Kornimate/medical-research-clean huggingface dataset:
effect of laser acupuncture on adhesive small bowel obstruction

Conditions: Adhesive Small Bowel Obstruction

Summary: adhesive small bowel obstruction (asbo) is one of the most common complications and is a major cause of admission after intra-abdominal surgery. to date, the ideal management of asbo remains controversial. the aim of this protocol designed as a double-blind randomized controlled trial is to investigate the efficacy of laser acupuncture (la) therapy in patients with asbo.


Eligibility criteria:
inclusion criteria: * aged 20 to 80 years * clinical symptoms and signs of mechanical obstruction exclusion criteria: * clear non-adhesive etiology of small bowel obstruction (e.g. tumor, hernia) * emergency surgical intervention before being admitted to the hospital * pregnancy * local skin infection on the acupoints, and limb amputees.

Keywords: adhesive small bowel obstruction laser acupuncture acupuncture
integral remediation for major depression ("rehabilitación integral para la depresión mayor", ridem)

Conditions: Major Depressive Disorder; Cognitive Symptom

Summary: available pharmacological and psychotherapeutic treatments are not effective for the treatment of cognitive symptoms of major depressive disorder (mdd). more recent studies have described that functional disability and the indirect costs of mdd (e.g., sick leaves at work, decreased productivity, ...) are related to persistent cognitive deficits. some programs of cognitive rehabilitation and cognitive training (developed for other pathologies) have been tested, but the results are inconsistent. there is an imperative need to develop a specific comprehensive rehabilitation program for mdd that includes the benefits of traditional functional remediation (fr) and computerized cognitive training (cct) programs adjusted for each patient's cognitive deficit.

objectives: to develop the integral rehabilitation program (fr + cct) and to demonstrate its efficacy in cognitive and functional remission (i.e. global remission) of patients with mdd in clinical remission. methodology: the project will consist of two stages: 1. - development and adaptation of the integral rehabilitation program for md, based on the program developed for bipolar disorder, and including a computerized cognitive training adjusted to the neuropsychological profile of each patient; 2. - a clinical trial, randomized, blind evaluator, with three intervention arms: integral rehabilitation (fr + cct); psychoeducation + online games; and treatment as usual. sample size will be a total of 90 patients with mdd in remission (full or partial).

Eligibility criteria:
inclusion criteria: * 18 and 60 years (males and females) * diagnosis of major depression (criteria diagnostic and statistical manual 5th edition, dsm-5) in remission or partial remission phase (scores below 14 in the hamilton depression rating scale-17 items (hdrs-17)) * cognitive symptoms (-1.5sd (standar deviation) in objective as subjective tests), * pdq \> 20 * fast\> 17 exclusion criteria: * intelligence quotient (iq) \< 85 * any medical condition that may affect cognition * presence of any comorbid psychiatric condition (including abuse or dependence on substances in the last three months) * electroconvulsive therapy (ect) in the previous year * other psychological intervention in the 6 months prior to the study.

Keywords: major depressive disorder cognitive remediation functioning full recovery functional remediation
zinc deficiency in dilated cardiomyopathy

Conditions: Zinc Deficiency

Summary: the aim of this study is to detect effect of oral zinc supplementation in pediatric patients with dilated cardiomyopathy.

cardiomyopathies are group of heart diseases that influence cardiac muscles directly and are not related to hypertension, congenital, valvular and pericardial diseases. the most common type of cardiomyopathy is dilate cardiomyopathy. dilated cardiomyopathy usually manifests as chronic systolic heart failure leading to arrhythmias and sudden death. trace elements are known to have a key role in myocardial metabolism. the human heart requires energy from micro and macro nutrients both to regenerate proteins and cells, and to support cyclic contractions. heart failure is associated with neuro-hormonal activation leading to elevated levels of inflammatory markers and oxidative stress. zinc is an essential micronutrient that impacts the cardiovascular system. there are multiple potential pathophysiologic causes for zinc deficiency in heart failure as result of impaired micronutrient consumption, hyper inflammatory state, diminished absorption and hyperzincuria from heart failure medications. zinc deficiency may play a role as primary and possible reversible cause of dilated cardiomyopathy. plasma zinc levels have been reported in multiple observational studies of patients with heart failure particularly in studies of idiopathic dilated cardiomyopathy, serum zinc levels have been found to be low. a small but growing body of evidence suggesting the role for oral zinc supplementation in the management of dilated cardiomyopathy however further evaluation of the impact on outcome is needed.

Eligibility criteria:
inclusion criteria: * children (1-18) year's age with impaired left ventricular systolic function due to dilated cardiomyopathy exclusion criteria: * patients with congenital heart diseases. * patients less than one year age.

Keywords: dilated cardiomopathy
identification of ascitic fluid bacterial pathogens in spontaneous bacterial peritonitis

Conditions: Primary Bacterial Peritonitis

Summary: several studies have pointed out changes in the epidemiology of the causative bacteria in sbp and bacterascites and in their susceptibility to antibiotics. in particular, the development of beta-lactamase enzymes, which confer resistance to clavulanate, or extended spectrum beta-lactamases in escherichia coli. the potential emergence of enterococci, methicillin-resistant s. aureus, or fluoroquinolone-resistant bacteria, following norfloxacin prophylaxis, is also a cause of concern since they may be associated with a higher risk of therapeutic failure. the microbial etiology of sbp remains relatively constant; however, the antibiotic resistance rate especially for third-generation cephalosporins (including cefotaxime and ceftazidime), ciprofloxacin, and ofloxacin increased dramatically

spontaneous bacterial peritonitis (sbp), defined as an infection of ascites in the absence of a contiguous source of infection. spontaneous bacterial peritonitis (sbp) is a common and potentially fatal bacterial infection in patients with cirrhosis and ascites, occurring in 10 to 30% of patients, with in-hospital mortality rates ranging from 20 to 30% . it is secondary to impaired humoral and cellular immune responses that result in indirect intestinal bacterial translocation into the ascitic fluid. sbp is also associated with a poor long-term prognosis for patients, as mortality rates can reach 50 to 70% at 1 year. early diagnosis and early optimal treatment of these infections with appropriate antibiotics and the prevention of hepatorenal syndrome with albumin are required . current european and most other international guidelines recommend the use of a third-generation cephalosporin as the first choice, or amoxicillin-clavulanate acid or fluoroquinolones as an alternative choice. these recommendations are based mainly on clinical trials that were very often conducted a decade or more ago, and on the assumption that e. coli would be involved in nearly half of the cases. several studies have pointed out changes in the epidemiology of the causative bacteria in sbp and bacterascites and in their susceptibility to antibiotics. in particular, the development of beta-lactamase enzymes, which confer resistance to clavulanate, or extended spectrum beta-lactamases in escherichia coli.the potential emergence of enterococci, methicillin-resistant s. aureus, or fluoroquinolone-resistant bacteria, following norfloxacin prophylaxis, is also a cause of concern since they may be associated with a higher risk of therapeutic failure.

Eligibility criteria:
inclusion criteria: * liver cirrhosis with ascites and suspected to have sbp. * ascitic fluid pmnl ≥ 250 cells/mm3 exclusion criteria: * ascitic fluid with polymicrobial infections * patients started empirical antibiotics without prior culture.

Keywords: sbp culture
cerebrum and cardiac protection with allopurinol in neonates with critical congenital heart disease requiring cardiac surgery with cardiopulmonary bypass

Conditions: Congenital Heart Disease in Children; Neuroprotection

Summary: neurodevelopmental impairment due to delayed brain development and brain injury is a fundamental problem in children with critical congenital heart disease (cchd). significant longterm motor-, cognitive-, and behavioral problems are the result of early postnatally and perioperatively induced brain injury. allopurinol, a xanthine oxidase inhibitor, prevents the formation of toxic free oxygen radicals, thereby limiting hypoxia-reperfusion damage. both animal and neonatal studies suggest that administration of allopurinol reduces hypoxic-ischemic brain injury, is cardioprotective, and safe. this study aims to evaluate the efficacy and safety of allopurinol administered early postnatally and perioperatively in children with a cchd requiring cardiac surgery with cardiopulmonary bypass.


Eligibility criteria:
inclusion criteria: * neonates with a prenatally or postnatally confirmed diagnosis of cchd requiring (anticipated) cardiac surgery with cpb within the first 4 weeks of life. * informed consent provided by both parents. exclusion criteria: * inability to enroll the patient before the start of delivery in case of prenatal diagnosis, or 24 hours before surgery in case of postnatal diagnosis. * doubt whether the aortic arch anomaly before birth requires cardiac surgery with cpb in the neonatal period. * gestational age below 36 weeks and/or birth weight less than 2000 gram. * surgery not requiring cardiopulmonary bypass. * decision for "comfort care only".

Keywords: congenital heart disease neuroprotection allopurinol brain injury cardiopulmonary bypass brain function brain oxygenation cardiac function neurodevelopmental outcome cardiac surgery hypoxic-ischemic brain injury neonates
observational study for the evaluation of tracheal stenosis in covid-19 patients

Conditions: Tracheal Stenosis

Summary: define the actual incidence of tracheal stenosis in patients who underwent either prolonged intubation or tracheostomy and to compare incidence, clinical course and outcome between covid-19 and non-covid-19 patients.

the ts1 is a national observational, multicentric, case-control clinical aiming at defining the actual incidence of tracheal stenosis in patients with covid-19 that underwent prolonged intubation or tracheal stenosis. information regarding anamnestic data, demographics, smoking or alcohol habits, comorbidity, previous history of prolonged ventilation or tracheostomy, and data about intensive care unit stay and treatment will be collected before discharging patients from hospital. all patients enrolled will perform an initial evaluation with a chest ct scan without contrast-enhancing at 2 months from hospital discharge along with pulmonary function test. if tracheal stenosis is detected, treatment according to currently available guidelines will be performed. patients with no signs of clinical, functional and radiological evidence of tracheal stenosis will perform a 3 and 6 months clinical follow-up from initial evaluation. a chest ct scan with pulmonary function test will be administered if symptoms of tracheal stenosis arise during clinical follow-up. if necessary, treatment according to currently available guidelines will be performed. patients will be followed-up for 8 months after hospital discharge.

Eligibility criteria:
inclusion criteria: * prolonged intubation, defined as the permanence of naso or oro- tracheal tube for more than 7 days * tracheostomy, whether surgical or percutaneous * minimum of 2 months follow-up from hospital discharge * positivity to sars-cov-2 infection confirmed using pcr on either nasal swab or bronchoalveolar lavage will be not an inclusion criterion; patients tested negative will be used as a control group exclusion criteria: * pediatric patients (\< 18 years of age) * patients without a minimum of 2 months follow-up from hospital discharge

Keywords: tracheal stenosis covid-19 prolonged intubation tracheostomy sars-cov-2
concurrent treatment for depressed parents and depressedadolescents

Conditions: Depression; Suicide

Summary: this study will develop an integrated treatment for adolescents who are depressed and suicidal and their parents who are depressed and have a history of suicidality.

depression, like many psychiatric disorders, has a genetic component that makes it more likely that members of the same family will have the disorder. depression in parents, particularly mothers, may put the children at greater risk for depression. when an adolescent whose parent is depressed develops depression himself or herself, treating both the parent and the adolescent may be more effective than treating only the adolescent. this study will test a depression treatment that targets depressed suicidal adolescents with a parent or primary caretaker who is also depressed and has a history of suicidality. participation in this study will last 6 months. participants will be randomly assigned to receive either concurrent parent and adolescent treatment or adolescent only treatment. for those assigned to concurrent treatment, both the adolescent participants and one of their parents will receive individual cognitive behavioral therapy (cbt) counseling sessions and joint family counseling sessions. in the adolescent only treatment condition, adolescent participants will receive individual cbt sessions, but parents will not, and both will receive joint family sessions. counseling sessions will last 1 hour and occur weekly for 3 months, and then every other week for 3 months. cbt identifies and attempts to change problematic thought patterns. all participants will receive medication consultation if necessary. participants will complete assessments at baseline, post-treatment, and 6 months after completing treatment. these assessments will include questionnaires and interviews about depression, suicidal thoughts, mood regulation, behavioral problems, and family. at post-treatment and the 6-month follow-up, participants will also be asked to give feedback about the counseling, medication consultation, and their satisfaction.

Eligibility criteria:
inclusion criteria for adolescents: * lives at home with at least one parent or guardian * speaks english * must have made a suicide attempt and be diagnosed with major depressive disorder (mdd) inclusion criteria for primary caretakers: * speaks english * current diagnosis of mdd and a history of suicidality exclusion criteria for adolescents: * judged to have developmental or cognitive delays or psychotic disorders on the basis of a standard psychiatric exam * diagnosis of bipolar disorder or a substance dependence (people with a diagnosis of substance abuse are eligible) * only one adolescent per family is eligible exclusion criteria for primary caretakers: * diagnosis of bipolar disorder or substance dependence * if taking antidepressants, not on a stable dose for 3 months

Keywords: suicidal ideation suicide attempts
efficacy and safety of sesame oil cake extract on improvement of cognitive function

Conditions: Cognitive Function

Summary: this study was the efficacy and safety of sesame oil cake extract on improvement of cognitive function

this study was a 12 weeks, randomized, double-blind, placebo-controlled human trial to evaluate. 70 subjects were participated in sesame oil cake extract or placebo group. to evaluate the changes of the evaluation items when sesame oil cake extract was taken three times a day compared with placebo.

Eligibility criteria:
inclusion criteria: * those who are at least 60 years of age at screening * those who word list memory / recollection/ recognition test scores of cerad -k decrease 1-2 sd number of normal value * those who agree to voluntary participation and to comply with the notice after fully hearing and understanding the details of this human trial exclusion criteria: * those with a past history of treatment with axis i disorder in scid(structured clinical interview for dsm-iv) which is a structured clinical interview in the diagnostic and statistical manual of mental disorders at screening or who have been treated within the last 3 years * those with alcohol abuse or dependence within the last 3 months * those who have clinically significant following severe illness (epilepsy, mental retardation, brain nervous system diseases, endocrine diseases, blood / malignant tumors, cardiovascular diseases, crohn's disease, etc.) * those who shows the following results in the laboratory test * ast, alt \> 3 times upper limit of normal range * other significant laboratory test opinion * those who take any prescription medicines or herbal medicines within 2 weeks before the first ingestion date or take any otc or vitamin preparations within 1 week * those who participate in other human trial within 2 months before the first ingestion * those who whole blood donation within 1 months before the first ingestion or component blood donation within 2 weeks * those who is deemed unsuitable for participating in the human trial due to other reasons

Keywords: cognitive function sesam esamesame oil cake
effect of cyproheptadine on ventilatory support-free days in critically ill patients with covid-19

Conditions: COVID-19 Pneumonia

Summary: this randomized controled open label clinical trial conducted in patients with hypoxemic respiratory failure admitted to the icu and requiring ventilatory support (invasive or non-invasive) is to evaluate whether treatment with cyproheptadine, a serotonin receptor antagonist, compared to usual care, increases the number of ventilator-free days.

some studies have shown increased platelet activation and reactivity in patients with covid-19. this platelet activation is associated with serotonin release. some characteristics observed during the evolution of covid-19 may be associated with these increased levels of serotonin. in this scenario, the antagonism of the action of serotonin could improve the clinical course of patients affected by covid-19. cyprohepatdine is an anti-serotonergic antihistamine drug with a long track record of safety and tolerability. investigators will randomize 274 patients who have tested positive for covid-19 and who will be admitted to the icu requiring ventilatory support (invasive or non-invasive). patients will be randomized to a 1:1 ratio for receiving usual care + cyproheptadine (8mg three times a day for 10 days) or usual care. patients will be followed until discharge to determine length of stay in the icu and hospital, mortality in the icu and hospital and days free from ventilatory support during the first 28 days.

Eligibility criteria:
inclusion criteria: * positive pcr for sars-cov-2 * icu admission \< 48 hours * age 18 years or older * need for invasive or non-invasive ventilatory support (non-invasive ventilation or high-flow nasal cannula) \< 48 hours exclusion criteria: * pregnancy or breastfeeding * refusal to sign the informed consent form * expected death in the next 24 hours * patients taking routinely ssri or monoamine oxidase inhibitor therapy * impossibility of using the enteral route * history of seizure disorder * history of adverse reaction to antihistamines or to cyproheptadine * readmission to the icu
atacicept in combination with rituximab in subjects with rheumatoid arthritis (august iii)

Conditions: Rheumatoid Arthritis

Summary: the primary objective of this study is to assess the safety and tolerability of combined treatment with atacicept and rituximab in subjects with active rheumatoid arthritis (ra) receiving re-treatment with rituximab.


Eligibility criteria:
inclusion criteria: * male and female subjects * greater than and equal to (\>=) 18 years of age at the time of informed consent * who have rheumatoid arthritis satisfying american college of rheumatology (acr) criteria with a disease history of at least 12 months * subjects must have active disease defined by das28 \>3.2 * subjects must have received previous treatment with rituximab and must be candidates for re-treatment with rituximab * female subjects of childbearing potential must be willing to avoid pregnancy by using an adequate method of contraception for 4 weeks before study day 1 (sd1), during the treatment period and for 12 months after the last dose of rituximab, and must have a negative urine pregnancy test at the screening visit and sd1 * other protocol defined inclusion criteria could apply exclusion criteria: * current neurological disease excluding migraine * inflammatory joint disease other than rheumatoid arthritis * any contraindication to rituximab as per national label * use of disease-modifying anti-rheumatic drugs (dmards; including methotrexate) for less than 3 months or change in dosing regimen within 28 days before sd1, or methotrexate dose regimen \>25 mg/week * participation in any interventional clinical trial within 1 month before sd1 (or within 5 half-lives of the investigated compound before sd1, whichever is longer) * prednisone dose regimen \>10 mg/day (or equivalent), or change in steroid dosing regimen within 28 days before sd1 * active or latent tuberculosis within the year before screening or major infection requiring hospitalization or intravenous anti-infectives within 28 days before sd1 * serum immunoglobulin g (igg) below 6 gram per liter (g/l) * known hypersensitivity to atacicept or to any of the components of the formulated atacicpet * known hypersensitivity to rituximab, to any of the components of the formulated rituximab or to murine proteins * breastfeeding or pregnancy * other protocol defined exclusion criteria could apply
safety of a diagnostic strategy with d-dimer testing for pe

Conditions: Venous Thromboembolism

Summary: to determine whether d-dimer testing, using the mda d-dimer assay, can be used to simplify the diagnostic process for pulmonary embolism (pe). this will be assessed by performing a cohort study in 1000 patients with suspected pe. to ascertain if an mda d-dimer result of less than 0.75 ug/ml feu obviates the need for further testing and therapy in patients with suspected pe.

prospective cohort study of 1000 patients in which those with a negative d-dimer result undergo no further testing and are followed for 3 months for venous thromboembolism. patients with a positive d-dimer undergo standardized testing.

Eligibility criteria:
inclusion criteria: * age 18 years or older * suspected pe exclusion criteria: * treatment with full-dose anticoagulants for 24 hours or more or an ongoing requirement for anticoagulants * other tests for pe performed prior to eligibility assessment (e.g.other d-dimer, v/q scan, pulmonary angiogram, spiral ct, compression ultrasound, venogram). * cardiorespiratory instability requiring immediate performance of other tests to diagnose or exclude pe (i.e. inability to wait 30-60 minutes for mda d-dimer result) * comorbid condition limiting survival to less than three months * patient has been asymptomatic for seven days prior to presentation * current pregnancy * contraindication to contrast (e.g., allergy, renal failure). * geographic in accessibility which precludes follow-up * presence of central venous catheter (permanent or temporary, including picc line) at the time of eligibility assessment

Keywords: pulmonary embolism deep vein thrombosis mda d-dimer testing diagnostic algorithm