Kornimate/medical-research-clean huggingface dataset:
an open label safety and immunogenicity study of myobloc (neurobloc; botulinum toxin type b) injectable solution in patients with cervical dystonia

Conditions: Cervical Dystonia

Summary: five hundred patients with a confirmed clinical diagnosis of cervical dystonia (cd)are planned for enrollment into this open label study. these patients will be type b toxin naive patients with cd. during this study patients will receive repeat injections of myobloc when deemed appropriate by the investigator. however, it will be recommended that injections occur not more frequently than every 12 weeks. total duration of exposure to myobloc will be targeted for at least two years, with potential exposure for up to 7 years in patients with earliest enrollment


Eligibility criteria:
inclusion criteria: * 18 years of age or older * body weight of at least 46 kilograms * history of cervical dystonia of at least one year's duration who in the opinion of the investigator requires treatment exclusion criteria: * inability to give informed consent * patient who has been previously treated with botulinum toxin type b * patient who has received a botulinum toxin type a injection in the last 12 weeks. * history of phenol injections involving the neck or shoulder region in the last 12 months. * patients with neck contractures or cervical spine disease
duration of antibiotic therapy for cellulitis

Conditions: Cellulitis; Erysipelas

Summary: cellulitis is among the most common infections leading to hospitalization, yet the optimal duration of therapy remains ill defined. pragmatically, dutch guidelines advise 10-14 days of antibiotics, which is the current standard of care. recently it has been shown that antibiotic treatment for pneumonia and urinary tract infections can safely and significantly be shortened. importantly, in an outpatient setting, treatment of uncomplicated cellulitis with 5 days of antibiotics was as effective as 10 days. we hypothesize that there is no difference in outcomes when patients hospitalized with cellulitis are treated with either a short-course (6 days) or standard-course (12 days) of antibiotics.


Eligibility criteria:
inclusion criteria: * admitted to receive intravenous antibiotics for cellulitis/erysipelas * 18 years of age or older * capable of giving written informed consent, able to comply with study requirements and restrictions exclusion criteria: * allergy for flucloxacillin, other beta-lactam antibiotics or one of the additives, or flucloxacillin induced hepatitis or liver enzyme disorders. * concurrent use of antibiotics for other indications * alternative diagnosis accounting for the clinical presentation. * all cases involving any of the following complicating factors: * use of antibiotics with gram-positive activity for more than 4 days in the past 7 days * intensive care unit admission during the last 7 days * severe peripheral arterial disease (fontaine iv) * severe cellulitis necessitating surgical debridement or fascial biopsy * necrotizing fasciitis * periorbital or perirectal involvement * surgery * life expectancy less than one month * risk factors associated with gram-negative pathogens as a causative agent: * chronic or macerated infra-malleolar ulcers, or infra-malleolar ulcers with previous antibiotic treatment, in patients with diabetes mellitus. * neutropenia * cirrhosis (child-pugh class b or c) * intravenous drug use * human or animal bite * skin laceration acquired in fresh or salt open water * fish fin or bone injuries

Keywords: antibiotics flucloxacillin therapy duration cellulitis erysipelas skin infections hospital
fluorescence cholangiography during cholecystectomy - a rct

Conditions: Cholecystitis; Gallstones

Summary: the primary objective is to compare the success rates of intraoperative fluorescent cholangiography using indocyanine green versus conventional x-ray cholangiography for the identification of bile duct anatomy during laparoscopic cholecystectomy for complicated gallstone disease in a randomized design with 120 patients.


Eligibility criteria:
inclusion criteria: * patient scheduled for planned laparoscopic cholecystectomy by one surgeon * complicated gallstone disease exclusion criteria: * open cholecystectomy * allergy towards iodine, urografin or indocyanine green * liver or renal insufficiency * thyrotoxicosis * pregnancy or lactation * legally incompetent for any reason * withdrawal of inclusion consent at any time

Keywords: fluorescence cholangiography indocyanine green cholecystectomy, laparoscopic
feasibility and acceptability of a healthy nordic diet intervention in depressed and non-depressed adults

Conditions: Depression; Major Depressive Disorder

Summary: in the future, we plan to conduct an 8-week diet intervention to investigate whether a healthy nordic diet improves depression symptoms. the present pilot study tested whether the planned meals and diets were well-liked and accepted by participants (both depressed and non-depressed) in order to ensure that the future diet intervention will be feasible and successful. we also investigated whether any changes in health occurred after 8 days of this diet intervention.

after providing their written informed consent, participants were randomized to receive either a healthy nordic diet or a control diet for 8 days. all meals were provided and minimal food preparation was required. participants picked up their food outside the study kitchen every 3 days. before and after the intervention, health-related self-rated questionnaires were completed. for every meal during the intervention, participants completed a questionnaire on their perceptions of the meal. every evening a questionnaire was completed to assess dietary adherence. at the end of the study, a final evaluation questionnaire was completed to assess participants' perceptions of the diet and study as a whole.

Eligibility criteria:
inclusion criteria: * if depressed, a score between 13 and 34 on the montgomery-åsberg depression rating scale, self-rated (madrs-s), indicating mild or moderate depression exclusion criteria: * a score of 8 or higher (out of a maximum of 12 points) on a brief diet survey (the retired version of the swedish food agency's online matvanekollen, conducted via phone interview), indicating a relatively healthy habitual diet * presence of food allergies, intolerances or sensitivities * consuming any form of special diet that excludes certain foods, for example a vegetarian or gluten-free diet * suicidality, indicated by a score of 4 or higher on the madrs-s suicidality question.

Keywords: depression major depressive disorder diet nutrition randomized controlled trial pilot study healthy nordic diet
efficacy and safety of pregabalin in treatment of neuropathic pain in patients with idiopathic small fiber neuropathy

Conditions: Idiopathic Small Fiber Neuropathy

Summary: the purpose of this study is to assess safety and efficacy of treatment with pregabalin in patients with idiopathic small fiber neuropathy proven by skin biopsy.this is an enriched enrollment randomized withdrawal study that comprises 4 phases: a screening and selection phase, a washout period from previous pain medication for enriched enrollment, an 8 week single blind pregabalin treatment phase; and a 4 week randomized withdrawal phase.

patients who show any increase in their pain intensity score during the washout phase will be eligible for the single blind pregabalin treatment phase. patients who respond to pregabalin, with at least 1 point improvement in neuropathic pain from baseline at the end of the single blind pregabalin treatment phase and meeting all other study requirements are considered eligible for participation in the withdrawal phase. these eligible patients are randomly assigned (1:1) to continue pregabalin or to be switched to placebo for a comparison of pregabalin efficacy and safety. patients who have a worsening of average pain relative to the last week of the single blind pregabalin treatment period by more than one point and average pain level \> =4 will be considered to have a loss of therapeutic response (ltr).

Eligibility criteria:
inclusion criteria: * subjects with idiopathic predominate-small fiber neuropathy * subject must have chronic peripheral neuropathic pain for more than 3 months * a score \>3 and \<8 on pain intensity scale for pain in prior week at first visit; * show increase in pain intensity scores during the wash off period; * age older than 18 years; exclusion criteria: * subjects with large-fiber predominant neuropathy * subjects with hiv infection, trigeminal neuralgia (tgn), toxic neuropathy (e.g. chemotherapy exposure), paraneoplastic neuropathy, mono-gammopathy, inflammatory neuropathy, celiac disease, systemic lupus, peripheral vascular disease, connective tissue disorders, hepatitis c, fabry disease, and diabetes; * subjects with uncontrolled thyroid or b12 disorders * subjects with complex regional pain syndrome * allergy to pregabalin * subjects at risk of suicide or self harm * subjects with any clinically unstable cardiovascular, hematological, autoimmune, endocrine, renal, hepatic, renal, respiratory, or gastrointestinal disease; epilepsy, symptomatic peripheral vascular disease including intermittent claudication, pernicious anemia, untreated hypothyroidism, venous insufficiency, or spinal stenosis. * history of known analgesic, alcohol or illicit drug abuse within 12 months of first visit; * pregnant females; breastfeeding females.
platelet response during the second cycle of decitabine can predict response and survival for myelodysplastic syndrome

Conditions: Myelodysplastic Syndrome

Summary: to assess the efficacy of decitabine and identify predictors for response to decitabine therapy.

* histologically confirmed myelodysplastic syndrome diagnosed with mds (de novo or secondary) based on the world health organization (who) classifications * survival and response analysis * response rate * overall survival * leukemia free survival

Eligibility criteria:
inclusion criteria: * histologically confirmed myelodysplastic syndrome diagnosed with mds (de novo or secondary) based on the world health organization (who) classifications
cardiac arrest and ventilation method

Conditions: Out-Of-Hospital Cardiac Arrest; Advanced Cardiac Life Support; Ventilation

Summary: comparison of manual ventilation and automatic mechanical ventilation during cpr, pilot \& feasibility study (cave-i trial)

this is a preliminary randomized clinical trials comparing the effectiveness of the automatic mechanical ventilation method compared to manual ventilation methods commonly performed during advanced cardiac life support (acls) in emergency room for out-of-hospital cardiac arrest.

Eligibility criteria:
inclusion criteria: * out-of-hospital cardiac arrest (ohca) * transferred by only ems without prehospital return of spontaneous circulation (rosc) * acls for at least 20 minutes in the emergency room * arterial blood gas analysis at least once during acls exclusion criteria: * in-hospital cardiac arrest (ihca) * not transferred by emergency medical service * rosc gained before arriving at the er * ohca caused by trauma * acls is not performed for more than 20 minutes because the death is obvious * not able to intubate the trachea
evaluation of the dental health condition in obesity patients before and after bariatric surgery

Conditions: Obesity; Periodontitis; Caries; Periapical Lesion

Summary: the aim of this study is to investigate whether there was an association between obesity and periodontitis, tendency to caries and periapical lesions. people who have a higher body mass index produce cytokines (hormone-like proteins), that lead to systemic/chronic inflammation (like periodontitis and periapical lesions), and obesity related dietary habits could result in an increment of dental caries because both the amount and the frequency of sucrose ingestion are important factors associated with the aetiology of the oral disease.


Eligibility criteria:
inclusion criteria: * obese pateints who intended to go bariatric surgery. exclusion criteria: * coronary heart disease
effect of intravenous acetaminophen on postoperative opioid-related complications

Conditions: Postoperative Pain

Summary: some patients have respiratory depression (decreased breaths per minute) after surgery. acetaminophen, an fda approved pain medication, may prevent this problem. the purpose of this study is to determine if acetaminophen decreases respiratory depression after surgery. the investigators will also evaluate the cost effectiveness of acetaminophen. patients having elective major abdominal surgery are being asked to participate in this research study. if eligible, a patient will have their baseline tidal volume (amount of air moved into or out of the lungs) and vital capacity (how much air the lungs are capable of holding) measured using a spirometer (apparatus for measuring the volume of air inspired and expired by the lungs) measured before surgery. three questionnaires will also need to be completed before surgery. the patient will then be randomized, like flipping a coin, to receive either acetaminophen or placebo (inactive substance) as an infusion throughout surgery and for the first two days thereafter. neither the patient nor his or her physician will know if the patient is assigned to study drug or placebo. regardless of study assignment, both groups will receive standard pain management medications and sedation. after surgery, the patient's blood pressure, activity, posture, respiratory rate, the electrical activity of the heart, oxygen saturation, tidal volume, minute ventilation and respiratory rate will be continuously monitored and recorded for 48 hours using a wireless pulse-oximeter and a respiratory volume monitor. 48 hours after surgery the patient will be asked to complete a patient satisfaction questionnaire, which will allow the patient to rate the satisfaction with the treatment received for pain. the patient will also be asked to complete a questionnaire about recovery. at discharge, the patient will be given two questionnaires about pain and quality of life.


Eligibility criteria:
inclusion criteria: * written informed consent * 18-85 years old * above 50 kg * american society of anaesthesiologists physical status 1-3 * scheduled for elective open or laparoscopic abdominal surgery, including colorectal, prostate, and hysterectomy surgeries * patients with anticipated hospitalization of two nights * expected to require parenteral opioids for at least 48 hours for postoperative pain * able to use iv patient-controlled analgesia systems exclusion criteria: * hepatic disease, e.g. twice the normal levels of liver enzymes * kidney disease, e.g. twice the normal level of serum creatinine * epidural analgesia or regional blocks (including transverse abdominis plane block) * acetaminophen sensitivity or known allergy * female patients who are pregnant or breastfeeding * patients taking warfarin
effect of exenatide plus metformin vs. insulin aspart plus metformin on glycemic control and hypoglycemia in patients with type 2 diabetes

Conditions: Type 2 Diabetes Mellitus

Summary: this study in germany is designed to compare the effects of twice-daily exenatide plus metformin and twice-daily premixed human insulin aspart plus metformin with respect to glycemic control, as measured by hba1c, combined with the percentage of patients with at least one treatment-emergent hypoglycemic episode. patients will be treated with study therapy for approximately 26 weeks.


Eligibility criteria:
inclusion criteria: * have been treated with diet and exercise and a stable, maximally tolerated dose of immediate-release or extended-release metformin, or the combination of metformin (any dosage) with sulfonylurea/meglitinides for at least 3 months prior to study start * have not received thiazolidinediones, or alpha-glucosidase inhibitors for longer than 2 weeks within 3 months prior to study start, and have not received any insulin formulation for more than 14 days (other than in emergency situations) and within 14 days prior to study start * have an hba1c between 6.5% and 10.0%, inclusive * have a body mass index (bmi) between 25 kg/m\^2 and 40 kg/m\^2, inclusive exclusion criteria: * have type 1 diabetes or known latent autoimmune diabetes in adults * are receiving chronic (lasting longer than 2 weeks) systemic glucocorticoid therapy (excluding topical and inhaled preparations) or have received such therapy within 2 weeks prior to study start * are receiving treatment for gastrointestinal disease with a drug directly affecting gastrointestinal motility (e.g., metoclopramide, cisapride, and chronic macrolide antibiotics) * have used any prescription drug to promote weight loss within 3 months prior to study start * have received treatment within 30 days prior to study start with a drug that has not received regulatory approval for any indication at the time of study entry * have previously completed or withdrawn from this study or any other study investigating exenatide or glp-1 analogs

Keywords: diabetes exenatide byetta amylin lilly
as-oct guided treatment of diffuse cscc

Conditions: Conjunctival Neoplasms

Summary: a prospective study was performed on 8 eyes of 8 patients who underwent amniotic membrane graft after diffuse conjunctival squamous cell neoplasia excision followed by topical mitomycin c 0.04% eye drop between march 2014 and january 2018.

surgical excision of the conjunctival tumour . a superficial corneal scraping was performed for corneal lesion then double freeze-thaw cryotherapy was applied to limbal edge and conjunctival margins.the amniotic membrane graft was secure and attached to the sclera and conjunctiva using ﬁbrin glue.topical mitomycin c 0.04%eye drop was prescribed 4 times daily per treatment cycle (1 cycle=1 week on 1 week off).

Eligibility criteria:
inclusion criteria: * diffuse ocular surface squamous neoplasia exclusion criteria: * localized ossn (less than ﬁve clock hours in limbal extent)

Keywords: conjunctiva squamous neoplasia amniotic
68ga-fapi-rgd pet/ct imaging in the lung cancer patients

Conditions: Lung Neoplasms

Summary: based on the high expression of specific receptors on the surface of diseased tissues and neovascularization, noninvasive targeted molecular imaging can be used to visualize lesions in vitro by combining specific ligands labeled with short half-life isotopes. lung cancer tissues express fibroblast activating protein fap, and also have high expression of integrin αvβ3 receptor on the surface of blood vessels. in this study, a novel dual-target imaging agent 68ga-fapi-rgd was used for pet/ct imaging of lung cancer.

conventional 18f-fdg pet/ct has important diagnostic value in cell metabolism level, early metastasis, judging malignant potential and prognosis of tumors. it has been routinely used for staging and restaging of most tumors, but there are still some tumors with low uptake of 18f-fdg pet/ct. moreover, 18f-fdg cannot distinguish between tumors and inflammatory diseases, such as tuberculosis and granuloma. receptor imaging with a single target also has some limitations in clinical application. for example, not all diseased cells express a large amount of single receptor on the surface, which greatly affects the judgment of the nature of the lesion. the dual-target molecular imaging based on fap expressed in the lesion site and integrin αvβ3 receptor highly expressed on the surface of the lesion neovascularization will overcome the above limitations and make full use of the advantages of the dual-target molecular imaging, which will greatly assist the diagnosis of malignant tumors such as lung cancer. in this study, a novel dual-target imaging agent 68ga-fapi-rgd was used for pet/ct imaging of lung cancer, compared with conventional 18f-fdg, or single target imaging agent 68ga-rgd or 68ga-fapi pet/ct imaging.

Eligibility criteria:
inclusion criteria: * patients with confirmed or suspected lung cancer; * 68ga-fapi-rgd and 18f-fdg(or 68ga-fapi or 68ga-rgd) pet/ct within 2 week; * signed written consent. exclusion criteria: * pregnancy; * breastfeeding; * any medical condition that in the opinion of the investigator may significantly interfere with study compliance.
prevalence, awareness and management of hypertension in acute care personnel

Conditions: Hypertension

Summary: the primary purpose of this study is to identify the percentage of health care workers working in an acute care hospital who have high blood pressure, to determine the awareness of their blood pressure status, and to see how well it is managed. study participants will come from the following three distinctly different types of departments: telemetry (clinical), non-telemetry (clinical), and non-direct patient care staff. all study participants are offered educational information surrounding high blood pressure and review the recommendation for their primary care engagement. study participants with high blood pressure will be asked to continue in the study for up to 6 months. it is intended that each study participant who continues will take their blood pressure three times a day and record the results in a study provided diary. each study participant should also make some of the suggested changes that promote a healthier lifestyle including exercising, improving their diet, and seeing their primary care provider. it is the thought that these changes will reduce the study participant's blood pressure. the secondary purpose is to determine the effect shift work has on these hospital employees and the potential positive effects of the three interventions.

research on hypertension (htn) in hospital personnel during work hours is limited yet research has been published on the relationship of job strain and the risk of cardiovascular disease. htn can be caused by sympathoadrenal activation brought on by long-term exposure to stressors and an inherent biomarker that is associated with an increased risk of cardiovascular disease. the primary purpose of this study is to quantify differences in htn prevalence, awareness and management in three distinctly different areas and shifts within an acute hospital. blood pressure (bp) will be taken during working hours along with pre and post sleep hours. the secondary purpose is to identify the effect of shift work within an acute care hospital and effectiveness of: bp monitoring, increases in physical activity, positive nutritional changes, and the correlation between a primary care provider visits and lowering bp.

Eligibility criteria:
inclusion criteria: * providence health system's southwest washington service area (swsa) employees * subjects who will be included in the intervention part of the study will have two consecutive bp readings of \> 140/90 * has or is willing to have collaborative pcp * understand and sign the informed consent form exclusion criteria: * under the age of 18 * has a severe systemic illness with life expectancy judged less than three years * has a severe vascular event such as myocardial infarction or cerebral vascular event in the past 90 days * is enrolled in another therapeutic program or similar study, and * has a condition which, in the opinion of the investigators, may prevent the subject from participating in the study

Keywords: hypertension acute hospital staff exercise diet