Kornimate/medical-research-clean huggingface dataset:
therapap equivalence crossover study

Conditions: Obstructive Sleep Apnea

Summary: the present study, theraequivalence, is a phase 2 crossover study designed to examine the efficacy and safety of therapap (tpap) vs. cpap alone in the treatment of osa.

the theraequivalence study is a randomized, controlled, crossover study in participants with osa. a split-night polysomnogram (psg) will be conducted on cpap and tpap (3.5 h each treatment arm) in previously diagnosed osa patients, to test the effectiveness of tpap vs. cpap. the sequence of periods for each participant are assigned in random order. therapeutic cpap level will be defined based on each individual's pressure levels from their currently used apap device deemed to eliminate breathing obstructions for at least 90/95% of the sleep period (p90/p95) + 1 cmh2o (cm of water pressure). p90/p95 will be defined based on the previous 2 months of adherent auto-adjusted positive airway pressure (apap) usage (defined as averaging \> 5 hrs/night). on tpap tthe pressure drop during inspiration is generally done in two steps and varies, as outlined in table 1, based on the set pressure level, with larger drops occurring when the set pressure is higher. however, the pressure never goes below 5 cm h20. this lower pressure is returned to the set pressure level about halfway through expiration. these pressure drops are designed to make tpap considerably more comfortable than cpap.

Eligibility criteria:
inclusion criteria: 1. ahi \> 10 on a previous psg. 2. cpap adherence for an average of 5 h/night in the 2 months before the study 3. bmi above 18 kg/m2, inclusive. exclusion criteria: 1. current clinically significant sleep disorder other than osa of a severity that would interfere with study participation or interpretability of data (including central sleep apnea, per central ahi \> 5 events/h). 2. current clinically unstable cardiac disease (e.g., rhythm disturbances, coronary artery disease or cardiac failure) or poorly controlled hypertension (\>140/90mmhg). 3. current clinically significant neurological disorder, including epilepsy/convulsions. 4. other serious major organ system disease including renal failure, lung disease, neuromuscular disease, or liver disease. 5. schizophrenia, schizoaffective disorder or bipolar disorder according to diagnostic and statistical manual of mental disorders-5 (dsm 5) or international classification of disease tenth edition criteria. 6. attempted suicide within 1 year prior to screening, or current suicidal ideation. 7. history of substance use disorder as defined in dsm-v within 24 months prior to screening visit. 8. a serious illness or infection in the past 30 days as determined by investigator. 9. clinically significant cognitive dysfunction as determined by investigator. 10. chronic oxygen therapy. 11. patients with hypoglossal nerve stimulation implant. 12. any non-previously mentioned vulnerable population. 13. any condition that in the investigator's opinion would present an unreasonable risk to the participant, or which would interfere with their participation in the study or confound study interpretation.
mild hypothermia for covid-19 ards

Conditions: COVID19 ARDS

Summary: some patients with covid have abnormally high carbon dioxide and low oxygen levels despite being on the ventilator. the hypothesis of the study is that the application of mild hypothermia to patients with covid will decrease their metabolic rate and improve their oxygenation and carbon dioxide levels.

a significant contributor to the morbidity and mortality from covid-19 is from the abnormal carbon dioxide and oxygen levels in covid-19 patients. metabolic studies done on covid-19 patients have shown that these patients have abnormally high metabolic rates. high metabolic rates results in increased carbon dioxide production and increased oxygen usage, both of which can result in high carbon dioxide and low oxygen levels. as some patients with severe covid-19 continue to have high carbon dioxide levels and/or low oxygen levels despite being on the ventilator, it is hypothesized that decreasing the metabolic rate in these covid-19 patients will help their oxygen and carbon dioxide levels. mild hypothermia is currently used in comatose survivors of cardiac arrest to improve mortality and neurological outcomes. mild hypothermia is also an effective way to reduce metabolic demand. the aim is to apply mild hypothermia to covid-19 patients to decrease metabolic rate in order to improve their oxygen and carbon dioxide levels. although the application for mild hypothermia has been widely adopted in some patient populations, it has never been applied in covid-19 patients. if we can develop a strategy to help improve the oxygen and carbon dioxide levels in covid-19 patients, it may lead to improvements in their overall outcomes.

Eligibility criteria:
inclusion criteria: 1. provision of signed and dated informed consent form from legally authorized representative. 2. stated willingness to comply with all study procedures and availability for the duration of the study 3. male or female, aged 18 years or above 4. covid positive 5. on mechanical ventilation with either: refractory respiratory acidosis (ph ≤ 7.20), hypercarbia (pco2 ≥ 55 mmhg), refractory hypoxia (po2/fio2 \ 30 exclusion criteria: 1. bleeding (active bleeding, platelets less than 50,000) 2. uncontrolled cardiac arrhythmia 3. history of cryoglobulinemia, major trauma, pregnancy 4. active non-covid-19 infection that is not controlled with antibiotic or antifungal regimen
chf-cov reduced (chronic heart failure with reduced ejection fraction - congestion evaluation)

Conditions: Chronic Heart Failure; Reduced Ventricular Ejection Fraction

Summary: heart failure (hf) is a significant cause of death and the leading cause of hospitalization in patients over 65 years of age. congestion is the main source of symptoms and the leading cause of hospitalization for hf. furthermore, congestive signs identified in asymptomatic patients are associated with the risk of developing symptomatic hf. the literature supports a multi-modality / integrative evaluation of congestion, combining clinical examination, laboratory results and ultrasound evaluation. the main objective of the chf-covreduced study is to identify congestion markers (clinical, biological and ultrasound) quantified during a consultation or day hospitalization for the monitoring of chronic hf with reduced left ventricular ejection fraction that are associated with the risk of all-cause death, hospitalization for acute hf or iv diuretics injection in a day hospital.


Eligibility criteria:
inclusion criteria: * patients with chronic acute heart failure with reduced ventricular ejection fraction admitted in hospital for scheduled day hospitalization or in consultation * patient with altered (left ventricular ejection fraction \<40%) and moderately altered (left ventricular ejection fraction between 40 and 50%) left ventricular ejection fraction * age ≥18 years * patients having received complete information regarding the study design and having signed their informed consent form. * patient affiliated to or beneficiary of a social security scheme. exclusion criteria: * comorbidity for which the life expectancy is ≤ 3 months * dialysis patient (peritoneal dialysis or hemodialysis) or patients with glomerular filtration rate \<15 ml/min/m2 at inclusion. * history of lobectomy or pneumonectomy lung surgery * severe pulmonary or pleural pathology preventing reliable acquisition of lung ultrasound images: severe emphysema, chronic pleurisy, pulmonary fibrosis, etc. * pregnant woman, parturient or nursing mother * adult person subject to a legal protection measure (guardianship, curatorship, safeguard of justice) * adult person who is unable to give consent * person deprived of liberty by a judicial or administrative decision, * person subject to psychiatric care pursuant to articles l. 3212-1 and l. 3213-1 of the public health code.
rates of pertussis disease among persons receiving pentacel® or other pertussis vaccines

Conditions: Pertussis

Summary: the purpose of this cohort study is to determine vaccine-specific rates of pertussis disease during the period of the study, among wisconsin residents younger than 60 months of age (the surveillance population), and to descriptively compare the proportion of such persons vaccinated with pentacel® vaccine who acquire pertussis disease to the proportion of such persons vaccinated with any other diphtheria and tetanus toxoids and acellular pertussis (dtap) vaccine who acquire pertussis disease. primary objective: to determine the rates and relative risk of pertussis disease among surveillance population members who have received pentacel vaccine or another pertussis vaccine.

the study will be conducted by the university of wisconsin school of medicine and public health, in collaboration with the wisconsin division of public health (wdph). epidemiological and laboratory surveillance for pertussis disease among wisconsin residents is routinely conducted by the wdph. during the period of the study, de-identified data regarding all incident pertussis cases will be obtained from wdph and vaccination coverage rates, by vaccine regimen, age group, and period of time, will be obtained from ongoing marketplace surveillance conducted on behalf of the sponsor by a national sample-survey organization. using these data, rates of pertussis disease will be determined. no vaccine will be administered as part of this study.

Eligibility criteria:
inclusion criteria : * persons will be under surveillance for this study whenever the following three conditions are true: the individual resides in wisconsin, is age birth through 59 months, and is within the surveillance period of 01 october 2009 through 30 september 2014 (or as extended in order to accrue 61,761 person years of pentacel vaccine exposure). exclusion criteria : * not applicable

Keywords: pertussis whooping cough pertussis vaccine
mindfulness based stress reduction for parkinson's disease: a longitudinal study

Conditions: Parkinson's Disease; Mindfulness Based Stress Reduction; Quality of Life

Summary: to investigate the efficacy of mindfulness-based stress reduction (mbsr),to improve hrqol, cognition, and mood, as well as to determine the longevity of the treatment response in individuals with parkinson's disease (pd).

eligible study participants will be randomly assigned to one of two interventions: 1) mindfulness based stress reduction for parkinson's disease; mbsr-pd or 2) creative education care (cec). study visits may be held remotely, via online video format (webex). interventions are held within a group format consisting of approximately 6-10 individuals with pd. groups will meet once per week for over a 9-week period. all participants will be administered a battery of neuropsychological tests to measure hrqol, cognition (e.g., executive function, attention, memory), and mood (i.e., anxiety, depression, and apathy), as well as motor symptoms, disease severity, and mindfulness engagement/practice. tests will be administered at baseline, 9 weeks (post-treatment), and 6- and 12-months (follow-up assessments) by an examiner blinded to group assignment.

Eligibility criteria:
inclusion criteria: 1. clinical diagnosis of pd based on uk brain bank criteria 2. \>40 years of age exclusion criteria: 1. secondary causes of parkinsonism (e.g. corticobasal degeneration, progressive supranuclear palsy, drug-induced parkinsonism) 2. other neurological conditions (e.g. stroke) 3. clinical diagnosis of dementia based on any previous neuropsychological testing 4. psychosis, antipsychotic treatment or treatment for substance abuse 5. uncorrected vision or hearing to adequately participate in the intervention 6. prior formal training in mbsr or regular current mbsr practice 7. recent or new participation in a psychological/behavioral treatment, such as cognitive behavioral therapy (cbt) 8. active/current suicidal ideation

Keywords: mindfulness parkinson's disease intervention
evaluation of medivr-kagura guided therapy

Conditions: Physical Disability; Cognitive Dysfunction

Summary: the objective is to evaluate medivr-kagura guided therapy for the treatments of physical and cognitive dysfunctions regardless of baseline disease in a prospective interventional design.

the patients sit on an upright chair, wear a head-mounted display (hmd) and grab two handheld controllers in a motion-tracked three-dimensional space called "room scale" of the medivr-kagura (medivr, inc. toyonaka city, osaka, japan). medivr-kagura can provide users with \>90 frames per second (fps) graphic operation with an approximately 110° viewing angle and accurate three-dimensional tracking technology. first, we evaluate conventional and maximum reaching distances at 0°, 45°, and 90° level surface for the left hand (0l, 45l, 90l) and at 90°, 135°, and 180° level surface for the right hand (90r, 135r, or 180r) for calibration in a sitting position. during rehabilitation, patients are instructed to touch a fixed objects or catch a falling objects at the pre-specified height and distance levels in each degree. horizontal distances were classified into three categories, namely long, middle, and short which were calculated using the following formulas: 0.9 \* maximum reaching distance, 0.9 \* (conventional + maximum reaching distances)/2, and conventional reaching distance respectively. a falling object disappeared at a 20 cm height for safety if the patients missed to catch it. the purpose of reaching hands was to stimulate and break down body trunk balance, and to train participants to balance for stable walking. by thinking about the timing and distance and recognizing the next targets repeatedly, cognitive function was simultaneously stimulated for dual-task training. the 7 parameters of the rehabilitation programs can be set like as follows: (1) distance (short, middle or long), (2) direction (0l, 45l, 90l, 90r, 135r, or 180r), (3) height of object, (4) size of object (center or outline), (5) size of sensing sphere of the controller, (6) falling speed of the square box (from 0 to 300 cm/s), and (7) intervals for each task. participants first underwent practical programs to familiarize themselves with medivr-kagura guided rehabilitation, followed by rehabilitation programs. provision of the rehabilitation programs will be personalized.

Eligibility criteria:
inclusion criteria: 1. patients with physical and/or cognitive dysfunctions 2. agreed to the participation of this study with written informed consent by themselves or guardians exclusion criteria: 1. inappropriate candidates at attending physician's discretion

Keywords: virtual reality physical cognitive
simultaneous islet-kidney transplantation in patients of type 1 diabetes with end-stage renal disease

Conditions: Type 1 Diabetes Mellitus; End-stage Renal Disease

Summary: the aim of this study was to evaluate the efficiency and safety of simultaneous islet-kidney transplantation in patients of type 1 diabetes with end-stage renal disease using a glucocorticoid-free immunosuppressive regimen with alemtuzumab induction. islet transplantation can result in insulin independence with excellent metabolic control when glucocorticoid-free immunosuppression is combined with the infusion of an adequate islet mass. alemtuzumab (campath-1h ®) is a 150-kda humanized igg1 monoclonal antibody that targets the cd52 antigen. prolonged lymphocyte depletion can be expected following alemtuzumab treatment.


Eligibility criteria:
inclusion criteria: * male and female patients age 18 to 60 years of age. * ability to provide written informed consent. * clinical history compatible with type 1 diabetes (t1dm) as defined by the who guidelines(1999) on the diagnosis and classification of diabetes mellitus. * manifest signs and symptoms that are severe enough to be incapacitating. * basal c-peptide\<0.5ng/ml * patients with poor diabetes control (hba1c \>7% but \<12%) * progressive diabetic complications. * end-stage renal disease(serum creatinine\>450μmol/l) exclusion criteria: * age \ 60 years * diabetic history \<5 years * bmi\>27 * body weight \>80kg * exogenous insulin requirement \>1 unit/kg/day * severe anemia (male \<8g/dl, female \<7g/dl) * low white blood cell count (\<3000/dl) * liver dysfunction * symptomatic peptic ulcer disease * any malignancy * active infection including hepatitis b, hepatitis c, hiv, or tb * panel reactive antibody \>20% * any medical condition that, in the opinion of the investigator, will interfere with the safe completion of the trial.

Keywords: islets of langerhans transplantation kidney transplantation type 1 diabetes mellitus alemtuzumab
neurobehavioral outcomes and quality of life in pediatric patients with brain or head/neck tumors receiving proton or photon radiotherapy

Conditions: Brain Tumor

Summary: background: neurobehavioral functions and quality of life (qol) are the important outcome measurements after radiotherapy in patients with brain tumors and even head/neck cancers. however, few studies have focused on neurobehavioral functions and qol after anti-cancer treatment particularly brain radiotherapy for pediatric/adolescent patients with brain tumors. this study thus aims to prospectively evaluate those functions in pediatric or adolescent patients with brain or head/neck tumors in order to provide useful information about their clinical outcomes. methods: a total of 72 pediatric/adolescent patients, who are diagnosed with brain tumors or head/neck cancers, were prospectively recruited. neurobehavioral functions will be evaluated using a neuropsychological battery, which includes general cognitive functions, intelligence, memory, executive functions, information processing and emotional/behavioral expressions. the qol will be evaluated by the health-related qol questionnaire. all participants will be examined at six phases, which include pre-treatment, 1-month post-treatment, 4-month post-treatment, 1-year post-treatment, 2-year post-treatment and 3-year post-treatment. expected results: patients'neurobehavioral functions and qol will show significant improvement after treatment, and the improvement will not be diminished across each post-treatment phase.


Eligibility criteria:
inclusion criteria: * pediatric patients diagnosed with brain tumors or head/neck cancers who are no older than 18 years old * patients should be considered indicated for receiving the subsequent course of local radiotherapy exclusion criteria: * patients who received radiotherapy once before * patients have visual and/or hearing impairments which obviously impede the administration of neurocognitive assessment * patients cannot underwent brain mri examination because of clinical contraindications, such as renal insufficiency (gfr \<30)

Keywords: pediatric brain tumors radiation therapy neurobehavioral functions proton radiotherapy
different regimens in influenza postexposure chemoprophylaxis in children

Conditions: Influenza; Exposure; Prevention

Summary: although the vaccination is the preferred method of influenza prevention, there are some occasions on which a postexposure prophylaxis (pep) is required. two neuraminidase inhibitors (nais) may be used in chemoprophylaxis in children: oral oseltamivir, and inhaled zanamivir. both, oseltamivir and zanamivir, are effective in treatment and in prophylaxis of influenza, and the efficacy is calculated to reach 70-90%. oseltamivir is used more frequently, since zanamivir is licensed in older children (5 years of age and above), and children under the age of 5 years are at higher risk of influenza complications. oseltamivir use correlated in children with higher risk of vomiting, with no increased risk of other adverse events, including those observed in adult patients (nausea, renal events, and psychiatric effects). the pep may be indicated by individual patient's characteristics (e.g. patients in high-risk group) or epidemiological reasons, i.e. prevention of institutional outbreaks.the one research that analyzed efficacy of 3-days pep versus 7 or 10-days and showed overall efficacy of shorter oseltamivir prophylaxis to be high and comparable to that of longer regimens. the study included several pediatric patients and made the investigators perform such an analysis in pediatric population. in this randomized controlled trial, the investigators aimed to compare efficacy, safety, and costs of 3 versus 7-days prophylaxis with oral oseltamivir in children hospitalized. the hypothesis is that 3-days duration of pep is not less effective than 7-days pep, and patients might gain from lower number of adverse reactions related to drug administration.

only applies to patients hospitalized due to other than influenza reasons. if a proven contact with influenza has taken place (influenza diagnosed by signs/symptoms and positive rapid influenza diagnostic test and/or pcr), a patient may be enrolled.

Eligibility criteria:
inclusion criteria: * patients hospitalized at the pediatric ward * age: 0-18 years old * confirmed contact with a person diagnosed with influenza * patient's, patient's parent/tutor's informed consent exclusion criteria: * lack of an informed consent * more than 48 hours after the first contact with influenza * severe adverse reaction to the drug- discontinuation of the prophylaxis * important to a parent/tutor drug intolerance (e.g. lack of tolerance of a drug's taste) * new contact with influenza after chemoprophylaxis has finished

Keywords: influenza chemoprevention oseltamivir child infant
deep sedation instead of general anaesthesia in percutaneous mitral valve repair using the mitraclip® system

Conditions: Mitral Regurgitation; Local Anaesthesia; Percutaneous Repair

Summary: percutaneous mitral valve repair (pmvr) with the mitraclip® system has emerged as a therapeutic alternative to surgical valve repair in patients who are at high risk and unsuitable for surgery. the pmvr procedure is typically performed under general anaesthesia, but the mitraclip® is also feasible in deep sedation. the aim of this study is to investigate the safety of deep sedation in patients undergoing the pmvr procedure and to evaluate how deep sedation in comparison to general anaesthesia influences procedural time and in-hospital stay.

percutaneous mitral valve repair (pmvr) with the mitraclip® system has emerged as a therapeutic alternative to surgical valve repair in patients who are at high risk and unsuitable for surgery. the pmvr procedure, however, is typically performed under general anaesthesia. it has recently been shown in a first approach that performing the mitraclip® in deep sedation is feasible; however safety parameters and a direct comparison to general anaesthesia are still missing the aim of this study is to investigate the safety of deep sedation in patients undergoing the pmvr procedure and to evaluate how deep sedation in comparison to general anaesthesia influences procedural time and in-hospital stay.

Eligibility criteria:
inclusion criteria: * severe mitral regurgitation * pmvr using the mitraclip® system exclusion criteria: -

Keywords: mitral regurgitation local anaesthesia percutaneous repair