Kornimate/medical-research-clean huggingface dataset:
sitagliptin regulation of intestinal and hepatic lipoprotein particle and hepatic glucose production in humans

Conditions: Hyperlipidemia

Summary: recent studies in both animals and humans has demonstrated that the hormone glp-1 (glucagon like peptide 1) reduces intestinal production of lipoprotein particles. the investigators therefore hypothesise that the drug sitagliptin which prevents the breakdown of glp-1 will reduce intestinal lipoprotein production in humans. the investigators are unable to speculate whether sitagliptin will affect hepatic lipoprotein production because of lack of of data from animal studies or in vitro data. sitagliptin is already an approved treatment for type 2 diabetes.

each subject will be studied twice 4-6 weeks apart in random order in this single blinded study. in study a they will receive a single dose of sitagliptin 100mg od. in study b they will receive placebo. a nasoduodenal tube will be sited under fluoroscopic guidance the day prior to the study. on the day of the study regular liquid formula (great shake plus) will be infused from 4am through the tube to maintain a constant fed state. a pancreatic clamp (octreotide with replacement glucose, insulin and growth hormone) along with saline/sitagliptin will be started at 7am. from 9am an iv bolus of deuterated-glycerol (d5-glycerol) along with a regular infusion of deuterated leucine (l-\[5,5,5-2h3\]. regular blood samples will be drawn to assess lipoprotein kinetics.

Eligibility criteria:
inclusion criteria: 1. men and women, aged 18 to 60 years 2. body mass index 20 kg/m2 to 27 kg/m2 3. hemoglobin above 130g/l. 4. normal glucose tolerance in response to a 75g, 2-hr ogtt exclusion criteria: 1. subject has a history of hepatitis/hepatic disease that has been active within the previous two years. 2. any significant active (over the past 12 months) disease of the gastrointestinal, pulmonary, neurological, renal (cr \> 1.5 mg/dl), genitourinary, hematological systems, or has severe uncontrolled treated or untreated hypertension (sitting diastolic bp \> 100 or systolic \> 180) or proliferative retinopathy 3. history of diabetes or ogtt indicative of diabetes or impaired glucose tolerance. 4. any history of a mi or clinically significant, active, cardiovascular history including a history of arrhythmia's or conduction delays on ecg, unstable angina, or decompensated heart failure. 5. any laboratory values: ast \> 2x uln; alt \> 2x uln tsh \> 6 mu/l 6. current addiction to alcohol or substances of abuse as determined by the investigator. 7. mental incapacity, unwillingness or language barrier precluding adequate understanding or cooperation 8. taking any prescription or non-prescription medications at the time of the study 9. having donated blood three months prior to and three months post study procedures 10. a pregnancy test will be performed 1 to 3 days prior to each study in all female subjects. those who test positive for pregnancy will be excluded.

Keywords: intestinal lipoprotein apolipoprotein b48 and apolipoprotein b100 pancreatic clamp dppiv inhibitor
attachment inhibitor comparison in heavily treatment experienced patients

Conditions: HIV Infections

Summary: the purpose of this study is to determine whether the bms attachment inhibitor (bms-663068) is effective in the treatment of heavily treatment experienced hiv-1 patients with multi-drug resistance.


Eligibility criteria:
inclusion criteria: * men and non-pregnant women with chronic hiv-1 infection * antiretroviral-experienced with documented historical or baseline resistance, intolerability, and/or contraindications to antiretrovirals in at least three classes * failing current antiretroviral regimen with a confirmed plasma hiv-1 rna ≥ 400 c/ml (first value from investigator, second from screening labs) * must have ≤ 2 classes with at least 1 but no more than 2 fully-active antiretrovirals remaining which can be effectively combined to form a viable new regimen, based on current and/or documented historical resistance testing and tolerability and safety * able to receive ≥ 1 fully active approved antiretroviral as part of the obt from day 9 onwards in the randomized cohort * subjects without any remaining fully active approved antiretroviral may be enrolled in the non-randomized cohort exclusion criteria: * chronic untreated hepatitis b virus (hbv) (however, patients with chronic treated hbv are eligible) * hiv-2 infection * alanine aminotransferase (alt) or aspartate aminotransferase (ast) \> 7 x uln * alkaline phosphatase \> 5 x uln * bilirubin ≥ 1.5 x upper limit of normal (uln) (unless subject is currently on atazanavir and has predominantly unconjugated hyperbilirubinemia)
point of care ultrasound to predict intensive care unit admission of patients presenting with sepsis to the emergency department

Conditions: Sepsis

Summary: the flopatch device will be applied to 150 septic patients in the emergency department before they receive fluid resuscitation. this study will assess whether initial flopatch measured volume-responsiveness and volume of fluids used will predict a composite outcome of mortality, intensive care unit admission, or rapid response team activation. the development of fluid unresponsiveness throughout the initial fluid resuscitation will be assessed and its association with the composite outcome will be assessed.


Eligibility criteria:
inclusion criteria: * emergency department patient * 18+ years old * systolic blood pressure less than 100mmhg * respiratory rate greater than 22 breaths per minutes * temperature greater than 38 degrees celsius or less than 36 degrees celsius * heart rate greater than 90 beats per minute exclusion criteria: * already intubated prior to emergency department arrival * ventilator-dependent * patients transferred from another hospital * pregnancy
suicide prevention and intervention in spain: the survive study

Conditions: Suicide; Suicide, Attempted; Depression

Summary: suicide is one of the leading causes of avoidable death worldwide. gathering population-representative data on the incidence of suicidal behavior, as well as developing effective secondary prevention strategies are imperative parts of evidence-based public health policies, currently lacking in spain. the suicide prevention and intervention study (survive) is a multi-site-cohort study with nested randomized-controlled clinical trials. the principal aims of the survive study are to determine the incidence of suicide attempts in spain and to investigate the efficacy of two secondary prevention programs.

suicide is the leading cause of avoidable death worldwide, demanding urgent attention. collecting national-representative data is the first step towards developing effective evidence-based public-policies. the survive study presents four inter-connected objectives: 1. to determine the incidence of suicide attempts in spain 2. to follow up suicide attempters with the aim of studying the probability of them re-attempting 3. to identify influential risk factors to explain suicide attempts and an increased risk of re-attempting 4. to determine the efficacy of secondary prevention programs to prevent suicide re-attempts in comparison to treatment as usual (tau). study design: multi-site-coordinated cohort study with nested randomized controlled trials. participants will be recruited at mental-health sites distributed across spain. participants: a cohort of 2.000 individuals presenting a suicide attempt will be established. individuals would be followed for 1-year, and assessed every 3 months. participants (age \>18) that meet inclusion/exclusion criteria will be randomly allocated to: 1) telephone-based management, or 2) ifightdepression for suicide (ifd-survive), a web-based-self-management tool. these interventions will be tested against tau. participants (age between 12-17) that meet inclusion/exclusion criteria will be randomly allocated to: 1)a face-to-face individual intervention designed for youths specific aware of mental health intervention for adolescents (sam) or 2) tau.

Eligibility criteria:
general inclusion criteria: * female and males, age \>= 12 years * having attended a hospital emergency department due to a suicide attempt * willing and able to comply with study procedures and to give written informed consent specific inclusion criteria for ifd-s: * minimum knowledge of internet use and availability of an internet device (tablet, computer, smartphone) * depressive symptoms according to phq-9 scores above 15 specific inclusion criteria for sam: * age between 12-17 * informed consent of legal guardians general exclusion criteria: * incapacity to give informed consent * lack of fluency in spanish * currently taking part in another clinical study which, in the opinion of the investigator, is likely to interfere with the objectives of the survive study.

Keywords: suicide suicide attempted depression secondary prevention mental health
segmentectomy for ground glass-dominant invasive lung cancer (ectop-1012)

Conditions: Segmentectomy; Lung Adenocarcinoma

Summary: this is a clinical trial from eastern cooperative thoracic oncology project (ectop), numbered as ectop-1012. the goal of this clinical trial is to confirm the theraputic effect of segmentectomy for ground glass-dominant invasive lung cancer with size of 2-3cm. the main questions it aims to answer are: * the 5-year disease-free survival of patients having ground glass-dominant invasive lung cancer with size of 2-3cm; * the post-operative lung function tests after receiving segmentectomy. participants will receive segmentectomy as the surgical procedure.


Eligibility criteria:
inclusion criteria: * patients who sign the informed consent form and are willing to complete the study according to the plan; * aged from 18 to 80 years old; * ecog equals 0 or 1; * not receiving lung cancer surgery before; * confirmed to be invasive lung adenocarcinoma intraoperatively or postoperatively; * ground glass-dominant lung nodules * consolidation-to-tumor ratio (ctr) ranges from 0 to 0.5, and tumor size ranges from 2 to 3cm; * cn0 without distant metastasis; * tumors could be completely resected assed by surgeons; * not receiving chemotherapy or radiotherapy before. exclusion criteria: * ctr is not 0-0.5, or size is not 2-3cm; * tumors could not be completely resected assed by surgeons; * not lung adenocarcinoma diagnosed cytologically or pathologically; * receiving lung cancer surgery before; * receiving radiotherapy or chemotherapy.
the short- and long term outcomes of early routine pci with the standard treatment in low-intermediate risk st-elevation myocardial infarction patients who successfully fibrinolysis.

Conditions: ST-elevation Myocardial Infarction

Summary: 1. objective: to evaluate short- and long-term in the stemi patients who successfully thrombolysis with early routine and delay percutaneous coronary intervention in low-intermediate risk patients. 2. educational/ application advantages: to evaluate the time of early and delay pci after received fibrinolysis had an effect to the short- and long-term clinical outcomes in low- intermediate grace risk score patients. no available of randomized controlled study in these group of the patients.

1.research design: intervention trial 1.1 study domain: stemi patients who will receive the fibrinolysis for reperfusion therapy 1.2 target population: stemi patients who will receive the percutaneous coronary intervention after fibrinolysis in lampang regional hospital and maharaj nakorn chiang mai hospital. 1.3 study population: stemi patients who will receive the percutaneous coronary intervention after fibrinolysis during the year of 2013-2014 at lampang regional hospital and maharaj nakorn chiang mai hospital inclusion criteria: 1. the patients who received the percutaneous coronary intervention after fibrinolysis 2. adult patients with age more than 18 years old 3. grace risk score less than 155 (low-intermediate risk) exclusion criteria: 1. the patients who received primary pci or rescue pci 2. the patients who had the previous history of coronary-artery bypass surgery 3. the high risk patients (such as cardiogenic shock, complete heart block, grace ≥155) 1.4 occurrence relation y (composite outcomes) = f (treatment early vs. delay \| confounders) 1.5 setting: the study will be conducted in lampang regional hospital and maharaj nakorn chiang mai hospital. 1.6 determinant (x): time to percutaneous coronary intervention (early vs. delayed). 1.7 events (y): composite outcomes (included of death, re-infarction, and recurrent ischemia), re-hospitalized with acs, and worsening heart failure.

Eligibility criteria:
inclusion criteria: 1. the patients who received the percutaneous coronary intervention after fibrinolysis 2. adult patients with age more than 18 years old 3. grace risk score less than 155 (low-intermediate risk) exclusion criteria: 1. the patients who received primary pci or rescue pci 2. the patients who had the previous history of coronary-artery bypass surgery 3. the high risk patients (such as cardiogenic shock, complete heart block, grace ≥155)

Keywords: pharmacoinvasive strategy
actual use trial of naproxen sodium

Conditions: Pain

Summary: an actual use trial to demonstrate that consumers will not exceed the labeled daily dose of aleve 24 hour at an unacceptable rate. two aspects of consumer use will be evaluated: 1) the frequency at which consumers exceed the label-defined daily dose, thus putting themselves at clinical risk, and 2) the reasons for exceeding the labeled daily dose.


Eligibility criteria:
inclusion criteria: * at least 12 years of age * report taking otc analgesics for pain on at least 5 days in the last month * report having had pain at least once in the last 3 months lasting longer than 12 hours or that they believe would have lasted longer than 12 hours if they had not treated it * able to read and understand english * provide written informed consent (subjects 12-17 years of age provide written assent and/or parent or legal guardian provide written consent) * provide contact information * purchase the investigational product exclusion criteria: * have participated in a trial involving otc analgesics in the last 6 months * they or someone else in the household work for a market research company, an advertising agency, a public relations firm, a pharmaceutical company, as a healthcare professional, or as part of a health care practice (eliminated for reasons of confidentiality or increased awareness of drugs and their labels) * have a history of known allergies to nsaids (i.e., naproxen, ibuprofen, aspirin, etc.) * have a history of heart surgery in the last 60 days or plans for heart surgery in the next 60 days * (female subjects) are pregnant or breastfeeding

Keywords: actual use trial
acute post streptococcal glomerulonephritis

Conditions: PSGN - Post-Streptococcal Glomerulonephritis

Summary: acute post streptococcal glomerulonephritis is an immunologic response of the kidney to infection, characterized by the sudden appearance of edema, hematuria, proteinuria and hypertension . it is essentially a disease of childhood that accounts for approximately 90% of renal disorders in children. the disease occurs especially in children between the ages of 2 and 12 years and young adults, and more often in male than in female .

acute post streptococcal glomerulonephritis are caused by group a beta haemolytic streptococci and follow upper airway infections such as pharyngitis or tonsillitis, by 14 to 21 days and 3-6 weeks after skin infection especially in warmer climates . in recent decades the number of patients with post streptococcal glomerulonephritis has decreased considerably in the united states and europe industrialized countries. in other parts of the world ,some developing communities. the incidence of post streptococcal glomerulonephritis has remained high. post streptococcal glomerulonephritis is one of the leading cause requiring hospital admissions in children , and it is also an important cause of acute renal failure in developing countries. though deaths due to this disease are rare, it can cause serious complications such as hypertensive emergency, congestive cardiac failure, renal failure, encephalopathy and retinopathy . acute post streptococcal glomerulonephritis can also progress to rapidly progressive glomerulonephritis which is defined as''a syndrome that progresses rapidly within a few weeks or months to renal failure and is accompanied by urinary findings of nephritis.'' the clinical concept of rapidly progressive glomerulonephritis includes various renal diseases that cause renal function to deteriorate over a subacute course. necrotizing crescentic glomerulonephritis is often observed in histopathological findings . acute post streptococcal glomerulonephritis was diagnosed in the presence of : features of acute nephritic syndrome. evidence of recent streptococcal infection. lower serum complement three levels. anti streptolysin o titre \>200 units/ml was considered as evidence of recent streptococcal infection

Eligibility criteria:
inclusion criteria: * children in the age groups of 2-15 years. presenting with clinical manifestation of acute nephritic syndrome will be included in the study. exclusion criteria: * children having history suggestive of chronic renal and cardiac disease in the past * children with congenital renal anomalies . * children with clinical manifestation of nephrotic syndrome . * children with clinical manifestation of acute nephritic syndrome due to other causes .
effects of head and neck cooling and heating on fatigue in multiple sclerosis and healthy men

Conditions: Multiple Sclerosis

Summary: local head and neck cooling strategies can help reduce multiple sclerosis-related fatigue, while heating can exacerbate heat-related fatigue. however, no study has detailed the peripheral and central responses to head and neck cooling (at 18°c) and heating (at 43 ± 1°c next to the scalp and neck skin) during fatiguing isometric exercise in non-challenging ambient temperature in multiple sclerosis and healthy male subjects. in addition, there is a lack of data describing the effects of head and neck cooling/heating and strenuous exercise on blood markers, muscle temperature, motor accuracy, and rate of perceived exertion. the investigators hypothesized that: (i) men with multiple sclerosis would be more affected by central and peripheral fatigue compared to healthy subjects; (ii) local cooling will result in greater central fatigue but will be associated with greater peripheral fatigue, whereas heating will result in greater central and peripheral fatigue in multiple sclerosis men; (iv) local cooling and heating will have a greater effect on the release of stress hormones, rate of perceived exertion and motor accuracy compared to the control condition in both multiple sclerosis and healthy groups.


Eligibility criteria:
inclusion criteria: * relapsing-remitting multiple sclerosis disease course according to mcdonald criteria * expanded disability status scale less than 4 points and fatigue severity scale score greater than 5 points in participants with multiple sclerosis * males * age between 18 and 45 years * sufficient tolerance to electrical stimulation exclusion criteria: * physical limitations that would impair the ability to perform neuromuscular testing * mental disorders, such as depression or anxiety, due to their recognized association with fatigue * involvement in temperature manipulation program for ≥ 3 months * attending any excessive physical exercise or sports programs * with blood/needle phobia

Keywords: multiple sclerosis cooling heating fatigue exercise
physical training in transposition of the great arteries

Conditions: Transposition of Great Vessels

Summary: in transposition patients after atrial switch operation, the morphological right ventricle serves as the systemic ventricle. these patients often develop signs of heart failure. it is not known, whether physical training can safely be recommended in these patients- like heart failure guidelines recommend training in patients with normal anatomy. furthermore it is not known, whether these tga-patients benefit from training with respect to cardiopulmonary exercise capacity.

this is a randomized, controlled, prospective trial on the safety of physical training in tga patients after atrial switch operation. in transposition patients after atrial switch operation, the morphological right ventricle serves as the systemic ventricle. these patients often develop signs of heart failure. it is not known, whether physical training can safely be recommended in these patients- like heart failure guidelines recommend training in patients with normal anatomy. furthermore it is not known, whether these tga-patients benefit from training with respect to cardiopulmonary exercise capacity. primary endpoints are systemic ventricle ejection fraction and volumes, exercise capacity. secondary endpoints are echo diastolic function, as well as laboratory markers of heart failure.

Eligibility criteria:
inclusion criteria: * age \>=18 years exclusion criteria: * tricuspid regurgitation grade 2 or more * sign. lvoto or rvoto * pacemaker or defibrillator * recent hospitalisation for heart failure (90 days)

Keywords: tga atrial switch training
the effect of cold therapy on pain and anxiety during the implanted port catheter removal

Conditions: Pain; Anxiety

Summary: this study was conducted as a quasi-experimental study to examine the effect of cold therapy on pain and anxiety during venous port catheter removal.

pain and anxiety experienced during diagnosis and treatment in cancer patients affect the physical, psychological, and interpersonal well-being of individuals and affect their lives in all aspects. nurses play a very important role in pain control. pain control is very important in terms of ensuring the comfort of patients and increasing their quality of life. in order to provide this control; nurses can use non-pharmacological treatment methods that they can apply independently in pain management. patients experience procedural pain during insertion and removal of an implantable port catheter, which is one of the painful invasive procedures that are placed under the skin with a small incision, and insertion of a needle into the port catheter. when the literature is examined, it is seen that there are a limited number of studies in which non-pharmacological methods are used in the control of pain and anxiety related to the implantable venous port catheter procedure, and in these studies, distraction, music therapy, and inhaler aromatherapy. however, no study was found in which cold application was used to reduce the pain and anxiety caused by the removal of the port catheter in cancer patients. therefore, the aim of the study is to evaluate the effectiveness of cold application on procedural pain and anxiety associated with port catheter removal, which is frequently used in the treatment of cancer patients. cold therapy as an independent nursing intervention in reducing anxiety and pain management during port catheter removal in cancer/oncology patients; can be transferred to clinical practice by oncology nurses, improving the quality of nursing care, ensuring patient safety, and increasing patient satisfaction. in addition, the results of the research may contribute to the literature in terms of increasing evidence-based information on the use of the cold application in procedural pain and anxiety control in cancer patients.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of cancer disease * 18 years and over * no analgesic medication before three hours before the catheter removal procedure * conscious and cooperative * no communication problems * no visual no vision problems * with stable vital signs * without a diagnosis of anxiety disorder * volunteer participation exclusion criteria: * body mass index less than 18.5 * receiving oxaliplatin infusions before venous port catheter removal

Keywords: cancer venous port catheter cold therapy pain anxiety