Kornimate/medical-research-clean huggingface dataset:
efficacy and safety of mitiglinide vs acarbose in patients with type 2 diabetes mellitus

Conditions: Type 2 Diabetes Mellitus

Summary: mitiglinide, a benzylsuccinic acid derivative, exerts selective action on the atp-dependent k (katp) channel of pancreatic β-cells and reportedly possesses a stronger affinity to the channel compared with other insulinotropic sulphonylurea receptor ligands, namely repaglinide and nateglinide. preprandial administration of mitiglinide efficiently reduces postprandial hyperglycemia and improves overall glycemic control. this was a 12-week, open, randomized study for comparing mitiglinide versus acarbose. the purpose of this study is to evaluate the efficacy and safety of mitiglinide vs acarbose in patients with type 2 diabetes mellitus.

group i (mitiglinide): mitiglinide 10 mg three times a day, orally, for 12 weeks group ii (acarbose): acarbose 50 mg three times a day, orally, for 12 weeks total subjects: 248, randomized to 2 groups at ratio of 1:1.

Eligibility criteria:
inclusion criteria: 1. subjects aged between 18 and 70, regardless of gender 2. subjects with type-2 diabetes mellitus diagnosed according to 1999 who criteria within 5 years 3. subjects who had not received insulin secretagogues, insulin sensitizers, incretin mimetics or alpha-glucosidase inhibitors 4. subjects whose fasting blood glucose \[fbg\] between7.0 and10.0 mmol/l and hba1c ratio is between 7.0% and 10.0% note: incretin mimetics contain glucagon-like peptide 1 (glp-1) receptor agonist (including glp-1 analogues) and dipeptidyl peptidase 4 inhibitors. exclusion criteria: 1. subjects with abnormal hepatic function whose aspartate transaminase (ast) and alanine transaminase (alt) are 2 times higher than the upper limits of normal (uln) 2. subjects with renal disfunction whose plasma creatinine concentration are more than 1.1 uln or positive urine protein 3. subjects with severe heart disease, liver diseases, kidney disease and other serious organic disease 4. subjects who have chronic intestinal diseases associated with marked disorders of digestion or absorption and may deteriorate as a result of increased gas formation in the intestine (like gastrocardiac syndrome, severe hernia, intestinal obstruction, intestinal ulcer and intestinal surgery) 5. subjects with endocrine system diseases such as hyperthyroidism and cushing's syndrome etc. 6. subject is contraindicated or hypersensitivity to both experimental drugs or comparator drugs 7. subjects who participated in other clinical studies as subjects within 3 months before this study 8. female subjects who have been pregnant , lactating or without contraception in childbearing potential 9. subjects judged unfit for this study by investigators

Keywords: mitiglinide acarbose type 2 diabetes mellitus
a pharmacokinetic study of tedizolid phosphate in pediatric participants with gram-positive infections (mk-1986-014)

Conditions: Gram-Positive Infections

Summary: the primary objectives of this study are to describe the single-dose, and multiple dose pharmacokinetics (pk) of intravenous (iv) tedizolid phosphate, or a single dose oral suspension of tedizolid phosphate, when administered to pediatric participants, full-term neonates, and preterm neonates.

per protocol, pk analysis in part a group 1 will be conducted across ages in cohorts 1 and 2 combined: part a group 1 cohort 1 + cohort 2: 28 days to \<24 months.

Eligibility criteria:
inclusion criteria: * is receiving prophylaxis for or has a confirmed or suspected infection with gram-positive bacteria and receiving concurrent antibiotic treatment with gram -positive antibacterial activity. * is at least 1 kg in weight. * is in stable condition as determined from medical history, physical examination, electrocardiogram (ecg), vital signs, and clinical laboratory evaluations. * has no clinically significant ecg abnormalities. * has sufficient vascular access to receive trial drug, and allow for required blood draws. * is able to receive medication by mouth, for those dosed with oral suspension; dose administration via feeding tube is acceptable. exclusion criteria: * has a history of seizures, other than febrile seizures, clinically significant cardiac arrhythmia or condition, moderate or severe renal impairment, or any physical condition that could interfere with the interpretation of the study results, as determined by the investigator. * has used rifampin within 14 days prior to dosing. * has used or will be using proton pump inhibitors, h2 blockers, or antacids (for participants in part b, i.e, oral suspension dose) at any time from 24 hours prior to dosing through 24 hours after dosing.. * has a recent (3-month) history or current infection with viral hepatitis or other significant hepatic disease. * has a history of drug allergy or hypersensitivity to oxazolidinones. * has had significant blood loss. * need for oral administration of topotecan, rosuvastatin, irinotecan, or methotrexate during administration of oral study drug. * used monoamine oxidase inhibitors (maois) or serotonergic agents including tricyclic antidepressants, selective serotonin reuptake inhibitors (ssris), and serotonin 5-hydroxytryptamine receptor agonists (triptans), meperidine, or buspirone within 14 days prior to study, or planned use while on study. * has received another investigational product within the 30 days prior to enrollment.
anatomical shoulder domelock system study

Conditions: Avascular Necrosis; Revision Surgery; Conditions Consequent to Earlier Operations; Arthritis, Rheumatoid; Arthritis, Degenerative; Arthritis;Traumatic

Summary: the objectives of this study are to confirm safety and performance of the anatomical shoulder domelock system when used in hemi or total shoulder arthroplasty by analysis of standard scoring systems, radiographs and adverse event records.

this study is a multicenter, prospective and retrospective, non-controlled pmcf study involving orthopaedic surgeons skilled in hemi and total shoulder arthroplasty procedures. a minimum of six study centers will be involved and a total number of 73 implants will be included into the study.

Eligibility criteria:
inclusion criteria: * patient is 18-80 years of age, inclusive * patient is skeletally mature * patient is suffering from severe shoulder pain and disability requiring unilateral or bilateral hsa or tsa based on physical exam and medical history * patient has failed conservative treatment * patient meets at least one of the following indications: * advanced wear and tear of the shoulder joint resulting from degenerative, posttraumatic or rheumatoid arthritis if bone stock is adequate. * avascular necrosis * conditions consequent to earlier operations * optional use in revision: in some medical conditions (e.g., early revision when adequate bone stock exists), the surgeon may opt to use primary implants in a revision procedure. additional criteria for retrospective patients: * patient has been implanted with the domelock system before site initiation visit. * information available must include at minimum demographic information, the operative report and details of the device implanted. exclusion criteria: * patient is unwilling or unable to give consent or to comply with the follow-up program * patients who have any condition which would in the judgement of the investigator place the patient at undue risk or interfere with the study. any patient who is institutionalized, or is a known drug abuser, a known alcoholic or anyone who cannot understand what is required of them * patient is known to be pregnant or breastfeeding * patient meets at least one of the contraindications: * patient's physical conditions that would impair adequate implant support and/or prevent the use of an appropriately sized implant, e.g., previous surgery, insufficient quality or quantity of bone, neuromuscular compromise or vascular deficiency in the affected limb in sufficient degree to endanger the success of the intervention e.g., absence of musculoligamentous supporting structures, joint neuropathy or other conditions that may lead to inadequate skeletal fixation * signs of infection * severe instability secondary to advanced loss of osteochondral structure * charcot's shoulder (neuroarthropathy)

Keywords: total shoulder arthroplasty hemi shoulder arthroplasty
the effect of a wearable hip assist robot on cardiopulmonary metabolic efficiency during stair ascent in elderly adults

Conditions: Gait, Unsteady; Health Behavior

Summary: the aim of this study was to identify the assistance effect of the new wearable hip assist robot, gait enhancing mechatronic system (gems) developed by samsung advanced institute of technology (samsung electronics co, ltd., korea) during stair ascent by comparing the energy expenditure of elderly adults with and without the gems.

primary objective of this study is to demonstrate the effect of a wearable hip assist robot on cardiopulmonary metabolic efficiency during stair ascent in elderly adults. fifteen elderly adults participated in this study. the stair ascent trials were designed to climb stairs from the first basement level to the fourth floor of the proton therapy center, samsung medical center, korea. the metabolic energy expenditure was measured using a portable cardiopulmonary metabolic system (cosmed k4b², rome, italy) while participants performed randomly assigned two different conditions consecutively:, free ascent without the gems (nogems) or robot-assisted ascent with the gems (gems). participants rested for 10 minutes between the two trial conditions.

Eligibility criteria:
inclusion criteria: * elderly adults who absence of a history of musculoskeletal or central nervous system diseases * high levels of physical performance (sppb \> 8) exclusion criteria: * elderly adults who absence of the ability to walk independently due to visual field defects, fractures, or severe muscle weakness * severe dizziness that might lead to falls * cognitive disorders that might be difficult to understand accurately in this study

Keywords: wearable hip assist robot elderly adult metabolic energy expenditure stair ascent
evaluation of product effectiveness of the intervention for patients with knee osteoarthritis

Conditions: Osteoarthritis, Knee; Product Use Issue; Sports Physical Therapy

Summary: osteoarthritis of the knee is a common, chronic joint pathology that causes participants to suffer from pain, dysfunction, and reduced quality of life. the goal is to improve the quality of life and rehabilitation of patients by making rehabilitation exercises electronic and the system can be personalized to their specific conditions. the focus of this study was on exercise interventions, and an interactive software was designed that combines repetitive motion and real-time feedback mechanisms. the software provides a series of rehabilitation movements that are specific to the characteristics of osteoarthritis of the knee in older adults, aiming to help participants gradually improve joint range of motion and muscle strength through exercise. the real-time feedback mechanism, on the other hand, monitors the participants' exercise status in real time through wearable devices, providing intuitive feedback to the participants to ensure that they perform the rehabilitation movements correctly, thus ensuring the scientificity and safety of the exercise. in this study, investigators designed an exercise assessment and exercise intervention system for patients with knee osteoarthritis. in the exercise assessment part, the study combines several tools. first, the womac scale was used to systematically assess patients' joint pain, stiffness, and dyskinesia. second, physical function tests are used to assess the patient's overall exercise capacity, including indicators such as the number of sit-ups and rises. in addition, a wearable device was designed in this paper for real-time collection of knee angle information.


Eligibility criteria:
inclusion criteria: 1. those who meet the diagnostic criteria for osteoarthritis and are diagnosed with osteoarthritis of the knee; 2. age greater than grade 18 years old; 3. good communication and comprehension skills, able to understand the questionnaire clearly; 4. informed consent and willingness to participate in the study. exclusion criteria: 1. patients with knee pain caused by other diseases; 2. patients with severe knee pain and discomfort; 3. patients with severe organic lesions of vital organs such as heart, brain and kidney; 4. patients who have been treated with knee replacement.

Keywords: older adults osteoarthritis sports rehabilitation product design
prevalence of constructed space maintainers in a group of egyptian children

Conditions: Tooth Loss

Summary: the purpose of the study is * to determine the prevalence of constructed space maintainers at pediatric dentistry and dental public health department, faculty of oral and dental medicine, cairo university. * to assess the knowledge, attitude and awareness of constructed space maintainers for pediatric patients' guardians at pediatric dentistry and dental public health department, faculty of oral and dental medicine, cairo university. and - to assess the knowledge, attitude and practice of pediatric dentists towards use of space maintainers in children, at pediatric dentistry and dental public health department, faculty of oral and dental medicine, cairo university.

the purpose of the study is * to determine the prevalence of constructed space maintainers at pediatric dentistry and dental public health department, faculty of oral and dental medicine, cairo university. * to assess the knowledge, attitude and awareness of constructed space maintainers for pediatric patients' guardians at pediatric dentistry and dental public health department, faculty of oral and dental medicine, cairo university. and - to assess the knowledge, attitude and practice of pediatric dentists towards use of space maintainers in children, at pediatric dentistry and dental public health department, faculty of oral and dental medicine, cairo university. po1: population: egyptian children with constructed space maintainers and their guardians attending pediatric dentistry and dental public health department, faculty of oral and dental medicine, cairo university. outcome1: prevalence of constructed space maintainers knowledge, attitude and awareness of constructed space maintainers for pediatric patients' guardians. po2 population2: pediatric dentists at pediatric dentistry and dental public health department, faculty of oral and dental medicine, cairo university. outcome2: knowledge, attitude and practice of pediatric dentists towards the use of the space maintainers.

Eligibility criteria:
i have two population 1st population is pediatric patients inclusion criteria for pediatric patients: 1. all patients with constructed space maintainers 2. positive patient's acceptance for participation in the study. 3. both genders are included. 4. children medically free from any systemic disease. exclusion criteria for pediatric patients: 1. patients with orthodontic appliances. 2. patient having one of the different following habit thumb sucking, lip biting, tongue thrusting etc. 2nd population is pediatric dentists: inclusion criteria for pediatric dentists: -all pediatric dentists having master degree and above. exclusion criteria for pediatric dentists: -pediatric dentists refused to participate in the study.
a study of incb050465 in primary sjögren's syndrome

Conditions: Primary Sjögren's Syndrome

Summary: the purpose of this study is to assess the impact of parsaclisib on the signs and symptoms of sjögren's syndrome (ss).


Eligibility criteria:
inclusion criteria: * primary ss diagnosed according to the revised american-european consensus group (aecg) criteria. * minimum score of 2 on the sgus score for parotid and submandibular glands. * eular sjögren's syndrome disease activity index (essdai) score ≥ 5. * positive serum titers of anti-ss-a and/or anti-ss-b antibodies. * symptomatic oral dryness score of at least 5 on patient questionnaire. * willingness to avoid pregnancy or fathering children based on protocol-defined criteria. exclusion criteria: * diagnosis of secondary ss according to the revised aecg criteria (eg, the presence of a previously diagnosed or a present diagnosis of rheumatoid arthritis, systemic lupus erythematosus, systemic sclerosis, mixed connective tissue disease, polymyositis, dermatomyositis, immunoglobulin g4-related disorder, sarcoidosis, or any other defined autoimmune rheumatologic disorder). * concurrent conditions and history of other diseases per protocol-defined criteria. * positive test results for tuberculosis (tb) from the quantiferon-tb gold test or t-spot.tb test. * positive serology test results for hiv antibody, hepatitis b surface antigen, hepatitis b surface antigen antibody, hbv core antibody, or hcv (hcv antibody with positive hcv-rna). * severely impaired liver function (child-pugh class c). * prior or ongoing therapy with protocol-defined drugs. * receipt of any live vaccine in the 30 days before screening. * no major surgery within 30 days before screening. inadequate recovery from toxicity and/or complications from a major surgery before starting therapy. * current alcohol or drug use that, in the opinion of the investigator, will interfere with the participant's ability to comply with the dose regimen and study evaluations. * laboratory values at screening outside the protocol-defined ranges.

Keywords: primary sjögren's syndrome pi3kδ inhibitor
placebo-controlled study of ono-2333ms in patients with recurrent major depressive disorder

Conditions: Major Depressive Disorder

Summary: the purpose of this study is to evaluate the safety and efficacy of ono-2333ms in patients with recurrent major depressive disorder


Eligibility criteria:
inclusion criteria: * diagnosed with recurrent major depressive disorder exclusion criteria: * patients with treatment resistance for depression * history of alcohol abuse/dependence, substance abuse/dependence within 6 months * has clinically significant unstable medical condition * has significant risk of suicide

Keywords: ono-2333ms major depressive disorder
a trial to find safe and active doses for an investigational drug, cx-904, for patients with advanced solid tumors

Conditions: Solid Tumors

Summary: the purpose of this first-in-human study, ctmx-904-101, is to characterize the safety, tolerability, pharmacokinetics (pk), pharmacodynamics (pd) and antitumor activity of cx-904 in adult subjects with metastatic or locally advanced unresectable solid tumors.

this is a first-in-human study evaluating the safety, tolerability, and activity of cx-904, a conditionally activated t-cell bispecific to egfr and cd3. the design includes single patient cohorts and a 3+3 design. escalating dose increments will be determined in discussion with a safety review committee.

Eligibility criteria:
inclusion criteria: * histologically confirmed metastatic or locally advanced unresectable solid tumor. must have received prior standard therapy. * measurable disease per recist 1.1 * eastern cooperative oncology group performance status of 0 or 1 * adequate baseline laboratory values * patients of childbearing potential or those with partners of childbearing potential must agree to use a highly effective method of birth control from signing the icf, and for a period of 30 days after the last dose of cx-904. * additional inclusion criteria may apply exclusion criteria: * history of malignancy that was active within the previous 2 years. exceptions include localized cancers that are not related to the current cancer being treated, that are considered to have been cured, and in the opinion of the investigator, present a low risk of recurrence * screening electrocardiogram demonstrating a mean qtcf value \> 480 msec; a screening echocardiogram with left ventricular ejection fraction (lvef) \< 50% * serious concurrent illness * history of or current active autoimmune diseases * history of myocarditis regardless of the cause * pregnant or breast feeding * additional exclusion criteria may apply
a study to assess the pharmacokinetics of ceftaroline in end stage renal disease patients and matched healthy subjects

Conditions: Renal Disease

Summary: the purpose of this study is to assess the safety, tolerability and pharmacokinetics of ceftaroline in a group of patients with renal disease and matching healthy subjects with normal renal function

an open-label, nonrandomised, phase i study to assess the pharmacokinetics of ceftaroline after intravenous administration of asingle dose of ceftaroline fosamil (200 mg) to patients with end-stage renal disease undergoing haemodialysis when compared to a single dose of ceftaroline fosamil (600 mg)

Eligibility criteria:
inclusion criteria: * provision of signed and dated, written informed consent prior to any study specific procedures * male and female subjects aged 18 to 75 years (inclusive) with suitable veins for cannulation or repeated venipuncture * women of childbearing potential must have a negative pregnancy test, be non-lactating, and be using a highly effective form of birth control for 3 months prior to enrollment, during the study, and for 3 months after completion of all study-related proceed * have a body mass index (bmi) between 18 and 35 kg/m2 and weigh at between 50 and 110 kg * haematocrit level higher than 30% at screening and baseline for each treatment period exclusion criteria: * history or presence of gastrointestinal, hepatic, or any other condition known to interfere with the absorption, distribution, metabolism, or excretion of drugs * any clinically significant abnormalities in clinical chemistry, haematology, or urinalysis results, as judged by the investigator * any clinically important abnormalities in rhythm, conduction, or morphology of resting ecg that may interfere with the interpretation of qtc interval changes * history of any clinically significant disease or disorder which, in the opinion of the investigator, may either put the subject at risk because of participation in the study, or influence the results or the subject's ability to participate in the study * receiving any dialysis treatment other than intermittent haemodialysis

Keywords: patient safety tolerability pharmacokinetics