Kornimate/medical-research-clean huggingface dataset:
an observational study of type 2 diabetes in patients starting on novomix® 30 treatment

Conditions: Diabetes; Diabetes Mellitus, Type 2

Summary: this study is conducted in europe. the aim of this observational study is to evaluate the incidence of serious adverse drug reactions when initiating or switching to insulin therapy with novomix® 30 in subjects with type 2 diabetes under normal clinical practice conditions


Eligibility criteria:
inclusion criteria: * patients with type 2 diabetes * insulin-naive or previously treated by basal only insulin therapy exclusion criteria: * patients who are unlikely to comply with the protocol * pregnancy or breastfeeding or intention of becoming pregnant
adaptation of melodic intonation therapy to spanish

Conditions: Post Stroke Aphasia

Summary: this study was conducted in three phases: the first phase involved creation of a spanish adaptation of the melodic intonation therapy; the second phase consisted of a pilot non-randomized intervention study to analyse its feasibility for use with 4 spanish patients with poststroke nonfluent aphasia; the third phase consisted of a pilot randomised, crossover, intervention pilot trial in a different set of patients with poststroke nonfluent aphasia (n=20)


Eligibility criteria:
inclusion criteria: patients diagnosed with nonfluent aphasia due to unilateral stroke in the left hemisphere without neuroimaging evidence of lesions in the right hemisphere who fulfilled the following criteria: * the time elapsed since the stroke exceeded 6 months. * patient had received a standard program of conventional speech therapy after stroke. * persistent nonfluent aphasia with the following characteristics: * severely restricted language, which might be limited to meaningless stereotypy; unlike that observed in verbal tasks, the patient might produce some real and relevant words when singing familiar songs. * poor repetition, even for single words. * moderately preserved language comprehension. * the nonstereotyped language was produced with a slurring of speech. * the total score for the repetition did not exceed the 70th percentile in the boston diagnostic aphasia examination. the score was obtained from the average score in three areas: repetition of words and repetition of phrases; listening comprehension exceeding the 15th percentile of boston diagnostic aphasia examination; and from the average score obtained in three areas: word comprehension, commands and complex ideational material. * the patient was motivated, emotionally stable and had good attention. * signed informed consent was provided. exclusion criteria: * patients with a history of a previous stroke other than the index event or with any clinical condition (e.g., short life expectancy, coexisting disease) or other characteristics that precluded appropriate follow-up in the study * patients participating in any therapeutic intervention clinical trials evaluating poststroke recovery * use of psychotropic drugs that interfere with patient evaluation.

Keywords: stroke aphasia melodic intonation therapy
evaluation of the efficacy of citrulline supplementation on the delay of delivery for women hospitalized for pre-eclampsia (citrupe)

Conditions: Pre-eclampsia; Pregnancy

Summary: pre-eclampsia (pe) complicates 2-8 % of pregnancies and is associated with high maternal and fetal morbidity and mortality. the early clinical manifestations are the occurrence of a maternal blood pressure and proteinuria. placental dysfunction impairs the nutrient supply to the fetus, and may be the cause of an intrauterine growth retardation (iugr). this is a disease that causes prematurity and currently the only known cure is delivery of the placenta. nitrogen monoxide (no) regulates the placental blood flow. however, pre-eclampsia is directly related to a failure of placental no production. in this context, several clinical trials have tested the effect of no donors such as l- arginine. however, supplementation with l -arginine in a randomized trial in nantes, has proved to be ineffective in severe vascular iugr. citrulline is a natural aminoacid precursor to arginine and in contrast to l-arginine escapes uptake in the liver and appears directly in the peripheral blood converted by the kidney in arginine, released into the systemic circulation, citrulline may therefore be more effective in the treatment of pre-eclampsia. this prospective, randomized, comparative and double-blinded study aims to prolong pregnancy for patients with pre-eclampsia before 36 weeks.


Eligibility criteria:
inclusion criteria: * age \>= 18 years old * pregnant woman * singleton pregnancy * woman with pre-eclampsia (\<36 weeks) without indication of forthcoming extraction * subjects affiliated with an appropriate social security system * subjects out of context of guardianship * written signed informed consent form exclusion criteria: * age \< 18 years old * isolated hypertension or isolated proteinuria * severe pre-eclampsia with indication of forthcoming extraction in emergency * term pregnancy \>= 36 weeks when diagnosis is done * multiple pregnancy * lactose intolerance * context of guardianship

Keywords: pre-eclampsia citrulline pregnancy
the effect of skin laxity on the picc

Conditions: Complications; Catheter

Summary: to evaluate the clinical effect of tunneled picc by comparing the rate of complications of the two groups of patients (tunneled picc vs conventional picc).

in this study, tunneled picc was compared with conventional picc. eligible subjects were randomly enrolled into the test group or control group by randomization (1:1), and observed and evaluated the occurrence of complications during and 7 ± 3 days, 30 ± 7 days, 60 ± 10 days, 90 ± 10 days, 120 ± 10 days (if any) after surgery and extubation at the end of treatment. to evaluate the clinical effect of tunneled picc by comparing the rate of complications of the two groups of patients

Eligibility criteria:
inclusion criteria: * patients ≥ 18 years old; * patients who need picc catheterization according to the doctor's advice; * there is no history of venous thrombosis, compression or blockage of superior vena cava, severe coagulation dysfunction and other contraindications for picc catheterization; * there is no serious cardiovascular disease, such as atrial fibrillation, pulmonary heart disease and other patients with abnormal p wave, and severe heart block before catheterization * patients who have not participated in other clinical studies; * patients who voluntarily participate in this clinical study and can cooperate with clinical follow-up exclusion criteria: * known allergy to catheter material; * the puncture site has a history of infection, injury and radiotherapy; * the puncture site has a history of venous thrombosis or surgery; * severe abnormal bleeding and coagulation function; * superior vena cava compression syndrome; * surgical side limbs of breast cancer patients undergoing radical mastectomy or axillary lymph node dissection; * the ipsilateral limb of the pacemaker and the arteriovenous fistula; * patient or her/his family members refuse to sign the informed consent form.
comparison of pre-test probability model for heparin-induced thrombocytopenia in post-operative cardiac surgery

Conditions: Heparin-induced Thrombocytopenia

Summary: heparin-induced thrombocytopenia (hit) is a pro-thrombotic immunological condition that occurs in some patients exposed to heparin. the incidence of hit is estimated at 0.1 to 0.3% of patients exposed to heparin, and rises to 3% in postoperative cardiac surgery. cardiac surgery under cec requires the use of high doses of heparin, which contributes to the increased incidence of hit in this population. this high incidence is also explained by the comorbid profile of cardiac surgery patients, who often present risk factors for hit (perioperative context, atrial fibrillation, organ failure, previous exposure to heparin, etc.). when it occurs postoperatively in cardiac surgery, there is a 28% increase in mortality, a 50% increase in morbidity, and an increase in hospitalization costs and length of stay. although usually detected in medical wards on the basis of probability scores (4t, hep), its diagnosis is less easy in postoperative cardiac surgery. because of the many differential diagnoses, the screening scores usually used are less effective, and hit is often diagnosed late, in patients who may have already developed a thromboembolic complication, which sometimes proves fatal. in addition, the diagnostic tests for hit are compromised and lose their sensitivity in postoperative cardiac surgery, given the high incidence of seroconversion observed after extracorporeal circulation. indeed, more than 50% of patients have antibodies to pf4/heparin, but only 1 to 2% of them have true hit.these elements highlight the need to develop effective screening scores for hit in postoperative cardiac surgery, given the complications to which patients are exposed in the event of underdiagnosis but also in the event of overdiagnosis. other screening scores are being studied, not yet validated in cardiac surgery, such as the cpb score or the gfht score. early recognition of hit would reduce the morbidity and mortality associated with this condition. the present study should make it possible to identify the most effective hit probability score among those used in routine screening and thus to orient towards screening for this condition as early as possible, and consequently reduce the associated morbidity.


Eligibility criteria:
inclusion criteria: * major patients, who underwent cardiac surgery with cardiopulmonarybypass between 01/01/2010 and 12/31/2021, in whom hit was suspected postoperatively. exclusion criteria: * patients with known preoperative hit, * cardiac surgery patients without bypass surgery, * diagnostic tests for hit not performed.

Keywords: cardiopulmonary bypass pre-test probability model
impact of music therapy on anxiety in patients with cancer undergoing simulation for radiation therapy

Conditions: Anxiety and Distress

Summary: this study looks at the effects of a protocolized music therapy intervention on state anxiety for patients with cancer undergoing simulation for radiation therapy. simulation, which is an imaging and diagnostic procedure, has been identified as producing significantly high levels of anxiety in many cancer patients.


Eligibility criteria:
inclusion criteria: * newly diagnosed patients with breast cancer, and newly diagnosed patients with head and neck cancer. * 18 or over. * fluent in english. exclusion criteria: * under 18 years. * pre-existing anxiety disorders.
potential correlation between heart rate variability with cardiovascular risk at different stages of metabolic syndrome

Conditions: Diabetes Mellitus

Summary: the study aims to assess the beat-to-beat heart rate variability (hrv) in different stages of metabolic diseases, including pre-diabetic and diabetic patients, compared to non-diabetic individuals. heart rate variability will be compared for some antidiabetic drugs used in different stages of metabolic diseases and correlated to different metabolic and inflammatory mediators.


Eligibility criteria:
inclusion criteria: 1. non-diabetic individuals: adults (18-70 years) with glycated hemoglobin (hba1c)\<5.7 and/or fasting blood glucose \<100 mg/l and with no classic symptoms of hyperglycemia 2. pre-diabetic: adults (18-70 years) who fulfil one of the american diabetes association (ada) criteria : * glycated hemoglobin (hba1c) =5.7-6.4% * fasting blood glucose level = 100 mg/dl to 125 mg/dl. fasting is deﬁned as no caloric intake for at least 8 hours. 3. diabetic patients: adults (18-70 years) who fulfil one of the american diabetes association (ada) criteria: * glycated hemoglobin (hba1c) ≥6.5% * fasting blood glucose ≥126 mg/dl. * a random plasma glucose ≥200 mg/dl. random is any time of the day without regard to the meals. exclusion criteria: * pediatric and elderly subjects * pregnant subjects * those with active myocardial infarction * those with acute decompensated heart failure * patients with pacemaker * patients with persistent atrial fibrillation, long-standing persistent and permanent atrial fibrillation
salivary cytokine profile as a biomarker for dental pain

Conditions: Cerebral Palsy; Dental Diseases

Summary: always reliable.pain is an important diagnostic tool in dentistry. the type of treatment, extent of treatment and, sometimes, even the decision on whether to treat or not is dependent on the pain history obtained from the patient.the absence of an accurate description of dental pain is a factor that severely limits dental treatment planning in children with cp. the aim of this study is to study to evaluate the salivary cytokine profile of children with cp who have severe dental problems and to compare this to verbal children who have a similar dental profile.

the sample with cp will be selected from individuals attending the dental clinics of the prince sultan bin abdulaziz humanitarian city (sbahc). the control patients will be selected from the dental clinics of the riyadh colleges of dentistry and pharmacy and be matched to the cp patients for age, gender and extent of dental problems. the sample will comprise of 20 patients with cp and 20 verbal controls.the oral health of all children will be recorded using who examination criteria .the teeth will be examined using who category ii criteria - clinical examination with lighting and without radiographs.aliva will be collected from the children using the passive drool method and stored in sterile plastics collection tubes. the collected sample will be stored at -600c until they can be analyzed. the cytokine profile of the saliva sample will be analyzed using an elisa kit for total cytokine profile (luminex performance human cytokine panel a, luh000, r\&d systems) to measure cytokines il-1 alpha, il-1 beta, il-8, and tnf-alpha. the pain perception of the verbal control group will be recorded using the validated arabic version of the short form of the mcgill pain questionnaire. the children will also indicate the extent of the pain using the wong baker faces ™ pain perception scale.normality of the total cytokine levels will be tested using the shapiro-wilkes test. the mann whiney u test will be used to compare the cytokine profile the cp and control group. the spearman correlation will be used to explore the relationship between the reported pain and cytokine profile levels. if found to be significant an initial cytokine-pain map will be proposed.

Eligibility criteria:
inclusion criteria: * cerebral palsy * at least one tooth with pulpal involvement * aged between 8-12 years * no neurological illness (for control group) * ability to verbalize pain (for control group) * one dental tooth with pulpal involvement matching the condition of the test group (for control group) exclusion criteria: * confounding neurological disorders * history of orofacial pain syndromes * absence of consent or assent
masitinib plus gemcitabine in pancreatic cancer

Conditions: Locally Advanced or Metastatic Pancreatic Cancer

Summary: the objective is to compare efficacy and safety of masitinib in combination with gemcitabine to placebo in combination with gemcitabine, in treatment of patients with locally advanced or metastatic pancreatic cancer and who have pain related to the disease.

masitinib is a selective tyrosine kinase inhibitor that is thought to promote survival via modulation of immunostimulation-mediated anticancer effects and modulation of the tumor microenvironment. the objective of this study is to evaluate the efficacy and safety of masitinib in combination with gemcitabine with respect to placebo in combination with gemcitabine for the treatment of non resectable locally advanced or metastatic pancreatic cancer patients with pain related to the disease. approximately 330 patients with pain visual analogue scale (vas) \> 20 and/or treated with 'opioid analgesics' dose ≥ 1 mg/kg/day at baseline will be randomized in a 2:1 ratio to the masitinib and placebo arms, respectively. the primary outcome measure is overall survival (os).

Eligibility criteria:
main inclusion criteria: 1. histologically or cytologically confirmed adenocarcinoma of the pancreas, non resectable locally advanced or metastatic stage 2. patient with pain related to the disease, as assessed by the investigator and the patient: * pain related to the disease as assessed by the investigator is defined as clinical and documented evaluation by the investigator during physical examinations at screening and/or baseline. * pain, as assessed by the patient is defined as at least one value out of two values \> 20mm on visual analogue scale at screening or baseline. visual analogic scale consists in the visual representation of pain amplitude as perceived by the patient. the amplitude is represented by a 100 mm long line having no reference marks. one extremity indicates an absence of pain (0 value) and the other the worst imaginable pain (100 value). or - patient treated with opioid analgesics at a dose ≥ 1 mg/kg/day (morphinic equivalent). 3. chemotherapy naïve patient for the advanced/metastatic disease main exclusion criteria: 1. patient with no pain related to the disease (as defined in the inclusion criterion number 2) 2. pregnant or nursing female patient

Keywords: pancreatic cancer tyrosine kinase inhibitor
cardiovascular assessment during copd exacerbation to improve diagnosis and treatment

Conditions: COPD (Chronic Obstructive Pulmonary Disease); Cardiovascular Diseases

Summary: this is a research study involving patients hospitalized for copd flare-ups. patients will be randomly assigned to two groups: one group will only see a pulmonologist (lung doctor), and the other group will also be seen by a cardiologist (heart doctor) during their hospital stay. both groups will fill out a questionnaire, and the pulmonologist will review their lung disease, adjust their treatment, and recommend follow-up care. the cardiologist will also assess the second group for heart diseases (like high cholesterol, diabetes, heart disease, high blood pressure, or heart failure) and start or adjust heart treatment if needed. both groups will be followed up by phone 1, 3, 6 and 12 months later to check for changes in treatment, new heart problems, copd flare-ups, or death.

this is a single-center, prospective, randomized study involving patients hospitalized for copd exacerbation. eligible patients will be identified either by the internal medicine department doctors or by reviewing the admission diagnoses of hospitalized patients in the hospital's database. after obtaining informed consent, the patients will be randomized into two groups. both groups will complete a background questionnaire and will be assessed by a pulmonologist during the hospitalization, who will focus on their lung disease, optimize basic treatment, and recommend follow-up as needed. the intervention group will undergo an additional evaluation by a cardiologist during the hospitalization, who will check for cardiovascular diseases (such as hyperlipidemia, diabetes, ischemic heart disease, hypertension, or heart failure) and adjust or start treatment according to new or existing diagnoses. both groups will receive follow-up phone calls about 1, 3, 6, and 12 months later to evaluate any changes in treatment following the intervention, new diagnoses or events of cardiovascular diseases, copd exacerbations, and mortality.

Eligibility criteria:
inclusion criteria: * documented copd (based on lung function tests, symptoms and relevant treatment). * aged 18-75 years. * mentally competent to understand and follow medical recommendations. exclusion criteria: * under 18 years of age. * unable to provide consent. * unstable concurrent disease.

Keywords: copd exacerbation cardiovascular disease comorbidity diagnosis screening
meditation effects on brain function in rheumatoid arthritis

Conditions: Rheumatoid Arthritis

Summary: the purpose of this study is to determine the neural mechanisms supporting meditation-based pain relief in rheumatoid arthritis (ra) patients. the scientific premise is that ra patients' use of different meditation practices during noxious thermal stimulation will alter neural function in brain areas associated with pain, evaluation, and emotional appraisal. the investigators will randomize ra patients to a brief 4-session course of intervention a (n=20) or intervention b (n=20). at post-intervention, participants will undergo functional mri (fmri) using a perfusion-based arterial spin labeling (asl) technique during noxious thermal stimulation to determine if the meditation practices differentially alter neural function during noxious thermal stimulation.


Eligibility criteria:
inclusion criteria: * withheld to preserve recruitment integrity. exclusion criteria: * withheld to preserve recruitment integrity.
yeast cells as antioxidant-producing probiotics

Conditions: Infertility, Male

Summary: the purpose of this study is to evaluate the efficacy of baker's yeast extractions , probiotic antioxidant, in scavenging the oxidative stress status mediated damage on sperm motility,progressive motility and vitality as well as comparing this potency to that of vitamin e in infertile men.

the practical part of the study took place from august 2020 to november 2021. the study population was made up of infertile males attending hawaa fertility center, banha city, qaliubiya, egypt. 40 study samples were collected from patients who indicated willingness to participate in the study and have had 3 to 7 days of sexual abstinence, using the masturbation method and ejaculated in wide mouthed plastic container as described by world health organization (who). samples were allowed to liquefy for 20 minutes and were examined for volume, viscosity, spermatozoa count by neubauer haemocytometer , oxidative stress level measurement by oxisperm, percentage of progressive motility and non-progressive motility and sperm vitality. the semen specimens were divided into ten equal fractions. first fraction was control, 0.1ml of liquefied semen mixed with 0.1ml ham's f10 medium and incubated at 37o c for 30 minutes., 2nd: vit. e, 3rd (yeast extraction ( ye).vitamin c was obtained from (sigma, germany), 3rd, 4th, 5th fractions (vit. c. 1,2,3), 0.1ml liquefied semen was mixed with 0.1ml ham's f10 medium supplemented with (0.02, 0.04, 0.06 mg/ml) vitamin c respectively and incubated at 37o c for 30 minutes. after semen specimen treated in all fractions, they were examined and assessed for microscopical changes, total motility, progressive motility, vitality, level of oxidative stress (os) were detected in all fractions 30 minutes later after addition of the antioxidants.

Eligibility criteria:
inclusion criteria: * must have been married for 1 year before inclusion into the study and were unable to achieve pregnancy * must have not received an antibiotic treatment for the last 4 weeks prior to sampling * showed oxidative stress- mediated asthenozoospermia in their semen exclusion criteria: * severe male factor

Keywords: male infertility oxidative stress antioxidants probiotics vitamin e baker's yeast