Kornimate/medical-research-clean huggingface dataset:
integrative parenteral nutrition in cancer patients

Conditions: Neoplasms; Parenteral Nutrition

Summary: although it is demonstrated that nutritional support can improve clinical outcomes, the literature shows that approximately 50% of cancer patients are not able to meet their estimated energy requirements. recent clinical studies suggest that a supplementary support for parenteral nutrition (pn) could significantly help to improve the nutritional status of malnourished cancer patients. international guidelines recommend the use of pn in malnourished, hypophagic, non-surgical cancer patients if enteral nutrition is not feasible and in patients affected by severe iatrogenic gastrointestinal complications and in whom inadequate food intake is anticipated for more than 7 days. however, there are no studies on the effects of integrative pn in hospitalized, malnourished, hypophagic, non-surgical cancer patients. recent studies have reported on the validity of bioelectrical impedance vector analysis in monitoring the body composition of patients receiving nutritional support. particularly, phase angle proved to be a superior prognostic marker than other nutritional screening tools.


Eligibility criteria:
inclusion criteria: * diagnosis of cancer (head-neck, lung, gastrointestinal, pancreas, biliary tract, haematology). * nutritional risk screening 2002 score ≥3. * expected duration of parenteral nutrition ≥7 days * availability to planned measurements * contraindication to enteral nutrition support * written informed consent exclusion criteria: * age \< 18 years * ongoing artificial nutrition before hospitalization * eastern cooperative oncology group performance status \>2
evaluation of long-acting muscarinic antagonists in copd

Conditions: Pulmonary Disease, Chronic Obstructive

Summary: in chronic obstructive pulmonary disease (copd), the airways of the lungs are narrowed or blocked. bronchodilators are drugs usually delivered through inhalers which help open up the airways. tiotropium is a type of bronchodilator drug known as a long-acting muscarinic antagonist (lama). for a long time tiotropium was the only available lama. more recently, a new lama called aclidinium has been approved for use in copd. there are potentially important differences between these two medications that might have an impact on the treatment of copd patients. in this study we aim to compare the effects of tiotropium and aclidinium in people with copd. the main comparison will be done using a very sensitive breathing test called impulse oscillometry


Eligibility criteria:
inclusion criteria: * male and female volunteers aged 40-80 years with moderate to severe copd (gold stage 2, 3). * on inhaled corticosteroids / long-acting beta agonists * fev1 30-80% predicted and fev1/fvc \<70%. * smoking history ≥10 pack-years. * ability to give informed consent * agreement for their general practitioner to be made aware of study participation and to receive feedback as relevant to the participant's well being exclusion criteria: * other respiratory diseases such as asthma, bronchiectasis or allergic bronchopulmonary aspergillosis * a copd exacerbation or respiratory tract infection requiring systemic steroids and/or antibiotics within 1 month of the study commencement (3 months if hospitalisation has been required) * any clinically significant medical condition that may endanger the health or safety of the participant * known or suspected sensitivity to/intolerance of investigational medicinal product * patients with prostatic hyperplasia, bladder outflow obstruction or glaucoma * pregnancy or lactation * unable to comply with the procedures of the protocol

Keywords: pulmonary disease, chronic obstructive long-acting muscarinic antagonists impulse oscillometry
the influence of motor imagery in fine motor skills

Conditions: Mental Retardation and Developmental Disabilities With No Organic Condition

Summary: the main purpose of this study is to ascertain whether the application of motor imagery together with normal practice improves fine motor skills in disabled individuals.

imagery is a cognitive process that can play an important role on the planning and execution of different movements or actions. the main purpose of this study is to ascertain whether the application of motor imagery together with normal practice improves fine motor skills in disabled individuals. in this study participated 42 subjects of both genders with disabilities, with a mean age of 37 (sd=12). subjects were randomly divided in two groups: a control group and an experimental one. the study procedures were applied on five different tasks of the psychomotor battery of fine motor skills (bpm). this instrument was applied in two stages, at the beginning of the study (pretest) and at the end of the 4 weeks (posttest). both groups performed the tasks twice a week for a month. motor imagery sessions were added on in the experimental group. participants on the experimental group were asked to mentally imagine themselves recreating tasks they had performed earlier on the initial assessment. for the analysis of the results, descriptive and inferential statistics were used. the t-test for independent samples, and the t-test for paired samples were applied.

Eligibility criteria:
inclusion criteria: * institutionalized individuals * individuals with disabilities who were able to perform motor tasks exclusion criteria: * individuals with hearing disability * individuals with visual disability * individuals without motor autonomy

Keywords: motor imagery fine motor skills disabled
evaluation of women with endocrine and reproductive-related conditions

Conditions: Endocrine Disease; Infertility; Leiomyoma; Endometriosis; Fibroids

Summary: this study was designed to allow inpatient and outpatient evaluation of women with a variety of reproductive and endocrine-related disorders for purposes of research and physician education. the evaluations may include ultrasound examinations, blood, saliva, and/or urine samples. in some cases, specific laboratory or x-ray studies will be performed to confirm the diagnosis or assist in the treatment of the patient. these additional tests will be conducted within the guidelines of current gynecologic practice. in some cases, the patient will receive medical or surgical treatment for their disorder. the purpose of this study is to provide an opportunity for physicians to evaluate women with medical conditions of reproduction. these evaluations and treatments will support clinical training and research for the accredited training program in reproductive endocrinology at the national institute of child health and human development (nichd).\

the specific objective of this protocol is to gain knowledge and collect data in order to allow for hypothesis generation in future research as well as give nichd investigators and trainees hands on experience related to the diagnoses, management, treatment and follow-up of reproductive endocrine disorders. such disorders include but are not limited to polycystic ovarian syndrome, endometriosis, primary ovarian insufficiency, recurrent pregnancy loss, primary amenorrhea and infertility. this information will be taken from standard medical care/procedures and follow up of patients and healthy volunteers. it allows investigation into the problems of these patients for the purpose of furthering general knowledge and teaching.

Eligibility criteria:
* inclusion criteria: * subjects aged 1-85 with reproductive endocrine related conditions. * young women, women of reproductive age, and older women are the focus of this protocol. * girls with reproductive disorders under the age of 18 will be studied and their assent will be obtained if possible along with the consent of their parent/guardian. * reproductive disorders of men will be included. exclusion criteria: * pregnant women over 23 weeks will be excluded, since there are no on-campus prenatal or neonatal facilities. if we see patients in consultation after 23 weeks, as is our practice, we will provide a report to the referring pi on that protocol as well as the patient's personal obstetrician. we do not provide long term obstetrical care. * patients specifically requesting in vitro fertilization will not be considered candidates and will not be seen under this protocol. these patients may be seen for a consultation, but will be referred for these services outside of the nih. * pregnant patients requiring fetal surgery will be excluded since there are no on-campus neonatal facilities.

Keywords: reproductive surgery infertility hormone replacement therapy gata 2 sickle cell natural history
early feeds in gastroschisis

Conditions: Gastroschisis

Summary: this study aims to evaluate the feasibility of initiating early feeds in neonates with gastroschisis, a condition where infants are born with their intestines outside the body.


Eligibility criteria:
inclusion criteria: * neonates with presumed simple gastroschisis * born at ≥ 34 weeks' gestation * hemodynamically stable * consented within 48 hours after abdominal closure * mothers who are ≥16 years old * mothers who speak english or spanish exclusion criteria: * neonates with evidence of complex gastroschisis at time of closure (any ischemic bowel, intestinal perforation, or obvious atresia with mesenteric defect) * presence of any major congenital anomalies * neonates who are receiving ionotropic medications * neonates who are wards of the state * neonates whose care is considered to be futile or those undergoing re-direction of care * neonates participating in another interventional trial * any patient deemed unfit for participation by study investigator(s)

Keywords: gastroschisis early feeds in gastroschisis
open label study for the use of transcranial ultrasound for treatment of age-related frailty

Conditions: Frailty; Aging

Summary: the purpose of this phase i open label study is to evaluate longer term tolerability and potential effectiveness of transcranial ultrasound in people with age-related frailty.

this study is designed to evaluate the safety and efficacy of focused ultrasound in patients with age-related frailty characterized by reduced physical and immunological functioning. the safety of this protocol will be closely monitored and data will be used to determine whether any significant safety issues exist when using focused ultrasound. adverse events will be noted whenever they occur but will be recorded at the time of the procedure and throughout routine follow-ups, which will persist weekly throughout the duration of the active study protocol. patients deemed potentially appropriate candidates for focused ultrasound therapy will be treated with 8 sessions of transcranial ultrasound, each of which consists of 10 to 30 minutes of active administration. clinical and safety outcome measures will be obtained throughout and after completion of the study protocol.

Eligibility criteria:
inclusion criteria: * age eligibility requirements fall in a range from 60 to 95 years of age * clinical appraisal by physician indicating signs of frailty (apart from a co-occuring condition), scoring 3\<x\<7 as denoted by the csha clinical frailty scale (rockwood, song, macknight, et al, 2005; golpanian, difede, pujol, et al., 2016) * mri of the brain including volume measurement of the hypothalamus exclusion criteria: * subjects unable to give informed consent * subjects who would not be able to lay down without excessive movement in a calm environment sufficiently long enough to be able to achieve sleep * pregnancy, women who may become pregnant or are breastfeeding * advanced terminal illness * subjects with scalp rash or open wounds on the scalp (for example from treatment of squamous cell cancer)
a study on the mechanism of cough hypersensitivity

Conditions: Cough

Summary: the aim of this study is described as follows, 1. to establish a validated method to test cough reflex sensitivity conducted by transient receptor potential vanilloid 1(trpv1). 2. to observe the variance of cough reflex sensitivity conducted by transient receptor potential ankyrin 1(trpa1) of chronic patients and the relationship between cough reflex sensitivity conducted by trpa1 and conducted by trpv1. 3. to study the distribution of trpa1 and trpv1 channels and their relationship to cough reflex sensitivity.

this study is divided into two major part, firstly,to observe the variance of cough reflex sensitivity of chronic cough patients and the relationship between it and airway inflammation. 1. recruit chronic cough patients and healthy volunteers as subjects. 2. help subjects to complete detailed history,physical examination,hull airway reflux questionnaire,chest x-rays,induced sputum,blood routine test,pulmonary ventilation function test and histamine provocation test before they enter this study. 3. complete allyl isothiocynate(aitc) cough provocation test the day subjects enter the study,then complete capsaicin（cap）cough provocation test after 3 days. 4. to detect the substance p(sp),calcitonin gene-related peptide(cgrp),prostaglandin e2(pge2),et al level in sputum supernatants. secondly,to observe the distribution of trpa1,trpv1 channels and the relationship between it and cough reflex sensitivity. 1）recruit chronic cough patients and healthy volunteers and complete related examinations as mentioned before. 2)collect mucosa specimens from upper trachea via endobronchial biopsy,and airway epithelial cells from 2nd or 3rd order bronchi via brushing. 3)evaluate the expression level of trpa1,trpv1 of mucosa specimens of subjects by immunofluorescent assay and image analysis software. 4)cultivate airway epithelial cells from subjects and evaluate the expression of trpv1,trpa1 and functional changes of it.

Eligibility criteria:
inclusion criteria: chronic cough group: 1. cough lasting ≥ 8 weeks,characterized by irritating dry cough. 2. sensitive to fumes，dust,the odorous and cold air. 3. with normal chest x-rays. 4.17-70 years old. 5.without smoking history. healty controls group: 1.17-70 years old. 2.without smoking hitory or stop smoking for more than 2 years. 3.without chronic cough. 4.without chronic respiratory diseases. 5.without chronic heart, liver, kidney,and autoimmune disease. 6.with normal chest x-rays. 7.with normal pulmonary ventilation function,and histamine challenge test showed negative result. exclusion criteria: chronic cough group and healty controls group: 1. with respiratory tract infection within 8 weeks. 2. with chronic respiratory diseases or severe heart, liver, kidney,and autoimmune disease. 3. using angiotensin-converting enzyme inhibitors(acei),bronchodilators,glucocorticosteroid,antihistaminics within one week. 4. women during pregnancy or lactation. 5. patients with malignant tumours.

Keywords: chronic cough cough reflex sensitivity transient receptor potential vanilloid 1 transient receptor potential ankyrin 1
shunt evaluation with alpe system in thoracic surgery

Conditions: Mechanical Ventilation; Thoracic Diseases

Summary: . the aim of this study, thus, is to evaluate shunt fraction and markers of alveolar distress during one lung ventilation (olv) at different levels of positive end expiratory pressure (peep). moreover, investigators will focus on predicting factors of high shunt levels during olv.


Eligibility criteria:
inclusion criteria: * patients scheduled for thoracoscopic lobectomy or thoracoscopic wedge resection in lateral decubitus. * patients american society of anesthesiologists physical status classiﬁcation score of 1-3 exclusion criteria: * patients with hemodynamic instability, * patients with severe chronic respiratory failure * patients with preoperative anemia (hemoglobin \<10 g 100 ml-1) * patients requiring unplanned conversion to thoracotomy
efficacy and safety of vildagliptin in subjects with impaired glucose tolerance

Conditions: Prediabetic State

Summary: the purpose of this study is to assess the safety and effectiveness of vildagliptin, an unapproved drug, compared to placebo in lowering post-meal blood glucose levels in people with pre-diabetes who have high blood sugar levels after meals.


Eligibility criteria:
inclusion criteria: * blood glucose criteria must be met * body mass index (bmi) in the range 23-45 exclusion criteria: * diagnosis of diabetes * serious cardiovascular events within the past 6 months * use of insulin or any oral antidiabetic agent * other protocol-defined exclusion criteria may apply

Keywords: pre-diabetes vildagliptin igt
multicenter post-approval study of the glaukos® istent® trabecular micro-bypass stent system in conjunction with cataract surgery

Conditions: Primary Open Angle Glaucoma

Summary: the purpose of this study is to assess the long-term safety of the glaukos® istent® trabecular micro-bypass stent model gts100 in conjunction with cataract surgery vs. cataract surgery only, in subjects with mild to moderate open-angle glaucoma.

the purpose of this study is to assess the long-term safety of the glaukos® istent® trabecular micro-bypass stent model gts100 in conjunction with cataract surgery compared to cataract surgery only, in subjects with mild to moderate open-angle glaucoma.

Eligibility criteria:
inclusion criteria: * mild to moderate primary open-angle glaucoma * currently treated with ocular hypotensive medication * pseudoexfoliative and pigmentary glaucoma are acceptable diagnoses * subject scheduled to undergo cataract surgery exclusion criteria: * primary angle-closure glaucoma; or secondary angle closure glaucoma, including neovascular glaucoma * retrobulbar tumor, thyroid eye disease, sturge-weber syndrome or any other type of condition that may cause elevated episcleral venous pressure

Keywords: primary open-angle glaucoma (poag) trabecular meshwork istent
serious game for parkinson's disease patients

Conditions: Parkinson's Disease

Summary: in this study the investigators aim to assess the feasibility and acceptability of a serious game to rehabilitate gait and balance disorders in 10 patients with parkinson's disease previously operated for deep brain stimulation of the sub thalamic nucleus.


Eligibility criteria:
inclusion criteria: * parkinson's disease * gait and balance disorders * chronic bilateral deep brain stimulation of the subthalamic nucleus (\> 1 year). exclusion criteria: * dementia * ongoing severe medical condition that prevented assessments

Keywords: gait and balance disorders serious game
sms messaging as a tool to improve cancer screening programs

Conditions: Mass Screening; Colorectal Cancer; Breast Cancer

Summary: the aim of this project is to assess the impact on health and economics of the implementation of text messaging (sms) in cancer screening programs. three interventions with sms will be evaluated through community trials. in the colorectal cancer screening program the following interventions will be tested: a) participation reminder: six weeks after sending the invitation letter of the colorectal cancer program if there has not been a response, a reminder sms will be sent in front of the usual method by letter; b) reminder to return the fecal occult blood test: sms reminder of test delivery versus no intervention. this reminder will be sent to the individuals who have gone to the pharmacy to pick up a fecal occult blood test and they have not returned it after 14 days. the impact on participation will be analyzed and, if applicable, the proportion of advanced neoplasms will be calculated by increase in participation. in the breast cancer screening program, the invitation by sms versus the usual invitation by letter will be studied in women who had participated in the previous screening round. the impact on participation will be analyzed. a cost-effectiveness analysis of the three interventions will be carried out. the incremental cost ratio of the interventions between cost variation and effectiveness variation will be calculated.

main hypothesis: the implementation of sms in population-based cancer screening programs will improve participation, especially in colorectal cancer screening, will allow a better resource management and reduce costs in both programs. specific hypothesis: sending the reminder sms will have an impact on participation greater than that obtained with the standard reminder (letter) in the colorectal cancer screening program. the effect of the colorectal cancer screening reminder sms will be greater among the individuals who have been invited for the first time and not previous participants. participation after receiving the invitation by sms in breast cancer screening will be equal to or better than the letter invitation. the alternative that includes sending sms will be cost-effective in relation to the current alternative that you use postal shipping.

Eligibility criteria:
inclusion criteria: * eligible individuals for colorectal cancer screening (intervention 1 and 2) * eligible women for breast cancer screening (intervention 3) * registered at the healthcare database (rca) exclusion criteria: * individuals without a mobile phone number registered at the rca * opt out from breast cancer screening and/or colorectal cancer screening

Keywords: uptake participation cost-effectiveness breast cancer screening colorectal cancer screening text-message mobile-health
study of lonafarnib in patients with recurrent squamous cell carcinoma of the head and neck (study p02530)

Conditions: Carcinoma, Squamous Cell; Head and Neck Neoplasms

Summary: the purpose of this study is to determine the safety and efficacy of an oral farnesyl protein transferase inhibitor (lonafarnib/sch 6636) as a single agent in adult patients with squamous cell carcinoma of the head \& neck and will help determine if further development is justified.


Eligibility criteria:
inclusion criteria: * histologically or cytologically proven squamous cell carcinoma of the head \& neck. * age greater than or equal to 18. * ecog performance status of 0 to 1 * measurable malignant disease. * patients that have failed at least one platinum-containing regimen and have received no more than three prior regimens and do not have other curative treatment options. * patients must be at least 2 wks post surgery or radiation therapy * patients must be at least 4 weeks post chemotherapy * meets protocol requirements for specified laboratory values. * written informed consent and cooperation of patient. * appropriate use of effective contraception if of childbearing potential. * no investigational drugs of any type within 30 days prior to administration. exclusion criteria: * prior exposure to farnesyl transferase inhibitors * medical conditions that would interfere with taking oral medications. * patients with significant qtc prolongation at baseline (\>500 msec.) * pregnant or nursing women * known hiv positivity or aids-related illness. * concomitant chemotherapy, hormonal therapy, radiotherapy or immunotherapy * patients with any signs of involvement of the dura, meninges, or brain. * patients with squamous cell carcinoma of the nasopharynx * patients who currently have other cancers or have been treated in the last 5 years for any other malignancy.

Keywords: squamous cell carcinoma of the head & neck
comparison of gated blood-pool spect and echocardiogram for ventricular function

Conditions: Ventricular Dysfunction

Summary: to compare the calculated biventricular ejection fraction from cadmium-zinc-telluride (czt) single photon emission computed tomography (spect) with planar equilibrium radionuclide angiography (erna), first-pass radionuclide ventriculography (fp-rnv) and echocardiogram.

to evaluate the feasibility of using czt spect as an "all-in-one" technique to provide information on both left ventricular ejection fraction (lvef) and right ventricular ejection fraction (rvef) derived from a single examination and compare with the values from traditional planar erna, fp-rnv and echocardiography.

Eligibility criteria:
inclusion criteria: * patients underwent transthoracic echocardiogram and resting cardiac function within interval of 90 days of each other exclusion criteria: * pregnancy