Kornimate/medical-research-clean huggingface dataset:
"efficiency of preventive interventions in community nursing to improve medication adherence in vulnerable elderly"

Conditions: Noncommunicable Diseases; Vulnerable Elderly

Summary: the purpose of the study is to design and investigate the effectiveness of a set of preventive interventions by community nurses in outpatient care in treating vulnerable elderly people to improve the extent to which they follow the agreed recommendations of a doctor or pharmacist regarding taking medication.

we will conduct a randomized controlled trial to determine the effectiveness of preventive interventions to improve adherence in vulnerable elderly people. the randomized controlled trial will include: vulnerable people over 65 years of age with preserved cognitive abilities who are receiving at least one medication for any medical condition and are being treated by an outpatient service; they live in their home environment, which in the first phase will show vulnerability and, at the same time, initial suboptimal adherence. we will inform the subjects verbally and in writing about the course, purpose, and goals of the study and obtain their written consent for inclusion in the study. they will then be randomly assigned to two groups: experimental and control. in the case of the experimental group, we will carry out a set of preventive interventions to support the improvement of medication adherence. the control group will receive regular nursing care from community nurses, to which we will add the so-called distractor. we will determine the effectiveness of preventive interventions based on changes in self-efficacy and adherent behavior. data on adherence behavior and self-efficacy will be collected at the beginning of the study, at the end of the implementation of the set of preventive interventions, and three months after the end of the implementation.

Eligibility criteria:
inclusion criteria: * vulnerable elderly 65years and older, * vulnerable elderly with preserved cognitive abilities, * vulnerable elderly receiving at least one medication for any medical condition, * vulnerable elderly treated by a community nurse, * community-dwelling vulnerable elderly, * suboptimal adherent vulnerable elderly. exclusion criteria: * vulnerable elderly with psychoses or dementia, * vulnerable elderly with cognitive disorders, * vulnerable elderly addicted to alcohol, * vulnerable elderly addicted to illegal drugs, * vulnerable elderly in the terminal phase of the disease (life expectancy less than 6 months).

Keywords: adherence medication preventive interventions community nursing vulnerable elderly
therapeutic confirmatory clinical trial to evaluate the safety and efficacy of "hugeltox inj." in essential blepharospasm

Conditions: Essential Blepharospasm

Summary: to compare the efficacy and safety of hugel-tox (botulinum toxin a, hugel, korea) against botox in the treatment of essential blepharospasm and to get a regulatory approval from kfda


Eligibility criteria:
inclusion criteria: * adult between ages 18 and 75 years * all patients, diagnosed of essential blepharospasm, with grade 2\~4 of severity of spmasm (by scott's method) exclusion criteria: * patients have undergone surgical surgery to treat blepharospmasm like myectomy or neurectomy * patients with hypersensitivity history to botulinum toxin products previously * patients with secondary blepharomspasm * patients with hemifacialspasm * patients with treatment following drugs ; anticonvulsants, tranquilizers, narcotics, aminoglycoside antibiotics, muscle relaxtants like baclofen etc., blockers of parasympathetic nervous system, levodopa * patients with previous injection of other botulinum toxin products in 3 months * patients with any other significant neuromuscular disease like myasthenia gravis * pregnant or breastfeeding women
study of initial steroid treatment in young children with nephrotic syndrome

Conditions: Steroid-Sensitive Nephrotic Syndrome

Summary: this study is a multicentric, prospective, randomized, double blind, placebo controlled trial compared the efficacy of 6 months vs. 3 months of initial prednisolone therapy in decreasing the incidence of frns with steroid-sensitive nephrotic syndrome in children age 1 year up to 6 years. three months tapering prednisolone or placebo are administrated follow by open-label 3 months standard prednisolone therapy.the cumulative incidence of frns and adverse events for one year were evaluated in the 3-month and 6-month groups.


Eligibility criteria:
inclusion criteria: * idiopathic, steroid-sensitive, first episode of nephrotic syndrome * age 12 months up to 6 years * written informed consent exclusion criteria: * nephrotic syndrome known to be secondary to a systemic disorder, e.g., immunoglobulin a (iga) nephropathy, systemic lupus erythematosus, henoch schonlein purpura, vasculitis, , hepatitis b or alport syndrome. * therapy with prednisolone for prior episodes of nephrotic syndrome * persistent estimated glomerular filtration rate (gfr) \<75 ml/min/1.73 m2 * patients who show relapse during the first 3 months of pre-randomization corticosteroid therapy for nephrotic syndrome * patients with initial steroid resistance * patients who are allergic to glucocorticoids * the compliance of patients or their guardians is poor
monitoring of the end-tidal carbon dioxide (etco2) as a severity criterion in copd exacerbations

Conditions: Pulmonary Disease, Chronic Obstructive; Exacerbation Copd

Summary: although we know that these numbers are underestimated, chronic obstructive pulmonary disease (copd) is a common chronic respiratory disease that affects between 8 and 12% of adults. according to a 2020 who report, it is the third most common cause of mortality in developed countries. this disease is punctuated by exacerbations associated with an 8% mortality of hospitalized patients, increased to 24% when the patient is admitted to intensive care unit. early detection and treatment of these exacerbations appears to be essential to improve patient survival. end-tidal carbon dioxide (etco2) is used to assess a patient's respiratory and hemodynamic status. indeed, etco2 is a non-invasive measure that could allow the estimation of arterial carbon dioxide (paco2) without performing blood gases, an arterial blood sampling, classically at the radial artery. this study aimed to find an etco2 value which at the time of the initial management, would be predictive of a severe copd exacerbation, as well as paco2.

the study will be conducted in the emergency departments of grenoble and lyon university hospitals. patients will be recruited by the dispatch nurse at the emergency department reception according to the inclusion and non-inclusion criteria. the etco2 will be measured at the emergency reception during assessment of vital signs by the same nurse with the help of a mask or oxygen glasses measuring etco2. the patient will then be treated conventionally according to current international recommendations. the physician in charge of the patient will be blinded to this measurement. once the patient is discharged from the emergency department, the primary and secondary endpoints will be collected by a clinical research associate 24 hours after admission from medical record.

Eligibility criteria:
inclusion criteria: * all patient presenting to the emergency department with acute dyspnea and with a history of copd documented or reported by the patient and/or family * male or female≥18 years old who did not oppose to participating in the study exclusion criteria: * hypotension (sbp \< 90 mmhg or mbp \< 65 mmhg) * patient already included in the study during a previous visit to the emergency department * patient already ventilated with invasive or niv during admission to the emergency department * copd exacerbation rejected after medical and additional examinations * non-communicative or non-french speaking patients, or with impaired comprehension, or with impaired consciousness * protected persons referred to in articles l1121-6 and l1121-8 of french public health code (deprived of liberty, tutorship or curatorship)

Keywords: chronic obstructive pulmonary disease capnography copd exacerbation
epidemiological features and clinical course of covid -19 infection in cancer patients: the rovid study

Conditions: Solid Tumor, Adult

Summary: the study aims to retrospectively collect epidemiological and clinical data in patients with solid tumors and sars covid2 infections belonging to oncology centers within the veneto oncology network

the aim of this study is to create a veneto oncology network with the aim of collecting clinical and epidemiological data of cancer patients affected by sar- covid-2 infection over a period of 1 year. descriptive statistical approaches will be used to process the data. the aim is to evaluate the development rate of severe clinical forms of infection in patients with sars-cov-2 and the possible association with tumour characteristics and treatment. in addition, the results of serological tests can be compared with the outcome of the diagnostic swabs and the clinical evolution of the infection in order to obtain more information regarding the significance of specific antibody development.

Eligibility criteria:
inclusion criteria: * be 18 years and older * cancer patients belonging to veneto 's oncological network * patients with sar cov-2 infection exclusion criteria: * patients with no sar cov2 infection * volunteers * no cancer patients
assessment of activities of daily living in adults with chronic low back pain using a nonoperative treatment modality

Conditions: Low Back Pain

Summary: the investigators hypothesize that treatment with non-invasive spinal decompression reduces discogenic low back pain (lbp), decreases visual analog pain scale scores, increases activities of daily living and decreases medication use.


Eligibility criteria:
inclusion criteria: * at least 18 years of age; * consented to the physician prescribed protocol; * presented with discogenic low back pain defined as low back pain for minimum of 12 weeks; * current ct scan exclusion criteria: * metastatic cancer; * previous spinal fusion or placement of stabilization hardware within 6 months; * instrumentation or artificial discs; * neurologic motor deficits, bladder, or sexual dysfunction; * alcohol or drug abuse * patient's with extremes of height (\ 203 cm) and body weight (\> 136 kg).
a phase 4 clinical study of brodalumab

Conditions: Psoriasis Vulgaris; Psoriatic Arthritis; Pustular; Psoriasis, Palmaris Et Plantaris; Psoriatic Erythroderma

Summary: this study \[4827-005 (post market)\] is designed to evaluate the safety and efficacy of long-term exposure to brodalumab in subjects with plaque psoriasis (psoriasis vulgaris, psoriatic arthritis) who have completed study 4827-003 (study 003) and in subjects with pustular psoriasis (generalized) or psoriatic erythroderma who have completed the study 4827-004 (study 004). 4827-005 study was conducted as phase 3 clinical trial until july 4th 2016 (approval date in japan). after that date 4827-005 study was switched to phase 4 study.


Eligibility criteria:
inclusion criteria: * subject has voluntarily signed the written informed consent form to participate in this study * subject has completed the study 4827-005 (phase 3) exclusion criteria: * subject has had a serious infection, defined as requiring systemic treatment with antibiotics or antivirals (excluding oral administration) * subject has been judged to be ineligible for participation in the study by the investigators/sub investigators
shock wave therapy for osteoporosis

Conditions: Osteoporosis

Summary: rationale: osteoporotic fractures are associated with high morbidity and mortality. this is why prevention of these fractures is important. the investigators have shown in animal studies that a single treatment with unfocused extracorporeal shock wave therapy leads to highly increased bone mass and improved biomechanical properties. unfocused extracorporeal shock wave therapy could have important implications for the prevention of osteoporotic fractures. objective: to assess the effect of unfocused extracorporeal shock wave therapy on bone mass. study design: a clinical pilot study. study population: twelve female patients are eligible if they are undergoing elective surgery of the lower extremity or elective spinal surgery under general anesthesia in the investigators hospital. intervention: when the patient is under general anaesthesia he/she will receive 3000 unfocused extracorporeal shock waves (energy flux density 0.3mj/mm2) to one distal forearm. the contra lateral forearm will not be treated and serves as a control. main study parameters/endpoints: the investigators will examine the effect on bone mass with the use of repeated dual energy x-ray absorptiometry measurements. these results are necessary to calculate the number of patients that are needed for larger studies. furthermore, the investigators will assess patient's discomfort. nature and extent of the burden and risks associated with participation, benefit and group relatedness: general anaesthesia is performed during treatment and pain after the procedure will be evaluated using pain scales and, if necessary pain medication will be prescribed by the orthopaedic surgeon. the dual energy x-ray absorptiometry-scans and x-rays will cause very low radiation exposure to the patient.


Eligibility criteria:
inclusion criteria: * female sex, age 50-80 years, normal dietary intake inclusive calcium and/or milk products and willing to participate exclusion criteria: * skin disease, systemic corticosteroid use, known systemic disease that interacts with bone (eg. rheumatoid arthritis, multiple myeloma, hyper(para)thyroidism, paget's disease or cushing's disease) or a previous wrist fracture

Keywords: high-energy shock waves
spanish registry on spontaneous coronary artery dissection

Conditions: Spontaneous Coronary Artery Dissection

Summary: multicenter observational prospective registry, spanish nationwide-based, of consecutive patients diagnosed with spontaneous coronary artery dissection (scad)

multicenter prospective registry on patients with diagnosis of spontaneous coronary artery dissection (scad). spanish nationwide based, the aims of the current registry are: 1. to analyze predisposing factors, potential triggers and associated pathologies of patients presenting with scad. 2. to study the clinical and angiographic presentation of these patients. 3. to analyze the value of intracoronary diagnostic techniques (oct, ivus) and non-invasive imaging techniques in the diagnosis of this pathology. 4. to better understand the in-hospital clinical evolution and the response to medical treatment or revascularization in these challenging patients, taking into account the angiographic or intravascular imaging morphological characteristics of scad and the treatment applied. 5. to analyze its long-term clinical evolution (adverse cardiovascular events, including recurrence of scad). 6. to identify those factors directly related to prognostic and risk of recurrence.

Eligibility criteria:
inclusion criteria: * those consecutive patients with a novel diagnosis of spontaneous coronary artery dissection (scad) that, after careful information, accepted to sign the informed consent form. exclusion criteria: * those patients unable to provide informed consent.
electrical vestibular nerve stimulation (vens) as a treatment for insomnia

Conditions: Insomnia; Sleep Disturbance

Summary: insomnia is known to be one of the most common health concerns in in the general population and has been associated with several health consequences. medications are known to be effective, and currently serve as the primary treatment for insomnia but their use is limited due to the risk of adverse events. cognitive behavioral therapy (cbt-1) has also been shown to be effective and safer in the treatment of insomnia but presents its own limitations such as the time, cost, and training required. the relationship between vestibular stimulation and sleep continues to be explored, however its usefulness in the treatment of insomnia is still unknown. vestibular stimulation itself has been shown to be safe across multiple populations. if vestibular stimulation is shown to be effective in the treatment of insomnia, it could serve as a safer alternative to medications. it could also require less cost, time, and training than cbt-1, providing a treatment option that is not only safe and effective, but broadly available to the general population. consequently this trial seeks to evaluate the efficacy of non-invasive electrical vestibular nerve stimulation as a method of improving sleep quality and quantity, as compared to a sham control, in patients newly diagnosed with insomnia.


Eligibility criteria:
inclusion criteria 1. signed informed consent 2. diagnosed insomnia with isi of 15 or greater at screening 3. males or females 4. 18-80 years of age inclusive on starting the study 5. ability and willingness to complete all study visits and procedures; in particular an agreement to engage with trying to use the device on a daily basis 6. agreement not to use prescription, or over the counter, sleep medications for the duration of the trial 7. agreement not to use sleep trackers for the duration of the study (e.g sleep app smart watches) 8. access to wi-fi (to connect ipod to internet) exclusion criteria 1. history of skin breakdown, eczema or other dermatological condition (e.g. psoriasis) affecting the skin behind the ears (image from participant required). 2. previous diagnosis of hiv infection or aids (hiv is known to cause a vestibular neuropathy which would prevent vens from working) 3. medication for insomnia (unless regime stable for last 3 months). 4. a history of stroke or severe head injury (as defined by a head injury that required a craniotomy or endotracheal intubation). (in case this damaged the neurological pathways involved in vestibular stimulation). 5. presence of permanently implanted battery powered medical device or stimulator (e.g., pacemaker, implanted defibrillator, deep brain stimulator, vagal nerve stimulator etc.). 6. pregnancy. 7. previous use of any vens device 8. participation in other clinical trials sponsored by neurovalens 9. have a member of the same household who is currently participating in this study. 10. history of vestibular dysfunction or other inner ear disease as indicated by the following screening questions:
multimodal orthognathic study comparing use of exparel with standard of care.

Conditions: Pain, Postoperative

Summary: a prospective, randomized clinical trial to determine if using liposomal bupivicaine in maxillary orthognathic procedures can reduce the post-operative use of opioids as well as improving the patient's quality of life, versus traditional bupivicaine alone.

a prospective randomized clinical trial to determine if using liposomal bupivicaine in maxillary orthognathic procedures can reduce the post-operative use of opioids as well as improving the patient's quality of life versus traditional bupivicaine alone. a total of 100 patients who would ordinarily undergo maxillary orthognathic procedures will be randomized into 2 groups. one group will receive 133mg of exparel (must limit volume of product due to spaces involved and other studies in oral surgery have used 133mg) at the completion of the procedure while the control group receives 50 mg of bupivicaine at the completion of the procedure as is typical standard of care. the injections will be made in similar regions near the incision lines. no other differences will be made between the groups. perioperative anesthesia will consist of non-opioid techniques, and patients will be monitored post-operatively during a 1 night hospital admission. patients will complete an anonymous daily diary for 7 days. the diary will consist of information regarding pain scores, quality of life (nausea, swelling, oral function, etc) and medicines taken. at one week post op the participant will return to the clinic where they will fill out a final questionnaire discussing the previous week's experience regarding the topics of the questionnaires.

Eligibility criteria:
inclusion criteria: * male or female 18 years or older * scheduled for maxillary orthognathic surgery * american society of anesthesiologists classification 1,2,3 * able to provide consent, adhere to study schedule, complete study journal exclusion criteria: 1 history of hypersensitivity or idiosyncratic reaction to amide-type local anesthetics or opioids. 2 contraindication to lidocaine, epinephrine, bupivacaine, or oxycodone 3 significant drug allergy history 4 positive result from urine drug screen at pre-op visit 5 currently pregnant or nursing at time of study or within 1 month of drug administration 6 severe renal or hepatic impairment, significant cardiovascular disease; migraines, frequent headaches 7 use of any of the following medication within 1 month of liposomal bupivacaine infiltration or if the medications are being given to control pain: selective serotonin reuptake inhibitors (ssris), serotonin nonadrenaline reuptake inhibitors (snris), gabapentin, pregabalin, or duloxetine. 8 current use of systemic glucocorticosteroids within 1 month of enrollment in the study. 9 no concurrent procedures with 2 weeks before or after orthognathic procedure 10 no more than 1 previous surgery for similar condition or diagnosis.
an evaluation of divalproex vs. olanzapine for alcohol abuse relapse prevention in patients with bipolar disorder

Conditions: Bipolar Disorder

Summary: this study will evaluate how effective mood stabilizers are in the treatment of bipolar disorder with comorbid alcoholism

bipolar affective disorder is a medical illness with substantial morbidity and mortality. further fueling the severity of this illness is the substantial co-occurrence with substance abuse that together poses an enormous public health problem. this study will evaluate the efficacy of divaproex sodium (dvpx) vs. olanzapine (zyp) vs. for alcohol relapse prevention and secondary mood stabilization. bipolar patients who are actively drinking will be randomized to either depakote er ® (flexible dose schedule up to 2500 mg) or zyprexa® (flexible dose schedule up to 20 mg). adjunctive benzodiazepine will be utilized for the treatment of alcohol withdrawal and as an adjunct anxiolytic during the early titration of dvpx and zyp. patients who, after 2 weeks, have stabilized will continue in the prophylaxis study which will last up to 46 weeks. flexible dose scheduling and adjunctive antidepressant treatment as clinically indicated will be done to maximize tolerability, treatment compliance, and mood stability. the primary outcome measure will be alcohol abuse relapse which will be defined, a priori, as 5 drinks in a 24 hour period. patients who have a relapse as such defined will be terminated from the study. secondary alcohol outcome measures (i.e. number of drinking days, % drinking days per month, standard drinks per drinking occasion, craving) will be assessed through the time-line follow-back method. secondary outcome measures of mood stabilization (major mood relapse and adjunctive medication) will be assessed by prospective life charting.

Eligibility criteria:
inclusion criteria: * age 18-65 * dsm-iv criteria for manic episode based on the scid (spitzer 1996) * dsm-iv criteria for alcohol dependence or abuse based on the scid. meeting criteria for polysubstance dependence or abuse will not be exclusionary. * alcohol dependence/abuse confirmed by corroboration. * negative urine pregnancy test l exclusion criteria: * inability to give informed consent * liver function tests greater than 3x the upper limit of normal * history of adverse reaction to divalproex sodium or olanzapine * history of seizure other than directly associated with prior alcohol withdrawal * history of major head trauma with loc \> 5 minutes or skull fracture * history of hypertension, neurologic illness * active hepatitis, hepatic encephalopathy, or history of pancreatitis * not practicing a reliable form of birth control

Keywords: bipolar alcohol