Kornimate/medical-research-clean huggingface dataset:
role of micrornas in t cell-driven inflammation in asthma

Conditions: Asthma

Summary: this will be a single center study of asthmatic subjects and healthy controls which will investigate mechanisms of asthma through detailed molecular analysis of airway tissues and fluids. the primary goal will be investigate the role of micrornas in th2-driven inflammation in asthma. the investigators hypothesize that asthma is associated with abnormal expression of mirnas in t cells which favors differentiation into th2-cells. the investigators further hypothesize that asthma is heterogeneous based on the presence and absence of th2-driven inflammation and that abnormalities in t cell mirna expression will be most prominent in a subgroup with high levels of th2-driven inflammation (as assessed using molecular markers that the investigators have previously established). finally, the investigators hypothesize that inhaled corticosteroids will normalize the t-cell mirna abnormalities observed in asthma, as corticosteroids treat th2-driven inflammation. the samples collected will also facilitate the pursuit of secondary analyses designed to investigate mechanisms of inflammation and remodeling in asthma as well as molecular phenotypes of asthma.


Eligibility criteria:
group a: inclusion criteria: * male and female subjects between the ages of 18 and 70 years group b: inclusion criteria: * male and female subjects between the ages of 18 and 70 years * history of asthma * no use of oral or inhaled corticosteroids for the treatment of asthma in the past 6 weeks * hyperreactivity to methacholine (pc20fev1 methacholine ≤ 8.0 mg/ml) * at least one of the following symptoms, beta agonist use, or fev1 criteria: * asthma symptoms on at least two days per week; or * beta agonist use on at least two days per week; or * fev1 \< 85% predicted groups a \& b: exclusion criteria: * current smokers (smoking within the last 12 months) or former smokers who have a total pack-year smoking history greater than 10 * pregnant women * subjects with a history of lung disease other than asthma * subjects with a history of a medical disease, which in the opinion of the investigator may put the subject at extra risk from study-related procedures or because the disease may influence the results of the study
biological matrices versus synthetic meshes

Conditions: Breast Cancer

Summary: in this feasibility study, 60 women undergoing reconstruction will be randomly allocated to receive biological or synthetic mesh and followed for 6 months. the findings will tell us if patients and surgeons are comfortable with not being able to choose which mesh is used for the operation. in the larger surgical study, the investigators plan to measure patients' satisfaction with the reconstruction, patients' quality of life, complications from the operation and costs over 5 years.

immediate breast reconstruction in women undergoing removal of the whole breast for cancer or risk reduction is most commonly done using breast implants. surgeons often use a sheet of mesh to cover the implant as standard treatment. it acts like an internal bra and supports the implant and re-creates a natural looking breast. natural(biological) or man-made (synthetic) meshes are used routinely in the nhs. biological ones are made from animal tissue (pig, cow) that have been made safe to use in people and are costly. synthetic meshes are made from net-like fabric and cost less. the choice about which mesh to use depends on surgeons' personal experience and how much money the hospital has for these operations. the two meshes may have different acceptability issues for patients because of their personal values, religious beliefs, ethnic background or views on animal welfare. a large uk review of breast reconstruction with implants gathered information up to 3 months after surgery on the use and outcomes of the two meshes. this suggests that both may be equally safe in the short-term. however, this information can be improved by comparing the meshes side-by-side and looking at how safe they are long-term. this is important as some side-effects only appear later after surgery. clinicians do not know how outcomes impact on patients' health and well-being. the best proof would come from a randomised surgical study, where a computer allocates patients to receive either the biological or synthetic mesh. investigators will measure how patients feel, how their health is, and record if they have any side-effects from the reconstructive surgery. this type of study would tell us how good each mesh is and if they are safe long-term. before starting such a study, investigators will run a smaller one that will help us understand if patients and surgeons would be comfortable taking part.

Eligibility criteria:
inclusion criteria: female age ≥ 18 women undergoing mastectomy and immediate one-stage mesh assisted implant breast reconstruction as standard treatment exclusion criteria: revision reconstruction surgery delayed reconstruction surgery

Keywords: breast reconstruction mesh acellular dermal matrix synthetic mesh breast cancer patient reported outcome
efficacy and safety of pioglitazone combination therapy in type 2 diabetes patients on a background of empagliflozin with metformin

Conditions: T2DM

Summary: phase 3 study to assess the efficacy and safety of ct-l03-301 in type 2 diabetes patients with insufficient glycemic control with metformin and empagliflozin combination therapy.


Eligibility criteria:
inclusion criteria: * adults at the time of signing the informed consent form (icf) * signed the written icf voluntarily after being fully informed of the objectives, methods, and effects of the study * diagnosed with t2dm exclusion criteria: * diagnosed with other types of diabetes than t2dm * history of hypersensitivity reaction to the components or drugs of the same class as the ip or the background therapy * uncontrolled severe complications of diabetes
role of adipose tissue in pathogenesis of insulin resistance

Conditions: Obesity; Insulin Resistance

Summary: the aim of the study was to investigate the relationship between insulin resistance and body composition in relation to secterion and expression of adipocytokines. obese subjects undergo 6 months hypocaloric diet and, before, during and at the end of the diet, plasma samples and subcutaneous adipose tissue samples are obtained for subsequent analysis. in addition, body composition and insulin resistance are measured before and during the diet.

the aim of the study was to investigate the relationship between insulin resistance and body composition in relation to secterion and expression of adipocytokines. obese subjects undergo 6 months hypocaloric diet without any medication and, before, during and at the end of the diet, plasma samples and subcutaneous adipose tissue samples are obtained for subsequent analysis. adipose tissue samples are obtained using needle biopsy. in addition, before and during the diet,body composition is measured using multifrequency bioimpedance and insulin resistance is evaluated using either hyperinsulinemic clamp or glucose/insulin - derived indices.

Eligibility criteria:
inclusion criteria: * obesity exclusion criteria: * diabetes * coronary heart disease * eating disorders * medication of beta blockers * medication of antiobesity drugs

Keywords: obesity insulin resistance hypocaloric diet adipose tissue adipocytokine
efficacy analysis of cetuximab plus irinotecan in patients with wild-type kras without regard to epidermal growth factor receptor (egfr) expressions

Conditions: Advanced Colorectal Cancer

Summary: the purpose of this study is to investigate the response rate of cetuximab plus irinotecan every 2 weeks in patients harboring wild-type kras with and without detectable egfr-expressing metastatic crc after failure to irinotecan in an exploratory manner.

twenty patients with positive-egfr results and 20 patients with negative-egfr results will be accrued in this study. all patients should have wild-type kras.

Eligibility criteria:
inclusion criteria: * colorectal adenocarcinoma, wild kras, 18-75 yr * estimated life expectancy of more than 3 months * ecog performance status of 0 to 1 at study entry * adequate bone marrow function * adequate liver function * documented progression during or within 3 months of irinotecan-containing regimens as a first-line chemotherapy * immunohistochemical evidence of a presence or absence of egfr expression by pharmdx kit * informed consent exclusion criteria: * central nervous system (cns) metastases or prior radiation for cns metastases. * intestinal obstruction or impending intestinal obstruction due to peritoneal carcinomatosis * surgery (excluding biopsy for diagnosis) during 4 weeks prior to inclusion in the study. * evidence of gastrointestinal bleeding * exposure to cetuximab * prior administration of monoclonal antibodies, egfr signal transduction inhibitors or egfr-targeted treatment * kras mutant status * patients with serious toxicity to previous irinotecan-based chemotherapy * other serious illness or medical conditions
a two week study to assess the tolerability of azd9668 in chronic obstructive pulmonary disease (copd) patients

Conditions: Chronic Obstructive Pulmonary Disease (COPD)

Summary: the purpose of this study is to assess the tolerability (effect of drug on body) and pharmacokinetics (effect of body on drug) of azd9668 in patients with mild to moderate copd


Eligibility criteria:
inclusion criteria: * mild to moderate copd * smokers or ex-smokers * post-menopausal females exclusion criteria: * past history or current evidence of clinically significant heart disease * lung disease other than copd * treatment with systemic steroids within 8 weeks of study visit 2 * treatment with antibiotics within 4 weeks of study visit 1 or study visit 2

Keywords: chronic obstructive pulmonary lung respiratory disease tolerability placebo-controlled pharmacokinetics copd
cerebral oxygen saturation monitoring during optimum cord management in preterm infants

Conditions: Pre-Term

Summary: this study will assess the feasibilty measuring cerebral oxygen saturations using a near infrared spectroscopy (nirs) monitor immediately after delivery of preterm infants. the investigators aim to evaluate the effects of optimum cord management on cerebral oxygenation in this cohort

optimal cord management is defined by delaying clamping of the umbilical cord for 1 minute after delivery and is recommend in all neonates, regardless of gestational age. transfusion of blood from placenta to baby in this minute enables smooth cardiovascular transition and stable cerebral perfusion. preterm infants are at increased risk of haemodynamic instability and brain injury if the cord is clamped too early. it remains unclear what the optimum time is to clamp the cord in preterm infants, and it is likely different for each baby. current monitoring of heart rate and peripheral oxygen saturations does not correlate well with oxygen delivery to the brain. near infrared spectroscopy (nirs) is a non-invasive method of measuring regional cerebral oxygenation saturations. nirs may be a helpful monitoring tool to guide optimum timing of cord clamping in preterm infants. this study aims to assess the feasibility of using the invos 5100 nirs monitor immediately after delivery in preterm infants born before 34 weeks gestational age. the investigators aim to assess if they can generate meaningful data on brain oxygen levels in the first few minutes of life. the secondary objectives are to use this data to describe the changes in heart rate, peripheral oxygen and cerebral oxygen saturations during placental transfusion and cord clamping. the investigators will use the invos device to measure cerebral oxygenation immediately after delivery, during placental transfusion and cord clamping. we will assess the feasibility of the invos device for this purpose. we will use the invos data and routinely collected data at delivery to evaluate the effect of optimum cord management on cerebral perfusion, heart rate and peripheral oxygen saturations.

Eligibility criteria:
inclusion criteria: * all babies eligible for optimum cord management born before 34 completed weeks gestational age * parental consent exclusion criteria: * multiple pregnancies * infants for whom resuscitation at birth is not appropriate * antenatal or immediate postnatal diagnosis of severe congenital anomaly * infants with complex congenital cardiac disease
restless leg syndrome: is there a response to buddhist walking meditation in hemodialysis

Conditions: Hemolysis; Restless Legs Syndrome

Summary: the restless leg syndrome is a common complaint in person who undergo hemodialysis. buddhist walking meditation efficacy was not investigated in those population

the total participants will be 40. all patients will be on hemodialyis. they complain restless leg syndrome. the participants will be divided to group i which received buddhist walking meditation. this program of meditation will be 30 minutes thrice weekly. before and after buddhist meditation walking, there will be 5 minutes stretching exercises working as warm up or cooling down respectively. the other group will serve as control one .. the number of patient in every group will be 20. the total duration of buddhist walking meditation will be 12 weeks.

Eligibility criteria:
inclusion criteria: * hemodialysis patient (40) * complain of restless leg syndrome * non obese patients exclusion criteria: * cardiac patients * chest diseases * mental diseases * hepatic diseases * lower limb orthopedic hurting
microcirculation and oxidative stress in critical ill patients in surgical intensive care unit

Conditions: Sepsis; ARDS; Liver Failure; Renal Failure; Brain Death

Summary: as medicine advances, many lives can be saved in the intensive care unit. however, when multiple organ failure occurs, the mortality rate of patients increases dramatically. therefore, the major goal in the intensive care unit is to prevent the occurrence of multiple organ failure. the sepsis protocol and early goal directed treatment have great effects to reduce development of multiple organ failure and to decrease the mortality rate. however, sometime the condition of patient deteriorated in spite of both the mean blood pressure and mixed venous oxygen saturation are normal. some experts recognize that there might be microcirculatory dysfunction of tissue or organ. the dysfunction of microcirculation might due to vasoconstriction or microthrombosis. vasoconstriction might result from systemic inflammation, reactive oxygen species, or dysfunction of synthesis of no (nitric oxide). microthrombosis might result from systemic inflammation, reactive oxygen species, imbalance of coagulatory system, or damage of endothelial cell. in clinical practice, the oxidative stress is related to circulatory shock, sepsis, acute lung injury, and acute respiratory distress syndrome. this study tries to investigate the relation between oxidative stress and microcirculation. furthermore, the investigators will try to investigate the correlation between the severity of oxidative stress and microcirculatory dysfunction and the severity of disease and prognosis. the investigators hope this study will help them to figure out the picture of disease progression of patients. it may conduct further study to modulate the oxidative stress, to improve the microcirculatory function, and finally to improve the outcome of patients.


Eligibility criteria:
inclusion criteria: * \> 18 y/o * related diagnosis made within 24h * group 1 - sepsis * group 2 - postoperative care * group 3 - ards * group 4 - renal failure * group 5 - liver failure * group 6 - brain death exclusion criteria: * pregnant patients * related diagnosis made longer than 24h * patients who have received antioxidants within 24h * patients who have received hyperbaric oxygen therapy * patients who have a hemoglobin value less than 9 g/dl * patients who have received no
feasibility and safety of neoadjuvant chemotherapy (flot ) for gastric cancer patients in china

Conditions: Chemotherapy Effect

Summary: neoadjuvant chemotherapy for advanced-stage gastric cancer is justified by various studies, however, there was not any large scale randomized controlled trial (rct) to support it until german oncologist introduced a novel regimen(flot regimen) in 2017. investigator assessed the flot regimen for safety and feasibility in chinese gastric cancer patients.

neoadjuvant chemotherapy for advanced-stage gastric cancer is justified by various studies, however, there was not any large scale rct to support it until german oncologist introduced a novel regimen(flot regimen) in 2017. flot regimen was prescribed for german patients and various questions are raised by experts from eastern countries. as the flot regimen was officially included in nccn 2018 guidelines, the investigator used standard protocol of flot regimen on chinese gastric cancer patients. safety and feasibility were assessed carefully to provide basic data for further large scale studies in china.

Eligibility criteria:
inclusion criteria: * sex: all * histology confirmed adenocarcinoma of the stomach or esophagogastric junction. * clinical stage: clinical tumor-node-metastasis (ctnm): stage iii，iva * performance status: eastern cooperative oncology group ecog 0- 2 * adequate renal, hepatic, hematologic, and pulmonary function. * written informed consent exclusion criteria: * uncontrolled cardiac disease, or other clinically significant uncontrolled comorbidities * distant metastases * prior chemo or radiotherapy * inclusion in another clinical trial * known contraindications or hypersensitivity for planned chemotherapy

Keywords: gastric cancer neoadjuvant chemotherapy flot regimen
technology enabled services to enhance depression care

Conditions: Depression; Anxiety

Summary: this study will compare two digital mental health interventions (dmhis). one dmhi will use an app called vira (which is a product developed and managed by ksana health), along with low intensity coaching provided via phone and both sms text and in-app messaging. the other dmhi will provide a broad range of information on how to manage symptoms of depression, anxiety, and stress. the dmhi will be evaluated with patients receiving care from rush university medical center's primary care and family medicine clinics, which serve racially, ethnically, and economically diverse communities; evaluations may also be extended beyond rush patients.

depression and anxiety are common and impose a tremendous societal burden in terms of cost, morbidity, quality of life, and mortality. yet, few people are able to obtain adequate or appropriate treatment. this trial will compare the ability of two digital mental health interventions (dmhis) to reduce depression and anxiety. one dmhi, called mood education app, provides information on depression and a broad range of strategies that are effective in improving symptoms. the other app, called vira, uses smartphone sensors to identify a few behavioral markers, including mobility patterns, physical activity, and sleep. the results of these sensed behavioral markers are used to give the participant behavior change recommendations through the vira app that are expected to result in symptom improvement. the dmhi will include low intensity coaching, which includes one or more brief phone calls and communication via sms text and in-app messaging. both treatments are 8-weeks long. the trial will be conducted within rush university medical center's primary care and family medicine clinics, although recruitment be expanded beyond these clinics.

Eligibility criteria:
inclusion criteria: * us citizen/ resident * 13 years or older * english speaking * owns an android or iphone smartphone with an up-to-date operating system * has used a smartphone in the last 7 days * phq-8 greater than or equal to 10 and/or gad-7 greater than or equal to 10 exclusion criteria: * children under the age of 13 * severe suicidality (as defined by presence of a plan + intent to act on that plan)
a study comparing the effectiveness and convenience of dietary therapy for irritable bowel syndrome (ibs)

Conditions: Irritable Bowel Syndrome

Summary: irritable bowel syndrome is a functional lower gastrointestinal disorder characterised by abdominal pain and altered bowel habit in the absence of organic pathology to explain the symptoms. irritable bowel syndrome has a prevalence of approximately 10% in adults, shows a female preponderance, and is more common in younger individuals. in clinical practice, irritable bowel syndrome accounts for almost a third of all gastroenterology cases seen in primary care, with a subsequent third of these being referred onto secondary-care for further evaluation. the economic burden of irritable bowel syndrome, in terms of medical expense, work absenteeism and loss of productivity, is considerable. the exact cause of irritable bowel syndrome is unknown. accordingly there has been a huge surge in interest for dietary therapies to help manage irritable bowel syndrome. to date, there are only a handful of small randomized controlled trials evaluating the efficacy of dietary therapy in irritable bowel syndrome. in light of this we plan to conduct the first randomized controlled trial directly comparing the effectiveness of the low-fodmap diet, british dietetic association diet, and the gluten free diet in irritable bowel syndrome. moreover, such a trial allows for a direct comparison of nutritional and gut microbial changes, both of which can suffer detrimental consequences following the implementation of restrictive dietary therapies. this study is also unique in that it takes into consideration the patients' perspective with regards to the convenience and cost-effectiveness of implementing such diets into routine day-to-day life. the study will aim to recruit 100 patients from sheffield teaching hospitals gastrointestinal clinics. following recruitment patients will be seen by a hospital dietitian where they will be randomized to one of the 3 diets. participants will complete a questionnaire portfolio weekly for one month as part of the study


Eligibility criteria:
inclusion criteria: 1. irritable bowel syndrome - as defined by abdominal pain and altered bowel habit in the absence of organic pathology to explain the symptoms.this is the contemporary definition as provided by the rome iv committee. 2. age 18-65 years 3. english literate 4. can travel to hospital 5. telephone/internet access exclusion criteria: 1. inflammatory bowel disease 2. coeliac disease 3. gastrointestinal cancer 4. previous abdominal surgery 5. scleroderma 6. poorly controlled diabetes 7. severe liver disease 8. severe renal disease 9. severe respiratory disease 10. severe cardiac disease 11. severe psychiatric disease 12. memory disorders 13. pregnant 14. current dietary interventions 15. recent/current use of probiotics 16. recent/current use of antibiotics 17. recent/current use of narcotics 18. currently titrated antidepressants (i.e. not on a stable dose)