Kornimate/medical-research-clean huggingface dataset:
routine post-operative supplemental nutrition

Conditions: Esophageal Cancer

Summary: patients undergoing an esophagectomy will be randomized to receive either (1) routine post-operative tube feeding for 1 month post-operative or (2) usual practice, which is tube feeding to continue in the hospital until the patient is taking adequate nutrition by mouth at pod#8, or upon discharge. specific aim 1 is to determine the occurrence of common complications and readmissions post-operatively between the two patient groups. the investigators hypothesize that routine use of tube feeding may reduce the occurrence of post-operative complications. specific aim 2 is to determine if routine dietary supplementation with enteral tube affects recovery and qol after esophagectomy. the investigators hypothesize that routine post-operative supplementation will enhance patients recovery and qol. for esophagectomy specifically, there is very limited literature evaluating the complication rate and qol associated with the length of post-operative tube feeding and adequate nutritional requirements. small randomized studies have not shown a benefit to routine tube feeding, although the numbers were very small, ranging from 12-70 per group. the investigators will randomize 200 patients for the purpose of this study.


Eligibility criteria:
inclusion criteria: * patients undergoing an elective esophagectomy * jejunal feeding tube placed at the time of surgery exclusion criteria: * emergent esophagectomy procedure * inability to provide informed consent or to complete testing or data collection * unwillingness to be randomized * tube feeding dependent on discharge

Keywords: esophageal cancer esophagectomy
overactive bladder education

Conditions: Urinary Bladder, Overactive; Urinary Incontinence, Urge

Summary: overactive bladder (oab) is a common, chronic condition, characterized by urinary "urgency, with or without urge incontinence, usually with frequency and nocturia." treatment adherence is a major barrier to management of oab and drug continuation is poor. many factors may play a role in non-adherence to medication management of oab including drug cost, side effects, and a lack of understanding of the disease and treatment process.studies show that recall of disease information and treatment is often suboptimal. literature shows that providing written materials is an efficacious way to aid in recall. based on known poor adherence to oab medication treatment and the clear role patient education methods have on patient information recall, the investigators believe that improvement of participant education through use of a oab care plan will improve participant understanding and treatment adherence. through this randomized trial, the investigators plan to evaluate whether implementation of a oab care plan improves understanding of disease and treatment options, treatment success, and satisfaction. this is a prospective, randomized, controlled study of oab counseling in new patients presenting to the urogynecology offices of hartford hospital. all new patients with a diagnosis of oab will be offered participation. all consenting participants will be randomized 1:1 to one of two groups: 1) standard care group or 2) care plan group. in the standard care group, participants will be counseled as the physician routinely counsels patients about oab, in the care plan group, participants will be counseled a printed "overactive bladder plan of care" information sheet. at the end of the visit, the participant will complete a baseline survey. the baseline survey includes basic demographic information, a physician satisfaction survey, and a oab knowledge survey. the participant will return for follow up as directed by the physician. at the follow up visit, participants in both groups will complete a followup survey. the followup survey will be completed before the participant sees the physician. the followup survey assesses oab knowledge. eight months after the baseline visit, each participant's chart will be reviewed for final data collection. if a participant progresses to a treatment method where she is satisfied and would like to remain, this will be documented.


Eligibility criteria:
inclusion criteria: * diagnosis of overactive bladder * able and willing to participate and consent * age \>17 years, \<90 years * female sex exclusion criteria: * male sex * patients who do not have a diagnosis of overactive bladder * age \ 89 years * unable or unwilling to participate * patients who are already being treated for overactive bladder * patients who are planning surgical intervention for pelvic organ prolapse prior to treatment of overactive bladder * patients who are planning surgical intervention for stress urinary incontinence prior to treatment of overactive bladder * pregnancy
pr-018: an open-label, safety extension of study pr-011

Conditions: Cystic Fibrosis; Exocrine Pancreatic Insufficiency

Summary: a study to evaluate long term safety and effect on ability to thrive of eur-1008 (apt-1008) 3,000 lipase units (zenpep® \[pancrelipase\] delayed release capsules) in infants with exocrine pancreatic insufficiency (epi) due to cystic fibrosis (cf).

this is a multi-center, open-label, safety extension of aptalis (formerly eurand) study pr-011 (nct01100606) in pediatric participants with epi due to cf. the study will be carried out in participants who completed the pr-011 study. the study is comprised of 5 visits: an enrollment visit, treatment visit 1 (3 months), treatment visit 2 (6 months), treatment visit 3 (9 months) and treatment visit 4 (12 months). once determined eligible for participation, participants will be enrolled into the study.

Eligibility criteria:
inclusion criteria: * participant's parent or guardian signed informed consent form (icf) * participants who have completed study pr-011 (nct01100606) exclusion criteria: * participant having any condition that would, in the investigator's opinion, limit the participant's ability to complete the study or will result in excess risk to the participant that is above the standard of care

Keywords: exocrine pancreatic insufficiency infants with cf
a safety and tolerability study of the combination of aliskiren/valsartan in patients with high blood pressure, followed by long-term safety and tolerability of aliskiren, valsartan and hydrochlorothiazide.

Conditions: Hypertension

Summary: assessment of the long-term safety and tolerability of the combination of aliskiren and valsartan (300 mg/ 320 mg) in patients with high blood pressure,followed by assessment of long-term safety and tolerability of the combination of aliskiren/valsartan/hydrochlorothiazide(hctz).


Eligibility criteria:
inclusion criteria: - * male and female outpatients 18 years of age and older. * for newly diagnosed/untreated patients with essential hypertension defined as msdbp ≥ 90 and \< 110 mmhg at visit 1 and visit 4 * for previously treated patients with essential hypertension defined as msdbp ≥ 90 and \< 110 mmhg after 2 to 4 weeks of washout (visit 4) * patients who were eligible and able to participate in the study and who consented to do so after the purpose and nature of the investigation had been clearly explained to them (written informed consent). exclusion criteria: * severe hypertension (msdbp ≥ 110 mmhg and/or mssbp ≥ 180 mmhg) * women of child-bearing potential, unless they met definition of post-menopausal or were using acceptable methods of contraception. * history or evidence of a secondary form of hypertension. * history of hypertensive encephalopathy or cerebrovascular accident. other protocol-defined inclusion/exclusion criteria may apply.

Keywords: hypertension, aliskiren, valsartan, hctz, blood pressure
a study of r1507 in combination with letrozole in postmenopausal women with advanced breast cancer

Conditions: Breast Cancer

Summary: this study aim was to determine the safety and efficacy of r1507 in combination with letrozole in patients with advanced breast cancer. in the first part of the study a cohort of patients with advanced breast cancer received letrozole 2.5mg po daily in combination with r1507 16mg/kg every 3 weeks.


Eligibility criteria:
inclusion criteria: * postmenopausal female patients; * stage iv or locally advanced breast cancer; * measurable disease; * letrozole failure (part 2); * eastern cooperative oncology group (ecog) performance status \<=2. exclusion criteria: * previous chemotherapy for metastatic breast cancer; * concurrent antibody or immunotherapy for advanced disease, within 4 weeks prior to receipt of study drug; * history of primary malignancy in 5 years prior to study, excluding adequately treated basal or squamous cell cancer of skin, or cancer in situ of cervix; * concurrent radiotherapy, or radiotherapy within 28 days prior to receipt of study drug.
sleep restriction treatment for insomnia

Conditions: Insomnia

Summary: with a prevalence of about 10% chronic insomnia is a common problem. the standard treatment for insomnia is cognitive behavioral therapy. according to many, the core element within this treatment is sleep restriction. this element has been examined separately in a couple of studies and also appears to be effective in isolation. in the current study the aim is to get more information about the effectiveness of this core element of the treatment. for this reason, a randomized study is conducted to compare sleep restriction with a diary control condition. the second aim in this study is to determine mechanisms behind treatments. network intervention analysis will be used to determine which specific symptoms are associated with therapy success. this is the reason that throughout the study weekly and daily measures will be conducted. the expectations are that: * participants in the sleep restriction condition will improve more on insomnia complaints than the sleep diary control condition (primary outcome) * participants in the sleep restriction condition will improve more on sleep diary outcomes and other secondary outcomes compared to the sleep diary control condition (secondary outcome)


Eligibility criteria:
inclusion criteria: * insomnia severity index score ≥ 10 * 18 years or older * self reported insomnia complaints: being awake ≥30 minutes per night, ≥3 nights per week, ≥ 3 months * daytime problems related to sleep complaints * sleep efficiency \< 85% * dutch speaking exclusion criteria: * (1) no acces to internet * (2) pregnant or breastfeeding * (3) working in night shifts * (4) currently in psychological treatment (started \< 6 months) or on wait-list for treatment * (5) cognitive behavioral treatment for insomnia in last 12 months * (6) concrete suicidal ideation * (7) schizophrenic or psychotic disorder * (8) high level of depressive complaints (bdi-ii \> 28) * (9) instable medication use (medication should not be tampered in last 6 weeks) incidental sleep-medication use is allowed

Keywords: insomnia behavioral treatment randomized controlled trial
vitreous fragments length after pars plana vitrectomy

Conditions: Vitreous Disorder; Vitreous Anomalies

Summary: to measure vitreous collagen fragments length after pars plana vitrectomy performed at different cut rates

pars plana vitrectomy consists in the removal of vitreous obtained with a vitreous cutter. the instruments attracts vitreous in its port through active suction and cuts with a blade at different cut rates. there is no consensus as to which cut rate would be ideal in order to minimize traction, neither there is agreement on whether increasing cut rates generate shorter collagen fragments or the fluid turbulence creates unpredictable flows at the port generating fragments of different length. the investigators plan to gather vitreous cut at 1,000, 2,000, 4,000, 8,000 and 16,000 cuts per minute and measure vitreous collagen average length

Eligibility criteria:
inclusion criteria: * patient undergoing pars plana vitrectomy for: * macular pucker * macular hole- * retinal detachment * age \>18 exclusion criteria: * unwilling to participate * previous trauma * vitreous haemorrhage
weight-based flow rates for children with bronchiolitis on high-flow nasal cannula: a pilot randomized control trial

Conditions: Bronchiolitis

Summary: this is a pilot study comparing a weight-based high-flow nasal cannula (hfnc) protocol with the current standard hfnc protocol for children \<2yo admitted to south shore hospital with bronchiolitis. we currently use a flat limit of 8 liters of hfnc to support work of breathing and hypoxia in these patients. we will compare that to a weight-based protocol, which will provide 2l/kg/min of flow (flows generally between 6 and 20l/minute) to this patient population. the goal of this pilot study is to assess the feasibility of our study design. we will evaluate the functionality of a new weight-based flow protocol. we will also evaluate the functionality of a new bronchiolitis scoring tool, the bronchiolitis assessment severity score (bass), and it's ability to guide care through the new protocol. we are also testing the feasibility of recruitment, randomization and retention. we are ultimately interested in whether a weight-based flow protocol reduces need for escalation to icu-level care for children with moderate-severe bronchiolitis on hfnc.

this is a pilot study comparing a weight-based high-flow nasal cannula (hfnc) protocol with the current standard hfnc protocol for children \<2yo admitted to south shore hospital with bronchiolitis. we currently use a flat limit of 8 liters of hfnc to support work of breathing and hypoxia in these patients. we will compare that to a weight-based protocol, which will provide 2l/kg/min of flow (flows generally between 6 and 20l/minute) to this patient population. the goal of this pilot study is to assess the feasibility of our study design. we will evaluate the functionality of a new weight-based flow protocol. we will also evaluate the functionality of a new bronchiolitis scoring tool, the bronchiolitis assessment severity score (bass), and it's ability to guide care through the new protocol. we are also testing the feasibility of recruitment, randomization and retention. we are ultimately interested in whether a weight-based flow protocol reduces need for escalation to icu-level care for children with moderate-severe bronchiolitis on hfnc.

Eligibility criteria:
inclusion criteria: * admission to inpatient pediatrics * clinical diagnosis of bronchiolitis * bass score of moderate or severe exclusion criteria: * non-english speakers * patients with urgent need for cpap, bipap or intubation

Keywords: high flow nasal cannula
influence of vasopressors on anti-xa activity in critically ill patients

Conditions: Critical Illness; Thrombosis

Summary: critically ill patients require antithrombotic prophylaxis. at the same time, majority of them is receiving various vasopressors. the aim of the study is to determine whether there is a difference in anti-xa activity, which is a marker of anti thrombotic activity of low molecular weight heparins, between the patients receiving norepinephrine with argipressin, compared to those receiving norepinephrine alone.


Eligibility criteria:
inclusion criteria: * circulatory failure * supported by continuous infusion of noradrenaline or noradrenaline and argipressin * receiving subcutaneous dalteparin for the prevention of venous thromboembolism. exclusion criteria: * contraindications for dalteparin * severe coagulopathy * acute or subacute bacterial endocarditis * pregnant women * bmi (body mass index) \> 30kg/m2 * chronic kidney disease with egfr (estimated glomerular filtration rate) \< 30 ml/min/1.73 m2 * renal replacement therapy * the patient died within 52 hours of starting vte (venous thromboembolism) prophylaxis with dalteparin
early palliative care in advanced lung and gastrointestinal malignancies

Conditions: Non-small Cell Lung Cancer; Small Cell Lung Cancer; Mesothelioma; Esophageal Cancer; Gastric Cancer; Liver Cancer; Pancreatic Cancer

Summary: the purpose of this study is to compare two types of care - standard oncology care and standard oncology care with early palliative care (started soon after diagnosis) to see which is better for improving the experience of patients and families with advanced lung and non-colorectal gi cancer. the study will use questionnaires to measure patients' and caregivers' quality of life, mood, coping and understanding of their illness.

subjects and their caregiver will complete a baseline questionnaire and then be randomized to a study group. subjects who are randomized to standard oncology care will follow up with their treating oncologist. they will consult with the palliative care team at their request or at the request of the treating oncologist. they will complete questionnaires at 12 weeks and 24 weeks after enrollment. subjects who are randomized to the standard oncology care with early palliative care will meet with a palliative care clinician at their next medical oncology visit or infusion visit. they will meet with the palliative care clinician at least every three weeks. they will complete questionnaires at 12 and 24 weeks after enrollment.

Eligibility criteria:
inclusion criteria: * confirmed metastatic lung cancer (nsclc, small cell lung cancer, and mesothelioma)or non-colorectal gi cancer (esophageal, gastric and hepatobiliary) not being treated with curative intent * informed of metastatic disease within the previous 8 weeks * no prior therapy for metastatic disease * able to read questions in english or willing to complete questionnaires with the assistance of an interpreter * relative or friend of patient who will likely accompany the patient to clinic visits exclusion criteria: * significant psychiatric or other co-morbid disease

Keywords: palliative care lung gastric liver pancreatic esophageal caregiver
effect of vagus stimulation on peripheral glucose metabolism

Conditions: Insulin Resistance; Glucose Intolerance

Summary: two important mechanisms play a major role in the pathogenesis of type 2 diabetes: insulin resistance of the target tissues and the impaired insulin secretion from pancreatic β-cells. postprandial factors (such as insulin) are perceived by the human brain and induce signals that regulate glucose metabolism via the parasympathetic nervous system. transcutaneous auricular vagus nerve stimulation (tvns) can be used on the outer ear to stimulate the auricular branch of the vagus nerve in humans. heart rate variability (hrv) in healthy people can be significantly increased via tvns, indicating a shift from sympathetic activity to parasympathetic activity. the hypothesis is that this postprandial shift results in a change in peripheral glucose metabolism. in turn, the increased parasympathetic activity could potentially result in a change in postprandial insulin sensitivity or secretion. to test this hypothesis, this study investigates the effect of vagal stimulation versus sham stimulation on insulin sensitivity, on insulin secretion, glucose tolerance, resting energy expenditure, and on parasympathetic tone (analysis of heart rate variability).


Eligibility criteria:
inclusion criteria: * hba1c \<6.5% * must be able to understand the explanations of the study and the instructions exclusion criteria: * any relevant (according to investigator's judgment) cardiovascular disease * neurological and psychiatric disorders * diabetes mellitus * active implants (e.g. pacemaker, cochlear implant, cerebral shunt) * asthma * skin diseases on the ear
evaluating the impact of limited compared with intense post-operative surveillance on patient-reported outcomes in patients with stage ii-iii soft tissue sarcoma of the trunk and extremities

Conditions: Stage II Soft Tissue Sarcoma of the Trunk and Extremities AJCC v8; Stage III Soft Tissue Sarcoma of the Trunk and Extremities AJCC v8; Stage IIIA Soft Tissue Sarcoma of the Trunk and Extremities AJCC v8; Stage IIIB Soft Tissue Sarcoma of the Trunk and Extremities AJCC v8

Summary: this phase ii trial studies how anxiety is affected by 2 types of follow-up after surgery, limited follow-up and intense follow-up, in patients with stage ii-iii soft tissue sarcoma of the trunk and extremities. in cancer survivors, the fear of cancer coming back (recurring) is common and may persist long after the end of treatment. it may also be exacerbated by return visits for imaging (surveillance). the purpose of this study is to determine how patients' anxiety and other cancer-related outcomes are affected by how often surveillance is done.

primary objective: i. to evaluate whether a risk-based limited follow-up surveillance is associated with reduced patient anxiety compared to risk-based intense surveillance. secondary objective: i. to evaluate the impact of reduced surveillance in low-risk patients on overall survival, time to local or distant recurrence, anxiety at early and late time-points, out of pocket costs, and number of missed or extra clinic visits, compared to the risk-based intense follow-up in both low-risk and high-risk patients. outline: patients are assigned to 1 of 2 groups based on risk status. group 1 (low risk): patients are randomized to 1 of 2 arms. arm i: patients undergo intense follow-up every 3 months for 2 years consisting of restaging with computed tomography (ct)-chest and imaging of the primary site. arm ii: patients undergo limited follow-up every 6 months for 2 years consisting of restaging with either ct-chest or chest x-ray (cxr) and imaging of the primary site. group 2 (high risk): patients undergo intense follow-up every 3 months for 2 years as in group 1, arm i.

Eligibility criteria:
iinclusion criteria: * ≥18 years old * completion of sarcoma therapy (chemotherapy, radiation therapy and/or surgery) within 8-14 weeks of study enrollment * willingness to complete surveys x 2 years exclusion criteria: * documented metastatic disease at the time of enrollment * non-english-speaking patients pregnant women will be included in this clinical trial.
gastroesophageal reflux and cardiorespiratory problems

Conditions: Gastroesophageal Reflux Disease; Apnea Infants; Desaturation of Blood; Bradycardia

Summary: cardiorespiratory and gastroesophageal reflux events often coexist in infants in neonatal intensive care unit (nicu) thus leading to drugs over-prescription and delayed discharge. through cardiorespiratory and ph-impedance monitoring this study aims to evaluate the temporal association between gastroesophageal reflux (ger) and cardiorespiratory (cr) events in a large number of infants with gastroesophageal reflux disease (gerd) and cr symptoms and, whether this association is significant, to clarify the impact of ger on cr events.

this is an observational retrospective study to describe the association between cardiorespiratory (cr) and gastroesophageal reflux (ger) events in infants who underwent synchronized 24h multichannel intraluminal impedance/ph-metry (mii/ph) and cr monitoring for ger disease symptoms and cr events. data are collected from medical records and database of the university neonatal intensive care unit of the sant'anna-regina margherita children hospital (turin). the symptom association probability (sap) index is used to identify those infants with significant associations between ger and cr events. in the group of infants with a positive sap index the differences in reflux characteristics are compared according to whether a reflux preceded or followed a cardiorespiratory event (30 s time window).

Eligibility criteria:
inclusion criteria: * synchronized mii-ph and cardio-respiratory monitoring lasting more than 12 hours, excluding meal periods; * exclusive enteral feeding * parents' informed consent exclusion criteria: * infectious, genetic, metabolic and neurological diseases * ventilatory support and/or oxygen supplementation at the time of mii-ph/cr monitoring * pharmacological therapies with effects on ger or apnoea during the week before mii-ph/cr monitoring

Keywords: gastroesophageal reflux apnea bradycardia desaturation impedance