Kornimate/medical-research-clean huggingface dataset:
metabolomic variations in the saxagliptin-treated type 2 diabetes mellitus patients

Conditions: Type 2 Diabetes

Summary: this study is an open-label, cohort study to evaluate the potential mechanisms of saxagliptin in the treatment of patients with type 2 diabetes (t2dm) using a comprehensive metabolomic method, in combination with fingerprint analysis and target analysis. it is a sub-study of study: d168l00008.


Eligibility criteria:
inclusion criteria: * all the subject inclusion criteria should be referred to study: d168l00008. briefly 1. provision of informed consent prior to any study specific procedures 2. diagnosed with type 2 diabetes 3. men or women who are 18 years of age. 4. patients should be drug naïve or treated with metformin alone on stable doses of for at least continues 8 weeks. 5. hba1c are between 7.5% and 11.0% exclusion criteria: * all the subject exclusion criteria should be referred to study: d168l00008. briefly 1. pregnant or breastfeeding patients. 2. insulin therapy within one year of enrolment(with the exception of insulin therapy during a hospitalization or use in gestational diabetes). 3. previous treatment with any dipeptidyl peptidase-iv (dpp-iv) inhibitors or glucagon-like peptide-1 (glp-1) analogue. 4. history of administration of any antihyperglycemic therapy (other than metformin) during the 8 weeks prior to visit 1(12 weeks for previous tzd). 5. treatment with systemic glucocorticoids other than replacement therapy. inhaled,local injected and topical use of glucocorticoids is allowed. 6. treatment with strong cytochrome p450 inhibitors. 7. gastrointestinal surgery that could impact the absorption of study drug. 8. contraindications to therapy as outlined in the saxagliptin package insert. 9. hypersensitivity to saxagliptin 10. have a history of, or currently have, acute or chronic pancreatitis. 11. type 1 diabetes, history of diabetic ketoacidosis or hyperosmolar non-ketonic coma. 12. any condition where, in the opinion of the investigator, participation in this study may pose a significant risk to the patient or could render the patient unable to successfully complete the study. 13. fasting plasma glucose \>15mmol/l.
copeptin in outcome prediction of an acute psychotic episode

Conditions: Acute Psychotic Episode; Schizophrenia Spectrum and Other Psychotic Disorders; Affective Disorder; Bipolar Disorder

Summary: an acute psychotic episode is a severe psychiatric syndrome which might occur in different psychiatric diagnoses. the outcome prediction of relapse rate of a psychotic episode within a certain time frame is difficult and depends on many factors. more and better predictors are required to improve the outcome prediction in order to adjust therapy and follow-up if patients suffer from this acute disease. copeptin, a surrogate marker for vasopressin, has been proven helpful in the prediction of the outcome in serious somatic diseases. additionally, a rise of copeptin due to psychological stress was shown. the aim of this study is to investigate the association of the neuroendocrine biomarker copeptin and the prediction of the onset of psychotic episode within one year.

an acute psychotic episode is a severe psychiatric syndrome characterised by symptoms like delusions, hallucinations, and perceptual disturbances. a psychotic episode might occur in different psychiatric diagnoses, such as schizophrenia spectrum disorders and affective disorders (depression and bipolar). the outcome prediction of relapse rate of a psychotic episode within a certain time frame is difficult and depends on many factors. more and better predictors are required to improve the outcome prediction in order to adjust therapy and follow-up if patients suffer from this acute disease. copeptin, a surrogate marker for vasopressin, has been proven helpful in the prediction of the outcome in serious somatic diseases such as stroke, myocardial infarction, and pneumonia. additionally, a rise of copeptin due to psychological stress was shown. some studies have shown an increase in vasopressin levels during acute psychosis, no study has been performed using copeptin. the aim of this study is to investigate the association of the neuroendocrine biomarker copeptin and the prediction of the onset of psychotic episode within one year.

Eligibility criteria:
inclusion criteria: * age 18-55 years * acute psychotic episode * informed consent as documented by signature exclusion criteria: * limited discernment due to psychiatric disorder to give informed consent * acute psychotic episode due to any organic reason * psychotic episode due to psychotropic substances * severe somatic disease (acute myocardial infarction, acute sepsis, acute stroke)

Keywords: copeptin outcome prediction
topical therapy with cooling effect in dry itchy skin

Conditions: Compensate the Roughness of the Skin; Compensate the Sensory Symptoms

Summary: dry skin is a physiological condition and is characterized in contrast to greasy skin by roughness, desquamation and lack of brightness of the skin surface. subjectively, feelings of tension, burning and itching can occur. the skin reacts more intensive on external and physical noxae. dry skin is caused by a lack of moisture. this is most common during the winter months, when heating systems dry the air. bathing with hot water, spending extended periods of time in the hot sun, and the skin's natural aging process also remove moisture and oils from the skin. it is diagnosed through clinical observation. people suffering from dry skin often desire to improve this condition for optical cosmetic reasons and due to the occasional feeling of tension. the aim of this investigation is to observe the improvement (or not) of dry itchy skin by a lotion containing a cooling compound

the patient use the lotion twice daily for a four-week period. additionally, the patient receives a documentation sheets to note several parameters. in a sensory assessment, product specific parameter such as spreadability, permeability, lubricating, smell of lotion and cosmetic acceptance during the treatment will be assessed (at the beginning, after 2 weeks, after 4 weeks, 2 weeks after stopping treatment). before and after skin care measurement, the skin surface will be investigated by d-squames and corneometer. after four weeks the skin care measurement will be terminated and the patient can continue with a treatment of his choice. a monitoring of at least 70 patients is intended.

Eligibility criteria:
inclusion criteria: 1. patients age: over 18 years 2. itch over vas 3 exclusion criteria: 1. pregnancy, lactating women 2. drug abuse 3. active psychosomatic and psychiatric disease 4. active cancer. 5. topical application of tacrolimus, pimecrolimus, corticosteroids or capsaicin two weeks before study start 6. intake of antihistamines, corticosteroids, cyclosporine a and other immunosuppressants, naltrexone, uv-therapy two weeks before study start 7. participation in any other research study during the previous 4 weeks.

Keywords: dry skin cooling itch
anakinra in myositis

Conditions: Polymyositis; Dermatomyositis; Inclusion Body Myositis

Summary: to investigate the effect of the interleukin-1 (il-1) blocking agent, anakinra, in patients with treatment-resistant inflammatory myopathies. patients and methods: fifteen patients with refractory polymyositis (pm), dermatomyositis (dm), or inclusion body myositis (ibm) were treated with 100 mg anakinra subcutaneously per day during 12 months. outcome measures included myositis disease activity score with improvement defined according to the international myositis assessment and clinical studies group (imacs) and for muscle performance the functional index of myositis (fi). in addition repeat muscle biopsies were performed


Eligibility criteria:
inclusion criteria: men and women aged 18 to 80 years with diagnosis of pm, dm or ibm based peter and bohan's and grigg's criteria. all patients had to be capable of giving informed consent. other inclusion criteria were muscle strength and/or function reduced at least 20 % below predicted values as measured by functional index (fi) \[45-47\] and failure to respond to treatment with high-dose glucocorticoids (0.75 mg/kg/day for at least one month) in combination with azathioprine and/or methotrexate for at least two months. - exclusion criteria: serious infections such as hepatitis, pneumonia, pyelonephritis in the previous 3 months; history of opportunistic infections such as tuberculosis, drug resistant atypical mycobacterium, active pneumocystis carinii, active cytomegalovirus infection; documented hiv infection; alcoholism, alcoholic liver disease or other chronic liver disease; chest x-ray suggestive of active tuberculosis; and pregnant, nursing mothers or patients with planned pregnancy within one and a half years of enrolment. -
continuous glucose monitoring in the intensive care unit

Conditions: Diabetes Mellitus

Summary: the aim of the proposed clinical trial is to study the use of the dexcom g7 continuous glucose monitor (cgm) within the intensive care unit (icu) environment. the overall goal is to validate the accuracy and practicality of the dexcom g7 when used to assess glycemia in critically ill patients.

the specific goals are 1) to work with intensive care unit (icu) staff, in a respiratory icu setting, to determine how best to place and maintain dexcom g7 continuous glucose monitors (cgms) on patients and how to place recording devices and chargers in that environment, 2) download cgm readings to the dexcom dashboard in an analyzable format, and 3) to compare simultaneous cgm readings with glucose measurements obtained in the course of routine care as recorded in the electronic medical record. the primary analytical goal is the correlation of cgm glucose measurements with those obtained in the course of routine care. a secondary goal is to determine the frequency of device malfunctions that occur either as a result of device failure (e.g. it falls off) or adverse events (e.g. removal due to skin irritation). study subjects will be patients admitted to the 6-icu umass memorial medical center (ummmc) university campus medical intensive care unit for any reason who have known diabetes or who are hyperglycemic (blood glucose concentration ≥200 mg/dl) with diabetes that was previously undiagnosed or unrecognized. all enrolled volunteers will have a dexcom g7 cgm place on the skin according to manufacturer's specifications. the devices will remain in place for 10 days or until discharge from the icu

Eligibility criteria:
inclusion criteria: campus medical intensive care unit for any reason who have known diabetes or who are hyperglycemic (blood glucose concentration ≥200 mg/dl) with diabetes that was previously undiagnosed or unrecognized. * persons with either type 1 or type 2 diabetes. * persons of either sex. * persons of any age over 18. * persons able to give informed consent or cognitively impaired adults whose legally authorized representative (lar) can give informed consent. * english or spanish speaking adults. exclusion criteria: * persons unable to provide informed consent. * cognitively impaired persons whose lar declines to provide informed consent. * patients receiving hydroxyurea, which interferes with sensor function. * patients receiving high dose acetaminophen (\> 4 gm/day), which interferes with sensor function. * anasarca affecting preferred areas for device placement (arm, upper buttocks, or thigh), which may interfere with sensor accuracy. * severe cachexia with absence of subcutaneous fat at preferred sensor placement sites, which might interfere with sensor accuracy. * persons who are pregnant. * prisoners.

Keywords: icu cgm accuracy diabetes hypoglycemia diabetes mellitus continuous glucose monitor intensive care
a phase ⅰ study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of hrs-5817 injection

Conditions: Obesity; Overweight

Summary: the purpose of this study is to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of hrs-5817 when administered subcutaneously (sc) as single ascending doses in adults who are affected by obesity.


Eligibility criteria:
inclusion criteria: 1. voluntarily sign the informed consent form prior to any study-related activities, understand the procedures and methods of the study, and agree to complete this study in strict accordance with the clinical study protocol. 2. males or females aged 18-55 years old (inclusive). 3. subjects who are generally healthy as judged by the investigator based on medical history, vital signs, physical examination, laboratory tests and electrocardiogram (ecg) results. 4. body weight change (difference between the maximum body weight and the minimum body weight within 3 months) of no more than 5 kg within the past 3 months. 5. female subjects of childbearing potential must agree to take highly effective contraceptive measures and avoid egg donation from the signing of the informed consent form to 6 months after the last dose, and must have a negative blood pregnancy test result before administration and not be breastfeeding. male subjects whose partners are women of childbearing potential must agree to take highly effective contraceptive measures and avoid sperm donation from the signing of the informed consent form to 6 months after the last dose. exclusion criteria: 1. known or suspected allergy to any ingredient in the investigational medicinal products or related products; or history of multiple and/or severe allergies to drugs or food, or history of severe anaphylaxis. 2. history of or suffering from major diseases of cardiovascular, endocrine (except primary obesity), mental, neurological, digestive, respiratory, blood, immune or genitourinary systems, which are not suitable for participation in this study as judged by the investigator. 3. subjects who have had severe trauma or undergone major surgical procedures within 6 months before screening, or who plan to undergo surgery during the study. 4. subjects who have participated in and used any other clinical trial drugs or medical device treatments within 3 months prior to screening or plan to do so during the study period, or within 5 half-lives of the investigational drug before screening (whichever is longer). 5. significant changes in diet and exercise habits within 1 month before screening, or failure to maintain a basically stable lifestyle such as diet and exercise during the study. 6. known or suspected history of drug abuse or substance abuse, or positive urine drug screening during the screening period. 7. other situations that may interfere with the evaluation of the study results or are not suitable for participating in this study as judged by the investigator.
preliminary study on the diagnostic value comparison of 18f-fapi-04 pet/ct and pet/mr in gastric cancer

Conditions: Gastric Cancer

Summary: this project aims to comprehensively analyze the diagnostic efficacy of suvmax, suvean, tlg, mtv, etc. in gastric cancer through 18f-fapi-04 pet/ct imaging combined with serum tumor markers and other methods, and construct a molecular imaging diagnostic model for gastric cancer; next, analyze the diagnostic efficacy of 18f-fapi-04 pet/ct and pet/mr multimodal imaging in evaluating suvmax, pet/ct-pci, and pet/mr-pci for gastric cancer peritoneal metastasis, and construct a molecular imaging diagnostic model for gastric cancer peritoneal metastasis; exploring the clinical value of 18f-fapi-04 pet/ct and pet/mr imaging in the diagnosis and staging of gastric cancer.


Eligibility criteria:
inclusion criteria: 1. age over 18 years old; 2. diagnosed as a patient with gastric cancer; 3. receive fapi pet/ct and fdg pet/ct imaging within one week; 4. perform serum tumor marker testing one week before and after scanning exclusion criteria: 1. history of other malignant tumors; 2. patients with severe infections, severe underlying diseases such as heart, kidney, and liver; 3. patients with contraindications for pet-ct examination, poor physical condition, and inability to tolerate the examination; 4. patients with unorganized pathology or incomplete clinical data
empagliflozin versus vildagliptin in cad patients with t2dm

Conditions: Coronary Artery Disease; Type 2 Diabetes

Summary: we compared the cardioprotective effects of empagliflozin, an sglt2 inhibitor, with those of vildagliptin, a dipeptidyl peptidase-4 (dpp-4) inhibitor, focusing on various inflammatory biomarkers lipid profile, and cardiac function, in patients with type 2 diabetes mellitus (t2dm).

this was a prospective, randomized, double-dummy, parallel-group trial that enrolled 120 patients with t2dm. the patients were randomized 1: 1 for 6 months administration of empagliflozin or vildagliptin. by using consecutive ascending randomization numbers in the treatment blocks allocated to each study site. the randomization was stratified by the presence or absence of statin and oral antidiabetic therapy. the randomization list was produced using an automated random number generator. clinical parameters, assessment of atrial myocardial function, lvef%, la diameter, glycemic and lipid profile, adiponectin, high-sensitivity c-reactive protein, and sortilin levels will be determined at baseline and after the 6 months of treatment period. patient compliance was evaluated by the counting of pills by a physician at selected time-points. in addition, patients were provided with individual diary cards to record administration of the study medication on a daily basis. these cards were checked regularly by site staff. the study will be approved by the local ethics committee and was conducted in accordance with the declaration of helsinki and its amendments. all included patients provided written informed consent.

Eligibility criteria:
inclusion criteria: 1. t2dm patients with chronic stable angina. 2. patients with glycated hemoglobin (hba1c) levels of 6.0-10.0%. 3. patients aged 20-80 years. 4. patients with a body mass index of ≥ 22 kg/m2. 5. patients who provided written informed consent. exclusion criteria: 1. patients with type 1 diabetes mellitus or secondary diabetes mellitus. 2. patients with renal dysfunction (estimated glomerular filtration rate \< 45 ml/min/1.73 m2). 3. patients with left ventricular ejection fraction (lvef) \< 30%. 4. patients with untreated cancer. 5. patients with hepatic cirrhosis. 6. patients with liver failure that was virus-, autoimmune- or drug-induced. 7. patients with alcoholism. 8. pregnant or breastfeeding patients, or those planning to become pregnant during the course of the study. 9. patients allergic to empagliflozin or vildagliptin. 10. patients with anemia (hemoglobin \< 12 g/dl).

Keywords: cad. t2dm. lvef%. sortilin. empaglilozin. vildagliptin.
ketorolac effects on post-operative pain and lumbar fusion

Conditions: Spinal Fusion

Summary: a double blind prospective randomized trial of iv ketorolac vs. placebo in management of patients undergoing lumbar one or two level spinal fusions. primary objective - to demonstrate ketorolac results in decreased postoperative opioid use following posterior spinal fusions during the first 48 hours. secondary objectives * to demonstrate that the use of ketorolac does not decrease spinal fusion in one or two level instrumented spinal fusions. * to demonstrate the use of ketorolac decreases the average length of stay following spinal fusions.


Eligibility criteria:
inclusion criteria: * 18-85 years of age * elective posterior lumbar instrumented fusion * one- or two-level fusion * consent to participate in study, and willing to adhere to study follow up exclusion criteria: * - - under age of 18 y/o or over age 85. * history of renal failure, dialysis or creatinine over 1.50mg/dl * active smoker or history of within the last 6 months * revision surgery * auto/worker compensation * active cancer or history of chemotherapy in last 6 months * active narcotic use within 3 months of surgery date. * infection at operative levels * any allergies to nsaids or opioids
the analysis of correlation about the spot urine sodium and the blood pressure in general population according to the income level

Conditions: Chronic Kidney Disease

Summary: increasing sodium intake raises blood pressure. and high salt intake could hinder the management of chronic disease. much previous research has confirmed that dietary habits are affected by economic status. so we compared sodium intake with economic status. we investigated the prevalence, extent and management, and the relevance of sodium intake with income level.


Eligibility criteria:
inclusion criteria: * all the patient who participated in the national survey exclusion criteria: * no pregnancy * malignancy
a study to evaluate the activity, and safety of vixarelimab in participants with moderate to severe active ulcerative colitis

Conditions: Moderate to Severe Ulcerative Colitis

Summary: this study aims to evaluate the pharmacodynamic (pd) effects of vixarelimab in the gut of participants with active moderate to severe ulcerative colitis (uc).


Eligibility criteria:
inclusion criteria: * diagnosis of uc established at least 3 months * moderately to severely active uc * participants must meet criteria for either advanced therapy failure or conventional therapy failure exclusion criteria: * diagnosis of crohn's disease or indeterminate colitis * suspicion of ischemic colitis, radiation colitis, microscopic colitis or infectious colitis * prior colectomy * prior treatment with systemic janus kinase (jak) inhibitors
study on sintilimab in stage iv high risk neuroblastoma

Conditions: Recurrent Stage IV High Risk Neuroblastoma

Summary: a phase i observational study on the safety and efficacy of treatment of recurrent stage iv high risk neuroblastoma with nivolumab


Eligibility criteria:
inclusion criteria: 1. 12 months to 12 years 2. histologic verification of stage iv high risk neuroblastoma at relapse following lack of complete response to at least two lines of therapy 3. fully recovered from the acute toxic effects of all prior anti-cancer treatment 4. at least 21 days after the last dose of myelosuppressive chemotherapy (42 days if prior nitrosourea) 5. at least 42 days after the completion of any type of immunotherapy, e.g. tumor vaccines 6. at least 56 days must have elapsed after transplant or stem cell infusion; patients with prior allogeneic transplants are not eligible 7. blood counts recovery including white cell count \>= 750/mm\^3 and platelet count \>= 50,000/mm\^3 8. creatinine clearance ≥ 50ml/min 9. liver function: total bilirubin ≤ 2 mg/dl, alanine aminotransferase or aspartate aminotransferase ≤ 2.5 u/dl (or \< 5 in case of liver impairment) 10. life expectancy of at least 4 months 11. negative pregnancy test in women of childbearing potential 12. use of an effective contraceptive method during the whole treatment and 13. up to 3 months after the completion of treatment in males and females 14. prior informed consent signed exclusion criteria: 1. patients requiring daily systemic corticosteroids are not eligible; patients must not have received systemic corticosteroids within 7 days of enrollment on study 2. patients who are currently receiving another investigational drug are not eligible 3. patients who are currently receiving other anti-cancer agents are not eligible 4. patients with a history of any grade autoimmune disorder are not eligible; asymptomatic laboratory abnormalities (e.g. antinuclear antibody (ana), rheumatoid factor, altered thyroid function studies) will not render a patient ineligible in the absence of a diagnosis of an autoimmune disorder 5. patients with \>= grade 2 hypothyroidism due to history of autoimmunity are not eligible; note: hypothyroidism due to previous irradiation on thyroidectomy will not impact eligibility 6. patients who have an uncontrolled infection are not eligible. 7. patients with active autoimmune disease. (any autoimmune state requiring medical treatment-including chronic medications)all immune modifying drugs should be stopped at least 7 days prior to enrollment