Kornimate/medical-research-clean huggingface dataset:
a multi-center 12-week study of hms5552 in t2dm

Conditions: Diabetes Mellitus, Type 2

Summary: this study evaluates the safety, tolerability, efficacy and population pk of hms5552 in type 2 diabetic adult subjects,there will be 5 groups ,4 groups will receive hms5552,while 1 will receive placebo.

glucokinase (gk, also called hexokinase iv or d) can phosphosphorylate glucose to glucose-6-phosphate (g-6-p) in pancreatic β-cells and liver cells, which represents the first step of glucose metabolism. gk also acts as a glucose sensor and exerts a key role in maintaining glucose homeostasis. hms5552 is a 4th-generation gk agonist or activator (gka), which was originally licensed from roche and subsequently developed by hua medicine. hms5552 has been shown to activate gk in pancreatic beta cells, liver and intestinal epithelial cells. it regulates systemic blood glucose through a variety of mechanisms including directly enhancing insulin release (pancreas), inhibiting production of endogenous glucose (liver) and by indirectly promoting glp-1 release (enteroendocrine l-cells).

Eligibility criteria:
inclusion criteria: 1. male \& female, 40\~75 years old 2. t2dm patients，anti-hyperglycemic drug-naïve and on diet \& exercise for at least 3 months, or with glucose controlled by metformin or α-glucosidase inhibitor alone 3. hba1c 7.5\~10.5% at screening and pre-randomization 4. fasting plasma glucose (fpg)7.0\~11.1 millimole/liter (mmol/l, local lab) at screening, and 7.0\~13.3 millimole/liter (mmol/l, central lab) at pre-randomization 5. bmi: 19\~30kg/m\^2 \& tg\<5.5mmol/l exclusion criteria: 1. t1d，secondary dm, pre-dm 2. kidney diseases or egfr mdrd\<60ml/min/1.73m\^2 3. unstable cvds 4. liver diseases 5. mental or cns diseases

Keywords: gka,t2dm,hms5552
development and pilot-testing of a patient self management approach for hypertension using personal electronic health records

Conditions: Hypertension

Summary: the project includes a systematic review to inform refinement of intervention components and a pilot rct to determine the uptake, feasibility, and potential value of a hypertension self-management strategy using personal health records. the review follows generally acceptable systematic review and/or meta-analytic techniques; with specific attention devoted towards accessing information and effectiveness data from unpublished studies or reports within grey literature and contacting individuals with expertise in chronic disease management in primary care. findings of the review will be used to expand/modify an existing intervention 'template' to yield an evidence-based strategy with potential to enhance self-management of hypertension in primary care. the pilot rct will assess the utility of the multifaceted intervention, delivered in part via a secure patient-controlled personal electronic health record, compared with the usual family practice management, for patients with undiagnosed or uncontrolled elevated blood pressure. patients who are hypertensive or identified as high risk are expected to benefit from the increased flexibility and autonomy of out-of-physician-office self-monitoring with self-management support. this initial evaluation will focus on the change in hypertension knowledge, patient self-efficacy, and patient engagement in self management activities after 3 months, in the intervention group compared to the control group; the feasibility and acceptability of the intervention to patients and providers; and the processes involved in linking the patient self-management experience back to the patient's health care providers to promote coordination of care. secondary outcomes include change in blood pressure, number and content of interactions with providers, and changes in management, including antihypertensive medication.


Eligibility criteria:
inclusion criteria: * over 40 years of age * diagnosed with htn, or being monitored for diagnosis, with a systolic bp \>140 (sbp \>130 mmhg if diabetes is diagnosed) at an office visit in the previous 6 months * own, borrow or be interested in purchasing a bp measurement device for home monitoring; or visit the clinic for self-assessment using the bptrutm (www.bptru.org)or monitor bp with a consistent device at a community pharmacy * regular access to email, to receive notices of new messages or prompts/reminders in myoscar

Keywords: hypertension self-management e-health
autotransfusion versus transfusion in cancer surgery

Conditions: Hemorrhage; Cancer Surgery; Transfusion

Summary: acute bleeding is one of the most frequent intraoperative adverse events and is burdened with a significant morbidity and mortality rate. the only available treatment for severe exsanguination is homologous transfusion, but this is itself complicated by side effects. nevertheless, systems exist allowing the recovery, treatment and intraoperative reinjection of lost blood, thus limiting transfusions.

acute bleeding is one of the most frequent intraoperative adverse events and is burdened with a significant morbidity and mortality rate. the only available treatment for severe exsanguination is homologous transfusion, but this is itself complicated by side effects (immunosuppression, increased rate of carcinological recurrence...). nevertheless, systems exist allowing the recovery, treatment and intraoperative reinjection of lost blood, thus limiting transfusions. the aim of this work is to collect and analyze the estimated bleeding and the hemoglobin level of patients who underwent an intermediate or major operation in the general block of the centre léon bérard in 2021 and who were transfused within 10 days of this operation. in the first stage of data analysis, the investigators will collect data related to perioperative transfusion currently performed at the centre léon bérard (year 2021). then, a pharmacoeconomic analysis will be carried out with an evaluation of the cell salvage technique by mini-hta (health technology assessment) type (clinical benefit, patient safety, target population, robustness of clinical evidence, budgetary impact, amount of investment, impact in terms of human resources (training), efficiency) with the objective of helping the centre léon bérard management to make a decision.

Eligibility criteria:
inclusion criteria: * surgery at the centre léon bérard in 2021 * transfusion from the day of surgery to the 10th postoperative day exclusion criteria: * digestive endoscopy, interventional radiology, brachytherapy * vascular access only * patient refusal

Keywords: intraoperative blood salvage cancer surgery pharmacoeconomic analysis transfusion
dociparstat sodium (cx-01) combined with standard induction therapy for newly diagnosed acute myeloid leukemia

Conditions: Acute Myeloid Leukemia

Summary: this was an exploratory phase 2, open label, randomized, multicenter, parallel group study to determine whether there was evidence that the addition of dociparstat (cx-01) at 2 different does levels to standard induction therapy (cytarabine+idarubicin, "7+3") and consolidation therapy had an additive therapeutic effect for subjects newly diagnosed with acute myeloid leukemia (aml) when compared with subjects receiving standard induction chemotherapy alone.

the primary efficacy endpoint was to assess whether dociparstat in conjunction with standard induction therapy for aml increased the complete remission rate based on the international working group aml response criteria. a total of 75 subjects were to be randomized in a 1:1:1 ratio to 1 of the following treatment groups: * group 1: cytarabine + idarubicin * group 2: cytarabine + idarubicin + dociparstat 0.125 mg/kg/hr * group 3: cytarabine + idarubicin + dociparstat 0.25 mg/kg/hr subjects received up to 2 induction cycles and up to 2 consolidation cycles and participated in the study for up to 18 months. clinical laboratory tests were conducted routinely, and bone marrow aspirates and biopsies were performed during the induction cycles. safety was monitored through adverse events and clinical laboratory results.

Eligibility criteria:
inclusion criteria: subjects had to meet all the following criteria to be eligible for enrollment in this study: 1. had newly diagnosed, de novo or secondary, previously untreated acute myeloid leukemia (aml). 2. had an eastern cooperative oncology group (ecog) performance status of 0 to 2. exclusion criteria: subjects who met any of the following criteria were not eligible for enrollment in this study: 1. had acute promyelocytic leukemia 2. had prior chemotherapy for aml. 3. had prior intensive chemotherapy or stem cell transplantation for the treatment of myelodysplastic syndrome. 4. had central nervous system (cns) leukemia.
post-marketing surveillance of micardis® (telmisartan) in patients with hypertension

Conditions: Hypertension

Summary: the primary objective of this survey is to prospectively investigate safety and efficacy in patients with hypertension treated with telmisartan in proper use in medical practice over a long period


Eligibility criteria:
inclusion criteria: * patients with hypertension exclusion criteria: patients with the following conditions * patients with a history of hypersensitivity of this product * women in pregnancy (included the possibility of pregnancy) * patients with severe biliary obstructive disorders or severe hepatic insufficiency
awake prone positioning in spontaneous breathing patients with acute hypoxic respiratory failure due to pneumonia

Conditions: Acute Hypoxemic Respiratory Failure

Summary: prone positioning has shown beneficial effects in intubated patients with severe respiratory failure and positive effects in awake patients with covid-19 pneumonia. conclusive evidence for patients with ahrf without covid-19 is still missing. we hypothesis that awake prone position in patients with ahrf is superior to standard supine/semi-recumbent position in terms of reducing the rate of tracheal intubation and/or all-cause death within 28 days after randomization.

prone positioning has shown beneficial effects in intubated patients with severe respiratory failure and positive effects in awake patients with covid-19 pneumonia. since the pandemic the rate of awake prone positioning has increased and became a standard medical therapy in icus worldwide. conclusive evidence for patients with ahrf without covid-19 is still missing. we hypothesis that awake prone position in patients with ahrf is superior to standard supine/semi-recumbent position in terms of reducing the rate of tracheal intubation and/or all-cause death within 28 days after randomization. furthermore, we aim to assess safety and tolerability of awake prone positioning in patients with acute hypoxic respiratory failure due to pneumonia on the icu.

Eligibility criteria:
inclusion criteria: * the focus of this trial is to treat patients with respiratory failure. the inclusion criteria are selected accordingly. patients meeting all of the criteria listed below will be included in the study: * patients in the intensive care unit * high possibility of pneumonia (community-acquired pneumonia or hospital-acquired pneumo-nia) either diagnosed by chest x-ray or computed tomography or clinically diagnosed at least with one of the following signs * appearance of purulent secretions or changes in characteristics (color, odor, quantity, consistency) * cough or dyspnea or tachypnea * evocative auscultation * presence of acute hypoxemic respiratory failure (pao2/fio2 ≤ 300 mmhg or spo2/fio2 ≤ 315) exclusion criteria: * patients are excluded from the study if any of the following criteria are met at screening or before ran-domization, a detailed list is shown in the study manual: * age below 18 * pregnant woman * patient is unlikely/unable to awake prone positioning, or to be compliant as indicated by the treating team * prolonged need (≥ 4 days) for hfno, niv or cpap before study inclusion * urgent need for endotracheal intubation * invasive mechanical ventilation * shock o defined as need for vasopressor ≥ 0.4 mcg/kg/min to maintain a mean blood pressure of ≥ 65 mmhg or systolic blood pressure ≥ 90 mmhg * participation in another clinical interventional trial in the last 3 months * previous participation in the prosa trial * long-term oxygenation therapy (ltot) or continuous positive airway pressure (cpap) therapy before hospital admission * treatment
t1rho imaging of liver in presence of iron

Conditions: Liver Fibrosis

Summary: liver t1rho is elevated in response to accumulation of extracellular matrix proteins during fibrosis. the presence of hepatic iron overload; however, can shorten the t1rho value. with proper correction, we can remove this confounding factor and improve the reliability of t1rho for early diagnosis of liver fibrosis. patients with early-stage liver fibrosis confirmed by biopsy will be recruited at the prince of wales hospital (hong kong). thirty patients and twenty healthy volunteers will be recruited. the liver iron content will be measured using the established t2\* mri relaxometry. breathhold black blood t1rho relaxometry will be used to collect t1rho data. the measured t1rho will be retrospectively corrected to remove the shortening effect caused by iron. we will use anova to compare the measurement with and without fibrosis. we will use pearson correlations between the disease state and the imaging measurements, and roc analysis to determine the diagnostic value of the proposed method.


Eligibility criteria:
inclusion criteria: * between age 18 and age 55 * informed written consent obtained exclusion criteria: * contraindications to mri such as the presence of metallic implants, claustrophobia and pregnancy

Keywords: quantitative rotating frame relaxometry, t1rho, early detection of liver fibrosis, hepatic iron
r2p field test of the ems liftkit: validating usability, usefulness, desirability, and effects on musculoskeletal injuries in ems providers

Conditions: Musculoskeletal Disorder

Summary: the long-term goal of our research program is to reduce the high incidence of musculoskeletal injury associated with person-handling tasks performed by ems providers/responders (nora public safety industry sector). the literature shows the significant burden of these injuries, many of which affect the back and are debilitating. there is a need for effective ergonomic tools that can assist ems providers in the patient handling tasks encountered in patient homes, particularly those patient handling situations that include restricted or tight spaces. to address this need, our prior work identified a set of potential ergonomic solutions, using a participatory process with ems providers, for physically challenging and frequently occurring patient handling tasks that occur in patient homes. a final product of this prior work was the development of the liftkit, which is a collection of seven tools that were shown in biomechanical validation studies with ems providers to effectively reduce physical demands during simulated patient handling tasks in a laboratory setting. the overall objective of this proposed research-to-practice application is to evaluate the liftkit's seven patient handling tools (interventions) in the field to assess their usability, usefulness, and desirability, as well as their impact with regards to preventing musculoskeletal injuries incurred during ems patient handling tasks. in this field study, 30 liftkits will be placed on ems vehicles that service urban, suburban, and rural communities. given the three-shift operation used by fire-service based ems departments, there is the potential to recruit between 180 and 270 ems providers for the study. immediately following the training on how to use the tools and at 4, 8, and 12 months following the training, participants will be interviewed and questioned about each tools' usability, usefulness, and desirability. frequency of each tool's use will be assessed with a questionnaire at the time of the interview and a daily run-use survey tool. musculoskeletal injury data due to patient handling tasks during the 12 month follow-up period will be compared with injury data from the three-year period prior to study initiation. the final product of this work will provide the important evidence needed to widely promote the adoption of the ergonomic tools within the liftkit, in order to reduce msd injury risk to ems providers associated with common patient handling tasks.


Eligibility criteria:
inclusion criteria: * working ems providers exclusion criteria: * none

Keywords: ems ergonomics musculoskeletal disorders back injury firefighter
the effect of kinesio taping applications on pain, neck awareness and functionality in neck pain

Conditions: Physiotherapy; Kinesiotape; Chronic Neck Pain

Summary: it is important to clarify neck awareness, functional status and pain severity in people with chronic neck pain. since neck pain, which has become a big problem among the public, cannot be treated definitively, it was aimed to examine the effect of kinesio taping technique on individuals with neck pain. the purpose of the research; to examine the positive and negative effects of kinesio taping applied in addition to traditional treatment on pain, functional status and neck awareness in patients with neck pain. the aim of this study by the researchers is to gain a new perspective on the treatments applied to individuals with neck pain.

neck pain is a common complaint that can occur for different reasons and is common among the public. the most common musculoskeletal system pathology after low back pain is neck pain. neck pain symptoms often do not provide a permanent solution. chronic neck pain is a sensory and emotional experience that affects an individual's quality of life, behavior and professional life. in addition, psychosocial status is also affected due to problems such as health expenses, work attendance problems, and work efficiency. early diagnosis and identification of risk factors are of great importance to prevent neck pain from turning into a chronic problem. 40-70% of the society complains of neck pain at least once in their lives. about ¼ of these are chronic neck pain. today, many occupational and personal risk factors for neck pain have been identified. the purpose of the research; the aim of this study is to examine the positive and negative effects of kinesio tape application in addition to traditional treatment on pain, functional status and neck awareness in patients with neck pain.

Eligibility criteria:
inclusion criteria: * agreed to participate in the study and signed the informed consent form, * having complained of neck pain for at least 3 months, * must be 18 years or older. exclusion criteria: * pregnancy * loss of function due to neurological or systemic disease, * having previously undergone cervical region and spine surgery, * having received physiotherapy in the neck and back area in the last 6 months, * being on another treatment during the study, * having a history of trauma affecting the spine.
evaluation of efficacy and safety of roxadustat for the treatment of chemotherapy induced anemia

Conditions: Chemotherapy Induced Anemia

Summary: the purpose of this study is to find out if roxadustat (also known as fg-4592) is safe and effective for the treatment of anemia in participants receiving chemotherapy treatment for cancer.

this study consists of three periods: 1. screening period up to 28 days 2. treatment period of up to16 weeks 3. a follow-up period of 4 weeks.

Eligibility criteria:
inclusion criteria: 1. diagnosis of non-myeloid malignancy 2. anemia caused by cancer treatment (myelosuppressive chemotherapy) defined as hb ≤10.0 grams (g)/deciliter (dl) at screening 3. planned concurrent treatment of cancer with chemotherapy for at least 8 additional weeks 4. estimated life expectancy ≥ 6 months at enrollment (day 1) exclusion criteria: 1. participants with cancer receiving chemotherapy when the anticipated outcome is cure 2. participants who are only receiving hormonal products, biological products, cancer immunotherapy or radiation therapy to treat/manage their cancer 3. history of leukemia 4. participants who have received an rbc transfusion or erythropoietic therapy within 4 weeks of enrollment 5. use of any investigational drug within 8-weeks prior to treatment with roxadustat 6. clinically significant anemia due to other etiologies 7. cardiovascular risks, such as myocardial infarction, stroke, heart failure or thromboembolic event (for example, deep vein thrombosis \[dvt\] or pulmonary embolism) within previous 6 months of screening 8. clinically significant or uncontrolled ongoing autoimmune disease (for example, rheumatoid arthritis, crohn's disease, celiac disease, etc.) 9. known human immunodeficiency virus (hiv), hepatitis b or hepatitis c infection

Keywords: anemia chemotherapy induced anemia myelosuppressive chemotherapy non-myeloid malignances
triclosan toothpaste and third molar surgery

Conditions: Dry Socket; Wound Infection

Summary: triclosan containing dentifrices are effective in the prevention of inflammatory complications following third molar surgery through reducing preoperative oral bacteria load.

this study may provide evidence on the effect of triclosan containing dentifrice on oral bacteria and oral inflammation prior to third molar surgery, and on the incidence of inflammatory complications after the surgery. if proven effective, dentifrice containing triclosan may be recommended prior to tooth extractions and replace antibiotics and other antimicrobial products as a prophylactic procedure before oral surgery procedures.

Eligibility criteria:
inclusion criteria: * must include at least one mandibular third molar with partial or full bony impaction * no sign of active pericoronal (around the crown) infections * must have not taken antibiotics for any reason in the past 30 days * must be healthy and between 18 and 35 years of age * must be able to read and sign an informed consent exclusion criteria: * subjects with systemic diseases and pregnant or lactating women * subjects with advanced periodontal diseases or having two or more untreated caries lesions * subjects who cannot read and sign an informed consent * subjects with signs of pericoronal infections

Keywords: third molars triclosan toothpaste dry socket wound infection
obesity effect on stroke and cardiovascular events

Conditions: Stroke, Acute

Summary: the relation between obesity and stroke recurrence is still under debate. in this study it has been sought whether baseline obesity is associated with recurrent stroke and major cardiovascular events in a long-time period.

five-years follow-up data of ege stroke registry for stroke recurrence and cardiovascular events regarding to obesity were analyzed. data include age, gender, stroke severity, neuroimaging studies, cardiovascular risk factors. within the inclusion period, all of the included patients were followed until censoring (10th of december 2011) or readmission because of recurrent stroke, cardiovascular event or death, whichever came first. the kaplan-meier method was used for survival analysis. cox proportional hazard model was applied to identify predictors of recurrent vascular events.

Eligibility criteria:
inclusion criteria: * all consecutive stroke patients. exclusion criteria: * incomplete baseline information, other factors making them unsuitable for follow-up,undetermined stroke, subarachnoid hemorrhage.

Keywords: obesity recurrent stroke ischemic stroke hemorrhagic stroke cardiovascular events vascular death