Kornimate/medical-research-clean huggingface dataset:
efficacy of chinese herbal medicine qing re huo xue in patients with rheumatoid arthritis

Conditions: Rheumatoid Arthritis

Summary: this study is a multicenter, randomized, double-blinded, placebo-controlled trial with two parallel arms. the aim of the study is to evaluate whether chinese herbal medicine qing re huo xue (qrhx) combined with methotrexate (mtx) might be better than qing re huo xue placebo combined with mtx for patients with active rheumatoid arthritis (ra).

to compare the efficacy and safety of chinese herbal medicine qing re huo xue (qrhx) and methotrexate (mtx) for patients with active rheumatoid arthritis (ra), a multicenter, randomized controlled trial will be conducted. two hundred and four patients with active ra will be randomly allocated (1:1) to treatment with qrhx 10g bid and mtx 10mg once a week for 24 weeks, or mtx plus qrhx placebo. the primary outcome is the bone marrow edema score in outcome measures in rheumatology clinical trials ra mri scoring (omeract-ramris) at week 24.

Eligibility criteria:
inclusion criteria: 1. subject has had a confirmed diagnosis of rheumatoid arthritis according to 2010 acr/eular ra classification criteria. 2. subject has a das28 crp disease activity score of \>3.2 at screening. 3. subject also experienced the following signs and symptoms: swelling, joint pain, and heat in the joints. 4. subject has had no prior exposure to oral glucocorticoids at a daily dose greater than 10 mg or to any biologic agents. 5. subject may has had previous exposure to nonsteroidal anti-inflammatory drugs (nsaids) prior to screening and must be on stable dose. exclusion criteria: 1. history or presence of a clinically significant medical disorder other than ra that, in the opinion of the investigator and medical monitor, would pose a risk to subject safety or interfere with the study evaluation, procedures, or completion. 2. subject has inflammatory, rheumatological disorders other than ra, where arthritis may be a prominent feature. 3. subject has received treatment with the prohibited therapies listed in the protocol, or changes to those treatments, within the prescribed timeframe. 4. pregnant or nursing an infant or with a life partner who is pregnant, nursing, or planning to become pregnant.

Keywords: rheumatoid arthritis qing re huo xue methotrexate randomized controlled trial
haemodynamic and geometric factors in atherosclerosis

Conditions: Atherosclerosis

Summary: the study is a prospective-observational, explorative single-centre cohort study aimed to examine the influence of hemodynamic and geometric parameters on the progression of atherosclerotic alterations in peripheral vessels (carotids, femoral artery). atherosclerotic alterations (imt, plaque volume) will be measured with a ultrasound (imt measurements and 3d quantitative plaque volumetry) and magnetic resonance imaging (mri). geometric parameters (e.g. carotid/femoral bifurcation angle, carotid/femoral bifurcation area) are assessed with magnetic resonance imaging (mri) and also 3d ultrasonography. a total of 100 patients with an asymmetrical plaque distribution in carotid and femoral arteries will be tested. only patients who are already enrolled in the "correlation of artherosclerotic plaque volume and intima media thickness with soluble p-selectin" (nct01895725) and who are tested prior for an asymmetrical plaque distribution will be included in this study. mri will be performed once whereas ultrasound imaging will be be repeated once per year (up to five times) to assess changes in these parameters over time. also plasma samples will be collected once yearly and tested for traditional and novel cardiovascular risk factors. the primary endpoint of the planned study will be the correlation between geometrical and hemodynamic parameters as stated above and the progression of atherosclerosis as measured by plaque volume and imt in the carotid and femoral arteries, respectively. secondary endpoints will include the correlation of geometrical and hemodynamic parameters with established (hypertension, smoking, diabetes, dyslipidemia) and novel risk factors (hscrp, p-selectin, cholesteryl ester transfer protein (cetp), intercellular adhesion molecule-1 (icam-1), cetp taqib polymorphism), with cardiovascular event rate, plaque localization, plaque morphology and the additional predictive value of geometrical parameters compared to an established risk score (score card).


Eligibility criteria:
inclusion criteria: * asymmetrical (side difference) plaque distribution in carotids/femoral arteries which was tested in at least two prior 3d-ultrasound examinations (absolute side difference in carotid arteries ≥ 30 mm3 or in femoral arteries ≥50 mm3 and relative side difference in carotid arteries/femoral arteries ≥50% ) exclusion criteria: * actual pregnancy, lactation period, chronic renal insufficiency (gfr\<20ml/min)
role of endoplasmic reticulum stress in the pathophysiology of type 2 diabetes

Conditions: Diabetes Mellitus, Type 2; Endoplasmic Reticulum Stress

Summary: the purpose of this study is to investigate whether endoplasmic reticulum (er) stress pathway is activated in peripheral tissues (adipose tissue) in insulin resistant diabetic patients compared to healthy subjects normoglycemic matched for age and sex an to investigate whether er stress pathway can be activated in response to insulin. indeed, some preliminar on rates studies shows that er stress pathway is activated by insulin in liver and adipose tissue showing that hyperinsulinemia might help trigger stress path er. for this, we propose a case control study of type 2 diabetic patients vs control subjects in which markers of er stress will be evaluated from abdominal subcutaneous adipose tissue obtained before and after euglycemic hyperinsulinemic. we chose to consider adipose tissue subcutaneous rather than visceral adipose tissue for obvious reasons of lesser invasiveness.


Eligibility criteria:
inclusion criteria: * specific criteria for diabetic patients: * having type 2 diabetes for at least 6 months * hba1c ≤ 8% * treated by lifestyle and dietary rules associated or not to a hypoglycemic therapy (metformin and / or sulfamid) and / or insulin secretors dependent glucose as inhibitors of dpp4 (dipeptidyl peptidase-4): vildagliptin, sitagliptin, saxagliptin * no modification of hypoglycemic therapy and / or insulin secretors for at least 3 months specific criteria for control subjects: * nondiabetic subjects (fasting blood glucose \<7.0 mmol / l without hypoglycemic treatment). * the control subjects should be matched to patients for age (± 5 years), sex, and bmi (± 2 kg/m2). common criteria for patients and control subjects: * aged 18 to 60 years * body mass index between 25 and 35 kg/m2 * accepting the constraints of the protocol and who signed the informed consent * systolic blood pressure \< 160 mmhg, diastolic blood pressure \< 90 mm hg (with or without antihypertensive treatment) * resting heart rate between 55 and 100 beats/min. * normal laboratory tests or not clinically significant abnormality for nfs platelets, pt, aptt, fibrinogen alt, ast, ggt, serum electrolytes, urea, creatinine, uric acid triglycerides, total cholesterol, hdl cholesterol * hcg negative blood (for female subjects) * affiliated to the social security. exclusion criteria: * current infections or recent infections (\<10 days) * neoplastic disorders (with the exception of carcinoma in situ of the cervix or cutaneous epithelioma), haematological, cardiovascular, psychiatric, neurological * poisoning smoking (\>10 cigarettes per day, what ever the duration of intoxication) * treatment with insulin or glitazones pregnancy, breastfeeding * body mass index \> 35 kg/m2 * any drug taken for less than 8 days without the inclusion of minor analgesics (aspirin, paracetamol), anti-hypertensive medications, oral hypoglycemic (metformin and sulphonylureas) and insulin secretors dependent glucose as inhibitors of dpp4 (dipeptidyl peptidase-4) and oral contraceptives.

Keywords: endoplasmic reticulum
non-invasive intravascular laser irradiation of blood in the treatment of children with temporomandibular disorders

Conditions: Temporomandibular Disorder

Summary: this study is blind, randomized controlled and have been carried out on children between 6 and 9 years of age, at the catholic university of uruguay, faculty of health sciences, postgraduate school, and surrounding schools. patients who present temporomandibular disorders, based on the diagnostic criteria will be the diagnostic criteria for temporomandibular disorders (dc/tmd) were included. the laser used was infrared, power 100 mw ±20%, wavelength 660nm ±10 nm, energy parameter 60j, continuous application. the technique is not invasive, the irradiation point is by continuous and direct transcutaneous application to the radial artery by means of a bracelet that inserts the laser beam. one session has been performed. there was a laser group, a placebo group. participants in all groups were re-evaluated after the procedure, following the same evaluation procedures used initially, evaluating the effects of ilib on pain and range of motion.


Eligibility criteria:
inclusion criteria: * healthy participants (asa i) age six to nine years with diagnosis of tmd in the mixed dentition phase and with jaw deviation and/or deflection. deviation is defined as the jaw following a deviated path to one side during opening. deflection is defined as the jaw following a deviated path without returning to the midline when the mouth is fully opened. exclusion criteria: * craniofacial anomalies or genetic syndromes due to the greater probability of the development of tmd associated with the malformation, which could be a confounding variable, malocclusion, use of a dental prosthesis, currently undergoing orthodontic treatment, need for orthognathic surgery or physical therapy due to the potential impact on the results of both the diagnosis and treatment, currently undergoing oncological treatment due to the need to avoid conditions that may exert an influence on the response to the proposed treatment and photosensitivity due to the incompatibility with part of the proposed treatment. individuals on medications could be included and the medications needed to be recorded in the results.
a study of anti-vegf monoclonal antibody hpv19 in patients with solid tumors

Conditions: Solid Tumors

Summary: hpv19 is a monoclonal antibody (mab) directed against vascular endothelial growth factor (vegf). hpv19 binds to human vegf with unique binding site on vegf different from that of bevacizumab(avastin) and inhibits the binding of vegf to it's receptors, vegf-r1 and vegf-r2. by preventing vegf binding to its receptors, growth of tumor blood vessels are inhibited and tumor growth prevented or slowed. in this study we are investigating the tolerability, safety, pharmacokinetics and anti-tumor activity of hpv19 in combination with chemotherapy in patients with solid tumors. hpv19 will give to patients by intravenous(i.v.) infusion with a single and multiple doses.


Eligibility criteria:
inclusion criteria: * confirmed malignity * measurable disease * performance status 2 or less(ecog) * life expectancy ≥3 months exclusion criteria: * hepatitis c virus (hcv), or hiv antibody positive * previously received anti-vegf mab or fusion-protein drugs within 28 days nearly * evidence of serious infection

Keywords: mab vegf antibody phase1
the effect of dural puncture epidural block technique on the effectiveness and safety of labor analgesia

Conditions: Labor Analgesia

Summary: dural puncture epidural is a clinical improvement of combined spinal-epidural and is widely used in maternal.dural puncture epidural technique improves labor analgesia quality and safety by increasing drug permeation.this study combines ultrasound real-time guidance technology. this technology ensures the accuracy of intervertebral space positioning and puncture success rate through operational visualization, and reduces the impact of operator proficiency on research results.

dural puncture epidural is a clinical improvement of combined spinal-epidural and is widely used in maternal. the implementation step is to complete the epidural puncture, temporarily do not place a tube, puncture the dura mater with a subarachnoid anesthesia needle, but do not directly inject drugs into the subarachnoid space, and then leave an epidural catheter for administration according to epidural block. the theoretical basis is that anesthetic drugs can originally penetrate into the subarachnoid space from the epidural space through a complete spinal dura, and the puncture hole formed by spinal dura puncture facilitates this process.after injecting high volume anesthetic drugs into the epidural space, the pressure increases, and the drug penetrates from the epidural space through the puncture hole along a pressure gradient to the subarachnoid space, thereby enhancing the effect of labor analgesia.dural puncture epidural also has the advantage of verifying that the epidural needle is in the middle of the epidural space again, thereby reducing the incidence of epidural catheter insertion failure or deviation to one side.this study combines ultrasound real-time guidance technology. this technology ensures the accuracy of intervertebral space positioning and puncture success rate through operational visualization, and reduces the impact of operator proficiency on research results.

Eligibility criteria:
inclusion criteria: 1. american society of anesthesiologists (asa) class i or ii; 2. single healthy pregnancy; 3. head showing first; 4. 37 to 41 weeks; 5. the labor process is active, and the cervix dilates\<5cm; 6. require epidural labor analgesia; 7. volunteer to participate in this study and sign an informed consent form. exclusion criteria: 1. presence of pregnancy diseases, such as pregnancy hypertension, pre eclampsia, pregnancy diabetes; 2. contraindications to intraspinal analgesia: 1) central nervous system diseases. 2) infection or septicemia at the puncture site. 3) coagulation dysfunction; 3. known cases of fetal malformation or increased risk of cesarean section, such as a history of uterine rupture; 4. persons with a history of mental illness, hysteria, epilepsy, etc. who cannot cooperate. 5. patients with long-term use of opioids, steroids, and chronic pain.

Keywords: labor analgesia delivery woman neonate effectiveness safety
objective brain function assessment of mtbi/concussion

Conditions: Brain Injuries, Traumatic; Concussion, Mild; Concussion, Intermediate; Concussion, Severe; Concussion, Brain

Summary: this study (part 3) is designed to build a database including eeg, neurocognitive performance, clinical symptoms, history and other relevant data, which will be used to derive a multimodal eeg based algorithm for the identification of concussion and tracking of recovery.

injured/concussed subjects will be studied at time of injury, and at 3 follow-up time points following injury. subjects will come from the sports and other populations of concussed individuals. they will be matched with controls i.e. not head injured subjects who will also undergo the same set of tests and the same time intervals as the injured subjects. an additional pool of uninjured (not head injured) subjects will be collected who will be assessed at a single time point. this data will be used to populate a database for the purpose of deriving a multimodal concussion index.

Eligibility criteria:
inclusion criteria: for injured subjects: 1. having sustained a traumatic closed head injury within 72 hours (3 days) from time of injury at time of brainscope assessment; 2. gcs 13-15 at time of brainscope assessment; 3. no hospital admission due to either head injury or collateral injuries for \>24 hours. for matched controls: 1. gcs 15 at time of brainscope assessment; 2. no prior history of concussion or tbi in the last year. exclusion criteria: 1. previously enrolled in the brainscope cas studies; 2. current cns active prescription medications taken daily, with the exception of medications being taken for the treatment of attention deficit disorder (add) or attention deficit hyperactivity disorder (adhd); 3. forehead, scalp or skull abnormalities that prevents headset application or eeg data collection; 4. history of brain surgery or neurological disease; 5. pregnant women; 6. subjects who do not speak english (non-english speaking parents are allowed to consent so long as translation of the consent form in their native language is available); 7. acute intoxication; 8. evidence of illicit drug usage; for injured subjects: 1. loss of consciousness ≥ 20 minutes related to the concussion injury; 2. active fever defined as greater than 100ºf or 37.78ºc at time of brainscope assessment; 3. evidence of abnormality visible on computerized tomography (ct) of the head related to the traumatic event (note: neuroimaging is not required for enrollment). for matched controls: 1. any focal neurological signs including aphasia, apraxia, diplopia, facial droop, dysarthria/slurred speech; 2. history of motor vehicle accident (mva) requiring an emergency department visit within the past 1 year.

Keywords: concussion mild traumatic brain injury sport related concussion non-sport related concussion
comparing effects of various combinations of 6 hertz(hz) rtms & lfrtms on motor recovery due to cerebrovascular disease

Conditions: Cerebrovascular Disease

Summary: to compare the effects of various combinations between 6 hertz(hz) rtms \& lfrtms on the limb motor dysfunction due to cerebral vascular disease.

it is the basic principle for functional recovery after cerebrovascular disease to restore the original balance in reciprocal inhibition between affected hemisphere and unaffected hemisphere. repetitive transcranial magnetic stimulation (rtms) is a noninvasive neuroplastic technique rebalancing interhemispheric competition after stroke. low frequency rtms (lfrtms) on contralesional hemisphere or high frequency rtms (hfrtms) on lesional hemisphere might be the basic choice. 6 hertz(hz) primed lfrtms on lesional primary motor cortex has the stronger effect than lfrtms alone does on one hand; the other newly-developed combination, i.e. hfrtms on lesional primary motor cortex and lfrtms on contralesional primary motor cortex might also be more effective than they do respectively on the other hand. the main aim of our research is to find out which combination is better by considering both safety and efficiency.

Eligibility criteria:
inclusion criteria: * aged from 30 to 90 years; * newly onset cerebral infarction or brain hemorrhage confirmed by mri or ct; * the disease duration is less than 20 weeks when recruited into the trial; * no existence of limb motor dysfunction before this onset, and new occurrence of unilateral limb motor dysfunction after this onset; * the physical and mental condition are good enough to cooperate with the assessment and treatment; * the nihss score: total 5-20,1a,1b,1c=0; * the subject or legal guardian sign the consent form. exclusion criteria: * during pregnancy; * with skull defect; * with metal implants, cardiac pacemaker, cochlear implantation; * epileptiform discharge in eeg.

Keywords: cerebrovascular disease repetitive transcranial magnetic stimulation
procalcitonin to shorten antibiotics duration in pediatricicu patients (proshort-ped) trial

Conditions: Sepsis

Summary: the purpose of this study is to give conclusive evidence on whether serial pct (procalcitonin) measurements can facilitate individual decision-making and shorten antibiotic treatment duration in patients with sepsis in the pediatric icu (intensive care unit).

in this study, the investigators aimed to design a multi-center trial addressing aforementioned flaws. the investigators will set stricter inclusion criteria, collect complete data on relapse or secondary infection, and include sufficient number of patients to show non-inferiority to conventional therapy by a delta margin of 10% \[11\]. the investigators aimed to give conclusive evidence on whether serial pct measurements can facilitate individual decision-making and shorten antibiotic treatment duration in patients with sepsis in the pediatric icu.

Eligibility criteria:
inclusion criteria: all patients with laboratory- or image-confirmed severe infection at admission or during stay in pediatric icu will be eligible for inclusion. \* definition of laboratory- or image-confirmed severe infection: * two or more of four signs of inflammation: * temperature \>38.3℃ or \<36℃ * heart rate \> 90 beats/min * respiratory rate \>20 breaths/min or paco2 (arterial pressure of carbon dioxide) \< 32 mmhg * wbc (white blood cell count) \> 12,000 cells/mm3, \ 5% band-form wbc * initial procalcitonin \> 0.5 ng/ml * presence of either laboratory or image evidence of infection * laboratory evidence: sign of inflammation in urine, csf (cerebrospinal fluid), ascites, pleural effusion or local abscess * image evidence: compatible findings on chest x ray, ultrasound, ct (computed tomography), mr image (magnetic resonance image) exclusion criteria: * age greater than 15 years or less than 1 month * known pregnancy * expected icu stay less than 3 days * neutropenia: anc (absolute neutrophil count) \<500/mm3 * specific infections for which long-term antibiotic treatment is strongly recommended: * lobar pneumonia or empyema * bacterial meningitis * osteomyelitis * infective endocarditis * local abscess * mediastinitin

Keywords: icu sepsis antibiotic therapy procalcitonin
comparison of two treatments for low back pain: "re spine" vs. physiotherapy

Conditions: Low Back Pain

Summary: the objective of this study is to assess the effectiveness of the "re spine" mattress, which was designed as an alternative to physiotherapy in the treatment of low back pain (lbp).


Eligibility criteria:
inclusion criteria: * low back pain exclusion criteria: * none