Kornimate/medical-research-clean huggingface dataset:
weight management for adolescents with idd

Conditions: Developmental Disabilities; Weight Loss; Body Weight; Down Syndrome; Body Weight Changes; Intellectual Disability

Summary: the goal of this study is to explore the impact of two different diets (conventional vs. enhanced stop light) and two different delivery systems (face-to-face vs. remote) on weight across 18 months in overweight and obese adolescents with intellectual and developmental disabilities.

rates of obesity and obesity related chronic health conditions are higher in adolescents with intellectual and developmental disabilities (idd) than those in the general population. many of the negative health consequences observed in obese adults are already present in obese adolescents with idd. this study is a 3 group randomized trial to evaluate the intervention delivery system and type of reduced energy diet. the investigators will randomize 123 overweight/obese adolescents with mild to moderate idd to one of 3 groups for an 18 month trial (6 month weight loss; 12 month weight maintenance): group 1) face-to-face/cd group 2) technology delivery/cd group 3) technology delivery/esld. all participants will receive a progressive program of physical activity. participants on the cd diet will be asked to consume a nutritionally balanced, reduced energy, high volume, lower fat ( fat=20-30% energy) diet. participants on the esld will consume pre-packaged portion controlled meals with the addition of 5 fruits and vegetables per day. ftf will meet with a health educator and will track progress using pen and paper records for both physical activity and diet. tech groups will receive the intervention using an ipad with the facetimetm application for video meetings with a health educator and will track progress using the lose it! application for both physical activity and diet.

Eligibility criteria:
inclusion criteria: * age 13-21 yrs * mild (iq of 74-50) or moderate (iq 40-49) idd, * of sufficient functional ability to understand directions, communicate preferences (e.g. foods), wants (e.g. more to eat/drink), and needs (e.g. assistance with food preparation) through spoken language. * overweight or obese (bmi ≥ 85th%ile on cdc growth charts, or waist circumference to height ratio \> 0.5 * living at home with a parent or guardian. * internet access in the home. * no plans to relocate outside the study area over the next 18 mos * physician consent for pa and diet. exclusion criteria: * insulin dependent diabetes * participation in a weight management program involving diet and pa in the past 6 mos * eating disorders, serious food allergies, consuming special diets, aversion to common foods, * diagnosis of prader-willi syndrome * currently pregnant, planning on/becoming pregnant during the study. * unable to participate in moderate to vigorous pa.

Keywords: diet obesity adolescents intellectual and developmental disability
efficacy of carbetocin in prevention of postpartum hemorrhage in obese versus non obese women

Conditions: Obesity, Maternal; Post Partum Hemorrhage

Summary: postpartum hemorrhage \[pph\] can have serious consequences and is the leading cause of maternal mortality globally. uterine contractility plays an important role in post-delivery uterine involution; impaired contractility can contribute to pph. should contractility be impaired among obese women, there would be implications for management. therefore, the investigators sought to investigate whether obese women would also experience a need for more uterine agents during the management of an obstetric hemorrhage.

the american college of obstetricians and gynecologists (acog) updated their definition of postpartum hemorrhage (pph) to be "blood loss greater than or equal to 1000 ml or blood loss accompanied by signs or symptoms of hypovolemia" . recent clinical and translational studies have suggested a decrease in uterine contractility among obese and morbidly obese women as a primary cause of obstetric hemorrhage. in the united states, the prevalence of maternal obesity has been steadily rising, with more than half of pregnant women classified as overweight or obese. a panel of obstetric experts has speculated that the rising prevalence of maternal obesity in developed countries may explain the increase in postpartum hemorrhage incidence. uterotonic drugs are recommended to reduce blood loss and the risk of postpartum hemorrhage (pph) after cesarean delivery. there are several prophylactic uterotonic agents available for use, including oxytocin, oxytocin/ergometrine, and carbetocin. carbetocin is a synthetic analog of oxytocin which provides a longer duration of action than oxytocin (half-life 85-100 min versus 3-4 min). the investigators aim to investigate the impact of carbetocin on uterine contractility in obese versus non-obese pregnant women undergoing elective cesarean delivery following carbetocin 100 mcg bolus iv administration as a prophylaxis of postpartum hemorrhage in a randomized controlled trial. the incestigators hypothesize that increased volume of distribution reduces the bioavailability of carbetocin and may be an explanation for reduced efficacy. also the investigators will examine uterine tone as a surrogate marker for the bioavailability of carbetocin.

Eligibility criteria:
inclusion criteria: * healthy women with a singleton pregnancy undergoing a cesarean delivery after at least 37 completed weeks of gestation under regional anesthesia. * aged (18-39) years and with signed informed consent. exclusion criteria: * emergency cesarean section due to fetal distress. * maternal comorbidities such as severe cardiovascular disorders, kidney or liver disorders, coagulopathies, as well as epilepsy. * uterine malformation. * fetal malformation. * known hypersensitivity to carbetocin or oxytocin. * uterine overdistention (as in polyhydramnios, twins, and fetal macrosomia) * injury of uterine vessels during cs.
detection of tumor dna in blood samples from cancer patients

Conditions: Cancer; Tumors

Summary: the aim of this study is to employ genomic detection methodologies to measure the relative amount of tumor nucleic acids in the blood of a cancer patient with diagnosed metastatic disease that is either commencing, currently undergoing or completed cytotoxic chemotherapy treatment. more generally, this approach will allow us to develop a quantitative measure of therapy efficacy via the counting of the relative changes in tumor molecules over the course of treatment.


Eligibility criteria:
inclusion criteria: * age 18 years or older * have metastatic disease with from a solid tumor (e.g. breast, lung, colon, pancreas, ovary, prostate...) or stage ii or iii solid tumors undergoing curative surgery or neoadjuvant therapy followed by surgery * starting treatment or a new line of treatment * able to understand and grant informed consent * able to have their blood drawn exclusion criteria: * unable to grant informed consent or comply with all study procedures. * has a hematological malignancy, i.e. myeloma, lymphoma, mds, leukemia

Keywords: dna in tumors cfdna wgs advanced stage cancer solid tumors
changing in skin physiology after microdroplet placement of stabilized hyaluronic acid in aging faces

Conditions: Aging

Summary: importance skin rejuvenation can be achieved effectively and safely by injection of a stabilized hyaluronic acid (ha)-based gel of nonanimal origin (nasha) injection using a stamp-type electronic multineedle injector. objective to determine the efficacy and safety of nasha using a stamp-type electronic multineedle injector, and if changes in skin physiology occur earlier than in previous trials. design, setting, and participants twenty-five patients were recruited to this single-center, evaluator-blinded, prospective, balanced (1:1), split-face randomized clinical trial.one dermatologist who was blinded as to the treatment side evaluated the skin hydration, melanin content, erythema, and elasticity of both cheeks using a corneometer, a mexameter, and a reviscometer, respectively, at each follow-up visit (0, 1, 2, 4, 8, and 12 weeks postinjection). the subjects and two independent investigators assessed the clinical improvement using the global aesthetic improvement scale (gais) at the every visit. twenty-four participants completed the study, and no participants withdrew due to adverse effects. interventions each participant submitted to a single treatment with a nasha injection to one side of the lower cheek. the cheek side to which the treatment was applied was chosen randomly.

twenty-five patients were recruited to this single-center, evaluator-blinded, prospective, balanced (1:1), split-face randomized clinical trial. twenty-four participants completed the study, and no participants withdrew due to adverse effects. each participant submitted to a single treatment with a nasha injection to one side of the lower cheek. one dermatologist who was blinded as to the treatment side evaluated the skin hydration, melanin content, erythema, and elasticity of both cheeks using a corneometer, a mexameter, and a reviscometer, respectively, at each follow-up visit (0, 1, 2, 4, 8, and 12 weeks postinjection). the subjects and two independent investigators assessed the clinical improvement using the global aesthetic improvement scale (gais) at the every visit. adverse events were self-reported by the patients completing a questionnaire.

Eligibility criteria:
inclusion criteria: * healthy people older than 25 years exclusion criteria: * known hypersensitivity to ha, an active skin disease, any autoimmune disorder, or significant renal, hepatic, or other medical diseases
study to assess the safety and patients' satisfaction of tears again* in the treatment of dry eye symptoms

Conditions: Dry Eye Syndrome

Summary: the purpose of this study is to determine safety and patients' satisfaction when using tears again to treat dry eye symptoms.


Eligibility criteria:
inclusion criteria: * suffer from at least two of the following ocular symptoms: burning, stinging, excessive tearing, dryness, grittiness, foreign body sensation ( including patients suffering from blepharitis). * use artificial tears or any other treatment for these symptoms three or more times a day. exclusion criteria: * known hypersensitivity to phenoxyethanol. * pregnant and lactating women. * receive other ophthalmic medication (except for eyelid hygiene preparations). * graft-versus-host disease patients. * participated during the last month in another clinical trial.

Keywords: dry eye syndrome
hand-assisted laparoscopic surgery (hals) for myomectomy

Conditions: Uterine Myomas

Summary: the aim of this study was to evaluate the feasibility and usefulness of hand-assisted laparoscopic surgery (hals) for myomectomy, and compare it with the open approach in myomectomy.

uterine myomas are the most common benign tumor of the female genital tract and the leading indication for hysterectomy. despite the fact that laparoscopic myomectomy is becoming increasingly popular, laparoscopic myomectomy remains underutilized because of inherit limitations. the limitations include technical challenges such as dissection of the myoma from its bed using the correct plane or multilayer closure of the myoma bed and the concern about the strength of the suturing and the subsequent risk of uterine rupture. as a result, laparoscopic myomectomy is currently performed only by expert surgeons. hand-assisted laparoscopic surgery (hals) is a unique surgical approach that may overcome the limitations of pure laparoscopic surgery. hals is not only less invasive than open surgery but also causes less technical challenges than laparoscopic surgery based on its manual nature and ability to use retractors. in gynecologic field, hals has also been employed in ovarian cancers and large ovarian tumors. in theory, hals seems appropriate procedure, similar to the open approach, for patients with multiple or huge myomas. to date, no report has evaluated the feasibility and usefulness of hals compared with open surgery (os).

Eligibility criteria:
inclusion criteria: inclusion criteria were as follows: women who had myoma-related symptoms such as menorrhagia, pelvic pressure/pain, or infertility; women who were not pregnant at the time of presentation (i.e., negative for urine pregnancy test or last menstrual period within the last 4 weeks); and women who were appropriated medical status for laparoscopic surgery (american society of anesthesiologists physical status classification 1 or 2). exclusion criteria: exclusion criteria included any other uterine or adnexal abnormalities (e.g., abnormal endometrial thickness, and suspected ovarian or uterine malignancy), any sign of genital infection, presence of submucosal or pedunculated myoma as a dominant myoma, treatment of gonadotropin-releasing hormone (gnrh) agonist 2 months before surgery, or an inability to understand and provide written informed consent.
study to evaluate darbepoetin alfa in pediatric subjects with anemia due to chronic kidney disease

Conditions: Anemia; Chronic Kidney Disease

Summary: the purpose of this study is to find out more about darbepoetin alfa in children less than 1 year of age with anemia (a decrease in red blood cells) due to kidney failure. this study will see if darbepoetin alfa is safe and well tolerated and whether it causes any side effects by taking blood samples and checking vital signs (heart rate, body temperature, and blood pressure tests) at specific times throughout the study. in addition, the study will evaluate the amount of darbepoetin alfa in the blood over time and look at special markers in the blood to evaluate how darbepoetin alfa works on anemia. darbepoetin alfa is approved by the united states food and drug administration (fda) and european medicines agency (ema) for use in adults, but not for all ages of pediatric subjects. therefore, studies need to be conducted in pediatric subjects (children) to determine the appropriate dose to use in younger children.


Eligibility criteria:
inclusion criteria: * girls and boys between birth and \< 1 year of age at the time of enrollment * body weight ≥ 3 kg at screening and enrollment * diagnosis of chronic kidney disease stage 3 to 5 with an estimated glomerular filtration rate \< 60 ml/min/1.73m2 without dialysis using the updated schwartz equation at screening; or on dialysis at screening * hemoglobin ≤ 9.0 g/dl within 7 days prior to enrollment * transferrin saturation ≥ 20% at screening exclusion criteria: * premature girls and boys (\< 37 weeks of gestation, counting from the first day of the mother's last menstrual period) * peritoneal dialysis subjects with an episode of peritonitis within 30 days prior to enrollment * history of cardiovascular events or thromboembolism * history of upper or lower gastrointestinal bleeding * history of seizures * active liver disease or history of liver disease * uncontrolled hypertension defined as stage 2 hypertension or greater. this is defined as a systolic or diastolic blood pressure value greater than the 99th percentile + 5 mmhg for a subject's age * major surgery 12 weeks prior to enrollment * red blood cell transfusions 12 weeks prior to enrollment * use of any erythropoiesis-stimulating agent within 12 weeks prior to enrollment * currently receiving antibiotic therapy for systemic infection within 4 weeks prior to enrollment * current or prior use of immunosuppressants (excluding low-dose corticosteroids, defined as ≤ 0.5 mg/kg per day prednisone or equivalent for ≤ 5 days) * subject is receiving a dose higher than 0.5 mg/kg per day of prednisone (or equivalent dose of another corticosteroid) for \> 5 days within 4 weeks prior to enrollment * receiving or has received any investigational drug (or is currently using an investigational device) within the 30 days or 5 half-lives (whichever is longer) prior to enrollment * subject has known hypersensitivity to darbepoetin alfa, r-huepo, or to any of the excipients

Keywords: paediatric dialysis ckd pediatric
efficacy of penile traction therapy using a novel device

Conditions: Penile Diseases

Summary: this clinical trial is designed to assess the safety, dosing, and preliminary efficacy of a novel penile traction device on correcting deformities relating to peyronie's disease, a condition which results in penile curvature and length loss. the trial is designed as a randomized, placebo-controlled study with men randomized to receiving no therapy or penile traction therapy 30 minutes once, twice, or three times daily. the study will occur over a 3 month period, after which an open label phase for 3 months will be conducted. final assessments for adverse effects will also be assessed at 9 months.

peyronie's disease (pd) is a fibrotic condition of the penis, affecting 1-13% of the us male population. the disease results in penile curvature and significant psychosocial bother. current preferred therapies for pd include repeated penile injections with bacterial enzymes and surgery. however, these therapies are expensive and in some cases result in permanent reductions in penile length and sensation. penile traction therapy (ptt) is a relatively newer treatment which has been proposed as a treatment for pd with preliminary data suggesting a potential role. however, currently available ptt devices are primarily designed for penile lengthening and have many significant limitations including a requirement of use for 9 hours daily and significant difficulties in personal application. given these limitations, a new penile traction device (restorex® ) was created and funded through mayo ventures and was specifically designed to treat men with pd. the primary objective of the current study is to evaluate safety of the device using various dosing schedules, with secondary endpoints designed to assess efficacy and subjective outcomes. to accomplish the study, a population of men from mayo clinic with pd will be enrolled and will be randomized to utilize the device for varying amounts of time. outcomes will be assessed at 3, 6, and 9 months, and results are to be used with the intent to publish in a scientific journal.

Eligibility criteria:
inclusion criteria: * diagnosis of peyronie's disease * current 30 degree curvature in a single plane (i.e. 20 degrees up, 15 degrees left would not be a candidate) * not undergoing other therapies for pd currently exclusion criteria: * stretched penile length \<7 cm * prisoners * erectile dysfunction unresponsive to phosphodiesterase-5 inhibitors or intracavernosal injection therapies * diabetes mellitus with evidence of end-organ damage (peripheral neuropathy, retinopathy, chronic kidney disease stage iii or higher)
goal-orientated coagulation management in hypothermic cardiac arrest surgery

Conditions: Cardiac Arrest

Summary: cardiac surgery including hypothermic cardiac arrest (hca) commonly involves perioperative transfusion of allogeneic blood products which is associated with increased morbidity and mortality. in this retrospective analysis, the investigator aimed to evaluate the effect of a thromboelastometry-guided treatment algorithm promoting fibrinogen concentrate as first line hemostatic agent on the perioperative use of allogeneic blood products.

the investigators will analyze the data of patients undergoing elective and emergent surgical procedures involving the ascendent aorta and/or the aortic arch with the help of hca from january 2009 to june 2011. the investigators will collect and document baseline characteristics, the use of thromboelastometry, thromboelastometric data, and perioperative laboratory data. in addition, the investigators will evaluate perioperative bleeding from mediastinal drainages, perioperative use of blood and hemostatic products, and the adverse events within the hospitalisation including re-exploration, renal impairment, myocardial infarction, severe brain injury, and death.

Eligibility criteria:
inclusion criteria: * cardiac surgery with hca due to pathology of the proximal aorta from january 2009 until june 2011 exclusion criteria: * none

Keywords: blood component transfusion hypothermic
alterations in cognitive function and cerebral blood flow after conversion from immediate release tacrolimus to slow release envarsus

Conditions: End Stage Renal Disease

Summary: the purpose of this study is to learn if conversion from immediate release tacrolimus to envarsus improves cerebral blood flow, brain blood flow response to exercise, and cognition.

each patient will have two study assessments: one at baseline and another one at 12 weeks after the baseline assessment. each assessment may be divided into 2 visits to accommodate the mri and tcd (transcranial doppler ultrasound). detailed medical history will be extracted from the patients' medical records, interviews and questionnaires. we will obtain brain mri (without gadolinium contrast) in enrolled patients. neuropsychological test (np) tests will include a standard battery to detect subclinical changes in cognition which can be missed by screening tests like the mini mental state exam.

Eligibility criteria:
inclusion criteria: * age between 18 and 85 years * english speaking (np tests will be in english); * able to sign informed consent * able to arrange transportation to and from study sites * without acute stroke, concussion or traumatic brain injury * received a kidney transplant at least 12 weeks before recruitment * stable kidney function with serum creatinine \<3mg/dl exclusion criteria: * are claustrophobic or have other contra-indication for mri * have hearing or visual impairment * are unable to read, write, speak or understand english * have uncontrolled psychosis or seizure disorder or are currently using antipsychotics or anti-epileptics * dual organ transplant * oxygen-dependent chronic obstructive pulmonary disease * diagnosis of dementia * unable to perform exercise on the nustep (muscle weakness or cardiac safety concern) * uncontrolled blood pressure

Keywords: end stage renal disease
activation of the sphingosine-1-phosphate (s1p) to s1p1 receptor subtype (s1pr1) axis in patients with endometriosis: identification of potential relevant biomarkers to diagnose and treat

Conditions: Endometriosis

Summary: patients seen at the slucare center for endometriosis (including those with or without pain) undergoing laser excision surgery for known or suspected endometriosis will be recruited for the study. per the pi's standard surgical approach to endometriosis, all areas of abnormal peritoneum will be excised (removed). after surgical excision has been performed, in order to provide standardized specimens for our research, a 3mm punch biopsy will be obtained from the excised peritoneum tissue. the 3 mm biopsy will be sent for research analysis, and the rest of the excised peritoneum tissue will be sent to histology (ssm) for evaluation and classification as having endometriosis or not. for each patient in the study, blood will also be collected to look for markers for endometriosis.

the study is investigator-initiated, prospective, comparative study. laparoscopic surgery for endometriosis on patients presenting with pain, infertility or both will be performed by the principal investigator at st. mary's hospital. we will be collecting preoperative, operative and postoperative follow-up data on all patients recruited for this study based on comprehensive preoperative questionnaires, which includes data collection on pain scores (by vas scales) and standardized qol scales, and the 6-12 month follow questionnaire. the surgical approach in the treatment of endometriosis is by excision only, so that all lesions (abnormal areas of peritoneum) are excised resulting in tissue specimens that are classified at a histologic level, which is the gold standard way to diagnose the presence of endometriosis.

Eligibility criteria:
inclusion criteria: * patients seen at the center for endometriosis (including those with or without pain) who are undergoing excision surgery. * patients who are undergoing laser excision surgery for known or suspected endometriosis will be recruited for the study. * completed a preoperative questionnaire exclusion criteria: * prior bilateral salpingo-oophorectomy * post natural menopause