Kornimate/medical-research-clean huggingface dataset:
fetal pillow randomized controlled trial

Conditions: Labor Complication

Summary: the purpose of this study is to evaluate outcomes following cesarean delivery for failure to progress with the use of the fetal pillow. our hypothesis is that time to delivery of the fetus is shorter with implementation of the fetal pillow.

women will be enrolled from the labor floor during their labor course when there is concern for cesarean section for failure to progress in the second stage of labor. these women may be approached if they have a prolonged labor course (before they reach full dilation), when they get to full dilation and start pushing, or following an unsuccessful operative delivery. all women who meet the inclusion criteria will be approached about participation in the study on labor and delivery. the process of informed consent will happen at that time on labor and delivery. all women will be enrolled by study staff or certain physicians at brigham and women's hospital who have agreed to help consent patients for this study. once consent is obtained, the subjects will then be randomized 1:1 into two parallel groups, the fetal pillow inflated (fpi) group and the fetal pillow not inflated (fpni) group. a random number generator will allocate the groups in blocks of ten. the fetal pillows used in the study have been donated by safe obstetrics systems. each patient will have a fetal pillow inserted vaginally by the obstetrician after catheterization of the bladder (if it has not been previously performed). once the fetal pillow is in place, the woman's legs will be placed flat on the operating table. the anesthesiologist will then inflate the fetal pillow if the patient has been randomized into the fetal pillow inflated (fpi) group. in the fetal pillow not inflated (fpni) group, the device will remain, not inflated, in the vagina. the obstetrician will therefore be blinded to the intervention. in the fpni group the obstetrician will continue to be able to use conventional methods for delivery of a second stage arrest including hand from below and reverse breech extraction. the fetal pillow will be drained by the circulating nurse in the operating room following delivery with removal at the end of the procedure by the obstetrician.

Eligibility criteria:
inclusion criteria: * women age 18-50 * term pregnancy (37- 41 6/7 weeks) * singleton gestation in cephalic presentation * fully dilated * both nulliparous and multiparous women * both spontaneous labor and labor inductions exclusion criteria: * breech presentation * presence of contraindication to vaginal delivery * prior cesarean section * presence of congenital anomalies

Keywords: maternal outcomes neonatal outcomes
investigating hearing aid frequency response curves

Conditions: Hearing Loss, Sensorineural; Hearing Loss, Bilateral

Summary: internal research on the manufacturer's hearing aid products has idenitfied areas in which the investigators can improve the hearing aid frequency response curve. this study aims to investigate the current freqeuncy response curve in the manufacturer's products to variations of these curves to determine if hearing aid users prefer the variations over the manufacturer's standard curve.

internal testing has identified areas in which the investigators can improve the performance of the manufacturer's hearing aid products. this should potentially lead to increased hearing aid user satisfaction due to an improvement in sound quality. however, the investigators are currently unsure if implementing these new frequency response curves will be preferred by the manufacturer's clients. therefore, a study is proposed in which hearing aid users will compare the manufacturer's current frequency response curve to variations made to the curve and determine which one they prefer while listening to live speech/music or while streaming speech/music.

Eligibility criteria:
inclusion criteria: * n2 - n4 hearing losses * health outer ear * no visible congenital or traumatic deformity of the outer ear * symmetrical hearing loss - no air-bone gap greater than 10 db at all 500, 1000, 2000, and 4000 hz. * ability to answer questions and repeat sentences * no history of problematic tinnitus or pain/discomfort from loud sounds * no history of active drainage from the ears in the past 90 daysinformed consent as documented by signature * willingness to wear different styles of couplings * willingness to wear binaural fitting * experienced users = more than 3 months of hearing aid experience. if not more than 3 months, they will be considered a new user (experience will not exclude them from study, only will be used to categorize them) * ability to travel throughout facility exclusion criteria: * contraindications to the medical device (md) in this study (e.g. known hypersensitivity or allergy to the investigational products) * limited mobility/not able to come to the scheduled visit * inability to produce reliable hearing test results * history of active drainage from the ear in the previous 90 days * abnormal appearance of the eardrum and ear canal.

Keywords: hearing loss hearing aids frequency response curves
laparoscopic approach in adhesive intestinal obstruction

Conditions: Efficacy of Laparoscopic Adhesiolysis

Summary: a clinical trail to evaluate the efficacy of laparoscopic approach in adhesive intestinal obstruction .

there was a rapid growth of minimally invasive operations. through its peritoneal tissue sparing character and minimal blood loss, laparoscopy was soon claimed to reduce adhesion formation and associated complications. the aim of this prospective clinical trial study is to evaluate the use of laparoscopy in management of clinically diagnosed adhesive intestinal obstruction and the criteria of selection to get the best results .

Eligibility criteria:
inclusion criteria: * patient who clinically diagnosed as adhesive intestinal obstruction. * both sexes * adult patients (above 18 years old exclusion criteria: * • patient refused to participate in this study. * patients not fit for laparoscopic surgery.
prediction of stn dbs motor response in pd

Conditions: Parkinson Disease

Summary: despite careful patient selection for subthalamic nucleus deep brain stimulation (stn dbs), some parkinson's disease (pd) patients show limited improvement of motor disability. non-conclusive results and the lack of a practical implantable prediction algorithm from previous prediction studies maintain the need for a simple tool for neurologists that provides a reliable prediction on postoperative motor improvement for individual patients. in this study, a prior developed prediction model for motor response after stn dbs in pd patients is validated. the model generates individual probabilities for becoming a weak responder one year after surgery. the model will be validated in a validation cohort collected from several international centers. the predictive model is made public accessible before data collection on: https://github.com/jgvhabets/dbspredict

predicting motor outcome after stn dbs in parkinson disease can be challenging for the clinician. current prediction studies report non-conclusive results on the most important predictors and are limited by used computational methods. traditional statistical analyses which focus on correlations are biased by predictor- and confounder-selection by the investigators. modern computational methods like machine learning prediction models are less limited by sample size and can consider a wider range of predictors which leads to less selection-bias. retrospective patient data is collected from multiple international centers. this retrospective, multicenter cohort is used to validate the model which is developed based on a single-center retrospective cohort. the goal is to develop a prediction tool that provides the clinician with a probability for weak response during the preoperative phase. this could support the clinician in including or informing the patient during preoperative counseling. the predictive model is made public accessible before data collection on: https://github.com/jgvhabets/dbspredict.

Eligibility criteria:
inclusion criteria: * underwent stn dbs for parkinson's disease * completed one year follow up after surgery exclusion criteria: - missing data in postoperative updrs ii, iii, iv

Keywords: deep brain stimulation motor outcome prediction model machine learning subthalamic nucleus
diurnal intraocular pressure and peripapillary retinal blood flow in medically controlled open-angle glaucoma

Conditions: Open-Angle Glaucoma

Summary: diurnal fluctuations of intraocular pressure (iop) and peripapillary retinal blood flow may have distinctive patterns in medically well-controlled open-angle glaucoma patients. in the results, we found a unique pattern, 'latent asymmetric iop', defined as the iop which differs between the eyes only when placed in the supine position. unique effects of this latent asymmetric iop on visual field and diurnal iop fluctuations were studied.

diurnal fluctuations of intraocular pressure (iop) and peripapillary retinal blood flow have been implicated to be one of the important factors to affect visual field progression. however, there was no study to investigate them in medically well-controlled open-angle glaucoma patients. so we want to find the unique patterns. study 1. subjects : patients with medically well controlled open angle glaucoma method : iop and peripapillary retinal blood flow were measured for 24 hours. the relationship between the two were studied. study 2. of the patients enrolled in study 1 , those on the same medical regimen for both eyes were analyzed for the presence of a latent asymmetric iop and it's influence and association with visual field and diurnal iop fluctuation.

Eligibility criteria:
inclusion criteria: * open-angle glaucoma * topical anti-glaucoma medications exclusion criteria: * ocular surgery history * other ocular disease history * oral glaucoma medications

Keywords: open-angle glaucoma diurnal fluctuation intraocular pressure peripapillary retinal blood flow latent asymmetric intraocular pressure
effect of educution in control nutrition and fluid control of hemodialysis patient

Conditions: End Stage Renal Disease

Summary: hemodialysis patients are required to adhere to diet and fluid restriction. the literature shows that hemodialysis patients have low adherence to diet and fluid restriction. failure to adhere to fluid control increases weight gain between two dialysis sessions. increased weight gain between two dialysis sessions can lead to signs and symptoms, such as heart failure, hypertension, edema and dyspnea. ultrafiltration is increased during dialysis to remove excess fluid from the body between two dialysis sessions. as a result, this leads to large changes in the patient's weight during dialysis sessions, leading to hemodialysis complications such as hypotension and muscle cramps. diet is important to prevent uremic complication for hemodialysis patient. diet restriction purposes to minimize uremic symptoms and fluid- electrolyte imbalance. as increase failure to adhere diet, serum phosphorus serum potassium rise and weight gain between two dialysis sessions increases. as a result, problems with the cardiac system, respiratory system and bones are experienced. diet and fluid restriction helps to prevent complications, to increase the quality of life and to reduce mortality. therefore, diet and fluid control vitally important for hemodialysis patients. nurses have an important place in providing diet and fluid management. desired success can be achieved in fluid and diet control by giving planned trainings to patients by nurses. in patient education, the health belief model is used as an effective guide, which explains the reason for the person's attitudes and behaviors. this model is based on explain why did the patient not adhere with the treatment and what motivates the patient. the model is based on the premise that they will change their behavior when people understand the severity of the illness. the health belief model can used education on diet and fluid contol of hemodialysis patients. in this study, health belief model components will be used as a guide in the preparation of the educational content to be given to hemodialysis patients. with this study planned to be done; it was aimed to determine the effect of health belief model-based education on diet and fluid control of hemodialysis patients. the study was planned as a randomized controlled trial.


Eligibility criteria:
inclusion criteria: * he is over 18 years old, * at least 6 months of hemodialysis treatment, * at least primary school graduate, * does not have a condition that interferes with language, hearing or visual communication, * patients who accept to participate in the study are included in the study exclusion criteria: * that do not meet the inclusion criteria, * those who are included in another training program on the subject

Keywords: hemodialysis education health belief model nursing
lci-ped-nos-exer-001: exercise in pediatric oncology patients

Conditions: Pediatric Cancer

Summary: the purpose of this study is to see if there are physical and emotional benefits to participating in a structured exercise regimen for those who are ages 2-25, are newly diagnosed with a blood or solid tumor cancer, and are currently undergoing or will begin cancer treatment.

this is a randomized, controlled trial to investigate if a structured exercise regimen will have benefit relative to the control arm by increasing and /or maintaining physical functioning in pediatric subjects undergoing chemotherapy and childhood cancer treatment as measured by 6-minute walk test and bot-2 brief or pdms-2.

Eligibility criteria:
inclusion criteria: 1. ages 2-25 at time of consent 2. subject has newly diagnosed cancer per investigator, and is planning to undergo chemotherapy for treatment of malignancy for at least 3 full cycles 3. ability of subject (and/or parent/guardian) to read and understand the english or spanish language 4. as determined and documented by the enrolling investigator, ability of the subject to understand and comply with study procedures for the entire length of the study exclusion criteria: 1. known cardiac dysfunction that, in the opinion of the investigator, would be unsafe for the child to participate in the exercise program 2. recent (within 4 weeks of enrollment) or planned surgery that will result in prolonged limited mobility not amendable to exercise modifications per investigator discretion 3. primary cns tumor 4. osteosarcoma

Keywords: exercise pediatric oncology
efficacy, safety, and tolerability of e2007 in levodopa treated parkinson's disease patients with motor fluctuations

Conditions: Parkinson's Disease

Summary: this is a multi-center, randomized, double-blind, placebo-controlled, parallel-group study of e2007 in levodopa treated parkinson's disease patients with motor fluctuations.


Eligibility criteria:
inclusion criteria: 1. male or female patients with idiopathic parkinson's disease fulfilling the united kingdom (uk) parkinson's disease society brain bank diagnostic criteria 7, with a good response to levodopa. 2. patients must have been diagnosed with idiopathic pd at \> 30 years of age. 3. patients must have predictable motor fluctuations of the wearing "off" type. 4. patients must rate between ii-iv on the hoehn \& yahr scale when in an "off" state. 5. patients must be taking optimized levodopa therapy. exclusion criteria: 1. pregnant or lactating women. 2. women of child bearing potential unless infertile (including surgically sterile) or practicing effective contraception (eg, abstinence, intrauterine device or barrier method plus hormonal method). these patients must have a negative serum beta-human chorionic gonadotrophin (b-hcg) test at the screening visit, and a negative urine pregnancy test at the baseline visit (day 0). these patients must also be willing to remain on their current form of contraception for the duration of the study. postmenopausal women may be recruited but must be amenorrheic for at least one year to be considered of non-child bearing potential as determined by the investigator. 3. patients with a past or present history of drug or alcohol abuse as per diagnostic and statistical manual - 4th edition (dsm iv) criteria. 4. patients with a past (within one year) or present history of suicidal ideation or suicide attempts. 5. patients with unstable abnormalities of the hepatic, renal, cardiovascular, respiratory, gastro-intestinal, hematological, endocrine or metabolic systems which might complicate assessment of the tolerability of the study medication.
serum caspase 3, annexin a2 and soluble fas levels and endometriosis

Conditions: Endometriosis; Apoptotic Pathway Deregulation

Summary: the study population will comprise of 90 women age varying between 15-55 years, those are candidate for laparoscopic surgery due to definition of \>4 cm endometrioma or any other benign ovarian cysts such as mature teratoma or simple serous cysts on ultrasound examination, chronic pelvic pain, infertility. the blood samples will be drawn for analysis of serum biomarkers.

the participants will be accepted for the study between 1st of august 2016 to 30th june 2017. 2 cc blood samples will be drawn from the antecubital vein for serum analysis of caspase 3, annexin a2 and soluble fas levels before the operations. the patients will divide into three groups. the group 1 will comprise of 30 patients with benign ovarian cysts such as mature teratoma or simple serous cysts on ultrasound examination. the group 2 will comprise of 30 patients with diagnosis of stage 1-2 endometriosis in guidance with the revised american society for reproductive medicine classification. the group 3 will comprise of 30 patients with diagnosis of stage 3-4 endometriosis in guidance with the revised american society for reproductive medicine classification. the blood samples will be kept in -80 c degree after centrifuge till at the end of the study.the relation between serum caspase 3, annexin a2 and soluble fas levels and severity of endometriosis will be analysed.

Eligibility criteria:
inclusion criteria: * the women ages varying between 15-55 years, those are candidate for laparoscopic surgery due to definition of \>4 cm endometrioma or any other benign ovarian cysts such as mature teratoma or simple serous cysts on ultrasound examination, chronic pelvic pain, infertility. exclusion criteria: * the women with malignant diseases, chronic bowel disease, other defined cause of infertility.
the study of intradialytic symptoms in subjects treated with qd 500vs qd 300

Conditions: End Stage Renal Disease on Dialysis

Summary: study goal is to determine the impact of dialysate flow rate (qd) on subject reported dialysis related symptoms and on time to recovery post dialysis.

the objective of this study is to determine if subjects who report dialysis symptoms while meeting adequacy (as determined by kt/v of 1.2 or greater) on thrice weekly dialysis or who have a recovery time of at least 4 hours when treated on a conventional, i.e. non tablo, hemodialysis device feel better with a reduced dialysate flow rate of 300ml/min based on an assessment of time to recovery post dialysis and subject reported symptoms via a modified weekly esas survey.

Eligibility criteria:
inclusion criteria: 1. subject has provided informed consent and has signed a health insurance portability and accountability act of 1996 (hipaa) compliant authorization statement. 2. subject is at least 18 of age. 3. subject has end stage renal disease (esrd) adequately treated with thrice weekly dialysis. 4. subject is currently stable on dialysis for at least 3 months on a conventional dialysis machine and qd of 500ml/min or higher with no change in the following dialysis prescription parameters over that time: qb, qd, dialyzer, time. 5. subject has a baseline kt/v of greater than 1.2. 6. subject has a stable vascular access. 7. subject reports time to recovery of more than 4 hours or a modified esas with at least 5 symptoms of which at least 2 are rated as moderate (rating of 4-6) or severe (rating of 7-10). exclusion criteria: - 1. subject is unable to complete the questionnaires. 2. subject is pregnant or planning to become pregnant. 3. subject is scheduled for a change in modality or expected kidney transplant in the next 3 months. 4. any other documented condition that the investigator feels would prevent the subject from successful inclusion in the study.

Keywords: hemodialysis flow rate
pathway of dyspneic patient in emergency in the north-east region (north-east paradise)

Conditions: Dyspnea

Summary: this is an observational retrospective multi-center study in patients managed for acute dyspnea by emergency department medical team. the main aim of the study is to evaluate factors associated with mortality risks in patients managed for acute dyspnea by an emergency department medical team, overall, as well as in subgroups of interest (male/female, age categories, mode of admission and comorbidities).


Eligibility criteria:
inclusion criteria: * man or women ≥ 18 years * patients with acute dyspnea cared by a medical team of the emergencies of chru of nancy, chr metz-thionville and ch d'epinal. exclusion criteria: * cardiorespiratory arrest before medical management by the emergency department team * adults under legal protection
low dose methoxyflurane and out-patient aesthetic surgery and facial filler

Conditions: Pain

Summary: the aim of the study is to generate real-world evidence on the effectiveness, safety and additional parameters of low dose methoxyflurane (penthrox®) in: aesthetic surgeries (eg. hair transplant, upper blepharoplasty, otoplasty, upper brow lift, and mentoplasty) and facial filler injections \[eg. hyaluronic acid (ha) and sculptra®\] in an outpatient aesthetic practice. this will be an open-label study, with a total of 60 patients undergoing a planned outpatient aesthetic surgery or filler injection (30 patients in each group).


Eligibility criteria:
inclusion criteria: 1. conscious adult patients: ≥ 18 years of age 2. patient is scheduled for an outpatient anesthetic surgery (eg. hair transplant, upper blepharoplasty, otoplasty, upper brow lift, and mentoplasty) or a facial filler injection (eg. ha, and sculptra®). 3. patient should understand the nature of the study and provide written informed consent 4. patient is able to follow all study requirements and procedures and complete required questionnaires exclusion criteria: 1. an altered level of consciousness, due to any cause, including head injury, drugs, or alcohol 2. clinically significant renal impairment 3. women of child bearing potential who are pregnant or peri partum, including labour 4. a history of liver dysfunction after previous methoxyflurane use or other halogenated anesthetics 5. hypersensitivity to methoxyflurane or other halogenated anesthetics, or to butylated hydroxytoluene 6. known or genetically susceptible to malignant hyperthermia or a history of severe adverse reactions in either patient or relatives 7. clinically evident or potential hemodynamic instability as per the opinion of the investigator 8. clinically evident respiratory impairment as per the opinion of the investigator 9. prior treatment with penthrox® within 3 months