Kornimate/medical-research-clean huggingface dataset:
swiss trauma registry

Conditions: Trauma, Multiple; Trauma

Summary: the swiss conference of cantonal health directors has transferred the planning of highly specialized medicine to a specialized body under the direction of the swiss academy of sciences. this specialist body has defined the treatment of critically ill as part of highly specialized medicine and founded the swiss trauma registry at 12 hospitals in switzerland. the registry is designed to provide a consistent and standardized approach and treatment outcomes in the short and long term quality control and as a basis for planning highly specialized medicine.


Eligibility criteria:
inclusion criteria: * injury severity code \> 16 and 7 or abbreviated injury scale \>3 for region of skull and brain exclusion criteria: * patients who will transferred in a burn unit * drowned patients
cardiopulmonary stress testing (cpet) allosure study

Conditions: Heart Failure; Transplant; Failure, Heart

Summary: 1. cell-free dna does not vary significantly as a function of the activity of immunologically quiescent cardiac transplant recipients, despite the metabolic demands of the transplanted organ. (the implication of the null result would be that no restrictions to patient activity, nor modification of cardiac rehabilitation prescription, would be necessary to maintain proper test characteristics of allosure testing). 2. in immunologically active cardiac transplant allografts, exercise prior to assay of donor-derived cell-free dna can be used to increase the sensitivity of the allosure test. (the implication of this would be that the optimal time-frame for drawing an allosure may actually be post-exercise, and that window will be characterized).

the specific research questioned aimed to be addressed with this proposed study are: i. are dd-cfdna levels in heart transplant recipients independent of recent cardiopulmonary exercise? more specifically, does the metabolic demand of maximal cardiopulmonary exercise in recent heart transplant recipients trigger a release of dd-cfdna (if so, then what is the time course for resolution back to baseline?) ii. if dd-cfdna does not release to any significant degree with cardiac allografts with short donor-ischemic time, does this test characteristic continue to hold for cardiac allografts transplanted after longer donor ischemic times? iii. in cardiac transplant recipients with medically stabilized, treated antibody-mediated rejection (amr) and persistent dd-cfdna elevation, does a discrete episode of maximal cardiometabolic activity trigger any additional elevation of dd-cfdna, and again, with what time course?

Eligibility criteria:
inclusion criteria: post-orthotopic heart transplant patients exclusion criteria: 1. orthopedic, neurologic and/or any other limitations that do not allow for exercise testing on a treadmill or cycle ergometer; 2. individuals who require supplemental oxygen or have current permanent tracheostomies will be excluded from this study; 3. individuals who are discharged to a long-term acute care facility; 4. skilled nursing facility or with palliative care or hospice care will be excluded; (e) inmates and pregnant women; (f) patients with antibody-mediate rejection that are not felt to be safe for cardiopulmonary stress testing.
beat the blues: treating depression in african american elders

Conditions: Depression; Stress Reduction; Behavioral Activation Treatment

Summary: the specific primary aims of the study are to: 1. test the immediate effect of the intervention at 4-months on depression in urban african american older adults (primary trial outcome; between group comparison). hypothesis: participants in the intervention group will report fewer depressive symptoms in comparison to control group participants receiving usual care. 2. test the maintenance effect of the intervention at 8-months on depression (within group comparison). hypothesis: participants in the intervention group will maintain reduced symptom presentation from 4 to 8 months. 3. evaluate acceptability (social validity) of the intervention and extent of engagement in activities by study participants (both intervention and wait-list control subjects). a secondary aim of this study is to assess the feasibility of conducting a clinical trial embedded in a community service setting and its dissemination using a community-academic partnership. we also propose three exploratory aims. first, we seek to evaluate the mechanisms of action, or pathways, by which treatment gains are obtained (gitlin et al., 2000). given that behavioral activation represents conceptually the key active ingredient of the proposed intervention, we plan to evaluate its mediational effect. second, we seek to evaluate whether the intervention has a differential treatment effect based on a study participant's gender, age, and living arrangement (alone or with others). given that previous research suggests that participant characteristics may moderate depressive symptoms and treatment outcomes, these exploratory analyses will provide insight as to whether this particular treatment benefits some groups more than others. third, we seek to evaluate whether the intervention has short and long-term effects on quality of life, functional difficulty, and self-efficacy to manage day-to-day tasks. previous research has shown that depressive symptoms exacerbate functional decline such that minimizing distress may have the added value of enhancing function and perceived efficacy for this group over time.


Eligibility criteria:
inclusion criteria: * african american * ≥55 years of age * english speaking * cognitively intact (mmse \>24) * depressed as measured by a score ≥5 on the phq-9 * must have a telephone * planning to live in the area for 8 months exclusion criteria: * not african american * \<55 years of age * does not speak english * mmse\<24 * not depressed as measures by a score of \<5 on the phq-9 * does not have a telephone * does not plan to live in the area for 8 months
effect of periodontal treatment on metabolic control in patients with type-2 diabetes mellitus treated in the cardiovascular healt program

Conditions: Periodontitis Chronic Generalized Moderate; Periodontitis; Periodontal Disease; Diabetes Mellitus Type 2

Summary: the objective of this clinical trial is to evaluate the effect of periodontal treatment on the reduction of glycated hemoglobin levels in adult patients with concurrent type 2 diabetes mellitus and periodontitis. non-surgical periodontal treatment and the application of a quality of life survey will be performed and then controls will be carried out for 1 year.

the aim of this clinical trial is to evaluate the effect of periodontal treatment on the reduction of hba1c levels in adult patients with type 2 diabetes mellitus who are users of the cardiovascular health program and also to measure their quality of life by means of a survey ohip-14sp. non-surgical periodontal treatment and subsequent follow-up of periodontal clinical parameters and hba1c values at 3, 6, 9 and 12 months will be performed.

Eligibility criteria:
inclusion criteria: * 1a. patients enrolled in the pscv with a diagnosis of type 2 diabetes mellitus and who, in turn, have a glycated hemoglobin ≥ 7% (during the last 6 months). * 1b. patients with a diagnosis of periodontitis (≥ 2 non-adjacent teeth with detectable clinical interproximal attachment loss or, attachment loss ≥ 3mm with depth to probing ≥ 3mm on free faces of ≥ 2 teeth, where the attachment loss was not attributed to non-periodontal causes (papapanou et al., 2018)). exclusion criteria: * 2a. patients who have received periodontal treatment during the last year. * 2b. pregnancy/lactation, because they are under treatment under the explicit health guarantee "oral and integral health of pregnant women". * 2c. therapy with antibiotics and/or non-steroidal anti-inflammatory drugs (nsaids) in the last 6 months prior to the study.

Keywords: hba1c periodontitis cardiovascular diseases diabetes mellitus type 2 diabetes mellitus scaling and root planing
observational study of delayed nausea and vomiting

Conditions: Vomiting

Summary: delayed emesis following administration of carboplatin-based chemotherapy despite prophylaxis with standard antiemetic prophylaxis (5-ht3 and corticosteroid) remains a clinically significant and distressing problem for patients with cancer. the incidence of delayed emesis appears to be higher in women compared to men.

all patients will be given the functional living index- emesis (flie), a standardized questionnaire. this is a self-administered questionnaire to assess the impact of nausea and vomiting on the patient's functional living, including physical activities, social and emotional function, and ability to enjoy food and drink. patients will complete the questionnaire during the 5 days following carboplatin administration (at 24 hours, 48 hours, 72 hours and 96 hours) during their first and third cycles of chemotherapy. the questionnaire should take approximately 10 minutes or less to complete. patients will also be interviewed by a trained cra or research nurse over the telephone 24-48 hours following carboplatin administration in order to assess the severity of the delayed nausea and vomiting.

Eligibility criteria:
inclusion criteria: * patients must have newly diagnosed, histologically or cytologically proven cancer, and be scheduled to receive chemotherapy with carboplatin at auc 5 or above. * patients should receive standard antiemetic prophylaxis prior to carboplatin administration, defined as 5-ht3 antagonist and dexamethasone. we will include only patients whose standard care includes treatment with a carboplatin-containing regimen and who are not being treated with aprepitant (emend®). * age \>= 18. * after being informed of the treatment involved, patients must give written consent. * entry to this study is open to both men and women and to all racial and ethnic subgroups. exclusion criteria: * no prior cytotoxic chemotherapy within the last 5 years. * should not be pregnant.

Keywords: nausea vomiting carboplatin cancer delayed emesis following treatment with carboplatin
efficacy and safety of ginseng extract on improvement of bone metabolism in menopausal women

Conditions: Osteopenia

Summary: recently, osteoporosis has been recognized as a serious health problem in the elderly, it has also increased in young • middle-aged layer. ginseng is history 2, 000 years korean typical herbal medicine which is used as a medicinal is known the mystery of elixir from a long time ago. a previous study was administered ginseng extract results in animal models induced osteoporosis, the bone-related biomarkers, including improved bone density and bone mass.

the investigators performed a 12-week, randomized, double-blind, placebo-controlled human trial to evaluate the efficacy and safety of ginseng extract on improvement of bone metabolism in menopausal women. the investigators measured serum osteocalcin, urinary deoxypyridinoline, dpd/oc ratio, serum ctx, ntx, ca, phosphorus, bsalp(vone specific-alkaline phosphatase), p1np(procollagen type 1 n-terminal propeptide), womac index(western ontario and mcmaster universities arthritis).

Eligibility criteria:
inclusion criteria: * age older than 40 years, after a amenorrhea 6 months in women * t-score less than -1.0, * osteocalcin 8(ng/ml) or more and dpd 5.2(nmdpd/mmcreatinine) or more, * subjects giving written informed consent exclusion criteria: * diagnosed osteoporosis * bmi ≤ 18.5kg/m2 or bmi ≥ 30 kg/m2 * cardiovascular disease, e.g. arrhythmia, heart failure, myocardial infarction, and patient with pacemaker * history of disease that could interfere with the test products or impede their absorption, such as gastrointestinal disease or gastrointestinal surgery * participation in any other clinical trials within past 2 months * laboratory test, medical or psychological conditions deemed by the investigators to interfere with successful participation in the study * pregnancy or breast feeding etc,.
cetuximab in treating patients with ménétrier disease at high risk of developing stomach cancer

Conditions: Gastric Cancer; Precancerous Condition

Summary: rationale: monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. some block the ability of tumor cells to grow and spread. others find tumor cells and help kill them or carry tumor-killing substances to them. purpose: this clinical trial is studying how well cetuximab works in treating patients with ménétrier disease at high risk of developing stomach cancer.

objectives: * evaluate clinical and biochemical parameter response in patients with ménétrier disease at high risk of developing gastric cancer treated with cetuximab. outline: this is a non-randomized study. patients receive cetuximab iv on days 1, 8, 15, and 22. treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity. patients complete a quality of life questionnaire at baseline and during week 4. projected accrual: a total of 10 patients will be accrued for this study.

Eligibility criteria:
disease characteristics: * histologically confirmed ménétrier disease * symptomatic disease, including gastrointestinal symptoms which interfere with daily life * patient is considering surgery * must have failed medical therapy that was given for 6 months * no helicobacter pylori infection patient characteristics: * not pregnant or nursing * negative pregnancy test * fertile patients must use effective contraception * no nyha class iii-iv cardiovascular disease * no clinically unstable pulmonary disease * no chronic disease requiring ongoing therapy for stabilization, including any of the following: * uncontrolled diabetes mellitus * malignancy * thyroid disease * hypertension * active infections requiring systemic antibiotics, antivirals, or antifungals * uncontrolled seizure disorder * active neurological disease * no unstable coagulation disorders (e.g., hemorrhagic diatheses or active bleeding disorders) that require medical management prior concurrent therapy: * not specified

Keywords: gastric cancer giant hypertrophic gastritis
patient-controlled sedation with propofol versus anesthesiologist-administered sedation for orthopedic surgery

Conditions: Orthopedic Disorder

Summary: the purpose of this study is to compare patient satisfaction with patient-controlled sedation with propofol and anesthesiologist-controlled sedation during orthopedic procedures of the upper limb under locoregional anesthesia.

this is an interventional, prospective, randomized, open-label, controlled, single-center study designed to evaluate the less commonly used patient-controlled sedation, comparing it with sedation administered by the anesthesiologist in a population of patients indicated for orthopedic upper limb surgery requiring additional sedation. once informed consent has been signed, patients will be randomized into one of two study arms in a 1:1 ratio, stratified by age: * experimental arm (1) : patient-controlled propofol sedation ; * control arm (2) : anesthesiologist-controlled propofol sedation. patient participation in the study lasts from 1 to 7 days maximum (from preoperative inclusion to hospital discharge).

Eligibility criteria:
inclusion criteria: * patients aged 18 and over; * patients indicated for orthopedic surgery of the upper limb under anaesthesia requiring additional sedation; * ability to use the patient-controlled sedation device; * body mass index less than 40 kg/m²; * american society of anesthesiologists class i to iii; * patient agreeing to study assessments and follow-up visits * patient having been informed and agreeing to participate in the study by signing an informed consent form. exclusion criteria: * contraindications to locoregional anesthesia (allergy, local infection, coagulation disorders); * surgery of the upper limb not compatible with locoregional anesthesia (arthroplasty); * patient unable to understand study information for linguistic, psychological or cognitive reasons linguistic, psychological or cognitive reasons ; * patient pregnant or likely to be pregnant, of childbearing age, without effective contraception or breastfeeding ; * patient participating in another clinical trial, or in a period of exclusion from another clinical trial; * patient under legal protection, or deprived of liberty by judicial or administrative decision administrative ; * patient not covered by a social security scheme.
tadekinig alfa (il-18bp) rescue therapy for car t cell related cytokine release syndrome (crs) and hlh-like syndrome

Conditions: CRS - Cytokine Release Syndrome; HLH

Summary: this is a pilot, open-label study to assess the safety and feasibility of using investigational drug(s) as rescue therapies for car t cell related crs and hlh-like syndrome (crhls).

this pilot, open-label trial will allow for co-enrollment of subjects participating in university of pennsylvania-sponsored, cci-initiated car t cell studies. as utilization of this investigational drug may be required emergently in the event of qualifying safety events post car t cell infusion, subjects may be consented/enrolled at the time they receive an investigational car t cell product. if/when use of this investigational drug is deemed clinically necessary, rescue therapy may then be initiated. cohort 1: will allow for the use of tadekinig alfa, an interleukin-18 binding protein that binds and neutralizes il-18. il-18 is a key mediator in systemic inflammatory conditions such as mas/hlh, which may contribute to the severity of car t cell-related cytokine release syndrome (crs) and hlh-like syndrome (crhls) and impact response to standard therapy. in addition, subjects experiencing other il-18 driven toxicity post car t cell therapy which is non-responsive to conventional treatment may also receive rescue therapy with tadekinig alfa as per clinical discretion.

Eligibility criteria:
inclusion criteria: 1. signed, written informed consent 2. male or female patients age ≥ 18 years 3. have been co-enrolled in a university of pennsylvania-sponsored, cci-initiated car t cell clinical trial. 4. subjects of reproductive potential must agree to use acceptable birth control methods, as described in protocol exclusion criteria: 1. pregnant or nursing (lactating) women. 2. known hypersensitivity to the active substance or one of the excipients of the investigational product(s).
inflammation and brain function - pilot study

Conditions: Sickness Behavior

Summary: in this randomized double blind cross-over study 8 healthy persons were injected with 0.8 ng/kg body weight lipopolysaccharide (lps) /endotoxin and placebo at two different occasions. the aim was to investigate how pain sensitivity and health perception change in response to an acute immune activation.

eight healthy participants were included in this randomized and balanced double blind cross-over study. they were injected two times, once with the active component and once with placebo. participants were recruited by advertising and screened through questionnaires and a health examination by a physician. they were asked not to engage in strenuous physical activities, sleep regular hours and refrain from alcohol the day before the experiment. if the participants felt ill, e.g. coming down with a cold, they were instructed to call and were rescheduled for a later appointment. c-reactive protein (crp) was assessed to exclude participants having an ongoing infection on the experimental day. pregnancy was also an exclusion criteria and a pregnancy test was administered for all female participants on arrival. several pain sensitivity measures were performed baseline and at peak inflammatory response 1-2 hours after injection. subjects filled out questionnaires at baseline, 90 minutes and 4,5 hours after injection. the study and the procedures used in the study are described in detail here: https://openarchive.ki.se/xmlui/bitstream/handle/10616/44650/thesis_bianka_karshikoff.pdf?sequence=8\&isallowed=y the following papers have been published using data from this study: olsson mj, lundstrom jn, kimball ba, gordon ar, karshikoff b, hosseini n, sorjonen k, olgart hoglund c, solares c, soop a, axelsson j \& lekander m. the scent of disease: human body odor contains an early chemosensory cue of sickness. psychol sci. 2014 jan 22. sundelin t, karshikoff b, axelsson e, hoglund co, lekander m, axelsson j. sick man walking: perception of health status from body motion. brain behav immun. 2015;48:53-6. karshikoff b, lekander m, soop a, lindstedt f, ingvar m kosek e, olgart höglund c, \& axelsson j. modality and sex differences in pain sensitivity during human endotoxemia. brain, behavior, and immunity. 2015 may;46:35-43

Eligibility criteria:
inclusion criteria: * healthy subjects exclusion criteria: * diagnosed physiological or psychiatric disease * needle anxiety or blood phobia * regular medication (excluding contraceptive pill) * infection in the last two weeks * pregnancy or breastfeeding * smoking * excessive alcohol use * body mass index in the range of obesity (\>30 kg/m2) or underweight (\<18.5 kg/m2) * invisible veins in the antecubital area of the arms

Keywords: sickness behavior cytokines psychoneuroimmunology
evaluation of minimal invasive glaucoma surgery

Conditions: Glaucoma

Summary: glaucoma is a neurodegenerative disease with an accelerated and progressiv retinal ganglion cell loss and concomitant visual field defects. glaucoma can be treated with eye drops, laser therapy or surgery. various surgical approaches to lower intraocular pressure are available, amongst which trabeculectomy is the gold standard. recently minimal invasive glaucoma surgery has been introduced and has become a good alternative to trabeculectomy. randomized clinical trials investigating the postoperative outcomes of various types of glaucoma surgery are limited.

150 patients will be randomized to one of the 3 surgeries. trabeculectomy preserflo® or xen® will be done according to a standard protocol data will be collected for 5 years after surgery, visual acuity, applanation tonometry, slit lamp biomicroscopy, endothelial cell cound, visual fields, optical coherence tomography of the optic disc, retina and anterior segment, impression cytology and life quality will be done on day of enrollment and during followup. mean intraocular pressure and number of glaucoma medications, endothelial cell loss, visual acuity, visual fields and assessment of life quality will be assessed during the post-operative follow-ups at one week, one month, 3 months, 6 months, 9 months, 1 year, 2 years, 3 years, 4 years and 5 years after surgery.

Eligibility criteria:
inclusion criteria: * patiens with glaucoma in which surgery is indicated to reach target intraocular pressure * subjects not anticipated to require any further surgery in the next 12 months exclusion criteria: * patients who do not want to make follow-ups at the department * angle closure, uveitic, neovascular, congenital glaucoma, iridocorneal endothelial syndrom, axenfeld-rieger syndrom. * prior filtering glaucoma surgery, suprachoroidal stent, retinal surgery, corneal graft surgery or cyclophotocoagulation * any major ocular inflammation up to 30 days prior to surgery * conjunctival scarring * allergy to any drugs required for the protocol

Keywords: migs xen® trabeculectomy preserflo®