Kornimate/medical-research-clean huggingface dataset:
music's effects on premature babies.

Conditions: Stress; Sleep

Summary: this project is being done in order to determine if the music of mozart will have a soothing effect on premature infants while in the neonatal intensive care unit (nicu). the primary effect to be anticipated will be a reduction in heart rate from baseline, decreased motor activity from baseline, as well as an increase of time in which the babies are in quiet sleep states while the music is being played. upon admission, all infants in the nicu are placed on monitors that continuously track their heart rate, respiratory rate, and oxygen saturation. during our study, data will be collected from the monitors already in use. total time of observation will be approximately 3 hours. in addition, a monitoring device called an actiwatch will also be used. this device looks similar to a traditional wristwatch and will be loosely strapped to the ankle or wrist of each infant using a foam and velcro strap. this device continuously monitors the baby's movements allowing us to determine if there is a change in the baby's activity level while the music is being played. it will record the baby's activity prior to the start of the music and will continue until 30 minutes after the music has stopped. the music of mozart will be played using a small speaker in the baby's isolette. the volume of the music will be set at 10 decibels over background noise, which on previous measurement has been found to be approximately 55 decibels (about the same as a running refrigerator or as the sound of rainfall; 60 decibels is the volume of normal conversation). the volume in the crib will be continuously monitored throughout the hour. as a final recording device, we will also intermittently be using video to capture the reactions of these infants to the music. the study will be done once a week per infant on the same day and at the same time every week


Eligibility criteria:
inclusion criteria: * all infants born at 28 weeks gestation or who are at least 28 weeks corrected age are eligible to participate. only those in isolettes (incubators) will be included. once a baby has been transitioned to a bassinet or crib, the baby will be pulled from the study. in order to be included, these infants must be in stable condition (without serious active medical issues) as decided by their doctor and must be breathing without the use of a ventilator. exclusion criteria: * exclusion criteria will include a history of intraventricular hemorrhage involving the white matter (as diagnosed by head ultrasound), as well as those infants born with severe congenital deformities.
the impact of myasthenia gravis in the real world

Conditions: Myasthenia Gravis

Summary: an international, non-interventional, prospective, community recruited, longitudinal, lifestyle study which aims to collect real-world evidence (rwe) from people living with myasthenia gravis (mg) in order to map the disease's natural history, its burden on patients and their families, its treatment, as well as its medical, social and pharmacoeconomic impact.

data was collected from people with mg using the myrealworld™ rwe platform , developed by the healthcare digital research company, vitaccess. participants downloaded a 'bring your own device' (byod) study app, myrealworld™ mg, onto their smartphones, which they used to enter data and complete surveys about their mg.

Eligibility criteria:
inclusion criteria: * adults (aged 18 years and over) with any stage and any subtype of myasthenia gravis disease * resident in belgium, canada, france, germany, italy, japan, spain, the uk, the usa, or denmark exclusion criteria: * no specific exclusion criteria

Keywords: myasthenia gravis disease neuromuscular diseases neuromuscular junction diseases nervous system diseases autoimmune diseases autoimmune diseases of the nervous system ocular myasthenia gravis generalized myasthenia gravis myasthenia gravis, generalized
an open-label follow-on trial to assess the long-term safety and efficacy of oral spm 927 in subjects with postherpetic neuralgia (phn)

Conditions: Postherpetic Neuralgia

Summary: this trial was the follow-on trial to a preceeding double-blind, placebo controlled trial which included patients with at least moderate pain due to postherpetic neuralgia. it was conducted at six sites in germany and has been clinically finalized. the patients had successfully completed the above mentioned trial in postherpetic neuralgia and, in the investigator's opinion, would benefit from long-term administration of lacosamide. after a 1-week run-in phase the patients were uptitrated to their optimal dose and then continued into the maintenance phase. dose adjustments were allowed throughout the trial.the change in pain was measured daily as well as interference of pain with sleep and general activity. as per protocol this trial was terminated after two years of treatment.


Eligibility criteria:
inclusion criteria: * postherpetic neuralgia exclusion criteria: * does not benefit from long term treatment
free study - fracture reduction evaluation

Conditions: Osteopenia; Osteoporosis; Multiple Myeloma; Bone Neoplasms

Summary: the primary objective of this study is to compare the effectiveness of standard medical therapy alone to kyphoplasty using the kyphx system for the treatment of acute vertebral body compression fractures.


Eligibility criteria:
inclusion criteria: * minimum of one painful, acute (edema present on mri obtained within a two weeks period prior to enrolment) thoracic or lumbar (t5-l5) vertebral body compression fracture, due to osteopenia arising from primary or secondary osteoporosis, multiple myeloma, or osteolytic metastatic tumors and maximum of three painful fractures requiring treatment. (note: a t2-weighted mri should be done unless it is not available); * minimum of one acute fracture to be treated that has height loss \> 15% of predicted height (average height of two adjacent "normal" vertebrae) when measured at the middle of the vertebral endplate. (note: if the adjacent vertebrae are not normal, the predicted height will be based on the height listed for the fractured vertebra in the table taken from black et al.) * pre-treatment vas score \> 4 on a scale of 10 where 0 is no pain, 5 is moderate pain and 10 is pain "as bad as you can imagine"; * patient 21 years of age or older; * the investigator and surgeon/radiologist agree before randomization that the fracture(s) can technically be reduced using an inflatable bone tamp (ibt); and * a signed informed consent is obtained from the patient. exclusion criteria: * previous vertebroplasty; * vertebral body fracture morphology prevents use of devices (such as endplate below pedicles); * pedicle fractures; * acute fracture(s) to be treated symptomatic \> 3 months at enrollment; * pre-existing (not the result of the index fracture) neurological deficit or radicular pain that is not well defined or unstable; * spinal cord compression or canal compromise requiring decompression; * disabling back pain secondary to causes other than acute fracture; * vertebral fracture due to primary or osteoblastic tumors; * patient is currently on anticoagulation therapy that can not be interrupted; * pre-existing conditions contrary to the kyphoplasty procedure: * systemic infection * local fractured vertebral body infection * temporarily non-reversible bleeding disorder * known allergy to any of the drugs, bone void filler material or contrast medium used in the treatment of study subjects * dementia and/or inability to give informed consent; * inability to walk or stand prior to the vertebral body fracture (walking aids are allowed); * mri contraindication (e.g. cerebral aneurysm clips, pacemaker, implanted biostimulators, cochlear implants, penile prosthesis); * pregnancy * participation in any other clinical trial within the last 30 days.

Keywords: osteopenia osteoporosis multiple myeloma osteolytic metastatic tumors vertebral compression fracture back pain spine
naloxone for optimizing hypoxemia of lung donors

Conditions: Brain Death; Organ Donors; Lung Transplantation

Summary: brain-dead patients who provide authorization for organ donation will be randomized to naloxone or placebo if baseline arterial blood gas (abg) after initiation of opo (organ procurement organization) management reveals hypoxemia, as defined by the ratio of partial pressure of oxygen in arterial blood (pao2) to fraction of inspired oxygen (fio2) below 300 mm hg, unless they have already been ruled-out for lung recovery. investigators aim to assess whether naloxone improves oxygenation prior to organ recovery more than placebo.

naloxone has been used by many opos for decades to improve the pulmonary status of brain-dead organ donors (based on anecdotal evidence and small uncontrolled studies). its efficacy in this population has never been assessed in a controlled clinical trial. the rationale for its use appears to be that it blocks the increase in capillary permeability that occurs with herniation and brain death (as demonstrated in a single sheep study of herniation). investigators aim to rigorously test this hypothesis in a randomized placebo-controlled trial in brain-dead organ donors who have baseline hypoxemia. the primary outcome will be the acute change in oxygenation (on first follow-up abg after naloxone as well as the final abg prior to organ recovery). investigators will also assess whether treatment results in more lungs being recovered and transplanted, after correcting for baseline variables such as age, blood group, smoking history, and cause of death. this study will be performed under the auspices of the organ donation research consortium and be carried out by multiple opos across the country. naloxone or blinded placebo (identical syringe filled with saline) will be given after the baseline abg shows hypoxemia (pfr - pao2 divided by fio2, on positive end-expiratory pressure \[peep\] of 5 and usually 100% fio2). naloxone and placebo will both be co-administered with a neuromuscular blocking agent (e.g. vecuronium, per center protocol) to obviate any increase in spinal reflex movements that may be potentiated by naloxone treatment. all other protocols for organ donor management should be maintained at each opo and no other study interventions are required. transplant centers will be informed (through donornet) that the organ donor being considered for lung recovery has been enrolled in this blinded clinical trial.

Eligibility criteria:
inclusion criteria: * brain-dead organ donor being managed by opo (organ procurement organization) * lungs being considered for recovery and transplant * baseline abg (after authorization) with p/f ratio \< 300 exclusion criteria: * no authorization for research * lungs already excluded for transplant (e.g. known chronic obstructive pulmonary disease \[copd\], human immunodeficiency virus \[hiv\] infection)
pet-ct-based study of central mechanisms of cortical metabolism in 18f-fdg and 18f-av1451 age-related deafness

Conditions: Age-related Hearing Loss; PET-CT

Summary: the participants were recruited from elderly subjects in the age range of 60-85 years and audiological assessments, cognitive function assessments, non-invasive brain imaging, behavioral assessments were collected from the normal control group, the elderly deaf non-hearing group and the elderly deaf hearing group according to the inclusion and exclusion criteria. the project aims to investigate the differences in auditory speech and cognitive function in age-related deafness at the behavioural level, and to investigate the central cortical metabolic mechanisms in age-related deafness at the brain imaging level.

the participants were recruited from elderly subjects in the age range of 60-85 years and audiological assessments (pure tone audiometry, speech audiometry), cognitive function assessments (simple mental state examination mmse scale, montreal cognitive assessment scale moca scale), non-invasive brain imaging (functional near-infrared spectroscopy fnirs, eeg/erp), behavioral assessments (functional near-infrared spectroscopy fnirs, eeg/erp, pet/ct, etc.) were collected from the normal control group, the elderly deaf non-hearing group and the elderly deaf hearing group according to the inclusion and exclusion criteria. the project aims to investigate the differences in auditory speech and cognitive function in age-related deafness at the behavioural level, and to investigate the central cortical metabolic mechanisms in age-related deafness at the brain imaging level.

Eligibility criteria:
inclusion criteria: * age\>50yrs，≤85yrs； * normal control group: normal hearing, no mci, i.e. mean air conduction hearing threshold (0.5, 1, 2, 4 khz) \< 25 db hl, no air-bone conduction difference, mmse score of 27-30; moca (corrected for educational attainment) score of 26-30; * elderly deafness without hearing aid group: patients diagnosed with elderly deafness, i.e. as a symmetrical, slowly progressive, binaural occurrence with age. hearing loss and reduced speech recognition with predominantly high frequency hearing involvement in the first place, with reference to the expert consensus on the diagnosis and intervention of hearing loss in the elderly 2019 edition, mean air conduction threshold (pta) \> 25 db hl, mean air conduction hearing threshold at high frequency (hf-pta) \> 25 db hl, no poor air bone conduction, and no previous hearing aid use. * no major neurological disorders, serious systemic diseases, family history of genetic predisposition, major psychological disorders. exclusion criteria: * pure tone audiometric cues with an average pure tone hearing threshold (500hz, 1khz, 2khz, 4khz) \> 91db hl. * excluding diseases such as noise deafness and drug-induced deafness. * basic information is incomplete.

Keywords: pet-ct age-related hearing loss 18f-fdg 18f-av1451 cortical metabolism
drug-drug interaction study of evobrutinib with midazolam in healthy participants

Conditions: Healthy

Summary: the study will investigate the effect of single dose and multiple doses of m2951 on midazolam pharmacokinetics (pk) in healthy participants.


Eligibility criteria:
inclusion criteria: * participants are overtly healthy as determined by medical evaluation, including no clinically significant abnormality identified on physical examination or laboratory evaluation and no active clinically significant disorder, condition, infection or disease that would pose a risk to participant safety or interfere with the study evaluation, procedures, or completion * participants have a body weight within 50.0 and 100.0 kilograms \[kg\] (inclusive) and body mass index within the range of 19.0 and 30.0 kilograms per square meter \[kg/m\^2\] (inclusive) * other protocol defined inclusion criteria could apply exclusion criteria: * history or presence of clinically relevant respiratory, gastrointestinal, renal, hepatic, hematological, lymphatic, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, dermatological, connective tissue diseases or disorders, as determined by medical evaluation * individuals with diagnosis of hemochromatosis, wilson´s disease, alpha 1 antitrypsin deficiency, or any other chronic liver disease including gilbert's disease will be excluded from the study * prior history of cholecystectomy or splenectomy, and any clinically relevant surgery within 6 months prior to screening * history of any malignancy * history of chronic or recurrent acute infection or any bacterial, viral, parasitic or fungal infections within 30 days prior to screening and at any time between screening and admission, or hospitalization due to infection within 6 months prior to screening * history of shingles within 12 months prior to screening * history of drug hypersensitivity, ascertained or presumptive allergy/hypersensitivity to the active drug substance and/or formulation ingredients; history of serious allergic reactions leading to hospitalization or any other hypersensitivity reaction in general, which may affect the safety of the participant and/or outcome of the study per the investigator's discretion * history of alcoholism or drug abuse within 2 years prior to screening, or positive for drugs of abuse, nicotine/cotinine or alcohol by the laboratory assays conducted during screening and day -1 * history of residential exposure to tuberculosis, or a positive quantiferon® test within 4 weeks prior to or at the time of screening * administration of live vaccines or live-attenuated virus vaccines within 3 months prior to screening * moderate or strong inhibitors or inducers of cytochrome p450, family 3, subfamily a (cyp3a4/5) within 4 weeks prior to the first administration of study intervention * other protocol defined exclusion criteria could apply

Keywords: midazolam cytochrome p450 autoimmune disorders inflammatory disorders sedative-hypnotic
pneumococcal conjugate vaccine with pneumococcal polysaccharide vaccine and tetanus/diphtheria vaccine

Conditions: Pneumococcal Infections

Summary: the purpose of this study is to learn whether or not giving a tetanus/diphtheria vaccination ("tetanus shot") before giving pneumococcal vaccine makes the pneumococcal vaccine more effective without causing too many side effects.

the only vaccine licensed in the united states for protecting adults against pneumococcal disease (ppv23) protects against invasive disease in observational studies but has generally been poorly effective against pneumonia or all-cause mortality in randomized clinical trials. another vaccine containing seven polysaccharide antigens conjugated to diphtheria toxoid (pcv7) is licensed for children and under investigation in adults. in this pilot study, we are comparing the safety and immunogenicity of three immunization schedules in adults: * td vaccine, 2-week interval, pcv7, 4-month interval, ppv23 * pcv7, 4-month interval, ppv23 * ppv23 we aim to: * compare the safety profiles of pneumococcal vaccines given on each of the three schedules * compare serotype-specific elisa antibody response to pneumococcal antigens given on each of the three schedules * compare functional serotype-specific antibody responses to pneumococcal antigens given on each of the three schedules * study the influence of diphtheria antibody levels at the time of pneumococcal conjugate vaccine administration on the magnitude of the immune response to pneumococcal antigens

Eligibility criteria:
exclusion criteria: * participation in any other investigational clinical trials except purely observational studies within 4 weeks prior to study start * any vaccination within 2 weeks prior to first study vaccine * evidence of systemic or local infection within one week prior to first study vaccine * hiv infection * renal failure * receipt of a pneumococcal or td vaccine within 5 years * current receipt of therapy for neoplastic disease * current receipt of immunosuppressive therapy * terminal illness withlife expectancy less than 3 months

Keywords: diptheria-tetanus vaccine pneumococcal vaccine adverse events following vaccination immunization immunogenicity
mechanisms mediating cardiovascular disease in children with obstructive sleep apnea

Conditions: Cardiovascular Diseases; Heart Diseases; Sleep Apnea Syndromes; Lung Diseases; Hypertension

Summary: to identify the early effects of obstructive sleep apnea on the cardiovascular system of children.

background: obstructive sleep apnea (osa) is an important clinical disorder occurring in men, women, and children with a prevalence of 4 percent, 2 percent and 1-3 percent, respectively. osa is under active study in adults and is definitely linked with increased cardiovascular morbidity, even in its mild to moderate clinical forms. in contrast, osa has not been well studied in children and the potential deleterious consequences on cardiovascular function have received little or no attention. design narrative: the study will examine in children 1) the interaction between osa and baroreflex dysfunction, 2) the relation of osa severity and baroreflex dysfunction to abnormalities in blood pressure control during wakefulness and sleep, 3) the association of the diminished baroreflex gain and impaired blood pressure control with an index of end organ damage, the left ventricular mass index, and 4) whether effective treatment of osa results in significant improvement in baroreceptor function, blood pressure control and a decrease in left ventricular mass index. a cross-sectional study will be conducted in 8-12 year old children with osa and a matched group of normal children. studies include baroreceptor function, 24-hour ambulatory blood pressure and left ventricular mass index. baroreceptor function will be measured by non-invasive techniques based on combined computer analysis of heart rate and blood pressure measured by portapres. 24-hour ambulatory blood pressure will be measured by a spacelab monitor and left ventricular mass index will be measured by direct m-mode echocardiogram. a longitudinal study will be conducted on the effect of adequate treatment of osa on baroreceptor function, daytime and nocturnal blood pressure and left ventricular mass index. a cohort of children with osa and a matched group of normal controls will be followed for a period of 12 months after treatment of the disorder. results are expected to show that children with osa have decreased baroreceptor sensitivity, elevated nocturnal blood pressure and increased left ventricular mass index and that effective therapy for osa, as determined by polysomnography, will improve or normalize baroreceptor sensitivity as well as nocturnal blood pressures and will lead to a decrease in left ventricular mass index.

Eligibility criteria:
no eligibility criteria
the investigation of the etco₂- paco₂ relation during laparoscopic colon surgery

Conditions: Colorectal Cancer

Summary: et-c02 is used to predict paco2 during surgery. there are controversies regarding the value of etco2 to predict paco2. the aim of this study was to investigate the relation between et-co₂ and paco₂ measurements in patients undergoing laparoscopic colorectal surgery. patient and surgical characteristics, mechanical ventilation adjustments, and intraabdominal pressure values and the corelation between these parameters and etco₂ - paco₂ difference were also investigated.

patient records from patients underwent colorectal surgery between 2010-2011 will be studied. it was planned to include patients undergoing laparoscopic colorectal surgery with a predetermined anaesthesia protocol. patients will receive a standardized general anesthetic and thoracal epidural anaesthesia. ventilatory parameters will be adjusted to maintain etco2 35 mmhg, paw 25 cmh2o.patient age, gen-der, bmi, asa classification, the duration of surgery, anesthesia, trendelenburg position and pneumoperitoneum. hemodynamic parameters, blood gas analyzes, ventilation parameters and etco₂ values will be recorded. we determined 6 timelines to compare the difference between paco₂ and etco₂. these timelines were the times where we could collect the most data regarding blood gas analyzes. preoperative period: to, 10th minute after the first insuflation and trendelendburg position: t₁,the first hour after the first insuflation and trendelendburg position: t₂, 10th minute after desuflation and supine position: t₃, 10th minute after the second insuflation and trendelendburg position: t₄, and 10th minute after the second desuflation and supine position:t₅. primary outcome measure is the difference between paco₂ and etco₂ a difference greater than 5 mmhg was assumed to be important.

Eligibility criteria:
inclusion criteria: * asa i-iii patients underwent laparoscopic colorectal resection exclusion criteria: * convertion to the open surgery

Keywords: arterial carbondioxide pressure colon surgery end-tidal carbondioxide laparoscopic trendelenburg