Kornimate/medical-research-clean huggingface dataset:
protandim and the metabolic syndrome

Conditions: Metabolic Syndrome

Summary: protandim will decrease markers of oxidative stress/inflammation in subjects with metabolic syndrome and proteomics will identify protein profiles that correlate with markers or/changes in oxidative stress.

evaluate the effects of protandim on protein profile changes and markers of inflammation and oxidation in subjects (40-60 years of age) with the metabolic syndrome.

Eligibility criteria:
inclusion criteria: * age = 40-60 years of age * meets at least 3 of the 5 criteria for the metabolic syndrome (as defined by ncep/atp iii criteria) ncep/atp iii criteria * central obesity as measured by waist circumference: * men - greater than 40 inches * women - greater than 35 inches * fasting blood triglycerides greater than or equal to 150 mg/dl * blood hdl cholesterol: * men - less than 40 mg/dl * women - less than 50 mg/dl * blood pressure greater than or equal to 130/85 mmhg or on anti-hypertensive rx * fasting glucose greater than or equal to 100 but \< 125 mg/dl exclusion criteria: * women taking hormone replacement therapy for post menopause * signs or symptoms of acute coronary syndrome * history of congestive heart failure (prior myocardial infarction, coronary artery disease including stent placement, coronary artery bypass graft, ebct calcium score of at least 100, or a positive stress test) * serum creatinine \> 1.5 mg/dl, ast or alt \> 2 times uln, hga1c \>6.5%, severely depressed or elevated blood cell lines, triglycerides \> 500, tsh outside of normal range, elevated calcium, blood pressure \> 160/100, urine protein \> 30 ,g/dl. * concurrent medical conditions/illnesses in which expected life expectancy is 2 years or less and/or are likely to require frequent hospitalizations and treatment adjustments (e.g., cirrhosis, active malignancy, , or highly active rheumatologic condition, lupus, rheumatoid arthritis or chronic obstructive pulmonary disease and diabetes). * participation in any other investigational substance or medical device study within 30 days before this trial and/or participation in such entity during this trial. * known pregnancy. * supplementation with nutraceuticals or if so one month washout before initiating the study before initiating this trial. * taking statins or fibrates to lower cholesterol * inability or unwillingness to provide written informed consent
safety and effectiveness of ciclesonide nasal spray in patients with perennial allergic rhinitis during one year treatment (by9010/m1-404)

Conditions: Perennial Allergic Rhinitis; Allergic Rhinitis; Hay Fever

Summary: the purpose of this study is to investigate the safety and effectiveness of ciclesonide nasal spray as compared with placebo (inactive substance) nasal spray in relieving symptoms of perennial allergic rhinitis.


Eligibility criteria:
main inclusion criteria: * general good health, other than perennial allergic rhinitis * history and diagnosis of perennial allergic rhinitis by skin prick test main exclusion criteria: * participation in any investigational drug trial within the 30 days preceding the screening visit * a known hypersensitivity to any corticosteroid or any of the excipients in the formulation * use of any prohibited concomitant medications as defined by the study protocol

Keywords: allergy perennial allergic rhinitis allergic rhinitis hay fever
determination of the antidepressant duloxetine in plasma to improve the knowledge of the analgesic action of antidepressants on chronic neuropathic pain

Conditions: Neuropathic Pain

Summary: the primary purpose of this protocol is to evaluate the lowest plasma concentration (ie before the daily taking dose of duloxetine) in patients relieved of at least 30% of their neuropathic pain with duloxetine treatment. the secondary purpose of this protocol is to determine plasmatic concentration peak (ie 6 hours after taking duloxetine) in patients relieved of at least 30% of their neuropathic pain with duloxetine treatment. others secondary purposes are to evaluate the intensity of neuropathic pain, to assess the degree of pain relief and to evaluate the sensation of the global improvement experienced by the patient.


Eligibility criteria:
inclusion criteria: * aged 40 to 75 years old * relieved of their neuropathic pain by 60 mg of duloxetine treatment (with a differential of\> 30% in the intensity of neuropathic pain with nrs, before and after treatment initiation) exclusion criteria: * concomitant treatment with enoxacin, fluvoxamine, flecainide, propafenone, metoprolol, risperidone, verapamil, omeprazole, modafinil, mequitazine, propafenone, tamoxifen, monoamine oxidase inhibitors.

Keywords: neuropathic pain antidepressant duloxetine liquid chromatography mass spectrometry
prehabilitation for gastrectomy

Conditions: Gastric Cancer

Summary: prehabilitation has been demonstrated to be an effective strategy to improve outcomes in patients undergoing some of the abdominal operations. it may increase the physical capacity of the patient, improve postoperative quality of life and even decrease the postoperative morbidity. currently, the most effective strategy seems to be a trimodal prehabilitation which includes: 1) nutritional support 2) psychological support and 3) physical training.

this study will investigate personalized trimodal prehabilitation for patients undergoing gastrectomy for gastric cancer. prehabilitation group: patients will undergo 6 minutes walking test (6-mwt), spiroergometry (vo2 max; at), a grip strength test, a timed up \& go (tug) test, 10 m sprint test and sit to stand test before and after prehabilitation. the trimodal intervention will involve: 1. nutritional intervention: the dietetic physician will perform physical examination and evaluation of the nutritional status to provide individualized care to each patient. patients will receive personalized recommendations for the prevention or correction of malnutrition. 2. psychological intervention: patients will undergo consultation by specialized onco-psychologist. the anxiety and depression level will be evaluated by had score and patients will be trained to perform techniques, such as relaxation to reduce and manage anxiety on at home basis. the psychologist also will enhance patients' motivation to comply with the exercise and nutritional aspects of the intervention. 3. exercise intervention: patients will be consulted by pm\&r physicians and physiotherapists and personalized exercise plans will be developed according to the results of 6mwt, at and vo2peak. exercises will focus on skeletal muscles and cardiopulmonary function training and the exercises feasible at home basis will be selected. all patients will undergo three supervised training sessions to learn the correct exercise techniques. all patients will be routinely contacted to ensure compliance with prehabilitation program. patients scheduled for surgery first by multidisciplinary tumor board will undergo 4 weeks prehabilitation program, while patients scheduled for perioperative chemotherapy will undergo prehabilitation while neoadjuvant treatment will be administered. control group: patients will also undergo 6 minutes walking test (6-mwt), spiroergometry (vo2 max; at), a grip strength test, a timed up \& go (tug) test, 10 m sprint test and sit to stand test before surgery or before and after neoadjuvant chemotherapy. patients will not undergo prehabilitation.

Eligibility criteria:
inclusion criteria: * patient ≥ 18 years old * patient agrees to participate in a clinical study * patient requires surgical treatment for gastric cancer exclusion criteria: * patient requiring surgical treatment for recurrent gastric cancer * patient condition not allowing to postpone surgery for at least 4 weeks * patients physical or mental condition which will not allow the patient to participate in prehabilitation program
the prognostic value of serum biomarkers in osteosarcoma

Conditions: Osteosarcoma

Summary: observational retrospective cohort study using laboratory data of blood tests prior to surgical and chemotherapy treatment and other histologic, clinical, and instrumental data related to patient history from digitized medical records and analysis of the same as predictors of outcomes.


Eligibility criteria:
inclusion criteria: * osteosarcoma diagnosed at the pathological anatomy of the rizzoli orthopaedic institute in bologna; * minimum 2-year follow-up period; * medical records, complete blood work and instrumental examinations, regular follow-up; * patients with age ≥ 2 years; exclusion criteria: * patients with osteosarcoma who have received medical treatment (surgery, radiotherapy or chemotherapy) in other hospitals prior to admission to our institute
optimized referral of knee patients to the orthopedic outpatient clinic

Conditions: Osteoarthritis, Knee

Summary: the purpose of the study is to evaluate an algorithm to screen patients with suspected knee osteoarthritis referred to an orthopedic outpatient clinic by using radiographs and patient-reported symptoms. it will be investigated whether the algorithm is able to identify which patients that are deemed relevant to undergo an orthopedic assessment. this will be evaluated by estimating the sensitivity of the new algorithm compared to with the traditional clinical assessment of the patients.

further description is provided as eligibility criteria and outcome measures.

Eligibility criteria:
inclusion criteria: * all patients with a new referral to the orthopedic outpatient clinic with suspected knee osteoarthritis. exclusion criteria: * cognitive or language problems that precludes the filling in of the questionnaires * unwillingness to answer the questionnaires * patients with rheumatoid arthritis, neurological diseases or cancer

Keywords: referral and consultation orthopedics
treatment of primary type i pterygia with argon laser

Conditions: Pterygium

Summary: introduction: pterygium is a wing shape degenerative and hyperplastic growth of the bulbar conjunctiva extending onto the cornea, most commonly on the nasal side. management of pterygium can be medical, surgical or combined. alternative treatments as photocoagulation of blood vessels of the pterygium, have been described, especially in recurrent pterygia. objectives: to determine whether argon laser treatment reduces the symptoms and pterygium size in primary type i pterygia patients when compared with medical treatment. subjects and methods: prospective, comparative and interventional study. patients with type i pterygia in both eyes were included. the eyes were randomly divided to receive either argon laser treatment or only topical medical treatment

pterygium is a wing shape degenerative and hyperplastic growth of the bulbar conjunctiva extending onto the cornea, most commonly on the nasal side. management of pterygium can be medical, surgical or combined. alternative treatments as photocoagulation of blood vessels of the pterygium, have been described, especially in recurrent pterygia. to determine whether argon laser treatment reduces the symptoms and pterygium size in primary type i pterygia patients when compared with medical treatment. subjects and methods: prospective, comparative and interventional study. patients with type i pterygia in both eyes were included. the eyes were randomly divided to receive either argon laser treatment or only topical medical treatment

Eligibility criteria:
inclusion criteria: * patients who had had symmetric type i pterygia in both eyes * assessments for the 6 month follow-up period after argon laser treatment exclusion criteria: * patients with diabetes mellitus, collagenopathies, previous ocular surgeries, and pregnant patients
optimized treatment strategy for highgrade1 (hgt1) bladder cancer based on substaging: a prospective observational cohort study

Conditions: Bladder Cancer

Summary: non-muscle invasive bladder cancer of high grade stage t1 (hgt1), has up to 20% risk of progression to invasive disease. because the depth of substaging seems to identify two separate groups with different progression risk (highgradet1a and highgradet1b), we design a differential treatment strategy for each group. the main hypothesis is that highgradet1a bladder cancer can spare a second endoscopic procedure.

only cases of initial diagnosis of highgradet1 and with a complete transurethral endoscopic resection (tur) of bladder tumor) can enter this protocol. highgradet1a will only receive standard bcg treatment (induction and maintenance). highgradet1b will undergo a second transurethral endoscopic resection (tur) after the induction of bacillus de calmette-guerin (bcg) and then continue mantenaince bcg and standard follow-up.

Eligibility criteria:
inclusion criteria: * hgt1 bladder cancer at initial diagnosis and after a complete tur exclusion criteria: * abscence of muscularis propria in the tur specimen

Keywords: hgt1 high risk bladder cancer substaging repeat transurethral resection (retur) lamina propria
role of statin in venous dysfunction in patients with venous thromboembolism event

Conditions: Venous Thromboembolism; Dyslipidemias

Summary: participants between the ages of 19 and 70 who were initially diagnosed with venous thromboembolism and were accompanied by dyslipidemia (ldl\> = 100 mg / dl) were enrolled. participants diagnosed with pulmonary embolism, pulmonary embolism ct, and peripheral b-mode ultrasound (b-mode ultrasound) only participants who do not meet the exclusion criteria should be enrolled in the study. once the participant is selected, the patient is informed of the study and receives the consent form. participants who are eligible for all of the criteria and who do not qualify as exclusion criteria should be enrolled in the study and randomly enrolled in a 1: 1 dose of rosuvastatin 20 mg once daily or equivalent. participants who previously used statins have a wash-out period of two weeks or more participants undergo a visit at 12 weeks after initiation of treatment. for fasting blood tests, patients visit on an empty stomach. outpatient follow-up observes side effects after last visit and observes changes in vital signs and weight. after 24 weeks of treatment, the participant visits for efficacy evaluation. we performed body weight, vital signs and blood tests (wbc, hemoglobin, bun, creatinine, crp, d-dimer, fibrinogen, pai-1, ast, alt, ck, total cholesterol, triglyceride, hdl and ldl). 1. primary evaluation item: improvement of venous insufficiency at 6 months 2. secondary evaluation items: improvement of blood lipid concentration, inflammation and blood clotting at 6 months comparison of numerical rate of change 3. tertiary evaluation items: recurrence of venous thrombosis


Eligibility criteria:
inclusion criteria: * 1. patients who were initially diagnosed with venous thromboembolism * 2. patients who were between 19 and 70 years of age with dyslipidemia (ldl\> = 100 mg / dl) exclusion criteria: * 1. under 18 * 2. active cancer status * 3. known cvd (ischemic heart disease, stroke, peripheral artery disease) * 4. ldl\> 190ml / dl or ldl \<100mg / dl * 5. contraindication for anticoagulation (noac) * 6. contraindication for statin(pregnancy, breastfeeding, active liver disease, elevation of liver enzymes, allergic reaction to a statin) * 7. patients with vital sign unstable with massive vte * 8. dvt remains in the vascular ultrasound
mr-guided prostate stereotactic body radiotherapy in seven days

Conditions: Prostate Cancer

Summary: the proseven trial is a prospective interventional study that will evaluate the toxicity and efficacy of mr-guided stereotactic body radiotherapy (sbrt) in the profound hypofractionated treatment of prostate cancer. patients will be treated in 5 daily fractions within a short overall treatment time (ott) of 7 days. a simultaneous integrated boost (sib) will be delivered to the intraprostatic dominant lesion (if present) in this study. besides a potential biological impact of this innovative prostate sbrt treatment, the reduced ott offers also benefits in terms of patient convenience. the primary endpoint is clinician reported grade 2 or more acute gastrointestinal (gi) and genitourinary (gu) toxicity, assessed using ctcae v 5.0 and rtog, measured up to 3 months after the first treatment fraction.


Eligibility criteria:
inclusion criteria: * age \> 18 y * histologically confirmed prostate adenocarcinoma * low risk: ct1c-t2a, gleason score 6, psa \< 10ng/ml * favorable intermediate risk: 1 intermediate risk factor, gleason 3+4 or less, \< 50% positive biopsy cores) * unfavorable intermediate risk: \> 1 intermediate risk factor, gleason 4+3, \> 50% positive biopsy cores) * limited high risk: ct3a with psa \ 7 and/or a psa \> 20ng/ml but \< 40ng/ml * world health organization performance score 0-2 * written informed consent intermediate risk factors: t2b-t2c, gleason 7, psa 10-20 ng/ml exclusion criteria: * transurethral resection (tur) \< 3months before sbrt * international prostate symptom score (ipss) \> 19 * prostate volume \> 100cc on transrectal ultrasound (trus) * stage ct3b-t4 * n1 disease (clinically or pathologically) * m1 disease (clinically or pathologically) * psa \> 40ng/ml * inflammatory bowel disease * immunosuppressive medications * prior pelvic rt * contra-indications for mri

Keywords: mr-guided radiotherapy stereotactic body radiotherapy
mindfulness based stress reduction in multiple sclerosis (ms)

Conditions: Multiple Sclerosis

Summary: this study focuses on stress, cognition, mood and fatigue and its effect on medication compliance. medication compliance is measured by the weight of discarded needles. the investigators will be administering neuropsychological testing at baseline and the final visit. the subjects will complete self-report assessments during their 8 weeks in the study. group a will have additional weekly phone support for meditation, while group b will have meditation training only.


Eligibility criteria:
inclusion criteria: * patients with either definite ms according to the revised mcdonald criteria (polman 2005) or patients with cis (defined as an initial ms relapse with objective documentation and 2 or more lesions within the cns of which at least one must involve the brain) * patients on ga therapy for at least 6 months * age 18 - 70 exclusion criteria: * unwilling to comply with study procedures * use of other dmt in conjunction with ga * unable to provide informed consent. * current (past 30 days) substance abuse * newly initiated (past 30 days) psychiatry treatment * enrolled in another program of meditation in the past six months.

Keywords: multiple sclerosis glatiramer acetate stress reduction medication adherence
unilateral epidural block versus ultrasound guided combined femoro-sciatic nerves block for patients with low ejection fraction

Conditions: Low Ejection Fraction Patients; Fracture Tibia

Summary: compare unilateral epidural anesthesia versus femoral/sciatic nerve block by ultrasound guided as anesthetic technique for cases with low ejection fraction undergoing insertion of nail tibia for fixation of fracture shaft tibia.

group a ;( unilateral epidural anesthesia group) forty patients with low ejection fraction (30-40%) will do elective insertion of nail tibia for fixation of fracture shaft tibia using unilateral epidural anesthesia. group b;;( ultrasound guided femoro/ sciatic nerve block group) forty patients with low ejection fraction (30-40%) will do elective insertion of nail tibia for fixation of fracture shaft tibia by femoral/sciatic nerve block using ultrasound guidance. for each patient, onset of sensory and motor block, degree of motor block, sign of sensory block in the contralateral lower limb for the epidural group, success in providing adequate anesthesia, hemodynamic changes, time of first analgesic request will be recorded.

Eligibility criteria:
inclusion criteria: * age 18 to 60 years old. * patients scheduled for elective insertion of nail tibia for fixation of fracture shaft tibia. * patients with low ejection fraction (30-40%). exclusion criteria: * patient refusal * uncooperative patient * unconscious patients * cases with head trauma * history of relevant drug allergy to local anesthetics * local infection at the site of the block * patients with coagulopathies and impaired platelet functions * patients with hemodynamic instability * previous neurological deficit in lower limb and previous femoral artery grafts or injuries.
utilization of a periodontal endoscope in nonsurgical periodontal therapy

Conditions: Periodontitis, Adult

Summary: the purpose of this study was to compare the clinical outcomes of teeth deep cleaning or scaling and root planing (srp) using a periodontal endoscope (perioscopy®) versus traditional srp using magnifying loupes for up to twelve months, utilizing a split mouth design.

twenty-five (25) patients were recruited for the study that exhibited mild to moderate periodontitis. srp or deep cleaning was rendered by the same experienced hygienist, following random assignment of the left or right half of the mouth to either recieve deep cleaning by using a periodontal endoscope (perioscopy®) or traditional deep cleaning using magnifying loupes. all the periodontal evaluations were done by the same periodontal resident at baseline, one month, three months, six months, and twelve months after deep cleaning.

Eligibility criteria:
inclusion criteria: * 18 years of age or older * in good general health * given a diagnosis of mild-moderate generalized chronic periodontitis per the 1999 world workshop classification of periodontal diseases and conditions * required whole mouth srp * teeth had a maximum of 6mm probing pocket depth at any site * at least one molar present in each arch, excluding third molars. exclusion criteria: * any requirement for antibiotic premedication prior to dental treatment * uncontrolled hypertension * uncontrolled diabetes * subject unwilling to sign the informed consent * subject needed any antibiotic intervention for unrelated conditions

Keywords: periodontitis scaling, subgingival non-surgical periodontal therapy
tight closed-loop systolic arterial pressure control

Conditions: Cardiovascular Diseases

Summary: the purpose of this case series is to evaluate the performance of a novel closed-loop (automated) vasopressor administration system that delivers norepinephrine using feedback from standard operating room hemodynamic monitoring (ev1000 monitoring device, edwards lifesciences, irvine, usa).

in this case series, the investigators will report the percentage of case time in hypotension (defined as systolic arterial pressure (sap) \< 117mmhg). the target mean arterial pressure (map) will be set at a sap of 130mmhg in all patients. definition of hypotension is target sap - 10% (130mmhg - 13 mmhg = 117 mmhg). we will use the same sap target in all patients even if we used a modified definition of hypotension from the study of futier and colleagues ( jama 2017). we won't use a individualized sap for each patient but the same sap target in all patients. the investigators want to demonstrate that the closed-loop system can prevent hypotension at this specific set point. the investigators have shown the system works well based on a target map but not yet using a target of sap. the investigators will test the system in a pilot study of 13 patients undergoing high-risk abdominal surgery which require the placement of a arterial catheter, the optimization of fluid therapy and a tight sap control. participants will receive standard patient care in that in no way will their anesthetic or surgical procedure will be altered as part of the study, with the exception of vasopressor administration ( automatically delivery instead of manually adjustments) fluids will be given as goal directed fluid therapy in order to maintain stroke volume variation below 13% (hospital guidelines).

Eligibility criteria:
inclusion criteria: * adult patients (age of \>17) * elective high-risk abdominal surgery * patients with an arterial line and in whom a goal directed fluid therapy protocol is applied manually (administration of fluid bolus to maintain a stroke volume variation \< 13%) exclusion criteria: * atrial fibrillation * pregnancy * subjects without the capacity to give informed consent