Kornimate/medical-research-clean huggingface dataset:
a study to investigate the safety, tolerability and pharmacodynamics of azd4144 in participants with obesity

Conditions: Healthy Participants

Summary: the aim of this study is to evaluate the safety and tolerability, and pharmacodynamics (pd) of azd4144 administered as repeated daily oral dosing.

this is placebo-controlled, parallel group and single centre study in healthy male and female participants with obesity and no known atherosclerotic cardiovascular disease (ascvd), chronic kidney disease (ckd), or type 2 diabetes mellitus. participants will be randomized in the ratio of 1:1 to receive either azd4144 or placebo. this study will comprise of: * a screening period of 28 days. * the treatment duration will be up to 28 days. * the visit frequency will be weekly up to a follow-up visit, followed by a final follow-up visit 28 days after the final dose of azd4144.

Eligibility criteria:
key inclusion criteria: * serum hscrp \> 2 milligrams per liter (mg/l). * all females must have a negative pregnancy test at the screening visit and at the randomization visit (visit 2). * females of childbearing potential must not be lactating and if heterosexually active must agree to use an approved method of highly effective contraception to avoid pregnancy from the time of first administration of study intervention until 3 months after the final follow-up visit. * have a body mass index (bmi) greater than or equal to (≥) 30 and less than or equal to (≤) 45 kilograms per meter\^2 (kg/m\^2). * have a waist to hip ratio of ≥0.9 for male and ≥0.85 for female participants. key exclusion criteria: * history of any clinically important disease or disorder which, in the opinion of the investigator, may either put the participant at risk because of participation in the study, or influence the results or the participant's ability to participate in the study. * history of myocardial infarction (mi), coronary revascularisation, stroke, revascularisation for peripheral arterial disease, or other pre-existing cardiovascular (cv) diseases. * history of diabetes (type 1 and type 2) or glycated haemoglobin (hba1c) ≥6.5%. * history or presence of gastrointestinal, hepatic, or renal disease or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs. * any clinically important illness, medical/surgical procedure, or trauma within 4 weeks of the first administration of study intervention. * any skin disorder, history of, or ongoing clinically significant allergy/hypersensitivity. * clinically significant serious active and chronic infections within 60 days prior to randomization. * known history of primary immunodeficiency (congenital or acquired) or an underlying condition that predisposes to infection.

Keywords: cardiorenal disease atherosclerotic cardiovascular disease chronic kidney disease type 2 diabetes mellitus atherosclerosis obesity
chondroitin sulphate efficay/safety in patients with knee osteoarthritis and psoriasis

Conditions: Osteoarthritis; Psoriasis; Joint Diseases; Muskuloskeletal Diseases; Skin Diseases

Summary: the purpouse of this study is to determine the efficacy and safety of chondroitin sulphate conventional treatment in patients with both knee osteoarthritis and plaque psoriasis.


Eligibility criteria:
inclusion criteria: * primary knee oa according to acr criteria; * oa of radiological stages 1 to 3 according to kellgren-lawrence; * vas of pain ≥30; * pasi ≥ 5. exclusion criteria: * known allergy to chondroitin sulphate; * other bone and articular diseases such as chondrocalcinosis, paget's disease, rheumatoid arthritis, psoriatic arthritis, acromegaly, hemochromatosis, wilson's disease; * patients with skin conditions that could interfere in the clinical trial evaluation

Keywords: chondroitin sulphate knee osteoarthritis psoriasis
study to evaluate the efficacy and safety of dwp16001 in patients with type 2 diabetes mellitus

Conditions: T2DM (Type 2 Diabetes Mellitus)

Summary: the purpose of this study is to determine the efficacy and safety of dwp16001 compared to placebo in the treatment of type 2 diabetes mellitus.


Eligibility criteria:
inclusion criteria: * patients aged 20 to 80 years * patients who was diagnosed with type 2 diabetes mellitus at least 8 weeks before * body mass index (bmi) between 20 and 45 kg/㎡ * patients with 7% ≤ hba1c ≤ 10% at screening * subject who has conducted a stable diet and exercise for at least 8 weeks exclusion criteria: * type 1 diabetes mellitus or secondary diabetes * severe diabetes complications (proliferative diabetic retinopathy, stage 4 or higher nephropathy or severe diabetic neuropathy, diabetic ketoacidosis) * clinical significantly renal disorders * creatinine clearance \< 60ml/min (0.84ml/s/㎡) or glomerular filtration rate(egfr) \< 60ml/min/1.73 * severe gastrointestinal disorder * uncontrolled hypertension (sbp \>180 mmhg or dbp \> 110 mmhg) * history of acute coronary syndrome, unstable angina, myocardial infarction requiring hospitalization, stroke, transient ischemic attack, severe heart failure (nyha class iii/iv), or heart arrhythmia
high-sensitivity troponin in the evaluation of patients with acute coronary syndrome

Conditions: Acute Coronary Syndrome; Myocardial Infarction

Summary: in patients with chest pain the diagnosis of a heart attack (myocardial infarction) is made where there is evidence of heart muscle damage using a blood test to measure the heart muscle protein troponin. a new a more sensitive troponin test may help us to identify patients with myocardial infarction more easily. the investigators propose to evaluate whether use of a novel high-sensitivity troponin test to lower the threshold for diagnosis of myocardial infarction is appropriate. if increased sensitivity does not reduce specificity for the diagnosis, then this new test will improve patient outcome through better targeting of therapies for coronary heart disease. however, if increased sensitivity leads to poor specificity, then patients may be misdiagnosed and given inappropriate cardiac medications with potentially detrimental outcomes. in ten secondary and tertiary care hospitals across scotland, the investigators will undertake a stepped wedge cluster randomized controlled trial of the implementation of a novel high-sensitivity troponin test. the primary end-point will be the one-year rate of cardiovascular death or recurrent myocardial infarction. this will establish whether the introduction of this high-sensitivity troponin test into routine clinical practice is beneficial to patient management and outcomes. a subset of patients will be asked to give consent for inclusion into a sub-study that will permit storage of blood samples and will require the completion of a survey during the index admission and after 6 and 12 months of follow up.


Eligibility criteria:
inclusion criteria: * suspected acute coronary syndrome * troponin i measurement as part of routine clinical care exclusion criteria: - none

Keywords: high-sensitivity troponin assay myocardial infarction unstable angina myocardial injury cluster randomized trial
effect of rosuvastatin in abdominal sepsis

Conditions: Sepsis

Summary: the purpose of this study is to determine whether rosuvastatin is effective as a coadjuvant drug in the integral management of abdominal sepsis acknowledged by surgery.

the sepsis is often lethal, the mortality's ranks are identified among 25 to 70%, this depends on definition, severity and co-morbidities. the number of deaths by sepsis could be similar to myocardial infarct. patients who get shock have 26-fold risk of death. in preliminary studies have been observed, that patients with treatment with statin have minor incidence of severe sepsis. a retrospective study suggests the association between using statins and reduction of bacteriemia by gram negatives and s. aureus. there are many experimental studies which demonstrate the possible profit in sepsis. however there are no clinical prospective studies for determinate if statins are effective in management of sepsis. the investigators designed this study to demonstrate the utility of rosuvastatin in one kind of sepsis, abdominal sepsis.

Eligibility criteria:
inclusion criteria: 1. man or women \> 18 and \< 80 years old with abdominal sepsis, confirmed diagnosis by surgery of broad peritonitis before 48 hours in progression 2. injury by steel or firearm with contaminated abdominal cavity 3. apache ii major or equal than 8 4. acceptance to be included exclusion criteria: 1. ingestion of: fibrates, niacin, cyclosporin, azoles, macrolides, inhibitors of protease, nefazodone, verapamil, diltiazem, amiodarone 2. hypovolemic shock iii and iv after get surgery 3. cardio-respiratory failure pre or trans surgery 4. allergy to used drug 5. use previous of statin 6. hepatopathy or myopathy and(or) history, hepatic failure (child b y c) 7. management in other hospital 8. pregnancy 9. thoracic injury, head injury (moderate and severe), multiple fractures or with bone exposition, rectal injury

Keywords: abdominal sepsis sepsis rosuvastatin
deep parasternal intercostal plane (dpip) block

Conditions: Postoperative Pain

Summary: in this study, we aimed to compare the effects of this block, which is routinely applied in our hospital but has not been studied in our hospital or in the literature before, on the pain in the first 24 hours after the operation, between the single-level and the two-level block.


Eligibility criteria:
inclusion criteria: * adult patients aged 18 years and older * american society of anesthesiologists physical status of ii-iii * undergoing elective coronary artery bypass grafting (cabg), valve repair/replacement, or combined cabg/valve procedure via median sternotomy exclusion criteria: * patients who are unable to communicate * patients who have had emergency surgery, reoperation, thoracotomy or mastectomy * patients with a history of chronic pain * patients who are using chronic opioids or sedatives * patients who have had a re-sternotomy within 24 hours of surgery * patients with liver or kidney failure * patients who are using narcotics
egg effects on the immunomodulatory properties of hdl

Conditions: Lipid Metabolism; Inflammation

Summary: the purpose of this study is to investigate the effects of egg intake on markers of hdl function and immune inflammation in healthy adults.

28 healthy men and women (age 18-35 years old) will be recruited to participate in a 16-week randomized crossover study. upon enrollment, all subjects will enter a 4-week run-in egg-free period where they will refrain from consuming any egg-based foods (period 1). subjects will then enter the first intervention period, where they be randomly assigned to consume either 3 whole eggs/day or the equivalent amount of egg white-based egg substitute/day for 4 weeks (period 2). afterwards, subjects will enter a 4-week washout period where egg-based foods are restricted (period 3), followed by a second intervention period, where they be assigned to the alternative whole egg- or egg white-based treatment for 4 weeks (period 4). subjects will come to the department of biology at fairfield university every two weeks to check-in, and to pick up their egg products during the intervention periods. subjects will be asked to maintain their normal diet and physical activity practices throughout all periods of the study. subjects will complete 5-day dietary records and physical activity logs at the end of each study period.

Eligibility criteria:
inclusion criteria: * 18-35 years old * body mass index (bmi) \< 30 kg/m2, or \< 30% body fat for men and \< 40% body fat for women * willingness to consume eggs or egg whites on a daily basis during study periods exclusion criteria: * \ 35 years old * bmi ≥ 30 kg/m2, or ≥ 30% body fat for men and ≥ 40% body fat for women * self-reported history of diabetes mellitus, coronary heart disease, stroke, renal problems, liver disease, cancer, pregnancy or lactation, autoimmunity, chronic infections, or egg allergy * taking lipid-lowering medications (e.g. statins, fibrates) * a preexisting medical condition or implanted medical device that prevents participation in bioelectrical impedance measurements of body composition * clinical lipid and glucose values that are highly elevated, including fasting triglycerides levels higher than 500 mg/dl, fasting glucose higher than 126 mg/dl, and plasma total cholesterol greater than 240 mg/dl

Keywords: egg hdl inflammation
medacta gmk sphere® vs. medacta gmk ps post-market outcomes study

Conditions: Osteoarthritis; Osteoarthritis, Knee; Joint Disease

Summary: the study is a prospective, randomized comparison of total knee arthroplasty with the medacta gmk sphere® knee compared to the medacta gmk ps knee, with comparison to data from previous trials of similar study design.


Eligibility criteria:
inclusion criteria: * patients willing to sign the informed consent. * patients able to comply with follow-up requirements including postoperative weight bearing restrictions and self-evaluations. * male and non-pregnant female patients ages 21 - 80 years of age at the time of surgery. * patients requiring a primary total knee replacement. * patients with a diagnosis of osteoarthritis (oa), traumatic arthritis (ta), or avascular necrosis (avn). * patients with intact collateral ligaments. exclusion criteria: * patients with inflammatory arthritis. * patients that are morbidly obese, body mass index (bmi) \> 40. * patients with a history of total or unicompartmental reconstruction of the affected joint. * patients with neuromuscular or neurosensory deficiency, which would limit the ability to assess the performance of the device. * patients with a systemic or metabolic disorder leading to progressive bone deterioration. * patients that are immunologically compromised, or receiving chronic steroids (\>30 days), excluding inhalers. * patients bone stock is compromised by disease or infection, which cannot provide adequate support and/or fixation to the prosthesis. * patients with knee fusion to the affected joint. * patients with an active or suspected latent infection in or about the knee joint. * patients whose surgery will utilize computer-assisted surgical navigation (caos) techniques. * patients whose surgery will utilize minimally invasive surgical techniques. * patients that are prisoners.
effects of oxygen status on hypoxia inducible factor 1-α and inflammation. a pilot proof of principle study.

Conditions: Hypoxia; Hyperoxia

Summary: it has been shown in in vitro and animal models that hypoxia can have pro-inflammatory effects and hyperoxia can have anti-inflammatory effects. the pro-inflammatory effect could be the result of activation of hypoxia inducible factor, a transcription factor that is known to activate many cell systems aimed at cell survival, including the inflammatory response. the anti-inflammatory effects of hyperoxia could be the annihilation of hypoxia inducible factor, but also a decrease in inflammation due to oxygen toxicity resulting in a decrease in clearance of pathogens. these effects have been sparsely studied in humans. therefore, we hypothesize that hypoxia results in an increase in hypoxia inducible factor in circulating leukocytes and increases inflammatory reactions, whereas hyperoxia decreases these reactions.


Eligibility criteria:
inclusion criteria: * age ≥18 and ≤35 yrs * male * healthy exclusion criteria: * use of any medication * smoking * history, signs or symptoms of cardiovascular disease * history of atrial or ventricular arrhythmia * (family) history of myocardial infarction or stroke under the age of 65 years * cardiac conduction abnormalities on the ecg consisting of a 2nd degree atrioventricular block or a complex bundle branch block * hypertension (defined as rr systolic \> 160 or rr diastolic \> 90 mmhg) * hypotension (defined as rr systolic \< 100 or rr diastolic \< 50 mmhg) * renal impairment (defined as plasma creatinine \>120 μmol/l) * liver enzyme abnormalities alkaline phosphatase\>230 u/l and/or alt\>90 u/l * medical history of any obvious disease associated with immune deficiency * crp \> 20 mg/l, wbc \> 12x109/l, or clinically significant acute illness, including infections, within 4 weeks before endotoxemia day * participation in a drug trial or donation of blood 3 months prior to the experiment * pre-existent lung disease or asthma * use of recreational drugs within 21 days prior to experiment day * visit to altitude \>1500m within 4 weeks prior to the experiment * air travel with flight time over 3 hours within 4 weeks prior to the experiment * history of acute mountain sickness * recent hospital admission or surgery with general anaesthesia (\<3 months) * claustrophobia * feelings of discomfort during a 10 minute test wearing the transparent respiratory helmet at the screening visit

Keywords: oxygen hypoxia hyperoxia inflammation innate immunity
effect of bile acids on glp-1 secretion

Conditions: Type 2 Diabetes; Obesity

Summary: the purpose of this study is to describe the physiological, pathophysiological and potentially therapeutic implications of bile-induced glucagon-like peptide-1 (glp-1) secretion in human glucose homeostasis.

the investigators hypothesize that even modest increments in endogenous glp-1 secretion will elicit important antidiabetic effects of glp-1. to evaluate whether bile acids have such effects, the investigators plan to perform intraduodenal infusion of two different bile acids and placebo.

Eligibility criteria:
patients with type 2 diabetes inclusion criteria: * danish caucasian ethnicity * normal haemoglobin * bmi \> 25 kg/m2 * hba1c \< 9% * informed consent exclusion criteria: * liver disease(alt and ast \> upper reference limit) * gastrointestinal disease * liver and biliary tract disease * nephropathy (serum creatinine \> 150 μm, and/or albuminuria) * treatment with insulin, glp-1 analogues and/ or dpp-4 inhibitors * treatment with medicine that can not be paused for 12 hours * previous abdominal surgery eg. cholecystectomy * bmi \ 35 kg/m2 healthy volunteers inclusion criteria: * danish caucasian ethnicity * normal haemoglobin * hba1c \< 6,0 (american diabetes association guidelines) * informed consent exclusion criteria: * liver disease(alt and ast \> upper reference limit) * gastrointestinal disease * liver and biliary tract disease * nephropathy (serum creatinine \> 150 μm, and/or albuminuria) * treatment with medicine that can not be paused for 12 hours * previous abdominal surgery eg. cholecystectomy * bmi \ 35 kg/m2 * first degree relatives diagnosed with diabetes * previously diagnosed with diabetes, or treated with antidiabetic agents

Keywords: type 2 diabetes glp-1 bile acid tgr-5
safety and immunogenicity of an investigational herpes zoster vaccine (z-1018) compared to shingrix® in healthy adults

Conditions: Shingles; Herpes Zoster; Vaccine-Preventable Diseases

Summary: this is a randomized, active-controlled, observer-blinded, dose-escalation multi-center trial of 2 doses of an investigational hz vaccine (z-1018) in approximately 440 healthy adults.


Eligibility criteria:
inclusion criteria: a subject must meet all of the following criteria to be eligible for enrollment (defined as receiving any study vaccine) in the study: 1. male or female, 50 to 69 years of age 2. be in good health in the opinion of the investigator, based upon medical history, physical examination, and laboratory evaluation 3. must be able to comprehend and follow all required study procedures and be available for all visits scheduled in the study 4. seronegative for human immunodeficiency virus (hiv) exclusion criteria: a subject with any 1 of the following criteria is not eligible for enrollment (defined as receiving any study vaccine) in the study: 1. history of hz 2. previous vaccination against varicella or hz 3. if female of childbearing potential, is pregnant, breastfeeding, or planning a pregnancy 4. known history of hiv (hiv 1/2 antibodies) 5. has a history of sensitivity to any component of study vaccines 6. has received any blood products or immunoglobulin within 90 days prior to study injection, or is likely to require infusion of blood products during the study period 7. has received the following prior to the first injection * 14 days: any non live vaccine * 28 days: * any live vaccine, including a covid-19 vaccine * systemic corticosteroids (more than 3 consecutive days) or other immunomodulators or immune suppressive medication, with the exception of inhaled steroids * granulocyte or granulocyte-macrophage colony-stimulating factor * any other investigational medicinal agent, including a covid-19 vaccine 8. chronic administration of immunosuppressants or other immune-modifying drugs within 6 months prior to the first vaccine dose 9. is undergoing chemotherapy or expected to receive chemotherapy during the study period; has a diagnosis of cancer within the last 5 years other than squamous cell or basal cell carcinoma of the skin 10. history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the subject's participation for the full duration of the study, or is not in the best interest of the subject to participate, in the opinion of the treating investigator 11. history of autoimmune disease
consecutive series outcomes review of patients undergoing a new single portal technique for endoscopic carpal tunnel release

Conditions: Carpal Tunnel

Summary: the purpose of this study is to report a new single portal endoscopic release technique and the sequence of the first 50 patients who underwent this release. this will be a chart review of the demographics, outcomes, and complications of a sequential series of patients undergoing a seg-way endoscopic carpal tunnel release (ectr).


Eligibility criteria:
inclusion criteria: * this will be a chart review of the first 50 patients who have had surgery using the single portal technique
observational registry of the treatment of glanzmann's thrombasthenia

Conditions: Congenital Bleeding Disorder; Glanzmann's Disease

Summary: this observational registry is conducted in europe, asia, africa and the united states of america (usa). the purpose of the registry is to evaluate the efficacy and safety of activated recombinant human factor vii (rfviia) during bleeding episodes and for the prevention of bleeding during invasive procedures/surgery in patients with glanzmann's thrombasthenia (gt) with past or present refractoriness to platelet transfusions. attention will be directed towards complications related to thrombo-embolic events and concomitant medications especially antifibrinolytics.


Eligibility criteria:
inclusion criteria: * patients with congenital gt defined as patients with lifelong bleeding tendency characterised by impaired or absent platelet aggregation, impaired clot retraction and prolonged bleeding time or prolonged platelet function analyser closure time. the patient has normal platelet counts and platelet morphology. optional diagnosis criteria are quantitative or qualitative evaluation of gp (glycoprotein) iib/iiia receptor including flow cytometry and identification of gene defects * signed informed consent by the patient or next of kin or legally acceptable representative to collect data on treatment of a given bleeding episode or surgical event as specified in the protocol. if informed consent is provided by the next of kin or legally acceptable representative, consent must also be obtained from the patient as soon as he/she is able to do so. informed consent must be obtained before entry of data into the registry exclusion criteria: * patients with acquired thrombasthenic states caused by autoimmune disorders (acute or chronic) or drugs

Keywords: glanzmann's thrombasthenia