Kornimate/medical-research-clean huggingface dataset:
bright light therapy on post-stroke insomniawith post-stroke insomnia

Conditions: Stroke Sequelae

Summary: the objective of this study was to determine the effectiveness of bright light therapy as a treatment for early, mild-to-moderate stroke patients with post-stroke insomnia.


Eligibility criteria:
inclusion criteria: * first occurrence of stroke for the patient * matched international classification of diseases (icd)-10 codes (nontraumatic subarachnoid hemorrhage \[i60\], nontraumatic intracerebral hemorrhage \[i61\], other and unspecified nontraumatic intracranial hemorrhage \[i62\], or cerebral infarction \[i63\]) (world health organization, 1997) * mild-to-moderate stroke (the national institutes of health stroke scale ≤14) * age ≥18 years * satisfactory cognitive function * post-stroke insomnia. exclusion criteria: * mini mental state examination (mmse) score of ≤10 * recurrent stroke * aphasia * transient ischemic attack * schizophrenia, bipolar disorder, mood disorder, previous insomnia disorder, or dementia before stroke * taking sleeping pills or antidepressants for 5 or more days within a 6-month timespan before the onset of stroke * post-stroke delirium * a national institutes of health stroke scale score ≥ 14 * previous eye disease or post-stroke eye disease * severe auditory impairment * the use of psychotropic medications (hypnotics, benzodiazepine, benzodiazepine agonists, antidepressants \[mirtazapine or trazodone\] or antipsychotics)
transplant optimization using functional imaging

Conditions: Bronchiolitis Obliterans; Lung Transplant Rejection

Summary: the objective of this study is to detect bronchiolitis obliterans syndrome (bos) in an early stage using the outcome parameters generated by functional respiratory imaging (fri). robust and automated segmentation algorithms will be developed for these parameters, focusing on quantitative computed tomography (ct) image analyses to provide the physician a more sensitive diagnostics tool. the evolution of bos over time will be monitored using non-rigid image registration methods.


Eligibility criteria:
inclusion criteria: * male or female patient ≥ 18 years old * written informed consent obtained * patient who had undergone a lung transplant a year ago or more. * female patient of childbearing potential who confirm that a contraception method was used at least 14 days before visit 1 and will continue to use a contraception method during the study * the patient must be able to perform the lung monitoring at home. exclusion criteria: * pregnant or lactating female * known history of or active airways or anastomotic complications requiring intervention such as stenting or dilation

Keywords: hrct high resolution computed tomography scans functional respiratory imaging fri computed tomography ct bronchiolitis obliterans bos lung transplant
anisakis blastocystis cryptosporidium fish prevalence

Conditions: Anisakis; Allergy; Occupational Exposure

Summary: anisakidae frequently infect fish species that are commonly eaten by humans. some of them are recognized as zoonotic agents, and have a high impact on human health. infestation results from the ingestion of living larvae from contaminated fishes. it can be asymptomatic or symptomatic, resulting in acute gastric, acute intestinal or chronic forms. allergic manifestations are frequently encountered in gastric forms, but isolated allergic symptoms can occur after ingestion of anisakidae antigens in raw or cooked fish. cutaneous contact or anisakis allergen inhalation have also been reported to induce allergy/anaphylactic reactions or sensitization in the occupational setting in spain, italy, sicilia or south africa. but no data is available in france. in this context, the investigators propose to determine and compare the frequency and characteristics of fish allergy in fish workers (fishermen and fish-processing factory workers) and a control population of workers without occupational exposure to fish, in boulogne-sur-mer, which is an important fishing port in france, and the first european center for fish processing.

162 fishermen, 162 fish-processing factory workers, and 162 control subjects will be consecutively recruited by their occupational doctor during a routine consultation. a standardized questionnaire will be used to collect epidemiological and clinical data on potential allergic manifestation resulting from digestive, cutaneous, or respiratory contact with fish. domestic and occupational risk factors for fish and anisakis exposure will also be collected for both allergic and non-allergic patients.

Eligibility criteria:
inclusion criteria: * fisherman followed by the "service de santé des gens de mer" of boulogne-sur-mer, fish-processing factory worker followed by the "service de santé au travail" of boulogne-sur-mer, or worker followed by the "service de santé au travail" of boulogne-sur-mer, but not working in a fish-processing factory. exclusion criteria: * pregnant or breast-feeding female * patient with no social insurance * patient unwilling to comply with the protocol * patient unable to understand the study and its objectives * patient under guardianship

Keywords: fisherman fish industry
effects of dietary proteins on postprandial lipaemia and incretin responses in obese subjects

Conditions: Postprandial Lipaemia; Postprandial Incretins; Postprandial Inflammation

Summary: the purpose of this study is to determine the effects of dietary protein on blood lipids and gut hormones after a fat-rich meal. hypothesis: certain dietary proteins reduce the amount of fat circulating in the blood stream following a fat rich meal. the effect is dependant of both the quality and the quantity of protein ingested.


Eligibility criteria:
inclusion criteria: * bmi \>30 kg/m2 \& \<45 kg/m2 exclusion criteria: * diabetes * lipid lowering drugs * liver-, kidney- and/or heart disease * serious hypertension (160/110)

Keywords: postprandial period postprandial lipaemia incretins subclinical inflammation obesity atherosclerosis triglyceride lipoproteins
clareon iol retrospective data collection

Conditions: Aphakia; Astigmatism

Summary: the purpose of this study is to provide real world evidence (rwe) on the performance of the clareon ultraviolet absorbing (uva) intraocular lenses (iols) to support the overall body of evidence on the clareon iol family.

in this retrospective postmarket study, the wavetec analyzor database will be reviewed. all available data that meet the data selection criteria as of the data cutoff will be analyzed.

Eligibility criteria:
data selection criteria (eyes): * must have undergone cataract extraction by phacoemulsification with implantation of a clareon uva iol (cc60wf, ccw0t3, ccw0t4, ccw0t5, ccw0t6, or cca0t0) using the wavetec ora system. * must have a bcdva in the wavetec analyzor database from ≥ 10 days after surgery. * predicted residual refractive error spherical equivalent (se) ≤ 0.75 d.
clinical investigation on the outcome of episealer talus post-operation for treatment of focal osteochondral defects

Conditions: Osteochondral Defect

Summary: this is a retrospective, observational, single-arm, multi-centre, post-market clinical investigation designed to verify clinical performance and safety of episealer talus post-operation for treatment of focal osteochondral defects on the talus bone in the ankle. this retrospective investigation aims to collect data from patients with focal osteochondral defects treated with episealer talus, to provide insight on the potential benefit of episealer talus in the treatment of focal osteochondral defects. the aim for the clinical investigation is to collect data from approximately 25 adult subjects who were treated for focal osteochondral defect with episealer talus implant in 6 clinics (sweden and germany) since january 2020, when the devices were ce-marked. the data collected for each subject will include demographics and data generated in relation to the surgery itself and the post-surgery phases including e.g. focal defect grade and position, collected through medical record review. each subject will also be asked to complete a set of qol questionnaires (sefas, faos and vas).

this is a retrospective, observational, single-arm, multi-centre, post-market clinical investigation designed to verify clinical performance and safety of episealer talus post-operation for treatment of focal ocds. the overall clinical investigation is based on the patient's reported outcome (pros) from ocd patients previously treated with episealer talus implant after january 2020. in total approximately 25 adult subjects, male or female, from 6 clinics (sweden and germany) will be included in the investigation. subjects will be identified by the investigational site team through medical record review and/or site knowing the subjects from performing the implantation after january 2020. following collection of the subject´s signed informed consent, subject demographics, health- and surgery-related data will be collected from the subjects' medical records. therefore, only one visit is planned for each subject during the clinical investigation. the performance variables relate to quality of life, and all subjects will be asked to fill in three questionnaires (sefas, faos and vas). the overall duration of the investigation is estimated to be 4 months, including a 1 month recruitment period. each subject is estimated to spend approximately 1-2 hour for completing the informed consent and completing the questionnaires. subject´s participation in the clinical investigation will be terminated once the questionnaires have been completed and the site team considers all data collected for the subject.

Eligibility criteria:
inclusion criteria: * signed informed consent form * patients ≥ 18 years old at the time of index procedure * patients who previously received episealer talus implant after january 2020 exclusion criteria: * "none"
the role of proper insulin injection technique in the treatment of diabetes mellitus

Conditions: Diabetes Mellitus, Type 2; Diabetes Mellitus, Type 1; Lipohypertrophy

Summary: this is a prospective, post-marketing, single-arm clinical investigation on the effects of optimal insulin injection technique, in conjunction with the use of disposable becton dickinson (bd) micro-fine plus 32g pen needles, by type i and type ii diabetes mellitus patients, with or without lipohypertrophy, on clinical outcomes like hba1c and hypoglycemic events, as well as changes in insulin total daily dose (tdd) and patient's quality of life (qol). during this study, each subject will be trained in the optimal insulin injection technique by personal training as well as by following online video training modules on a specific web-based platform.


Eligibility criteria:
inclusion criteria: 1. type 1 or type 2 diabetes mellitus; 2. at least 1 year of experience with insulin self-administration; 3. use of insulin pen for insulin injections. 4. hba1c \> 7.5 % measured at study entry or maximally 30 days prior to screening. 5. bmi below 40 kg/m2 at study entry. 6. daily self-control of blood glucose level; 7. access to the internet for watching video lessons. 8. only outpatients are eligible for the study. 9. availability of signed informed consent of the patient for inclusion in the study. exclusion criteria: 1. pregnant women or women planning to become pregnant during the time of study, breastfeeding women; 2. subjects using an insulin pump; 3. those using treatment with a glucagon-like peptide (glp)-1 receptor agonists alone; 4. subjects not fluent in russian (reading and writing). 5. patients at high risk for ketoacidosis and/or hyperglycemia. 6. psychic, physical or any other reasons hampering patient participation in the study (based on the reasonable opinion of the physician-investigator).
recharge: a brief psychological intervention to build resilience in healthcare workers during covid-19

Conditions: Stress; Burnout; Anxiety; Depression; Covid19

Summary: the healthcare industry is inherently demanding, stressful, and, at times, emotionally draining. on a typical day, many workers must make rapid and critical decisions, manage numerous demands, team conflicts, and challenging situations with patients and their families. for some health care workers (hcw), the current pandemic - covid-19 - has also exacerbated these challenges. providing psychological support is key in alleviating stress among hcws, yet the situation does not require therapy because hcws do not principally suffer from a mental disorder. recharge was specifically developed for hcws and is an abbreviated online version of problem management plus, an evidence-based intervention that helps to cope with stress in times of crisis. as a brief psychological intervention for adults affected by adversity emerging from stress exposure, recharge teaches people three well-documented strategies to manage acute stress (a: managing stress, b: managing worry, c: meaningful activity). it includes psychoeducation, arousal reduction techniques, managing worries and problem-solving skills, behavioral activation, and enhancement of meaningful activities, which are all based on the principles of cognitive-behavioral therapy. the aim of this study is to evaluate the efficacy of recharge to reduce stress in hcws and enhance their work performance. participants in this randomized controlled trial (rct) study are randomly assigned to either recharge or the active control group. to this end, stress including symptoms of burnout, worries, anxiety, depression, ptsd, and work performance will be measured at baseline, post-intervention, and at a 2 and 6 month follow up.


Eligibility criteria:
inclusion criteria: * anxiety and depression checklist (k10) score of 16 or higher * healthcare worker * sufficient german language comprehension * access to teleconferencing platform exclusion criteria: * currently participating in a similar study * currently in psychotherapeutic treatment / coaching * currently on sick leave for more than 2 weeks

Keywords: health care workers stress anxiety depression burnout work load covid-19 resilience brief psychological intervention
ex vivo study of the mechanism of action of active ingredients on the intestinal microbiota

Conditions: Microbial Colonization

Summary: to design and understand the mechanism of action of different combinations of nutraceuticals coupling bacteria, fibers and polyphenols, which can act on the 4 pillars simultaneously via an innovative ex-vivo model approach coupled with functional and quantitative metagenomics.

the objective of the study is to collect fresh stools from 4 healthy volunteers, in order to study the mechanism of action of probiotic strains, polyphenols and fibers, alone or in combinations. these fresh stools will be cultured in vitro in fermenters, and the samples taken at different culture times will be analyzed in terms of microbial composition (shotgun metagenomic analysis) and their cellular activity (functional metagenomic analysis).

Eligibility criteria:
inclusion criteria: * person with a low fiber diet (\<17g / day). exclusion criteria: * taking antibiotics and / or transit modulators in the 3 months preceding the sample; * colonoscopy in the last 3 months; * person under legal protection measure (curators, tutors, etc.).
pilot study of between visit interaction to improve glycemic control in pregnancy with pre-existing diabetes

Conditions: Type 1 Diabetes, Pregnancy

Summary: hypothesis: increased contact with the diabetes care team throughout pregnancy will lead to improved glucose control during pregnancy.

patient will have weekly contact through the mayo patient on-line services to send in their blood glucose readings and to receive recommendations back regarding insulin dose changes. information will be analyzed regarding the magnitude of change in insulin dosing and in glycemic variability.

Eligibility criteria:
inclusion criteria: * adult pregnant women with type 1 diabetes utilizing either an insulin pump or multiple daily injection insulin program to manage their diabetes inclusion criteria: * female with type 1 diabetes and pregnancy * edd prior to november 15, 2014 * 18 years of age and older * on insulin pump or multiple daily injection insulin program * signed patient consent form exclusion criteria: * exclusion criteria: * female with type 1 diabetes and pregnancy under age 18 or older than age 45 * female with type 2 diabetes or gestational diabetes and pregnancy

Keywords: type 1 diabetes pregnancy glycemic variability between visit contact
pain (pain ai intervention) platform for patients at home

Conditions: Pain

Summary: the purpose of this research is to identify physiological markers to determine pain intensity and build an artificial intelligence (ai) enabled system to objectively measure pain intensity. researchers hope to personalize pain medication regimens to help prevent medication over-use.


Eligibility criteria:
inclusion criteria: * patients undergoing low-risk outpatient plastic surgery procedures with expected pain intensities ranging from mild to severe. exclusion criteria: * patients with treated or untreated cardiopulmonary syndromes. * patients with treated or untreated ophthalmologic pathologies. * patients with skin pathologies that prevent us from using the tens device. * patients with pathologies or conditions preventing them from appropriately using their voice. * patients with barriers to effective communication. * patients with poor digital literacy. * patients incapable of taking oral medication. * patients who are currently taking medical therapy for chronic pain. * patients with a previous diagnosis of severe anxiety disorders. * patients who are immobile at baseline.

Keywords: physiological markers for pain intensity ai to objectively measure pain intensity medication over-use
the effects of intravenous ibuprofen on pain, oxidative stress and inflammation in laparoscopic hysterectomy operations

Conditions: Analgesia; Ibuprofen; Acetaminophen; Oxidative Stress

Summary: objective: the aim of this study is to evaluate whether the exposure of oxidative stres in the peroperative period and the postoperative 24th hour can be decreased with the thiol-disulfide homeostasis (tdh) method and c-reactive protein (crp) with intravenous ibuprofen used for postoperative analgesia in patients undergoing total laparoscopic hysterectomy material and method: sixty-nine patients with american society of anesthesiologists (asa) scores i and ii who scheduled for laparoscopic hysterectomy were included in the study. the patients were randomly divided into two groups as ibuprofen and paracetamol (group ip) and paracetamol (group p) with the sealed envelope method. when the vascular access was established from all patients (t0), after blood was drawn for tdh and crp measurements, while 30-minute lasting iv infusion of 800 mg ibuprofen diluted with 0,9% isotonic and iv infusion of 1 g paracetamol was started simultaneously, only 1g of paracetamol infusion was administered in group p. in the ip group 800 mg ibuprofen and 1 g paracetamol, in the p group only paracetamol, the medicines specified for each group administered intravenously every 6 hours. the postoperative pain level in the patients was evaluated at the 1st, 2nd, 6th, 12th and 24th hours with the visual analogue scale (vas). rescue analgesia with 1mg/kg tramadol as an iv bolus was applied to patients whose vas score was 4 and above. other blood samples for crp and tdh were taken before insufflation (t1), after desufflation (t2) and at the postoperative 24th hour (t3). demographic and hemodynamic data of the patients, duration of anesthesia and trendelenburg position, need for additional analgesia, presence of nausea and vomiting, vas scores, pathology results, crp and tdh levels were recorded.


Eligibility criteria:
inclusion criteria: * elective total laparoscopic hysterectomy, aged between 30 and 65, body mass index (bmi) below 35, asa class i and ii exclusion criteria: * trauma patients to be operated in emergent conditions, asa risk classification iii-iv and more, have a postoperative intensive care indication, active and clinical symptoms of anemia, platelet level lower than 30000 / mm3, history of gastrointestinal bleeding in the last 6 months, history of bleeding diathesis or increased patients at risk of intracerebral hemorrhage, oliguric and / or need dialysis in the last 1 month before surgery, or have received dialysis, patients who used a combination of warfarin, lithium, angiotensin converting enzyme (ace) inhibitor and furosemide medication or who needed to use any analgesic, muscle relaxant or sedative medication within the last 24 hours. patients who had a hypersensitivity reaction to any anesthetic or analgesic drug to be used in the study patients did not want to participate in the study
glucose control for glucocorticoid induced hyperglycemia during chemotherapy

Conditions: Hyperglycemia Steroid-induced

Summary: objective: to determine which regimen results in best glycemic control and safety profile, expressed as glucose values within target range and occurrence of hypoglycemia. secondary objective is to compare patient satisfaction, clinical outcomes and toxicity. study design: randomized open label cross-over study study population: patients ≥ 18 years, who developed glucocorticoid induced hyperglycemia requiring initiation or adjustment of antihyperglycemic agents in a previous chemotherapy cycle. patient should have ≥2 cycles of chemotherapy scheduled, with 3-10 consecutive days of ≥12,5mg prednisone-equivalent glucocorticoid and a wash-out period of 4-38 days between each cycle. intervention: subjects will be treated by insulin regimen a and b in random order during two consecutive cycles of chemotherapy. a) intermediate acting insulin 0.01 iu / mg prednisone-equivalent / kg body weight once daily subcutaneous b) short-acting insulin according to sliding scale regimen, dose adjusted to current grade of hyperglycemia. main study parameters: difference in fraction of blood glucose measurements (bgm) within target range and occurrence of hypoglycemia. nature and extent of the burden and risks associated with participation, benefit and group relatedness: both study treatments are just a slight variation in regular care for glucocorticoid induced hyperglycemia. glycemic control is likely to improve due to treatments and increased counselling. all subjects will receive both treatment regimens. the burden consists of 16-32 extra bgms over 2 x 4-10 days, wearing the glucose sensor, 1 venipuncture (if hba1c and creatinin are not determined in routine laboratory within 3 months before start), and 1 randomization visit to the outpatient clinic. potential risk is the occurrence of hypoglycemia, as is present in any insulin therapy. the investigators account for this risk by giving subjects dietary advice and education how to prevent, recognize and treat hypoglycemia.


Eligibility criteria:
inclusion criteria: * age ≥ 18 years * written informed consent * glucocorticoid induced hyperglycemia in previous cycle of chemotherapy that required therapy initiation or adjustment * duration of glucocorticoid cycles 3-10 consecutive days and 4-38 glucocorticoid-free days between 2 cycles * prednisone-equivalent dose of ≥ 12,5mg * at least 2 more cycles of chemotherapy to receive exclusion criteria: * history of hypo-unawareness * continuous tube or parental feeding * continuous (maintenance) systemic glucocorticoid therapy

Keywords: glucocorticoid induced hyperglycemia, insulin, chemotherapy