Kornimate/medical-research-clean huggingface dataset:
significant activities in the integrated person-centered care model

Conditions: Old Age; Dementia; Old Age; Debility

Summary: the increasing life expectancy and global aging population necessitate changes in long-term gerontological services based on person-centred care approaches. this study aims to improve person-centred care in geriatric centers through meaningful activities and the role of occupational therapists and direct care professionals in developing these activities. a descriptive cross-sectional quasi-experimental design was proposed, with 10 participants.

background: increasing life expectancy means that the ageing of populations globally is on the rise. it is therefore important to promote changes in long-term gerontological services based on person-centred care approaches, in which meaningful occupation serves as a basis and is supported by appropriate professional support, such as the occupational therapist and the direct care professional. objective: to improve person-centred care in a geriatric centre, through the use of meaningful activities and to identify the role of the occupational therapist and direct care professional in the development of these activities. methods: a descriptive cross-sectional quasi-experimental pre-post single-group design is proposed. a total of 10 participants. the methodology used will be mixed. the data collection techniques and tools will be the pdc evaluation instrument pre and post intervention and a survey at the end of the project.

Eligibility criteria:
inclusion criteria: * that the direct care worker has a degree as a nursing assistant, dependency care technician, geroculturist or certificate of professionalism. * the worker must speak and understand spanish. * the residence must offer service during the day, in the morning or afternoon shift. * workers must have been with the department for more than 4 months. exclusion criteria: * workers who work night shift only. * workers on rotating shifts in all departments of the residence. * workers absent at the time of the study due to temporary leave, vacations or other causes.
thyroid surgery with the new harmonic scalpel or the electrothermal bipolar vessel sealer

Conditions: Thyroidectomy

Summary: the objective of this study is to compare the results of total thyroidectomy using the new harmonic scalpel device to that with the electrothermal bipolar vessel sealer.

the harmonic scalpel and the electrothermal bipolar vessel sealing system (ligasure precise) have been both shown to be safe and effective in thyroid surgery. the moderate dissection capabilities of the previous harmonic scalpel instruments available for thyroid surgery have led to an innovative technical improvement of the device (focus) that has very recently been implemented and has been made available in 2008. comparison of the utilization of this new device, however, with the electrothermal bipolar vessel sealer has not been performed in any study. the objective of this study is to compare the results of total thyroidectomy using the focus to that with the ligasure device in respect to hemostasis, operative time and perioperative complications. all patients undergoing a total thyroidectomy in our endocrine surgery department are randomized into those operated with focus (group a) and those with ligasure (group b).

Eligibility criteria:
inclusion criteria: * total thyroidectomy exclusion criteria: * hemithyroidectomy or subtotal thyroidectomy * additional surgical procedures together with the total thyroidectomy (i.e., parathyroidectomy or cervical lymph node dissection)

Keywords: thyroid surgery total thyroidectomy harmonic scalpel electrothermal bipolar vessel sealer hemostatic device
post market registry study of the aeriseal system

Conditions: Pulmonary Emphysema

Summary: * obtain and analyze medical record data on patients with advanced emphysema who receive treatment with the aeriseal system to better understand safety and effectiveness in the post-market setting; * provide participating physicians access to specified data sets for the purpose of generating scientific manuscripts about the effects of aeriseal system treatment.


Eligibility criteria:
inclusion criteria: * advanced emphysema * aeriseal system treatment exclusion criteria: * have a primary diagnosis of asthma, chronic bronchitis or bronchiectasis * have had frequent copd exacerbations within the past year * require mechanical ventilatory support * have a pretreatment dlco \ 60% predicted * have a pretreatment fev1 \< 20% predicted and homogeneous emphysema * have giant bullae * have undergone lung transplantation, lung volume reduction surgery, or lobectomy * are intolerant of corticosteroids or antibiotics * are pregnant or breast-feeding

Keywords: emphysema gold stage iii gold stage iv aeriseal system homogeneous heterogeneous upper lobe predominant ulp chronic obstructive pulmonary disease copd lung volume reduction surgery lvrs bronchoscopic lung volume reduction blvr
a study to compare dysport® and botox® in the treatment of cervical dystonia

Conditions: Cervical Dystonia

Summary: 1. to examine the non-inferiority of dysport in the clinical efficacy and safety in comparison with botox®, assuming a bioequivalence ratio of 2.5:1 units, in the treatment of cervical dystonia. 2. double blind, randomised, multi center, crossover study

1. prospective, randomized, head-to-head, double-blind, cross-over study. 2. total patients: a group 51, b group 51 3. study duration: 16 + 4 + 16 weeks. eligible patients will be randomised at baseline to receive either dysport® or botox® and monitored at weeks 2, 4, 8, 12, 16 weeks. after 4 weeks of wash out period, then the patients get the other treatment (i.e, patients who have got dysport will be then administered with botox) 4. compare the tsui change score from baseline to 4 weeks after injection.

Eligibility criteria:
inclusion criteria: * patients ≥ 18 years of age of both genders, * cervical dystonia * symptoms with a minimum duration of 18 months, * negative pregnancy test in sexually active women, * able to participate in the study (understand goals of botulinum toxin a treatment and sign informed consent form). exclusion criteria: * patient with cervical contractures * known significant underlying dysphasia * patients who have received botulinum toxin treatment within the past 4 months. * contraindication to botulinum toxin treatment * any disease that might affect neuromuscular function (myasthenia gravis, eaton-lambert syndrome, als ...) * patients who have received oral anti-spasticity medication, phenol therapy, myotomy or denervation surgery, deep brain stimulation for cervical dystonia, * patients who required more than 500 units of dysport or 200 units of botox. * any concomitant treatment that could interfere with the action of botulinum toxin, * subjects having participated within the last 3 months or currently participating in an investigational drug study, * pregnancy, * lactation.

Keywords: cervical dystonia botulinum toxin
electroconvulsive therapy (ect) in patients with super refractory schizophrenia

Conditions: Refractory Schizophrenia; Super Refractory Schizophrenia

Summary: introduction: in spite of recent advances in schizophrenia treatment, 30% of patients still do not respond properly to antipsychotic therapy. these patients are considered treatment-resistant or refractory, and the best choice for them is clozapine. however, even supported by the literature as the best known antipsychotic in terms of efficacy and rates of response, a considerable number of patients will still not respond to this treatment, remaining symptomatic and dysfunctional. these patients are classified as super-refractory (clozapine-resistent). in these cases, augmenting strategies are necessary, and some have been in use: typical and atypical antipsychotics, mood stabilizers, antidepressants and electroconvulsive therapy (ect). some studies have favored ect, but no definitive conclusion has been drawn. objective: test the electroconvulsive therapy efficacy and safety as augmenting strategy to clozapine-resistant patients, as compared to placebo (sham ect). methods: this is a pilot double blind, placebo controlled and randomized study to assess electroconvulsive therapy efficacy as augmenting strategy to clozapine in super-refractory schizophrenia. the ect treatment will be delivered with either a mecta spectrum 5000q or 4000q device, and the procedure is under general anesthesia and monitorization, after informed consent. the hospital will follow national protocols and regulations on ect. sham ect consists in habitual patient preparation and sedation, without stimulation. patients that fit inclusion criteria will have their clozapine blood levels dosed and undergo structured assessments at baseline, after 6 treatments and at the end of the cycle of 12 ect sessions (thrice a week protocol). the assessments will be based on cgi (clinical global impression) and panss (positive and negative syndrome scale) scales. all medication will be maintained, except lithium carbonate.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of schizophrenia or schizoaffective disorder (dsm-iv-tr); * ages between 18 and 55 years old, both genders; * must be using adequate contraception if a fertile woman; * must be on clozapine treatment for at least 6 months, with or without augmenting strategies; * must be clozapine-resistent (super-refractory patient), defined by a cgi-severity ≥ 4, panss total score ≥ 60 and at least 4 items of the positive subscale ≥ 4 at baseline. exclusion criteria: * clinical somatic disease not stabilized in the three months preceding the study; * other axis i disorders (dsm-iv-tr); * laboratory tests with significantly abnormal values that persist for more than two weeks; * lack of permanent residence during the study period; * history of poor treatment adherence. * history of ect use in the past six months that precede the start of the study.

Keywords: schizophrenia electroconvulsive therapy refractory schizophrenia super refractory schizophrenia clozapine
the effect of reloading prasugrel in a patient who has already received a loading dose (ld) of clopidogrel

Conditions: Acute Coronary Syndrome

Summary: the primary objective of this study is to compare platelet reactivity between patients receiving a loading dose of clopidogrel and a reloading dose of prasugrel to patients receiving only a loading dose of prasugrel.

this is a prospective, open-label, non-randomized trial of approximately 260 patients with acute coronary syndrome (acs) undergoing percutaneous coronary intervention (pci). in order to compare platelet reactivity, as assessed by the verifynow p2y12 assay, we plan to recruit two study groups of interest: 1. patients who have already received a 600 mg loading dose (ld) of clopidogrel in preparation for pci will receive a loading dose of 60 mg of prasugrel. 2. patients who have not received a ld of clopidogrel will receive a 60 mg ld of prasugrel prior to pci. a subset of 40 patients from each study group (80 patients total) will undergo additional platelet reactivity testing with the vasodilator stimulated phosphoprotein (vasp) assay.all patients will be followed throughout the duration of the hospital stay.

Eligibility criteria:
inclusion criteria: 1. patients age 18 or older, of both genders 2. presenting with an acs, defined as at least two of the following: symptoms consistent with myocardial ischemia; st segment elevation or depression of at least 1 mm in 2 or more contiguous leads on ekg; cardiac troponin i level above the upper limit of normal. 3. an initial invasive strategy (e.g. early angiography) is planned. 4. no contraindications to prasugrel therapy. exclusion criteria: 1. known allergies to aspirin, clopidogrel, or prasugrel. 2. patient known to be pregnant or lactating. 3. patient with known history of bleeding diathesis, or currently active bleeding. 4. platelet count \<100,000/mm3 at the time of enrollment. 5. hematocrit \<25% at the time of enrollment. 6. on warfarin therapy at the time of pci, or patient likely to require warfarin therapy post-pci. 7. received fibrinolytics within the past 48 hours. 8. received a glycoprotein iib/iiia inhibitor within the past 48 hours, or if a strategy for pci involving a glycoprotein iib/iiia inhibitor is planned. 9. taking maintenance thienopyridine therapy in the previous 7 days. 10. known blood transfusion within the preceding 10 days. 11. patients treated with non-steroidal anti-inflammatory drugs (nsaids) within the previous 5 days. 12. patients with known chronic liver disease. 13. age greater than 75 years. 14. body weight less than 60 kg. 15. history of stroke or transient ischemic attack. 16. surgery planned within 1 month. 17. patient likely to require coronary artery bypass grafting. 18. any significant medical condition that, in the investigator's opinion, may interfere with the patient's optimal participation in the study.

Keywords: acute coronary syndrome clopidogrel prasugrel
primary care group therapy for depression/anxiety for women in petropolis

Conditions: Depression; Anxiety Disorders

Summary: this is a randomized controlled trial comparing two groups: 1) enhanced usual care and 2) enhanced usual care plus group psychological intervention. in both groups a "stepped care" approach was used to the management of anxiety and depression among women seen in primary care.

all patients received enhanced primary care, which included: (1) the nurses and doctors from the family health teams were trained by matrix team mental health professionals on clinical aspects of depression and anxiety, including diagnosis, appropriate medication interventions, psycho-education, and cognitive and problem solving therapy. (2) given the high co-occurrence of anxiety and depression, the intervention was modified from the depression-only chile model to emphasize co-occurring anxiety and depression in diagnoses, appropriate prescription of anxiolytics and antidepressants. (3) all providers received weekly group or individual consultation with a matrix team mental health professional, either psychiatrist or psychologist. an qualitative study of participating petrópolis family health programme doctors and nurses demonstrated their satisfaction with the training. patients in the intervention arm received enhanced primary care plus a 9-session group intervention (seven sessions weekly then two sessions every 15 days). the intervention included two psycho-educational sessions with information about depression and anxiety disorders, two sessions on the development of pleasant activities including relaxation exercises, two sessions on solving problems therapy, one session on the problem of overcoming negative thoughts and emotions, one session on relapse prevention, and a final closure and review session which included a small party. the patients from the intervention arm also received additional outreach from the family health teams, including home delivery of psychotropic medication when needed and active outreach and engagement by community workers if patients missed group sessions.

Eligibility criteria:
inclusion criteria: * female patients who came to the primary care unit for any type of consultation for themselves (e.g., not for a child). * general health questionnaire positive screen (\>5 at two time points) * positive diagnosis of depression or anxiety per the mini mental state examination. exclusion criteria: * diagnosis of bipolar disorder, mania, severe suicidal ideation * cognitive impairment that would limit their ability to consent or take part in the study. -pregnant.
osteopathic single case research for patients with chronic low back pain

Conditions: Chronic Low-back Pain

Summary: this study aims to collect primary data from patients with low back pain to assess the effect of standard osteopathic management and biopsychosocially-informed osteopathic care using a single-case experimental design.

after being informed about the study and potential risks, all osteopaths and patient participants giving written consent will be screened for eligibility. when entering the trial, patients will be randomised to early, intermediate or late intervention with either standard osteopathic management or biopsychosocially-informed osteopathic management.

Eligibility criteria:
inclusion criteria: * 18 or more years old * agree to take part in the study and provide formal online consent after having been assessed as capable of providing informed consent by the osteopath * being fluent enough in english to be able to understand content of consent forms (and participate in osteopathic treatment without an interpreter) * presenting with non-specific low back pain of a duration of a minimum of 12 weeks) * nrs score between 5 and 9 on a 11-point scale * psfs score between 2 and 7 at baseline * who can be contacted by email * available for an appointment within two days around the randomisation date exclusion criteria: * under 18 * lacking capacity to give consent * presenting with low back pain with a known or suspected pathological cause (e.g. infection, cancer or fracture) * people for whom osteopathic treatment may be contra-indicated (as assessed by the osteopath in the initial consultation) or who disclose information during their course of treatment which requires referral for other medical investigations or care * lbp of less than 12 weeks * nrs score below 5 or above 9 * psfs score above below 2 or above 7 * patients providing less than 3 data points during baseline
trx4 monoclonal antibody in type 1 diabetes (t1 dm)

Conditions: Diabetes Mellitus, Type 1

Summary: the purpose of this study is to optimize several multi-dose regimens of otelixizumab, determine the highest biologically active dose, evaluate biomarkers and surrogates of efficacy, and to evaluate the effects of each multi-dose regimen of otelixizumab against standard safety and efficacy parameters.


Eligibility criteria:
inclusion criteria: * adults 12 to 45 years old who are in good general health * confirmed diagnosis of insulin requiring type 1 diabetes mellitus with good glycemic control * measurable c-peptide levels exclusion criteria: * females must not be pregnant or lactating and willing to practice contraception * no prior malignancy, other than non-melanoma skin cancer * body mass index (bmi) \> 32 at screening

Keywords: type 1 diabetes mellitus diabetes mellitus type 1 type 1 diabetes diabetes mellitus diabetes
norursodeoxycholic acid vs placebo in psc

Conditions: Primary Sclerosing Cholangitis

Summary: double-blind, randomized, multi-center, placebo-controlled, comparative, phase iii trial. the study will be conducted with two treatment groups in the form of a parallel group comparison and will serve to compare oral treatment with either 1500 mg/d norursodeoxycholic acid capsules or placebo capsules for the treatment of primary sclerosing cholangitis.


Eligibility criteria:
inclusion criteria: * signed informed consent * verified psc * liver biopsy available for review * if pre-treated with udca patient must be on stable dose not exceeding 20mg/kg/bw * patients with or without concomittant ibd exclusion criteria: * history or presence of other concomitant liver diseases * presence of cholangiocarcinoma * secondary causes of sclerosing cholangitis * small duct cholangitis in the absence of large duct disease * any known relevant infectious disease * abnormal renal function * any active malignant disease * known intolerance/hypersensitivity to study drug
association between mother and child weight gain: statistical methods with validation

Conditions: Obesity, Childhood

Summary: using retrospective data from the vanderbilt university medical center electronic health record, the investigators will study the association between mother's weight / weight change before and during pregnancy and the development of childhood obesity up until 5 years of age.

the investigators are extracting de-identified retrospective data from the vanderbilt university medical center electronic health record for mother-child pairs. from this data, the investigators will study the association between mother weight change during pregnancy and the risk of her child developing obesity during the first 5 years of life. included mothers must have at least one weight measurement and at least one height measurement; they must have at least one child with weight/length measurements at birth and one additional same day height/weight measurement at or before 5 years of age.

Eligibility criteria:
inclusion criteria: * mother-child pairs in the vanderbilt university medical center (vumc) electronic health record. * the mothers must have at least one height measurement. * the mothers must also have at least one weight measurement during pregnancy. * the child must have birth length and weight measures and at least one same day height/weight measurement during their first 5 years of life.
oral diclofenac for retinal photocoagulation in diabetic retinopathy

Conditions: Pain

Summary: the purpose of this study was to evaluate the analgesic effect of oral potassium diclofenac in patients with proliferative diabetic retinopathy submitted to retinal photocoagulation. two groups of patients were followed and the effect of the treatment (diclofenac plus laser) was compared to placebo (placebo plus laser). pain associated with treatment was recorded using a visual analog scale 15 minutes after the procedure.


Eligibility criteria:
inclusion criteria: * 1)high-risk proliferative diabetic retinopathy in both eyes exclusion criteria: * 1)history of prior laser treatment or vitrectomy; 2) allergy to non-steroidal anti-inflammatory drugs; 3) any condition affecting comprehension of vas pain score test; 4) contra-indications for diclofenac use such as pregnancy, bleeding disorders, asthma, or renal failure; 5) use of any analgesic drug for the last 24 hours.

Keywords: pain retinal photocoagulation potassium diclofenac