Kornimate/medical-research-clean huggingface dataset:
methorexate and knee osteoarthritis

Conditions: Pain Reduction; Physical Function Improvement

Summary: osteoarthritis (oa) is considered a complex, multifactorial disease leading to considerable pain and functional disability amongst older adults in particular.synovial inflammation and proliferation has emerged as a key component of oa and as a potential predictor of worsening disease. methotrexate (mtx) is widely used in the treatment of all inflammatory rheumatic diseases. accordingly, the aim of the present study is to assess the efficacy of methotrexate (mtx) in decreasing pain and inflammation in symptomatic knee oa. 128 patients with clinical and radiographic criteria of primary knee oa pain,were recruited. patients meeting the eligibility criteria are randomized in a 1:1 ratio to receive either 25mg/week oral mtx (n=64) or placebo (n=64) together with their usual therapy provided the dosages are kept constant for 32 weeks. the primary outcome measure is pain reduction and secondary outcome measures is improvement in physical function scores. keywords: methotrexate knee osteoarthritis inflammation pain reduction physical funtion


Eligibility criteria:
inclusion criteria: * primary knee osteoarthritis * synovitis * pain exclusion criteria: * other inflammatory conditions * hepatic insufficiency * renal insufficiency

Keywords: methotrxate, knee osteoarthritis, inflammation, pain, function
cryoablation for advanced and refractory desmoid tumors

Conditions: Desmoid Tumors

Summary: desmoid tumors, also called aggressive fibromatosis, are rare, locally invasive tumors with no potential for metastasis. the incidence is approximately 2 to 4 per million per year in the general population. the "watch and wait" policy is the standard of care for newly diagnosed patients in europe. patients who progress have first-line medical treatment, surgery is no longer the treatment because there is a high rate of recurrence (\> 60%) and radiotherapy is not very suitable because the patients are often young and the tumors are large. cryoablation seems to be an effective therapeutic option that should be evaluated.


Eligibility criteria:
inclusion criteria: * adult patient (≥18 years old) * having undergone cryoablation for an advanced desmoid tumor refractory to medical treatment * having not expressed their opposition, after being informed, to the reuse of their data for the purposes of this research. exclusion criteria: * subject who expressed their opposition to participating in the study * patient already included in another ongoing study * subject under guardianship or curatorship * subject under safeguard of justice

Keywords: desmoid tumors fibromatosis invasive tumors radiotherapy cryoablation
composite variability index and propofol remifentanil anesthesia

Conditions: Measure of Nociception

Summary: the purpose of the study is to determine if the new composite variability index (cvi) is capable of detecting changing effect compartment concentrations of remifentanil. in addition, it is planed to detect if the change in cvi in response to a standardized painful stimulus is dose-dependent.

on the day of surgery, patients receive anesthesia by propofol infusion. as soon as the patient is unresponsive und unconscious (bis 40-60) and a steady state is achieved, a standardized painful stimulus is applied by electrical stimulation of the ulnar nerve (tetanic stimulation \[70 ma\], 30 seconds, 50 hz) in group 1. thereafter remifentanil is infused to an effect compartment concentration target of 1 ng/ml. the standardized stimulus is applied again as the remifentanil target is reached. this procedure is repeated with remifentanil targets of 2 ng/ml and 3ng/ml. in group 2 remifentanil is targeted to effect compartment concentrations of 3 ng/ml followed by 2,1, and 0 ng/ml. after measuring the effect of the last painful stimulus the patient is intubated for surgery. throughout the study the composite variability index and standard monitoring is recorded.

Eligibility criteria:
inclusion criteria: * patients undergoing surgical procedure in general anesthesia exclusion criteria: * pregnancy, drug abuse, cardiac arrhythmia, obesity

Keywords: composite variability index bispectral index electromyography nociception pain
effect of alendronate 70mg formulation on bone turnover markers and patient reported outcomes

Conditions: Osteoporosis, Postmenopausal

Summary: compare the data obtained with two formulations of alendronate 70 mg (tablets vs effervescent tablet for buffered solution) on the change in bone turnover markers, on gastric tolerance and on treatment adherence (including compliance and persistence).


Eligibility criteria:
inclusion criteria: * post-menopausal women (at least 5 years after natural / surgical menopause). * patients on treatment with alendronate 70mg tablets or alendronate 70mg effervescent tablets for 6-8 months and who will be continued to be treated for a minimum of 12 months. * available btms (s-ctx), biochemistry (calcium, phosphate, 25-oh vit d, pth, creatinine) and dxa (lumbar spine, total hip and femoral neck) at the initiation of the treatment. * ability to sign an informed patient consent exclusion criteria: * patients who had received a prior osteoporosis treatment with anti-resorptive drugs (bisphosphonate or denosumab) or teriparatide before starting alendronate 70 mg. * any secondary cause of osteoporosis including current treatment with glucocorticoids or aromatase inhibitors, inflammatory disorders, malabsorption * metabolic or cancer bone disease * contra-indications to bisphosphonates according to product labelling * known or suspected allergy to study product(s) or related products * inability to sign an informed consent * previous participation in this study
effects of an amino acid and chromium-picolinate containing drink on glucose metabolism

Conditions: Type 2 Diabetes; Prediabetes

Summary: it has previously been shown in healthy overweight subjects, that table water including a defined amount of amino acids and chromium can decrease the postprandial glucose and insulin response. in this study, the effect of this table water on glucose excursions after a test meal containing a defined amount of available carbohydrates, protein and fat will be studied in patients with early type 2 diabetes or prediabetes according to guidelines that are treated with dietary measures or metformin only. the study will be conducted in a cross -over design, double blinded and placebo controlled including 20 participants. the primary endpoint of the study is the incremental area under the curve for plasma glucose (iaucgluc) within 180 minutes after ingestion of the meal.


Eligibility criteria:
inclusion criteria: * early type 2 diabetes (i.e. on metformin or diet only) * prediabetes (i.e. fpg 100-125 mg/dl or igt 2h pg in ogtt 140-199 mg/dl) * hba1c \< 7% * bmi 28,0-39,9 kg/m² exclusion criteria * any antidiabetic medication other than metformin * psychiatric disease * acute infections * alcohol or drug abuse * malignant tumors or hematologic disorders * heart failure nyha iii-iv * acute coronary syndrome * any macrovascular event within previous 3 months * chronic kidney disease \> stage 3 * pregnancy or lactation
the new serial treatment of temporomandibular disorders

Conditions: Temporomandibular Disorder

Summary: the purpose of this study is to look at temporomandibular joint (tmj) pressure as a guideline to analyze the different treatments for temporomandibular disorder (tmd), and judge the feasibility of the adjust tmj pressure treatment and to reach a conclusion on the different treatments for different types of tmd, and determine the new serial treatment of temporomandibular disorders.

temporomandibular disorder is a common disease nowadays, but there is no guideline for the treatment of tmd. tmd can be divided into masticating muscles dysfunction; internal derangement; inflammation; osteoarthrosis, this study will classify the internal derangement, inflammation and osteoarthrosis into three types according to the tmj pressure. then the patient will receive the adjust pressure treatment according to their tmj pressure. the first part of the tmd patients will receive psychogenic treatment, medicine, physical treatment, bite plate, occlusion treatment, rebuilding occlusion treatment, orthodontic treatment, et. if the patients do not have a good curative effect, part of them will change the treatment into arthrocentesis, arthroscopic treatment or operation treatment, the other part of patients, according to their tmj pressure, receiving the associated adjust pressure treatment or adjust pressure treatment only. this study will call on the patients for three years and collect the clinical information, then doing the medical statistics.

Eligibility criteria:
inclusion criteria: * limited month opening * abnormal of the month opening type * paint during the month open or close * condylar position paint * clicking of the temporomandibular joint * enlargement of the upper temporomandibular joint gap * dislocation of the temporomandibular disc * bone of the temporomandibular joint changement * patient in the age of 16-60 * voluntary patient exclusion criteria: * dysimmunity disease * dysfunction of heart liver and kidney disease * patient can not do the guide line * life-threatening patient * serious limited mouth opening * epilepsy * tetanus * pregnancy or women in the pregnancy period * supportive temporomandibular disease

Keywords: create the new serial treatment of tmd promote the classification of biodynamics in the tmd evaluate the effect of adjusting tmj treatment establish the new standard of the tmj treatment invent new device to measure pressure without trauma
a study of effects of delay in the first bathing time of body temperature and the rate of exclusive breastfeeding

Conditions: Newborn Hypothermia

Summary: using delaying the first bathing by 8 hours as an interventional measure, considering the consistent effect of physiological maturity, newborns with a gestational age of ≥37 weeks were selected as the subjects in the nursery cases, and randomly assigned to the delayed bathing group and the routine bathing group , 10 minutes before bathing, immediately after bathing, 10 minutes, 30 minutes, and 60 minutes to analyze the differences in body temperature of the cases, and the differences in the rate of exclusive breastfeeding at discharge.

the subjects of this study came from newborn babies in the nursery of a teaching hospital in the northern region. the research design was reviewed and approved by the human trials committee. can freely choose whether to participate in the research project or withdraw, willing participants to inform the research project and fill in the consent form and basic information form, inform that they can withdraw at any time during the research period, and divide the participating infants into the experimental group and the control group through a random allocation form , after the newborn arrives in the baby room, the nursing staff will evaluate the newborn, and then perform an oil bath with baby oil to remove the fetal fat on the body, and then follow the newborn bathing procedure of our hospital. wash the whole body with water, about 1-2 hours after birth; the control group took the first bath as usual; the experimental group postponed the last step of washing the whole body after washing the face and head to 8 hours after birth , personnel must wear gloves to take care of newborns before bathing. the bathing process was performed by nurses in the baby room. body temperature was measured 10 minutes before, immediately after, 10 minutes, 30 minutes, and 60 minutes after bathing, and the exclusive breastfeeding situation at the time of discharge was counted. after all measurements are completed, a 100 yuan supermarket coupon will be given.

Eligibility criteria:
inclusion criteria: * apparently normal newborn with status ranging from normal to good * mean gestational age ≥37 weeks * birth weight ≥2500 g * apgar score of at least 7 within 1-5 minutes * birth rectal temperature ≥36.5°c * without any major change or signs or symptoms of sepsis. exclusion criteria: * the mother is younger than 20 years old * has recently had symptoms of fever, leukocytosis, respiratory tract infection or urinary tract infection * the mother has diseases such as diabetes, hyperthyroidism, and a positive history of type b streptococcus or other blood and body fluid infectious diseases.

Keywords: delayed bathing body temperature breastfeeding
reducing pain levels and increasing comfort of premature infants during aspiration

Conditions: Pain; Premature Baby 26 to 32 Weeks; Premature Baby 33 to 36 Weeks; Aspiration

Summary: the aim of this study was to investigate the effect of using amigurumi octopus on the pain and comfort of the newborn in premature infants undergoing endotracheal aspiration. it is a randomized controlled quasi-experimental design. the study will be conducted in the neonatal intensive care unit of health sciences university bursa high specialization training and research hospital. the population of the study will consist of preterm hospitalized in the neonatal intensive care unit during the period of the conducted study. in the calculation of the sample size, the power level is 80% and the significance level is 5%. it was determined by the statistical expert that the number of babies that should be included for each group is 26 and the total number of babies required for the whole study is 52 when the effect size is determined as 0.8 for the investigation of the difference between the experimental and control groups in terms of the premature infant pain profile (pipp) variable. based on aforementioned information, the study sample was determined as 80 preterm infants in which 40 for experimental groups and 40 for control groups. block randomization method will be applied for the randomization of the groups. pipp=premature infant pain scale and premature infant comfort scale (pbiq) will be used as a case report form for the collection of the study data. all the patients included in the study will be intervened by the nurse having a neonatal nursing experience by paying attention to aseptic conditions in accordance with the routine aspiration criteria of the unit. standardization will be ensured by intervening in all patients with the same application by the same nurse. during the endotracheal aspiration procedure, the octopus will be given to experimental group 10 minutes before the procedure. babies will be allowed to touch the octopus for 10 minutes during and after the procedure. physiologic parameters of the infants before, during and after the procedure will be reported and recorded by camera. according to the video recordings, pipp-r and pics scale evaluations of the infants will be made by two research nurses other than the main researcher conducting the study. the routine aspiration application steps of the unit will be applied to the control group without any intervention.


Eligibility criteria:
inclusion criteria: * gestational age range of 26-36 weeks * the baby should be between postnatal day 0 and 5 (postnatal day of baby should be between 0 and 5 days.) * need for invasive mechanical ventilator support * need for endotracheal aspiration * no analgesic, opioid and sedative medication was applied within the 4 hours before the endotracheal aspiration * at least 2 hours passed since the last painful procedure exclusion criteria: * receiving analgesic medication * major congenital anomaly * having a pneumothorax tube * stage iii and intraparenchymal hemorrhage * receiving a sedative medication
collection of efficacy and safety data of chinese patients who have received faslodex 250mg treatment

Conditions: Breast Cancer

Summary: this study is a post-authorisation study, committed to center for drug evaluation (cde) and china food and drug administration (cfda), in order to provide more effectiveness and safety data about faslodex in real world clinical practice in china. the primary objective of this study was to evaluate the effectiveness of faslodex 250mg monthly to treat post-menopausal women with oestrogen receptor-positive locally advanced or metastatic breast cancer, for disease relapse on or after adjuvant anti-oestrogen therapy or disease progression on therapy with an anti-oestrogen, in terms of progression-free survival (pfs), by collecting real world data according to chinese physicians' clinical practice.

a multicenter, non-interventional, prospective study to collect effectiveness and safety data in chinese patients who have received faslodex treatment under the condition of actual usage in clinical practice

Eligibility criteria:
inclusion criteria: * chinese postmenopausal women with estrogen receptor positive, locally advanced or metastatic breast cancer failure to previous anti-estrogen therapy, already received faslodex 250mg treatment as determined by treating physician. * the prescription of the faslodex is clearly separated from the decision to include the subject in the nis, and is part of normal medical practice. the recruitment of the patient to the study should be within 1 month of the first faslodex injection. * provision of subject informed consent. exclusion criteria: * if participating in any controlled clinical trial, the subject cannot take part in this study. * hypersensitivity to the active substance, or to any of the other excipients. * pregnancy and lactation, or severe hepatic impairment.

Keywords: chinese post-menopausal women oestrogen receptor-positive locally advanced metastatic breast cancer fulvestrant 250 mg failure to adjuvant anti-oestrogen therapy
protocol for women at increased risk of developing breast cancer

Conditions: Breast Cancer

Summary: to assess the effects of twelve months of celecoxib administration by evaluating breast tissue needle aspirations, to determine if cell growth can be slowed.

a blind randomized study of celecoxib in women at high risk of developing breast cancer. subjects are to take twelve months of drug/placebo. at baseline and after twelve months subjects will have a random periareolar fine needle breast aspiration that will be assessed for epithelial cell growth and other markers of risk. baseline and twelve month serum samples will also be assessed for hormones and growth factors which may be associated with breast cancer risk. mammograms at baseline and twelve months will also be assessed for breast density changes.

Eligibility criteria:
inclusion criteria: * women who have a high risk of breast cancer * older than 18 years exclusion criteria: * anticoagulants * marked breast tenderness * pregnant or within twelve months of breast feeding/childbirth

Keywords: breast atypia double-blind randomized clinical trial rct celecoxib cox-2 inhibitor placebo high risk for breast cancer breast epithelial hyperplasia ki-67 chemoprevention
the effects of tmz on diabetic nephropathy

Conditions: Diabetic Nephropathies

Summary: with the improvement of people's living standard, the prevalence of diabetes is increasing year by year. in present, 350 million people worldwide are suffering from diabetes, and by 2035, there will be as high as 600 million. diabetes causes a variety of complications, including diabetic nephropathy, which is one of the most common complications of diabetes. diabetic nephropathy is a microvascular complication of diabetes. microalbuminuria and glomerular filtration rate decrease are the main manifestation. even more, it can progress to end-stage renal changes. data showed that diabetic nephropathy accounts for about 40% of patients with end-stage renal disease receiving renal replacement therapy. however, the treatment of diabetic nephropathy is still lacking. in the past 40 years, few drugs have been proven to ameliorate the progression of diabetic nephropathy. even though, the renal function of a large number of diabetic nephropathy patients is gradually deteriorating. therefore, it is urgent to find a therapeutic drug that acts on different targets. trimetazidine is a piperazine derivative. it is mainly used in the treatment of stable angina pectoris. its safety has been well verified. in recent years, the role of trimetazidine in acute renal damage has been widely reported. a large number of studies have shown that trimetazidine can reduce the effect of contrast agent on renal function and reduce the incidence of contrast nephropathy. there fore, trimetazidine is a promising drug for delaying the progression of diabetic nephropathy.

in the present study, there will be 2 groups last for 6 months. one is the control group, who will not receive trimetazidine and the another is the trimetazidine group, who will receive the treatment of trimetazidine, 35mg bid orally.

Eligibility criteria:
inclusion criteria: 1. older than 18 years of age; 2. type 2 diabetes mellitus; 3. egfr ≥30 to \<90 ml/min/1.73 m2; 4. urinary albumin creatinine ratio (uacr) ≥ 30 mg/g; exclusion criteria: 1. women who are already pregnant or planning to become pregnant; 2. sbp \>180mmhg and/or dbp \>110mmhg; 3. uacr ≥ 3000 mg/g 4. other non-diabetic renal diseases (such as polycystic kidney disease, lupus nephritis, anca-associated vasculitis, etc.); 5. nyha cardiac function grade iii or above 6. those who have a history of cancer or are currently suffering from cancer; 7. receiving immunosuppressant, cytotoxic or other immunosuppressive therapy in the first 6 months; 8. patients with acute coronary syndrome, acute cardiac insufficiency or severe cerebrovascular disease in the previous month; 9. patients refused to comply with the requirements of the study to complete the study; 10. in the investigator's judgment, the patient is unable to complete the study or comply with the requirements of the study (for management reasons or other reasons);
the sparc trial: stereotactic prostate ablative radiotherapy using cyberknife

Conditions: Prostate Cancer

Summary: giving a higher dose of radiation to the dominant tumour nodule within the prostate is hypothesized to improve tumour control. this trial will assess whether this technique, delivered in 5 treatments, can be delivered without increasing side effects.

aim to assess if a focal boost can be delivered to the dominant tumour nodule alongside 36.25 gy in 5 fractions to the whole prostate gland. primary end-point: acute toxicity (radiation therapy oncology group (rtog), international prostate symptom score (ipss)) secondary end-points: prostate specific antigen (psa) nadir and 2-year biochemical control late toxicity (ipss, rtog, international index of erectile function (iief-5)) quality of life (eq5d scale) inclusion criteria * prostate cancer patients with any of the following: * psa\>20 * gleason grade 4+3 or higher * stage t3a * exclusion criteria * nodal or metastatic disease * psa\>40 * stage t3b or higher study interventions this is a phase ii study which will recruit 20 patients. a dose of 36.25 gy in 5 fractions will be delivered to the whole prostate with a simultaneous integrated boost up to 47.5 gy in 5 fractions or to the highest dose possible within dose constraints. the boost volume will be defined on the multiparametric magnetic resonance scan by the specialist radiologist.

Eligibility criteria:
inclusion criteria: prostate cancer patients with any of the following: * psa 20-40 * gleason grade 4+3 or higher * stage t3a exclusion criteria: * nodal or metastatic disease * psa\>40 * stage t3b or higher

Keywords: sbrt (stereotactic body radiotherapy) focal boost prostate