Kornimate/medical-research-clean huggingface dataset:
compliance with continuous positive airway pressure therapy in patients with obstructive sleep apnea syndrome

Conditions: Sleep Apnea, Obstructive

Summary: the aim of the study is to know the adherence to treatment and compliance of patients diagnosed with sahs and with indication of cpap from the sleep unit of the hospital de sabadell.

the investigatror's objective will be to know the adherence to treatment and compliance of patients diagnosed with sahs and with indication of cpap of the sleep unit of the hospital de sabadell. is a cohort study. the dependent variables are adherence to treatment (% patients who continue using cpap one year after initiation of treatment) and objective compliance with treatment (defined as use of ≥4h / night). for a confidence level of 95%, a sample of 405 patients was recruited, recruited consecutively at a rate of 33 patients per month among those diagnosed with sahs and those indicated with cpap treatment. this number foresees a possible abandonment rate of 5%. for the statistical analysis of the data related to compliance with the therapy and compliance with the follow-up process, descriptive analysis of the data with means, median and 95% ci, or percentages with 95% ci. for the statistical analysis of the factors influencing compliance: multivariate logistic regression.

Eligibility criteria:
inclusion criteria: * patients over 18 years of age treated with cpap based on the diagnosis of osas (clinical picture and ahi\> 10). exclusion criteria: * diagnosis of a psychiatric illness or dementia. * communication problems or inability to read and speak spanish.

Keywords: treatment adherence and compliance attitudes continuous positive airway pressure cross-cultural validation
opioid reduction initiative during outpatient pediatric urologic procedures using exparel

Conditions: Urologic Diseases; Hypospadias; Undescended Testes; Chordee; Hydrocele; Orchiectomy

Summary: this study aims to evaluate the utility of long-acting liposomal bupivacaine (exparel®) in improving pain scores and reducing narcotic pain requirements in pediatric patients following minor urologic procedures.


Eligibility criteria:
inclusion criteria: * pediatric patients 6 years and older undergoing minor pediatric urologic surgery * patients who are otherwise eligible to receive routine care following minor urologic surgery exclusion criteria: * contraindication to receiving local anesthetics (i.e. pre-existing cardiac, renal, hepatic dysfunction) * pediatric patients younger than 6 years of age * pediatric patients with a history of pain syndromes or are unable to tolerate opiate medication * unwilling to participate in 48 hours and 10-14 day follow-up phone calls
clinical pediatric pneumonia score in critically ill children

Conditions: Community Acquired Pneumonia

Summary: the purpose of the study is to create a clinical pneumonia tool that can be used to predict the cause of community-acquired pneumonia, which is a lung infection that began outside of the hospital in critically ill children therefore limiting unnecessary antibiotic use. the investigators will enroll critically ill children admitted with acute respiratory failure and suspected pneumonia. each patient will receive a clinical pneumonia score blinded from culture and respiratory viral panel results. all care after samples obtained will be at the discretion of the picu team. the investigators believe that our clinical pneumonia scale with procalcitonin will accurately designate viral from bacterial etiologies.


Eligibility criteria:
inclusion criteria: * all intubated pediatric patients * age 1 day to 21 years * admitted to the lluch picu with suspected pneumonia for the next 6 months * have received antibiotics for less than 12 hours * have been intubated for less than 24 hours * patients must be english or spanish speaking for consent purposes. exclusion criteria: * patients who have received antibiotics for greater than 12 hours * patients who have been intubated for greater than 24 hours * patients who are unable to tolerate non-bronchoscopic bronchoalveolar lavage

Keywords: procalcitonin community acquired pneumonia pneumonia score
a study to assess the effects of renal impairment on the pharmacokinetics, safety, and tolerability of intranasally administered esketamine

Conditions: Renal Impairment; Healthy

Summary: the purpose of this study is to evaluate the pharmacokinetics of a single dose of intranasally administered esketamine in participants with impaired renal function when compared to participants with normal renal function.

this is an open-label (all people know the identity of the intervention), single-dose, single-center, parallel group study to characterize the pharmacokinetics and safety of a single 28 milligram (mg) dose of esketamine in both participants with varying stages of renal impairment and healthy participants. a total of approximately 32 medically stable men and women with varying degrees of renal function impairment or no renal impairment will be enrolled. the study consists of a screening period of up to days -21 to -2, open label phase of days -1 to 4, and end-of-study (11 plus \[+\] or minus \[-\] 2 days after final dose). the participants will be assigned to 1 of 4 groups (8 participants per group) based on creatinine clearance (clcr,m). safety and tolerability will be assessed from the time of consent until the end of the study.

Eligibility criteria:
inclusion criteria: * signed an informed consent document indicating they understand the purpose of and procedures required for the study and are willing to participate in the study * for women of childbearing potential, must have a negative serum beta-human chorionic gonadotropin (beta-hcg) pregnancy test at screening; and a negative urine pregnancy test on day minus (-) 1 * comfortable with self-administration of intranasal medication and able to follow instructions provided * hemoglobin concentration of greater than or equal to (\>=) 10 grams per deciliter (g/dl) (only for cohorts 1, 2, and 3) * platelet count of \>= 50,000 counts/microliter (only for cohorts 1, 2, and 3) exclusion criteria: * current or previous diagnosis of psychotic or major depressive disorder (mdd) with psychosis, bipolar or related disorder, intellectual disability, borderline personality disorder, or antisocial personality disorder * a lifetime history of cerebrovascular disease including stroke or transient ischemic attack, aneurysmal vascular disease * unstable coronary artery disease or myocardial infarction in the last 12 months or any unstable angina requiring revascularization procedure, hemodynamically significant valvular heart disease, or new york heart association class iii-iv heart failure * has had a renal transplant or diagnosis of systemic lupus erythromatosus or renal carcinoma * has a nasal piercing * participant requires dialysis (only for cohorts 1, 2, and 3)

Keywords: renal impairment healthy esketamine
neuroplasticity in maternal opioid use disorder (oud)

Conditions: Opioid Use Disorder

Summary: opioid use disorder (oud) remains a major public health problem particularly for mothers in the perinatal period, for whom stress, relapse rates, and risk for overdose are elevated. the perinatal period is characterized by significant neural reorganization that determines outcomes for mothers and infants. oud is also associated with neural reorganization, specifically neural circuitry implicated in stress regulation and reward processes. interventions should therefore take advantage of this changing perinatal biology to enhance treatment response by targeting the aberrant neural circuitry compromised by maternal oud. the investigators have developed and refined an evidence-based intervention for mothers with oud designed to target these neural mechanisms and enhance the reward of caregiving; however, this has yet to be formally tested. therefore, the investigators will examine maternal neuroplasticity using high-dense array electroencephalography (eeg) in mothers with oud in response to our intervention. there will be 1 laboratory visit at pre-treatment, followed by 12 sessions of the evidence-based parenting intervention, and 1 laboratory visit at post-treatment. this study will attempt to validate the importance of taking advantage of the neuroplasticity in the perinatal period to optimize outcomes for mothers with oud.

this is a study conducted at the child study center (csc) in the yale school of medicine. it involves mothers in treatment for oud who are caring for infants who are 4-12 months old. 15 mothers will complete 1 study visit, which will last 2.5 hours. it will start with informed consent and then will include demographics, eeg/erp, a multidimensional assessment of mentalization (a brief self-report questionnaire, a 5-minute speaking task, and a one-hour interview) and several clinical measures (depression, anxiety, stressful life events). participants will then complete 12 treatment (mothering from the inside out (mio)) visits, and 1 post-treatment data collection visit. visits 2-13 (1 hour each) consist of participation in mothering from the inside out (mio). visit 14 (2.5 hours) includes participation in the erp paradigm and the multidimensional assessment of mentalization (a brief self-report questionnaire, a 5-minute speaking task, and a one-hour interview) and several clinical measures (depression, anxiety, stressful life events).

Eligibility criteria:
inclusion criteria: * biological mother of infants between 4-months and 12-months of age * 21-45 years of age at time of recruitment * enrolled in substance use treatment and on mediation for opioid use disorder (moud). exclusion criteria: * incapable of giving informed consent * child spends less than 50% of time in mother's custody. * non-english-speaking * unable to complete the study because of pending legal cases or unable to supply two forms of contact for the purpose of follow-up * physiological addiction to a substance that requires detoxification, defined as difficulties with physiological withdrawal from substances (e.g. delirium tremens, shaking, nausea).
effects of lee silverman voice treatment big on dynamic balance in parkinson's patients

Conditions: Parkinson Disease; Motor Disorders; Balance; Distorted

Summary: to determine the effects of lee silverman voice treatment big on dynamic balance in parkinson's patients

this study will be conducted to compare the effects of lee silverman voice treatment big and conventional physiotherapy on dynamic balance in patients of pd. patients will be recruited according to inclusion criteria and data will be collected from riphah rehabilitation center, national hospital lahore. dynamic gait index will be used as data collection tool to test dynamic balance of patients. patients will be allocated to intervention groups by randomization. after approval from ethical committee, data collection will be started and informed consent will be taken from all patients.

Eligibility criteria:
inclusion criteria: * stage i, ii, iii parkinson's patients on hoehn \&;yahr classification * able to walk without assistive devices * stable medication 4 weeks prior to and during study exclusion criteria: * patients with depression or dementia * disabling bradykinesia to make sure patients are efficient to engage and cooperate in conventional physical therapy

Keywords: parkinson disease balance; distorted motor disorders
genicular nerve block versus its combination with infiltration between popliteal artery and capsule of posterior knee

Conditions: Postoperative Pain

Summary: comparison of the analgesic and physical recovery effect of genicular nerve block (gnb) alone and (gnb + infiltration between popliteal artery and posterior capsule of the knee (ipack) in patients undergoing total knee replacement

comparison of preemptive analgesia of (gnb) with (gnb+ ipack) on postoperative pain control and recovery of knee physical activity in patient undergoing total knee replacement.

Eligibility criteria:
inclusion criteria: * adult patients aged between 21 to 60 years * undergoing primary unilateral elective total knee arthroplasty under spinal anesthesia * having informed consents * patients with physical status asa i \& ii * both genders * body mass index less than 40 kg/m2. exclusion criteria * patients with peripheral vascular disease * patients with history of allergy to local anesthesia or opioid analgesia, * those on anti-platelet, anticoagulant or b blocker drugs * patients with acute decompensated heart failure * patients with hypertension * patients with heart block * patients with coronary disease * patients with bronchial asthma * patients with bleeding disorders * patients with compromised renal or hepatic function * pregnant female.

Keywords: genicular ,ipack, total knee
cryobiopsy or forceps biopsy during semirigid thoracoscopy: a comparative study

Conditions: Pleural Effusion; Pleural Diseases

Summary: the purpose of this study is to compare cryobiopsies with forceps biopsies during semirigid thoracoscopy.

the investigators are going to compare diagnostic yield and size, morphological features, immunohistochemistry as measures of the quality of the samples. the secondary aim is to evaluate safety with focus on bleeding intensity.

Eligibility criteria:
inclusion criteria: * 18 or more years old * unilateral pleural effusion of unknown origin * pleural irregularities suspicious for pleural malignancy * referral for thoracoscopy after less invasive means of diagnosis had failed exclusion criteria: * uncontrolled bleeding tendency * unstable cardiovascular status * severe heart failure * ecog performance status 4 * persistent hypoxemia after evacuation of pleural fluid * pleural symphisis, fibrothorax

Keywords: flex-rigid pleuroscopy cryobiopsy pleural biopsy pleural effusion safety thoracoscopy
study of posoleucel (formerly known as alvr105; viralym-m) in kidney transplant patients with bk viremia

Conditions: BK Virus Nephropathy; BK Virus Infection

Summary: the purpose of this study is to compare posoleucel (formerly known as alvr105; viralym-m) to placebo in kidney transplant recipients who have high or low levels of bk virus in their blood.


Eligibility criteria:
inclusion criteria: * patients who had a kidney transplant performed greater than or equal to 28 days prior to enrollment * at least 1 identified, suitably matched posoleucel (alvr105) cell line for infusion is available. * capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (icf) and in the protocol. * contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. exclusion criteria: * undergone allogeneic hematopoietic cell transplantation * evidence or history of graft versus host disease (gvhd) or cytokine release syndrome (crs). * uncontrolled or progressive bacterial or fungal infections * known or presumed pneumonia * ongoing therapy with high-dose systemic corticosteroids (ie, prednisone dose \>0.5 mg/kg/day or equivalent). * pregnant or lactating or planning to become pregnant. * weight \<40 kg. * patients who received, or planned to receive abatacept or belatacept, within 3 months of screening
exhaled nitric oxide in asthma management

Conditions: Asthma

Summary: this study will compare the absolute and relative effectiveness of managing real-life asthma with and without the use of niox mino® and niox flex® to measure exhaled nitric oxide (eno) as a marker of underlying airway inflammation to guide appropriate management. as exhaled nitric oxide responds rapidly to environmental changes and can act as a marker of underlying inflammation it is proposed that incorporating eno monitoring into routine asthma management treatment allows strategies to be more accurately tailored to the patients needs, increasing the probability of good asthma control.


Eligibility criteria:
inclusion criteria: 1. aged: 6-80 years 2. evidence of active asthma (diagnostic code and/or ≥6 prescriptions for asthma therapy at any time in their records) 3. evidence of current asthma treatment (≥2 asthma prescriptions during baseline year and outcome year) 4. have at least one year of up-to-standard (uts) baseline data and at least one year of uts outcome data (following the ipd) exclusion criteria: 1. had a copd read code at any time; and/or 2. had any chronic respiratory disease, except asthma, at any time; and/or 3. patients on maintenance oral steroids during baseline year 4. smoker or ex-smoker aged over 60

Keywords: real-world observational nitric oxide inhaled corticosteroid uk
medico-economic study of patient matched cutting blocks (ancillary) myknee ® lbs during knee arthroplasty gmk ®.

Conditions: Osteoarthritis

Summary: total knee arthroplasty represents over 70 000 surgical procedures per year in france, increasing about 10% each year since the early 1990s. clinical experience shows a strong rate of success on pain relieve and improvement of knee articular function for these patients. longevity of the implants had been proved to depend on the biomechanical design and implantation techniques, particularly the bone cuts during the surgery. to improve the precision of these cuts, the patient matched cutting blocks developed by medacta company allows to adapt bone cuts to the patient anatomy improving the reliability of these procedure. a reduction of surgical time and bleeding would be another benefit expected with this type of ancillary. the objective of this study is to demonstrate the advantage of patient matched cutting blocks for total knee arthroplasty on realiability for both clinical and radiological criteria, morbidity reduction during and after the procedure and also a benefit on an economic point of view.


Eligibility criteria:
inclusion criteria: all patients requiring a total knee arthroplasty line: primary or secondary osteoarthritis advanced beyond medical treatment. exclusion criteria: distorded axes or laxity requiring the establishment of constrained prosthesis

Keywords: ancillary tailored medico-economic study, total knee replacement primary or secondary osteoarthritis
ppi test in gp patients

Conditions: GERD

Summary: the purpose of this study is to determine the diagnostic value of two week treatment with nexium as a confirmatory test for patients with suspected reflux disease.


Eligibility criteria:
inclusion criteria: * age ≥ 18 years * symptoms suggestive for gastric acid reflux disease during 2 or more days per week exclusion criteria: * treatment with prokinetic or acid secretion inhibitors within 4 weeks prior to inclusion * treatment with a ppi for more than 30 days within the last 3 months prior to inclusion * history of proven peptic ulcer disease, unless successfully treated with helicobacter pylori eradication longer than 1 month before inclusion

Keywords: gastroesophageal reflux disease heartburn acid-related diseases acid reflux disease nexium
genetic analysis of pediatric psoriasis

Conditions: Psoriasis

Summary: this study will ascertain approximately 150 subjects, which will include pediatric psoriasis patients diagnosed before age 12, parents not affected by psoriasis, and if a family history is indicated, up to third-degree family members. saliva (or buccal swabs in the case of infants) will be obtained for dna isolation.


Eligibility criteria:
inclusion criteria: * patients (of any age) who developed psoriasis before 12 years of age and who have no family history of psoriasis in either parent. * parents of patients who developed psoriasis before 12 years of age * up to third-degree family members (first cousin, grandparent, great-grandparent) with or without psoriasis, if family history is indicated. exclusion criteria: * patients, parents, and other family member unable to give a saliva or buccal swab sample. * patients, parents, and other family member unable to give written informed consent.
a thorough corrected qt interval trial

Conditions: Dyslipidemia

Summary: the purpose of this study is to determine the effects of k-877 on ecg parameters with a focus on cardiac repolarization compared with placebo in healthy adult subjects.


Eligibility criteria:
inclusion criteria: * subject provides written informed consent before any study specific evaluation is performed. * subject is a healthy adult male or female volunteer, of any race and ethnicity, between the ages of 18 and 45 years, inclusive. * subject has a body mass index of 18 to 30 kg/m2, inclusive. exclusion criteria: * subject has clinically relevant abnormalities in the screening or check in assessments. * subject has a supine blood pressure after resting for at least 5 minutes that is higher than 140 mm hg systolic or 90 mm hg diastolic, or lower than 90 mm hg systolic or 60 mm hg diastolic. * subject has a supine heart rate (hr) (as measured at screening or check-in during collection of vital signs) after resting for at least 5 minutes that is outside the range of 40 to 90 beats per minute.
use of tocofersolan (vedrop®) to prevent or treat refractive vitamin e deficiency in infants and children

Conditions: Short Bowel Syndrome; Vitamin E Deficiency

Summary: patients with short bowel syndrome or other forms of intestinal failure/fat malabsorption are unable to tolerate adequate oral or enteral feedings. they require that nutrition be given as enteral nutrition that is delivered by feeding tube. often these children take supplements such as vitamins to help improve their nutritional status but, due to their condition, they have difficulty absorbing the supplement sufficiently and most of it is lost in the stool. the drug that will be studied, tocofersolan (vedrop®) is a form of vitamin e, a type of the fat soluble vitamin needed in the human diet. it has been formulated in such a way that it may be more easily absorbed by patients with this condition. the main purpose of the study is to learn about the safety and tolerability of this form of vitamin e. before receiving the study drug, the severity of the child's vitamin e deficiency will be determined by a blood sample, followed by giving them a daily dose of tocofersolan (vedrop®) either orally or through their feeding tube. after a 4 weeks of therapy, a second blood sample will be checked and the child will continue either same dose of tocoferssolan or it will be adjusted in response to the blood levels. if the study drug works as it is designed to do, there should be an increase in the concentration of the vitamin e in the child's blood, suggesting that the drug was absorbed. at each visit, a sample of blood will be obtained to assess the child's vitamin e status and general health. patients will remain on tocofersolan for approximately one year or as long as the study remains open. based on the european pediatric experience, patients should be expected be on tocofersolan a minimum of 3 months, ideally 6 months to see optimal clinical response.


Eligibility criteria:
inclusion criteria: 1. patients with intestinal failure or fat malabsorption who have refractory vitamin e deficiency (defined as vitamin e level \< 5 mg/l) despite receiving vitamin e supplementation with currently available enteral vitamin e products for at least 6 months or requiring the provision of vitamin parenterally as part of a multivitamin infusion. exclusion criteria: 1. pregnancy 2. use of warfarin or any related vitamin k antagonist. 3. enrollment in any other clinical trial involving an investigational agent (unless approved by the principal investigators of the other trial) 4. the parent or guardian or child unwilling to provide consent or assent