Kornimate/medical-research-clean huggingface dataset:
study of tumor tissue from patients with melanoma treated on clinical trial est-1690

Conditions: Melanoma (Skin)

Summary: rationale: studying samples of tumor tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in dna and identify biomarkers related to cancer. it may also help doctors predict how patients will respond to treatment. purpose: this research study is looking at tumor tissue samples from patients with melanoma treated on clinical trial est-1690.

objectives: * to validate the prognostic role of several biomarkers suggested by gene expression profiling and tissue microarray (tma) studies (e.g., ncoa3, spp1, and rgs1) on the outcome associated with melanoma in the est-1690 cohort using ihc analysis. * to examine the potential predictive role of such biomarkers in patients undergoing adjuvant interferon alfa therapy. * to analyze the correlation between the intensity of biomarker expression and survival of this cohort both in the observation and in the interferon-treated groups. * to examine the prognostic role of these biomarkers on the outcome associated with melanoma in the est-1690 cohort using quantitative-pcr. * to isolate rna from the primary specimens from patients enrolled in the est-1690 cohort to assess the expression of genes suggested by cdna microarray and ihc analyses (e.g., ncoa3, spp1, and rgs1) as prognostic or predictive markers. outline: samples from the est-1690 cohort are obtained and analyzed for several biomarkers (i.e., ncoa3, spp1, and rgs1) via immunohistochemistry and quantitative pcr. rna is isolated from the specimens to assess gene expression via quantitative pcr.

Eligibility criteria:
disease characteristics: * diagnosis of melanoma * no metastatic disease at diagnosis * treated on protocol est-1690 * primary tumor tissue specimens available patient characteristics: * not specified prior concurrent therapy: * see disease characteristics

Keywords: stage iii melanoma recurrent melanoma
the danish on-pump, off-pump randomization study (doors)

Conditions: Ischemic Heart Disease

Summary: background: coronary artery bypass grafting (cabg) can be performed either with or without the use of cardiopulmonary bypass (cpb) to obtain myocardial re-vascularisation. the investigators hypothesize that cabg without the use of cpb may reduce the risk of perioperative death, stroke, myocardial infarction and other serious complications. the aim of the present study is to compare the incidence of complications and the clinical efficacy of cabg with and without the use of cpb in elderly patients.

conventional coronary artery bypass grafting (ccabg) using cardiopulmonary bypass has for decades been applied to obtain myocardial re-vascularisation and, hence, improved quality of life and survival. it does, however, bear a risk of death, stroke, myocardial infarction and other serious complications. during recent years, an equivalent operation performed on the beating heart without cardiopulmonary bypass (off-pump coronary artery bypass grafting, opcab) has gained popularity helped by the advent of mechanical stabilization devices and improved surgical techniques. observational studies suggest that this technique is associated with a lower incidence of stroke, per operative arrhythmias and even mortality than conventional ccabg. this is especially the case in elderly patients and patients with significant co-morbidity. only few randomised, controlled trials have been conducted and most of these included mainly or only low-risk, relatively young patients. these studies have documented the safety and efficacy of opcab compared with ccabg, but none of the trials has had the statistical strength to determine whether the rate of serious complications is lower after opcab operations. one recent study found graft patency to be significantly lower after opcab than after ccabg operations. the investigators find that there is a need of a larger scale randomised trial to compare the results of ccabg and opcab operations, especially in elderly patients. this patient group is poorly represented in earlier randomised trials, whereas observational studies and theoretical considerations imply that they may benefit the most from avoiding cardiopulmonary bypass. aims: primarily, to compare the incidence of death, stroke and myocardial infarction after ccabg and opcab procedures in a population of elderly patients. furthermore, to compare quality of life and graft patency, and cost- effectiveness after ccabg and opcab.

Eligibility criteria:
inclusion criteria: * age seventy years or above * admitted for first time coronary artery bypass operation exclusion criteria: * given information cannot be understood * aortic crossclamping not safe due to calcification * preoperative cardiac conditions demanding cardiopulmonary bypass * re-do cardiac surgery * patients requiring operation within the same day after conference

Keywords: off-pump coronary artery by-pass grafting randomization stroke myocardial infarction mortality graft patency quality of life
early intervention in very preterm children

Conditions: Prematurity; Speech Sound Disorder

Summary: * the aim of the present study is to examine the effectiveness of a short, highly structured parent based speech intervention program on speech development in very preterm children with a speech sound disorder (ssd) at 2 years of age. * the hypothesis of this study is that early intervention on speech development is effective in improving the speech development in preterm children with ssd at 2 years of age compared to a no treatment group (usual care at this age).


Eligibility criteria:
inclusion criteria: * birth weight \< 1500 grams or gestational age \< 32 weeks * singleton birth * no major neurodevelopmental disabilities, and * dutch speaking family background

Keywords: speech sound development
phase 1 in-vivo biliary study of ksp/qrh heptapeptide dimer

Conditions: Cholangiocarcinoma

Summary: the overall aim of this feasibility study is to develop new technologies for improved detection of cholangiocarcinoma using the sfe-based molecular-imaging mini-cholangioscope (mc) system. this study will combine the use of a fluorescent-labeled peptide dimer that binds specifically to know biomarkers of cholangiocarcinoma for use as a novel imaging agent to guide endoscopic biopsies. this phase 1b study will be used to provide early evidence of efficacy for the topical application of a peptide dimer that binds to molecular targets that are specific for biliary intra-epithelial neoplasia. a dimer is needed because cancer in the biliary tract is genetically heterogeneous. qrh binds specifically to epidermal growth factor receptor (egfr), and ksp binds specifically to human epithelial growth factor receptor (her2). the study will look at peptide binding in subjects having a medical condition requiring an ercp to diagnose a potential biliary disorder. the phase 1a first-in-human studies of safety with topical administration by ingestion of ksp/qrh dimer (hum00141420) has been completed.


Eligibility criteria:
inclusion criteria: subject meets all of the following criteria: * scheduled for an outpatient ercp to diagnose a potential biliary disorder (such as an indeterminate biliary stricture) * subject is medically cleared for the procedure (e.g. washout for anticoagulants, co-morbidities) * age 18 to 100 years * willing and able to sign informed consent exclusion criteria: * subjects with known allergy or negative reaction to any components of the study drug (list these) * subjects on active chemotherapy or radiation treatment * pregnant or trying to conceive * anything that, in the opinion of the investigator, would place the individual at increased risk or preclude the individual's full compliance with or completion of the study
acetic acid for optical characterization of colonic polyps

Conditions: Colonic Polyps

Summary: adenomas and hyperplastic polyps are polypoid lesions that can occur in any part of the colon. currently all polyps should be resected endoscopically, however adenomas have the potential to develop into colorectal cancer whereas hyperplastic polyps do not. this approach enables the lesions to be evaluated under the microscope. currently only the pathological diagnosis can distinguish exactly between adenomas and hyperplastic polyps. acetic acid (aa) chromoendoscopy is already widely used in order to improve optical determination of mucosal lesions in the upper gastrointestinal tract. in the colon only few studies investigated the impact of aa in differentiating normal mucosa from suspicious mucosa. the aim of the present study is to evaluate the value of spraying acetic acid as an adjunct for optical characterization of colon polyps. using aa may be beneficial for determining optical diagnoses of colon polyps during real time colonoscopy. this is a single-arm proof of principle study. if colon polyps are found during colonoscopy a 1.5 percent aa solution will be used for chromoendoscopy. endoscopists are encouraged to use the narrow band imaging (nbi) function of the endoscope prior to the use of aa. after aa is sprayed endoscopists will diagnose the polyp optically. endoscopists have to predict adenomatous or non-adenomatous histology based upon optical features of the polyp. all polyps will be resected endoscopically so that histopathological diagnoses can be determined. after completing the trial the investigators aim to compare optical and histopathological-based diagnoses of polyps. histopathological diagnoses will serve as the gold standard. based upon this information the accuracy of the optical diagnoses will be calculated. the investigators hypothesis is, that optical-based diagnosis using nbi and aa will be accurate in \> 75% of all polyp cases.


Eligibility criteria:
inclusion criteria: * indication for colonoscopy exclusion criteria: * pregnant women * emergency investigation * history of inflammatory bowel disease * contraindication for polyp resection
open international study on quality of life in irritable bowel syndrome (ibs) patients before and after 8 weeks treatment with mebeverine/pinaverium bromide

Conditions: Irritable Bowel Syndrome

Summary: a study to evaluate, by country and overall, the changes from baseline of the irritable bowel syndrome quality of life (ibs qol) total score after 4 and 8 weeks of treatment with duspatalin® or dicetel® in ibs patients.


Eligibility criteria:
inclusion criteria: * irritable bowel syndrome patients diagnosed by rome iii criteria (18 years or older) exclusion criteria: * pregnancy and lactation * specific contraindications to mebeverine hydrochloride or pinaverium bromide

Keywords: abdominal pain diarrhea mebeverine hydrochloride constipation pinaverium bromide irritable bowel syndrome bloating quality of life
fasted exercise training in type 2 diabetes

Conditions: Diabetes Mellitus, Type 2

Summary: this study compares aerobic exercise training performed before breakfast (i.e., in the fasted state) to similar training performed after breakfast in people with type 2 diabetes. training will take place over 16 weeks.

people with type 2 diabetes (t2d) are encouraged to increase their physical activity (pa). sometimes, increasing the amount of pa can be difficult. therefore, simply recommending that individuals preform more exercise may not be effective in the long term. recent short-term studies have started to explore how to maximize the effect of a single bout of exercise. for example, short term studies suggest that exercise performed after a meal may decrease blood sugars more than exercise performed after a meal. however, research in people without diabetes shows this may not be the best approach in the long-term. to date, no long-term study has compared the effects of exercise performed at different times of the day in people with t2d. this study will compare the effects of 16 weeks of regular exercise before breakfast compared to 16 weeks of regular exercise after breakfast. it is expected that exercise before breakfast (i.e., in the fasted state) will lead to greater improvements in blood sugar control, without the addition of more exercise. it could be very motivating for people with diabetes to know that they can get more benefits from exercise by changing when exercise is performed, rather than trying to increase the amount of exercise.

Eligibility criteria:
inclusion criteria: * physician diagnosed type 2 diabetes * treated with diet and/or glucose lowering medications, but not insulin, for at least 6 months * sedentary (defined as reaching \<150 minutes of aerobic exercise per week) * a1c below 9.0% * bmi ≥25 kg/m2 * central obesity as determined by waist circumference according to diabetes canada cutoffs: * greater or equal to 94cm for males of european, sub-saharan african, eastern mediterranean and middle eastern descent, * greater or equal to 90cm for males of south asian, chinese, japanese, south and central american descent, * greater or equal to 80cm for females * able to walk for 50 minutes exclusion criteria: * smoking * consuming more than 10 alcoholic drinks/week * history of stroke, myocardial infarction, or coronary artery disease * resting heart rate \<100 bpm * resting blood pressure \<160/100 mmhg * implantable device, such as a pacemaker, that would not be safe for magnetic resonance imaging

Keywords: exercise glycated hemoglobin liver fat continuous glucose monitoring
sodium bicarbonate ringer's solution versus normal saline for early fluid resuscitation in patients with sepsis

Conditions: Sepsis, Septic Shock

Summary: at present, people still have different opinions on choosing which kind of crystalloid solution for patients with sepsis, and there is no unified standard yet. it is necessary to conduct systematic studies on comparison of different fluid resuscitation methods on the efficacy and safety of crystalloid solution for patients with sepsis. therefore, this study focuses on the efficacy and safety of sodium bicarbonate ringer's solution compared with normal saline.

sepsis and septic shock are clinical emergencies requiring immediate treatment and fluid resuscitation. early effective fluid resuscitation can improve the prognosis of patients. so far, there is no perfect crystalloid solution. normal saline is the most readily available and economical crystalline fluid for clinical resuscitation. it is isoosmotic and can meet the basic needs of patients in the early rehydration. but it lacks acid-base buffer system and potassium, calcium and magnesium ions, and the level of chloride ions is also significantly higher than that of plasma. sodium bicarbonate ringer's solution contains physiological levels of na+(130mmol/l), k+(4mmol/l), ca2+(1.5mmol/l), mg2+(1mmol/l), hco3-(28mmol/l) and cl-(109mmol/l). it also has citric acid/ sodium citrate buffer system (citrate3-1.3mmol/l), ph7.3, and osmotic pressure 276mosm/l. it is the most similar solution to extracellular fluid. theoretically，compared with normal saline, sodium bicarbonate ringer's solution can maintain acid-base balance faster and better when restoring the microcirculation without affecting the level of chloride ion. therefore we hypothesize that sodium bicarbonate ringer's solution can promote the body to restore to acid-base balance more quickly, and improve organ function more significantly than normal saline.

Eligibility criteria:
inclusion criteria: * diagnosed as sepsis or septic shock according to the definition of sepsis-3.0 with fluid resuscitation requirement; * aged between 18 and 80, male or female; * signed informed consent (with delay within 24 hours). exclusion criteria: * patients with hypermagnesemia; * patients with hypothyroidism; * patients predicted to die or discharged within 24 hours after admission; * patients with previous history of mental illness, severe hepatic and renal insufficiency, severe cardiac disease, primary severe central nervous system lesions; * pregnant or breast-feeding women; * patients who have received cardiopulmonary resuscitation； * patients who participated in other clinical trials within 30 days; * patients have other conditions that are not appropriate for inclusion according to the researcher's judgment.

Keywords: fluid resuscitation, crystalloid solution
immunogenicity and safety study to assess influenza vaccine formulated with haemagglutinin (ha) antigen from two different suppliers

Conditions: Influenza

Summary: the purpose of this study is to assess the humoral immune response and safety of the parenteral formulation of the 2010/2011-season virosomal subunit influenza vaccine inflexal v using two different ha antigen suppliers (adimmune and csl), in groups of young and elderly adults, using the ema (european medicines agency) regulation as a guideline.


Eligibility criteria:
inclusion criteria: * healthy female and male adults * aged ≥18 years on day 1 * written informed consent exclusion criteria: * acute exacerbation of bronchopulmonary infection (cough, sputum, lung findings) or other acute disease * acute febrile illness (≥38.0 °c) * prior vaccination with an influenza vaccine (including the h1n1 pandemic swine flu vaccine) in the past 330 days * known hypersensitivity to any vaccine component * previous history of a serious adverse reaction to influenza vaccine * history of egg protein allergy or severe atopy * known blood coagulation disorder * chronic (longer than 14 days) administration of immunosuppressants or other immune-modifying drugs within 6 months before the first dose of the study vaccine, incl. oral corticosteroids in dosages of ≥0.5 mg/kg/d prednisolone or equivalent (inhaled or topical steroids are allowed) * known immunodeficiency (incl. leukemia, cancer, hiv seropositivity) * investigational medicinal product received in the past 3 months (90 days) * treatment with immunoglobulins or blood transfusion(s) received in the past 3 months (90 days) * pregnancy or lactation * participation in another clinical trial * employee at the investigational site, or spouse and children of the investigator, or relative living in the same household as the investigator and/or are dependent on the investigator * suspected non-compliance

Keywords: influenza virus vaccination immunisation
a study of the safety and tolerability of ibi321 in patients with advanced solid tumors

Conditions: Advanced Solid Tumors

Summary: this first-in-human open-label,dose-escalation study is designed to evaluate the safety, tolerability, and primary efficacy of ibi321 in participants with locally advanced, recurrent, or metastatic incurable tumors for whom standard therapy does not exist, has proven to be ineffective or intolerable.


Eligibility criteria:
inclusion criteria: 1. subjects able to give voluntary informed consent, understand the study and are willing to follow and complete all the test procedures. 2. patients with advanced solid tumors who had failed standard treatment. 3. male or female subjects ≥18 years and ≤75 years. 4. at least one measurable lesion per recist version 1.1 5. eastern cooperative oncology group (ecog) performance status ≤1 6. life expectancy of ≥ 12 weeks. 7. adequate hematologic and end organ function exclusion criteria: 1. any anti-cancer therapy, whether investigational or approved, including chemotherapy, hormonal therapy, targeted therapy, or immunotherapy. 2. failure to recover from adverse events from the most recent anti-tumor treatment 3. acute or chronic hepatitis b, hepatitis c or human immunodeficiency virus (hiv) infection. 4. subjects with cns metastasis unless they are asymptomatic or adequately treated with radiotherapy and/or surgery and subjects are neurologically stable with minimal residual symptoms/signs. 5. any other serious underlying medical (e.g., uncontrolled hypertension, active uncontrolled infection, active gastric ulcer, uncontrolled seizures, cerebrovascular incidents, gastrointestinal bleeding, severe signs and symptoms of coagulation and clotting disorders, other serious cardiac conditions not listed in exclusion criteria), psychiatric, psychological, familial or geographical condition that, in the judgment of the investigator, may interfere with the planned staging, treatment and follow-up, affect patient compliance or place the patient at high risk from treatment-related complications. 6. pregnancy, lactation, breastfeeding
prospective study in pelvic radiotherapy patients

Conditions: Gynaecological, Urological or Rectal Cancer

Summary: symptoms such as diarrhoea and abdominal discomfort are common side effects of radiotherapy for tumours in the pelvis and usually occur within 2 weeks of starting treatment. once the course of radiotherapy has been completed these symptoms usually subside, but in some patients they may continue and sometimes cause significant problems. it is not clear what processes are occurring to trigger such symptoms. there are a number of possibilities and we would like to investigate these further. if we can identify specific reasons for symptoms being worse in one patient compared to another, then we can try to either prevent or treat these. the aim of this study is to look for differences in the way that the bowel adapts to radiotherapy in patients who do and those who don't experience bowel symptoms during their course of radiotherapy.

patients with pelvic cancers may be treated with radical radiotherapy as part of their disease management. acute intestinal changes such as diarrhoea, abdominal pain and nausea ocur in about 75% of patients. severe acute changes predispose to chronic, intractable intestinal changes. nutritional intervention during radiotherapy may protect the bowel from toxicity. a number of nutritionally related changes in bowel function may cause acute intestinal problems during radiotherapy. these include: bile-acid \& pancreatic enzyme potentiated damage to mucosa causing loss of epithelial integrity and in turn increased permeability to antigens and luminal bacteria; bile-acid malabsorption, decreasing the gut's ability to digest fat; reduced disaccharidase activity due to loss of the intestinal brush border, causing malabsorption of sugars leading to osmotic diarrhoea; statis/ dysmotility in the small intestine prompting bacterial overgrowth. there is little prospective data in patients undergoing radiotherapy to help to identify which are important. to understand what changes are relevant during a 6-week course of radiotherapy we plan this prospective observational study. any changes identified in this study could be ameliorated by specific nutritional intervention in future studies.

Eligibility criteria:
inclusion criteria: * any patient with gynaecological, bladder or rectal malignancy about to embark ona 5-6 week course of radical radiotherapy to the pelvis who is able to give informed consent exclusion criteria: * patients unable or unwilling to give informed consent * patients who have already started radiotherapy

Keywords: nutritional status bowel symptoms radical radiotherapy to pelvis gynaecological, urological or rectal cancer