Kornimate/medical-research-clean huggingface dataset:
hypnotics to improve polysomnography yield: eszopiclone vs ramelteon?

Conditions: Obstructive Sleep Apnea

Summary: this study is being conducted to determine if eszopiclone is as effective as ramelteon when used as a pre-medication (sleeping pill) in sleep studies performed to diagnose and treat sleep apnea.

many veterans suffer from sleep disordered breathing with a high prevalence of undiagnosed obstructive sleep apnea. one test that can be effective in the diagnosis of sleep apnea is the polysomnogram (psg). split-night psg consists of a diagnostic phase in the first half of the night and a continuous positive airway pressure titration (cpap) in the second half of the night. cpap is the standard, most effective therapy for obstructive sleep apnea. due to the unfamiliar sleep environment of the laboratory and instrumentation that must be used (application of electroencephalogram leads), patients are frequently not able to sleep adequately. in these cases, the psg must be repeated. oral hypnotic agents are often used as a pre-medication to increase the yield of psg in an attempt to decrease the need for repeat studies. numerous data is available on the effects of premedication with oral short-acting hypnotics on psg quality and efficacy of cpap titration. in one study, eszopiclone, a nonbenzodiazepine gaba-receptor agonist short-acting hypnotic, has been shown to improve psg quality and cpap titration. another short-acting hypnotic, ramelteon, was recently approved by fda but the effects of ramelteon in improving psg quality and efficacy of cpap titration are unclear. the advantage of ramelteon over eszopiclone is the lack of drug dependency or abuse potential. this study aims to evaluate the efficacy of ramelteon compared to eszopiclone when administered prior to split-night psg and cpap titration.

Eligibility criteria:
inclusion criteria: * referred by va long beach sleep clinic at their initial evaluation during outpatient consultation for suspect obstructive sleep apnea. exclusion criteria: * sleep disorders other than obstructive sleep apnea * no prior psg * uncontrolled medical condition * prior known adverse reaction to eszopiclone or ramelteon * liver disfunction * current alcohol abuser * current illicit drug abuser * alcohol consumption 12 hours prior to polysomnography * decompensated psychiatric disorders * severe dementia * concomitant use of benzodiazepines, trazodone, narcotics, barbiturates or other medications with sedative or hypnotic effects

Keywords: obstructive sleep apnea eszopiclone ramelteon polysomnography
study investigating the best method of treatment of bile duct stones in higher risk patients

Conditions: Choledocholithiasis; Higher Risk Patients

Summary: the aim of the trial is to compare two operations which are used to treat bile duct stones. the hypothesis of the study is that there is no difference between endoscopic sphincterotomy followed by laparoscopic cholecystectomy or laparoscopic bile duct exploration during laparoscopic cholecystectomy in the treatment of bile duct stones in higher risk patients.


Eligibility criteria:
inclusion criteria: * gallbladder stones * at least strong evidence of bile duct stones (abnormal lfts and dilated bile duct) * higher risk (\>70yrs, \>60yrs with co-morbidity, \>50 with bmi\>40) exclusion criteria: * not fit for general anaesthesia * cholangitis requiring emergency ercp * previous upper gi surgery making ercp impossible

Keywords: common bile duct calculi choledocholithiasis endoscopic sphincterotomy cholecystectomy, laparoscopic laparoscopic bile duct exploration
cervical epidural and stellate ganglion block in upper limb complex regional pain syndrome

Conditions: Stellate Ganglion Block; Cervical Epidural; Complex Regional Pain Syndromes

Summary: evaluate the efficacy of two regimens of management in relieving chronic refractory pain in patients with upper limb complex regional pain syndrome after orthopedic trauma

ideal therapy for complex regional pain syndrome is multimodal with the use of physical therapy, psychotherapy, and pharmacologic therapy to complement interventional procedures. within pharmacotherapy, drugs most often utilized include non steroidal anti-inflammatory drugs (nsaids), gamma-aminobutyric acid receptor agonists (i.e., gabapentin, pregabalin), and n-methyl-d-aspartate (nmda) receptor antagonists (i.e., ketamine). in complex regional pain syndrome treatment, stellate ganglion block (sgb) is a well-established method of nerve blockade of the sympathetic ganglia in the lower cervical and upper thoracic region. epidural block have differential block as sensory, motor, and sympathetic. nerve functions are blunt at different rates and to different degrees. sensory block occurs with a lower concentration of local anathesia and develops faster than motor block with coexisting sympathectomy.

Eligibility criteria:
inclusion criteria: 1. patients aged more than 21 years old of both sexes with american society of anesthesiologists i and ii 2. upper limb trauma patients with pain disproportionate to the degree of tissue injury and persists beyond the normal expected time for tissue healing 3. patients diagnosed as (complex regional pain syndrome ) based on budapest criteria there should be at least one symptom or sign in three of the four previous categories that can not be explained by other diagnosis. 4. the average daily pain intensity required on numerical rating scale is 7 or more for at least 3 months despite of standard therapy which includes: (pharmacologic therapy non-steroidal anti-inflammatory drugs, antiepileptic drugs(aeds), antidepressants), as well as physical therapy and psychiatric care. exclusion criteria: * patient refusal * patients with unstable psychological or psychiatric conditions, including: untreated bipolar disorder, post-traumatic stress disorder, major depression, severe personality disorder and psychotic illness * patients have recently undergone major interventional pain procedures, such as nerve blocks or implantable therapies. * patients with known drug dependency or substance use disorder specifically related to ketamine or other psycho-stimulant drugs * patients with previous severe reactions, contraindication or allergy to ketamine * patients with hepatic or renal impairment * active infection at the injection site * known allergies to medications * previous neck surgeries * raynaud's disease or raynaud's phenomena * coagulopathy
twk10 improves muscle mass and functional performance in frail older adults

Conditions: Frail Elderly Syndrome; Sarcopenia

Summary: to explore the effect of "lactobacillus plantarum twk10 (hereinafter referred to as twk10)" produced by synbiotech biotechnology co., ltd. on alleviating and improving the aging and debilitating diseases of the elderly. methods: it is expected to recruit 55-85-year-old senior citizens, who are assessed by the clinical frailty scale (cfs) as debilitating disease grades 1 to 4 as the experimental subjects of this study. all subjects were divided into three groups according to the principle of balance order of frailty grades, namely (1) placebo group (placebo group, average 77.4 years old), (2) supplement twk10 probiotic 2x1010 cfu/day dose group (twk10-l) group, average 77.1 years old), (3) supplemented with twk10 probiotic 6x1010 cfu/day dose group (twk10-h group, average 79.0 years old). the experiment was supplemented for 24 consecutive weeks, and before supplementation, 6 weeks, 12 weeks, 18 weeks, the whole body composition and bone density test, as well as the functional fitness test were carried out in sequence. the items include: 3 meters walking ( balance and gait assessment), 10-meter walking, 30-second sit-ups, and changes in the maximum grip strength of the left and right hands. results: the experimental data showed that in the functional test, supplementing the twk10-h group significantly improved the 3m gait balance, 10m walking, and lower limb muscle strength (30-second sit-ups) in the functional test. in terms of body composition and bone density, twk10-h can significantly increase relative muscle mass after 18 weeks of supplementation. conclusion: this study confirmed that supplementation of lactobacillus plantarum twk10 for 18 consecutive weeks can significantly promote the improvement of functional tests for the elderly, such as: 3m gait balance, 10m walking, lower limb muscle strength and grip strength, and can maintain and improve muscle mass. it has the effect of improving the frailty and muscle loss of the elderly.


Eligibility criteria:
inclusion criteria: * the clinical frailty scale (clinical frailty scale, cfs) assessed as frailty grade 1\~4. exclusion criteria: * diagnosed by the attending physician and confirmed that there is no stroke, hypertension patients and no exercise contraindications * can't sit to stand independently * long-term antibiotics.
sensing-glove system in manual therapy

Conditions: Spinal Manipulation

Summary: the objective of this clinical trial is to assess manual therapists' attitudes towards using a sensing-glove system for measuring spinal manipulation force and to compare the effectiveness of two interventions in enhancing their attitudes. the primary questions it aims to address are: * are manual therapists receptive to employing a sensing-glove system to measure the force applied during spinal manipulations on patients? * can we enhance manual therapists' attitudes towards this system through either a brief informational video demonstration or a supervised practice session with the system? researchers will compare the impact of a 7-minute informational video to that of a 20-minute supervised practice session to determine if manual therapists' attitudes towards the use of a sensing-glove while treating their patients can be positively influenced. participants will: * engage in a single experimental session. * complete a questionnaire at the beginning of the experimental session. * undergo one of the two interventions and promptly complete two questionnaires following this intervention. * undergo the other intervention and promptly complete the same two questionnaires following this intervention.

this study aimed to evaluate manual therapists' acceptability of a sensing-glove system for measuring spinal manipulation's force-time characteristics and compare the effectiveness of two interventions in enhancing their acceptability and usability perception. participants will undergo two acceptability-enhancing interventions in randomized order: a 7-minute informational video and a 20-minute supervised practice session. at the start of the session and after each intervention, the acceptability and perception of usability towards the system will be assessed.

Eligibility criteria:
inclusion criteria: * being a licensed chiropractor or a last-year intern in a university outpatient chiropractic clinic exclusion criteria: * reported any upper limb injury preventing them from executing manual therapies during the time of the study * previous experience with the sensing-glove system

Keywords: chiropractic manual therapy acceptability usability force-time characteristics
alveolar echinococcosis: parasite viability and innovative markers for the follow-up of patients treated with albendazole

Conditions: Alveolar Echinococcosis

Summary: study design to define improved management of patients with hepatic alveolar echinococcosis treated with albendazole and especially make appropriate and timely decision of treatment withdrawal . based on exploratory analysis of existing and newly developed biological and imaging exams, for diagnosis and follow-up, and study of the relationship of these markers to the viability of the parasite and/or the activity of the parasitic lesions the study included two series of patients: operated on (curative hepatectomy) // non-operated on

close follow-up of the patients, based on who guidelines (brunetti, acta tropica 2010), including albendazole bloods levels determination. clinical exam, sampling and storing (biobank) of blood specimens at inclusion, m1, m3, m6, m9, m12, m18, m24, m30, m36, m44, m48. additional sampling for operated on patients : m15 and m21. imaging each year (us, ct, pet-ct \& rmi). preservation of operative specimens samples at -80°c: samples taken at different location (center and periphery of the lesions) and in distant non-infected liver, for further studies of the immune response, rna detection, and albendazole dosages.

Eligibility criteria:
inclusion criteria: * hepatic alveolar echinococcosis * without antiparasitic treatment or with antiparasitic treatment and hepatectomy programmed exclusion criteria: * patients with exclusively extra-hepatic form of alveolar echinococcosis * women without effective contraception (contraindication to benzimidazoles) * the immunosuppressed patients or receiving an immunosuppressive treatment will not be the object of a stop of the post-operative treatment by albendazole on 1 year after the intervention of radical resection; they can be included in the study but will receive the albendazole during 2 years; this exclusion applies to the patients treated by liver transplant.

Keywords: albendazole benzimidazole echinococcus multilocularis alveolar echinococcosis liver diseases
uninterrupted direct-acting oral anticoagulation in patients undergoing transradial percutaneous coronary procedures

Conditions: Coronary Artery Disease; Bleeding; Direct Acting Anticoagulant Adverse Reaction

Summary: up to 20-30% of patients who are candidates for direct oral anticoagulation (doac) present with concomitant ischemic heart disease and often require coronary angiography with or without percutaneous coronary intervention (pci). the decision whether to continue the doac throughout periprocedural period or interrupt doac before planned procedure represents a substantial challenge in daily clinical practice. the objective of this study is to evaluate the safety of uninterrupted direct-acting oral anticoagulation in patients undergoing trans-radial percutaneous coronary procedures.

the study design is an investigator-initiated, single-arm, open-label, pilot study in patients treated with doac undergoing trans-radial percutaneous coronary procedures. because of the exploratory nature of this study, no formal sample size calculations are required. on the basis of previous pilot studies with similar designs, a sample of 200 patients is planned; with a safety stopping rule based on the occurrence of barc type 3 or 5 bleeding. in the present trial, if during the enrollment period more than 3 cases of barc 3 or 5 bleeding occur up to 30-day follow-up, patient recruitment will be terminated. this number is based on the reported 1.6% barc type 3 or 5 bleeding in patients undergoing transradial percutaneous coronary procedures.

Eligibility criteria:
inclusion criteria: * patients under anticoagulation with doac and any indication for diagnostic or therapeutic trans-radial percutaneous coronary procedures. at least 25% of the population undergoing pci will be included. exclusion criteria: 1. aged \< 18 years 2. cardiogenic shock 3. major active bleeding at the time of the procedure 4. use of mechanical circulatory support 5. chronic total occlusions 6. pre-planned vascular access different from radial artery access (i.e. femoral, brachial, ulnar) 7. inability to provide informed consent 8. unable to understand and follow study-related instructions or unable to comply with study protocol 9. currently participating in another trial 10. pregnant women
long-term effects of laser refractive surgery

Conditions: Myopia

Summary: this study will determine if there are short- and long-term postoperative differences in visual and corneal outcomes between different laser refractive surgical procedures.

we will measure postoperative differences in visual acuity, contrast sensitivity, corneal light scatter, density of keratocytes and subbasal nerves, corneal sensitivity, corneal topography and wavefront between prk performed with epithelial removal by a laser or by a rotary brush and between lasik performed by using a microkeratome or by using a femtosecond laser. measurements will be made at baseline and at intervals over 5 postoperative years in 21 lasik patients, 20 prk patients, and 20 unoperated controls.

Eligibility criteria:
myopia 1-10 diopters no other ocular abnormalities except presbyopia
trial of sertraline to treat children with fragile x syndrome

Conditions: Fragile X Syndrome

Summary: this study is a control trial of sertraline (zoloft) in fragile x syndrome children aged 2 years to 5 years 8 months old. the trial is six months long, and each participant will receive a series of tests at both the beginning and end of the study. the researchers hope to show improvements in language and a decrease in autistic symptoms.

this is a single center study and the uc davis mind institute for fragile x syndrome (fxs) patients aged between 2 years and 5 years, 8 months old funded by the health resources and services administration (hrsa). it is a double-blind control trial of sertraline (zoloft), an anti-depressant typically used in the treatment of depression, obsessive-compulsive disorder, panic disorder, and other conditions. the researchers are investigating the use of this selective serotonin reuptake inhibitor (ssri) in fxs because a retrospective study has shown significant improvements in language and decreases in autistic behavior. there is also emerging evidence regarding the stimulation of brain-derived neurotrophic factor (bdnf) and the stimulation of neurogenesis when an ssri is given early on in the development of animal models of down syndrome. the researchers hope to see improvements in language stimulation, social gaze and social reciprocity, spatial attention, and a decrease in autistic behaviors. the aim of this study is to carry out a double-blind placebo controlled trial of sertraline in children with fxs who are between the ages of 2 years and 5 years, 8 months old. at baseline, the researchers will assess behavioral and cognitive development. these children will be treated for six months with either sertraline or placebo. at the end of the six months, the researchers assess the same behavioral and cognitive measures as at the beginning of the study. the researchers will also assess the side effects of the sertraline treatment throughout the study. on march 14, 2017 two secondary outcomes for each of the primary outcomes were added for clarification of measurements at baseline visit and at six-month visit. in april 2017 additional updates were made to report primary and secondary outcome results. by june 2, 2017 all outstanding secondary outcome results had been added. in july 2017, additional updates to the outcome measures and limitations sections were made to address prs review comments. in the process of responding to these comments, a duplicate reported outcome measure was identified and deleted. in august 2017, additional updates to the outcome measures were made to address prs review comments issued in response to the july 2017 updates.

Eligibility criteria:
inclusion criteria: * fragile x syndrome exclusion criteria: * current or past ssri treatment * current or past maoi (monoamine oxidase inhibitor ) treatment * serious co-morbid medical disorder affecting brain function and behavior (not including fragile x syndrome). * uncontrolled seizure disorder or epilepsy * bipolar disorder * latex allergies

Keywords: fragile x syndrome pediatrics sertraline autism
electrocardiography versus pulse oximetry for newborn heart rate determination

Conditions: Prematurity

Summary: the goal of this study is to compare the time required for accurate heart rate measurement of the preterm newborn when using pulse oximetry versus electrocardiography leads.


Eligibility criteria:
inclusion criteria: * gestational age of 24-32 weeks exclusion criteria: * babies with open abdominal defects

Keywords: premature baby heart rate resuscitation
daily duration of compression treatment in patients with symptomatic chronic venous disease

Conditions: Chronic Venous Insufficiency; Varicose Veins of Lower Limb

Summary: aim of study is to investigate the optimal duration and daily regimen of compression treatment in patients with chronic venous disease


Eligibility criteria:
inclusion criteria: * symptomatic chronic venous disease * c0-c4 according to ceap-classification exclusion criteria: * c5-c6 according to ceap-classification * intolerance to compression socks * patient's unwillingness to use compression socks * inability to use compression socks

Keywords: chronic venous disease compression treatment compression socks treatment duration regimen
prospective observational study of erythropoietin-iron interaction in anemia of renal disease

Conditions: Anemia of End Stage Renal Disease

Summary: the purpose of this study is to prospectively collect data on doses of erythropoietic stimulating agents (esa) and intravenous iron, and the markers of erythropoietic activity and iron status. these data will be used to derive mathematical models which will subsequently guide dosing of both agents, such that a desired therapeutic outcome is achieved in every patient, while minimizing patient exposure to both agents.

data will be collected from 120 subjects undergoing hemodialysis treatment at 3 clinical sites across united states (40 per site).5.5 ml blood specimen will be drawn during midweek treatment (wed/thu) to measure: hemoglobin concentration hematocrit red blood cell count platelet count reticulocyte percentage reticulocyte hemoglobin mean cellular hemoglobin mean cellular hemoglobin concentration mean cell volume red cell volume distribution width mean platelet volume serum iron serum ferritin transferrin saturation hepcidin soluble transferrin receptor weekly esa and iron dose delivered will also be recorded. from these data: 1. a mathematical model will be established to find biomarkers most descriptive with respect to erythropoiesis-iron synergy, 2. a mathematical model will be established to correlate iron dose with iron markers.

Eligibility criteria:
inclusion criteria: * receiving or expected to receive esa exclusion criteria: * life expectancy less than 12 months * frequent (once or more per month w/in last 6 months) uncontrolled blood loss * frequent (once or more per month w/in last 6 months) hospitalization * frequent (once or more per month w/in last 6 months) access complications

Keywords: anemia chronic kidney disease erythropoiesis stimulating agents erythropoietin iron iron deficiency