Kornimate/medical-research-clean huggingface dataset:
effects of swaddling on infants during feeding

Conditions: Premature Birth

Summary: the purpose of this randomized, within-subject, cross-over study is to examine if swaddling affects bottle feeding performance in infants born preterm. results from research will have implication on neurobehavioral and physiologic outcomes as important indicators for the possible effect of swaddling during bottle feeding.

once an infant is orally feeding a minimum of two times per nursing shift for four consecutive nursing shifts, the infant will be randomly assigned to receive the intervention (swaddling) or control condition (no swaddling) first, by the research ot randomly choosing an envelope with the assignment enclosed. the intervention and control feedings for each infant will be consecutive and will take place at the infant's bedside in the nicu. infants will be assessed at each nursing care time for feeding readiness by the research ot and feeding ot according the policies of the nyu langone medical center nicu, which utilizes the infant-driven feeding scale-readiness (appendix b) (ludwig \& waitzman, 2006). when the infant demonstrates readiness, the first condition will be initiated. at the next feeding when the infant demonstrates readiness, the opposite condition will be applied. if the infant is not available due to procedures or not demonstrating feeding readiness, at the next two caregiving times after the first feeding, the infant will be discontinued for that day and will start the study over the next day.

Eligibility criteria:
inclusion criteria: * all infants born before 34 weeks gestational age will be included as long as they do not have any exclusion criteria * infants born before 34 weeks gestational age is 33 weeks 3 days to 35 weeks 0 days, with attainment of exclusive bottle feeding at 36 weeks gestational age at the earliest. * infants who are multiples will be included but restricted to twins and triplets. * infants will only be included if their parents provide informed consent for participation of their infant in the study. exclusion criteria: the exclusion criteria are factors commonly associated with feeding problems in infants beyond prematurity, including: * infants who are exclusively breastfed * higher order multiples than twins and triplets (ie. quadruplets) * infants with conditions that may affect feeding performance: 1. grades iii and iv intraventricular hemorrhage 2. necrotizing enterocolitis 3. congenital cardiac anomalies (except medically managed patent ductus arteriosus) 4. genetic syndromes 5. craniofacial abnormalities

Keywords: swaddling
the effect of intravenous lidocaine on pain after thyroidectomy

Conditions: Postoperative Pain

Summary: this prospective randomized study aims to evaluate the effectiveness of intravenous lidocaine injection on the relief of pain in patients undergoing thyroidectomy. a total 56 patients will be randomized into one of two groups(group c or group i) based on excel number generation. patients in group c will receive normal saline intravenous injection, and patients in group i will receive an intravenous bolus injection of 1.5mg/kg lidocaine followed by a continuous lidocaine infusion of 2mg/kg/hr. visual analogue scale pain scores, fentanyl consumption, the frequency at which patients pushed the button(fpb) of a patient-controlled analgesia system, and presence or absence of nausea and vomiting will be recorded at 2,4,8,12,24,48 hours postoperatively.


Eligibility criteria:
inclusion criteria: * total thyroidectomy exclusion criteria: * mental change * allergy to local anesthetics

Keywords: pain lidocaine intravenous thyroidectomy
enhancing equitable and effective (e-3) post traumatic stress disorder (ptsd) disability assessment

Conditions: Post-Traumatic Stress Disorder

Summary: this project evaluated the impact of semi-structured, standardized interviews on the initial ptsd c\&p on the examination.

our objective is to compare the process and outcomes of c\&p exams for ptsd conducted with caps and whodas-ii interviews versus the ptsd exams conducted without the caps and whodas-ii interviews. this project will conduct a randomized controlled trial on 688 veterans to evaluate the effects of the caps/whodas instruments on the initial ptsd c\&p examination process. study outcomes include variation in assessing the dsm-iv components of ptsd, diagnostic accuracy, veteran perception of the exam process, vba rater utility and resource utilization. this project will 1) demonstrate the feasibility of conducting program evaluation and intervention studies on the ptsd c\&p examination process, 2) develop research tools, instruments and methods for c\&p evaluation, 3) provide data on the value-added contribution of caps and whodas-ii to the ptsd assessment process and examination report, and 4) inform the business case of utilizing the caps and whodas-ii in the ptsd c\&p process. the ultimate aim is to improve the reproducibility, consistency and validity of the ptsd examination process while maintaining a level of efficiency and cost restraint that provides veterans with an exam process that is fair, accurate and equitable across vha.

Eligibility criteria:
inclusion criteria: 1. veterans referred to vha for an initial ptsd compensation and pension examination 2. informed consent exclusion criteria: 1. mentally impaired, not able to give informed consent 2. english speaking

Keywords: disability examination clinician administered ptsd scale quality of care
does increasing auditory cueing affect gait parameters in children with cerebral palsy during a functional task?

Conditions: Cerebral Palsy; Children

Summary: to determine the clinical efficacy of auditory cueing using a cross over design to investigate whether increasing auditory cueing frequency by 20% above self paced cadence affects gait parameters in children with cerebral palsy when performing a functional task.

introduction: cerebral palsy is a non progressive disorder occurring in early brain development, resulting in inefficient ambulatory pattern. the use of sensory cues to facilitate loco-motor activity has been suggested as providing the necessary trigger to synchronise movement with greater beneficial outcomes observed at higher frequency intensities within the adult population. thus auditory cueing could have the potential to alter gait parameters during a functional task. aim: to explore if increasing auditory cueing frequency (ac20) affects gait during a functional task compared to auditory cueing at self-paced cadence (acsc). method: nineteen children with cp levels 1 and 2 on the gross motor function classification scale participated using paired analysis. outcomes were compared to the mean values for temporal spatial gait data within the conditions using a cross over design. ts data was obtained by using the gaitrite® walkway system whilst walking holding a cup.

Eligibility criteria:
inclusion criteria: * children with cerebral palsy aged 5 to 11 years old who were scored as levels 1 to 2 on the gross motor function classification scale. * cognitive status average or above on the weschler intelligence scale for children. * able to hear without the use of a hearing aid. exclusion criteria: * hearing impairment that results in the use of a hearing aid. * walking with assistance of a mobility aid. * cardiovascular problems or other associated health problems which limits the child waking multiple times over the gaitrite®.

Keywords: auditory cueing gait
expanded access program for ct1812 (zervimesine)

Conditions: Dementia With Lewy Bodies

Summary: this is a multi-center, open label, expanded access program (eap) that will provide 100 mg ct1812 for up to one year to participants with mild-to-moderate dlb.

participants will be screened for eligibility by physical, laboratory, psychometric and neurologic examinations. after having met all inclusion criteria, and none of the exclusion criteria, participants will be enrolled. the first dose will be taken in the clinic. participants and their caregivers/study partner will have a study visit clinic for repeat psychometric/neurologic testing, safety procedures and lab sample collection. each participant and caregiver/study partner will participate in a screening period of up to 7 days, followed by an open label treatment period of 360 (± 4 days) days and a follow up visit at day 390 (± 2 days) for a maximum of 397 days of study participation including screening.

Eligibility criteria:
inclusion criteria: 1. participants must meet either one of the following criteria: 1. randomized participant in protocol cog1201 and completed the study or 2. referred by their treating physician to a participating cog1202 study site with a confirmed diagnosis of dlb, have a historical mri or ct-scan on file, a baseline mini mental status examination score (mmse) of 18 - 27 inclusive and be approved by sponsor. 2. participants must have caregiver(s) / study partner who in the opinion of the site principal investigator, has contact with the study participant for a sufficient number of hours per week to provide informative responses on the protocol assessments, oversee the administration of study drug, and willing and able to participate in study visits and some study assessments. the caregiver/ study partner must also provide informed consent to participate in the study. 3. men or women 50- 86 years of age (inclusive). 4. must have had no clinically relevant findings, other than change for progression of dlb, on historical mri or ct scan. 5. in the opinion of the investigator, must be able to complete all protocol evaluations. exclusion criteria: 1. if enrolled in the previous ct1812 clinical trial for dlb (cog1201), did not complete the clinical trial, or had an adverse event that could cause an undue risk, or progressed to severe dlb and cannot complete study assessments. 2. any neurological condition that may be contributing to cognitive impairment and beyond those caused by the participant's dlb. 3. history of cancer within 3 years of screening with the exception of fully excised non-melanoma skin cancers or non-metastatic prostate cancer that has been stable for at least 6 months based on imaging or prostate-specific antigen (psa) levels. 4. clinically significant, advanced or unstable disease that may interfere with outcome evaluations. 5. any condition, which in the opinion of the investigator or the sponsor makes the participant unsuitable for inclusion.

Keywords: dementia
acupuncture versus sham for radiotherapy-induced emesis

Conditions: Nausea; Vomiting

Summary: the aim of this study is to evaluate if acupuncture prevents or reduces nausea or vomiting during radiotherapy

treatment with acupuncture is, despite sometimes unclear evidence, increasing in cancer care. acupuncture is used for indications such as pain and nausea, but for radiotherapy (rt) induced nausea it is still an unexplored treatment. for evaluation of the method, the use of sham acupuncture as a control treatment provides a tool resembling placebo for drugs. the aim of the studt is therefore to investigate whether acupuncture reduces nausea caused by radiotherapy in a patient group with a \>50% risk of experiencing the symptoms (abdominal or pelvic region). patients are randomised to invasive acupuncture (ia) or placebo acupuncture (pa) 30 min, 2-3 times/week during the whole rt period. ia is administered bilaterally to the point pc6 using an invasive needle and pa with a needle, which looks identical but is not pointed and is not fixed in its handle. when this comes into contact with the surface of the skin and gives a feeling of penetration it glides upwards in its handle and is therefore shortened, which gives an illusion that the needle has entered the tissue. nausea and vomiting is documented in diaries and questionnaires under the entire treatment period as well as two and four weeks after radiotherapy.

Eligibility criteria:
inclusion criteria: * patients of at least 18 years of age * with gynaecologic-, anal-, rectal-, colon-, ventricle-, pancreatic- or testicular tumours * willing to give their informed consent * able to take part in the entire treatment and data collection procedure * had planned radiation over an abdominal and/or pelvic field (with or without concomitant chemotherapy) with the volume of at least 800 cm3 and a dose of at least 25 gy. exclusion criteria: * use of antiemetic treatment or persistent nausea within 24 hours prior to the start of radiotherapy * ever received acupuncture against nausea, or during the last year received acupuncture for any indication.

Keywords: acupuncture therapy cancer emesis expectations placebo
acthar gel for multiple sclerosis that keeps getting better and worse (rrms)

Conditions: Multiple Sclerosis, Relapsing-Remitting

Summary: this study will enroll about 66 participants who experienced a relapse of rrms that steroids did not help. the doctor will put participants into a treatment group. each person has an equal chance of being in either one of two groups (like flipping a coin). one group will receive a shot of study medicine (called acthar gel) under their skin every day for 14 days. the other group will receive a shot every day for 14 days, too, but there is no medicine in it (called placebo).


Eligibility criteria:
key inclusion criteria: * had a clinical diagnosis of relapsing-remitting multiple sclerosis (rrms) * had a relapse with onset ≤42 days prior to the baseline visit * had started treatment with 3 to 5 days (inclusive, over a period of up to 7 days) of specific high dose corticosteroids within 28 days of the onset of the first relapse symptom * had failed to obtain improvement of at least 1 point in one or more functions on the function systems score (fss) 14 days following their first dose of high dose corticosteroids * has an expanded disability index scale (edss) score of 2.0 to 6.5 (inclusive) at the baseline visit

Keywords: relapsing, remitting multiple sclerosis rrms
measurement of the skin sympathetic nerve activity during stellate, thoracic, and lumbar sympathetic ganglia block

Conditions: Chronic Pain Requiring Stellate, Thoracic, and Lumbar Sympathetic Ganglia Blockade

Summary: sympathetic nerve activity can be measured transcutaneously in awake patients by computer-based filtering of raw signal obtained via skin leads attached on the chest and the right arm. electrocardiogram can be removed by applying a high-pass filter setting of 150 hz. electromyogram can be filtered by applying a high-pass filter setting of 500 hz or a band-pass filter setting of 500-1000 hz. currently, the therapeutic effect of stellate, thoracic, and lumbar sympathetic ganglia block (sgb, tsgb, and lsgb, respectively) in patients with chronic pain is generally evaluated by using thermogram/thermography (change in temperature of the upper or lower extremeties) or questionnaire-based scoring. however, it is not known whether the skin sympathetic nerve activity (skna) can be measured in patients undergoing sgb/tsgb/lsgb and used as an alternative tool for assessing the therapeutic effect of sgb/tsgb/lsgb. therefore, we planned this pilot study to observe whether the skna can be obtained in patients undergoing sgb/tsgb/lsgb and whether it is well correlated to thermogram or questionnaire-based scoring. if the skna is observed and decreases after sgb/tsgb/lsgb, it will be presented in milivolt (uv) and compared to that of pre-block values.


Eligibility criteria:
inclusion criteria: * outpatient patients undergoing stellate, thoracic, and lumbar sympathetic block for chronic pain disease exclusion criteria: * patients denial * peripheral vascular disease in the head and the upper extremities. * prior thoracic sympathectomy/sympathicotomy * prior resection or ablation (chemically or mechanically) of stellate, thoracic, and lumbar sympathetic * coagulapathy * infectious disease * allergy to local anesthetics
study of the model to predict 3-month mortality risk of acute-on-chronic hepatitis b liver failure

Conditions: Acute-on-chronic Hepatitis B Liver Failure

Summary: this study was to predict 3-month mortality risk of acute-on-chronic hepatitis b liver failure (achblf) on an individual patient level using artificial neural network (ann) system. the area under the curve of receiver operating characteristic (auroc) were calculated for ann and meld-based scoring systems to evaluate the performances of the ann prediction.

hepatitis b virus (hbv) is a major human pathogen which causes high morbidity and mortality worldwide. hbv is one of the leading causes for rapid deterioration of liver function, which is a serious condition termed as "acute-on-chronic liver failure (aclf)" with high mortality. there is a high prevalence of hbv in asian developing countries where acute-on-chronic hepatitis b liver failure (achblf) accounts for more than 70% of aclf and almost 120, 000 patients died of achblf each year. the transplantation of liver is the basic and strong effective therapeutic option for achblf patients. however, liver transplantation is difficult to be extensively applied due to the shortage of liver donors and other socioeconomic problems. thus, an early predictive model, which is objective, reasonable and accurate, is necessary for severity discrimination and organ allocation to decrease the mortality of achblf. meld-based scoring systems still failed to predict the mortality of a considerable proportion of patients and their predictive accuracy was not satisfying enough. the ann is a novel computer model inspired by the working of human brain. it can build nonlinear statistical models to deal with the complex biological systems. in the recent years, ann models have been introduced in clinical medicine for clinical validations, including predicting the hepatocellular carcinoma patients' disease-free survival and preoperative tumor grade, predicting the mortality of patients with end-stage liver disease and identifying the risk of prostate carcinoma.

Eligibility criteria:
inclusion criteria: * acute hepatic insult manifesting as jaundice and coagulopathy * complicated within 4 weeks by ascites * and/or encephalopathy in a patient with chronic hbv infection exclusion criteria: * patients with evidence of non-b hepatitis virus * alcohol abuse leads to liver failure * autoimmune leads to liver failure * oxic or other causes that might lead to liver failure * past or current hepatocellular carcinoma * liver transplantation * serious diseases in other organ systems
vasoconstriction trial with leo 90100 aerosol foam

Conditions: Psoriasis Vulgaris

Summary: vasoconstriction study with leo 90100

this study compares the pharmacodynamic activity of leo 90100 with dermovate cream, diprosone ointment, elocon cream, locoid ointment and leo 90100 vehicle using a human skin blanching test

Eligibility criteria:
inclusion criteria: * subjects demonstrating adequate vasoconstriction to diprosone® ointment within 15 days prior to dosing (unoccluded application of diprosone® ointment for 4-6 hours must show a visual score of skin blanching of at least one unit (visual scale (0-4)). * subjects without signs of skin irritation/disease/disorders/symptoms or blemishes on test sites (e.g. erythema, dryness, roughness, scaling, scars, moles, sunburn). exclusion criteria: * abnormal pigmentation of the skin or skin type that could, in any way, confound interpretation of the trial results (skin type v and vi on the fitzpatrick scale). * female subjects who are breastfeeding.
lymph node ratio and kras mutation in r colon cancer

Conditions: Colon Cancer Stage III

Summary: clinical impact of ln ratio with kras expression in colon cancer

lnr and k ras were evaluated with correlated with different clinicopathological parameters of the patients, pfs and os.

Eligibility criteria:
inclusion criteria: * stage iii colon cancer exclusion criteria: * stage i, ii, iv
homeopathic treatment of fatigue in children receiving chemotherapy

Conditions: Cancer

Summary: cancer-related fatigue has been described as a subjective feeling of physical, emotional, and/or cognitive tiredness. fatigue is frequently identified as one of the most troublesome symptoms in pediatric cancer patients. fatigue affects children with cancer throughout the trajectory of their disease. treatment interventions for cancer-related fatigue have been largely unsuccessful. homeopathy involves treatment of patients with diluted natural substances aimed at stimulating the body's healing system. in the efficacy trial literature, individualized homeopathy shows the most promise over other forms of homeopathic intervention. individualized homeopathic treatment involves a unique yet established method of case taking. during the consultation, the homeopath asks a series of broad questions to elicit subjective symptoms related to the patient's disease, their medical history, as well as particular characteristics (physical or psychological) related to the individual. this study will recruit children receiving chemotherapy to undergo homeopathic remedies to treat their fatigue. this study hypothesizes that homeopathic treatment will effectively treat fatigue.


Eligibility criteria:
inclusion criteria: * diagnosed with any type of cancer. patients may have newly diagnosed, relapsed or a second malignant disease. * receiving any type of chemotherapy administered intermittently (i.e. not continuous administration) with or without radiation treatment * discharge from sickkids is anticipated to occur following completion of the current inpatient chemotherapy or chemotherapy is being administered as an outpatient * between 2 and 18 years of age (age range for which instruments are available and children may be able to comply with homeopathy) a score on the symptoms distress scale (sds) of 2 or higher * able to ingest medications in lactose/sucrose globule or liquid form * reside within greater toronto area or willing to travel to the riverdale homeopathic clinic. participants living outside of the greater toronto area who wish to receive home visits may be eligible provided that permission is granted by the homeopath investigator * a parent or caregiver must be able to read and write in english. * patients who are currently receiving cam including homeopathy are eligible. exclusion criteria: * previous history of allergy to the homeopathic products

Keywords: cancer fatigue chemotherapy pediatrics homeopathy
a study of surgical techniques during cystectomy

Conditions: Bladder Cancer

Summary: the purpose of this study is to look at two standard surgical techniques used during a radical cystectomy and see whether they influence outcomes such as length of stay in the hospital and infections after surgery. this trial will evaluate whether the following surgical methods influence outcomes: a ureteral stent is a thin tube that is placed in the ureter to drain urine from the kidney. ureteral stents are often used to promote urine drainage after radical cystectomy, but may come at risk of urinary tract infection. alvimopan is a standard drug used to promote return of bowel function following surgery. doctors do not know whether alvimopan is beneficial in current clinical practice. the surgeon will decide whether participants will receive a stent and/or alvimopan, but if they are unsure what the best approach is, a surgical technique has been assigned by chance to them.


Eligibility criteria:
inclusion criteria: stent vs. no stent * patients aged ≥21 years who are scheduled to undergo radical cystectomy for treatment of bladder cancer with one of the consenting surgeons at msk alvimopan vs. no alvimopan * patients aged ≥21 years who are scheduled to undergo radical cystectomy for treatment of bladder cancer with one of the consenting surgeons at msk exclusion criteria: stent vs. no stent * no exclusion criteria alvimopan vs. no alvimopan * patients on chronic opioid therapy are ineligible to receive alvimopan and will be excluded from this cohort of the trial

Keywords: cystectomy ureteral stents alvimopan 24-361