Kornimate/medical-research-clean huggingface dataset:
automated fetal weight estimation: a multicenter validation using fractional limb volume

Conditions: Birth Weight; Fetal Growth Retardation; Fetal Weight; Fetal Macrosomia

Summary: this trial is a collaborative study between 4 sites worldwide. a total of 600 research subjects will be enrolled. we will investigate the validity of using 5d limb volume software to improve on estimated fetal weight predictions over a broad range of gestational ages. the purpose is to compare the accuracy and precision of birth weight predictions based on this new technology as compared to the current 2d birth weight prediction models.

ultrasound has been used for over 20 years to estimate fetal weight prior to birth. sometimes this estimation is not always similar to what the baby actually weighs. in addition to the regular measurements taken at routine ultrasound exams, 3d ultrasound of the baby's arm and leg soft tissue may give us more precise information on how much the baby weighs. this measurement is called fractional limb volume. fractional limb volume (flv) is a soft tissue measurement of the arm or thigh that can be used to evaluate body composition. this measurement mostly reflects the fat and muscle development with a small amount of bone. the recent introduction of 5d limb volume software (samsung, seoul, korea) now makes it possible to efficiently and reproducibly measure semi-automated flv using a computer guided technique. subjects will receive one ultrasound scan 4-7 days before their delivery. both 2d and 3d measurements will be taken. these measurements will then be used to estimate fetal weight. we will compare estimated weight to actual birth weight in order to determine the accuracy and precision of the 5d limb volume technology. this data may also be used to develop new weight estimation models that could provide better accuracy and/or precision than what is currently provided using published methods.

Eligibility criteria:
inclusion criteria: 1. pregnant women (28-42 weeks) within 4-7 days of delivery 2. planned delivery at the collaborating hospital where the fetal us scan was performed 3. body mass index at first official prenatal appointment below 35.0 kg/m2 4. firm us dating criteria (early crown-rump length \< 14 weeks gestational age) exclusion criteria: 1. presence of technical factors (e.g. obesity) that make it difficult to visualize fetal structures 2. oligohydramnios determined by amniotic fluid index less than 5cm 3. fetal distress or unstable maternal condition 4. structural or chromosomal fetal anomalies
integrated care for pediatric obesity using telehealth

Conditions: Pediatric Obesity

Summary: obesity is perhaps the most urgent public health crisis in pediatrics. thus, managing childhood obesity is a top priority among pediatricians in primary care settings. however, effective treatment typically is multidisciplinary, and most practices currently do not have the infrastructure for coordinating integrated care. with the advent of the affordable care act (aca), innovative systems for building multidisciplinary teams to provide integrated care through a patient-centered medical home will be at a strategic advantage. the use of electronic technologies for delivering health-related information or services, known as telehealth, is an innovation with the potential to streamline integrated care and transform interventions for chronic diseases. we propose a pilot study to evaluate telehealth for treating pediatric obesity in collaboration with a community practice (wareham pediatrics). patients aged 10 to 17 years who participate in the telehealth intervention study (n=40) will be randomly assigned to an "immediate" intervention group or a "wait list" control group. subjects in the "immediate" intervention group will begin the 6-month telehealth intervention at the time of enrollment in the study and then receive general patient/family counseling from their primary care providers (pcps) at routine office visits during a 6-month follow-up period. those in the "wait list" control group will receive general patient/family counseling from their pcps for 6 months followed by the telehealth intervention for 6 months. thus, the total duration of participation in the study for each subject will be 12 months. the telehealth intervention will include dietary, physical activity, and behavioral management counseling provided by videoconferencing from the owl clinical providers at boston children's hospital to children in their homes, or at a telehealth station at wareham pediatrics.


Eligibility criteria:
inclusion criteria: * aged 10 to 17 years * bmi ≥95th percentile for age and sex * no known significant obesity comorbidity or cause requiring urgent medical evaluation or treatment in a subspecialty program other than an obesity program * no known physical limitations to changes in diet or activity level (i.e., concern for cardiac disease, primary gastrointestinal disease, or orthopedic concerns) * patient at wareham pediatrics practice exclusion criteria: * unstable home environment (homeless, temporary living situation, lack of working phone or electricity) * inability to actively participate in treatment (developmental delay, nonverbal, severe psychiatric illness). * physician diagnosis of a major medical illness or eating disorder. * chronic use of any medication or supplement that may affect study outcomes. * another member of the family (i.e., first degree relative) or household participating in the study. * planning to relocate from current area of residence during the proposed timeframe for study participation

Keywords: pediatric obesity telehealth
predictors of therapeutic success and adverse events in endoscopic ampullectomy

Conditions: Ampulla of Vater Adenoma; Ampulla of Vater Disease (Benign/Malignancy)

Summary: although ampullary tumors are rare (representing 0.6-0.8 % of all digestive cancers), their estimated incidence has increased in recent years (\<1 per 100 000 per year). most noninvasive ampullary tumors of the major papilla occur as sporadic and asymptomatic lesions, detected during conventional upper endoscopy performed for another indication. nonetheless, they can present with jaundice (17%), pain (14%), pancreatitis (4%), cholangitis (1%), and can be associated with common bile duct stones (up to 38%). resection of ampullary adenomas is warranted to prevent malignant progression. the most recent european society of gastrointestinal endoscopy (esge) recommend endoscopic ampullectomy as the standard of care approach for ampullary adenomas without intraductal extension, due to excellent outcomes of technical and clinical success (high complete and curative resection rates of 94% and 87%, respectively), with lower morbidity and recurrence rates. this procedure as a low rate of mortality (of 0.4%), but the rate of adverse events can exceed 20%. the most frequent adverse events are acute pancreatitis (12%), intraprocedural and/or delayed bleeding (11%), perforation (3%), cholangitis (3%), ampullary stenosis (2.5%). also there is a high recurrence rate of up to one third after endoscopic resection; up to two thirds are identified at the first follow-up endoscopy, requiring additional endoscopic resection or surgery.

the relevance of the study is to assess the predictors for therapeutic success, adverse events and recurrence after endoscopic ampullectomy is of paramount importance to develop expertise in this challenging procedure. the occurrence of adverse events after endoscopic ampullectomy carries a significant impact on the prognosis and recovery, possibly limiting a broader proficiency in this procedure. thus, identifying significant predictors is crucial to more accurately select the patients and to evolve strategies to prevent and minimize the incidence and severity of adverse events.

Eligibility criteria:
inclusion criteria: * adult patients (≥18 years) submitted to endoscopic resection of an ampullary adenoma with the following features were included: * lesions up to 30 mm (including with laterally spreading component) * with low-grade or high-grade dysplasia on preprocedural histology * with no intraductal extension * with no evidence of invasive malignancy on endoscopic assessment (including endoscopic features including hard consistency, friable or ulcera:ve surface and spontaneous bleeding) * a minimum follow-up period of one year afer endoscopic ampullary resection. exclusion criteria: * patients with lesions with the following features were excluded: * intraductal extension * evidence of invasive malignancy * other non-adenomatous lesions * patients who underwent endoscopic resection or surgical ampullectomy prior to enrollment * patients with a follow-up of less than a year after endoscopic ampullary resection * patients with pancreas divisum.
a human in vivo feeding study of the blood monocyte response to dietary lipid intake

Conditions: Atherosclerosis

Summary: the aim of the present study is to identify the effects of different dietary fats on the body's immune system and how different types of cells respond. there will be two rounds of recruitment in order to satisfy different aims of the study. in the first round, volunteers will be asked to undergo five separate 1-day assessments where you will be given diets in the form of milkshakes differing in amounts of fats. volunteers recruited for this round will also be given the opportunity to participate in the second round of recruitment and feeding. a second round of recruitment will then take place to complete recruitment, if required. in the second round, volunteers will be asked to undergo two separate 1-day assessments in the form of milkshakes with differing fats, one of which will contain a tracking label added to the food during preparation. this label is in the form of is a 'stable isotope' and safe to consume (used commonly in some medical tests - see below for further information) and will allow the researchers to later find the food particles within blood cells. during these 1-day assessments blood samples will be collected to identify the impact different diets have on the immune system, specifically monocyte cells thought to play an important role in the development of atherosclerosis, a primary cause of cardiovascular disease.


Eligibility criteria:
inclusion criteria: * healthy men * aged between 18-65 years (inclusive) * body mass index of between 18.5-25kg/m2 exclusion criteria: * female * undiagnosed metabolic syndrome (assessed at initial screening) * current smokers * substance abuse * excess alcohol intake * significant medical illness including: diabetes, established cardiovascular disease, cancer, gastrointestinal disease (e.g. inflammatory bowel disease or irritable bowel syndrome), kidney, liver or pancreatic disease or autoimmune or inflammatory disease processes. * taking regular medications * major surgery in last 6 months
a study of alks 3831 in adults with acute exacerbation of schizophrenia (the enlighten-1 study)

Conditions: Schizophrenia

Summary: this study will evaluate the efficacy of alks 3831 in adult subjects with acute exacerbation of schizophrenia.


Eligibility criteria:
inclusion criteria: * has a body mass index (bmi) of 18.0 - 40.0 kg/m\^2 * meets criteria for the diagnosis of schizophrenia * resides in a stable living situation when not hospitalized * is willing and able to provide government-issued identification * additional criteria may apply exclusion criteria: * has had a psychiatric hospitalization for more than 30 days during the 90 days before screening * subject initiated first antipsychotic treatment within the past 12 months, or \<1 year has elapsed since the initial onset of active-phase of schizophrenia symptoms * subject poses a current suicide risk * subject has a history of treatment resistance * subject has a history of poor or inadequate response to treatment with olanzapine * subject requires or has had electroconvulsive therapy (ect) treatment in the 2-month period prior to screening * subject has a diagnosis of moderate or severe alcohol or drug use disorder * subject has a positive urine drug screen for opioids, amphetamine/methamphetamine, phencyclidine, or cocaine at screening * additional criteria may apply

Keywords: alkermes alks 3831 samidorphan schizophrenia acute exacerbation of schizophrenia
spatial cognition assessment in virtual reality

Conditions: Spatial Neglect

Summary: unilateral spatial neglect (usn) is a highly-prevalent neuropsychological syndrome following a cerebral stroke characterized by massive impairments in daily life. the evaluation and the rehabilitation of usn encounter many limits whereas immersive virtual reality (vr) could be an efficient tool to go through these limits by imitating an environment of perception and action very close to the real one. the investigators will test a multisensory battery of evaluation based on vr for the diagnostic of usn.


Eligibility criteria:
inclusion criteria: * unilateral right stroke exclusion criteria: * epilepsy / migraine * craniotomy * major sensory/motor deficit * severe cognitive impairment

Keywords: spatial neglect virtual reality assessment
fear of activity in situations (facts) - study 2016

Conditions: Chronic Heart Failure; Fear of Movement (Fear of Physical Activity)

Summary: the aim of the study is to evaluate the psychometric properties of the newly developed fear of activity in situations - heart failure (facts-hf 15) scale. the facts-hf 15 is a questionnaire assessing fear of physical activity (fear of movement) in patients with chronic heart failure. facts-hf 15 assesses cognitions and emotions that can occur during physical activity, independent of avoidance behavior. firstly, the study aims at evaluating the instrument's reliability and validity and to investigate associations of fear of physical activity with demographic, medical, and psychosocial patient characteristics. secondly, the study aims at assessing everyday physical activity using accelerometric measures to test the hypothesis that fear of physical activity in patients with heart failure is related with lower actual physical activity.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of heart failure stage b or c (hunt et al., 2005), or: new york heart failure classification ii to iiib: 1. systolic dysfunction: left ventricular ejection fraction \< 45% in the last 6 month 2. diastolic dysfunction: left ventricular ejection fraction \>= 45% in the last 6 month exclusion criteria: * complex ventricular arrhythmias * acute myocarditis * symptomatic cardiac valve stenosis * instable angina pectoris * other severe diseases, that impair physical activity (e.g., advanced stages of cancer) * insufficient language skills in german to answer the questionnaires * insufficient cognitive skills to answer the questionnaires

Keywords: heart failure fear of physical activity motor activity
clinical efficacy of roxithromycin in men with chronic prostatitis/chronic pelvic pain syndrome

Conditions: Chronic Prostatitis; Chronic Pelvic Pain Syndrome

Summary: roxithromycin is effective in the treatment of intracellular organisms, including chlamydia and mycoplasma, and exhibits anti-inflammatory and immunomodulatory effects on respiratory diseases. to explore the potential therapeutic benefit of roxithromycin in chronic prostatitis/chronic pelvic pain syndrome (cp/cpps), this study compared the effect of roxithromycin with ciprofloxacin and aceclofenac.

a total of 75 patients with cp/cpps were randomized to three groups in open-label: group 1, ciprofloxacin; group 2, aceclofenac; and group 3, roxithromycin. the patients were treated for 4 weeks and were subsequently followed for 12 weeks. changes from baseline in the total and domain scores of the nih chronic prostatitis symptom index (nih-cpsi) were evaluated.

Eligibility criteria:
inclusion criteria: * diagnosis of category iiia of iiib chronic prostatitis * nih-cpsi (national institute of health chronic prostatitis symptom index) score ≥ 15 exclusion criteria: * urinary tract infection or uropathogen within the past 12 months * serious medical problems * nih consensus exclusion criteria13 (presence of active urethritis, urogenital cancer, urinary tract disease, functionally significant urethral stricture, neurological disease affecting the bladder, etc.) * drug therapy that might affect lower urinary tract functions within the past 3 months
peer-led social media intervention to prevent hiv among young men who have sex with men (ymsm)

Conditions: Pre-Exposure Prophylaxis; Hiv; Men

Summary: the aim of this study is to examine the effect of social media intervention on the use of pre-exposure prophylaxis (prep) by young men who have sex with men (ymsm) in the greater new haven area.

there are three specific aims of this study. in the first specific aim, two focus group discussions (fgds) of ymsm will be conducted to assess the feasibility and acceptability of social media intervention. in the second specific aim of the study, a quasi-pre-post experimental study will be conducted to examine the effect of social media intervention on prep uptake (primary outcome) and prep use intention, hiv testing, prep knowledge, self-efficacy and social support (secondary outcome). in the third specific aim of the study, the most important topics around prep will be assessed on the facebook page of the intervention group by conducting a content analysis.

Eligibility criteria:
inclusion criteria: * biologically male or transgender man * self-identification as gay or bi-sexual * resident of greater new haven area * willing and able to use facebook during the span of the study exclusion criteria: * • women will not be included in the study * under the age of 18 and over the age of 29 * unable to provide informed consent * verbally or physically threatening to research staff

Keywords: pre-exposure prophylaxis (prep) social media intervention
long-term ultrasound guided foam sclerotherapy versus classical surgical stripping study

Conditions: Varicose Veins

Summary: the aim of this study is to investigate the long-term follow-up of the previously conducted foam study.

it describes the long-term quality of life (qol) after ultrasound guided foam sclerotherapy (ugfs) and surgical stripping, outcomes with regard to clinical, and ultrasound recurrence, progression of venous disease, predictive value of the presence of central / deep venous obstruction for recurrence of varicose veins and the long term cost analysis. recurrence of varicose veins was defined as the presence of one or more venous symptoms such as pain, cramps, restless legs and a tired/heavy feeling in the treated leg, in combination with the presence of reflux longer than 0·5 s. the initial definition of recurrent reflux, which is defined as reflux for more than 2 cm in length in the treated vein segment (proximal great saphenous vein (gsv) ) as measured by colour flow duplex ultrasound (dus). dus findings of the treated proximal gsv were categorized as: 1, absence of reflux; 2, reflux; 3, occlusion; 4, partial occlusion with reflux; 5, absence of vein, is being used. patients in categories 2 and 4 are considered to have reflux.

Eligibility criteria:
inclusion criteria: * all patients included in previous foam study exclusion criteria: * no received informed consent

Keywords: foam ugfs stripping incompetence
investigation of the effects of diaphragm exercises in children with cerebral palsy

Conditions: Cerebral Palsy Spastic Diplegia

Summary: the aim of this study is to examine the effects of diaphragmatic myofascial relaxation exercise and diaphragmatic breathing exercises added to the conventional physiotherapy and rehabilitation program in children with diplegic cerebral palsy (cp), primarily on mip, mep, and secondarily on thoracic cage mobility, pulmonary functions and sitting ability.

this research is a randomized controlled trial. volunteers diagnosed with cerebral palsy who applied to marmara university pendik training and research hospital will participate in the research. a voluntary consent form will be obtained from the participants at the beginning of the study. demographic and clinical information form will be filled for each patient at the beginning of the study before clinical evaluations. demographic and clinical information form; age, gender, height, weight, body mass index (bmi), how many weeks were born, birth weight, drug use, disease history, number of siblings, neonatal intensive care hospitalization history, education level of parents will be questioned. the gross motor functional classification system (kmfss) will be used to determine the functionality levels of the volunteers who will participate in the study. the following tests will be applied to all of the volunteers who will participate in our study before and after the intervention: respiratory muscle strength measurement thoracic cage mobility assessment pulmonary function tests gross motor functional measurement (part b) children meeting the inclusion criteria will be randomly assigned to two groups. the control and research groups will receive an individualized conventional rehabilitation program for 45 minutes, 2 days a week for 8 weeks. in addition to conventional rehabilitation, manual diaphragmatic relaxation exercises and diaphragmatic breathing exercises will be applied to the children in the research group two days a week. after 8 weeks of intervention and control group applications, the evaluations made at the beginning of the intervention will be repeated. the evaluations of the two groups will be compared statistically and the results will be interpreted.

Eligibility criteria:
inclusion criteria: * being diagnosed with spastic diplegic cerebral palsy * being between the ages of 5-15 * gross motor functional classification system 1,2 or 3 * to be at a cognitive level to be able to understand and apply the instructions in the tests (sft, mip, mep) to be applied exclusion criteria: * having had a surgical operation in the last 6 months * presence of scoliosis detected above 30 degrees * having a planned surgery within 3 months from the start of the study * have a chronic lung disease

Keywords: cerebral palsy respiratory strength pulmonary functions sitting ability