Kornimate/medical-research-clean huggingface dataset:
psyche cognitive remediation & social recovery study

Conditions: Early Psychosis

Summary: this study is a pilot feasibility study embedded in the early intervention in psychosis (eip) services in ireland. it explores the feasibility and acceptability of a combined cognitive remediation training and social recovery therapy intervention.

the cognitive remediation and social recovery in early psychosis (crestr) study is a feasibility study recruiting participants from the health service executive early intervention in psychosis (eip) services in sligo, meath and cork and the adult mental heath service in galway. this study explores the feasibility and acceptability of a novel, 15-week multicomponent psychosocial intervention which combines cognitive remediation training (crt) and social recovery therapy (srt). primary and secondary outcome measures are described later in this registration. the intervention components include: component 1: the crt programme used in this study is the computerised interactive remediation of cognition- training for schizophrenia (circuits). circuits is a web-based crt programme which targets metacognition, specifically strategy use, in addition to massed practice of cognitive functions (attention, memory and executive functioning). collaborative goal setting related to real-world tasks are integral to the programme with the programme tasks and exercises increasing in difficulty in response to the participant's performance and progress. this will be the primary focus of 1:1 therapy for the first 7 weeks with remote practice sessions occurring between therapy visits. after 7 weeks remote practice will continue and the focus of in-person therapy sessions will bridge to social recovery therapy as detailed below. component 2: social recovery therapy (srt) focuses on addressing barriers to individuals interacting in their social environment e.g., social anxiety. it is informed by cognitive behavioural theory and addresses individual goals. srt follows an established protocol. in summary, this consists of therapy delivered in three stages. stage one will include engagement and formulation with the purpose of identifying a problem list and establishing a therapeutic relationship. stage two will include preparing for new activities with identification of pathways to activity and collaboration with community stakeholders. stage three will include engagement in new activities using behavioural experiments to promote social activity. this is the primary focus of in-person therapy sessions from week 8 to 15 alongside remote practice of the crt programme.

Eligibility criteria:
inclusion criteria: * aged between 18 and 60 years of age * within the first 5 years of a diagnosed psychotic disorder * community based and clinically stable * ability to give informed consent exclusion criteria: * history of organic impairment * iq\< 70 * history of head injury with loss of consciousness \> 5-minute duration

Keywords: recovery cognitive remediation training cognitive behavioural therapy psychosis
elaboration of a multi-dimensional indicator of quality in palliative care

Conditions: Terminal Illness; End of Life

Summary: the purpose of this study is to elaborate a multi-dimensional indicator of the quality in palliative care for patients of end-of-life. the study will, as secondary objectives: * elaborate in a standard manner one set of indicators of organization and inner working of a palliative care setting. * compare according to these indicators, the qualities of 3 types of palliative care: palliative care unit in hospitals, specified identified bed for palliative care patients and non-specified bed. * explore the relationship between organizational aspects and results in term of burden.

a multicentric study aims on quality of palliative care and will be conducted in three types of 7 palliative care settings: two hospices, two hospital-based palliative care units and three medical units where a mobile palliative care team intervenes.

Eligibility criteria:
inclusion criteria: * aged ≥ 18 years. * patient with serious progressive illness and in terminal phase (life expectancy \< 3 months): oms stage is 3 or 4, regardless of etiology. * patient informed their diagnosis or not. * hospitalized at the moment of inclusion in one of the following care settings: palliative care unit, identified bed or non-identified bed in a care department of short stay. * no-oppose to participate to the study, by patients, their families or trusted person. exclusion criteria: * patient has difficulties in reading, writing or understanding french language, also their family. * hospitalization in the palliative care setting \< 48 hours.

Keywords: palliative care quality indicator multi-dimensional
effect of empagliflozin + linagliptin + metformin + lifestyle in patients with prediabetes

Conditions: Prediabetic State; Insulin Resistance

Summary: type 2 diabetes is a worldwide epidemic disease, and preventive strategies are needed to face this health problem. the goal of this trial is to evaluate the effect of empagliflozin + linagliptin + metformin + lifestyle on physiopathological parameters, sush as glucose metabolism, insulin resistance, pancreatic beta cell function and cardiovascular function in patients with impaired fasting glucose plus impaired glucose tolerance, during 12 months

the main goal of this clinical trial is to compare the effect of two different treatments during 12 months: 1. lifestyle modification program + metformin 850 mg twice daily 2. lifestyle modification program empagliflozin (12.5 mg) + metformin (850 mg) once daily plus linagliptin (2.5 mg) + metformin (850 mg) once daily on the following parameters, after 12 months of treatment 1) glucose metabolism, evaluated by oral glucose tolerance test 2) insulin resistance evaluated by the oral glucose tolerance 3) insulin secretion, evaluated by the oral glucose tolerance 4) pancreatic beta cell function, evaluated by the oral glucose tolerance test 5) cardiovascular function, evaluated by standard echocardiography by left ventricular ejection fraction all the patients will have a basal evaluation with an oral glucose tolerance test, lipid profile and body composition measurement by dual energy x-ray absorptiometry (dexa). after the basal evaluation, if the patients results with impaired fasting glucose and impaired glucose tolerance, they will be invited to the intervention phase where they will be randomized to one of the two treatment groups. patients will have a follow-up visit every month to review the adherence to the lifestyle modification program and to the medication, and every 6 months an ogtt. after 12 months , patients will repeat the same evaluation performed at basal.

Eligibility criteria:
inclusion criteria: * patients with prediabetes, defined for the existence impaired glucose tolerance (glucose between 140 and 199 mg/dl at the 2 hours of the oral tolerance glucose test (ogtt) with impaired fasting glucose (fasting glucose between 100 and 125 mg/dl) * patients who accept to participate in the study and sign the informed consent letter. exclusion criteria: * patients with diagnosed type 2 diabetes previously or detected during the ogtt * patients in actual treatment or during the last 3 months with metformin, pioglitazone or another antidiabetic drug, including insulin * serum creatinine \> 1.6 mg/dl * hypertriglyceridemia very high (\>500 mg/dl) * pregnant women * altered arterial hypertension (systolic \>180 mmhg or diastolic \>105 mmhg) * excessive alcohol intake, acute or chronic * medications or medical conditions that affect glucose homeostasis (thiazides, beta blockers, glucocorticoids for systemic use, weight-reducing drugs or anorexigenics, cushing´s syndrome, thyrotoxicosis

Keywords: prediabetes
blood pressure during rate control in patients with tachycardic atrial fibrillation at the emergency department

Conditions: Atrial Fibrillation

Summary: the aim of this study is to analyse blood pressure during rate control therapy in patients with tachycardic atrial fibrillation in a real-world emergency cohort.

atrial fibrillation (af) is the primary clinical problem in 3.3% to 10.0 % emergency department (ed) admissions. rate control is an integral part of the management of symptomatic tachycardic af patients. according to the recent guidelines beta-blockers, digoxin, the calcium channel blockers diltiazem and verapamil, amiodarone or combination therapy should be considered for rate control. haemodynamic side-effects in particular hypotension may occur. heart rate and blood pressure behavior in an ed population during rate control therapy in patients with tachycardic atrial fibrillation will be analysed.

Eligibility criteria:
inclusion criteria: * age \> 18 years * atrial fibrillation or atrial flutter and heart rate ≥ 110 bpm * indication for rate control * informed consent exclusion criteria: • inclusion criteria not met
ct perfusion images in assessing treatment response in patients with pancreatic cancer

Conditions: Pancreatic Ductal Adenocarcinoma

Summary: this pilot clinical trial studies how well computed tomography (ct) perfusion images work in assessing treatment response in patients with pancreatic cancer. analyzing specific measurements on the ct perfusion images may help doctors better determine how a tumor responds to chemotherapy and/or radiation therapy and may help guide treatment for patients with pancreatic cancer.

outline: patients undergo ct perfusion sequence during the first 40 seconds of the baseline standard of care ct scan and during follow-up ct scans at 2 and possibly 4 months after chemotherapy, at 4-6 weeks after radiation therapy, or prior to definitive surgery. after completion of the study, patients are followed up periodically for 2 years.

Eligibility criteria:
inclusion criteria: * signed informed consent form * a diagnosis of pancreatic ductal adenocarcinoma exclusion criteria: * patients unable to provide informed consent * women who are pregnant or intending to become pregnant during the study * patients with body mass index greater than 40 kg/m\^2 * history of severe allergic-like reaction to iodinated contrast media
the acute effect of boxing on balance, neuropsychological, and visual functions

Conditions: Craniocerebral Trauma

Summary: prior research has investigated the effect of repetitive head trauma as it relates to physiological and psychological function. boxing is one particular sport which predisposes athletes to a large amount of head impacts. we plan to assess the effects of a boxing tournament on balance, neuropsychological, and visual functions.

this is a prospective, repeated measures cohort study, which is able to make within-subject (pre and post boxing tournament) comparisons on measures of physiologic and behavioral function. we plan to enroll boxing athletes who are participating in a boxing tournament. each individual will be assessed on the following tests: balance (dynamic and static balance), vestibular-ocular motor function, neuropsychological function, and symptoms. additionally, each boxing match will be video recorded and the total number of head impacts they sustain will be documented. * in order to prospectively assess how a boxing tournament affects balance, neuropsychological, and visual functions from pre-tournament assessments to post-tournament assessments (specific aim 1), we plan to test all athletes before competition at the pan-american games begins (pre-test) and after they have been eliminated from the tournament (post-test). * in order to measure the associations between the number of head blows sustained during a boxing tournament with balance, neuropsychological, visual, and symptom deficits, we will also use a video camera to record each match and count the total number of hits to the head.

Eligibility criteria:
inclusion criteria: 1. participation in boxing at a pre-specified tournament 2. medically cleared to participate in the tournament, as determined by the attending medical staff exclusion criteria: 1. any pre-existing neurological disorder, including but not limited to stroke, intracranial hemorrhage, any movement disorder, and cerebral palsy. 2. any currently active psychiatric condition, including specifically major depression, bipolar disorder or schizophrenia. a history of a psychiatric condition but no ongoing psychiatric episode (e.g. not currently undergoing treatment for a major depressive episode) would not be an exclusion. 3. any unstable medical condition

Keywords: brain concussion balance locomotion mild traumatic brain injury
home test of new sound processor

Conditions: Hearing Loss

Summary: the purpose of this clinical investigation is to test a new sound processor (sp) to compare hearing performance of the new sound processor with unaided hearing and baha 5 sp in adult subjects and to investigate which device (new sound processor versus baha 5) the subjects prefer.


Eligibility criteria:
inclusion criteria: * adult subject (18-\<70 years of age) * at least 12 months experience from using a baha connect system (percutaneous baha) * subject with a conductive or mild to moderate mixed hearing loss. that would benefit from improved hearing from bone conduction device as judged by the research audiologist * willing and able to provide written informed consent exclusion criteria: * signs of infection around the implant site * unable to follow investigational procedures * unable or unwilling to comply with the requirements of the clinical investigation as determined by the investigator * investigator site personnel directly affiliated with this investigation and/or their immediate families; immediate family is defined as a spouse, parent, child, or sibling. * cochlear employees * currently participating, or participated within the last 30 days, in another interventional clinical investigation/trial involving an investigational drug or device.

Keywords: conductive hearing loss mixed hearing loss
diagnostic reasoning and sense of alarm at dyspnoea and / or chest pain

Conditions: Chest Pain; Dyspnea

Summary: dyspnea and chest pain represent 1.5% of general practice consultations. they may be a sign of many diseases, potentially serious. the concept of gut feelings brings a sense of alarm and reinsurance. the sense of alarm reflects a sense of mistrust about the patient's clinical situation, in the absence of objective argument. the sense of reinsurance reflects a sense of confidence about the patient's situation, in the absence of objective argument. gut feelings plays a key role in the diagnostic reasoning in general practice. a questionnaire measuring the gut feelings was validated in french after a linguistic validation procedure.

dyspnea and chest pain represent 1.5% of general practice consultations. they may be a sign of many diseases, potentially serious. the concept of gut feelings brings a sense of alarm and reinsurance. the sense of alarm reflects a sense of mistrust about the patient's clinical situation, in the absence of objective argument. the sense of reinsurance reflects a sense of confidence about the patient's situation, in the absence of objective argument. gut feelings plays a key role in the diagnostic reasoning in general practice. a questionnaire measuring the gut feelings was validated in french after a linguistic validation procedure. the objective of the research is to calculate the precision of the sense of alarm the general practitioner facing a consultant for chest pain or dyspnea and patient

Eligibility criteria:
inclusion criteria: * patients between 18 and 80 years * patients consulting on primary care for chest pain or dyspnea

Keywords: primary care chest pain dyspnea
hyperglycemia and cardiovascular outcomes with type 2 diabetes

Conditions: Diabetes Mellitus, Type 2; Acute Myocardial Infarction

Summary: the primary objective was to demonstrate a difference between two insulin strategies, one targeting postprandial (pp) hyperglycemia and the other targeting fasting and interprandial hyperglycemia, on time until the first combined adjudicated cardiovascular (cv) event (primary outcome defined as cv death, nonfatal myocardial infarction \[mi\], nonfatal stroke, coronary revascularization, or hospitalized acute coronary syndrome).

the purpose of this study is to evaluate the effect of two different treatment strategies on cv outcomes in patients with type 2 diabetes while aiming to achieve and maintain hba1c \<7.0% in both groups. only patients who have recently experienced an acute mi will be considered for participation in this trial.

Eligibility criteria:
inclusion criteria: * are at least 30 years old * have had type 2 diabetes for at least 3 months prior to visit 1 * were admitted to the coronary care unit (ccu) within 18 days prior to visit 1 for an acute mi * are capable and willing to do specified study procedures * have given informed consent to participate in the study in accordance with local regulations exclusion criteria: * were on one of the following therapies prior to admission to the ccu for the recent mi: a)diet therapy only and have glycosylated hemoglobin (hba1c) \<1.15 times the upper limit of normal or b) an intensive basal/bolus insulin regimen * are using any oral antihyperglycemic medication at the time of visit 2 and are unwilling to stop the use of such medication for the duration of the study * have substantial myocardial damage, which would significantly outweigh the potential benefit of the treatment strategies for diabetes * have the most severe form of congestive heart failure * have liver disease so severe that it precludes the patient from following and completing the protocol

Keywords: diabetes mi heart attack
incidence of postoperative neuromuscular blockade in post-anesthesia care unit at parkland hospital: does size matter?

Conditions: Residual Neuromuscular Blockade

Summary: this prospective, observational study will assess 100 subjects in the post-anesthesia care unit (pacu) at parkland hospital. upon arrival to the pacu, patients' train-of-four (tof) ratio will be calculated using the stimpod nms450 accelerometer to determine the presence of any residual paralysis. any patient with a tof ratio \< 0.9 will be reassessed every 10 minutes until the ratio is ≥0.90. the time it takes to reach a tof ratio ≥0.9 will be recorded. subjects will be classified according to bmi categories: lean as \<30 kg/m2, obese as 30≤bmi≤39.9 kg/m2, and morbidly obese as bmi ≥40 kg/m2. this data will serve as a baseline to assess the incidence of residual nmb that currently occurs in our pacu so that we may use this pilot data to design future studies that aim to reduce the incidence of residual nmb.

upon arrival to the pacu, patients enrolled in the study will be evaluated for residual paralysis with train-of-four (tof) stimulation using the stimpod nms450 accelerometer set to 30 ma. any patients who have residual paralysis will be assessed q10 minutes until the tof ratio is ≥0.9. the time to achieve a tof ratio ≥0.9 will be recorded. any adverse events (e.g., hypoxia, reintubation, aspiration) that arise during the patient's pacu stay will be documented.

Eligibility criteria:
inclusion criteria: * 18-80 years old * undergoing non-emergent surgery with general endotracheal anesthesia * asa physical status classification 1 to 4 * willing and able to consent in english or spanish * no personal history of neuromuscular disease exclusion criteria: * age less than 18 or older than 80 * patient does not speak english or spanish * planned postoperative intubation or icu admission * allergy to sugammadex, neostigmine, glycopyrrolate, or rocuronium * family or personal history of malignant hyperthermia * patient refusal * monitored anesthesia care (mac) or regional anesthesia planned * pregnant or nursing women * "stat" (emergent) cases * estimated creatinine clearance \<30 ml/min * pre-existing muscle weakness of any etiology
comparison of efficacy and safety of paricalcitol injection with maxacalcitol injection in adult japanese chronic kidney disease subjects receiving hemodialysis with secondary hyperparathyroidism

Conditions: Secondary Hyperparathyroidism; Hemodialysis

Summary: this study is a comparison of the efficacy and safety of paricalcitol injection with maxacalcitol injection in adult japanese chronic kidney disease patients receiving hemodialysis with secondary hyperparathyroidism. the main objective of this study is to demonstrate the efficacy of paricalcitol injection in reducing levels of parathyroid hormone without clinically significant hypercalcemia, compared to maxacalcitol injection.


Eligibility criteria:
inclusion criteria: * adult chronic kidney disease (ckd) stage 5 patients undergoing dialysis with stable dialysate calcium and phosphate binders * on three times weekly hemodialysis for at least 3 months prior with intact parathyroid hormone (ipth) greater than or equal to 300 pg/ml, adjusted normalized serum total calcium (ca) greater than or equal to 8.4 to less than 10.2 mg/dl, serum phosphorus (p) less than or equal to 6.5 mg/dl. exclusion criteria: * patients with a recent history of severe cardiovascular or hepatic disease, uncontrolled hypertension or uncontrolled diabetes * patients who have received a parathyroidectomy or ethanol infusion within the prior year * patients taking drugs that affect ipth, calcium or bone metabolism * patients who will need to take chronic doses (greater than or equal to 2 consecutive weeks) of cytochrome p450 inhibitors (e.g., clarithromycin, grapefruit products) or inducers (e.g., carbamazepine, rifampicin) * female patients who are pregnant, possibly pregnant, wish to become pregnant, or participate in breastfeeding during the study period.

Keywords: secondary hyperparathyroidism paricalcitol hemodialysis maxacalcitol