Kornimate/medical-research-clean huggingface dataset:
respiratory muscle training in icu patients

Conditions: Critical Illness; Inspiratory Muscle Strength; Mechanical Ventilation; Respiratory Muscle Training

Summary: respiratory muscle weakness is common after mechanical ventilation and occurs early. this can limit functional recovery. respiratory muscle training is often neglected in clinical practice. some data indicates that inspiratory muscle training increases inspiratory muscle strength and quality of life. the aim of the study is to assess the impact of combined inspiratory and expiratory muscle training on inspiratory muscle strength. the second aim is to assess the impact of this training program on expiratory muscle strength.


Eligibility criteria:
inclusion criteria: * patient from mechanical ventilation after at least 24 hours of support * collaborative patient exclusion criteria: * confusion, mental disorder * not french speaking * pulmonary surgery in the past 12 months * external ventricular drain * previous pneumothorax or pneumothorax not drained * rib fractures * alveolar hemorrhage * hemodynamic instability * labial occlusion impossible (face burn, facial paralysis) * patient refusal
safety and efficacy of mometasone furoate delivered via concept1 device or twisthaler® device in adult and adolescent patients with persistent asthma

Conditions: Asthma

Summary: the purpose of this study is to compare the efficacy, safety and pharmacokinetics of mometasone furoate delivered via concept1 device or twisthaler® device in adult and adolescent patients with persistent asthma.


Eligibility criteria:
inclusion criteria: * males or females who were ≥ 12 years old at the time informed consent was obtained * patients with persistent asthma, diagnosed according to gina 2010 guideline and who additionally met the following criteria * patients who were receiving ics treatment up to the maximum dose per day as indicated in the corresponding package leaflet and also a stable ics regimen for at least 4 weeks prior to screening (visit 2). * patients whose level of asthma control according to gina 2010 guideline was "partly controlled" or "uncontrolled" at screening (visit 2). * patients with a pre-bronchodilator fev1 value of ≤ 80% of predicted normal value at screening (visit 2). * patients who demonstrated an increase of ≥ 12% and 200 ml in fev1 over prebronchodilator value within 30 minutes after inhalation of 400 μg of salbutamol (360 μg of albuterol) at visit 2 or between visit 2 and visit 5. * patients who were confirmed as "ics sensitive" by acq-5 and fev1 at visit 5. key exclusion criteria included: * patients diagnosed with copd as defined by the global initiative for chronic obstructive lung disease, updated 2010. * patients with concomitant pulmonary disease, pulmonary tuberculosis (unless confirmed by chest x-ray to be no longer active), or clinically significant bronchiectasis. * patients with any chronic conditions affecting the respiratory tract (e.g., chronic sinusitis) or chronic lung diseases, which in the opinion of the investigator may interfere with the study evaluation or optimal participation in the study. * patients with seasonal allergy which is likely to deteriorate his/her asthma condition during the study period judged by the investigator. * patients who have had a severe asthma attack/exacerbation requiring hospitalization in the 6 months prior to visit 1 or any time between visit 1 and visit 5 must discontinue from the trial (screening failure). * patients who have had an emergency room visit for an asthma attack/exacerbation within 4 weeks prior to visit 1 or any time between visit 1 and visit 5 must discontinue from the trial (screening failure). * patients who have ever required intubation for a severe asthma attack/exacerbation. * patients who have had a respiratory tract infection within 6 weeks prior to visit 1, or any time between visit 1 and visit 5 must discontinue from the trial (screening failure). other protocol-defined inclusion/exclusion criteria may apply

Keywords: asthma
core-ole: a study of olezarsen (isis 678354) administered subcutaneously to participants with severe hypertriglyceridemia (shtg)

Conditions: Severe Hypertriglyceridemia

Summary: the purpose of this study is to evaluate the safety and tolerability of olezarsen in participants with shtg.

this is a multi-center, open-label extension (ole) study of approximately 800 participants with shtg who would be rolled over from studies isis 678354-cs5 (nct05079919) or isis 678354-cs6 (nct05552326). day 1 of this study may be same as the week 53 visit of either isis 678354-cs5 or isis 678354-cs6, as applicable. participants will receive olezarsen during the 157-week treatment period. the study will include a 31-day qualification period, a 157-week treatment period, and a 13-week post-treatment period.

Eligibility criteria:
key inclusion criteria: * satisfactory completion of either isis 678354-cs5 or isis 678354-cs6 with an acceptable safety profile, per investigator judgment. satisfactory completion requires that the patient did not terminate early from treatment. * participants must be on a stable regimen of lipid-lowering therapy that should adhere to standard of care (soc) per local guidelines. a patient may be eligible if their regimen of lipid-lowering therapy has been changed recently, provided that lipid lowering medications are optimized and stabilized for at least 4 weeks prior to the end of the qualification period of this ole study; ideally, such changes are initiated after week 53 of the index study (isis 678354-cs5 or cs6). * a patient may re-enroll in the study after having completed the study when the treatment period was 53 weeks, if the patient satisfactorily completed the study with an acceptable safety profile, per investigator judgment. in the case of re-enrollment, there is no limit on the time gap between completion of treatment under the previous protocol and dosing upon re-enrollment (i.e., may exceed 17 weeks between doses). key exclusion criteria: • have any new condition or worsening of existing condition which in the opinion of the investigator would make the participant unsuitable for enrollment, or could interfere with the participant participating in or completing the study, including need for treatment with disallowed medications, or need to change the required stable regimen as per either isis 678354-cs5 or isis 678354-cs6 study entry criteria. it is acceptable to adjust a regimen of lipid-lowering therapy as described in the second key inclusion criterion above, and it is acceptable to adjust or stop lipid-lowering therapy at or after week 13 per investigator judgment. note: other inclusion/exclusion criteria may apply.

Keywords: isis 678354 olezarsen
alcohol and opioids

Conditions: Opioid Use; Alcohol Drinking

Summary: this study will examine the effects of doses of alcohol/placebo and doses of opioid/placebo, alone and in combination. the primary outcomes are related to pharmacodynamic measures (subjective ratings of drug liking and other abuse-related effects; physiological outcomes) to determine the interaction effects of these compounds.


Eligibility criteria:
inclusion criteria: * healthy adults ages 21-55 * current non-medical use of opioids * previous alcohol use exclusion criteria: * physical dependence on opioids, alcohol, or benzodiazepines/sedative/hypnotics * seeking treatment for drug use * significant medical problems

Keywords: opioid opiate alcohol
carepartner collaborative integrated therapy in sub-acute stroke

Conditions: Stroke

Summary: carepartner and collaborative integrated therapy (care-cite) is a novel, web-based carepartner focused intervention designed to foster problem solving and skill building while facilitating carepartner engagement during upper extremity functional activities in the home setting. the proposed study will evaluate the application of the care-cite intervention paired with usual and customary care during the sub-acute stroke.

stroke is a leading cause of serious, long-term disability in the united states, and has a particularly harmful impact on individuals and families. approximately 4.8 million stroke survivors require assistance from family members who are often untrained and ill prepared for the burdens associated with stroke rehabilitation. family carepartners are key contributors to stroke recovery, but their efforts can lead them to experience a high level of burden and depressive symptoms, reduced quality of life and increased stress in the context of high levels of family conflict surrounding the recovery process. rehabilitation therapy interventions have primarily targeted stroke survivor outcomes without specifically addressing the well-being of the carepartner. the researchers of this study have developed a theory-based, family-centered intervention, carepartner and collaborative integrated therapy (care-cite), designed to engage carepartners during stroke survivor upper extremity (ue) functional task practice in the home. residual ue impairments occur in up to 80% of stroke survivors and are a primary factor in loss of functional independence. care-cite guides the carepartner in collaborative goal setting and providing autonomy support (characterized by empathy, choice and reducing use of controlling language) for the stroke survivor to promote motivation and creative problem solving in ue self-management. participating stroke survivor and carepartner dyads will be randomized to receive the care-cite intervention with usual customary care, or usual customary care alone for four weeks.

Eligibility criteria:
inclusion criteria for stroke survivors: * 1-3 months post ischemic or hemorrhagic event * discharged from inpatient neurologic rehabilitation to their home * have minimal to moderate upper extremity (ue) deficits (actively initiate 20 degrees of wrist and 10 degrees of finger extension) * no severe cognitive deficits (mini -mental test \>24) * no physician determined major medical problems that would limit participation in outpatient therapy inclusion criteria for carepartners: * spouse/partner or family member * dwelling in the same household * self-identify as the primary caregiver of the stroke survivor * \>21 years old * able to read and write english * have no significant cognitive deficits (mini -mental test \>24) * familiar with using a computer and accessing websites, or with using a tablet exclusion criteria: * none

Keywords: telehealth rehabilitation care partner sub-acute stroke care-cite stroke survivors
usefulness of ultrasound-derived fat fraction for quantification of hepatic steatosis in patients suspected of masld

Conditions: MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease

Summary: this study aims to evaluate the diagnostic utility of ultrasound-derived fat fraction (udff) in assessing hepatic steatosis in patients with suspected metabolic dysfunction-associated steatotic liver disease (masld). using a prospective, cross-sectional design, the study will compare udff results with established diagnostic methods, including liver biopsy, mri proton density fat fraction (pdff), and controlled attenuation parameters (cap) measurements. the ultimate goal is to determine if udff can serve as a non-invasive alternative to liver biopsy for diagnosing and staging hepatic steatosis, potentially reducing the need for invasive procedures in masld management.

this prospective observational study, conducted at a single tertiary institution, will investigate the efficacy of ultrasound-derived fat fraction (udff) and point shear wave elastography (p-swe) as non-invasive methods for quantifying liver fat content and fibrosis in patients scheduled for liver biopsy or surgery. the study will enroll 150 participants, suspected of masld and who are candidates for liver biopsy or resection. the study will utilize siemens ultrasound equipment to measure the udff using attenuation coefficient (ac) and backscatter coefficient (bsc) values for liver fat quantification. additionally, te parameters, such as controlled attenuation parameter (cap) and liver stiffness measurement (lsm), will be recorded for comparison. the primary outcomes will assess udff's diagnostic accuracy against liver biopsy and mri-pdff. secondary outcomes will include assessment of intra- and inter-observer variability, and correlations with patients' clinical data, such as bmi, liver fibrosis stages and liver function tests. expected benefits include validating udff as a reliable, non-invasive alternative for liver fat assessment, potentially reducing the need for invasive biopsies in managing liver disease.

Eligibility criteria:
inclusion criteria: * patients older than 18 and younger than 80 years * patients suspected of masld * patients who are planned to undergo either liver biopsy or surgery * patients willing to provide written informed consent. exclusion criteria: * patients with a large tumor in rt. hemiliver causing difficulty in performing udff measurement * patients with previous liver surgery or transplantation * patients with insufficient pathologic specimen for analysis of steatosis and fibrosis grade. * any other condition which, in the opinion of the investigator, would make the patient unsuitable for enrollment or could interfere with completing the study.

Keywords: masld ultrasound steatosis liver diseases fibrosis
deep brain stimulation in patients with luts

Conditions: Bladder Dysfunction; Neurogenic Bladder

Summary: deep brain stimulation (dbs) is a neurosurgical procedure using a device that improves motor symptoms of specific neurological and movement disorders such as parkinson's disease or essential tremor. as part of the patient's care, the dbs is implanted when symptoms cannot be satisfactorily controlled with medications or conventional therapies. lower urinary tract symptoms are common in patients who have underlying neurological or movement disorders and control over lower urinary tract function is poorly understood. in this study investigators are evaluating the effects of dbs on lower urinary tract function.

deep brain stimulation (dbs) is a neurosurgical procedure that improves motor symptoms of specific neurological and movement disorders such as parkinson's disease or essential tremor. dbs is implanted when symptoms cannot be satisfactorily controlled with medications or conventional therapies. after insertion of deep electrodes, electrical stimulation will be delivered to modulate specific neurons in certain areas of the brain. despite, the known motor effects for dbs, its nonmotor effects on other organs such as the urinary tract and bladder function remains unclear. lower urinary tract symptoms such as frequency, urgency, urinary incontinence, or incomplete bladder emptying are common in patients who have underlying neurological or movement disorders. in addition, central neural control over lower urinary tract function is still poorly understand. in this trial investigators plan to evaluate the effects of deep brain stimulators (dbs) on lower urinary tract function. this trial is designed to test the hypothesis that dbs improves objective and subjective symptoms of lower urinary tract function in specific patient populations. the investigators plan to test this hypothesis by using validated patient reported outcome questionnaires and urodynamic testing (both are part of routine care for neurogenic bladder) before and after dbs implantation. in addition, this trial will shed some light in understanding higher neural control of bladder and potentially identify target areas for future intervention.

Eligibility criteria:
inclusion criteria: * patients who are a candidate for deep brain stimulation (dbs) as standard care for neurologic symptoms and have a moderate or greater urinary bother american urological association symptom score (auass≥8) exclusion criteria: * pregnant, breastfeeding mothers and all individuals younger than 18 years of age will be excluded. patients with history of urinary diversion or augmentation cystoplasty will also be excluded.

Keywords: overactive bladder underactive bladder urinary incontinence
memory problems perceptions among patients and accompaniers during diagnosis process :

Conditions: Memory Disorders; Alzheimer Disease

Summary: this study aims to prospectively examine the memory problem perceptions of patients with memory complaints \[mcs\] and their accompaniers during the diagnostic process.

through the french adaptation of the "illness perception questionnaire memory", this study aims to prospectively examine the memory problem perceptions of patients with memory complaints \[mcs\] and their accompaniers during the diagnostic process. the investigators plan to recruit 125 patients with mcs who come for the first time at the research and resources memory center in nancy, france. participants have to express mcs and must be free of dementia diagnosis at the first visit. participants also need to be accompanied by an accompanier and both have to be fluent in french. this study has been approved by our local ethics committee (committee for the protection of persons) and the french health security agency. after giving their informed consent, patients and accompaniers are followed up throughout the diagnostic process with three visits : at their first visit, at one month after the first visit, and at six months after the diagnosis disclosure.

Eligibility criteria:
inclusion criteria: for patients with memory complaints: * age over 18 years * have a memory complaints with a qpc score greater than or equal to 3 * be accompanied by a next of kin * folstein mmse greater than or equal to 15/30 * have given their written consent after receiving clear and intelligible oral and written information * social security coverage for accompaniers : * age over 18 years * consent to participate at the study with the patient * have given their written consent after receiving clear and intelligible oral and written information * social security coverage * be in contact with the patient at least 8 hours per week. it could be physical contact or telephone contact. exclusion criteria: for patients with memory complaints: * sensory deficit interfering with the completion of the questionnaires * level of french insufficient to complete the questionnaires * legally protected person * diagnosis of neurocognitive disorders already established * treatment for alzheimer disease * refusal or inability to obtain written informed consent form from the patient * included in another experimental study at inclusion visit for accompaniers: * sensory deficit interfering with the completion of the questionnaires * level of french insufficient to complete the questionnaires * refusal or inability to obtain written informed consent form from the accompanier
controlled study of ono-1101 in patients with postoperative tachyarrhythmias in japan

Conditions: Postoperative Supraventricular Tachyarrythmia

Summary: the purpose of this study is to evaluate the efficacy and safety of ono-1101 in postoperative supraventricular tachyarrhythmias.


Eligibility criteria:
inclusion criteria: 1. 20 years or older 2. postoperative supraventricular tachyarrhythmias 3. within 7 days postoperatively 4. other inclusion criteria as specified in the protocol exclusion criteria: 1. acute myocardial infarction (within 1 month after onset) 2. severe heart failure \[new york heart association (nyha) functional class iii or higher\] 3. atrioventricular block (grade ii or higher), or sick sinus syndrome 4. other exclusion criteria as specified in the protocol

Keywords: ono-1101 landiolol hydrochloride postoperative supraventricular tachyarrhythmia
cerebral oxygen saturation monitoring in cardiac surgery (cosmics)

Conditions: Cardiac Disease; Cognitive Dysfunction

Summary: neurological dysfunction continues to be one of the complications of considerable concern in patients undergoing cardiac surgery. it was previously reported in the literature, that cerebral oxygen desaturation during cardiac surgery was associated with an increased incidence of cognitive impairment. this study aims to determine whether continuous monitoring of cerebral oximetry improves the neurocognitive outcome in coronary artery bypass surgery when associated with predetermined intervention protocol to optimize cerebral oxygenation.

despite all the progress over the last decades regarding the improvement of the perioperative care of patients with heart disease and the development of new surgical techniques, neurological dysfunction continues to be one of the complications of the greatest concern in patients undergoing cardiac surgery with cardiopulmonary bypass. brain injury can manifest itself through permanent or temporary injury, contributing to the increase in-hospital mortality, in the length of stay in intensive care, in the length of hospital stay, to a higher incidence of motor dysfunction requiring rehabilitation, and consequently, to reduced quality of life. even though the causes of brain injury are multifactorial, perioperative cerebral hypoperfusion, tissue hypoxia, and thromboembolic events are among the main factors related to neurological dysfunction. several clinical studies have indicated an association between cerebral desaturation and the increase of neurological complications. cerebral oximetry monitoring using near-infrared spectroscopy (nirs) is a non-invasive technique used to estimate regional cerebral oxygen saturation (rso2) and has been associated with diminishing the incidence of neurological complications. there is no consensus in the literature about its real benefit, mainly due to the absence of well-designed scientific studies that demonstrate that cerebral desaturation associated with intervention measures to improve rso2, are related to the prevention of neurological dysfunction in adult cardiac surgery. the study hypothesis evaluates whether continuous monitoring of cerebral oximetry improves the neurocognitive outcome in coronary artery bypass surgery when associated with early interventions to optimize rso2.

Eligibility criteria:
inclusion criteria: * age 60 or older * elective coronary artery bypass graft surgery using cardiopulmonary bypass * preoperative cognitive assessment by means of mini-mental state examination (mmse) test, greater than or equal to 24 * signed informed consent exclusion criteria: * patients with focal neurologic deficit * carotid artery stenosis greater than 70% * patients with pre-existing cognitive dysfunction * patients with psychotic disorders * history of allergy to adhesive part of the electrode * history of craniofacial surgery

Keywords: intraoperative neurophysiologic monitorings