Kornimate/medical-research-clean huggingface dataset:
measure of frailty in perioperative setting

Conditions: Frailty

Summary: though most physicians believe they can identify frail patients, frailty is a poorly characterized and complex clinical syndrome. frailty has been categorized four dimensions by de vries et al: 1) physical (physical activity, nutrition, mobility, strength and energy); 2) biochemical (nutritional and inflammatory biomarkers); 3) psychological (cognition and mood); and, 4) social (social contact and support). 1 however, the pathophysiology of frailty remains unclear. two broad hypotheses have been proposed. deficit accumulation model: this hypothesis assumes that frailty occurs due to accumulation and additive effect of multiple deficits, which occur across various domains. the more deficits a person has, the more likely that person is to be frail. frailty in this paradigm is thus measured by identifying the number of positive factors/ deficits from a list. this is used to create a proportional index of deficits, expressed as the ratio of deficits present to the total number of deficits considered. many studies have used a modified frailty index (mfi) with 11 factors, which has shown to correlate well with patient outcomes after surgery. phenotype model: fried et al in 2001 proposed a phenotype based model, in which she identified various clinical features that define frailty as a clinical syndrome. this criterion, known as fried index, consists of 5 factors- shrinking, weakness, exhaustion, slowness, and low physical activity level. the fried index is the most commonly used phenotype-based assessment tool to evaluate frailty. an advantage is its ease-of use during preoperative visits. measurement of these factors in a perioperative setting was further characterized by makary et al in 2010, and was the basis for the hopkins frailty score (hfs). currently, there exists no gold standard for assessment of frailty, especially in the perioperative setting. in the absence of a well-accepted gold standard, a measurement of frailty which would predict adverse postoperative outcomes would be useful. however, no study has compared the prognostic abilities of hfs and mfi, after non-cardiac surgery. all adult patients presenting to pre anesthesia evaluation clinic (pace) at cleveland clinic main campus will be included in the this prospective observational cohort study. frailty would be evaluated prospectively using hfs and components of mfi will be obtained from cleveland clinic perioperative health documentation system registry (phds).


Eligibility criteria:
inclusion criteria: * adult patients (18-100 years of age) * patients presenting to the pace clinic for non cardiac surgery exclusion criteria: * children (under 18 years of age) * patients presenting to the pace clinic for cardiac surgery
gut microbiome and treatment for gynecological cancer patients receiving immunotherapy

Conditions: Gynecologic Cancer; Immunotherapy; Gut Microbiome

Summary: 30 participants with advanced or recurrent gynecological cancer from are enrolled for this study. eligible participants then provide fecal specimen, blood, vaginal swab, oral mucosal swab and receive food dietary recommendation. additional samples are collected for results analysis.

30 patients diagnosed with advanced or recurrent gynecological cancer who plan to receive immunotherapy treatment with a checkpoint inhibitor at ahmg adventhealth orlando gynecological oncology group are recruited. patients will be recruited 1-2 weeks prior to the beginning of treatment and appropriate informed consent will be obtained. fecal samples; blood; saliva and vaginal swab samples will be collected among participants prior to their first treatment, after four doses of immunotherapy, and again at the completion of immunotherapy (follow-up). these 4 biomarker samples will undergo metatranscriptomic analysis, also known as rnaseq, method of sample analysis. only rna molecules are sequenced, while dna is degraded. for bacterial community analysis. these findings will help to design a future study to examine the role of the gut microbiome in antitumor immunity and its effect on immune checkpoint inhibitor therapy for advanced or recurrent gynecological cancer. nhanes food frequency questionnaire will be collected prior to participants' first treatments. the short-term goals of this pilot study are to obtain preliminary data on the gut bacterial microbiome of patients with advanced or recurrent gynecological cancer. the long-term goals of this study is to begin to understand how the gut microbiome changes within an individual patient undergoing immunotherapy, to gut microbiome differs among patients undergoing immunotherapy, and to examine whether the gut microbiome is associated with the response to cancer immunotherapy.

Eligibility criteria:
inclusion criteria: * adult females \> 18 years old * advanced or recurrent gynecological cancer patients from ahmg advent health orlando gynecologic oncology group * patients for whom an immunotherapy regimen has been ordered exclusion criteria: * patients unable to provide fecal specimens at three time points * patients unable to read or understand informed consent * taking medications that may affect gut microbiome: * proton pump inhibitors (ppis) * metformin * antibiotics * laxatives * patients who are receiving investigational agent

Keywords: biome microbiome gastrointestinal immune check point inhibitors nutrition diet viome ici icis rnaseq anti-tumor immunity cancer gynecology
safety and efficacy of (pn-152,243)/pn-196,444 in the prevention of thrombocytopenia

Conditions: Sarcoma

Summary: intensive chemotherapy is associated with significant thrombocytopenia, often requiring platelet transfusion to maintain platelet counts. this investigational drug has demonstrated the ability to increase platelet counts. this study will test the safety and efficacy of an investigational drug in the prevention of thrombocytopenia in patients with high-risk sarcoma receiving ai (adriamycin/ifosfamide) chemotherapy.


Eligibility criteria:
inclusion criteria: * patients must be newly diagnosed with moderate or high-grade sarcoma and be receiving ai (adriamycin/ifosfamide) chemotherapy exclusion criteria: * patients must not have active bleeding (exclusions do apply) or history of platelet disorder
effect of osteopathic manipulative medicine (omm) on pulmonary function and speech in parkinson's disease

Conditions: Parkinson's Disease

Summary: the purpose of this study is to investigate the effect of selected osteopathic manipulative medicine (omm) techniques on the respiratory system of people with parkinson's disease (pd) in comparison to light touch. effectiveness will be measured through pulmonary function tests, chest wall expansion, and voice analysis. selected subjects will be randomly assigned to one of the two groups: omm treatment group or light touch group. although omm treatment has been used on pd patients, a randomized controlled study has not been done to establish its effect on pd respiratory function. the authors believe that this study will show omm's effectiveness.

osteopathic manipulative medicine (omm) on the thoracic cage and diaphragm is commonly used in clinical practice to address myofascial imbalances, including muscle spasms to improve thoracic cage excursion. prior research has demonstrated that manual approaches applied to the thoracic cage have positive results with lung function and reducing inflammation. parkinson's disease (pd) is a common disabling and progressive neuro-degenerative disorder. morbidity and mortality are frequently associated with pulmonary dysfunction in patients with pd. pulmonary function tests (pft) have been utilized to document respiratory impairment in pd patients. researchers estimate that 89% of people with pd have speech and voice disorders including disorders of laryngeal, respiratory and articulatory function. these authors hypothesize that performing omm on the thoracic cage of pd subjects will show improvement in pft, chest expansion, and speech production. subjects with pd meeting the criteria for the study will be randomly assigned to either an omm treatment or light touch control group. each subject will be involved in one treatment visit. during this visit, the following will be measured before and after omm or light touch procedures: maximal and minimal chest circumference; sound pressure, duration, and perceptual measures during sustained vowel phonation and rainbow reading; forced vital capacity (fvc), forced expiratory volume/1 second (fev1), peak expiratory flow (pef), forced expiratory flow 25%-75% (fef25-75%), and maximal voluntary ventilation (mvv). data analysis will be performed with spss using analysis of covariance to measure significance.

Eligibility criteria:
inclusion criteria: * medically diagnosed with parkinson's disease * on a stable medication dose * over the age of 18 exclusion criteria: * no clinical diagnosis of parkinson's disease * - medication that might cause pulmonary dysfunction * inability to perform pft because of anatomical abnormalities * clinical signs of dementia * pacemaker that interferes with pectoral traction * metastatic cancer

Keywords: parkinson's disease osteopathic manipulative medicine speech pulmonary function
clinical outcomes of single stage versus two-stage treatment of severe obesity

Conditions: Obesity, Morbid

Summary: laparoscopic roux-en-y gastric bypass (lrygb) in super obese patients (bmi≥50kg/m2) is a challenging operation. weight reduction with intragastric balloon (igb) prior to lrygb may improve operative outcomes and improves weight loss. we assessed 155 patients, with a bmi≥50 kg/m2 who underwent either intra-gastric balloon (igb) insertion followed by lrygb (two-stage group), or lrygb as the definitive bariatric procedure (single-stage group) in our institution. two stage procedure was adopted for high-risk individuals.


Eligibility criteria:
inclusion criteria: * patients, with a bmi≥50 kg/m2, underwent either intra-gastric balloon (igb) insertion followed by lrygb (two-stage group), or lrygb as the definitive bariatric procedure (single-stage group) exclusion criteria: * na
bone development in adolescent girls: effects of calcium and exercise

Conditions: Osteoporosis

Summary: osteoporosis is a major public health problem. prevention of osteoporosis depends in part on good bone development in childhood and adolescence. this study will evaluate a weight-bearing exercise program and high-calcium diet on bone development in adolescent girls.

there are currently few safe and effective methods for restoring lost bone to the osteoporotic skeleton. therefore, prevention of osteoporosis is crucial. if skeletal development can be maximized during growth, young people will begin adulthood with optimal bone mass and will be less likely to develop osteoporosis in later years. this study will determine the effects of weight-bearing physical activity and a high-calcium diet on bone mass in adolescent girls. participants in this study will be randomized to one of three study arms. girls in arm 1 will consume their usual diets and will participate in a weight-bearing exercise program that meets 3 times per week. girls in arm 2 will also participate in a weight-bearing exercise program that meets 3 times per week and will be given high calcium foods to supply 1500 mg of calcium per day. girls in arm 3 will consume their usual diet and maintain their customary activity level. study visits occur every 6 months; participants will be followed for 4 ½ years. assessments will include a medical and social history and measurements of spine, hip, radius, and total body bone mineral content (bmc); calcaneal speed of sound (sos); height; weight; and tanner stage.

Eligibility criteria:
inclusion criteria * tanner stage of development: stage 1 exclusion criteria * history of lactose intolerance, milk allergy, corticosteroid or anticonvulsant therapy, familial hypercholesterolemia, mental or physical handicaps, cancer, rheumatoid arthritis, asthma, or any other significant health problem * body mass index (bmi) \>= 85th percentile for age and gender * regularly have more than two practice sessions per week of dance, gymnastics, or organized team sports

Keywords: weight-bearing exercise calcium-rich diet adolescents females bone mass osteopenia
comparison of indacaterol with that of placebo in 'maintenance naïve' patients with copd using blinded tiotropium as active control

Conditions: Chronic Obstructive Pulmonary Disease (COPD)

Summary: this study will compare the efficacy of indacaterol versus placebo (i.e., rescue medication only) and tiotropium in patients with chronic obstructive pulmonary disease (copd) who have not received maintenance copd medication for at least 12 months prior to entry (described hereafter as "maintenance naïve", see inclusion criteria).

the purpose is to provide efficacy data comparing the long-acting beta-2 agonist, indacaterol, with short-acting rescue therapy in maintenance-naive patients belonging to gold 2011 groups a and b.

Eligibility criteria:
inclusion criteria: * patients with stable chronic obstructive pulmonary disease (copd) groups a or b according to gold 2011. * patients with a post-bronchodilator forced expiratory volume in one second (fev1) ≥50% and \<80% of the predicted normal, and post-bronchodilator fev1/ forced vital capacity (fvc) \< 0.7 * patients with no record of receipt of maintenance medication for copd. * patients with a mmrc dyspnea score ≥1 at visit 2. * current or ex-smokers who have a smoking history of at least 10 pack years. exclusion criteria: * patients who have not achieved acceptable spirometry results at run-in, in accordance with american thoracic society (ats) / european respiratory society (ers) criteria for acceptability and repeatability. * patients who have had 2 or more copd exacerbations that required treatment with antibiotics, systemic steroids (oral or intravenous) or hospitalization in the 12 months prior to visit 1. * patients who have had a respiratory tract infection. * patients requiring long-term oxygen therapy (\>12 hours a day) on a daily basis. * patients with a) any history of asthma, or b) onset of respiratory symptoms prior to age 40 years. * patients with allergic rhinitis who use a h1-antagonist or intra-nasal corticosteroids intermittently. treatment with a stable dose is permitted. * patients with concomitant pulmonary disease (e.g., lung fibrosis, sarcoidosis, interstitial lung disorder, pulmonary hypertension) or active pulmonary tuberculosis * other protocol-defined inclusion/exclusion criteria may apply.

Keywords: copd chronic obstructive pulmonary disease indacaterol tiotropium
pathogenesis and cerebrovascular manifestations of septic encephalopathy

Conditions: Sepsis

Summary: septic encephalopathy is an important complication of sepsis. why some patients with sepsis develop septic encephalopathy is unknown. we will investigate whether patients who develop this condition have different patterns of cerebrovascular reactivity and whether it is possible to predict the development of septic encephalopathy from early measurements of cerebral perfusion or from the eeg. we will specifically test the hypotheses that septic encephalopathy may not be predicted by changes in the eeg, and that cerebrovascular autoregulation is not dysfunctional in septic encephalopathy.


Eligibility criteria:
inclusion criteria: * sepsis * admission to icu exclusion criteria: * cns infection * history of cerebrovascular disease

Keywords: sepsis encephalopathy cerebral perfusion electroencephalogram
a bilateral dispensing clinical trial of sapphire lens against senofilcon a lens over 2 weeks

Conditions: Myopia; Hyperopia

Summary: to evaluate the clinical performance of an investigational silicone-hydrogel lens when worn on a daily wear modality over two weeks of lens wear.

this was a randomized, bilateral, 2 week cross over, double-masked, dispensing study comparing sapphire test lens against the senofilcon a control lens. this study results were not used to support design validation of the test lens.

Eligibility criteria:
inclusion criteria: * is at least 17 years of age for canada and 18 years of age for the usa and has full legal capacity to volunteer * has read and signed an information consent letter * is willing and able to follow instructions and maintain the appointment schedule; * is an adapted soft contact lens wearer * requires spectacle lens powers between -0.50 to -6.00 diopters sphere (0.25d steps) or +1.00 to +8.00 diopters sphere (1.00d steps) * has no more than 0.75 diopters of refractive astigmatism * willing to wear contact lens in both eyes * has manifest refraction visual acuities (va) equal to or better than logmar equivalent of 20/25 in each eye * to be eligible for lens dispensing, the subject must have va of logmar equivalent of 20/30 or better in each eye with the study lenses and the investigator must judge the fit as acceptable exclusion criteria: * is participating in any concurrent clinical or research study * has any known active\* ocular disease and/or infection * has a systemic condition that in the opinion of the investigator may affect a study outcome variable * is using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable * has known sensitivity to the diagnostic pharmaceuticals to be used in the study * is pregnant, lactating or planning a pregnancy at the time of enrolment (by verbal confirmation at the screening visit) * is aphakic * has undergone refractive error surgery
the role of interferon-gamma in immune responses to invasive candidiasis

Conditions: Fungal Infection; Candidiasis

Summary: the purpose of the study is to investigate the role of the human immune response to candidemia/invasive candidiasis as it relates to the cytokine interferon-gamma.

in this study, patients with candida bloodstream infection, peritonitis/intra-abdominal abscess, and pleural empyema will be enrolled. persistent candidiasis confirmed by culture will be defined as follows: (i) candida bloodstream infection present for \>48 hours after initiation of effective antifungal treatment and after removal of intravenous devices, (ii) intra-abdominal infection (peritonitis or abscess) that persists for \>96 hours after source control intervention and effective antifungal treatment, (iii) pleural empyema that persists for \>96 hours after placement of drainage catheter and effective antifungal treatment. outcomes in patients with and without persistent candidiasis will be assessed.

Eligibility criteria:
subjects must meet all following inclusion criteria to qualify for the study: 1. willing and able to provide written informed consent. if the subject is unable to consent for himself/herself, a legally authorized representative must provide informed consent on his/her behalf. 2. males or females ≥18 years of age 3. patients having one or more systemic signs attributable to candidemia or invasive candidiasis (fever, hypothermia, hypotension, tachycardia, tachypnea, local signs of inflammation). 4. isolation of candida from blood, intra-abdominal abscess/peritoneal fluid or pleural fluid. exclusion criteria subjects must not meet any of the following exclusion criteria to qualify for the study: 1. severe neutropenia (absolute neutrophil count \<500 cells/microl) 2. profound lymphopenia (\<300 cells/microl) 3. the principal investigator (pi) is of the opinion the subject should not participate in the study. 4. females who are pregnant.
stromal vascular fraction enriched prp in treatment of post-acne scars

Conditions: Acne Scars - Atrophic

Summary: in a split face fashion, 30 patients will be randomized into 3 groups: group a: rt side treated with svf enriched prp, lt side treated with prp group b: rt side treated with svf enriched prp, lt side treated with svf group c: rt side treated with prp, lt side treated with svf


Eligibility criteria:
inclusion criteria: * patients with atrophic post acne scars without any previous treatment trials. * adequate blood picture, no anemia, no bleeding or platelet disorders. exclusion criteria: * pregnant and lactating females. * elderly. * patients with bleeding tendencies.
biobank for african american prostate cancer research in florida

Conditions: Prostate Cancer

Summary: the purposes of this study are: a) to develop a statewide biobank for prostate cancer among men of african ancestry in florida and; b) to examine whether smoking increases the aggressiveness of prostate cancer using several biological approaches. investigators plan to contact african american prostate cancer patients regarding participation. this project has 3 main components. eligible patients may choose to participate in any or all parts of the study: questionnaires; saliva samples; tumor tissue.

this project will create the first state-wide data and biospecimen bank for men of african ancestry with prostate cancer. the sampling strategy and size of the study population ensure that the cohorts is representative, enhancing validity of studies based on this resource. in addition, there are no data on the role of smoking in african american prostate cancer. the approach to share the resource with florida prostate cancer researchers is innovative and possible because the four annual prostate cancer symposiums organized by moffitt has unified many florida prostate cancer researchers who are now well connected and actively collaborating, as evidenced by publications and funded projects among participants.

Eligibility criteria:
inclusion criteria: * the initial recruitment of cases will be done with 3 mailings: the first to introduce the study to the participant from florida cancer data system (fcds) of the florida department of health and ask them to complete the eligibility form and contact information update form; a second mailing to those who are determined to be eligible for the study to obtain the informed consent form and the baseline survey; and a third mailing to those who completed the survey to obtain a saliva sample and medical release form for tissue. * histologically biopsy confirmed, primary prostate cancer, diagnosed between january 2013 and december 2015 * african american or black; hispanic black; afro-caribbean * are at least 20 years old * are a resident of florida * additional criteria may apply exclusion criteria: * does not meet inclusion criteria

Keywords: prostate disease prostatic neoplasm biobank prostate cancer in black males biospecimen smoking and the aggressiveness of prostate cancer