Kornimate/medical-research-clean huggingface dataset:
hemodynamic effect of norepinephrine versus vasopressin on the pulmonary circulation in cardiac surgery patients:

Conditions: Cardiac Disease

Summary: the relative increase in the mpap with the same unit increase in map adjusted for baseline, and rv function assessed by gls, between vp and ne in patients with normal and increased pulmonary artery pressure, who require vasopressor support during cardiac surgery.

the specific aims of our study are to compare 1) the relative increase in the mpap with the same unit increase in map adjusted for baseline and 2) rv function assessed by gls, between vp and ne in patients with normal and increased pulmonary artery pressure, who require vasopressor support during cardiac surgery. we hypothesize that the use of vasopressin compared with norepinephrine induces a lower mpap-to-map ratio, in cardiac surgical patients with and without pulmonary hypertension who require intraoperative vasopressor support. second, we will test the hypothesis that vasopressin is associated with improved right ventricular global longitudinal strain compared to norepinephrine in patients requiring vasopressor support during cardiac surgery.

Eligibility criteria:
inclusion criteria: adults\> 18 years of age * elective cardiac surgery with the use of cpb * patients with pulmonary artery catheter insertion * systemic hypotension (map \< 70 mmhg) requiring continuous infusion of vasopressor exclusion criteria: * transplant surgery * ventricular assist device implantation other than intra-aortic balloon counter-pulsation * pulmonary endarterectomy * thoracoabdominal aneurysm repair * inhalational pulmonary vasodilators (e.g. epoprostenol) administration before insertion of pulmonary artery catheter * vasopressin is started as the first choice of pressor per clinical staff discretion
effect of shape and surface treatment of the transmucosal abutments on peri-implant health.

Conditions: Edentulous; Alveolar Process, Atrophy

Summary: the sample was comprised by 10 patients in which 40 dental implants are placed in an atrophic maxilla. all the implants were connected to 4 types of transepithelial abutment: i.e: parallel anodized abutment(n=10); parallel mechanized abutmen(n=10)t, convergent anodized abutment(n=10); and convergent mechanized abutment (n=10) three months after insertion implants were extracted with the surrounding hard and soft tissues for the histological evaluation of the clinical performance.


Eligibility criteria:
inclusion criteria: * totally edentulous patients in the upper arch and carriers of conventional complete dentures for more than ten years, without temporomandibular disorders exclusion criteria: * evidence of systemic or psychic pathology that contraindicates implant treatment.
high- and low-risk actinic keratosis referrals to secondary care

Conditions: Actinic Keratoses

Summary: this study evaluates the implementation of the general practitioners guidelines 'suspicious skin lesions' and investigated whether their publication and implementation has led to a reduction in the proportion of referrals of low-risk patients with actinic keratosis to secondary care, after publication of the general practitioners guidelines and implementation activities.

in the dutch healthcare system, patients are first examined by the general practitioner who decides whether a referral to a dermatologist is indicated. both general practitioners and dermatologists can diagnose and treat patients with actinic keratosis. therefore, it is necessary to distinguish which patients the general practitioner should refer to a dermatologist and which patients are suitable to be treated by the general practitioner. this retrospective data study evaluates the proportion of low risk actinic keratosis patients in 2019 en 2018.

Eligibility criteria:
inclusion criteria: * patients of 18 years and older * referred to dermatologist for suspicion of actinic keratosis and diagnosed as actinic keratosis by the dermatologist * treated at maastrichtumc+ or tergooihospital exclusion criteria: * different diagnosis than actinic keratosis * referred by a different specialist than the general practitioner * referred with multiple problems * referred for a second opinion * if the patients was treated as different diagnosis than actinic keratosis by general practitioner

Keywords: general practitioners guidelines actinic keratosis general physician dermatology low-risk patients referrals
french database of left atrial appendage closure

Conditions: Atrial Fibrillation and Other Dysrhythmias | Patient

Summary: patients with atrial fibrillation are exposed to a high risk of thrombus in the left atrium that can induce cerebral vascular events or systemic embolisms. this justifies the prescription of anticoagulant therapies in patients with high risk of thromboembolic event. percutaneous left atrial appendage closure is a new interventional strategy for patients with high risk of cardiovascular events and a counter-indication for long term treatment with anticoagulant agents. however, only few data are available on effectiveness and prognosis of patients treated by this new interventional strategy. this national database record per-procedure and follow-up data of patients treated by left atrial appendage closure. this database is strictly observational. percutaneous left atrial appendage closure is performed only for the purpose of patient care. no specific intervention is performed specifically for the database. neither left atrial appendage closure procedure nor patient follow up are modified by patient inclusion in the database.


Eligibility criteria:
inclusion criteria: * patients referred to a french interventional cardiology department for percutaneous left atrial appendage closure in routine care * signature of an inform consent form for inclusion of data recorded during care in the database exclusion criteria: none
paraffin bath therapy for chronic hand eczema

Conditions: Eczema

Summary: objective: chronic hand eczema (che) is a common inflammatory skin disease has a major medical psychological and socio-economic implications that affect quality of life (qol)and work ability. this study, the first randomized controlled trial that will be conducted to evaluate the effect of paraffin bath therapy (pbt) in the treatment of che.

design: the study design is a randomized controlled trial with measures at pre-and post-intervention. subjects: sixty patients with moderate to severe chronic hand eczema (che) will participate in the study. they will be classified randomly into two groups of equal number; paraffin group and the control group. interventions: paraffin group will receive paraffin bath therapy for 5 days per week for 12 weeks in addition to routine skin care program while the control group will receive routine skin care program. outcome measures: objective scoring atopic dermatitis, subjective item score and dermatology life quality index (dlqi) will be assessed before, at 6th week and at 12th week of treatment.

Eligibility criteria:
inclusion criteria: * age from 20-40 years * time elapsed from the beginning of the disease ; more than three months according to the guideline of the german dermatological society exclusion criteria: * active eczematous lesions on other parts of the body; * malignant or premalignant skin tumors

Keywords: paraffin bath therapy, hand eczema, scorad, dlqi, itching
assessment of adherence to medication in atrial fibrillation - an emonitoring drug dispensing device study

Conditions: Adherence, Patient; Atrial Fibrillation

Summary: the astoria study is a prospective cohort single-armed multicenter observational study that aims to assess adherence to rivaroxaban using a high technological electronical pillbox connected to a phone application in a group of atrial fibrillation patients with indication of long term anticoagulation treatment in routine clinical practice.


Eligibility criteria:
inclusion criteria: * female or male patient with age \> 18 years * patients with atrial fibrillation * patients initiated, continued on or switched to rivaroxaban for the indication atrial fibrillation with intended lifelong treatment (cha2 ds2-vasc score ≥ 1). * the patient must agree to the use of the electronic medication adherence monitoring device, the so-called pilloxa box and need to have a sufficient understanding of the app and functionality in conjunction with the use of the pilloxa box. * signed informed consent * no participation in an investigational program with interventions outside of routine clinical practice * no contra-indications according to the local marketing authorization exclusion criteria: * participation in an investigational program with interventions outside of routine clinical practice * contra-indications according to the local marketing authorization
amg 162 in the treatment of bone loss in subjects undergoing aromatase inhibitor therapy for non-metastatic breast cancer

Conditions: Breast Cancer; Low Bone Mineral Density; Osteopenia

Summary: the purpose of this trial is to evaluate amg 162 in the treatment of bone loss in subjects undergoing aromatase inhibitor therapy for non-metastatic breast cancer.


Eligibility criteria:
* histologically or cytologically confirmed adenocarcinoma of the breast * subjects with early stage disease who are estrogen receptor positive and who have completed their treatment pathway (surgery, chemo-therapy, radiation, and/or hormone therapy) and are currently on or will initiate aromatase inhibitor therapy, and are expected to stay on aromatase inhibitor therapy for the duration of the 24-month study * all treatment pathway must be completed ≥ 4 weeks prior to study entry, and all acute toxic effect of any above therapy must be resolved to ≤ grade 1 by national cancer institution (nci) common terminology criteria for adverse events (ctcae) * female \> 18 years of age * ecog performance status 0 and 1 * lumbar spine, total hip or femoral neck bmd equivalent to a t-score classification of -1.0 to -2.5 * subject is willing and able to provide signed consent before any study-specific procedure other criteria also apply.

Keywords: breast cancer bone loss associated with aromatase inhibitor therapy (ait) for non-metastatic bc osteopenia low bone density
study of tcelna (imilecleucel-t) in secondary progressive multiple sclerosis

Conditions: Autoimmune Diseases of the Nervous System; Multiple Sclerosis; Secondary Progressive Multiple Sclerosis; Disease Progression; Brain Atrophy

Summary: the purpose of this study is to determine whether tcelna (imilecleucel-t, autologous t-cell immunotherapy) is effective in the treatment of secondary progressive multiple sclerosis (spms).

subjects whose myelin reactive t-cell can be identified by epa will are randomized and provide blood to manufacture tcelna. approximately 5 weeks after receipt of the subject's whole blood procurement, the subjects will receive either tcelna or placebo and will complete baseline assessments and will receive study treatments at weeks 0, 4, 8, 12, and 24 (visits 3-7), totaling 5 doses in year one. approximately one month prior to the week 52 visit a second blood procurement will be performed and the subject will receive the second series of treatments as received in the first year study schedule. subjects will be evaluated for changes in disability and cognitive function every 3 months, and radiographic changes annually.

Eligibility criteria:
inclusion criteria: * diagnosed with ms as defined by the modified mcdonald criteria * spms defined as relapsing-remitting disease with recent progression in ms-related neurological deficits * edss score 3.0 - 6.0, inclusively * presence of myelin reactive t-cells exclusion criteria: * diagnosed with primary progressive ms * treatment with beta-interferon, glatiramer acetate or dimethyl fumarate 30 days prior to screening * treatment with acth, any over-the-counter or prescription corticosteroids 60 days prior to screening * treatment with ivig, plasmapheresis or cytopheresis 90 days prior to screening * treatment with mitoxantrone, teriflunomide, fingolimod, natalizumab, azathioprine, cyclosporine, methotrexate or mycophenolate mofetil 1 year prior to baseline * any prior treatment with cladribine, cyclophosphamide, total lymphoid irradiation, t cell or t cell receptor products, or any therapeutic monoclonal antibody, except natalizumab * previous treatment with any other ms investigational drug 1 year prior to screening * all non-ms investigational drugs must have a minimum washout of 30 days prior to screening or 5 half-lives, whatever is the longest period of time. * hiv or hepatitis infection * history of cancer * any other significant medical condition that, in the opinion of the investigator, could cause cns tissue damage or limit its repair.

Keywords: multicenter study randomized controlled trial individualized medicine immunotherapy myelin proteins biological agents
hfnc during awake craniotomy - impact on patient comfort

Conditions: Pulmonary Atelectasis; Patient Comfort

Summary: background: patients undergoing awake brain surgery are exposed to non-humidified, non-warmed oxygen/air mix flow through a face mask for a prolonged duration. this causes increased discomfort, inadequate breathing with the risk for hypoxia perioperatively. humidified high flow nasal cannula (hfnc) oxygen therapy potentially improves patient comfort, oxygen/air exchange, improves surgical conditions and prevents atelectasis of the lung, compared to traditional oxygen administration using a face mask in patients undergoing awake brain surgery. results of this trial will be used to initiate a more extensive, multicenter trial to further characterize the potential impact of hfnc.

background: patients undergoing awake brain surgery are exposed to non-humidified, non-warmed oxygen/air mix flow through a face mask for a prolonged duration. this causes increased discomfort, inadequate breathing with the risk for hypoxia perioperatively. hypothesis: humidified high flow nasal cannula (hfnc) oxygen therapy improves patient comfort, oxygen/air exchange, improves surgical conditions and prevents atelectasis of the lung, compared to traditional oxygen administration using a face mask in patients undergoing awake brain surgery. methods: after obtaining ethics approval and written informed patient consent, 20 patients undergoing scheduled awake brain surgery will be randomized to either hfnc therapy or standard face mask. evaluation of patient satisfaction, pain / dry upper airway along with drawing of arterial blood gases to measure oxygen/carbon dioxide content of the blood will be performed during and after the procedure. lung ultrasound will be performed in the recovery room to determine the presence of atelectasis. expected results and significance: we expect that hfnc improves patient comfort as well as breathing / arterial oxygen content in long-duration awake brain surgery. this could result in higher patient satisfaction, shorter times in pacu, a shorter requirement for oxygen therapy, decreased risk for hypoxia during surgery and better elimination of carbon dioxide - which could lead to better surgical conditions due to softer brain tissue and therefore shorter time for the surgical procedure. potential positive results of this trial will be used to initiate a more extensive, multicenter trial to further characterize the potential impact of hfnc.

Eligibility criteria:
inclusion criteria: * adult patients undergoing elective awake craniotomy exclusion criteria: * asa \> 4 * pregnant females * body mass index (bmi) \> 40 * elective postoperative mechanical ventilation/conversion to general anesthesia * denial of consent * obstructive sleep apnea requiring cpap * severe copd requiring home oxygen therapy

Keywords: awake craniotomy hfnc oxygen therapy atelectasis ultrasound patient comfort
dosing of ketorolac in the emergency department

Conditions: Acute Pain

Summary: the optimal dose of ketorolac in the emergency department setting is no clear. we will compare 3 doses to determine the optimal dose.

patients from 4 groups will be treated with 3 different doses of ketorolac. the groups are 1. headache 2. abdominal pain 3. musculo-skeletal pain 4. viral syndrome. the doses will be 0, 10, 30mgs of ketorolac to clarify the placebo effect and the optimal dosage as a function of condition.

Eligibility criteria:
inclusion criteria: \> 18 y/o exclusion criteria: pregnant allergic other contraindication
multiple dose safety study of npt088 in patients with mild to moderate probable alzheimer's disease

Conditions: Alzheimer Disease

Summary: the purpose of the study is to evaluate the safety and tolerability of multiple doses of npt088 in patients with mild to moderate probable alzheimer's disease. the study will also evaluate the pharmacokinetics, immunogenicity and exploratory pharmacodynamic characteristics of multiple doses of npt088.

this study is a multicenter phase 1, randomized, double-blind, placebo-controlled, multiple-dose, dose-escalation safety and tolerability study of npt088 or placebo in patients with probable ad with a mmse score of 16-27. enrolled patients will receive an intravenous infusion of npt088 or placebo once a month for six months during this study. four dose cohorts are planned with the first two cohorts enrolling 9 patients each (6 npt088: 3 placebo) and the final two cohorts enrolling 24 patients each (16 npt088: 8 placebo) for a total of 66 patients (44 npt088: 22 placebo).

Eligibility criteria:
inclusion criteria: for enrollment in the study, participants must * be between 50 and 85 years of age, inclusive * have a mini mental state examination (mmse) scores between 16-27 (inclusive) * have a modified hachinski score of less than or equal to 4 * have a diagnosis of probable alzheimer's disease (ad) according to consensus criteria defined by the national institute on aging-alzheimer's association work group * have a clinical dementia rating scale (cdr) of 0.5 or 1.0, with the memory box score equal to or greater than 0.5 * have a positive florbetapir positron emission tomography (pet) amyloid scan * consent to apolipoprotein e (apoe) genotyping * be willing to undergo repeat magnetic resonance imaging (mri) and pet imaging * be on stable doses of allowed medications for at least 30 days prior to screening. concurrent treatment with cholinesterase inhibitors and/or memantine is allowed * be in good healthy apart from the clinical diagnosis of ad * have a dedicated caregiver who provides care at least 4 hours a day for 4 days a week and will provide informed consent for their participation exclusion criteria: for enrollment in the study, participants must not: * have a history of, or screening mri indicative of any significant brain abnormality * have any major medical illness or unstable medical condition or in the opinion of the investigator have any reason that may interfere with the participants ability to comply with the study procedures and abide by study restrictions or with the ability to interpret safety data * reside in a nursing home or need 24-hour care and supervision * take excluded medications * have exclusionary values on the screening blood and urine sample * have been treated with immunomodulators to treat ad * have participated in an investigational drug or device study within 90 days * have a known allergy to study drug

Keywords: gaim amyloid anti-abeta anti-tau
hiv upbeat: understanding the pathology of bone disease in hiv-infected patients.

Conditions: Osteoporosis

Summary: despite the prevalence of osteopenia and osteoporosis in the hiv positive population, relatively little is known about the underlying pathology. this prospective cohort study aims to gain further understanding about a number of issues relating to low bone mineral density in hiv-infected subjects.

this study will follow hiv positive and negative subjects annually for 5 years. the aims of this study include: * to describe the pathology underlying low bone mineral density * to assess the relationship between low bone mineral density and antiretroviral therapy exposure * to assess the relationship between low bone mineral density and vitamin d /pth status and/or markers of bone metabolism * to assess the relationship between osteopenia and subsequent changes in bone mineral density and markers of bone metabolism * to assess the validity of the currently available fracture risk assessment tool in predicting fractures in hiv positive populations

Eligibility criteria:
inclusion criteria: * age \>18 years * be able to provide written, informed consent * be able to attend the research centre in a fasting state and undergo dexa scanning exclusion criteria: * subjects on bisphosphonate therapy at screening * pregnant or breastfeeding female subjects * subjects with a previous clinical history of primary hyperthyroidism or hiv negative subjects with elevated parathyroid hormone at screening * hiv-negative subjects with a prior history of osteoporosis

Keywords: human immunodeficiency virus low bone mineral density osteopenia osteoporosis fracture
efficacy and safety of repaglinide combined with insulin nph in subjects with type 2 diabetes

Conditions: Diabetes; Diabetes Mellitus, Type 2

Summary: this trial is conducted in asia and south africa. the aim of this trial is to compare the efficacy and safety of repaglinide plus insulin nph (insulin neutral protamine hagedorn) with insulin nph alone in subjects with type 2 diabetes inadequately controlled on repaglinide.


Eligibility criteria:
inclusion criteria: * type 2 diabetes * hba1c (glycosylated haemoglobin): 7-13% (both inclusive) * bmi (body mass index) maximum 35 kg/m\^2
reports on sleep quality and thermoregulation among veterans

Conditions: Sleep Disturbance

Summary: to assess and compare the quality of sleep self- reported by veterans with sleep disorders before and after use of the chilipad cooling mattress pad

a non-randomized convenience sampling study of n=20 adult male or female veterans (\> 18 years of age) with self-reporting sleep disturbance and will utilize a chilipad cooling mattress for the 5-week study period

Eligibility criteria:
inclusion criteria: * adult male and female veteran patients (\> 18 years of age) * self-report of sleep disturbance, defined as "sleep of poor quality, timing, efficiency, or duration" exclusion criteria: * non-adult patients \< 18 years of age. * patients with chart documentation or self-report of illegal drug use, impaired orientation and cognition or currently incarcerated. * initiated cam or non-cam treatments for sleep disturbance in the last 4 weeks. * changed dose of a cam or non-cam treatments for sleep disturbance in the last 4 weeks. * initiated antidepressants in the last 3 months. * changed of an antidepressant in the last 3 months. * patients who describe their health as fair or poor.

Keywords: chilipad sleep disorders