Kornimate/medical-research-clean huggingface dataset:
effectiveness of pharmaceutical care in the adherence of systemic lupus erythematosus treatment

Conditions: Systemic Lupus Erythematosus; Medication Adherence

Summary: this project aims to improve adherence rate through pharmaceutical care in patients with systemic lupus erythematosus (sle) to help achieving therapeutic goals and finally to improve the quality of life of these patients.

adherence to treatment is a primary determinant for the effectiveness of health care. non-compliance may lead to therapeutic failure, make more difficult and complex the management of chronic diseases or cause death. the effectiveness of interventions on adherence has an important impact in the health of the population. systemic lupus erythematosus (sle) is an autoimmune disease with high proportion of hospital admissions and deaths and high cost of treatment. the prevalence of adherence in this group of patients in brazil is very low (31.7%) and the drug treatment is complex. our aim is to assess the effectiveness of pharmaceutical care in the adherence of drug treatment by sle patients attended in a rheumatology outpatient clinic in rio de janeiro, brazil. randomized clinical trial (pragmatic trial), in which 120 adult patients with confirmed sle diagnosis will be followed for 12 months, and randomized in two groups: the intervention group (attended by a pharmacist according to the dader method for pharmaceutical care), and the control group (attended by a non-pharmacist professional with counseling on hygiene/nutrition and reduction of risks in lupus therapy). the main outcome will be adherence to drug therapy and secondary outcomes the improvement of the medical condition and the quality of life of the patients.

Eligibility criteria:
inclusion criteria: * sle diagnosis according to the 2012 slicc (systemic lupus international collaborating clinics group) sle classification criteria. * treatment with corticosteroids and antimalarials. * history of biopsy-proven lupus nephritis classes iii, iv, or v (2003 international society of nephrology / renal pathology society) or nephritic/nephrotic lupus flare not undergone to kidney biopsy. exclusion criteria: * current renal replacement therapy. * renal transplantation. * ongoing pulse therapy with cyclophosphamide and/or methylprednisolone. * aid by caregiver. * any psychiatric illness. * inability to understand the questions of the questionnaire. * patients'unwillingness to sign the informed consent.

Keywords: systemic lupus erythematosus pharmaceutical care pharmaceutical services medication adherence
postoperative outcomes after positive intraoperative messages

Conditions: Postoperative Pain; Postoperative Nausea; Postoperative Vomiting

Summary: the patients scheduled for laparoscopic cholecystectomy will be allocated to 3 groups. group a and b patients will listen to a positive message under general anesthesia. group c patients will not listen to the message. the postoperative pain, analgesic consumption and frequency of nausea, vomiting and emergence agitation episodes will be documented and compared between the 3 groups.


Eligibility criteria:
inclusion criteria: * laparoscopic cholecystectomy. * asa 1-3 exclusion criteria: * hearing loss. * chronic use of drugs which affect the central nervous system (antidepressants, antiepileptics, opioids, benzodiazepines)

Keywords: emergence agitation
comparison of anesthesia effects of sevoflurane and propofol combined with dexmedetomidine in intraoperative neuromonitoring during thyroidectomy

Conditions: Thyroid Nodule

Summary: according to the previous studies, it is reported that the use of sevoflurane in the maintenance of anesthesia may lead to delayed occurrence of positive electromyographic (emg) signal and lower obtained signal amplitude. in this study, the investigators aimed to investigate the anesthetic effect of sevoflurane combined with dexmedetomidine for neuromonitoring during thyroid surgery. the investigators hypothesize that sevoflurane combined with dexmedetomidine can reduce the movement or spontaneous activity of vocal cords in patients and without affecting the emg signals.

recurrent laryngeal nerve (rln) injury is one of the most serious common complications in thyroid operation. compared with the traditional operation under direct eye vision alone, application of intraoperative neural monitoring (ionm) is able to help surgeon in identifying the rln during thyroid dissection, and enabling continuous monitoring of the neurological function during operation, thus reducing the incidence of intraoperative rln injury. sevoflurane is a common inhaled anesthetic in clinical practice, with the effect of prolonging the action time of muscle relaxants. according to the previous studies, it is reported that the use of sevoflurane in the maintenance of anesthesia may lead to delayed occurrence of positive electromyographic (emg) signal and lower obtained signal amplitude, which may affect the surgeon's judgment on neurological function during the operation. in this study, the investigators aimed to investigate the anesthetic effect of sevoflurane combined with dexmedetomidine for neuromonitoring during thyroid surgery. the investigators hypothesize that sevoflurane combined with dexmedetomidine can reduce movement or spontaneous activity of vocal cords in patients without affecting the ionm signal.

Eligibility criteria:
inclusion criteria: * patients scheduled for thyroidectomy under general anesthesia * american society of anesthesiologists (asa) grade of i or ii * aged 18 to 65 years * body mass index (bmi) \< 32 kg/m2. exclusion criteria: * patients with rln or vagus nerve injury were identified preoperatively * severe cardiovascular, pulmonary, liver and kidney diseases * history of allergy to narcotic include rocuronium -pregnancy or lactation- * history or current usage of medication which may interfere neuromuscular transmission; * family or personal history of malignant hyperthermia * myasthenia gravis * potential risk of airway difficulty * unable to cooperate.
the influence of the thickening of bowman's capsule on the clinical prognosis of patients with diabetic kidney disease

Conditions: Diabetic Kidney Disease; Extracellular Matrix Alteration

Summary: diabetic kidney disease (dkd) is the leading cause for renal replacement therapy in developed country. dkd is also the primary cause of eskd among middle-aged and elderly people in china. renal pathological markers have been proved to have clinical and prognostic value in both non diabetic and diabetic kidney diseases. to discriminate lesions by various degrees of severity, the working group of the renal pathology society (rps) developed a pathologic classification for dkd in 2010. the classification is based on glomerular lesions, with a separate evaluation for interstitial and vascular lesions. in a decade, there were several new characteristics common to dkd, such as the presence of mesangiolysis, glomerular hyalinosis, segmental sclerosis and extracapillary hypercellularity, which have been noted in patients with diabetes and may have prognostic importance. but it is still unclear whether thickening of bowman's capsule predicts the progression of dkd.


Eligibility criteria:
inclusion criteria: * 1) age ≥ 18 years old, male or female 2) patients diagnosed as diabetes kidney disease by renal biopsy exclusion criteria: * 1) patients combined with non diabetes kidney disease; 2) patients with kidney transplant failure; 3) patients undergoing zero point puncture for kidney transplantation; 4) less than 5 glomeruli in the renal puncture sample.

Keywords: diabetic kidney disease extracellular matrix parietal epithelial cells
methylnaltrexone as a method to improve ticagrelor uptake in morphine treated stemi patients

Conditions: STEMI; Morphine; Ticagrelor; Methylnaltrexone

Summary: this study will examine the impact of the peripheral opioid antagonist methylnaltrexone on the onset of effect of ticagrelor in morphine treated patients with st elevation myocardial infarction (stemi). half of the participants will receive methylnaltrexone, while the other half will receive placebo.

the rate of drug absorption in the gastro-intestinal tract is often determined by the rate of gastric emptying. morphine treatment, which is frequently given in order to relieve pain in patients with stemi, is known to delay gastric emptying, and has indeed emerged as a predictor of delayed/poor antiplatelet response in patients receiving oral prasugrel or ticagrelor. in recent years, morphine has been found to delay the onset of oral p2y12-inhibitors. to counteract this, the investigators hypothesized that an opioid antagonist may be used. the opioid antagonist naloxone has previously been shown to reduce the morphine induced delay in gastric emptying however, naloxone crosses the blood-brain barrier (bbb) and reduces the pain relieving effects of morphine. in contrast, the morphine antagonist methylnaltrexone has a reduced passage over the bbb and acts primarily as a peripheral morphine antagonist without affecting the morphine-mediated central analgesic effects. the aim of the planned study is to evaluate whether methylnaltrexone bromide may reduce the morphine induced delay in onset of platelet inhibition after a loading dose of 180 mg ticagrelor in morphine treated patients with stemi undergoing primary percutaneous coronary intervention (pci), where a rapid and adequate platelet inhibition after the administration of ticagrelor is crucial. as morphine is an inclusion criterion, all patients included in the study will be on morphine treatment. thus, morphine treatment is not an intervention to be administered as part of the protocol. stratification according to inferior and anterior/lateral stemi will be perform to avoid imbalance in the location of myocardial infarction between the groups.

Eligibility criteria:
inclusion criteria: * diagnosis of stemi * administration of a 180 mg loading dose ticagrelor * analgesic treatment with intravenous morphine pre-pci exclusion criteria: * cardiac arrest * body weight \> 114kg * vomiting after intake of ticagrelor loading dose * use of naloxone before inclusion or during sampling period * inability to understand study outline and instructions * methylnaltrexone bromide contraindication * age \<18 years; 8) women in fertile age * administration of ticagrelor during the week before inclusion * treatment with cangrexal * ongoing long-term opioid treatment.
early infant diagnosis point of care pilot

Conditions: HIV

Summary: in mozambique, early infant hiv diagnosis (eid, i.e. hiv screening of infants under 18 months of age) is conducted using molecular diagnostics at central laboratories in maputo, nampula, beira and quelimane. however, test volumes are growing and many parts of the country do not have close access to laboratories. test samples are transported over large distances and this can introduce testing delays, especially for patients in rural and remote areas of the country. there are now new poc eid technologies becoming available that will enable diagnosis of hiv in infants within minutes or a couple of hours on site in the clinic, operated by non technical staff and without laboratory infrastructure. this protocol describes a plan to conduct an evaluation of a point-of-care (poc) early infant diagnosis (eid) testing technologies that are being considered for use in mozambique, and to pilot those technologies in order to provide more effective diagnostics and clinical care to patients. during this implementation pilot, sites are randomized to use either conventional or poc eid testing only before the inclusion of the patients in the study. no consent will be asked to the parents or guardians. a written permission will be asked to the direção provincial de saúde of both provinces to implement the poc device as routine in those intervention sites. all the information that will be analyzed will be collected from the routine care and it will be analyzed as a group.


Eligibility criteria:
inclusion criteria: * born to hiv positive mother * from 4 weeks to 18 months of age * came to ccr consultation for early infant diagnosis exclusion criteria: * with a valid positive test by other center

Keywords: hiv diagnostic children
alisporivir (deb025) and boceprevir triple therapies in african american participants not previously treated for chronic hepatitis c genotype 1

Conditions: Hepatitis C

Summary: this study will assess the safety and efficacy of alisporivir (alv) and boceprevir (boc), each in combination with peginterferon alfa-2a (peg) and ribavirin (rbv), in african american participants who have never received treatment for their chronic hepatitis c (hcv) genotype 1 infection.


Eligibility criteria:
inclusion criteria: * chronic hcv genotype 1 infection * no previous treatment for hcv infection * african american ethnicity * serum hcv rna ≥ 1000 iu/ml, assessed by quantitative polymerase chain reaction or equivalent at screening visit, no upper limit * a liver biopsy within 3 years prior to baseline exclusion criteria: * hcv genotype different from genotype 1 or co-infection with other hcv genotype * co-infection with hepatitis b or hiv * any other cause of relevant liver disease other than hcv * presence or history of hepatic decompensation * alanine aminotransferase (alt) ≥ 10 times uln, more than 1 episode of elevated bilirubin (\> uln) in past 6 months other protocol-defined inclusion/exclusion criteria may apply

Keywords: chronic hepatitis c cyclophilin inhibitor
novel wearable device for heart failure management

Conditions: Heart Failure

Summary: heart failure (hf) is a major cardiovascular disease with high readmission and mortality rate. a wearable device that could remotely monitor and detect the worsening hf early before the symptoms appear will help reduce hf readmissions effectively. the purpose of the current study is to examine the efficiency of a novel wearable device based on flexible strain sensor comparing to the clinical 'gold standard,' and then transform it into a clinical application.

the prospective cohort study aims to examine the efficiency of a novel wearable device based on a flexible strain sensor to improve the outcomes of patients with hf compared to the standard-of-care without wearable device monitoring. the primary and secondary endpoints will be examined in subgroups determined by baseline variables reflecting demography,nyha functional class,left ventricular ejection fraction,natriuretic peptide,additional co-morbidities,and others.

Eligibility criteria:
inclusion criteria: 1. diagnosis of hf ≥ 3 months 2. diagnosis of nyha class iii hf 3. subjects with age ≥ 18 years 4. at least 1 hf hospitalization within 12 months prior to enrollment 5. subjects with elevated ambulatory levels of bnp/nt-probnp exclusion criteria: 1. subjects unable to cooperate to complete the trial. 2. subjects with severe arrhythmia. 3. subjects with cardiac shock. 4. subjects with acute myocardial infarction. 5. subjects with local skin infections and injuries in the jugular vein area 6. subjects with active uncontrolled infections 7. subjects with egfr \< 25 ml/min/1.73m2 8. pregnant women, or women likely to undergo pregnancy 9. subjects with life expectancy less than 6 months

Keywords: novel wearable device remote monitoring right heart catheterization
a study to learn about brigatinib treatment information available in chinese participants with non-small-cell lung cancer (nsclc)

Conditions: Non-small Cell Lung Cancer (NSCLC)

Summary: the main aim of this study is to learn about the time between the start and stop of treatment with brigatinib in chinese participants with non-small-cell lung cancer (nsclc) and who have been positively diagnosed with having the anaplastic lymphoma kinase (alk) gene. other study aims are to learn about the progression of nsclc and participants' response to treatment with brigatinib.

this is a non-interventional, ambispective (retrospective + prospective) study of chinese participants with alk-positive locally advanced or metastatic nsclc receiving brigatinib as their first line of treatment from september 1, 2022.this study will evaluate the time-to-treatment discontinuation and other efficacy outcomes of brigatinib in participants with nsclc in real-world settings. this study will enroll approximately 200 participants in the following cohort: • brigatinib 90 mg/180mg this study is an ambispective study that will have prospective data collection if participants enrolled after the study initiation or it will have retrospective data collection if the participants have already started receiving brigatinib as first line treatment before study initiation. this multi-center trial will be conducted in china. participants will be followed up for safety from signing informed consent until 36 months after the last dose of treatment or until death of the last participant. the overall time for data collection is approximately 8 years.

Eligibility criteria:
inclusion criteria 1. age ≥ 18 years. 2. participant with histologically/cytologically confirmed locally advanced or metastatic nsclc. 3. participants with alk gene rearrangement confirmed by local hospital medical records. 4. participants who received brigatinib since september 1, 2022 as first line treatment confirmed by medical records. 5. participants who have at least one medical record after the start of brigatinib treatment. exclusion criteria 1. participants participated in nsclc-related interventional clinical trials after locally advanced or metastatic nsclc diagnosis and during brigatinib treatment. 2. previously received any other tkis, including alk-targeted tkis. 3. previously received more than 1 regimen of systemic anticancer therapy for locally advanced or metastatic disease. 4. participants have been diagnosed as malignancies (excluding completely resected basal cell carcinoma, bladder carcinoma in situ, cervical carcinoma in situ) in addition to nsclc within the past 5 years.

Keywords: drug therapy real-world data anaplastic lymphoma kinase tyrosine kinase inhibitors
nonincised papillae in the treatment of intrabony defects.

Conditions: Reconstructive Surgical Procedure

Summary: the primary objective of the present study is to clinically and radiographically evaluate nonincised papillae surgical approach and entire papilla preservation approach for the treatment of intrabony defects with gtr membrane and hydroxyapatite graft.

various procedures to treat intrabony defects by preserving the interdental papilla include conventional, simplified, and modified papilla preservation techniques. the drawback of these techniques is the post-surgical gingival recession. in order to overcome this drawback, the "entire papilla preservation" technique has been proposed, by preserving the whole integrity of the defect associated papilla providing a tunnel-like undermining incision. recently a novel surgical procedure, termed nonincised papillae surgical approach (nipsa), was designed to maintain the integrity of the interdental soft tissues covering intrabony defects. this would prevent biomaterial exposure associated with loss of papillary height, increase the amount of space for hard and soft tissue regeneration, and minimize gingival recession.

Eligibility criteria:
inclusion criteria: 1. systemically healthy individuals within an age group 30-60yrs with chronic periodontal disease. 2. presence of two or more intrabony defects with probing pocket depth ≥5mm, cal≥5mm, and radiographic depth ≥4mm. 3. adequate attached gingiva of 3mm and vestibular depth of 8mm. - exclusion criteria: 1. uncontrolled systemic disease. 2. pregnancy and lactation. 3. defects involving lingual sites. 4. presence of restoration in the experimental teeth. 5. smokers -

Keywords: periodontitis; reconstructive surgical procedure; guided tissue regeneration; surgical flaps;treatment outcome
intravenous iron may increase depression among hemodialysis patients

Conditions: Depression; Hemodialysis Complication; Iron Deficiency Anemia

Summary: the aim of this study is to assess whether increased ferritin after intravenous iron therapy will lead to increased prevalence of major depression among treated patients.


Eligibility criteria:
inclusion criteria: 1. age was above 19 years, 2. patient on maintenance hemodialysis, 3. patient had iron deficiency anemia (ferritin \> 100 ng/ml) exclusion criteria: 1. patient has history of depression or already using antidepressant medication, 2. lack of ferritin level increase ≥ 50% from baseline level before iv iron administration, 3. patient already on oral or intravenous iron supplement
water intervention for thinking in kids (witikids ) study

Conditions: Low Fluid Intake, Chronic

Summary: the aim of this study is to determine the influence of changes in water intake on changes in cognitive function among preadolescent children. further, the proposed work will determine the relationship between urinary markers of hydration process and cognitive function. we hypothesize that an increase in water intake will result in greater cognitive performance. in addition, improvements in hydration demonstrated by lower urine concentration will be correlated with greater cognitive performance.


Eligibility criteria:
inclusion criteria: 1. parental/guardian consent 2. normal or corrected-to-normal vision based on the minimal 20/20 standard in order to complete the cognitive task (below 20/20 vision). exclusion criteria: 1. participants younger than 9 years and older than 10 years at the time of testing age. 2. prior diagnosis of cognitive or physical disability, including adhd (severe asthma, epilepsy, chronic kidney disease, and dependence upon a wheelchair/walking aid). 3. use of anti-psychotic, anti-depressant, anti-anxiety medication, as well as those medications used for add/adhd (use of any anti-psychotic, anti-depressant, anti-anxiety, and add/adhd medications). 4. participants must have not yet reached, or be in the earliest stages, of puberty, as measured by a modified test of the tanner staging system 5. iq below 85 6. use of medications that alter urinary excretion and water metabolism 7. use of internal electronic device, such as a pacemaker

Keywords: water children cognition hydration
frenkel's exercises for sub-acute ischemic stroke patients

Conditions: Stroke, Ischemic

Summary: this single-blinded, randomized controlled was aimed to compare the efficacy of frenkel's and conventional balance exercises in improving balance and quality of life in patients with subacute ischemic stroke. the participants of group a received 'frenkel's exercises'. in contrast, group b participants received 'conventional balance exercise' interventions three days/week for 30-60 minutes for four weeks. the data was collected pre and post-treatment on the berg balance scale and stroke specific-quality of life.


Eligibility criteria:
inclusion criteria: 1. patients aged between 35 to 75 years. 2. first-ever ischemic stroke and hemiparesis within 7 to 30 days of onset. 3. reduced proprioception of the lower limb with a score of ≤12 on the nsa (kinesthetic and tactile sensation test), 4. able to comprehend tasks and follow directions with a score of ≥21 points on the mini-mental state examination (mmse). 5. able to independently perform standing motions for ≥1 minute. exclusion criteria: 1. patients with lower limb fractures within 6 months. 2. severe pain. 3. limited range of motion. 4. cerebellar ataxia. 5. medically unstable.

Keywords: stroke disability exercise balance quality of life.