Kornimate/medical-research-clean huggingface dataset:
duloxetine as an analgesic in patients without central sensitivity after same sitting bilateral total knee arthroplasty

Conditions: Osteoarthritis of Knee; Central Sensitization; Central Sensitisation

Summary: analgesic effect of 20mg duloxetine was evaluated at regular short term intervals in patients without central sensitivity and undergoing bilateral single sitting total knee arthroplasty for tricompartmental osteoarthritis using standardised patient related outcome measures like the visual analogue score.

patients who underwent bilateral, single-sitting total knee arthroplasty for tricompartmental knee osteoarthritis were evaluated preoperatively for having central sensitivity. only patients without central sensitisation were recruited and randomised into two groups with one group given 20 mg duloxetine capsules and the other group given a starch capsule of same shape, make, and weight as a placebo. patients were evaluated for pain at rest and movement using vas. a 6-hourly calculation of vas was done over the first 48 hours and the average was recorded. subsequent measurements at 1 week, 2 weeks, 4 weeks, and 3 months after surgery was done by a blinded clinician. additional, drug safety, nsaid consumption and overall patient satisfaction were studied.

Eligibility criteria:
inclusion criteria: * bilateral tricompartmental knee osteoarthritis * underwent primary, bilateral tka in single-sitting exclusion criteria: * american society of anesthesiologists physical status iv * hamilton depression scale (hamd) and/or hamilton anxiety scale (hama) scores \> 7 * known intolerance or allergy to any of the study drugs, alcohol, tobacco, narcotic, or opioid dependence * patients on anticoagulants * known hepatic/renal dysfunction * serious cardiac/cerebrovascular comorbidities * hba1c≥7 * patients who were already on duloxetine or other snris, monoamine oxidase inhibitors, tricyclic antidepressants, triptans, lithium, other antiepileptics, or buspirone.

Keywords: duloxetine total knee arthroplasty analgesic central sensitisation pain snri chronic
association between helioderma and response to immunotherapy in patients with metastatic melanoma

Conditions: Metastatic Melanoma

Summary: melanoma is one of the most aggressive forms of skin cancer, representing only 5% of all skin cancer but 80% of all death by skin cancer. diagnosis and treatment of melanoma must be early because prognosis depends on stage disease. immunotherapy is used in metastatic melanoma. however, all patients not respond to immunotherapy. helioderma (photoaging) is a marker of exposure to uv rays and therefore of mutagenesis. thus, helioderma could be associated with the response to immunotherapy.

the detection and management of melanomas must be very early because the prognosis largely depends on the extent of the disease at the time of diagnosis. for patients with melanoma, immunotherapy or dual therapy is used as treatment in unresectable and metastatic (ajcc stage iv) cases, depending on mutation status. primary immunotherapy is possible in mutated patients in the absence of threatening progression. however, not all patients respond well to immunotherapy, so biomarkers that predict treatment response are needed to optimize patient benefit. the onset, development, and course of melanoma are based on the accumulation of genomic changes, including high loads of ultraviolet-induced mutations, which make melanoma the most immunogenic tumor. in several tumor types, tumor mutation load (tmb) and immune infiltration have been reported to predict response to immunotherapy. indeed, the higher the tmb, the more the tumor is likely to produce a neo-tumor antigen, target of the reactivation of the immune system. no threshold value of tmb has been determined to date, having a predictive value in melanoma. the degree of helioderma could be a potentially discriminating marker of the degree of uv exposure and therefore of mutagenesis. preliminary results have reported the interest of this approach but must be confirmed because it was a small study (russo et al). uv-induced dna damage results in clinical signs of heliodermia or photoaging: more or less deep wrinkles, loss of elasticity, thinning of the skin, lentigo pigmentary disorders, yellowish color of the skin, telangiectasias, on the skin areas exhibited. helioderma could therefore be an easily accessible clinical predictor of a good response to immunotherapy. the aim of the study is to study association between helioderma and response to immunotherapy in patients with metastatic melanoma.

Eligibility criteria:
inclusion criteria: * metastatic melanoma * whatever the mutation braf status * treated by immunotherapy or specific therapy * aged more than 18 * agreeing to participate to the study exclusion criteria: * patient whose treatment by immunotherapy has already started * patient who have had a radiotherapy or chemotherapy treatment * patient with an unknown primary melanoma, choroidal melanoma * patient with other cancer (except basal cell and squamous cell skin cancer) * patient with genetic predisposition for melanoma * aged less than 18 * adult not agreeing to participate to the study

Keywords: metastatic melanoma immunotherapy helioderma response
reduction of cardiovascular risk in severe mental illness

Conditions: Severe Mental Illness; Schizophrenia; Bipolar Disorder; Affective Disorders; Schizoaffective Disorder; Personality Disorder

Summary: background: patients with severe mental illness (smi) have a higher prevalence of cardiovascular risk factors (cvrf) than the general population and a control of these risk factors poorer. serious mental illness often causes health teams to focus interventions in mental illness and put aside the cvrf. objectives: this project aims to assess the cvrf, stratify the cardiovascular risk, adequate drug treatment to reduce this risk and evaluate the effectiveness of an intervention by professional community nurses in patients with smi. materials and methods: prospective study of a cohort of patients over 18 years with a diagnosis of smi with two cross sections to evaluate the cardiovascular risk and adequacy of drug treatment. the investigators calculate the risk to the cardiovascular risk tables with the score (systematic coronary risk evaluation) for countries of low cardiovascular risk and the of framingham regicor (heart registry of girona, spain). the adequacy of pharmacotherapy will be assessed contrasting it with the recommendations of the program of preventive activities and health promotion of family medical association. the intervention will be conducted by professional nurses and consist of an initial psycho-educational intervention, and two more reinforcement throughout twelve months, of duration less than 30 minutes that will be addressed in an integrated manner the clinical situation with regard to cardiovascular risk. if necessary, pharmacological treatment will be prescribed. twelve months after the first intervention, a second evaluation on cardiovascular risk and the effectiveness of the intervention will be performed.


Eligibility criteria:
inclusion criteria: * patients with a severe mental illness as schizophrenia, bipolar disorder, affective disorder, schizoaffective disorder or personality disorder and others who receive clinical follow-up in osona (a county) mental health center. * inclusion will be delayed in patients with acute psychiatric symptoms. exclusion criteria: * renal or hepatic failure, metabolic or endocrine disorder * patients who do not accept to participate

Keywords: cardiovascular risk factor severe mental illness drug appropriateness drug compliance lifestyle counseling
alternate dosing study of mk-6024 in adults with metabolic dysfunction-associated steatotic liver disease (masld) (mk-6024-016)

Conditions: Metabolic Dysfunction-Associated Steatotic Liver Disease; Non-alcoholic Fatty Liver Disease; Nonalcoholic Fatty Liver Disease; Liver Disease

Summary: this study will evaluate the effect of efinopegdutide administration once every 2 weeks (q2w) versus once weekly (q1w) on mean relative reduction from baseline in liver fat content (lfc) after 28 weeks, as well as the safety and tolerability of the different regimens of efinopegdutide.


Eligibility criteria:
inclusion criteria: the main inclusion criteria include but are not limited to the following: * has body mass index (bmi) ≥25 kg/m\^2 (≥23 kg/m\^2 for asian participants) and has stable weight, defined as ≤5% gain or loss of body weight for at least 3 months before screening * has no history of type 2 diabetes mellitus (t2dm) or has a history of t2dm with a glycated hemoglobin (a1c) ≤9% and the t2dm is controlled by diet or stable doses of oral antihyperglycemic agents (ahas) exclusion criteria: the main exclusion criteria include but are not limited to the following * has a history or evidence of chronic liver disease other than metabolic dysfunction-associated steatotic liver disease (masld) or metabolic dysfunction-associated steatohepatitis (mash) * has evidence of decompensated liver disease including, but not limited to ascites, esophageal or gastric variceal bleeding, hepatocellular carcinoma, hepatic encephalopathy, splenomegaly, or spontaneous bacterial peritonitis * has a history of pancreatitis * has a history of type 1 diabetes mellitus (t1dm), diabetic ketoacidosis, or diabetes secondary to pancreatectomy. * has symptomatic hyperglycemia * has a history of a bariatric surgical procedure ≤5 years before screening or a known clinically significant gastric emptying abnormality * has a history of obesity with a known secondary cause * has significant systemic or major illnesses, including recent (≤6 months before screening) onset of events of congestive heart failure, unstable angina, myocardial infarction, arterial revascularization, stroke, or transient ischemic attack * is unable to have magnetic resonance imaging-estimated proton density fat fraction (mri-pdff) due to: claustrophobia to a degree that prevents tolerance of an mri-pdff scanning procedure. note: sedation is permitted, at the discretion of the investigator; metallic implants that prevent mri-pdff examination; exceeds the body habitus and/or weight limitations for the mri scanner
randomized clinical trial evaluating the efficacy of topical imiquimod in high grade cervical intraepithelial lesions

Conditions: High Grade Intraepithelial Neoplasia; Cervix Cancer

Summary: cervical cancer is one of the leading malignancies affecting women, with 311,000 deaths in 2018, most of them seen in underdeveloped countries. this neoplasm has a pre-invasive state, such as cervical intraepithelial neoplasia (cin), which is caused by hpv (human papillomavirus) infection. the female organism most often is able to eliminate the virus, especially in young patients. however, when the infection becomes persistent, especially for subtypes 16 and 18, the risk of cin developing an increased. cytological screening programs can efficiently and wirelessly do this. as high-grade intraepithelial lesions (cin 2/3) are as demonstrated by worse regression rate, only 13.3% at one year, and higher risk for progression to invasive cancer. as cin 2/3 need treatment, and as more therapies as they are excisional, which theoretically are better, however, they may compromise the reproductive future of women who are unthreatened, increasing the risk of preterm labor, premature rupture of amniotic membranes, low weight birth and perinatal mortality. this relationship aroused interest in seeking alternative therapies. decrease antiviral activity directed against hpv, associated with a higher rate of elimination of the infection. immediate, an agent that stimulates like dendritic cells to producer cytokines and activates epithelial t cells. imiquimode, when used in vulvar neoplasias, has been shown to be effective, presenting satisfactory results without treatment of cin 2/3 of the uterine cervix, requiring a better scientific compilation. based on these data, this study aims to evaluate the efficacy of topical immunomodulatory treatment for high-grade cervical intraepithelial lesions.


Eligibility criteria:
inclusion criteria: * women between the ages of 25 and 50 with histological diagnosis of cin 2/3; * living 300 km or less from the city of barretos-são paulo / brazil. exclusion criteria: * suspected adenocarcinoma (in situ or invasive) or invading squamous cell carcinoma by colposcopy and/or citology; * being pregnant or breastfeeding; * women with some immunodeficiency or transplanted; * previous treatment history for cin 2/3.

Keywords: high grade cervical intraepithelial neoplasia immunomodulatory treatment
interest of treatment of obstructive sleep apnea syndrome by constant cpap and auto cpap

Conditions: Obstructive Sleep Apnea Syndromes

Summary: the investigators propose a multicentric controlled randomized trial whose goal is to evaluate the possibility of a prediction of the efficiency of apap (automatic continuous positive airway pressure) and constant cpap (constant positive airway pressure) in 800 severe obstructive sleep apnea syndrome (osas) patients according to their profile of pressure variability.

multicenter open randomized clinical trial involving 800 patients with severe osas. after inclusion in the study, the patients will be proposed to initiate cpap at home (resmed s9 or philips pr1) using systematically an apap mode between wide range of pressure variations (4 to 20 cm h2o) during the first 7day-period of time. after this first period of treatment, an analysis of the report will be released from the apap in order evaluate the residual ahi, the duration of cpap use and the amount of leaks in order to confirm cpap efficiency and observance. pressure parameters (efficient pressure and variability) will be collected. after randomization according to the further mode of ventilation to use (apap vs constant cpap), the patients will be treated at home for 3 months. in the constant cpap group, efficient pressure will be determined as the p95 (resmed) or the p90 (philips) as recommended by the manufacturers, while in the apap group, the patients will be treated within the same range of pressure variations than during the first 7 day-period. clinical and polygraphic evaluation will be done after 3 months of treatment, using the combined criteria previously described. in each group, results will be considered according to the efficient pressure value and its variability that were evaluated at the end of the first 7 day-period of treatment

Eligibility criteria:
inclusion criteria: * adult patients \> 18 with severe osas (ahi \> 30/h) * patients naive of any previous osas treatment * written informed consent exclusion criteria: patients * with more than 20% of central events at the initial polygraphic recording * previously treated by cpap * previously treated for osas by any surgical procedure involving upper airways * \< 18 * with cardiac insufficiency * with chronic obstructive pulmonary disease or obesity-hypoventilation syndrome * without health insurance * pregnant or lactating * presumed uncooperativeness or legal incapacity
freestyle libre and hospital admissions in type 2 diabetes

Conditions: Type 2 Diabetes

Summary: this study aims to investigate the utility of a combination of structured nurse led intervention and the use of freestyle libre in adults with type 2 diabetes who have suffered an episode of severe hypoglycaemia in terms of mortality, unscheduled healthcare contacts and quality of life.

it is increasingly recognised that hypoglycaemia carries risk to individuals with all forms of diabetes. research has shown high rate of mortality in those with type 2 diabetes following an episode of severe hypoglycaemia and a previous pilot trial conducted in the uk suggested that this could be improved by a structured nurse led intervention aimed at modifying glycemic therapy to avoid hypoglycaemia, instigating regular blood glucose monitoring and providing education to participants on common triggers for hypoglycaemia and how to avoid them. in this trial, the investigators will randomise individuals with type 2 diabetes who have suffered an episode of severe hypoglycaemia requiring emergency service call out to two arms. one arm will receive standard of care/treatment as usual and the other will receive a structured nurse led intervention as well as the use of a flash glucose monitoring system, freestyle libre. active participation in the trial for both arms will be a total of twelve months (with the main intervention months 0-6.) participants electronic records will be analysed for death and unscheduled healthcare contacts for a total of two years after recruitment. the primary outcome measure is mortality between groups. secondary outcomes include the use of estimated hba1c (a variable produced by the freestyle libre device) compared to laboratory hba1c, quality of life measures, effects on glycemic control and the number of unscheduled healthcare contacts.

Eligibility criteria:
inclusion criteria * aged \>18 * confirmed diagnosis of type 2 diabetes * suffered an episode of severe hypoglycaemia requiring ambulance call out * able to provide informed written consent exclusion criteria * a form of diabetes mellitus which is not type 2 or the diagnosis is uncertain * currently pregnant * dialysis dependent renal failure * unable to provide informed written consent

Keywords: hypoglycaemia
clinical study of asahi vie dialyzer in canada

Conditions: Kidney Failure, Chronic

Summary: the purpose of the study is to obtain performance data on the asahi vie-21 dialyzer (vie-21) .

the objective of the study is to evaluate specific parameters related to vie-21 performance including (a) performance evaluated by uremic solute removal rates of urea, creatinine, albumin and b2-mg, (b) determination of kuf, (c) biocompatibility evaluated by wbc, platelet and c3a measurements, (d) type and number of adverse events, (e) type and number of device malfunctions. prospective, open-label, non-randomized, single-armed, controlled study. each patient shall have data collected for six dialysis sessions each on a control dialyzer prior to and after 36 sessions with the vie-21. these data shall be the basis of comparison for the vie-21 performance. these data will be utilized in support of a us regulatory submission.

Eligibility criteria:
inclusion criteria: 1. patients ≥ 18 years and ≤ 80 years of age 2. stable on maintenance hemodialysis for at least 12 weeks 3. patients expected to remain on hemodialysis for at least 24 weeks 4. patients on hemodialysis for more than 3 hours per treatment and on a 3 times per week schedule 5. patients whose vascular access is obtained via arteriovenous fistula or graft, is well maintained and is capable of obtaining blood flow rate ≥ 350 ml/min during the study period 6. patients using high-flux dialyzers (kuf ≥ 40 ml/hr/mmhg) with surface area ≥ 1.5 square meters and ≤ 2.2 square meters 7. patients capable of understanding the informed consent form 8. written consent and willingness to participate in the study exclusion criteria: 1. medical conditions requiring regular blood transfusion 2. patients with a history of more than one week hospitalization related to infection, inflammation or surgery within the past 12 weeks 3. patients having participated in another clinical investigation within the past 12 weeks, currently participating or having a plan of participating in any other clinical investigation (patients in an observational study without any interventions or in post-market surveillance do not need to be excluded) 4. patients who have difficulty in maintaining vascular access function within the past 12 weeks 5. patients who are known to be hepatitis b virus (hbv), hepatitis c virus (hcv) or human immunodeficiency virus (hiv) positive 6. female patients who are pregnant, breast feeding or planning a pregnancy within the study period 7. patients having received blood purification therapy other than conventional dialysis within the past 12 weeks 8. patients who cannot tolerate heparin 9. any serious medical, social or psychological condition that in the opinion of the investigator would disqualify a patient from participation
comparative clinical trial to evaluate efficacy and safety of bcd-055 and remicade® in patients with ankylosing spondylitis

Conditions: Ankylosing Spondylitis

Summary: bcd-055-2 is international multi-center comparative double-blind randomized clinical trial to evaluate efficacy and safety of bcd-055 (jsc "biocad", russia) and remicade® in patients with ankylosing spondylitis. bcd-055 is biosimilar of infliximab (jsc "biocad", russia)


Eligibility criteria:
inclusion criteria: * signed informed consent * active ankylosing spondylitis according to modified criteria of new york classification (1984), that was diagnosed at least 3 months prior to screening. * active disease according to basdai (score 4 or more) if nonsteroidal antiinflammatory drugs were used in the last 3 month prior to screening. * mean backache intensity equals 4 points or more. exclusion criteria: * previous therapy of ankylosing spondylitis with monoclonal antibodies (including tumor necrosis factor) * total spinal ankylosis * history of tuberculosis * body mass more than 120 kg * patient is taking corticosteroids for up to 4 weeks in a dose more than 10 mg (recalculated to prednisolone) before signing informed consent. * prior use of disease-modifying antirheumatic drugs including methotrexate, sulfasalazin, chloroquine or hydroxychloroquine for up to 4 weeks before randomization. * prior use of alkylating agents for up to 12 months prior to signing informed consent. * intraarticular use of corticosteroids for up to 4 weeks before randomization. * prior use of live or attenuated vaccines for up to 8 weeks before signing informed consent.