Kornimate/medical-research-clean huggingface dataset:
csp #2025 - geriatric out-of-hospital randomized meal trial in heart failure: veterans affairs (gourmet-va)

Conditions: Heart Failure

Summary: the purpose of this multi-center clinical trial is to study the efficacy and safety of providing nutritional support added to the study-defined standard of care which consists of standardized dietary education and a single dietary counseling session shortly after discharge, versus study-defined standard of care alone.


Eligibility criteria:
inclusion criteria: * aged 60 years * veterans enrolled in a vha facility * hospitalized ( 24 hours) with new hf or worsening chronic hf * dentition, swallowing function, etc. sufficient to safely consume food and liquid of standard composition and texture (i.e., no pureed food, no thickened liquids needed) * able and willing to provide informed consent and perform study activities exclusion criteria: * food allergies or intolerances that cannot be accommodated by study diet * on dialysis or estimated glomerular filtration rate \<30 at randomization * serum potassium (non-hemolyzed) \>6.0 mmol/l during index hospitalization * heart transplant or active transplant listing * left ventricular assist device present or anticipated \<6 months * malignancy or other non-cardiac condition limiting life expectancy to \<12 months * planned admission to a skilled nursing facility following hospital discharge, or discharge to other location/situation where veteran does not have control over diet * lack of space to store food for a week or equipment to prepare food * severe cognitive impairment (slums score \<20, or \<19 if less than high school education completed) * severe food insecurity (5 or 6 points on the usda 6-item food insecurity screen) * body mass index \>50 kg/m2 * other medical, psychiatric, behavioral, or logistical condition which, in the clinical judgement of the site investigator, makes it unlikely the patient can effectively participate in or complete the study
early treatment versus expectant management of pda in preterm infants

Conditions: Patent Ductus Arteriosus

Summary: patent ductus arteriosus (pda) in very preterm newborns is associated with severe neonatal mor-bidity: intraventricular hemorrhage (ivh), bronchopulmonary dysplasia (bpd), necrotizing en-terocolitis (nec), retinopathy of prematurity (rop). existing methods of management pda do not reduce the incidence of these diseases. the efficacy of cyclooxygenase inhibitors (cox) which are currently the standard of treatment in extreme preterm infants is about 70-80%. cox inhibitors have significant side effects. on the other hand, surgical ligation of the ductus arteriosus is associated with deterioration due to cardio-pulmonary problems and long-term complications. paracetamol has been proposed for treatment of hemodynamically significant pda because it has a different mecha-nism of action compared with cox inhibitors and a better safety profile. recently, expectant approach has becoming more popular, although there is not enough evidence to support it. the objective of this study is to investigate whether in preterm infants, born at a ga less than 32 weeks, with a pda (diameter \> 1.5 mm) at a postnatal age of \< 72 h, an expectant management is non-inferior to early treatment with regard to the composite of mortality and/or severe morbidity.


Eligibility criteria:
inclusion criteria: * gestational age \< 32 weeks * birthweight \<1500 g * age less than 72 hours * pda diameter \> 1.5 mm * signed informed consent obtained from both parents exclusion criteria: * birthweight ≥ 1500 g and/or gestation age ≥ 32 weeks * lack of informed consent of the parents * congenital heart defect, other than pda and/or patent foramen ovale (pfo) * the presence of a clinically apparent hemorrhagic syndrome * any intraventricular hemorrhage (ivh) in the first 48 hours or ivh grade 3-4 * a platelet count of \< 50,000/mm3 * a serum creatinine concentration of \> 110 μmol/l * oliguria \<1 ml/kg/h * suspected/apparent nec * suspected/apparent lung hypoplasia

Keywords: pda ibuprofen paracetamol expectant management
is sensorimotor training effective following a distal radius fracture?

Conditions: Distal Radius Fractures

Summary: the purpose of this study is to compare the short-term outcomes of individuals who have surgery (volar plate) for a wrist (distal radius) fracture who have routine hand therapy treatment versus routine hand therapy treatment and sensorimotor activities. individuals who meet inclusion criteria at the facilities collecting data will be invited to participate. if they agree to participate, they will randomly and blindly (via concealed envelopes) be assigned to the control (routine treatment) or the sensorimotor treatment group. data collection will occur at 3- and 6-weeks post initiation of skilled therapy and will include measurement of joint position sense, function via the patient rated wrist and hand, pain via the numeric pain rating scale, and range of motion at the digits and wrist.

the study is an interventional study investigating the effectiveness of sensorimotor activities in addition to traditional occupational therapy intervention versus traditional intervention only for patients following a distal radius fracture with volar plate fixation. a convenience sample of patients from 2 outpatient orthopedic hand therapy departments will be invited to participate in the study. the treatment for both groups will be identical with one group receiving the addition of sensorimotor activities. participants will be divided into one of the two groups. they will be made aware that at any point they can choose to no longer participate in the study, and it will not affect their treatment.

Eligibility criteria:
inclusion criteria: * distal radius fracture with volar plate fixation * understand english * 18 years or older * available to attend skilled occupational therapy visits a minimum of 1x per week. exclusion criteria: * prior surgery to the involved wrist/hand * cognitive impairment * distal radius fracture managed by casting or by another means of fixation
prospective observational study of the sacubitril-valsartan treatment effectiveness.

Conditions: Heart Failure

Summary: the aim of this prospective study is to demonstrate if there is any difference in the treatment response to sacubitril-valsartan depending on the ventricular disfunction ethiology in patients with severe systolic disfunction heart failure.


Eligibility criteria:
inclusion criteria: * patients older than 18 years old. * ejection fraction (ef) ≤ 40%. * treated with optimal medical treatment for at least 3 months and remained in functional class ii, iii or iv. * patients with ischemic or non ischemic etiology. exclusion criteria: * patients with enolic etiology. * patients with any contraindication for taking sacubitril-valsartan. * patients with ef \>40%.

Keywords: heart failure severe systolic disfunction sacubitril-valsartan
feasibility and safety study of the endologix fenestrated stent graft system

Conditions: Abdominal Aortic Aneurysm

Summary: the aim of this study is to evaluate the safety and feasibility of the endologix fenestrated stent graft system for the endovascular repair of juxtarenal or pararenal aortic aneurysms.

the endologix fenestrated stent graft system that will be used in this study has three components, listed below: 1. endologix unibody bifurcated stent graft 2. endologix fenestrated proximal extension stent graft 3. endologix renal stent graft

Eligibility criteria:
inclusion criteria: * adequate iliac/femoral access compatible with the required delivery systems * non-aneurysmal infrarenal aortic neck \<15mm in length * most caudal renal artery to aortoiliac bifurcation length \>= 70 * sma to aortoiliac bifurcation length \>=90mm * proximal non-aneurysmal aortic neck below the sma with diameter 18 to 34 mm, length \>=15mm and angle \<=60° to the aneurysm sac * angle \<=60° (clock face) between the sma and ca * renal arteries both at or below the sma by \<=35mm and within 30mm of each other axially, with 4 to 8mm lumen diameter, and with clockface angle of 90° to 210° to each other * common iliac artery distal fixation site with: distal fixation length \>=15mm, with diameter \>=10 mm and \<=23 mm and angle \<=90° to the aortic bifurcation * ability to preserve at least one hypogastric artery exclusion criteria: * life expectancy \<2 years as judged by the investigator * psychiatric or other condition that may interfere with the study * participating in the enrollment or 30-day follow-up phase of another clinical study * known allergy to any device component * coagulopathy or uncontrolled bleeding disorder * contraindication to contrast media or anticoagulants * ruptured, leaking, or mycotic aneurysm * aortic dissection serum creatinine (s-cr) level \>2.0 mg/dl * traumatic vascular injury * active systemic or localized groin infection * connective tissue disease (e.g., marfan's syndrome) * recent(within prior three months)cerebrovascular accident * recent(within prior three months)myocardial infarction * prior renal transplant * length of either renal artery to be stented \<12mm * significant occlusive disease or calcification of either renal artery (\>70%) * an essential accessory renal artery * indispensable inferior mesenteric artery * untreated aneurysmal disease of the descending thoracic aorta * clinically significant mural thrombus circumferentially in the suprarenal segment * prior iliac artery stent implanted that may interfere with delivery system introduction * unsuitable vascular anatomy * pregnancy

Keywords: abdominal aortic aneurysm fenestrated renal stent juxtarenal pararenal endologix renal
a study to evaluate psoriasis outcomes and safety events in patients with chronic moderate to severe plaque psoriasis (response)

Conditions: Psoriasis

Summary: this was a multicenter, prospective, 5-year surveillance study of approximately 5000 raptiva-treated patients and approximately 500 non-raptiva treated patients (formerly 2500 comparison patients who were treated with a biologic therapy other than raptiva) with chronic moderate to severe plaque psoriasis who were candidates for treatment with raptiva.


Eligibility criteria:
inclusion criteria: * have ever had a physician's diagnosis of chronic moderate to severe plaque psoriasis and be a candidate for treatment with raptiva * are being treated with or initiating raptiva therapy at the time of enrollment * be able to provide written informed consent * be willing and able to fully to participate for the duration of patient follow-up (5 years) exclusion criterion: * have previously received at least one dose of raptiva and are not currently using or restarting treatment with raptiva at the time of enrollment

Keywords: plaque psoriasis response raptiva efalizumab
whole-body vibration with or without localized radiofrequency and body composition in obese female

Conditions: Obesity

Summary: the aim of this study is to evaluate the effect of whole-body vibration in the presence or absence of localized radiofrequency on body composition in obese female subjects. moreover, strength tests will be performed. the study hypothesis is that whole-body vibration induces positive changes in body composition i.e., reduction of fat mass and increase of lean mass with associated increase in performance. the possible additive role of radiofrequency will also be assessed.

* recruitment of female obese subjects * baseline assessment (body composition with dual energy x-ray absorptiometry (dxa) and strength tests) * 2-mo whole body vibration training (2 sessions a week, 30 min per session) with or without local delivery of radiofrequency (two randomly selected groups) * final assessment (body composition with dxa and strength tests) * data collation and analysis

Eligibility criteria:
inclusion criteria: * bmi: \>25 * normal locomotion * informed consent form signed exclusion criteria: * acute illness * endocrine pathologies or diabetes mellitus * vascular pathology * pacemaker * pregnancy

Keywords: whole-body vibration radiofrequency muscular strength exercise body composition
vinayasa yoga and mood

Conditions: Affect; Stress, Psychological

Summary: the purpose of this study is to examine the immediate and cumulative effects of yoga on stress and mood among young adult college students attending an 8-week program in vinyasa yoga.

traditional vigorous aerobic exercises (tae), such as running and bicycling have been shown to improve mood and relieve stress. yoga is an ancient physical and mental practice that as a form of exercise may share properties of tae and in turn offer similar mood and stress effects. however, scientifically rigorous studies examining the psychological effects of yoga and published in peer-reviewed western journals are rare. the aim of this research was to establish preliminary evidence for the acute effects of vinyasa yoga on mood and stress among young adults.

Eligibility criteria:
inclusion criteria: * adult ages 18 or older * english-speaking exclusion criteria:

Keywords: yoga, exercise affect mind/body therapies stress, psychological
unraveling mechanism of action of extracorporeal photopheresis in heart and lung transplant patients

Conditions: Heart Transplanted Patients; Lung Transplanted Patients; Chronic Lung Allograft Dysfunction (CLAD); Cardiac Allograft Vasculopathy

Summary: this is a prospective observational single center national study. lung and heart transplant patients with a definite diagnosis of chronic lung allograft dysfunction (clad) or cardiac allograft vasculopathy (cav) will be assigned for extracorporeal photopheresis (ecp) as per common clinical practice to a 6-month ecp cycle with the aim of limiting progression of organ dysfunction. the exact mechanisms of ecp in chronic rejection after lung and heart transplantation (clad and cav) are elusive but it is thought to induce apoptosis of lymphocytes and to generate regulatory t cells, which modulate transplant immune rejection by a complex effect.

the primary objective of the present study is to identify the biomarkers associated to response to ecp after 6 months of treatment.

Eligibility criteria:
lung transplanted patients will be enrolled according to current per center protocol at diagnosis of established clad grade 1-2 (diagnosis will be made according to published guidelines) . rate of graft function decline will be classified as rapid (\>/= 100 ml/month) or slow (\ 10% decline with respect to baseline value at ecp initiation in graft function will be classified as non-responders.heart transplanted patients with demonstrated cav in a recent angiography (\<6 months) in absence of acute cellular or antibodies mediated rejection at myocardial biopsy, will be enrolled the diagnosis of cav will require the presence of thickening of the arterial intima in any epicardial artery.

Keywords: ecp, heart and lung rejection, mirna
drug use-results survey in participants infected with hepatitis c virus genotype 2

Conditions: Chronic Hepatitis C Virus

Summary: the main objective of this study is to evaluate the safety and effectiveness of paritaprevir/ritonavir/ombitasvir with ribavirin used for participants infected with chronic hepatitis c virus (hcv) genotype 2 in daily practice in japan.


Eligibility criteria:
inclusion criteria: * hcv genotype 2 participants treated with paritaprevir/ritonavir/ombitasvir plus ribavirin in daily practice. exclusion criteria: * participants who have been previously treated with paritaprevir/ritonavir/ombitasvir and ribavirin.

Keywords: genotype 2 paritaprevir hepatitis c virus (hcv) ritonavir ombitasvir
high dose chemo with autologous bmt for treatment of metastatic breast cancer

Conditions: Breast Neoplasms

Summary: to evaluate the response rate and the response duration of high dose chemotherapy with autologous bone marrow transplantation as intensification following induction chemotherapy in metastatic breast cancer and to evaluate prospectively the subdivision of patients with metastatic breast cancer according to prognostic groups.

there are 2 phases to this study: 1) induction- which consists of the administration of chemotherapeutic drugs- at the end of this phase if the cancer has responded, bone marrow will be collected and frozen untol ready for re-infusion; 2) 2nd phase- involves high-doses of chemotherapy followed by infusion of bone marrow cells

Eligibility criteria:
inclusion criteria: * histologically confirmed diagnosis of breast cancer * age 18-70 * breast cancer at first clinical evidence of metastatic disease * must have objectively measurable or evaluable disease or be in complete remission exclusion criteria: * previous diagnosis of another invasive carcinaom within 10 years (except skin cancer) * cns involvement

Keywords: breast cancer cancer treatment breast cancer treatment
salivary antioxidant capacity before and after complete dental rehabilitation

Conditions: Dental Caries in Children

Summary: salivary samples were obtained from 20 children in their fifth year of life diagnosed s-ecc and 20 age and sex matched controls. complete dental rehabilitation under general anesthesia was performed for the 20 children with s-ecc, and follow up salivary samples were obtained one week and three months post operatively. the tac was measured using a commercially available oxygen radical absorbance antioxidant assay measurement kit (zen-bio orac™, ams biotechnology, abington uk).

background: the association of total salivary antioxidant capacity (tac) to severe early childhood caries (s-ecc) has been studied in the past. it is not clear if tac is an indicator of the inflammatory response to the lesion or a marker of the disease. aim: this study aimed to measure the salivary tac levels in children with early childhood caries before and after dental treatment and compare the results to caries free children. methodology: salivary samples were obtained from 20 children in their fifth year of life diagnosed s-ecc and 20 age and gendersex matched controls. complete dental rehabilitation under general anesthesia was performed for the 20 children with s-ecc, and follow up salivary samples were obtained one week and three months post operatively. the tac was measured using a commercially available oxygen radical absorbance antioxidant assay measurement kit (zen-bio orac™, ams biotechnology, abington uk).

Eligibility criteria:
inclusion criteria: * medically fit children * age below 71 months * test group - to be diagnosed with severe ecc * control group - to be caries free exclusion criteria:

Keywords: antioxidant capacity
helmsley 3.0: abbreviated mre

Conditions: Crohn's Disease

Summary: the purpose of our study is to compare an abbreviated magnetic resonance imaging (mri) of the bowel or magnetic resonance enterography (mre) protocol to a conventional, standard of care mre in children and adults with crohn's disease.

this multi-center study will evaluate the effectiveness of an abbreviated magnetic resonance imaging (mri) of the bowel or magnetic resonance enterography (mre) to document the presence and severity of small bowel inflammation, the presence and features of stricturing and penetrating disease in children and adults with crohn's disease. the abbreviated mri of the bowel or mre will not involve iv contrast or an injection of glucagon and water will replace the oral contrast used in standard of care mres. scan time will be greatly reduced with the abbreviated mre ( approximately 15 minutes) compared to a standard of care mre (approximately 60 minutes).

Eligibility criteria:
inclusion criteria: * established crohn's disease diagnosis in patients 10 and older * undergoing clinical magnetic resonance enterography (mre) examinations for any reason(s) below * staging/ restaging/ follow- up of intestinal inflammation * evaluation of known or suspected luminal narrowing/ stricturing disease * evaluation of known or suspected internal penetrating disease exclusion criteria: * undergoing initial imaging for suspected crohn's disease where the diagnosis of crohn's disease has yet to be definitively established * new crohn's disease diagnosis, undergoing baseline imaging * isolated colonic disease * known or suspected pregnancy * contraindication to magnetic resonance imaging (mri) * ileostomy or prior ileal resection * less than 10 years of age * unable or unwilling to follow imaging procedures * non- english speaking

Keywords: magnetic resonance imaging (mri) crohn's disease magnetic resonance enterography (mre)
review of post-study clinical endoscopy reports in follow up to may2016-07-01

Conditions: Familial Adenomatous Polyposis

Summary: this study reviews post study clinical endoscopy reports in follow up to patients who participated in may2016-07-01 with weekly erlotinib for familial adenomatous polyposis. reviewing follow up medical records may help researchers examine the extent of rapid progression of familiar adenomatous polyposis disease burden after discontinuation of weekly erlotinib.

primary objective: i. to review clinical endoscopy reports, pathology reports, and other medical records related to standard-of-care endoscopic evaluations for all participants in the parent study, may2016-07-01, to determine the extent of reports of rapid progression of recurrent polyps after completion intervention and follow up under the parent protocol. outline: patients who participated in may2016-07-01 undergo review of medical records.

Eligibility criteria:
inclusion criteria: * may2016-07-01 study participants for whom medical records are available and accessible exclusion criteria: * may2016-07-01 study participants who have opted out of medical records reviews or for whom consent for medical record review cannot be confirmed/documented
a study of the efficacy of prolonged-release melatonin versus placebo in diabetic patients suffering from insomnia

Conditions: Diabetes Mellitus, Type 2; Insomnia

Summary: objective - type 2 uncontrolled diabetic patients often have low endogenous melatonin and suffer from sleep disorders. the effect of a prolonged-release melatonin (prm) formulation on glucose lipid metabolism and sleep is studied in type 2 diabetes patients with insomnia.

methods: in a randomized, double-blind, crossover study, the subjects were treated for 3 weeks with 1 tablet per night of 2 mg prolonged-release melatonin or placebo, with one week washout period in between. sleep was objectively monitored by wrist actigraphy. fasting glucose, fructosamine, insulin, c-peptide, triglycerides, cholesterol (total, hdl and ldl) and some antioxidants were assessed at baseline and end of each period.

Eligibility criteria:
inclusion criteria: * diabetic patients with proven presence of the disease who complained of insomnia. exclusion criteria: * patients with liver or renal problems (serum creatinine above 1.5 mg/dl).

Keywords: melatonin insomnia diabetes sleep