical interview for dsm iv (first, spitzer, gibbon, \& williams, 2002). 2. a chronic or recurrent lifetime history of depression, with either chronic persistence of symptoms or a history of at least three previous episodes of depression, two of which needed to have occurred during the last two years. 3. self-reported severity of current symptoms on a clinical level as indicated by a phq-9 score of 10 or more. 4. age 18 to 65 thus excluding cases of late life depression given that such cases might diﬀer in aetiology. 5. fluency in spoken and written english. 6. have individual access to a computer or mobile device with internet connection and video link. exclusion criteria: 1. history of schizophrenia, schizoaffective disorder, bipolar disorder, current abuse of alcohol or other substances, organic mental disorder, pervasive developmental delay, primary diagnosis of obsessive-compulsive disorder or eating disorder, or regular nonsuicidal self-injury. 2. current treatment with cbt more than once a month. 3. regular meditation practice (meditating more than once per week). 4. inability to complete research assessments through difficulty with english, visual impairment, or cognitive difficulties. 5. we will allow patients who are currently taking antidepressants into the study provided that the medication has not been changed during the last four weeks before entry into the study.
effect of thoracic spine mobilization on sympathetic nervous systems

Conditions: Erythema

Summary: this pilot study aims to i) represents the feasibility of the study design and ii) to point out acute effects of thoracic spine mobilization on skin-blood flow, erythema and the sympathetic nervous system.


Eligibility criteria:
inclusion criteria: * age 20 - 30 years * healthy persons exclusion criteria: * current pain * blood pressure medications * osteoporosis * cardiac or neurological symptoms * pregnancy * thromobosis

Keywords: skin blood flow skin redness sympathetic nervous system regional blood flow
a phased-implementation feasibility and proof-of-concept study to assess incorporating the nida ctn common data elements (cdes) into the electronic health record (ehr) in large primary care settings ("cde-ehr-pc" study), phase 2

Conditions: Substance Abuse

Summary: this is a 4-phase study to implement the nida (common data elements) common data elements (cdes) in primary care settings. the study will be conducted at three adult primary care clinics, in two large health systems. each phase will include deliverables essential to move to the next phase, and an independent advisory committee will review progress and make recommendations at each transition about how best to progress to each subsequent phase. based on progress during earlier phases, the advisory committee may recommend expansion to additional clinics or health systems during the second part of phase 4. phase 2 prepares for implementation of the screening and cds tools as part of routine clinical practice. a key component of this phase is tailoring the screening and cds tools through an iterative process of usability testing and adaptation of their design. in the kta framework, this phase corresponds to the 'select, tailor, and implement interventions' step. simultaneously, investigators will plan for implementation in one clinic of the mshs system by identifying clinical champions, educating clinic leadership and staff, and conducting a workflow analysis to identify barriers and facilitators of implementation.


Eligibility criteria:
inclusion criteria: * english speaking adult individuals aged 18 years or older, and employee at a wave 1 clinic. * clinical implementation leaders clinical implementation leaders are practicing pcps who provide feedback to the research team and support their colleagues on implementing screening, using the cds, and carrying out clinical interventions and referrals to address unhealthy substance use. one or two primary care providers will be identified from each clinic site to advise the research team on implementation and to serve as a resource for their colleagues. exclusion criteria: * inability to provide informed consent.