Kornimate/medical-research-clean huggingface dataset:
treatment of cholestatic pruritus with sertraline

Conditions: Pruritus; Liver Cirrhosis, Biliary; Hepatitis C

Summary: the goal of this study is to find an effective and well-tolerated medical therapy for itching due to liver disease. persons with primary biliary cirrhosis or chronic hepatitis c are currently being enrolled in the study. persons participating in the study are given sertraline, a medication which is also often used for depression,to treat their itching. the dose is gradually increased as the effect on itching and any other potential side effects are carefully monitored.


Eligibility criteria:
* itching for at least 3 months * primary biliary cirrhosis or hepatitis c * elevated alkaline phosphatase for at least 6 months

Keywords: cholestatic pruritus sertraline primary biliary cirrhosis hepatitis c
a diaphragmatic electrical activity based optimization strategy during pressure support ventilation

Conditions: Respiratory Insufficiency

Summary: pressure support (ps) is a commonly used mode of ventilation which is triggered based upon the patient's own inspiratory efforts. for the most part, pressure support is well tolerated by patients. however, because the trigger for pressure support is an inspiratory effort by the patient, and because the resulting support is constant, the ventilator response can be "out of sync" with the patient's needs. the problem of patient-ventilator asynchrony has been documented to be large in approximately one quarter of patients who require mechanical ventilation. asynchrony is associated with increased or abnormal work of breathing (wob) and prolonged duration of mechanical ventilation. diagnosing asynchrony at the bedside can be challenging. electrical activation of the diaphragm (eadi) recording can provide clinicians with a more accurate picture of patient-ventilator synchrony and may thus result in decreased asynchrony and decreased or normalized work of breathing for the patient. the purpose of this physiologic study is to evaluate the role of protocolized pressure support ventilation (based upon eadi) in comparison to standard pressure support ventilation.

pressure support will be readjusted according to eadi recording in different steps. the optimized pressure support will be compared to the initial pressure support.

Eligibility criteria:
inclusion criteria: patients who are ventilated using a partial ventilator support mode (i.e. pressure support) and meet one of the following criteria: * known chronic pulmonary obstructive disease * suspected intrinsic peep on the expiratory airway pressure and flow tracings * resistive pressure (i.e. eak pressure-plateau pressure) higher than 20 centimeters of water (cmh2o) at a flow of 60 l/min or higher than 15 at a flow of 45 l/min in volume controlled ventilation (preferably after a tracheal aspiration maneuver) * known chronic restrictive pulmonary disease with respiratory failure * restrictive pulmonary disease characterized by a measured compliance of less than 30 ml/cmh2o * obesity with bmi ≥ 30 kg/m2 * existence of frequent asynchronies noticed on the ventilator waveforms * expected duration of ventilation of more than 24 hours exclusion criteria: * contraindication to naso/orogastric tube (ngt/ogt) placement (known esophageal problem such as hiatal hernia or esophageal varicosities, active upper gastro-intestinal bleeding, any other contraindication to the insertion of a ngt/ogt) * poor short term prognosis (defined by the clinician in charge as a high risk of death during the next 7 days) or ongoing palliative treatment. * patients with "do not resuscitate" order already established and in palliative care * patients younger than 18 years old

Keywords: pressure-support asynchrony
elastography in patients with idiopathic inflammatory myopathies

Conditions: Idiopathic Inflammatory Myopathies

Summary: the aim of our study was to assess the performance of compression-strain us elastography in patients with idiopathic inflammatory myopathies over time and to study these findings with clinical and functional parameters as well as biochemical and electromyographic tests.

this study will be carried out on four groups: group (i): twenty children diagnosed to have idiopathic inflammatory myopathies(iim) * group (ii): twenty adults diagnosed to have iim * group (iii):20 healthy children matching age and sex as first control group to children with iim . * group (vi):20 healthy adults matching age and sex as second control group to adults with iim. all patients will be evaluated at baseline at \& 4-months follow up using semi-quantitative strain elastography

Eligibility criteria:
inclusion criteria: * to fulfill criteria of diagnosis of childhood and adult idiopathic inflammatory myopathies exclusion criteria: * patients with age less than 2 years were excluded from the study due to inability to perform manual muscle testing and functional scales. * the presence of a associated illness that may result in nerve or muscle affection
panelux ptca : proposing an alternative treatment to patients for whom des implantation is not indicated, thanks to pantera lux drug eluting balloon

Conditions: Coronary Artery Disease; High Bleeding Risk Patients

Summary: the propose of this study is to demonstrate, whenever using drug eluting stent is not possible, the clinical security at 12 months, of the combinaison bare metal stent plus drug eluting balloon.


Eligibility criteria:
inclusion criteria: 1. subject has provided a written informed consent 2. subject \>/= 18 years. 3. patient affiliated to social security 4. patient acceptable candidate who accept to be contacted at different terms of clinical follow up (1, 6 and 12 months) 5. subject eligible for percutaneous coronary intervention and undergoing a chronical oral anticoagulant treatment or undergoing any semi-urgent invasive or non cardiac surgical planned intervention with major bleeding risks 6. subject eligible for dual anti platelet therapy (dapt) of acetyl salicylic acid and clopidogrel for at least 3 weeks 7. de novo coronary lesions: \>/= 50% - \<100% 8. subject, vessels and target lesion eligible for angioplasty with pro-kinetic energy stent implantation and final post-dilatation with pantera lux drug eluting balloon. 9. target lesion length \</= 26 mm , visual estimation or by quantitative coronary angiography (qca) 10. reference diameters targeted vessels \>/=2.5mm and \</= 4.0 mm (visual estimation or qca) exclusion criteria: 1. pregnant or breast feeding females or females who intend to become pregnant during the time of the study 2. subject with a life expectancy less than 1 year 3. vulnerable subject, protected by law, unable to give his/her consent 4. subject currently enrolled in other medical or drug study and has not reached the primary outcome measures of that study 5. subject unable to be contacted for the clinical follow up at 1, 6 and 12 months 6. subject under chronical oral anti-coagulant treatment (optionnal indication) 7. subject undergoing any urgent invasive or surgical intervention with major bleeding risk, which can not maintain dual anti-platelet therapy (dapt) for at least 3 weeks 8. in stent restenotic lesion 9. target lesion on vessels with nominal diameter \< 2.5 mm 10. target lesion is located in or supplied by an arterial or venous bypass graft 11. chronical total occlusion (cto) 12. angioplasty indication for stemi 13. patient with signs of cardiogenic shock 14. angioplasty antecedent with stent implantation (before 12 months for des, before 6 months for bms) 15. "staged procedure" \> 8 days after the initial angioplasty 16. documented left ventricular ejection fraction (lvef) \</= 30% 17. target lesion requiring before stent implantation a device other than a pre-dilatation balloon (including, but not only restricted to laser, cutting balloon, directional coronary atherectomy, rotational atherectomy etc...) 18. known allergies to acetylsalicylic acid, active agent such paclitaxel, expicients like bhtc (butiriltri-n-hexyl citrate), cocr, silicon carbide.

Keywords: pro-kinetic energy bms + pantera lux deb combination
nurse-led program efficacy on blood pressure control

Conditions: Hypertension; Home Blood Pressure Measurement

Summary: the diagnosis and control of hypertension depend on accurate measurements of blood pressure (bp); alternative approaches to measuring bp, such as ambulatory blood pressure monitoring or home blood-pressure self-measurement (hbpm), are gaining increasing acceptance in the diagnosis of hypertension and the monitoring of hypertensive patients.to achieve accurate bp measurements at home, measurement guidelines must be closely followed. however, previous studies have shown that patient compliance is in most cases unsatisfactory.the study aims at evaluating the efficacy of a family nurse (fn)-led home blood pressure management (hbpm) training program in improving bp control based on a comparison with routine care and management.

the quality of hbpm was found to be higher in patients who received some form of training in bp measurement from healthcare professionals than in patients who did not receive training. although self-estimation of bp may be prone to error, this risk can be minimized through adequate patient education and training that includes simple but nonetheless important recommendations. however, unclear is whether specific training offered by nurses, who frequently have a close relationship with their hypertensive patients, could result higher patient adherence to hbpm recommendations. therefore, we assume that a specifically tailored training program conducted by a family nurse (fn), when provided in addition to usual care, could improve patient adherence to hbpm recommendations. study design: single-blind, multicenter, randomized controlled trial.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of hypertension. * patients who visited one of two family practice offices located in chieti or pescara. * speaking and reading italian. * having an active phone number and an email address. * providing a signed informed consent. exclusion criteria: * mental illness. * cognitive impairments. * pregnancy. * institutionalization (nursing home).
effect of ultrasound acupoints on patients with polycystic ovary syndrome

Conditions: Polycystic Ovary Syndrome

Summary: this study will be conducted to evaluate the effect of ultrasound acupoints on menstrual irregularity and hormone levels on polycystic ovary syndrome (pcos) patient.

pcos is a life-long condition and although the exact cause is yet to be identified, it is believed to have epigenetic origins. it is the main gynecological endocrinopathy of reproductive age. it is the most common cause of infertility due to anovulation. in many countries, it represents the leading cause of female infertility. signs and symptoms are mediated by hormonal disorder including elevated androgens and fasting insulin, and abnormal relative ratio of the gonadotropins luteinizing hormone (lh) and follicle stimulating hormone (fsh). endocrine imbalances occur within the framework of disordered ovarian folliculogenesis, chronic anovulation, clinical signs of hyperandrogenism and metabolic syndrome. the standard treatment of pcos includes oral medications, lifestyle changes, and surgery. pharmacology-based treatments are effective in only 60% of patients. therefore, acupuncture provides an alternative. acupuncture therapy in female with pcos and ovulatory disorder has been known to bring enduring useful results on the endocrine system and menstrual cycle, without complications. in women with pcos and ir, acupuncture was superior to metformin in improving glucose metabolism and had a lower incidence of gastrointestinal adverse effects. there were no studies using ultrasound acupoint to improve symptoms of pcos patients, so this study will discuss this method to describe its effect on pcos patients.

Eligibility criteria:
inclusion criteria: * adults range between 18 and 35 years. * all patients will be stopped drugs that affect the result during study period. * body mass index (bmi) not exceeding 30 kg/m2. * have the symptoms of oligomenorrhea or amenorrhea (appendix i). * no documented or observable psychiatric or neurological disorders that would interfere with study participation (eg, dementia or psychosis). * not having any type of cancer. exclusion criteria: * any malignancy * patients with severe or unstable cardiorespiratory or musculoskeletal diseases that may influence the accuracy of quantitative sensory testing results. * participants who refuse to stop the drugs that affect the study during study period. * contraindications to therapeutic ultrasound including active cancer in region of hands or feet, presence of deep vein thrombosis, complete numbness in hands or feet, metal or plastic implantation.
immunogenicity and persistence of hepatitis b vaccination in hiv-infected patients

Conditions: Hepatitis B Vaccine

Summary: at present, hiv-infected patients of hepatitis b vaccination in are vaccinated with hepatitis b vaccine according to the standard three-dose schedule immunization program, and the effect of preventing hbv infection is not ideal. this is a randomized, controlled trial. the study will evaluate the immunogenicity and persistence of 20 µg and 60 µg recombinant hepatitis b vaccine with three or four injections at months 0, 1, and 6 or 0, 1,2, and 6 in hiv-infected patients

participants are randomized in a ratio of 1:1:1 into 20 µg recombinant hepatitis b vaccine group at months 0, 1, and 6 or 20µg recombinant hepatitis b vaccine group at months 0, 1, 2, and 6 or 60µg recombinant hepatitis b vaccine group at months 0, 1, 2, and 6. hbsag and anti-hbs will be tested during the study period. adverse reactions will be recorded after vaccination.

Eligibility criteria:
inclusion criteria: * serologically negative for hepatitis b surface antigen (hbsag), hepatitis b surface antibody (anti-hbs) and hepatitis b core antibody (anti-hbc) at enrollment * sign informed consent, willing to participate in this study exclusion criteria: * being pregnant * intolerance or allergy to any component of the vaccine * any vaccination during the month preceding enrollment * cd4 cell count ≤ 200 cells/µl * patients with severe acute or chronic diseases (such as liver disease, blood disease, cancer), acute onset of chronic diseases and fever * the use of immunosuppressive agents in patients with nearly three months

Keywords: hepatitis b vaccine randomized controlled trial hiv-infected patients immunogenicity long-term immune response
efficacy and safety of jm-010 in pd with levodopa-induced dyskinesia

Conditions: Parkinson's Disease; Levodopa Induced Dyskinesia (LID)

Summary: the purpose of a randomized, double-blind, placebo-controlled, 2-way crossover study is to evaluate the efficacy, safety/tolerability and pharmacokinetics of jm-010 for the treatment of subjects with parkinson's disease (pd) with levodopa-induced dyskinesia (lid).


Eligibility criteria:
inclusion criteria: * written informed consent. * subject with a diagnosis of moderate to severe idiopathic pd with showing responsiveness to levodopa. * all anti-parkinsonian medications and levodopa must be stable for at least 1 week prior to the start of the run-in period. * subject with stable predictable peak-effect lid of at least 2 hours of the awake day and with at least moderately disabling. * amantadine and/or monoamine oxidase (mao) inhibitor must be stopped at least 2 weeks prior to the start of treatment period 1(tp 1). exclusion criteria: * diagnosis is unclear or a suspicion of other parkinsonian syndromes exists, such as secondary parkinsonism, parkinson-plus syndromes or other neurological degenerative diseases. * history of any other brain surgery or surgery for the treatment of pd. * current primary psychiatric diagnosis of acute psychotic disorder or other primary psychiatric diagnoses. * a history of psychosis and/or treatment with antipsychotics within 3 months prior to the start of treatment period 1(tp1). * a history of, or current, seizure disorders and subjects requiring treatment with anti-convulsants. * clinically significant abnormal laboratory data at screening. * clinically relevant ischemic heart symptoms or history of myocardial infarction, coronary artery bypass surgery or percutaneous transluminal coronary angioplasty, within the previous 12 months prior to the start of tp1. * history of cerebrovascular accident or transient ischemic attack, coronary vasospasm/prinzmetal's angina. * history of serotonin syndrome. * breast feeding or pregnant women.

Keywords: parkinson disease levodopa induced dyskinesia (lid) dyskinesia
effect of aromatherapy on anxiety in relatives of emergency patients.

Conditions: Emergency Service, Hospital; Aromatherapy; Anxiety

Summary: this study aims to determine the effect of aromatherapy (lavender oil) application on the anxiety level of relatives of patients admitted to the emergency department. the hypotheses of the study are as follows: h1: aromatherapy (lavender oil) application has an effect on the anxiety level of relatives of patients presenting to the emergency department. h0: aromatherapy (lavender oil) application has no effect on the anxiety level of relatives of patients presenting to the emergency department.

in the experimental group; after the patient is registered in the emergency department, the participant introduction form and state-trait anxiety scales will be applied as a pre-test to the relatives of the patients who agree to participate in the study. the participants will be made to smell lavender oil dropped on gauze by the researchers for an average of 3-5 minutes. after the intervention, the state and trait anxiety scales will be applied as a post-test approximately 15 minutes later. in the control group; after the patient is registered in the emergency department, the participant introduction form and state-trait anxiety scales will be applied as a pre-test to the relatives of the patients who agree to participate in the study. no intervention will be made to the participants in the control group. after a certain waiting period (after an average of 15 minutes), the state and trait anxiety scales will be applied as a post-test.

Eligibility criteria:
inclusion criteria: 1. being 18 years of age or older 2. not having a problem with smell 3. accompanying the patient 4. not having a psychiatric problem exclusion criteria: 1. refusing to participate in the study or wanting to leave 2. having an upper respiratory tract infection 3. known history of allergy (lavender oil) 4. having a chronic respiratory disease

Keywords: emergency department aromatherapy anxiety
comparison of the blood sugar lowering effect and safety of two insulin treatments in type 2 diabetes

Conditions: Diabetes; Diabetes Mellitus, Type 2

Summary: this trial is conducted in europe, africa and the united states of america (usa). the aim of this trial is to compare the safety and efficacy of two different insulin treatments, the "basic" and the "advanced" treatment in type 2 diabetes.


Eligibility criteria:
inclusion criteria: * type 2 diabetes mellitus for more than 6 months * hba1c (glycosylated haemoglobin a1c) between 7.5 % and 10.0% at trial initiation (screening) * bmi (body mass index) less than 40 kg/m2 * basal insulin treatment for at least 3 months (nph once or twice daily, insulin glargine or detemir once daily) * treatment with one to 3 oads exclusion criteria: * known or suspected allergy to trial products or related products * women who are pregnant, are breast-feeding or intend to become pregnant within the next 48 weeks * previous participation in any trial including this for the last 6 months * use of more than 1 u/kg of basal insulin daily at trial initiation (screening)
the effects of bromelain supplement in patients with diabetic foot ulcers

Conditions: Diabetic Foot Ulcer (DFU)

Summary: this study will be conducted on people over 18 with diabetic foot ulcers.. the first group will receive the standard treatment along with bromelain supplement and the second group will receive the standard treatment and placebo. the informed consent form prepared in advance will also be provided to the patients so that they are fully familiar with the study process. wound surface area, rate of pain, rate of inflammatory factors (esr and crp) will be assessed at baseline and every two weeks.


Eligibility criteria:
inclusion criteria: * patients over 18 years old * patients diagnosed with diabetic foot ulcers of category 0, 1 and 2 according to the wagner criteria * patients aware of the study process for monitoring after filling out the informed consent form exclusion criteria: * people who are allergic to pineapple, celery, carrot and fennel * pregnant and lactating women * severe kidney failure (gfr\<30) * severe liver failure (child pugh b, c) * patients with hemophilia * people taking anticoagulant drugs, anti-platelet and thrombolytic * patients with irregular heartbeat and tachycardia * patients with asthma

Keywords: diabetic foot ulcer bromelain
polarity action in electrical stimulation transcutaneous donors for treatment areas burned patients

Conditions: Burn

Summary: to evaluate the effect of the polarity of the electric current in healing.

the objective of this study is to evaluate the effect of the polarity of the current in healing. both will be compared to the effects of electrical stimulation of high voltage (hves) and neuromuscular transcutaneous electrical stimulation (tens) in the treatment of donor sites (da) of burn patients. it is a prospective, controlled clinical, randomized, blinded. will be assessed 60 subjects aged 18-59 years, of both sexes, underwent the surgical procedure of grafting (pce) were randomly divided into small blocks 5:5:5 three groups: undergoing therapeutic procedure with hves undergoing therapeutic procedure with tens and control. therapeutic procedures will be applied around the da, thigh or scalp, after 24 hours of pce until complete healing. the variables will be the healing time estimated by the removal of the dressing rayon, clinical evaluation, scar quality, the vancouver scale; pain, the pain numerical scale evaluation (pns); blood perfusion by thermography; quality of healing by digital imaging, quantification of areas of crusts by the software image j; skin biomechanical aspects as firmness, the durometer being performed reassessment at the end of treatment. data will be submitted to analysis of normality by the shapiro-wilk test and the effect of behavior among groups and pre- and post-intervention will be evaluated by anova-two way followed by post-hoc (bonferroni) or friedman, with p \<0.05. comparing groups, before a normal distribution is applied anova followed by tukey, and otherwise will be applied the kruskal-wallis test and post-hoc dunn, p\<0.05.

Eligibility criteria:
inclusion criteria: * victims of second deep degree and third degree burns, aged between 18 and 59 years * both sexes * underwent the surgical procedure of grafting (pce) with donor area of the scalp or thigh thick standardized mean (0.20 mm). exclusion criteria: * diabetes, * infectious processes * use of medications that alter the healing process (corticosteroids, chemotherapy, radiotherapy, among others) * cognitive impairment * agreeing not to sign the consent form and clarified or that do not fit the inclusion criteria described.