Kornimate/medical-research-clean huggingface dataset:
walking in pregnancy and prevention of insomnia in third trimester using pedometers

Conditions: Insomnia

Summary: randomized control trial (rct), were healthy but sedentary women are selected in their first trimester of pregnancy. this rct has two interventions arms (pedometer plus a goal of 11,000 steps / day and pedometer without goal) and a control group arm, without the use of pedometer. the main objective is to promote physical activity in pregnancy decreasing the prevalence of insomina at their third trimester of pregnancy.

general objective: to determine the effect of a walking program during pregnancy in the prevention of the appearance of insomnia in the third trimester of pregnancy, in the increase of the quality of sleep and in the improvement of the quality of life throughout pregnancy. specific objectives: comparison of the interventions group versus the control group; at the beginning, middle and end of the program of the following indicators: 1. average steps/day; 2. frequency of insomnia; 3. hours of night sleep and quality of sleep; 4. quality of life level. methodology: randomized control trial in parallel in healthy sedentary pregnant women belonging to the virgen de las nieves hospital in granada, spain. at 12 weeks of gestation (gw) they will be invited to participate and randomly assigned to the intervention group i2 (pedometer, with goal of 11,000 steps / day), intervention group i1 (pedometer without goal) and control (without pedometer). duration of the intervention: 13-32 gw. at 12, 19 and 31gw the average steps/day will be measured in groups i2 and i1. in weeks 13, 20 and 32gw, the following variables will be collected: the athens insomnia scale, the sleep quality index (pittsburgh), adherence to the mediterranean diet (predimed), physical activity (short ipaq), quality of life (psi), the consumption of toxic substances (caffeine, illegal drugs, alcohol and tobacco), the anthropometric variables of pregnant woman.

Eligibility criteria:
inclusion criteria: * low risk pregnancies that are attending in the unit of obstetrics and gynecology of the hospital materno-infantil de granada. * sedentary women (\ 30 min.; equivalent to \<7.000 steps/day). * with mobile phone and e-mail * without intellectual deficits or difficulty to understand the language. exclusion criteria: * chronic disease: diabetes, high pressure, cardiac or respiratory disease, liver or kidney disease or mobility problems. * women with relative or absolute repose. * active women (\>5 days/week of moderate-vigorous physical activity at least \>30 min.; equivalent to \>7.000 steps/day). * insomnia at beginning of pregnancy or having drugs for sleep problems.

Keywords: pedometer watch, walking, pregnancy, insomnia
improving sleep after tka using mirtazapine and quetiapine

Conditions: Osteo Arthritis Knee; Insomnia

Summary: use of mirtazapine and quetiapine for improvement of sleep quality after tka

background after knee replacement surgery there is a loss of quantity and quality of sleep. loss of sleep is associated with increased pain perception. subsequently, patients use more analgesic medication and it takes them longer to fully recover from surgery. low doses of the tetracyclic antidepressant mirtazapine and the neuroleptic quetiapine are nowadays off-label prescribed for insomnia and improve length and quality of deep sleep phases. quetiapine and mirtazapine could improve sleep after knee replacement surgery and improve patient recovery. this placebo-controlled, randomized, double-blind study investigates the effect of quetiapine and mirtazapine on functional recovery after total knee arthroplasty. methods this is a prospective, single center, double-blinded randomized controlled trial. 165 patients with knee osteoarthritis scheduled for total knee arthroplasty will be randomly allocated to a low-dose quetiapine (ldq), a low-dose mirtazapine (ldm) group or a placebo group. outcomes will be evaluated at baseline, 2, 4, 6 and 12 weeks after surgery. functional outcome after total knee arthroplasty is measured using a patient related outcome measure through the oxford knee score (oks). in order to measure postoperative sleep quality, patients will be monitored using the leeds sleep evaluation questionnaire (lseq). furthermore, pain is registered using a visual analogue scale (vas), weekly opioid use is monitored, and general health status is reported through the eq-5d. analyses will be conducted on an intention-to-treat basis using logistic and linear mixed regression models. this trial complies with the spirit guidelines for randomized controlled trials. discussion this study will provide clinicians with evidence whether quetiapine contributes to rehabilitation of patients undergoing fast-track knee replacement surgery.

Eligibility criteria:
inclusion criteria: * indication for tka exclusion criteria: * use of benzodiazepines * use of anti-depressants * use of oxycodone * patients diagnosed with obstructive sleep apnea syndrome, severe respiratory insufficiency, or myasthenia * a known hypersensitivity to mirtazapine, quetiapine and/or related to the gelatinous (placebo) capsule * insufficient understanding of the dutch language.
evaluation of the long-term safety, pharmacodynamics, and exploratory efficacy of gz/sar402671 in treatment-naïve adult male patients with fabry disease

Conditions: Fabry Disease

Summary: primary objective: to assess the long-term safety of gz/sar402671 in adult male participants with fabry disease who previously completed study act13739 (nct02489344). secondary objective: to assess the long-term effect of gz/sar402671 on pharmacodynamic and exploratory efficacy endpoints in adult male participants with fabry disease who previously completed study act13739.

the total duration of this extension study (lts14116) was up to 31 months (30 months of treatment and one month post-treatment follow-up).

Eligibility criteria:
inclusion criteria : * male participant with fabry disease who previously completed study act13739. * participants, willing and able to provide signed informed consent. * sexually active participants, willing to practice true abstinence in line with their preferred and usual lifestyle or using two acceptable effective methods of contraception. exclusion criteria : -participants, in the opinion of the investigator, unable to adhere to the requirements of the study. the above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
short-term effects of live music in preterm infants

Conditions: Prematurity

Summary: the purpose of this study is to determine the effects of pentatonic live music on physiological parameters in preterm infants.


Eligibility criteria:
inclusion criteria: * gestational age 26-34 weeks; no use of cpap (continous positive airway pressure) or any other form of mechanical ventilation; signed informed consent of the parents exclusion criteria: * heart defect or known cardiac arrhythmia; other diseases of the preterm and newborn period (including infections and chromosomal aberrations) which make an additional diagnostic and therapeutic intervention unacceptable; detection of deafness (teoae, transitory evoked otoacoustic emission)

Keywords: preterm infants, music, neonatal intensive care unit (nicu)
study comparing two different methods of treating periodontal disease

Conditions: Periodontal Diseases

Summary: the purposes of this study are to: 1. compare the clinical effectiveness of a traditional and a medical model of periodontal therapy; and 2. determine the value of the two approaches to periodontal therapy.

this application was developed to test the following hypothesis: a medical model of periodontal therapy, when compared to a traditional model, is as clinically effective, is more valuable, and can be realistically implemented in clinical practice. to accomplish this task a prospective, blinded, community based, cohort trial will be carried out. two analytical techniques will be employed to compare the outcomes of periodontal therapy: clinical effectiveness and value. the two primary outcome variables for assessing clinical effectiveness will be clinician centered (attachment level) and patient centered (quality of life). the key outcome variable for value determination is cost of care. value is then determined by dividing the outcome by the cost of care. thus a similar outcome at reduced cost increases value. this facilitates calculating cost-effectiveness and cost-utility of care, preparing decision analysis trees, and carrying out sensitivity analysis. there are two significant reasons for testing a medical model of care. if the hypothesis is correct: 1. this would increase access to periodontal care; and 2. it would offer a cost-effective method to treat periodontal infections that are correlated with systemic health problems. these points argue for a direct comparison of the medical and traditional models of care.

Eligibility criteria:
inclusion criteria: * \>/= 4 or more periodontally involved teeth as defined by pocket depth of \>/= 6mm. * \>/= 14 teeth. * \> 18 years of age. * reside in the greater boston area. exclusion criteria: * those patients requiring prophylactic antibiotic for dental treatment.
patient satisfaction study: clean intermittent self-catheterization teaching

Conditions: Anxiety

Summary: to compare patient satisfaction and anxiety scores between female subjects undergoing urinary incontinence and/or pelvic reconstructive surgery who are instructed preoperatively in the technique of clean intermittent self-catheterization (cisc) by means of an instructional video and those who do not receive specific preoperative instruction in cisc, other than basic informed consent regarding risks of postoperative urinary retention.


Eligibility criteria:
inclusion criteria: * enrollment will be offered to all women undergoing pelvic reconstructive and/or urinary incontinence surgery by the division of urogynecology, department of obstetrics and gynecology at magee womens hospital. exclusion criteria: * subjects who have performed cisc in the past will be excluded. * subjects whose score on the mmse reflects dementia (\<24) will be excluded. * subjects anticipated to have placement of a suprapubic catheter placement at the time of surgery will be excluded. * subjects deemed by the enrolling physician to be incapable of physically performing self-catheterization will be excluded.

Keywords: anxiety satisfaction incomplete bladder emptying clean intermittent self-catheterization prolapse/incontinence surgery
diagnosis of acquired punctal stenosis using anterior segment optical coherence tomography

Conditions: Punctal Stenosis

Summary: purpose of the study to evaluate the lower puntum dimensions in cases of acquired punctal stenosis(aps), using anterior segment optical coherence tomography (as-oct).

(b)examination: 1. external examination: should be done to rule out causes of watering other than punctal stenosis (facial palsy, lacrimal pump failure, swelling in lacrimal sac area and regurge test) 2. slit lamp examination: for tear meniscus, lid margin, conjunctiva and punctual orifice 3. fluorescein dye disappearance test: performed with a drop of 2% fluorescein in lower conjunctival sac, patient is instructed not to wipe the eyes. after 5 minutes, presence of staining in the tear film is assessed with cobalt blue filter. 4. probing and lacrimal syringing, if patent confirms punctal stenosis to be the cause of epiphora rather than block in the lower lacrimal drainage system. 5. anterior segment optical coherence tomography examination (as-oct) for the lower punctum: measuring the outer puntcal diametre, inner punctal diameter and punctal depth. examination of the lower punctum was performed using spectral domain oct machine; rtvue model-rt100 cam system (optovue inc., fremont, ca, usa) version 6.2, by attaching the cornea/anterior module lens (cam). cam lens has a wide-angle, high-magnification lens of 10 mm working distance. the axial resolution was 5 μm, and the lateral resolution was 8 μm. the scan beam has wavelength of 840 ± 10 nm. the two red external illumination (light emitting diode ) led on headrest were approximated on each side of the lower punctum for proper illumination and imaging of the punctum. gentle eversion of the medial part of the lower lid was performed to expose the lower lid punctum, so the vertical canaliculus was brought to be at an axial plain without undue stretching or pressure to the lower lid. line scan was the used examination scan, containing 1020 a-scans/line, and is 8mm in length. measurements of the external punctal diameter, internal punctal diameter, and punctal depth were performed on the b-scan image of the lower punctum (by selecting it from the review window), using distance measurement tool. external punctal diameter was measured as a line connecting highest points on the medial and lateral punctal walls. internal punctal diameter was measured as a horizontal line just above the narrowing. the distance between the line representing the external punctal diameter and the floor of the punctum was calculated and referred to the punctal depth results: data wil be collected and statistically analysed

Eligibility criteria:
inclusion criteria: patients with acquired punctal stenosis exclusion criteria: 1. punctal agenesis 2. congenital punctal stenosis 3. allergic occlusion 4. lid malposition 5. canalicular, nasolacrimal, sac and duct obstruction 6. previous eyelid or lacrimal drainage surgery 7. untreated conjunctivitis, blepharitis

Keywords: acquired punctal stenosis epiphora lower punctum as-oct
controlled myelofibrosis study with oral janus-associated kinase (jak) inhibitor treatment-ii: the comfort-ii trial

Conditions: Myelofibrosis

Summary: this was an open label, randomized study comparing the efficacy and safety of randomized 2:1 ruxolitinib tablets versus best-available therapy, as selected by the investigator. the purpose was to compare the efficacy, safety and tolerability of ruxolitinib (inc424/incb018424) given twice daily to the best-available therapy, in subjects with primary myelofibrosis (pmf), post polycythemia vera myelofibrosis (ppv-mf) or post essential thrombocythemia myelofibrosis (pet-mf).

this study included a randomized treatment phase, followed by an extension phase. the treatment phase lasted from study day 1 (day of randomization) to the occurrence of a protocol-specified progressive disease event or study conclusion, whichever came first. the extension phase (including crossover of control group patients) lasted from the progressive disease event until the earliest of the following events: a) the patient was no longer receiving clinical benefit, b) the patient chose to withdraw from the study, or c) the study ended. all patients received ruxolitinib in the extension phase of the study. maximum individual patient duration was 5 years.

Eligibility criteria:
inclusion criteria: * subjects must be diagnosed with pmf, ppv-mf or pet-mf according to the 2008 world health organization criteria * subjects with mf requiring therapy must be classified as high risk or intermediate risk level 2 according to the prognostic factors defined by the international working group * subjects with an ecog performance status of 0, 1, 2 or 3 * subjects with peripheral blood blast count of \< 10%. * subjects who have not previously received treatment with a jak inhibitor exclusion criteria: * subjects with a life expectancy of less than 6 months * subjects with inadequate bone marrow reserve as demonstrated by specific clinical laboratory counts * subjects with any history of platelet counts \< 50,000/µl or anc \< 500/µl except during treatment for a myeloproliferative disorder or treatment with cytotoxic therapy for any other reason * subjects with inadequate liver or renal function * subjects with clinically significant bacterial, fungal, parasitic or viral infection which require therapy * subjects with an active malignancy over the previous 5 years except specific skin cancers * subjects with severe cardiac conditions * subjects who have had splenic irradiation within 12 months

Keywords: myelofibrosis post-polycythemia vera myelofibrosis post-essential thrombocythemia myelofibrosis
redesigning patient handling tasks to prevent nursing back injuries

Conditions: Back Pain; Occupational Diseases

Summary: this study is one of several initiated by the investigators to reduce musculoskeletal injuries in patient care providers. nurses have one of the highest incidences of work related back injuries of any profession. over the past 20 years, efforts to reduce work-related injuries in nursing have been largely unsuccessful.

background: this study is one of several initiated by the investigators to reduce musculoskeletal injuries in patient care providers. nurses have one of the highest incidences of work related back injuries of any profession. over the past 20 years, efforts to reduce work-related injuries in nursing have been largely unsuccessful. objectives: the goal of this study is to reduce the incidence and severity of occupational musculoskeletal injuries in nursing through the redesign of stressful patient handling tasks. this study addresses three objectives: 1) conduct a quantitative, biomechanically based, ergonomic evaluation of the eleven "at risk" tasks in nursing practice; 2) redesign the techniques or equipment needed to perform these tasks safely or with reduced risk of musculoskeletal injury; and 3) conduct laboratory- based assessment of the biomechanical benefit of the proposed intervention strategies. methods: using a randomized experimental design with a control group, ten "at risk" tasks will be evaluated. the sample included 160 experienced nursing staff. data were collected using: 1) caregiver data form and anthropometry data sheet; 2) 3-d electromagnetic tracking system; 3) emg; and 4) modified borg scale for perceived comfort. include: caregiver characteristics, joint torque, spinal forces, spinal tolerance limit and damage load limit, erector spinae surface emg, joint angles, percent of population capable of performing each task by gender, velocity of lift, reach, heart rate, and perceived comfort. status: this project is complete.

Eligibility criteria:
inclusion criteria: subjects included rns, lpns, and nas with a minimum of 6 months experience and a job description that included a minimum of 80% direct patient care responsibilities. subjects were required to be injury free for at least one year, as evidenced by a brief orthopedic examination and interview. the orthopedic evaluation included an examination of posture, gait, range of motion, sensory deficits, muscle exam, and straight leg raise. we excluded subjects with self-report of injury or any positive finding of back musculoskeletal disorders within the past 12 months. exclusion criteria:

Keywords: musculoskeletal disorders patient lifting occupational accidents
bump the lump - intervention for the treatment of globus pharyngeus

Conditions: Globus Pharyngeus

Summary: to develop a standardized speech-language pathology treatment protocol to systematically address globus pharyngeus (gp) as a proof of concept

globus pharyngeus (gp), often described as a persistent lump or tightness in the throat, accounting for 4% of new referrals to ear, nose, and throat (ent) clinics. this condition is reported in the literature in up to 46% of healthy individuals and has been shown to significantly impact patients' quality of life. the key diagnostic criteria for gp include at least 12 weeks duration of symptoms without dysphagia or gastroesophageal reflux as the causative symptom, and in the absence of major esophageal motor disorders. while the exact etiology of gp remains elusive, research suggests a multifactorial nature involving physical, psychological, and functional components. behavioral therapy with a speech-language pathologist is often recommended as a treatment option for patients with gp. a review of the literature examining slp interventions for gp shows that slp treatments lack standardization, leading to inconsistency and limited efficacy across therapeutic interventions. therefore, there is an urgent need to further investigate behavioral interventions for gp and develop a standardized treatment protocol to address the condition systematically.

Eligibility criteria:
inclusion criteria: * volunteer adult patients (age 18 and over) evaluated at the atrium health wake forest baptist center for voice and swallowing disorders who report a complaint of globus pharyngeus exclusion criteria: * patients diagnosed with a swallowing disorder will be excluded from the study

Keywords: speech-language pathologist laryngeal hygiene voice therapy techniques
lidocaine patch versus intravenous lidocaine in pain relief after cesarean section

Conditions: Cesarean Section Complications

Summary: to evaluate the efficacy of lidocaine patch applied around wound in reduction of postoperative pain and illus compared to intravenous lidocaine infusion and placebo after cesarean section.

the use of lidocaine as a local anesthetic is a common and widely used in practice. lidocaine patches can be used for localized pain control and can be placed every 24 hours. the use of lidocaine patches in post-operative patients has been reported in one case report in obstetric literature. there is one study that reports decreased immediate postoperative pain when lidocaine patches were placed at laparoscopic port sites following gynecologic surgery as measured by visual analog scale score and the prince henry and 5-point verbal rating pain scale . there have been no studies looking at the impact of lidocaine patches in obstetric surgical procedures, specifically cesarean sections.

Eligibility criteria:
inclusion criteria: * female * primary or secondary cesarean delivery * able to consent to research study exclusion criteria: * 3 or more prior cesarean deliveries * history of abdominoplasty * history of abdominal hernia repair with mesh * allergy to lidocaine * allergy to adhesives in medical tape * women who received general anesthesia for their cesarean delivery * women with active substance abuse * women methadone or suboxone for a history of opiate abuse
a static passive stretching on glenohumeral rotation range of movement in elite swimmers

Conditions: Shoulder Injury

Summary: shoulder injury is a common problem of overhead athletes, as swimmers. it's reported a reduction of side-to-side glenohumeral rotation from 11 to 18 degrees can increase 1.9 points the injury risk, because an alteration in biomechanics can turn lead to clinical findings of impingement and labral pathology. posterior deltoid is a main muscle for propulsion in swimming stroke. to our knowledge, it isn't known how a posterior deltoid static passive stretch could reduce glenohumeral rotation restriction after swimming competition.


Eligibility criteria:
inclusion criteria: * elite swimmers exclusion criteria: * shoulder surgery * dislocation

Keywords: shoulder glenohumeral stretching