Kornimate/medical-research-clean huggingface dataset:
effect of the side of interscalene block on bradycardia and hypotension in beach chair position

Conditions: Shoulder Surgery; Beach Chair Position; Interscalene Block; Hypotension; Bradycardia; Autonomic Nervous System

Summary: the left interscalene block has a different effect on heart's autonomic nervous system, compared to right interscalene block. this effect is evident on the occurrence of bradycardia and hypotension during shoulder surgery in the beach chair position


Eligibility criteria:
inclusion criteria: * elective shoulder surgery * age 50- 80 years old * asa ii - iv exclusion criteria: * coagulopathy disorders * infection at the puncture site for the interscalene block * neurological deficit on the side to be operated * allergy to local anesthetics * psychiatric disorders * patient's refusal * problems with patient communication * failure of the interscalene block
cyclophosphamide in treating young patients with severe autoimmune enteropathy

Conditions: Diarrhea; Gastrointestinal Complications; Unspecified Childhood Solid Tumor, Protocol Specific

Summary: rationale: cyclophosphamide may help control the symptoms of autoimmune enteropathy . purpose: this phase ii trial is studying how well cyclophosphamide works in treating young patients with severe autoimmune enteropathy.

objectives: primary * determine the rate of treatment-free remission in young patients with severe autoimmune enteropathy treated with high-dose cyclophosphamide. secondary * determine the toxic effects of this drug in these patients. outline: patients receive cyclophosphamide iv over 1 hour on days 1-4. patients then receive filgrastim (g-csf) iv or subcutaneously once daily beginning on day 10 and continuing for 3 days or until blood counts recover. after completion of study treatment, patients are followed periodically for up to 1½ years. projected accrual: a total of 7-11 patients will be accrued for this study.

Eligibility criteria:
disease characteristics: * diagnosis of severe autoimmune enteropathy * condition is resistant to conventional therapy * histologic evidence of severe villous atrophy with intense lymphocytic infiltrate of the lamina propria by small intestinal biopsy within the past 3 months * disease failed to respond after ≥ 2 months of corticosteroid therapy at a dose of ≥ 0.5 mg/kg/day or ≥ 40 mg/day for patients \> 20 kg and 1 of the following therapies: * cyclosporine resulting in ≥ 1 whole blood level of \> 200 ng/ml * tacrolimus resulting in ≥ 1 whole blood level of 5 ng/ml * at least 50% estimated caloric needs provided by parenteral nutrition * history of intractable diarrhea, defined as frequent watery stools for \> 3 months that does not respond to dietary restriction * no celiac disease, defined by a history of positive antiendomysial antibody or tissue transglutaminase antibody * no primary immunodeficiency or x-linked autoimmunity-allergy dysregulation patient characteristics: performance status * lansky 60-100% life expectancy * not specified hematopoietic * not specified hepatic * not specified renal * not specified cardiovascular * ejection fraction ≥ 40% or shortening fraction ≥ 20% pulmonary * fvc or fev_1 ≥ 50% of predicted (for patients \> 8 years of age) * no clinically abnormal pulmonary function or abnormal pulse oximetry (for patients ≤ 8 years of age) other * not pregnant * negative pregnancy test * fertile patients must use effective contraception during and for at least 9 months after completion of study treatment * no known chromosomal abnormality prior concurrent therapy: biologic therapy * no immunizations for at least 6 months after completion of study treatment endocrine therapy * see disease characteristics * at least 5 days since prior corticosteroids * no concurrent dexamethasone as an anti-emetic other * at least 5 days since other prior immunosuppressive medications (e.g., tacrolimus or cyclosporine)

Keywords: unspecified childhood solid tumor, protocol specific gastrointestinal complications diarrhea
outcomes in cardiogenic shock patients treated by mechanical circulatory support device : impact of shock team

Conditions: Cardiogenic Shock; Short Term Mechanical Circulatory Support; Shock Team

Summary: in this before-after monocenter study, the authors teste the hypothesis that the implementation of a dedicated shock team could improve the outcome of patients with refractory cardiogenic shock assisted by mechanical circulatory support.

short term mechanical circulatory support (stmcs) are the last resort therapeutics when refractory cardiogenic shock occurs. growing technical possibilities like impella make the right choice at the right time challenging. at bordeaux university hospital, we have gathered the main protagonists which are the surgeon, the interventional cardiologist,and the intensivist as a shock team in january 2013. from that time, diagnosis of refractory cardiogenic shock triggers a multidisciplinary meeting driven by a common algorithm. the objective of this study is to perform a before-after comparison between decision of stmcs for refractory cardiogenic shock without shock team from january 2007 to january 2013 and after implementation of the shock team from april 2013 to april 2019.

Eligibility criteria:
inclusion criteria: * diagnosis of cardiogenic shock * \>1 sign of refractory cardiogenic shock : dobutamine \>10µg/kg/mn, epinephrine\>0.25µg/kg/mn or milrinone \> 0.5µg/kg/mn ; scvo2\<55% ; po2/fio2\<100 * no major counter indication to short term mechanical circulatory support : sofa score \> 15, prolonged cardiac arrest, severe chronic disease, direct lvad implantation or heart transplantation, counter indication for systemic anticoagulation exclusion criteria: * age \< 18years * post cardiotomy cardiogenic shock * implantation of impella 2.5 alone * implantation of intra aortic balloon pump alone

Keywords: extra corporeal membrane oxygenation cardiogenic shock impella shock team long term mechanical circulatory support
safety study of farletuzumab, carboplatin and pegylated liposomal doxorubicin (pld) to treat platinum-sensitive ovarian cancer

Conditions: Epithelial Ovarian Cancer

Summary: the purpose of this study is to evaluate whether combination therapy with farletuzumab (morab-003), carboplatin, and pegylated liposomal doxorubicin (pld) is safe.

farletuzumab (morab-003) is a monoclonal antibody that has the potential to be an effective agent against epithelial ovarian cancer (including primary fallopian tube and peritoneal adenocarcinoma) in combination with other drugs. farletuzumab works by a different mechanism from other cancer therapeutics and has been shown to be well tolerated. this study allows the opportunity to determine if the combination therapy of farletuzumab, carboplatin, and pld 1. is safe, or 2. to assess the potential drug-drug interaction, and 3. to prolong response to chemotherapy.

Eligibility criteria:
inclusion criteria: * diagnosis of epithelial ovarian cancer * must have measurable disease by ct or mri scan * must have relapsed as defined by ca-125 or radiologically within 6 months or more of completion of first- or second-line platinum chemotherapy * must have been treated with surgery and be a candidate for repeat carboplatin therapy * must have a normal cardiac ejection fraction at baseline exclusion criteria: * subjects who never responded to first- or second-line platinum-based chemotherapy or whose relapse occurs \<6 months from the last platinum therapy * subjects who have received other therapy to treat their ovarian cancer since last relapse * known central nervous system tumor involvement * evidence of other active invasive malignancy * clinically significant heart disease * known allergic reaction to a prior monoclonal antibody therapy or have any documented haha * previous treatment with morab 003 (farletuzumab) * previous treatment with anthracyclines * clinical contraindications to use pld

Keywords: epithelial ovarian cancer ovarian cancer
nutritional status in neuroblastoma in sao paolo, brazil

Conditions: Neuroblastoma

Summary: this study proposes to investigate the effect of treatment of neuroblastoma on nutritional status, assessed by body mass index (bmi) z score, and body composition evaluated by mid-upper arm circumference (muac), from diagnosis through 1-year post end of treatment. the study also aims to investigate the nutritional status and its role in toxicities, infection, survival rates, disease relapse, cost of care and readmission rates, as well as health-related quality of life. the study will take place in sao paolo in brazil, where an estimated sample of 50 children with neuroblastoma will be recruited for the period of 2 years.

in brazil, cancer represents the leading cause of death by disease in children and adolescents from 1 to 19 years old. neuroblastomas correspond to nearly 10% of all cancer diagnoses among children younger than 15 years of age, with an incidence of 1 case per 100,000 children of this age group. about 500 new cases of neuroblastoma (nb) are diagnosed annually in brazil. the complexity and intensity of treatment result in several treatment-related toxicities (trt) that make it challenging to maintain nutritional status in these nutritionally at-risk patients. in brazil, up to 26% of undernutrition at diagnosis has been found in patients with solid tumors. in neuroblastoma, high prevalence rates of malnutrition have been reported elsewhere with up to 80% of children at diagnosis and 20-50% during treatment classified as undernourished. it's important to underscore that nutritional status is a modifiable risk factor, therefore it needs more attention and close monitoring. it is important to better comprehend the effect of treatment for neuroblastoma on nutritional status and body composition, for which prospective longitudinal studies are required. therefore, in this prospective cohort study, the investigators will evaluate the fluctuations in nutritional status over the course of treatment in children with neuroblastoma at the study center in são paulo, brazil. the results of this study will drive the development of evidence-based guidelines for the nutritional care of children with neuroblastoma and set research priorities for subsequent investigations.

Eligibility criteria:
inclusion criteria: * diagnosis of high-risk neuroblastoma at itaci, according to the pediatric oncology group (pog)/children's cancer study group (ccg) classification (international neuroblastoma staging system (inss) stage) * age under 18 years * informed consent from a legal guardian to participate in the study exclusion criteria: * patients who have received previous chemotherapy * first assessment performed more than 48 hours after the beginning of treatment

Keywords: malnutrition childhood cancer nutrition aspect of cancer child malnutrition brazil sao paolo
progression delaying effect of escitalopram in alzheimer's disease

Conditions: Alzheimer's Disease

Summary: this study aimed to test whether escitalopram would slow the brain atrophy in patients with mild to moderate ad over the 52-week period.

* study institutions: four university hospitals in korea * design: multi-center, randomized, placebo-controlled, double-blind clinical trial * subjects: 74 probable alzheimer's disease patients who have been taking donepezil at stable dose within 2 months (escitalopram 37 : placebo 37)

Eligibility criteria:
inclusion criteria: * age:40\~90 years * education:not illiterate * clinical dementia rating (cdr):0.5\~2 * modified hachinski ischemic score (rosen et al., 1979):less than 4 * dementia according to dsm-iv criteria * probable alzheimer's disease according to nincds-adrda criteria * current ongoing donepezil medication at stable doses (5 \~ 10 mg/day) for at least 2 months exclusion criteria: * evidence of delirium, confusion or altered consciousness * evidence of parkinson's disease, stroke, brain tumor and normal pressure hydrocephalus * evidence of infectious or inflammatory brain disease * evidence of serious cerebrovascular diseases * current major depressive disorder or other major psychiatric illnesses * evidence of serious or unstable medical illnesses which can significantly change cognitive state * history of alcohol or other substance dependence * any antidepressant medications within the previous 4 weeks * absence of a reliable and cooperative collateral informant * any conditions which prohibit mri scan, such as presence of pacemaker or cerebrovascular clip, and claustrophobia * evidence of focal brain lesions on mri including lacunes and white matter hyperintensity lesions of grade 2 or more by fazeka scale

Keywords: alzheimer's disease escitalopram mri
folinic acid in children with autism spectrum disorders

Conditions: Autism Spectrum Disorder

Summary: the investigator planned to study the efficiency of folinic acid treatment on autistic symptoms in children suffering from autism spectrum disorder.

the aim of this study is to realise a pilot study in france in order to evaluate the efficiency of folinic acid in treatment of autism spectrum disorder and get first estimations about prevalence of auto antibodies anti-frα in france. the study is a randomized controlled trial monocentric,evaluating folinic acid 10mg per day versus placebo, in single-blind during 12 weeks. primary objective : the primary objective is to evaluate the efficiency of folinic acid (calcium folinate) 5mg twice a day during 12 weeks on reduction of autistic troubles, particularly on communication and social interaction secondary objective : * evaluate the efficiency of folinic acid on reduction of autistic symptoms perceived by parents * evaluate the constancy of auto antibodies anti-frα rates

Eligibility criteria:
inclusion criteria: 1. children with autism spectrum disorders defined by : autism diagnostic observation schedule (ados), autism diagnostic interview (adi), childhood autism rating scale (cars) or diagnosed by a physician (pediatrician, child psychiatrist) 2. children aged 3 to 10 years 3. weight\> 10 kg 4. language impairment (based on the medical assessment) 5. ability to maintain other therapies started before the study 6. no changes of therapeutic treatments within the 8 weeks before the start of the study exclusion criteria: 1. treatment may impair folate metabolism (methotrexate, anticonvulsivants : phenobarbital sodium valproate, phenytoin, primidone, carbamazepine, valproic acid, divalproex, antibiotics : tetracycline, trimethoprim, pyrimethamine, inhibitors of proton pump inhibitors of histamine-2) 2. antipsychotic treatment (including treatment with risperidone) 3. vitamin or mineral supplementation exceeding guidelines 4. children with severe irritability (aberrant behavior checklist\> 17) 5. gastroesophageal reflux disease 6. any known renal or liver disease 7. child born premature (\<37sa) 8. known intolerance to lactose 9. hypersensitivity / allergic reaction to calcium folinate 10. the sibling children with autism spectrum disorders
local wound infiltration in renal surgery

Conditions: Postoperative Pain

Summary: multimodal analgesia is a rational approach to treat various components of postoperative pain.

local anesthetic wound infiltration is widely recognized as a useful adjunct during multimodal postoperative pain management whether given before operation or perioperatively.

Eligibility criteria:
inclusion criteria: * asa i or ii, aged between 30 and 65 yr, and undergoing open renal surgery exclusion criteria: * history of adverse reactions to local anaesthetics, chronic hepatic disease, chronic renal disease chronic pain, chronic preoperative opioid consumption, psychiatric disorders which would prevent postoperative assessments,
high intensity interval gait training in multiple sclerosis

Conditions: Multiple Sclerosis

Summary: over 90% of persons with ms (pwms) complain of difficulty with walking. high intensity interval gait training (hiigt), where persons alternate brief periods of walking at high speeds with periods of rest has been found to improve walking in other neurologic diagnoses. however its impact on pwms is not known. most gait training in ms is done continuously at a slower pace. the purpose of this study is to compare the effects of hiigt to traditional moderate intensity continuous gait training (micgt) in pwms.

purpose: to determine whether pwms will have greater improvements in gait with hiigt as compared to micgt. primary question: does hiigt results in greater improvements in gait parameters in pwms than micgt? secondary question: will hiigt result in greater improvements in balance, lower extremity strength, lower extremity range of motion and hr when compared to micgt in pwms? hypothesis: hiigt will result in greater improvements in gait parameters in pwms than micgt. justification: previous research has shown that micgt, moderate intensity interval training and high intensity non-gait interval training is effective in pwms. hiigt has been shown to be effective in persons with stroke but the effects of hiigt on pwms are not known. outcomes and dissemination of information: we will present our findings at national conferences and submit manuscripts of our findings to the appropriate peer reviewed journal.

Eligibility criteria:
inclusion criteria: * persons diagnosed with multiple sclerosis. * the ability to walk for 6 minutes continuously with or without assistive device. * the ability to read, understand and sign a consent form so that they are able to understand the study we are doing * above the age of 18 exclusion criteria: * any cardiopulmonary, orthopedic, or non-ms neurologic disease as we are only examining the effects of ms and need to rule out the impact of other conditions * report of a recent exacerbation. rationale: the impact of the rationale can interfere with the impact of the independent variables
virgin coconut oil contact lens as ocular rewetting agent

Conditions: Dry Eyes

Summary: this is a clinical trial where 44 subjects dry eyes were instilled with virgin coconut oil (vco cl) using contact lenses as its vehicle. all subjects are healthy subjects with no other ocular diseases except for having some dry eye symptoms (included with mcmonnies questionnaires). parameters measured at baseline and after 15 minutes of insertion and were compared. the control eyes were inserted with contact lenses soaked in saline (ccl). the eye that wears the vco cl or the ccl were chosen randomly by masked operator. at the end of this study, the parameters measured will indicate if the vco cl was able to retain tears in the eye and remove the dry eyes symptoms.

a new study using contact lens pre-soaked in virgin coconut oil (vco cl) was conducted to determine the safety of the agent on dry eye human. efficacy of the vco cl was assessed by measuring tbut, anterior eye assessment, corneal staining, ph, and schirmer value and the measurement of residual vco volume in tears before instillation (0 minute) and at 15 minutes after insertion. wilcoxon signed rank and mann whitney u test were used to analyse any changes in all the measurable variables. the differences of the tbut, corneal staining and residual vco volume in tears value in both eyes were analyzed. these study data will suggest if the vco cl is safe and effective and can be recommended to be used as an option for dry eyes in human

Eligibility criteria:
inclusion criteria: * dry eye symptoms (according to mcmonnies questionaires) * written consent exclusion criteria: * no ocular diseases * no systemic diseases * not wearing contact lenses regularly for the past 6 months

Keywords: contact lens vco tbut dry eyes
apm in the evoke scs system to program patients with chronic pain of the trunk and/or limbs

Conditions: Chronic Pain; Pain, Chronic

Summary: study to evaluate the use of the assisted programming module (apm) in the evoke spinal cord stimulation (scs) system to program patients with chronic pain of the trunk and/or limbs.


Eligibility criteria:
inclusion criteria: * subject has or is planning to undergo a temporary trial with evoke system within the fda approved indication. * subject is willing and capable of giving informed consent and able to comply with study-related requirements. exclusion criteria: * there are no exclusion criteria.
promotion of active lifestyle in pneumonia patients

Conditions: Pneumonia

Summary: patients who have suffered a pneumonia used to reduce their activity levels because of the symptoms and the fear to suffer breathlessness. these patients often have sequelae after the hospitalization that previous studies have associated with a lack of physical activity. the main objective of this research is to investigate the efficacy of a rehabilitation program for promotion higher activity levels in quality of life and self-perceived discapacity of pneumonia patients.


Eligibility criteria:
inclusion criteria: * patients of both sexes. * agreed to participate. * pneumonia patients meeting the diagnosis criteria for this disease. exclusion criteria: * neurological or orthopaedic pathologies that limited voluntary movement. * cognitive impairment that prevented them from understanding and answering the questionnaires. * patients who don´t understand spanish language

Keywords: pneumonia rehabilitation activity promotion
efficacy study of recombinant interleukin-21 in the treatment of ovarian cancer

Conditions: Cancer; Ovarian Cancer

Summary: this trial is conducted in europe. the aim of this trial is to investigate the efficacy of ril-21 and caelyx in cancer patients who have relapsed after, or have persistent disease after, first line therapy. patients will be treated for 6 months.


Eligibility criteria:
inclusion criteria: * advanced epithelial ovarian cancer (stage iib-iv) * persistent or progressive disease after or relapse within one year of completion of first line therapy * measurable or assessable disease * eastern cooperative oncology group status less than or equal to 2 exclusion criteria: * history of any other active malignancy * signs of cns metastasis * more than one prior chemotherapy regimen * radiotherapy (bone) less than 4 weeks prior to start of treatment and radiotherapy (visceral) less than 8 weeks * first line chemotherapy completed at least 1 month prior to start of treatment
impact of a mental health curriculum for high school students on knowledge and stigma

Conditions: Mental Disorders; Education Curriculum; Comparative Effectiveness Research; Early Intervention; Adolescents

Summary: this study examines the effectiveness of a school based mental health literacy intervention for high school students, on improving mental health knowledge and reducing stigma. twenty-four high schools in the regional area of ottawa, canada were randomly assigned to either the curriculum or control condition at a two to one ratio. the educational curriculum was integrated within grade 11 and 12 provincial "healthy living" courses, delivered by teachers, and replaced existing educational content on mental health.

there is limited evidence and consensus on the effectiveness of school-based mental health educational programs, and no standardization for mental health education being taught in schools. this study examines the effectiveness of a school-based mental health literacy intervention for adolescents, on knowledge and stigma. a secondary objective was to determine the generalizability and applicability of an educational resource for mental health in high schools.

Eligibility criteria:
inclusion criteria: * students enrolled in the healthy living course of participating ottawa area community high schools. exclusion criteria: * students not enrolled in the healthy living course of participating ottawa area community high schools. * students with an english reading and comprehension level lower than the sixth grade

Keywords: mental health knowledge stigma mental health literacy