Kornimate/medical-research-clean huggingface dataset:
validation of frontal eeg to formal polysomnography in the icu

Conditions: Sleep Deprivation; Sleep

Summary: the purpose of this study is to compare a 2-lead frontal electroencephalogram recording to a formal polysomnography (psg) in detecting sleep vs. wake and depth of sleep in both healthy and icu patients.

sleep in the intensive care unit (icu) is poor and not well understood. formal polysomnography (psg) is the gold standard measure, but impractical for critical care. the relative influence of environment, illness and interventions on sleep in critically ill patients is therefore essentially unknown. interventions to improve sleep have been pragmatic and outcomes subjective or indirect, and uninformed. when it is done, formal psg in critical illness demonstrates fragmented, shortened, interrupted and non-circadian sleep, with environmental noise, light, and frequent physical stimulation causing arousals.

Eligibility criteria:
group 1: healthy subjects in sleep lab: inclusion criteria * age 18 or older * scheduled for a standard of care polysomnography lasting at least 8 hours for any condition exclusion criteria * patient/legally authorized representative declines consent group 2: icu patient, not sedated, not ventilated inclusion criteria * age 18 or older * anticipated to stay in intensive care unit overnight (minimum 8 hours) * glasgow coma scale score of 13 or great exclusion criteria: * intubated with endotracheal tube * sedated (includes sedative drugs such as propofol, dexmedetomidine, versed infusion above 2mg/hr, ketamine infusion above 0.2 mg/kg/hr). group 3: icu patient, sedated and ventilated inclusion criteria: * age 18 or older * anticipated to stay in the intensive care unit overnight (minimum 8 hours) * intubated, sedated, and ventilated exclusion criteria: * presence of traumatic brain injury * planned extubation in next 8 hours * scheduled to leave the intensive care unit for any reason in the next 8 hours * anticipated life expectancy of less than 24 hours * electroencephalogram monitoring (current or scheduled in the next 8 hours) * hemodynamic instability (defined as: (i) mean arterial pressure \ 20 minutes with efforts to raise it or (ii) \>2 liter fluid administered in 2h after operating room and anticipating on-going needs for fluid resuscitation or (iii) icu md determination of "atypical and profound hemodynamic instability" or (iv) pi determination after evaluation. * refractory hypoxemia - defined as saturation \<88% on sp02 despite efforts to increase it * hemorrhage - defined as \>500cc chest tube output in 2h and anticipated need of more than 2 units of packed red blood cells in immediate post op period. this does not include cell-saver.
enhancing connections: helping the mother with breast cancer support her child

Conditions: Breast Cancer

Summary: this is a 6-state randomized controlled trial (rct) that uses a behavioral intervention to enhance parenting skills for school age children when a mother is recently diagnosed with early stage breast cancer. efficacy analyses will include measures of the child's and mother's psychosocial adjustment, including enhanced parenting quality and skills related to the cancer.

this is a phase 3 randomized clinical trial of recently diagnosed mothers with local or regional breast cancer and their school age child. after baseline measures are taken, mothers are randomized into either intervention and control group. intervention participants are given 5, 1-hour at home educational counseling sessions by a specially trained nurse. control participants are mailed an educational booklet whose content focuses on supportive parenting behaviors that are part of the face to face sessions given to the experimental group. the theoretical framework for the study derives from bandura's social cognitive theory, a contextual model of parenting, and stress and coping theory. efficacy is evaluated through standardized valid and reliable questionnaires of psychosocial functioning in the mother (affect, mood, self-efficacy) and psychosocial functioning in the child (cognitive-emotional functioning, including behavioral problems, anxiety, depressed mood, and cancer-related concerns). primary study hypotheses will be evaluated comparing pre-posttest measures of the intervention compared to controls at post-test and 1-year follow up.

Eligibility criteria:
inclusion criteria: * local or regional breast cancer recently diagnosed * able to read and write english * has one or more school age child(ren) living at home * married to a man or in a committed long-term intimate relationship with a male partner exclusion criteria: * non-english speaking * advanced stage breast cancer * not recently diagnosed * single mother

Keywords: breast cancer, child functioning, parenting, self-efficacy, psychoeducational intervention counseling
value of cardiac output monitoring by supra-sternal doppler/echocardiography in intensive care unit

Conditions: Shock

Summary: the aim of this study is to evaluate the concordance between the measurement of cardiac blood flow by non-invasive supra sternal ultrasound and the measurements performed by invasive monitoring in intensive care patients already equipped with an invasive monitoring. this invasive monitoring consists of catheters used to measure the cardiac output allowing the supply of organs and is installed when there is need to monitor the blood flow in different hemodynamic reasons. the patient's care will not be modified, the study just requires a supplementary measure in an exam already perform in the standard care. the principal hypothesis is that we can show a concordance between this non-invasive measure and the standard invasive monitoring.

the aim of this study is to evaluate the concordance between the measurement of cardiac output by non-invasive supra sternal ultrasound and the measurements performed by invasive monitoring (trans pulmonary thermodilution or right heart catheterization) in intensive care patients already equipped with an invasive monitoring. cross sectional study was performed in reims university hospital. patients who will be included in this study are patients who already have an invasive cardiac output monitoring such as trans pulmonary thermodilution or right heart catheterization for many reason as septic shock, cardiogenic shock or any shock state. cardiac output will be measured by supra-sternal and transthoracic echography and by invasive monitoring (trans pulmonary thermodilution or right heart catheterization). intra-class correlation coefficient will be calculated to assess the concordance between the measurement of cardiac blood flow by non-invasive supra sternal ultrasound and the measurements performed by invasive monitoring.

Eligibility criteria:
inclusion criteria : - patient admitted in intensive care unit at the reims university hospital and in whom invasive monitoring of cardiac output is already placed. exclusion criteria: - age under 18 yo

Keywords: shock hemodynamic
psychological variables in physiotherapy treatment of low back pain: a comparison of group and individual treatment

Conditions: Low Back Pain

Summary: the purpose of the study is to determent whether there is a difference between two types of treatments in physiotherapy (individual vs group) for patients with low back pain (lbp), in terms of their sensation of how they have been helped and their treatments' outcomes measures. the study hypothesizes are: a) based on the results of literature review which does not reveal a clear difference between group and individual treatments' outcomes for lbp, it is hypothesized that no difference will be found in treatment results for the two types of group treatments in the present study also, b) the assumption is that different distribution of therapeutic factors will be found in the two types of treatments (individual, group), c) patients' sensation of how they have been helped will be connected to treatment results.

200 patients with lbp looking for physiotherapy treatment in 15 clinics at maccabi healthcare service in israel will be recruited. (100 after competion individual therapy, 100 after competion of group therapy). as part of the regular routine in these clinics, patients will be asked to fill the lfsq, a questionnaire which deals with their back functional status, their level of pain and fear avoidance of physical activity before and after treatment. in the present study, patients will be asked to fill the lfsq again, 6 months after treatment completion. in two weeks from treatment completion, patients will be interviewed on the telephone. the interview will focuse on their sensation of how they have been helped. it will include an open-ended question and 18 closed questions. the main study variables will include: participants' perception of functional status, level pain, level of fear avoidance of physical activity, patient-therapist bonding, and helpful therapeutic impacts (client's sense of how she or he has been helped).

Eligibility criteria:
inclusion criteria: * low back pain, * 18 years old and older * hebrew speakers , who filled the lfsq (lumbar functional status questionnaire) at first visit * agreed to participate in this study exclusion criteria: * pregnant * after back or hip operation in the last year * back problem from non- orthopedic origin

Keywords: low back pain lumbar pain
use of warfarin after the first trimester in pregnant women with aps

Conditions: Recurrent Miscarriage; Antiphospholipid Syndrome

Summary: evaluation of shifting to oral vitamin k antagonist after the first trimester instead of using low molecular weight heparin (lmwh) throughout pregnancy in pregnant women with antiphospholipid syndrome (aps)

women will be randomly divided into two groups; one will be subjected to anticoagulant therapy by enoxaparin throughout pregnancy and the other will be subjected to anticoagulant therapy by enoxaparin in the first trimester then warfarin after the first trimester until termination of pregnancy.

Eligibility criteria:
inclusion criteria: * pregnant women with aps diagnosed according to the revised classification criteria for aps in 2006 in sydney, australia * early pregnancy body weight is 50-90 kg exclusion criteria: * women with systemic lupus erythematosus (sle) * women with active thromboembolic disorders * women with history of previous thromboembolic disorders

Keywords: antiphospholipid syndrome aps warfarin
sb-480848 in major adverse cardiovascular events - integrated summary of efficacy and safety from the stability trial (lpl100601) and the solid-timi-52 trial (sb-480848/033)

Conditions: Coronary Heart Disease

Summary: the overall objective of this integrated analysis is to evaluate the clinical safety and efficacy of long-term treatment with darapladib enteric coated tablets, 160mg, as compared to placebo when added to standard of care in subjects with clinical manifestations of cardiovascular disease (chronic coronary heart disease (chd) and post acute coronary syndrome (acs)). with respect to efficacy, the key purpose of this integrated analysis is to evaluate the effects of darapladib on the following endpoints: urgent coronary revascularization for myoacrdial ischemia, fatal/non-fatal stroke, time to subsequent major adverse cardiovascular event (mace), and heart failure requiring hospitalization. the first occurrent of mace, major and total coronary events as well as the individual components of mace will also be evaluated descriptively.

the objective of the integrated safety analysis is to characterize the safety profile of darapladib in subjects with clinical manifestations of cardiovascular disease (chronic coronary heart disease (chd) and post acute coronary syndrome (acs)). the purpose of the integrated efficacy analysis is to test the effects of darapladib on select endpoints which are not part of the testing hierarchies associated with the individual studies, namely: urgent coronary revascularization for myocardial ischemia, stroke, subsequent mace, and heart failure requiring hospitalization, for all other endpoints, the intent of the integrated analysis is to provide increased precision of the estimated effects of darapladib.

Eligibility criteria:
inclusion criteria: * this is an integrated analysis therefore inclusion criteria are not applicable. exclusion criteria: * this is an integrated analysis therefore exclusion criteria are not applicable.

Keywords: cv risk cardiovascular disease atherosclerosis acute coronary syndrome
predicting colorectal cancer - tissue samples to evaluate tumour characteristics and treatment response

Conditions: Colorectal Neoplasms

Summary: all adult patients with colorectal cancer presenting within the sahlgrenska university hospital or treated at any time at sahlgrenska university hospital are eligible and will be asked to participate. we already have biopsies taken at surgery in patients that receive surgery, but this study will include all patients and the biopsies will be taken during endoscopy for diagnosis of the primary tumour. biopsies will then be taken during follow-up exams prior surgery but after neoadjuvant treatment. biopsies will also be taken during surgery and in cases where surgery is not necessary biopsies will be taken regularly during follow-up exams. blood samples and in relevant cases urinary samples and mouth swabs will be taken at all timepoints when biopsies are taken. if it is not possible to take biopsies prior treatment blood samples will still be drawn.


Eligibility criteria:
inclusion criteria: * colorectal cancer exclusion criteria: * not colorectal cancer
post-market assessment on safety and performance of j-shaped xfine lead

Conditions: Bradycardia

Summary: the primary objective of this study is to evaluate the safety and the electrical performances of the right atrial j-shape (jx model) xfine endovascular passive lead at 3 months post implant.


Eligibility criteria:
inclusion criteria: 1. subject has reviewed, signed and dated the informed consent form 2. subject newly implanted (de novo) with a jx xfine within 10 days, connected to a dual chamber (dr) pacemaker from microport crm s.r.l and any commercially available is-1 right ventricular lead 3. subject is willing and capable of participating in all testing/ visits associated with this clinical study at an approved clinical study center and at the intervals defined by this protocol. exclusion criteria: 1. subjects with documented permanent or persistent af 2. included in another clinical study that could confound the results of this study such as studies involving intra-cardiac device 3. subject has had any pacing or icd system implants 4. patient implanted despite a contraindication for cardiac pacing system implantation (i.e. patient implanted with a defibrillator, patient contraindicated for a single dose of 310 μg of dexamethasone sodium phosphate, patient implanted with a tricuspid replacement heart valve or with a significant tricuspid valve disease that may lead to future replacement heart valve surgery) 5. age less than 18 years old, incapacitated or under guardianship or kept in detention 6. life expectancy less than 1 year
standard of care lifestyle support for stage iii nsclc patients

Conditions: Non Small Cell Lung Cancer

Summary: offering an early-initiated supportive care program to stage iii nsclc patients to prevent deterioration of performance status and increase compliance of patients that complete chemoradiation as well as the patients receiving 12 months of durvalumab.

in inoperable stage iii non-small cell lung cancer (nsclc), consolidation immune checkpoint inhibition with the pd-l1 inhibitor durvalumab, given within 6 weeks after completion of concurrent platinum-based chemoradiotherapy (ccrt) for 12 months results in remarkable improvement of 3-year overall survival rates (57% vs 43.5%). this tri-modal therapy has become the new standard of care. unfortunately, the tri-modal therapy frequently causes adverse events such as fatigue and, to a much lesser degree, cough, dyspnea and pneumonitis, resulting in treatment cessation in 15% - 53% of the patients (15%) (53%). for the most optimal overall survival (os) and disease-free survival (dfs), compliance to the full treatment regimen, i.e. in the ideal situation 100% of patients completing their full course of ccrt and receiving durvalumab for one year, is expected to have significant and relevant beneficial effects. optimizing patients' fitness is essential in order to handle the tough full treatment regimen.

Eligibility criteria:
inclusion criteria: * pathological diagnosis of adequately staged (according to standard practice using chest-ct, fdg-pet, brain imaging mri/ct) nsclc * participant is willing and able to give informed consent for participation in the trial * aged 18 years or above * scheduled to receive one of the following two therapeutic strategies: * concurrent chemotherapy and radiotherapy with photons (60 gy in 30 fractions of 2 gy) followed by durvalumab in patients with stage iii nsclc * concurrent chemotherapy and radiotherapy with protons (60 gy in 30 fractions of 2 gy) followed by durvalumab in patients with stage iii nsclc * able and willing to comply with all trial requirements exclusion criteria: * mixed non-small cell lung cancer with other histology such as small cell lung cancer * not able to comply with the study protocol * less than 18 years old * pregnancy or not able to comply with adequate contraception in women with child baring potential * previous radiotherapy to the chest for benign or malignant conditions, including radiation for breast cancer * previous malignancy treated with chemotherapy, immune therapy or radiotherapy (irrespective of when this happened) * previous malignancies treated with surgery only are allowed if 2 years or more before inclusion in the present study
blood biomarker of alzheimer's disease (ad)

Conditions: Alzheimer Disease

Summary: currently, no cures or disease modifying therapies exist for alzheimer's disease (ad). this is partially due to the inability to detect the disease before it has progressed to a stage where there are clinical manifestations. the identification and validation of high throughput biomarkers to measure disease progression (as well as identify pre-clinical disease onset) is critical to the development of disease-modifying or even preventative therapies. in this study, we are testing a blood biomarker for stratification of alzheimer's disease patients and healthy volunteers. this study may lead to future blood tests that may help earlier diagnosis of alzheimer's disease and detect the disease progression.


Eligibility criteria:
inclusion criteria: alzheimer's disease patients: * 50 years and older * ad patient who is seen at the memory disorders clinic * ad diagnosis * non smoking * no cancer treatment in the last 5 years * informed consent from the patient or the patient's legally authorized representative (lar) * patient and/or lar able to read and speak english healthy control participants: * 50 years and older * non smoking * no cancer treatment in the last 5 years * age matched to ad subject * able to read and speak english exclusion criteria: alzheimer's disease patients: * known additional neurological disease healthy control participants: * neurological degenerative diseases (such as parkinson's, alzheimer's or huntington's)

Keywords: alzheimer's disease biomarkers blood
study of wafermine™ for post-bunionectomy or abdominoplasty pain

Conditions: Acute Pain; Bunion; Abdominoplasty

Summary: this study evaluates the safety and effectiveness of wafermine™ for post-bunionectomy or post-abdominoplasty pain over a 24 hours period. for subjects undergoing bunionectomy, 2 out of 3 subjects will receive wafermine™ and 1 out of 3 subjects will receive placebo. for subjects undergoing abdominoplasty, 3 out of 4 subjects will receive wafermine™ and 1 out of 4 subjects will receive placebo.


Eligibility criteria:
inclusion criteria: * scheduled for a bunionectomy or mini abdominoplasty with no additional planned procedures. * good general health without clinically significant renal, hepatic, cardiac or respiratory disease, as determined by the investigator. exclusion criteria: * for those undergoing bunionectomy, other painful conditions involving the surgical foot. * positive lab values for hepatitis b or c or hiv
knee hinge prosthesis following tka infection

Conditions: TKA Infection

Summary: between 2009 and january 2016, the investigators included 49 patients from four hospitals in lyon who had a total knee arthroplasty (tka) infection and who benefited of a knee arthroplasty revision with a rotating hinge prosthesis. this retrospective and descriptive cohort aims at studying the functional results after 2 years follow up.


Eligibility criteria:
inclusion criteria: - all the patients who had a rotating hinge knee arthroplasty for septic revision after total knee arthroplasty, proved by bacteriological samples or purulent drainage at involved site or other obvious clinical signs or radiological signs of infection exclusion criteria: - patients who benefited of a hinge prosthesis following a unicompartmental prosthesis, following a mechanical issue on a total prosthesis

Keywords: hinge knee prosthesis tka infection rotating hinge prosthesis hinge knee arthroplasty
the efficiency of video-based exercises in individuals with stroke

Conditions: Stroke

Summary: the aim of the study is to compare the video-based balance coordination exercise program and the video-based conventional exercise program in patients with subacute stroke.

thanks to telerehabilitation, it will be possible for individuals to learn the exercise programs in the most appropriate way and to communicate easily with their physiotherapists with video images. in this way, it will be ensured that individuals can perform their exercises at the optimum level in non-clinical environments. the aim of the study is to compare the conventional home exercise program performed with video-based telerehabilitation and the balance coordination program in subacute stroke patients.

Eligibility criteria:
inclusion criteria: * male and female patients aged 40 - 65 years * having been diagnosed with stroke by a specialist physician and at least 3 months and maximum 6 months have passed since the diagnosis * no serious medical complications * being able to understand verbal and visual commands * getting at least 24 points on the mini mental state test * able to walk at least 10 m without assistance using crutches or a walker * having signed the consent form exclusion criteria: * situations that will prevent assessments or communication with the individual * being on psychotropic medication * people with ataxia or any other cerebellar symptoms * other problems that would preclude evaluation and/or treatment

Keywords: stroke telerehabilitation balance coordination
individualized exercise program for treatment of fatigue in patients after hematologic stem cell transplant (hsct)

Conditions: Fatigue

Summary: the purpose of this study is to investigate the impact of fatigue in severely affected transplant patients.

investigates impact of a monitored program in kinesiology lab at the university of calgary on fatigue in severely affected transplant patients.

Eligibility criteria:
inclusion criteria: * severe fatigue post transplant exclusion criteria: * other conditions contributing to fatigue (graft versus host disease)

Keywords: transplant fatigue exercise malignant disease