Kornimate/medical-research-clean huggingface dataset:
determine the improvement in activity status/quality of life (qol) of patients with rheumatoid arthritis (ra) during treatment with lodotra (prednisone)

Conditions: Arthritis, Rheumatoid

Summary: rheumatoid arthritis is the most common rheumatic disease with symptomatic morning stiffness which entails a quite essential restriction in the everyday life and in the life quality. this observational, uncontrolled, multicentric study is aimed to assess the improvement in the activity status or qol of subjects with ra being treated with the tempus tablet.

rheumatoid arthritis is characterised with a sudden onset , with pains in the little finger or toe joints, progressively affecting various joints and symptomatic morning stiffness. for subjects with ra, morning stiffness entails a quite essential restriction in the everyday life and in the life quality. this observational, uncontrolled, multicentric study is aimed to assess the improvement in the activity status or qol of subjects with ra being treated with the tempus tablet. a total of 8,000 subjects with diagnosed, active ra will be included in the study the study will apply to 2 target groups: general physicians, practicing doctors and interns (in-house doctors) with an observation period of 3 months; and specialists (rheumatologist) with an observation period of 9 months. three subjects are expected per in-house doctor and 10 subjects per rheumatologist. objectives primary objective: * to examine, to what extent the subject will be directly benefited with the decrease in the morning arthritis symptom in the sense of an improvement in the life quality and the activity status 1. the activity status will be assessed in 3 different areas: occupational activities, tasks in the household and leisure activities 2. the life quality is assessed on the basis of the haq-di secondary objectives: * to record side effects of tempus tablet when used under everyday conditions * to collect socioeconomic data such as e.g. aids or applications

Eligibility criteria:
inclusion criteria: * subjects who correspond to the permitted indication of the drug of lodotra * subjects from age of 18 years with diagnosed, active ra with associated symptoms such as morning stiffness of the joints, which is either already being treated with low dose of glucocorticoids or will be treated again with glucocorticoid therapy exclusion criteria: * - subjects with contraindications are excluded from the participation

Keywords: arthritis, rheumatoid prednisone
cetuximab given for 3 weeks as neoadjuvant treatment in locally advanced tongue cancer ; a new paradigm of treatment

Conditions: Squamous Cell Carcinoma

Summary: to compare the disease free survival (dfs) rate of a preoperative cetuximab treatment followed by operation and postoperative radiation-cisplatin-cetuximab treatment paradigm for advanced oral cavity cancer, , with the dfs rate of historical controls (from the rtog 9501 and eortc 22931 studies in which treatment was with surgery followed by radiotherapy and cisplatin) with a similar stage of the disease.

this non-randomized, open-label, single center phase ii study, will determine if patients with advanced oral tongue cancer that are treated with induction doses of cetuximab followed by treatment with radiation therapy concurrently with cetuximab and cisplatin (when indicated by positive margins or extra-capsular extension), will have improved pfs and improved survival and feasible toxicity, compared with patients treated in previous clinical trials (rtog 9501 and eortc 22931) with standard therapy: radiotherapy of 60 gy with or without a 6-gy boost (rtog 9501) or 66 gy (eortc 22931) delivered through a conventional fractionation regimen of five once-daily sessions per week, and cisplatin in a dose of 100 mg/m2 on days 1, 22, and 43.. twenty five patients will be recruited. cetuximab treatment will be started (day 0) with 400 mg/m2 followed by two doses of 250 mg/m2 (once weekly on day 7 and 14). surgery will be performed on day 31 followed by treatment with radiation therapy concurrently with cetuximab (250 mg/m2, once weekly) and cisplatin 35 mg/m2 (days 70-112; when indicated by positive margins or lymph nodes with extra-capsular extension). pet-ct and biopsies will be performed before starting with cetuximab, just before surgery and after chemo-cetuximab-rt to determine efficacy of treatment, and to compare the diagnostic properties of the pet-ct with that of the biopsies. the changes, before and after treatment with cetuximab, of protein levels in saliva, and tumor tissue and of microrna levels in tumor tissue will be studied and correlated with pfs. the quality of life will be assessed. data from clinical trials rtog 9501 and eortc 22931 will be used as historical controls.

Eligibility criteria:
inclusion criteria: pathologically confirmed, previously untreated, resectable squamous cell carcinoma of the tongue at disease stage iii or iv; age ≥18 to ≤80; eastern cooperative oncology group (ecog) performance status 0-1;willingto give written informed consent for participation in this study - exclusion criteria: any prior head and neck malignancy or other malignancy in the last 5 years but bcc; prior head and neck radiation; documented evidence of distant metastases; pregnancy or lactation; clinically significant cardiovascular disease; known hypersensitivity to any of the components of the treatment; legal incapacity; clinically relevant neuropathy; any medical or psychiatric illness which would compromise the patient's ability to tolerate this treatment, or interfere with the study objectives. -

Keywords: tongue squamous cell carcinoma locally advanced cetuximab
covid-19 fear and compliance with protective measures of students

Conditions: Covid-19

Summary: this study was carried out to determine the fear of covid-19 and the compliance with protective measures of students who continue their education face-to-face during the covid-19 pandemic process.

the study was carried out descriptively. the study population of a province pandemic period junior ongoing training to face in turkey. sample constituted reached 188 students with snowball sampling method. the data of the study were collected using the "questionnaire form" prepared by the researchers and the "covid-19 fear scale". data collection tools were applied to the participants electronically via google forms.

Eligibility criteria:
inclusion criteria: students who volunteered to participate in the study, had their parents' consent, had a web-based smart device, and continued face-to-face education were included. exclusion criteria: -

Keywords: covid-19 school student fear protective measure
mesenchymal stem cells to intervene in the development of type 1 diabetes: a blinded randomized study

Conditions: Type 1 Diabetes Mellitus

Summary: this project aims to evaluate the efficacy of autologous mesenchymal stem cell treatment to preserve insulin production and beta-cell mass in recently diagnosed patients with type 1 diabetes mellitus. the hypothesis to be tested is that an increased number of circulating mesenchymal stem cells will provide immune modulatory properties, and thereby stop the immune process in islets causing progressive beta-cell death.


Eligibility criteria:
inclusion criteria: * fasting c-peptide \>0.12 nmol/l * within three weeks of diagnosis of type 1 diabetes exclusion criteria: * body mass index (bmi) \>30 * unstable cardiovascular status incl. new york heart association (nyha) class iii/iv * patients with known or previous malignancy * active infections incl. serological evidence of infection with hiv, treponema pallidum, hepatitis b (patients with serology consistent with previous vaccination and a history of vaccination are acceptable) or hepatitis c. * immune suppressive treatment * women being pregnant or nursing, or women physiologically capable of becoming pregnant, unless they are using effective methods of contraception during study
a study to evaluate the safety and efficacy of pf-04958242 in subjects with cognitive impairment associated with schizophrenia (cias)

Conditions: Cognitive Impairment Associated With Schizophrenia (CIAS)

Summary: the purpose of this study is to determine whether pf-04958242 is safe and effective in the treatment of cognitive dysfunction in schizophrenia subjects

this study was previously posted by pfizer, inc. sponsorship of the trial was transferred to biogen.

Eligibility criteria:
key inclusion criteria: * otherwise healthy male and/or female subjects between the ages of 18 and 50 years, inclusive, with diagnostic statistical manual of mental disorders, fifth edition (dsm-5) diagnosis of schizophrenia of at least 2 years duration as confirmed by the m.i.n.i 7.0 for psychotic disorders * evidence of stable schizophrenia symptomatology \>=3 months (ie, no hospitalizations for schizophrenia, no increase in level of psychiatric care due to worsening of symptoms of schizophrenia). * subjects must be in ongoing maintenance atypical antipsychotic therapy (except clozapine), on a stable treatment regimen for \>=2 months prior to baseline/day 1, including concomitant psychotropic treatments. subjects should be on no more than 2 background antipsychotics. * subject must have an identified informant * subject must reside in a stable living situation for at least 12 weeks prior to screening. key exclusion criteria: * subjects with a current dsm-5 diagnosis of schizoaffective disorder in the judgment of the investigator. * subjects with a current dsm-5 diagnosis of major depressive episode, manic and hypomanic episode, panic disorder, agoraphobia, social anxiety disorder, obsessive-compulsive disorder, post-traumatic stress disorder, generalized anxiety disorder on the m.i.n.i 7.0 for psychotic disorders or in the judgment of the investigator. * subjects with a lifetime dsm-5 diagnosis of antisocial personality disorder, anorexia nervosa, bulimia nervosa, binge-eating disorder on the m.i.n.i 7.0 for psychotic disorders or in the judgment of the investigator. * subjects who meet the dsm-5 diagnosis of moderate or severe psychoactive substance use disorder (excluding nicotine dependence) within 12 months of screening on the m.i.n.i 7.0 for psychotic disorders interview and as determined by the investigator. * subjects with significant extrapyramidal symptoms which have not been stabilized with anticholinergics. note: other protocol defined inclusion/exclusion criteria may apply
effectiveness and safety evaluation of aqueduct -100 device

Conditions: Cervix Uteri Dilation

Summary: evaluation of efficacy and safety of using aqueduct -100 - cervical dilator device

there are predominantly two major dilatation techniques that are employed in dilating the cervix. the first technique uses expansible dry solid material, such as laminaria (seaweed) is inserted into the cervix in its dried stiff form. in the cervix it comes into contact with body fluids that cause the laminaria to swell and enlarge the cervical cavity. the second more widespread procedure, involves the use of series of solid, rod like instruments of graduated diameter used in serial fashion by the physician (hegar dilators). the physician first inserts a rod like dilator and replaces it with the dilator of next higher diameter. this procedure continues until adequate dilatation occurs. the problem is that each of the above-mentioned methods has its shortcomings: the use of the laminaria method (rarely done) requires preliminary patient visit, for insertion of the laminaria rod and is extremely slow and typically involves often as much as 10-12 hours for a significant amount of dilatation to occur. the use of rod-like instruments (hegar) requires general or regional anesthesia, when local anesthetics are used, the patient nevertheless frequently experiences a great amount of discomfort from the procedure. the mechanical dilatation of the cervix demands a large amount of longitudinal force that may damage or even puncture the cervix and the uterus. aqueduct 100 is a catheter for use in dilating various body cavities and especially the human cervix. the device will enable continuous, fast and safe dilatation of the cervix to a pre-determined diameter as a pre-procedure to intrauterine surgeries.

Eligibility criteria:
inclusion criteria: * subjects, females, 18 years of age or older. * subjects undergoing any process that requires dilation (intrauterine procedures) * subjects willing to sign informed consent form. exclusion criteria: * subjects younger than 18 years of age * subject with sex transmitted diseases, or with infectious diseases (hiv, hcv). * subjects unwilling to sign the informed consent form.

Keywords: cervix cervical dilation balloon catheter
the effect of massage ball application on blood pressure, fatigue and anxiety in pregnant with preeclampsia

Conditions: Preeclampsia

Summary: the aim of this study is to determine the effect of massage ball application on arterial blood pressure, fatigue and anxiety in pregnant women diagnosed with preeclampsia.

hypertensive disorders are one of the common disorders in pregnancy that cause complications in the mother and the fetus. preeclampsia, one of the hypertensive disorders of pregnancy, is defined as the presence of hypertension, proteinuria or organ damage that occurs after the 20th week of pregnancy. preeclampsia affects 5% to 7% of all pregnancies. it causes more than 70,000 maternal deaths and 500,000 fetal deaths worldwide each year. preeclampsia is among the main causes of maternal mortality and morbidity. preeclampsia is the first cause of maternal death due to hypertension. according to the report on causes of maternal death in our country, 14.2% of pregnant women died due to hypertensive diseases in 2019. pregnancy-induced hypertension is the second leading cause of maternal deaths. preeclampsia causes increased blood pressure in pregnant women, cardiovascular diseases, cerebrovascular accidents, and dysfunction in organs such as the liver, kidney and uterus. in addition to affecting the systems, it is also a condition that causes anxiety and fatigue in pregnant women. the most effective treatment for preeclampsia is delivery. in hospital, treatment includes mgso4 therapy, blood pressure monitoring, urine monitoring, a high-protein and salt-restricted diet, and control of fetal movements and midwifery care to keep blood pressure at normal levels and prevent eclampsia. in addition to medical treatment in preeclampsia, complementary treatments such as music therapy, acupuncture and massage are also used. massage application helps relax the muscles. it is stated that massage applied to pregnant women positively affects anxiety, blood pressure and fatigue. equipment such as tennis ball, golf ball and massage ball are used for muscle relaxation. it is thought that massage ball application, one of the methods used in massage, will reduce anxiety, fatigue and be effective in lowering blood pressure.

Eligibility criteria:
inclusion criteria: * in the 20th - 40th week of pregnancy, * least literate, * does not have any diagnosed problems related to fetal health, * diagnosed with preeclampsia, * will be hospitalized for at least 3 days, * not having any physical or mental disability, * those who are over 18 years of age, * agreeing to participate in the research, * women with loss of sensation/sensation, exclusion criteria: * those with chronic hypertension, * diagnosed with eclampsia, * those with hellp findings, * hospital stay of less than 3 days,

Keywords: preeclampsia midwifery arterial blood pressure anxiety fatigue
radiation therapy compared with no further treatment following surgery in treating patients with prostate cancer

Conditions: Prostate Cancer

Summary: rationale: radiation therapy uses high-energy x-rays to damage tumor cells and may be an effective treatment for prostate cancer. purpose: randomized phase iii trial to compare radiation therapy with no further treatment in treating patients with stage iii prostate cancer following radical prostatectomy.

objectives: * compare local recurrence rates, acute and late morbidity, overall survival, disease-free survival, and cancer-related survival of patients with pt3 pn0 adenocarcinoma of the prostate randomized following radical prostatectomy to postoperative conventional pelvic irradiation (60 gy) vs no further treatment until relapse. * better define the selective pathologic indications for radiotherapy in patients with pt3 pn0 disease. outline: this is a randomized study. * arm i: patients undergo radiotherapy daily, 5 days a week, for 5 weeks, followed by boost radiotherapy for 1-1.4 weeks. * arm ii: patients are observed. local relapse is treated with conventional pelvic radiotherapy. patients are followed every 3 months during the first postoperative year, every 6 months until the fifth year, and annually thereafter. projected accrual: a total of 1000 patients will be accrued for this study within 7.5 years.

Eligibility criteria:
disease characteristics: * histologically documented invasive adenocarcinoma of the prostate staged pt3 pn0 after radical prostatectomy * preoperative staging must have been t0-3 n0 m0 based on physical exam, chest x-ray, bone scan, ct or mri of entire pelvis and abdomen, and serum psa * at least 1 of the following features must be present: * complete capsule invasion (i.e., perforation) * positive surgical margins (microscopic or gross) * seminal vesicle invasion * radiotherapy must begin within 16 weeks following surgery, after recovery of urinary function patient characteristics: age: * 75 and under performance status: * who 0-2 hematopoietic: * not specified hepatic: * not specified renal: * not specified other: * no other malignancies prior concurrent therapy: biologic therapy: * not specified chemotherapy: * not specified endocrine therapy: * no more than 4 months of preoperative hormonal therapy radiotherapy: * not specified surgery: * radical prostatectomy required within 12 weeks with recovery of urinary function

Keywords: adenocarcinoma of the prostate stage i prostate cancer stage iib prostate cancer stage iia prostate cancer stage iii prostate cancer
the effects of nitrogen protoxide and oxygen on corneal endothelial in pediatric patients

Conditions: Cornea; Anesthesia; Reaction

Summary: to evaluate the mean changes in endothelial cell and corneal pachymetry in eyes that operated under n2o + sevoflurane and o2 + sevoflurane general anesthesia.

40 eyes of 40 patients who had extraocular surgery under general anesthesia will be included in this prospective study. cell density, cell variatio, hexagonality rate and pachymetry specular microscopy results at before surgery and 1 week and 1 month after surgery will be analyzed. o2 (1 l/min) with 50% air and n2o (1 l/min) with 50% air will be applied to each group with flow rate 2 l/min totally, respectively. the duration of surgery will be recorded.

Eligibility criteria:
inclusion criteria: * 40 eyes of 40 pediatric patients who had extraocular surgery under general anesthesia exclusion criteria: * none

Keywords: nitrogen protoxide oxygen corneal endothelial pediatric
efficacy and safety of sotalol in children with arrhythmia

Conditions: Arrhythmia

Summary: this study aims to investigate the efficacy and safety of oral sotalol alone or combination with other anti-arrhythmic medicines in the treatment of arrhythmias in children. the study will regularly monitor the holter, electrocardiogram (ecg), echocardiography (echo), blood routine, urine routine, serum ion, liver and kidney function, troponin i, hypersensitive troponin t, n-terminal pro-brain natriuretic peptide (nt pro-bnp), etc, before and after receive sotalol therapy. compare the degree of arrhythmia improvement in patients and the side effects after oral sotalol.

monitoring the holter, ecg, echocardiography , blood routine, urine routine, serum ion, liver and kidney function, troponin i, hypersensitive troponin t, nt pro-bnp beforehand. eligible patients should stop all anti-arrhythmia drugs and digitalis, tricyclic antidepressants, beta blockers or calcium antagonists for at least 5 half-lives, and then do holter. randomly grouped. judging the results according to the situation before and after oral sotalol.

Eligibility criteria:
inclusion criteria: 1. age 0 day to 14 year-old 2. diagnosis of tachycardia (paroxysmal supraventricular tachycardia, paroxysmal atrial tachycardia, ventricular tachycardia, idiopathic ventricular tachycardia, premature ventricular contraction) and had an episode within 3 months; premature ventricular contractions (pvc) (total 10000 times/d, or\>5000 times/d with multiple source pvc, or total \> 3000 times/d but with paired pvc+ multiple source pvc, or ventricular tachycardia); 3. although pvc≤ 10000 times/d, but there are obvious symptoms such as palpitation, chest tightness, fatigue, dizziness and other symptoms that need improvement. 4. signed informed consent before the trial 5. good compliance exclusion criteria: 1. heart failure that is ineffective in conventional treatment; 2. left ventricular ejection fraction (lvef) ≤ 50%; 3. suffering from bronchial asthma; 4. resting sinus heart rate (hr) in newborns \<90 bpm; -8 yrs \<80 bpm; ≥ 8 yrs \<60 bpm; 5. corrected qt interval (qtc) ≥ 450ms; 6. ii ° -iii ° atrioventricular block (avb); 7. severe liver, renal dysfunction, acute myocardial infarction, acute myocarditis, electrolyte imbalance have not been corrected; 8. the child has undergone major surgery in the past 4 weeks; 9. the child has participated in other clinical trials in the past 4 weeks; 10. the child has digestive, nervous, circulatory, kidney or liver disease
using telmisartan alone or combination of telmisartan -hctz in the treatment of mild to moderate essential hypertension

Conditions: Hypertension

Summary: the aim of this therapeutic observation is to demonstrate the efficacy and safety of telmisartan or telmisartan and hctz in the treatment of patients with mild-to-moderate essential hypertension under normal conditions of use after market launch.

study 502.465(nct00638911) was planned and conducted as 6 independent substudies with varying country participation. one study database, a data management plan or a tsap were not planned and do not exist which precludes baseline and outcome analyses.

Eligibility criteria:
inclusion criteria: 1. male or female patients over the age of 18 years, with mild-to-moderate essential hypertension with values of mean morning seated diastolic bp more than 90 mmhg and less than 109 mmhg and or mean morning seated systolic bp more than 140 mmhg and less than 180 mmhg 1. newly diagnosed patients 2. patients failing to reach target blood pressure of less than 140 on 90 on their current antihypertensive treatment exclusion criteria: 1. pre-menopausal women who do not use adequate contraception who are pregnant or nursing 2. cholestasis and biliary obstructive disorders 3. severe hepatic impairment 4. severe renal impairment creatinine clearance less than 30 ml pro min 5. refractory hypokalaemia hypercalcaemia 6. known hypersensitivity to any component in the formulation of micardis/micardis plus