Kornimate/medical-research-clean huggingface dataset:
diazoxide choline controlled-release tablet (dccr) for very high triglycerides

Conditions: Hypertriglyceridemia

Summary: the hypothesis of this study is that dccr is effective as both monotherapy and in combination with a statin in lowering triglycerides in subjects with very high triglycerides

very high triglyceride is a risk for pancreatitis. studies have shown diazoxide choline has the potential to effectively lower triglycerides in patients with very high triglycerides.

Eligibility criteria:
inclusion criteria: fasting triglycerides * difference between visit 3 (7 days prior to baseline visit) and visit 4 (3 days prior to baseline visit) ≤ 60% (compared to the higher value of visit 3 or visit 4) * run-in triglycerides\* ≥ 500 mg/dl and \< 1500 mg/dl \*run-in triglyceride is defined as the average fasting triglycerides for visit 3 (7 days prior to baseline visit) and visit 4 (3 days prior to baseline visit). statin use * either statin-naive - must not be on statin at screening and remaining as such during the run-in/washout period and throughout the study * or statin-treated * must be receiving a stable and effective dose of statin for ≥ 3 months without significant side effects or intolerance prior to screening * must be willing to switch to 20 mg atorvastatin at the start of the run-in/washout period and continue throughout the study medication washout * all subjects must be willing to undergo washout of all other lipid-lowering medications fasting ldl cholesterol * ≤ l60 mg/dl at both screening visit and visit 4 glycemic status * fasting glucose \< 126 mg/dl at screening visit * hba1c \< 6.5% at screening visit exclusion criteria: medications: recent, current, anticipated * administration of investigational drugs within 1 month prior to screening visit * thyroid hormones or preparations within 1 month prior to screening visit (except in subjects on stable dose of replacement therapy for at least 1 month) * thiazide diuretics within 2 weeks prior to screening visit * discontinuation of beta-blockers within 1 month prior to screening visit or planned discontinuation of beta-blocker therapy * anticipated requirement for use of prohibited concomitant medications history of allergic reaction or significant intolerance to: * diazoxide * thiazides * sulfonamides * fenofibrate or fenofibric acid derivatives lifestyle changes • subjects intending to change exercise habits, quit smoking and/or quit alcohol use during the initial 12-week placebo-controlled treatment period of the study specific diagnoses, medical conditions and history * known type i or iii hyperlipidemia * known type 1 dm * known type 2 dm * any other clinically significant endocrine, cardiovascular, pulmonary, neurological, psychiatric, hepatic, gastrointestinal, hematological, renal, or dermatological disease interfering with the assessments of the study medications, according to the investigator specific laboratory test results • any relevant biochemical abnormality interfering with the assessments of the study medications

Keywords: hypertriglyceridemia
impact of tight glycaemic control in acute myocardial infarction

Conditions: Myocardial Infarct; Hyperglycemia

Summary: to determine whether tight glycaemic control with insulin improves myocardial function and myocardial perfusion (measured by myocardial contrast echocardiography) and novel vascular risk factors in patients with acute myocardial infarction and hyperglycaemia.

we will randomise patients with acute myocardial infarction and blood glucose levels (bgls) \>=10mmol/l within 24 hours of pain onset, to either tight glucose control (aiming bgls 4.5 - 7mmol/l) with an insulin infusion (for 24 hours) followed by subcutaneous insulin or standard control (bgl 6 - 12mmol/l) without the use of an insulin infusion. serial myocardial contrast echocardiography will measure changes in myocardial perfusion and function from baseline to 3 months between each group. we will also measure changes in inflammatory and endothelial markers over this time to see whether tight glucose control improves these surrogate endpoints.

Eligibility criteria:
inclusion criteria: * age \>=18years * acute myocardial infarction * blood glucose level \>=10mmol/l * wall motion abnormality on baseline echocardiogram exclusion criteria: * active infection/inflammation * cardiac shunt * cognitive impairment * insulin allergy

Keywords: acute myocardial infarction hyperglycaemia insulin infusion
registration of skin-temperatures and sleep-wake behaviour

Conditions: Vasospastic Syndrome

Summary: we study the skin-temperature (skin temperature measurement on different skin regions) and circadian rest-activity cycles (wrist activity monitoring) of 40 women in their daily life. this project will provide further information at which circadian phase vasospasms occur in daily routine life (one week recordings). special interest lays on the time before sleep. the attained results could be used to establish a therapy with few side effects for people with difficulties initiating sleep because of vasospasm.

we study the skin-temperature and circadian rest-activity cycles of 40 women in their daily life. 20 women with vasospasm and difficulties of initiating sleep and 20 women without vasospasm and no difficulties of initiating sleep. women without contraceptives will be examined in the luteal phase (i.e. in the two weeks before menstruation). the ambulant registry will be done continuously during one week with so called i-buttons (ibuttontm, maxim, usa). these will be fixed to various parts of the body (i.e. wrist, ankle, ...) with fixomull, a medical bond. also the subjects have to wear a instrument for registration activity, the so called actiwatch (cambridge, uk). the data that will be gained from these instruments, shall help us to objectify sleep-latency and sleep-fragmentation ("sleeping-through"). furthermore, the subjects obtain a sleep-and activity-dairy, that has to be filled before and after sleeping. at one day, that the proband can choose, saliva samples have to be taken by the subjects themselves. in the saliva, the concentration of melatonin will be qualified. the attained results could be used to establish a therapy with few side effects for people with difficulties of initiating sleep because of vasospasm.

Eligibility criteria:
inclusion criteria: * subjects have to show a vasospasm and difficulties of initiating sleep (screening with questionnaires and interview) * controls have to show no vasospasm and no difficulties of initiating sleep (screening with questionnaires and interview) exclusion criteria: * bad health or unhealthy conditions * allergies (i.e. nickel) * medication * bmi\<18 * migraine * delayed sleep phase syndrome * advanced sleep phase syndrome * alcohol- or drug problems * smokers * blood donation in last three months before study * participation at an other clinical study in last three months before study * shift work in last three months before study * long-distance flight (\> 2 time zones) in last month before study

Keywords: vasospasm circadian sleep-disorders
evaluation of the effect of telmisartan (micardis® 80 mg/ micardisplus® 80/12.5 mg) on blood pressure and cardiovascular risk factor index in high risk hypertensive patients

Conditions: Hypertension; Cardiovascular Diseases

Summary: the study is designed to evaluate the effect of treatment with micardis/micardisplus on blood pressure and its ability to reduce different indicated cardiovascular risks. further on, the study will evaluate the current antihypertensive treatment pattern in the daily practice among the patient population at increased cardiovascular risk.


Eligibility criteria:
inclusion criteria: * diagnosis of essential arterial hypertension (bp\>140/90 mm hg or bp\>130/80 mm hg for diabetic patients) * at least an additional cardiovascular risk factor exclusion criteria: * hypersensitivity to the active substance or to any of the excipients in any ace inhibitor or angiotensin receptor blocker (arb) available on the local market * pregnancy and lactation * diseases involving biliary obstruction * severe liver impairment
probiotic intervention after surgical removal of mandibular third molars

Conditions: Surgery--Complications; Molar, Third

Summary: single-center, double-blind, randomized trial of probiotics l. plantarum kabp-051 (cect7481) and l. brevis kabp-052 (cect7480) taken twice daily for 7 days after surgical removal of both mandibular 3rd molars. patients were assessed for surgery-derived complications in a follow-up visit 7 days after surgery, and provided daily evaluations of pain, swelling and eating difficulty in a patient diary.

this was a single-centre, prospective, double-blind, randomized, placebo-controlled, parallel-group study to evaluate whether probiotic supplementation during 1 week after surgery reduced post-surgery complications compared to placebo. healthy subjects of both genders aged between 14 and 25 years who required the surgical removal of both mandibular 3rd molars were recruited from the department of oral and maxillofacial surgery at the foundation of hospital de nens de barcelona (children's hospital of barcelona). patients were randomly assigned to receive probiotic tablets containing a mixture of l. plantarum kabp-051 (cect7481) and l. brevis kabp-052 (cect7480) or to receive placebo, twice a day for 7 days post surgery. patients were assessed by trained specialists for surgery-derived complications (fever, oral alveolitis, alveolar osteitis, trismus) in a follow-up visit 7 days after surgery. patients also provided daily evaluations for pain, swelling and eating difficulties in a patient diary.

Eligibility criteria:
inclusion criteria: * otherwise healthy male and female undergoing surgical removal of both third mandibular molars. * aged between 14 and 25 years. * providing informed consent if 18yr and older, or parents/guardians providing informed consent otherwise exclusion criteria: * subjects with gingival index (gi; according to loe and silness. 1963) or dental plaque index (pli; according to silness and loe. 1964) above 2 in the cpi community periodontal index) teeth subset. * subjects having used probiotics or antibiotics within 30 days prior to study enrollment. * tobacco use * pregnant and breastfeeding women. * known allergies to ingredients in study products. * not willing to refrain from using mouthwashes during the study period

Keywords: probiotic molar removal surgery oral pain maxillofacial surgery
bcd regimen in newly diagnosed idiopathic multicentric castleman's disease (imcd)

Conditions: Idiopathic Multicentric Castleman's Disease

Summary: to explore the effectiveness and safety of bortezomib, cyclophosphamide and dexamethasone (bcd regimen) in newly diagnosed idiopathic multicentric castleman's disease (imcd) patients.

this will be a single center, open-labeled, single arm, phase-ii pilot study. the treatment and the response evaluation phase will last from the time of enrollment up to 21 months (evaluation will be carried out every 3 months in the first 9 months and every 6 months from month 9 to month 21). the maintenance and follow-up phase to assess for progression of disease will last from 21 months to 45 months after enrollment (evaluation will be carried out every 12 months). the total study duration will be 4 years after the last patient starts study medication.

Eligibility criteria:
inclusion criteria: 1. demography: ≥18 years, all race/ethnic groups in china; 2. newly diagnosed and previously untreated (patients are allowed to have received oral prednisone for up to 1 week before enrollment) symptomatic imcd patients (symptomatic disease is defined by the presence of clinical symptoms with the nci-ctcae grading ≥1 that are attributable to the disease, and for which treatment is indicated; imcd diagnosis is based on the international consensus diagnostic criteria); 3. clinical laboratory values meeting these criteria at screening: absolute neutrophil count ≥ 1·0 x 109/l, platelets ≥ 50 x 109/l, alanine aminotransferase (alt) within 2·5 x upper limit of normal (uln); total bilirubin within 2·5 x uln; estimated glomerular filtration rate (according to mdrd formula) \<15ml/min; 4. women of childbearing potential must agree to use birth control measures during the study and for at least 3 months after receiving the last dose of study agent, and must have a negative pregnancy test at screening period. men must agree to use birth control measures during the study and for at least 3 months after receiving the last dose of study agent; 5. informed consent must be signed. exclusion criteria: 1. age under 18 years; 2. immunosuppressive or anti-neoplastic drugs within the last 3 months; 3. serious diseases including malignancy; 4. plan to have babies within 1 year after enrollment (for women and men), or pregnancy / breast-feeding (for women); 5. known hypersensitivity to study agents; 6. active infection requiring systemic treatment; 7. other severe concurrent disease (eg. uncontrolled diabetes, symptomatic coronary heart disease) that is likely to interfere with study procedures or results, or that in the opinion of the investigator would constitute a hazard for participating in this study; 8. unwilling or unable to provide informed consent; 9. unwilling to return for follow-up at pumch.

Keywords: idiopathic multicentric castleman's disease bcd regimen efficacy safety
a clinical feedback system in ostomy care

Conditions: Ostomy; Quality of Life; Adaptation, Psychological

Summary: background: living with an ostomy can be challenging and adapting to life with an ostomy can be particularly complex, with regard to both the physical and psychosocial aspects. follow-up with a stoma care nurse is usually performed after surgery to support the adaptation process. in this project, we describe a new model of ostomy care, where a clinical feedback system (cfs) is implemented in order to improve the adaption process of patients with an ostomy. we also present a plan for evaluating patients experience with the cfs and their clinical outcomes. methods: we include patients who had recently performed colostomy, ileostomy, or urostomy surgery. the intervention includes self-reported measures for adaptation to life with an ostomy and health-related quality of life (hrqol), as well as patient experiences and satisfaction recorded by the clinical feedback system. the measures are electronically assessed before each clinical consultation at 3, 6, and 12 months after surgery. the scores are instantly analysed and graphically presented for use during the consultation and the patient and stoma care nurse can discuss the findings. patient experiences and satisfaction with care will be measured with the generic short patient experiences questionnaire. adaptation to the life with ostomy will be measured with the ostomy adjustment scale, and hrqol with the short form 36. discussion: this study presents a novel approach that could lead to improved consultation, more patient involvement, and better adaptation to life with an ostomy.

the study protocol is avaliable on request, and will also be published in a open acsess peer-reviewed journal.

Eligibility criteria:
inclusion criteria: * \>18 years of age * living with a colostomy, ileostomy, or urostomy for a minimum of 3 months * being able to read and write norwegian exclusion criteria: * \< the 3 weeks follow-up after surgery are not included * patients who have their ostomy removed \<12 months after surgery
efficacy of prf application on clinical parameters and gcf platelet-derived growth factor-bb and periostin levels

Conditions: Periodontitis

Summary: determine the efficacy of the non-invasive application of prf on periodontal clinical parameters(pocket reduction) and the levels of pdgf-bb and periostin in the gingival crevicular fluid.

the adjunctive use of prf with conventional scrp may improve clinical healing, decrease tissue morbidities such as pain and discomfort, increase patient acceptance, reduce treatment time. since prf can be utilized as a safe, natural method to repair tissues at a low cost. our aim is to evaluate the effectiveness of the non-invasive application of prf as an adjunct to scrp in patients with stage iii grade b periodontitis through measurements of gingival crevicular fluid levels of pdgf-bb and periostin before and after treatment and compare it with scrp alone. a split-mouth procedure will be performed to reduce confounders as possible.

Eligibility criteria:
inclusion criteria: * systemically healthy patients. * patients with periodontitis. exclusion criteria: 1. medical history of systemic disease: diabetes, pregnancy, or lactation. 2. previous periodontal treatment for the last 6 months 3. grade ii mobility 4. smoker or alcoholic patient. 5. teeth with untreated caries, endodontic lesions 6. symptoms of recent acute illness e.g., covid-19 will be excluded as well

Keywords: prf pdgf-bb periostin
comparison of spinal stabilization exercises vs maitland mobilization along with laser therapy

Conditions: Low Back Ache

Summary: comparison of spinal stabilization exercises vs maitland mobilization along with laser therapy in non-specific low back ache

comparison of spinal stabilization exercises vs maitland mobilization along with laser therapy for finding the better method for the treatment of non-specific low back ache

Eligibility criteria:
inclusion criteria: * both male and female within the age range of 18-60 years. * visual analogue scale that scores 3 and higher. * non radiating low back pain exclusion criteria: * patients with a history of spinal diseases and injury * spinal stenosis * degenerative changes * neuropathy * intervertebral disc collapse. * spinal discectomy * spinal laminectomy
a study of ly2189265 in japanese participants with type 2 diabetes mellitus

Conditions: Type 2 Diabetes Mellitus

Summary: the purpose of this trial is to examine the efficacy and safety of once-weekly ly2189265 in participants with type 2 diabetes mellitus who are not taking oral antidiabetic medication.

rescue therapy (defined as alternative antihyperglycemic medication use or dose modification of oral antihyperglycemic medication \[oam\]) may have been initiated during the planned treatment period if the participant discontinued study drug or met prespecified thresholds for severe, persistent hyperglycemia. efficacy data, as well as data for hypoglycemic episodes from participants who permanently discontinued study treatment but switched to another diabetes medication and remained in the study, were censored from the point of initiating new treatment onwards.

Eligibility criteria:
inclusion criteria: * participants who have had a diagnosis of type 2 diabetes mellitus before screening. * participants who have been oral antihyperglycemic medication (oam)-naïve (diet and exercise only) or been taking oam monotherapy except for thiazolidinedione (tzd) and are willing to discontinue this medication. participants taking oam monotherapy must complete 8-week washout period prior to randomization. * participants who are oam naïve with a screening glycosylated hemoglobin (hba1c) value of 7.0% to 10.0% and randomization hba1c value of 7.0% to 10.0%, or who are taking oam monotherapy with screening hba1c value of 6.5% to 9.0% and randomization hba1c value of 7.0% to 10.0%. * participants who have a body mass index (bmi) of 18.5 kilograms per meter squared (kg/m\^2) to 35.0 kg/m\^2. exclusion criteria: * participants who have a diagnosis of type 1 diabetes. * participants who have previously been treated with any other glucagon-like peptide-1 (glp-1) analog. * participants who have been receiving more than half of the maximum dose of sulfonylureas at screening. * participants who have been currently taking insulin or tzd, or have had previous insulin or tzd treatment within 3 months before screening. * participants who have obvious clinical signs or symptoms of pancreatitis, a history of chronic pancreatitis or acute pancreatitis at screening, as determined by the investigator. participants who have a serum amylase concentration ≥3 times the upper limit of the reference range and/or a serum lipase concentration ≥2 times the upper limit of the reference range, as determined by the central laboratory at screening. * participants who have self or family history of medullary c-cell hyperplasia, focal hyperplasia, or medullary thyroid carcinoma (mtc).

Keywords: glp-1
clinical utility of methylation-based prognostic assay for barrett's esophagus

Conditions: Barrett Esophagus; Esophageal Cancer

Summary: capsulomics has developed a prognostic assay for patients with diagnosed barrett's esophagus (be). this study will measure how gastroenterologists make surveillance and treatment management decisions when presented with different clinical and prognostic assay information.

capsulomics has developed a prognostic assay for patients with diagnosed barrett's esophagus (be). this study will measure how gastroenterologists make surveillance and treatment management decisions for virtual patient cases when presented with different clinical and prognostic assay information. the data from this study will be published in a peer-review scientific journal.

Eligibility criteria:
inclusion criteria: 1. be currently practicing board-certified gastroenterologist practicing in the united states 2. have practiced (as a board-certified gastroenterologist) for greater than 2 3. be english-speaking 4. have ≥ 50 barrett's esophagus patients under care annually 5. have internet access 6. have no prior experience with the methylation assay test 7. provide voluntary informed consent to participate in the study. exclusion criteria: 1. non-practicing gastroenterologists 2. less than two years of gastroenterology practice 3. non-english speaking 4. does not have access to the internet 5. does not consent to participate in study