Kornimate/medical-research-clean huggingface dataset:
vortioxetine vs sertraline in mexicans

Conditions: Depression; Type 2 Diabetes Mellitus

Summary: depression in patients with type 2 diabetes is often undiagnosed and remains untreated, leading to poor therapy adherence and ill health-related outcomes. the aim of study was evaluated the effect of vortioxetine versus sertraline in the treatment of depression, diabetes-related distress and control metabolic in subjects with type 2 diabetes and depression. was included patients who were glycosylated hemoglobin ≥ 7.5%, 18 to 60 years of age and written consent . pharmacological treatment for depression was assigned randomly: vortioxetine (10 mg/day) or sertraline (75 mg/day) for 8 weeks. biochemical parameters, anthropometric measures and depression symptoms were evaluated before and at the and at the 8 weeks after antidepressant treatment.

the assessment consisted of an extended face-to-face interview. the patients answered a structured questionnaire used to collect: sociodemographic characteristics (gender, age, education, occupation and marital status) and clinical data (pharmacotherapy, habits, consumed of drugs, diabetes complications and comorbidities). depression was screened using hamilton depression rating scale score ≥ 14 (ham-d), center for epidemiologic studies depression scale revised in spanish (ces-dr35), and problem areas in diabetes questionnaire (paid-v); anthropometrics measurements were evaluated (weight, waist circumference and body mass index). besides, blood samples were drawn for the following biochemical parameters: fasting plasma glucose, glycated hemoglobin (hba1c), cholesterol and triglycerides. patients who gave informed consent and convened inclusion criteria were attended by a psychiatrist. the pharmacological management were randomly assigned: vortioxetine (10 mg/day) or sertraline (75 mg/day) for 8 weeks, in addition, the patients maintained their established anti-diabetic treatment (oral hypoglycemic or insulin). the study ended at the 8th week, subjects were attended by psychiatrist and blood samples were drawn for evaluated biochemical parameters and the structured questionnaire previously described was applicated.the clinical measures and biochemical parameters were done baseline and after 8-week pharmacological treatment. finally the effect of both antidepressants were compared.

Eligibility criteria:
inclusion criteria: * individuals had to be between 18 and 85 years of age * clinical diagnosis of type 2 diabetes mellitus based on the american diabetes association criteria, * they had to receive anti-diabetic treatment, clinical diagnosis of major depressive episode according association diagnostic and statistical manual of mental disorders, five edition (dsm-v) * ratings scale score ≥ 14 by means of hamilton depression scale (ham-d) * patients had to give verbal and written informed consent for this study exclusion criteria: * neurological illness * psychoactive medications * type i diabetes * active suicidal ideation.

Keywords: depression type 2 diabetes mellitus vortioxetine sertraline
neurophysiological attention test (nat) for objective assessment of adult adhd

Conditions: Attention Deficit Hyperactivity Disorder

Summary: the purpose of this study is to refine a new assessment tool for attention deficit/hyperactivity disorder (adhd) and then to test its validity (i.e. ability to discriminate between individuals with adhd and healthy controls.

the purpose of this study is to build upon the success the novel approach and software for analyzing electroencephalography (eeg) data to identify biomarkers of adhd in adults by further refining the method. then to test the ability of this new assessment tool to differentiate between adults with adhd and healthy controls by comparing the classification accuracy of the metrics from the new tool to the classification accuracy of existing behavioral tests for adhd.

Eligibility criteria:
inclusion criteria: specific inclusion criteria for adhd are: 1. meet established diagnositic and statistical manual-5 criteria for adhd predominately inattentive or combined subtype with clinically significant levels of impairment, diagnosed by structured clinical interview, the mini international neuropsychiatric interview, and corroborating information 2. clinical global impression-severity (cgi-s) score ≥ 4 for adhd 3. no lifetime history of dsm-5 bipolar disorder, psychotic disorder, pervasive developmental disorder, obsessive-compulsive disorder, substance abuse, or substance dependence (except nicotine) as assessed with the mini international neuropsychiatric interview (mini). 4. able in the opinion of the investigator to complete all required study procedures. exclusion criteria: exclusion criteria for both groups are: 1. history of diagnosis of childhood disorder other than adhd (e.g. autism, dyslexia) 2. history of any general medical condition likely to require chronic use of medication with identified central nervous system (cns) effects suspected to alter cognitive performance 3. history of seizure disorder, brain tumor, other major neurological disorder or head injury resulting in loss of consciousness 4. serious oxygen deprivation 5. current psychopathology requiring ongoing treatment with antipsychotic medications, mood stabilizers, benzodiazepines, or anticonvulsants 6. current untreated psychopathology which is rated to be primary in terms of severity (greater than adhd severity) 7. current treatment with guanfacine.

Keywords: electroencephalography attention
the impact of pentoxifylline and vitamin e on radiotherapy-induced toxicity in head & neck cancer patients

Conditions: Head and Neck Neoplasms

Summary: the purpose of this study is to determine whether pentoxifylline and vitamin e are effective in prevention of radiotherapy- induced toxicity in head and neck cancer patients treated with concurrent chemoradiotherapy.

this is a randomized controlled prospective study of pentoxifylline and vitamin e given on daily basis throughout the period of concurrent chemoradiotherapy to patients with carcinoma of the head and neck. all patients will be followed up to 90 days since the first day of treatment. the incidence and severity of adverse events will be assessed according to the national cancer institute common terminology criteria for adverse events version 4.

Eligibility criteria:
inclusion criteria: * adult patients * measurable disease * patients with squamous cell carcinoma of the head and neck eligible for treatment with concurrent chemo- radiotherapy * able to understand and willing to sign a written informed consent document exclusion criteria: * pregnant or lactating women, since imaging cannot be done in this setting. * patients treated with vitamin e and/ or pentoxifylline for any other indication * patients with recent cerebral and/or retinal hemorrhage * patients who have previously exhibited intolerance to pentoxifylline or methylxanthines such as caffeine, theophylline, and theobromine. * patients treated with oral anticoagulants. * absolute neutrophil count ≤1.5×109/l * platelets ≤100×109/l * ast ≥ 2.5 x institutional upper limit normal (uln) * serum creatinine ≥ 1.5 mg% for males \& 1.4 mg% for females * serum bilirubin ≥ 1.5x institutional upper limit normal (uln)
study on inferior vena cava thrombosis

Conditions: Inferior Vena Cava Thrombosis

Summary: this study will focus on patients having inferior vena cava (ivc) thrombosis, either with or without thrombosis in other veins. the purpose of this study is to assess risk factors, safety and effectiveness of treatment options, and outcomes of patients with ivc thrombosis.

thrombosis of the inferior vena cava (ivc) is a rare form of deep venous thrombosis (dvt). optimal treatment strategies and clinical outcomes are not well established. this multicenter, international, observational study will assess the effectiveness and safety of current treatment options in patients with ivc thrombosis, and describe the long-term outcomes of patients with ivc thrombosis. patients with an objective diagnosis of ivc thrombosis, either with or without proximal lower extremity dvt will be included. information will be collected on baseline characteristics, risk factors for thrombosis, symptoms, mode of diagnosis, presence of concomitant lower limb dvt, pe, ivc filter or unusual site thrombosis (splanchnic, gonadal and renal veins), treatment modalities (anticoagulation and/or thrombolysis), choice of anticoagulant, dose and duration of treatment, recanalization assessment (if available), recurrence of vte during follow up, bleeding according to international society on thrombosis and haemostasis criteria, development post-thrombotic syndrome (pts) according to villalta score and mortality during follow up. patients should be followed up for 24 months from diagnosis. the number of visits is left to the discretion of the treating physician, but information on clinical outcomes at two intermediate time points is requested.

Eligibility criteria:
inclusion criteria: 1. consecutive adult patients (\> 18 years) with an objective diagnosis of ivc thrombosis, either with or without proximal lower extremity dvt (involving the femoral, common femoral, or iliac veins) will be eligible for the study. 2. diagnosis should be obtained by either doppler ultrasonography, ct angiography or mri angiography. 3. patients who had objective diagnosis of ivc thrombosis within 6 months prior to the starting of the registry will also be eligible, providing they are prospectively followed up by the participating centers and all requested information is available. exclusion criteria: patients enrolled in interventional studies.

Keywords: inferior vena cava (ivc) thrombosis anticoagulation deep vein thrombosis (dvt)
anesthetic topical adhesive (synera™) to reduce injection pain with subcutaneous multiple sclerosis medications

Conditions: Multiple Sclerosis

Summary: the purpose of this study is to see if applying an anesthetic topical adhesive, synera®, will reduce the injection pain. relieving injection site pain may improve the tolerability of multiple sclerosis medications. study hypothesis: pre-medication with synera will have a significant effect on pain ratings as measured by the visual analog scale and local injection site reaction scale.

open-label prospective study of synera to reduce injection pain in 30 patients with relapsing forms of multiple sclerosis taking interferon beta or glatiramer acetate. the duration will be 3-6 weeks (1-2 weeks of baseline observation followed by 2-4 weeks of on-drug observation), depending on which multiple sclerosis drug product is being studied. the study will include down-titration from 60 to 30 minutes of application to assess for any difference in responses. we define one primary outcome measure,"pain upon injection" by visual analog scale (vas). secondary measures will include 24-hour ratings of pain by vas and 24-hour local injection site reaction (lisr) scale score.

Eligibility criteria:
inclusion criteria: * confirmed diagnosis of multiple sclerosis based on mcdonald or poser criteria (no sub-type restrictions) * aged \>18 * regular use of one of the follow multiple sclerosis medication treatments: interferon beta subcutaneous (15 subjects, betaseron, extavia or rebif), or glatiramer acetate subcutaneous (15 subjects, copaxone). * no change in disease modifying therapy in 60 days. * mean score of ≥1.0 on local injection site reaction scale and mean pain upon injection score ≥4.0 during baseline period. * at least 4 valid diary entries over screening period. * no multiple sclerosis exacerbation for 60 days prior to screening. * written informed consent exclusion criteria: * females who are breast-feeding, pregnant or have potential to become pregnant during the course of the study (fertile and unwilling/unable to use effective contraceptive measures). * cognitive deficits that would interfere with the subject's ability to give informed consent or perform study testing. * concurrent application of any topical medication to treat injection site reactions from screening through final visit. * history of allergy to lidocaine, tetracaine or paba (para-amino benzoic acid) containing products. * patients receiving class 1 antiarrhythmic agents (i.e. tocainide, mexiletine) * any other serious and/or unstable medical condition
colorectal emergencies in elderly patients.

Conditions: Emergency Colorectal Surgery in Ultra 80 Patients

Summary: colon diseases can turn in a clinical emergency with the onset of some important complications. some critical conditions are more common in aged patients because they are more frails. the aim of this study is to examine ultra 80 patients, undergoing emergency colorectal surgery, evaluating the aspects associated with post-operative complications and other problems in the short term. from november 2020 to february 2022 we have included 32 consecutive patients older than 80 undergoing emergency surgery due to colon diseases. we have collected and analysed all demographic, and operative data and then applied cr-possum score and correlated with postoperative hospital stay and the onset of postoperative complications according to clavien dindo classification. postoperative factors were selectively evaluated based on the clinical scenario and different colic pathologies. there was no statistically significant differences, in terms of postoperative hospital stay, postoperative complications, reoperation rate and 30-day mortality. the number of cases of blood transfusions was significant, more numerous in case of intestinal perforation and bleeding cases. the value of operative severity score in the bowel perforations, was significantly higher. the use of a score to stratify the risk is a useful tool especially in elderly patients to undergo emergency surgery. the cr-possum score was important for predicting morbidity in our study. emergency manifestations of colon diseases in the elderly show higher morbidity and mortality rates.


Eligibility criteria:
inclusion criteria: * age older than eighty * emergency conditions exclusion criteria: * trauma cases
effect of radiotherapy concurrent of ttfields in patients with glioblastoma

Conditions: Glioma; Glioblastoma

Summary: ttfields has been approved by the fda for the treatment of patients with glioblastoma multiforme. however, the clinical effect and safety of radiotherapy concurrent of ttfields is not definite. in this study, the investigators conduct a phase ii clinical trial to evaluate the efficacy and safety of this strategy.

the investigators plan to recruit 30 patients to evaluate the efficacy and safety of this strategy.

Eligibility criteria:
inclusion criteria: * performance status of 0-1 (eastern cooperative oncology group performance status) * histologically confirmed glioblastoma * no cerebrospinal fluid and distant metastatic disease. exclusion criteria: * with a history of brain radiotherapy * severe hepatic and renal dysfunction

Keywords: glioblastoma ttfields radiotherapy
slnd versus non-dissection following esd for t1a stage esophageal squamous cell carcinoma

Conditions: Esophageal Cancer

Summary: this is a study from fujian cancer hospital thoracic of surgery project, numbered as fjchtosp-1. systematically mediastinal lymph node dissection (sld) versus non-dissection following endoscopic submucosal dissection (esd) for t1a stage esophageal squamous cell carcinoma: a single-center, prospective clinical trial.

participants will be evaluated for inclusion criteria and exclusion criteria, and then sign informal consent if desired. participants will be randomly assigned to the intervention according to a prepared random tables. participants in the systematically mediastinal lymph node dissection (slnd) group will receive systematically mediastinal lymph node dissection, while those in the non-slnd group will not receive mediastinal lymph node dissection. the primary endpoint is 3-year disease-free survival (dfs). the sample size are estimated with reference to investigators' previous data, in which the 3-year dfs was 62.7% for patients diagnosed with t1a stage esophageal squamous cell carcinoma and underwent endoscopic submucosal dissection without slnd. investigators assumed that if 3-year dfs of patients in slnd group was over 80%, then investigatorswould deem the slnd group to be superior to the non-slnd group. the sample size are estimated to be 102. therefore, the total number of patients enrolled are designed to be 102.

Eligibility criteria:
inclusion criteria: * clinical stage t1an0m0. * a lesion detected on endoscopic ultrasound featured as t1a stage. * age 18 to 75. * patients who have signed the informed consent form. exclusion criteria: * • other than invasive adenocarcinoma by pathological analysis. * not complete resected or curative intent. * patients who have history of other malignant tumors. * patients who have history of thoracic surgery. * patients who have received radiation, chemotherapy or other treatments previously.
effect of preoperative silodosin on feasibility of ureteral access sheath insertion

Conditions: Renal Stone

Summary: the ureteral access sheath (uas) is an ancillary device widely used by urologists to facilitate fast, repeatable, and safe access to ureters and collecting systems; improve visibility; reduce the risk of infection by reducing intrarenal pressure; and protect ureters and scopes when extracting multiple stones during surgery. insertion of ureteric access sheath may be difficult due to tight ureter, so sometimes preoperative stenting might be needed. silodosin is an α1a adrenoceptor with high affinity and selectivity for the ureteric muscle, which may reduce ureteral spasm. oral a1-blockers can reduce intraureteral pressure, and may reduce maximal ureteral access sheath insertion force.¹ preoperative silodosin protects against significant ureteral injury related to uas insertion during furs and decreases postoperative pain level. silodosin premedication might be an effective and safe technique to replace prestenting.²


Eligibility criteria:
inclusion criteria: * all patients with renal stones who will undergo flexible ureteroscopy and planned for using ureteral access sheath exclusion criteria: * paediatric age group (less than 18 year)
shock wave versus low level laser on chronic venous ulcer

Conditions: Venous Ulcer

Summary: to find out the difference in the effect of shock wave therapy and low level laser therapy on venous ulcer patient as regards the following outcomes; 1. medical state of patient no ( diabetes, hypertension,obesity,cancer , rheumatoid) 2. the degree of ulcer 3. recurrence of ulcer 4. the degree of pain and disabilities 5. inflammatory marker

45 venous ulcer patient of both sexes will be recruited in this study from cardiovascular units in nasser institute hospital , their age ranged from 45 to 60 years old and randomly divided into 3 equal groups 1. study group (a) include old age patients with venous ulcer will receive extra corporeal shock wave therapy along with conservative treatment (compression therapy (pressure garment),lifestyle changes, physical activity) plus medical treatment 2. study group (b) include old age patient with chronic venous ulcer will receive low level laser therapy along with conservative treatment (compression therapy (pressure garment), lifestyle changes,physical activity) plus medical treatment 3. control group (c) include old age patients with venous ulcers will receive conservative treatments ( compression pandaging, lifestyle changes, physical activities) plus medical treatment the study will be conducted when the patient stable medically and will be conducted until complete healing of ulcer

Eligibility criteria:
inclusion criteria: * all old age patients will be * ranging from 45-60 years old * with bmi from (25-30) * chronic venous ulcer grade 2 or 3 * ulcers non infected with superficial blood insufficiency * open ulcers. exclusion criteria: * -diabetes * hypertension * rheumatoid arthritis * obesity * musculoskeletal disorders * dementia * cerbrovascular stroke * deep venous thrombosis * deep venous ulcer * venous ulcer grade 4 * smokers

Keywords: shock wave , low level laser
a prospective study of two daily disposable contact lenses

Conditions: Myopia

Summary: the purpose of this study was to evaluate the performance of a novel silicone hydrogel contact lens, dailies total1® (dt1) compared to the standard hydrogel material in 1-day acuvue® moist® (1davm) contact lens in contact lens wearers identified as having contact lens-related dryness symptoms.

three study visits occurred over the course of 28 ± 3 days.

Eligibility criteria:
inclusion criteria: * be of legal age of consent and sign written informed consent document and hipaa form. * currently wearing soft contact lenses and identified as having contact lens-related dryness symptoms based upon responses to the contact lens dry eye questionnaire. * wearing either daily disposable contact lenses or bi-weekly/monthly replacement contact lenses, daily wear use only (no extended wear use). * able to achieve distance visual acuity of at least 20/25 in each eye with study lenses in the available parameters, -0.50d to -6.00d. * willing to wear study lenses for at least 8 hours/day and at least 5 days/week. * willing and able to follow instructions and maintain the appointment schedule. * other protocol-defined inclusion criteria may apply. exclusion criteria: * neophyte or current wearer of dailies total1® or 1-day acuvue® moist™ contact lenses. * requires monovision or presbyopic correction. * any systemic or ocular disease or disorder complicating factors or structural abnormality that would negatively affect the conduct or outcome of the study. * recent (within 7 days of enrollment) or current ocular infection, active ocular inflammation, glaucoma or preauricular lymphadenopathy. * clinically significant lash or lid abnormality. * systemic disease that, in the investigator's best judgment, would prohibit or confound safe contact lens wear. * history of ocular surgery/trauma within the last 6 months. * topical or systemic antibiotics use within 7 days of enrollment. * other protocol-defined exclusion criteria may apply.

Keywords: myopia contact lenses dry eyes comfort replacement
implementing screening and brief interventions for excessive drinkers in primary health care

Conditions: Alcohol-Related Disorders

Summary: the objective of this study is to investigate the efficacy of an implementation program specifically designed to increase alcohol screening and brief intervention rates in primary health care.

alcohol is an important risk factor for several diseases, even when consumed moderately. screening and advising at-risk drinkers to cut-down is a highly effective and cost-effective intervention when conducted in primary healthcare settings. however, these interventions are seldom implemented at the primary care level. twelve out of the 26 primary health care units of the dão lafões grouping of primary health care centres will be randomized to two groups: the intervention arm will receive the new implementation program; the control group will be on a waiting list for receiving the implementation program and will receive the intervention after the testing phase of the trial is completed. the study will last for one year, starting in january 2017. the implementation program was designed in order to overcome known barriers for implementing alcohol screening and brief advice in primary health care. the behaviour change wheel and the theoretical domains framework were used to pinpoint the constructs and behaviour change techniques most suited to address the barriers in order to achieve practice changes.

Eligibility criteria:
inclusion criteria: * primary health care units of the dão lafões grouping of primary health care centres (family physicians/general practitioners, family medicine residents, practice nurses and receptionists) exclusion criteria: * primary health care units with four or less general practitioners * primary health care units that have a specific alcohol program already implemented

Keywords: mass screening counseling primary health care