Kornimate/medical-research-clean huggingface dataset:
nutritional approach in adults followed up in spanish hospitals for heart failure (bocados-ic)

Conditions: Heart Failure

Summary: this is a randomized, controlled, open-label, prospective, multicentre clinical trial designed to assess the effects of a nutritional intervention on morbidity and mortality in patients with chronic heart failure. through a simple 1:1 randomization process, patients will be assigned to the control group or the intervention group. patients in the intervention group will undergo an individualised nutritional intervention program consisting of 3 pillars: diet optimization, specific recommendations ,and nutritional supplementation if nutritional targets are not achieved.


Eligibility criteria:
inclusion criteria: * patients older than 65 years with malnutrition (mna-sf score ≤ 11) with chronic ambulatory heart failure (hf). exclusion criteria: * admission for heart failure (hf) in the last month, * chronic renal failure on dialysis. * patients already on nutritional treatment. * concomitant diseases which, apart from the hf itself, could lead to a life expectancy of less than 1 year, * patients included in other clinical trials. * patients whose clinical situation makes it impossible to perform a nutritional assessment according to the design established in the study protocol or who do not give their consent for this purpose. * patients who during admission undergo surgical or percutaneous treatment to correct the cause of acute hf,

Keywords: heart failure malnutrition
effect of ultrasound guided thoracic interfascial plane block versus erector spinae plane block after mastectomy

Conditions: Pain, Acute; Erector Spinae Plane Block; Mastectomy, Modified Radical; Thoracic Interfascial Plane Block; Pain, Chronic

Summary: this study will be conducted to compare the efficacy of ultrasound guided thoracic interfascial plane block versus ultrasound guided erector spinae plane block on acute and chronic pain after modified radical mastectomy surgery.

various thoracic nerve blocks performed for pain control after breast cancer surgery provide superior analgesic effect and reduce postoperative nausea and vomiting as a result of the decreased use of opioid analgesics. ultrasound-guided erector spinae block (esb) is a regional anesthesia technique; recently described by forero et al, in management of thoracic neuropathic pain. it became popular because it is much safer and easily administered than other alternative regional techniques as paravertebral and thoracic epidural block. esb leads to effective postoperative analgesia when performed at t 4-5 level for breast and thoracic surgery, and t 7 level for abdominal surgeries. spread of local anesthetic following esb in the cephalic and caudal directions can lead to analgesia from c7 to l2-3. there have been several reports that thoracic interfascial plane block is useful for multimodal analgesia in patients undergoing mastectomy, thoracic interfascial plane block including pecto-intercostal fascial plane block (pifb) and serratus intercostal fascial plane block (sifb). thoracic interfascial plane block is the peripheral nerve block that targets the intercostal nerves branches distributed in the chest and axilla, although pifb and sifb are thought to be relatively easy to perform there have been no reports of the simultaneous performance of the two blocks.

Eligibility criteria:
inclusion criteria: * female patients admitted for modified radical mastectomy surgery. * american society of anesthesiologists (asa) physical activity i, ii * aged (18 - 65) years exclusion criteria: * patient refusal. * patient with neurological deficit. * patient with bleeding disorders (coagulopathy, thrombocytopenia anticoagulant, and antiplatelet drugs). * uncooperative patient. * infection at the block injection site. * patients with a history of allergy to drugs.
the effect of moderate-dose steroid therapy in sepsis

Conditions: Sepsis

Summary: despite the new developments in sepsis treatment, mortality rate is still high. discussions on steroid treatment in sepsis are going on. in this study, we aimed to investigate the effects of moderate dosage steroid treatment and endocrinologic changes occurring in sepsis on prognosis in patients with sepsis.

this prospective, randomized, single-centre, double-blind, placebo-controlled trial was conducted between april 2005 and may 2008 in the department of medical icu and the department of infectious diseases of erciyes university medical school. the study was approved by our institutional review board and informed consent was obtained from the patients' relatives. the study did not alter therapy, and each patient's clinical care was determined by their own physician.

Eligibility criteria:
inclusion criteria: * patients over 17 years old and diagnosed with sepsis were included in the study consecutively exclusion criteria: * already known pre-existing adrenal disease or adrenalectomy, known malignancies, tuberculosis that might have involved the adrenal gland, and administration of steroids within the 3 months before the admission. in addition, patients with burns, hemorrhagic shock or those who had suffered myocardial infarction were not included.

Keywords: cortisol, prednisolone, adrenal insufficiency, sepsis
study to evaluate of the efficacy and safety of ruxolitinib cream in participants with hidradenitis suppurativa

Conditions: Hidradenitis Suppurativa

Summary: the purpose of this study is to evaluate the efficacy and safety of ruxolitinib cream in participants with hidradenitis suppurativa. this is a randomized 16-week double-blind, vehicle-controlled (dbvc) study followed by a 16 week open label extension period (ole) with an active treatment for participants who complete the dbvc period.


Eligibility criteria:
inclusion criteria: * diagnosis of hs based on clinical history and physical examination for at least 3 months. * diagnosis of hs (hurley i or ii) with the following: 1. a total an count of 3 to ≤ 10, with no draining tunnels at screening and baseline visits. and 2. the an count at the screening and baseline visits: * an of 3 should affect at least 1 distinct anatomical area * an of \> 3 to ≤ 10 should affect at least 2 distinct anatomical areas. * baseline skin pain or itch nrs score ≥ 1. * agreement to not use topical and systemic antibiotics for treatment of hs during the study. * agreement to not use a diluted beach bath or topical antiseptic washes containing chlorhexidine gluconate or benzoyl peroxide on the areas affected by hs lesions during the study. * willingness to avoid pregnancy or fathering children exclusion criteria: * presence of draining tunnels at screening or at baseline visits. * concurrent conditions and history of other diseases: 1. active ongoing inflammatory diseases of the skin other than hs that might confound the evaluation of hs. 2. any other concomitant skin disorder (eg, generalized erythroderma such as netherton's syndrome), pigmentation, or extensive scarring that in the opinion of the investigator may interfere with the evaluation of hs an or compromise participant safety. 3. immunocompromised (eg, lymphoma, acquired immunodeficiency syndrome, or wiskott-aldrich syndrome). 4. chronic or acute infection requiring treatment with systemic antibiotics, antivirals, antiparasitics, antiprotozoals, or antifungals within 2 weeks before baseline. 5. active acute bacterial, fungal, or viral skin infection (eg, herpes simplex, herpes zoster, chicken pox, clinically infected ad, or impetigo) within 2 weeks before baseline. * laboratory values outside of the protocol-defined criteria. * use of any prohibited medications per protocol-defined criteria. * pregnant or lactating participants, or those considering pregnancy during the period of their study participation. * other exclusion criteria may apply.

Keywords: hidradenitis suppurativa skin disease ruxolitinb cream
effects of tocotrienols supplementation on platelet aggregation in subjects with metabolic syndrome

Conditions: Metabolic Syndrome; Platelet Aggregation, Spontaneous

Summary: the objective of this study is to address the anti-thrombotic effects of tocotrienols supplementation via modulation of platelet activation, thrombotic markers, inflammatory markers and endothelial function. it is hypothesized that 2 weeks supplementation of tocotrienols will be able to suppress platelet aggregation in subjects with metabolic syndrome.

a double-blind, randomized, crossover study comparing the effects of tocotrienols vs. placebo will be conducted in subjects with metabolic syndrome. subjects will be supplemented with tocovid suprabio 200 mg twice daily (or placebo) for 2 weeks followed by a postprandial challenge on day 14. during the postprandial challenge, venous blood samples will be collected during fasting. subjects are then required to consume a high fat breakfast meal containing 50g fat and 100ml milkshake, followed by the assigned capsules. venous blood samples will be drawn at 2, 4 and 6 hours after consumption of capsules. a washout period of at least 14 days will be in place before the commencement of the second treatment.

Eligibility criteria:
inclusion criteria: * age 25-60 year * haemoglobin level \>11.5 g/dl in women and \>12.5 g/dl in men * serum ferritin \> 15µg/l * according to clinical practice guidelines, management of type 2 diabetes mellitus in malaysia (2009), metabolic syndrome subjects are identified with: * waist circumference ≥ 90 cm in men and ≥ 80 cm in women and with any two of the following criteria: * elevated triacylglycerols \> 1.7 mmol/l * low hdl cholesterol \< 1.0 mmol/l in men and \< 1.3 mmol/l in women * elevated blood pressure ≥ 130/≥85 mm hg * fasting glucose ≥ 5.6 mmol/l to 7 mmol/l exclusion criteria: * medical history of myocardial infarction, angina, ischemic attack, hemorrhagic stroke, deep vein thrombosis, coronary artery disease, bleeding disorder, cancer, allergy to vitamin e * smoker * lactose intolerance * pregnancy or lactation * current use of vitamin e, medications modulating blood coagulation, hypertension, lipid-lowering and glucose-lowering agents, corticosteroids * significant hepatic and renal impairment * fever, cold or infection during bleeding day * alcoholic

Keywords: tocotrienols platelet aggregation metabolic syndrome platelet activation thrombosis
nutrition and prostate cancer

Conditions: Prostate Cancer

Summary: the purpose of this study is to assess the efficacy of fermented soy vs. placebo in 72 adults with localized prostate cancer prior to radical prostatectomy.

this is a parallel group, double-blind, randomized clinical trial with two arms. the primary aim is to assess the efficacy of fermented soy vs. placebo in 72 adults with prostate cancer. this study has 1 primary aim and 3 (1a thru 1c) sub aims. aim 1 is to assess the effect of fermented soy (qc) on psa (prostate specific antigen) in parallel, in aims 1a-1c will assess tumor-specific effects of qc: aim 1a: identifying the anti-tumor effects of qc. this will be done by culturing multiple human cancer cell lines with qc at a range of concentrations, followed by readouts at different time points, of tumor cell apoptosis, proliferation, and senescence. aim 1b: identify a hierarchy of tumors that are responsive to qc. from the data in aim one an attempt will be made to identify a hierarchy of anti-tumor effects. aim 1c: investigate the signaling pathways in tumor cells that are modified by qc. to do this, full genomic profiling will be conducted for breast and prostate tumor cell lines, and will be done in conjunction with analysis of the relevant signaling pathways, and will include p53 and p21 activation pathways.

Eligibility criteria:
inclusion criteria: * histologically verified prostate cancer (at any stage) * scheduled to be treated by radical prostatectomy within the next 4-10 weeks * understanding and willingness to provide consent exclusion criteria: * previous (within 6 months of enrollment) or concurrent hormonal therapy or chemotherapy; specifically, treatment with 5-alpha reductase inhibitors (finasteride and dutasteride) * history of hormone dependent malignancies * concomitant thyroid disease or currently taking thyroid hormone replacement medication * current high-dose soy consumption, micronutrient, or herbal supplements, on soy or vegetarian nutrition, or any other extreme dietary habits * current or past history of any liver or pancreas disease * history of allergy or hypersensitivity to soy-containing products * malabsorption conditions that might interfere with absorption of the investigational product

Keywords: fermented soy
training-induced cerebral reorganization in schizophrenia

Conditions: Schizophrenia

Summary: the purpose of this study is to reveal the effects of computer-aided cognitive-auditory training on cerebral reorganization in schizophrenia.

impairment in cognitive functions is one of the main symptoms in schizophrenia and is currently one of the challenges in the treatment of the disease. in this study we compare effects of two computer-aided training programs. one focused on auditory perception and processing as a basic ability underlying higher order information processing. the other training involves a variability of cognitive abilities. both trainings are computer-aided and time-intensive, including up to twenty sessions within four weeks.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of schizophrenia and disorders with psychotic features * intact hearing abilities exclusion criteria: * mental retardation * age over 60 * insufficient german language knowledge

Keywords: schizophrenia neuroplasticity sensory gating cognitive impairment meg disorders with psychotic features
prehospital intubation of covid-19 patient with personal protective equipment

Conditions: Intubation Complication; Intubation; Difficult or Failed; Cardiac Arrest; Influenza; Safety Issues

Summary: the safety and efficacy of a laryngoscopy as a primary intubation tool in urgent endotracheal intubation of cardiac arrest patients with suspected/confirmed covid-19 has not been well-described in the literature. this study will answer whether using a vie scope laryngoscope will impact on the efficacy and safety of intubation compared with a traditional direct laryngoscopy.

intubation will be carried out in full personal protective equipment conditions of the operator

Eligibility criteria:
inclusion criteria: * all adult patients requiring out-of-hospital intubation exclusion criteria: * patient under 18 years old * patients with criteria predictive of impossible intubation under direct laryngoscopy

Keywords: endotracheal intubation cardiac arrest personal protective equipment laryngoscope vie scope covid-19 sars-cov-2 emergency medicine
efficacy of prophylactic low level laser therapy (lllt) performed by nurses for decreasing severity of oral mucositis during hematopoietic stem cell (hsc) transplantation

Conditions: Hematologic Malignancy

Summary: the lllt has an anti-inflammatory, analgesic effect and accelerates the healing of ulcerated lesions. there are little data in the literature showing its efficacy in prevention of mucositis in cohorts of patients with hematopoietic stem cells transplantation. the main objective of this study is to assess the efficacy of a prophylactic low level laser therapy performed by nurses on the severity of oral mucositis during hsct.

the main end point for efficacy is the reduction of severe mucositis (grade 3 or more). the secondary efficacy endpoints are the reduction of mucositis, whatever the grade, the reduction of time with mucositis, the time to onset of mucositis symptoms, the reduction of pain intensity and evaluation of quality of life.the secondary endpoints for safety are severe adverse events and potential toxicity. patients will be allocated at inclusion with a 1/1 ratio either to laser-on or laser-off groups. in the laser group, patients will undergo laser therapy performed by nurses, which will consist of irradiation of the whole oral cavity during 2 minutes with 250mw power. in the laser-off group, laser therapy will be carried out with equipment off during the same time, and still performed by nurses. protective eye shields will be used to avoid detrimental effects on eyes and to keep the subjects blind.

Eligibility criteria:
inclusion criteria: * patient undergoing autologous or allogeneic hsc (hematopoietic stem cell) transplantation with myeloablative conditioning * patient affiliated to a social security * signed inform consent exclusion criteria: * patient undergoing hsct (hematopoietic stem cell transplantation) with reduced intensity conditioning slavin (fb2) or seattle (f-2 gy tbi) * protected major patient * pregnant woman * patient with pacemaker * epileptic patient

Keywords: mucositis low level laser therapy autograft allograft
intra-operatory neurophysiological monitoring changes as a predictive clinical outcome measure in lumbar radiculopathy.

Conditions: Lumbar Disc Disease

Summary: the purpose of this study is to determine the relation among: (1) changes in voltage and amplitude of trans-operatory records obtained through the use of intra-operative neurophysiological monitoring (ionm), and (2) clinical outcomes; of patients who underwent 1 or 2 levels surgical decompression at lumbar spine. ionm is the use of real time neurophysiological techniques during spinal surgeries. the modalities included in this study are: * somatosensory evoked potentials (sseps). * trans-cranial electric motor evoked potentials (tcemeps). * spontaneous electromyography (emg). clinical outcome of the patients will be assessed through a careful evaluation of clinical data, as well as the application of three outcome scales: * oswestry disability index 2.1a * visual analogue scale for pain * patient's overall impression of change

radiculopathy associated to lumbar disk disease is one of the most common reasons for a spine surgeon to be consulted. the pathophysiology of degenerative spine disease is acknowledged as complex, involving a wide array of risk factors ranging from genetic polymorphisms, to behavioural characteristics. while conflicting opinions exist with regard the direction of treatment for lumbar disk disease, de-compressive surgery is currently the gold standard for patients in which protocols of physiotherapy and analgesics have failed to comply. intraoperative neurophysiological monitoring (ionm) is widely used in the practice of spine surgery as a mean of preventing and reducing severe complications inherent to surgical techniques like paraparesis, paraplegia and quadriplegia. indeed, a great deal of funding and work have been devoted to research projects seeking to determine the impact of ionm in reducing these risks. the results of such projects have been notoriously interesting, and frequently opposing to each other. this has lead to an open debate on weather the use of ionm may or not be justified by better outcomes in patients who undergo such procedure. to our knowledge there is no study in the literature that has addressed the potential role of the iom to predict the long-term outcome of the patient in therms of radicular symptoms improvement.

Eligibility criteria:
inclusion criteria: * diagnosis of lumbar disk disease * clinical signs of radiculopathy * undergoing neurological surgery of the spine exclusion criteria: * previous neurological surgery of the lumbar spine * more than 2 levels intervened at the surgery * serious post-operatory complications

Keywords: ionm lumbar disk disease degenerative spine disease radiculopathy intraoperative neurophysiological monitoring somatosensory evoked potentials electromyography
transcatheter microguidewire drilling for transseptal left atrial access

Conditions: Heart Diseases; Atrial Septal Dilatation

Summary: this study aims to investigate the safety and efficacy of transcatheter microguidewire drilling (tmd) for transseptal left atrial access in patients with abnormal atrial septal morphology.

despite the widespread application and decades of experience, brockenbrough-needle transseptal puncture still risks cardiac perforations and secondary pericardial effusion/tamponade, especially in patients with abnormal atrial septal morphology. to facilitate atrial septal crossing, different methods and devices have been developed, including radiofrequency energy, excimer laser, safesept wire and so on. however, these are still limited by availability and cost, and the advantages might be further offset by the potential risks. in addition, these methods are performed mainly with the linear insertion technique, which might result in less forward-force to penetrate atrial septum and displacement of needle-tip. therefore, it is necessary to develop a safe, available and low-cost transseptal procedure for these patients. through a brockenbrough needle, the hard "back-end" of the microguidewire (0.014-inch) has the potential to drill through the atrial septum with ease. compared with a standard linear insertion technique, the penetration might be improved and less force is required with the bidirectional rotation technique, and the related risks might be reduced with the modified tsp due to the thin microguidewire. after the passage of the needle, the soft-end of microguidewire can be introduced into left pulmonary superior vein, which can become a safe rail for the introduction of puncture dilator/sheath. in this study, we examined the effectiveness and safety of microguidewire-assisted tsp for patients with complex atrial septum.

Eligibility criteria:
inclusion criteria: 1) patients with atrial septal aneurysm (a bulging of the atrial septum of at least 10 mm beyond the plane of the atrial septum into either the right or left atrium); 2) or patients with previous multiple transseptal punctures (≧2); 3) or patients with thickened atrial septum (thickness ≧3 mm); 4) or patients with enlarged right atrium (≧ 6 cm) and diminished left atrium (\< 3 cm); 5) or patients with prior mitral valve surgery; 6) or patients with atrial baffles. exclusion criteria: 1) associated atrial septal defect or patent foramen ovale; 2) associated interrupted inferior vena cava; 3) presence of implanted cardiac devices; 4) echocardiographic evidence of intracardiac thrombus, mass, tumor or vegetation; 5) thromboembolic events within the last 6 months; 6) patients unable to grant informed, written consent.

Keywords: transseptal puncture microguidewire
obsessions and suicidality in youth with bipolar 1 disorder

Conditions: Obsessions; Suicide; Bipolar I Disorder; Obsessive-Compulsive Disorder

Summary: obsessive-compulsive disorder (ocd) is a common co-morbidity with bipolar i disorder, a comorbidity that is known to increase suicide risk. this study aimed to assess the presence of ocd in youth diagnosed with bipolar i disorder \& to evaluate the association between ocd and suicide in the same cohort. eighty subjects diagnosed with bipolar i disorder were enrolled in this study, subjects were divided according to the presence or absence of ocd to group a: bipolar disorder patients with ocd (n = 26), group b: bipolar disorder patients without ocd (n = 54). the following scales were applied: dimensional yale-brown obsessive compulsive scale (dybocs)- beck scale for suicidal ideations (bssi) - hamilton depression rating scale (hdrs) and young mania rating scale (ymrs). the results revealed that dybocs score of group a was 30.23±0.43, \& of group b was 18.50±1.88 with a significant difference (p\<0.01). there was a significantpositive correlation between bssi and age, age of onset and ymrs in group a (p\<0.01). the study demonstrated that ocd is a common comorbidity in youth with bipolar i disorder and may be associated with a greater risk of suicide than in youth with bipolar i disorder without co-morbid ocd. furthermore, co-morbidity of ocd with bipolar i disorder in youth may be associated with younger age of onset and more severe symptoms profile.


Eligibility criteria:
inclusion criteria: - can read and write, agreed to sign the consent, diagnosed with bipolar i disorder exclusion criteria: * refused to sign the consent, active manic phase, recent substance use

Keywords: bssi dybocs bipolar disorder