Kornimate/medical-research-clean huggingface dataset:
effects of a ketogenic diet on acute stroke

Conditions: Acute Stroke

Summary: the purpose of this controlled, randomized intervention is to investigate whether a fat-based (ketogenic) diet given for a week has a positive effect on blood sugar, mortality and function in patients hospitalized with acute stroke compared to the effect of a usual diet. the study hypothesis is that a ketogenic diet and reduced availability of glucose to the brain cells will reduce the volume of neuronal damage in the brain and improve function. the intervention will take place at the neurological units of glostrup and bispebjerg hospital in denmark.

a ketogenic diet can induce ketosis after a period of 2-3 days and offer the brain an alternative energy substrate to glucose in the form of ketone bodies. feeding the brain ketone bodies can potentially benefit a stroke patient's brain in several ways: stroke is characterized by impaired blood and oxygen supply to brain cells. this can cause glucose to convert to lactate which is toxic for the brain. decreasing glucose availability to brain cells may thus potentially decrease the area of damage in the ischemic penumbra (perifephery of the stroke). compared with sugar, burning ketone bodies requires less oxygen to produce the same amount of energy, suggesting that brain cells could have a potential greater chance of surviving during circumstances of reduced oxygen supply. by decreasing mitochondria activity, ros synthesis is also decreased, which can help decrease the necrotic area around the ischemic penumbra. furthermore, the ketogenic diet does not induce an increase in blood sugar which could be an advantage since many stroke patients are admitted with hyperglycemia associated with a worse outcome.

Eligibility criteria:
inclusion criteria: * patients with ischemic or hemorrhagic stroke. * nihss score of at least 5. * both primary and recurrent cases. * inclusion as early as possible, but no later than 72 hours from symptom onset. * patients with expected hospitalization for a minimum of seven days. * adult patients with cognitive ability to give informed consent. * patients with writing and orally accepted participation. exclusion criteria: * patients with sah and traumatic hematoma. * patients with pancreatic insufficiency (steatorrhea). * patients unable to give informed consent.

Keywords: stroke, ketogenic diet, ketosis, ischemia, brain, ketones, hyperglycemia, neuroprotection
probiotics and the prevention of traveler's diarrhea

Conditions: Travelers' Diarrhea

Summary: the present study is designed to evaluate the effect of a mixture of probiotics on the prevention of traveler's diarrhea (td) in subjects who travel to a country with a high risk for developing td. subjects will be asked to take one capsule containing a mixture of probiotics or a placebo capsule a day, within the week before departure, during the travel and up to 3 days after return. they will note the following outcomes in a diary: occurence of diarrhea, number and consistency of stools, duration of the diarrhea, presence of diarrhea-related symptoms and need for rescue medication. the present study will examine if the use of the probiotics capsule reduces the occurence of traveler's diarrhea as compared to the placebo capsule.


Eligibility criteria:
inclusion criteria: 1. male and female subjects aged 18 or over. upper age limit set by subject's ability to participate in the study; 2. subject must give written informed consent; 3. plan to travel to a geographic area with high risk of td with a travel duration between 12 and 14 days; 4. subjects must be willing to refrain from using anti-diarrheal medications or antibiotics during the study period, unless they become clinically indicated in which case a rescue regimen can be administered; 5. subjects willing to refrain from eating yoghurt and taking other probiotics during the study; 6. female subjects of child-bearing potential must agree to use adequate birth control during the study period. this will be defined as hormonal contraception or a double barrier-method. exclusion criteria: 1. subjects who have been previously treated with protecflor® or who have participated in previous lallemand-sponsored studies; 2. subjects who have been born in a developing country. 3. subjects with a history of substance or alcohol abuse or any other psychological condition that may, in the investigator's opinion, adversely affect their co-operation with the study; 4. subjects who receive a cholera vaccine 5. subjects with chronic diarrhea; 6. subjects with chronic disease such as irritable bowel syndrome (ibs) or inflammatory bowel disease (ibd) or ulcerative colitis (uc) ; 7. subjects with gastrointestinal (gi) surgery during the last 3 months; 8. subjects who took systemic antibiotic 15 days or less prior to the study; 9. subjects with immunodeficiency's or immune suppression; 10. subjects being treated for cancer with radiotherapy and/or chemotherapy; 11. subjects with organ transplants; 12. subjects treated with immunosuppressant drugs; 13. subjects receiving another probiotic preparations or having received probiotic preparations within the last 15 days; 14. subjects with tube feeding, ileostomy and colostomy; 15. subjects diagnosed clostridium difficile colitis within the last 3 months; 16. women who are pregnant, or who will not consent to using adequate birth control during the study period; 17. women who are breastfeeding.

Keywords: probiotics traveler's diarrhea prevention
e- ab sensor - based real-time diagnosis of enterovirus type 71

Conditions: EV71

Summary: to develop a real-time diagnostic technique with e- ab sensor for entervirus 71 detection, the investigators conduct a prospective clinical study. in comparison with results from direct sequencing of entervirus 71, the investigators evaluate the performance of e- ab sensor, including reproducibility, sensitivity, specificity, and cross-reaction. the potential factors which may interfere with the results would be investigated. with such technique, the investigators hope to make early diagnosis and give ev71 patients early treatment to reduce the complications and case-fatality rate.

entervirus 71 is one of the most important infectious diseases in children and the important concern in public health. since 1998, ev71 has become an endemic disease in taiwan and caused hundreds of severe cases and dozens of fatal cases each year due to lack of ev71 vaccine. family transmission study also showed that it is highly contagious among households as well as in daycares or kindergartens. therefore, a rapid diagnosis is clinically necessary and can provide clinicians the rapid answers and make early treatment possible to reduce the complications and case-fatality rate. in addition, early diagnosis of the patients will alert parents and public health workers to prevent the contacts earlier and to limit the ev71 spread. electrosensing antibody probing system (e- ab sensor), which was developed for the rapid and sensitive detection of hapten, proteins or viral antigen in medical samples, will be used for analyzing the interaction kinetics between q.anti-ev71 and its antigen ev71 present in ev71 patients and normal sample. the system incorporates the use of engineered semiconductive antibodies or virus in vertical and lateral chip (evchip) or lateral flow through (evsignal) formats. in electrosensing virus probing, semiconductive antibodies are bound as a suitable electrosensing probe which specifically and selectively binds ev71 epitope target molecules in the test serum. in comparison with results from direct sequencing of ev71, the investigators evaluate the performance of e- ab sensor, including reproducibility, sensitivity, specificity, and cross-reaction. the potential factors which may interfere with the results would be investigated. e- ab sensor threshold decisions must maximize its sensitivity. therefore, the threshold value in the test group is to find the decision could have 90% sensitivity and 90% specificity. with such technique, the investigators hope to make early diagnosis and give ev71 patients early treatment to reduce the complications and case-fatality rate.

Eligibility criteria:
inclusion criteria: * a: the patients with confirmed or suspected infection. * b: the patients without disease. exclusion criteria: * patients will be excluded if they couldn't sign the consent.

Keywords: ev71
124i-evuzamitide pet/ct imaging in patients with lumbar spinal stenosis and carpal tunnel syndrome

Conditions: Lumbar Spinal Stenosis; Carpal Tunnel Syndrome (CTS); Cardiac Amyloidosis

Summary: this clinical trial will use the amyloid-binding radiotracer, 124i-evuzamitide, to potentially detect amyloid, in the heart and elsewhere, in patients who have a history of lumbar spinal stenosis and/or carpal tunnel syndrome.

this is a single center, open label, pilot study using an amyloid-reactive peptide labeled with iodine-124 (124i-evuzamitide) and pet/ct imaging to detect the presence of cardiac and extracardiac amyloid in patients who have undergone surgical intervention for lumbar spinal stenosis (lss) or carpal tunnel syndrome (cts) and who have amyloid-positive connective tissue \[ligamentum flavum (lf) in lss patients or tenosynovium in cts patients\] assessed at the time of the corrective surgery.

Eligibility criteria:
inclusion criteria: * must be ≥ 60 years of age. * must have given written informed consent (signed and dated) and any authorizations required by local law and be able to comply with all study requirements. * must have a congo red positive ligamentum flavum or tenosynovial specimen analysis after laminectomy or carpal tunnel release surgery that is visually categorized as either "extensive" amyloid load or "mild/moderate" amyloid load by an experienced reviewer. * those with mild/moderate amyloid load in the connective tissue who also have a history of at least one other orthopedic clinical manifestation, including, but not limited to, carpal tunnel syndrome, lumbar spinal stenosis, trigger finger, biceps tendon rupture, and shoulder/hip/knee arthroplasty. * females must be non-pregnant and non-lactating. exclusion criteria: * subjects on dialysis. * subjects with a confirmed diagnosis of systemic amyloidosis, other than musculoskeletal tissue. * inability or unwillingness to comply with the study requirements. * subjects taking heparin, or heparin derivatives (e.g. low molecular weight heparins) for anticoagulation. * inability to lie still for \~40 minutes on the pet/ct scanner. * history of iodine (potassium iodide) allergy. * other reason that would make the subject inappropriate for entry into this study.

Keywords: iodine-124-evuzamitide pet imaging amyloidosis spinal stenosis carpal tunnel syndrome p5+14
m3-jia: making mindfulness matter for children with jia

Conditions: Juvenile Idiopathic Arthritis; Children; Mental Health; Mental Well-being

Summary: the investigator will evaluate the efficacy of m3©, an intervention for patients with jia and their caregivers. children with juvenile arthritis and their parents will attend an 8 week online program called making mindfulness matter (m3). this is a facilitator-led program that integrates knowledge and skills related to mindfulness, social-emotional learning, neuroscience, and positive psychology to promote coping and resiliency for children and families in context of the challenges of pediatric chronic disease. the child program is designed for children 4-12 years of age, with each lesson including a variety of concrete ways to teach children skills based on their age/developmental level.

this pilot rct is essential to refine the implementation of the intervention to families with a child with jia and collect information pertaining to the feasibility and effectiveness of the intervention in preparation for a subsequent multicentred trial across canada. the investigator will propose to test if the m3© program improves the child's health related quality of life (hrqol) and mental health for children with jia and caregivers. additionally, to address the knowledge gap on the relationship between mental health and disease outcomes in jia. m3 is a promising mindfulness-based intervention which may have mental health benefits for children with jia and caregivers.

Eligibility criteria:
inclusion criteria: * children aged 4 to 12 years diagnosed with jia * children have reasonable comprehension of spoken language and can follow simple instructions * children with jia and their caregivers are willing to attend intervention sessions and have access to technology and internet to attend the online sessions. * children with jia and their caregivers have an adequate understanding of english exclusion criteria: * other major co-morbid disorders (e.g. crohn's disease, diabetes, renal failure). * concurrent enrollment in other intervention trials or practicing any complementary health interventions such as yoga, meditation, or daily mindfulness practice.

Keywords: m3 mindfulness
systemic propranolol for the treatment of paediatric patients with infantile hemangiomas

Conditions: Infantile Haemangiomas

Summary: this is retrospective study. the patients treated with oral propranolol at a dose of 2.0 mg/kg per day. growth parameters (height and weight) were measured at the beginning, the end of treatment and 2 years after treatment. the weight-for-age z-score (waz), height-for-age z-score (haz) and weight-for-height z-score (whz) calculated by the who anthro software were used to assess physical development, and the who child growth standards were used as the standards.


Eligibility criteria:
inclusion criteria: * ihs diagnosed by medical history and physical examination * no previous treatment with other medications exclusion criteria: * a history or risk of asthma, reactive airway disease, impaired renal or liver function, heart defects or arrhythmia, hypotension and hypersensitivity to propranolol * infants who did not adhere to the treatments or attend follow-up visits * infants with other known risk factors for developmental delay or growth restriction, such as prematurity, small for gestational age, or other major congenital malformations, were also excluded * no other treatment was used during the oral propranolol course
post authorisation safety study of triaxis as a 5th dose in 4-6 year old spanish children

Conditions: Diphtheria, Tetanus and Pertussis

Summary: primary objective: this is a descriptive study and the primary objective is to determine the incidence of injection site and systemic adverse events after triaxis administration as a 5th dose of tetanus, diphtheria and acellular pertussis vaccine in 4-6 year old children


Eligibility criteria:
inclusion criteria: * aged 4 to 6 years on the day of enrolment. * have received, on the day of enrolment, immunisation with triaxis as a 5th dose for diphtheria, tetanus, pertussis vaccination in routine practice in accordance with the spanish version of the eu smpc and the spanish immunisation recommendations. * have received a complete course of immunisation with diphtheria, tetanus and pertussis (4 doses). * participant and participant´s parent/legal representative are able to comply with all study procedures. * written informed consent obtained from at least one parent/legal representative of the participant before the participant is enrolled in the study exclusion criteria: * have been previously vaccinated with a 5th dose of tetanus, diphtheria and pertussis. * presence of a contra-indication or cautions to vaccination in accordance with the spanish version of the eu smpc: 1. hypersensitivity to vaccines of diphtheria, tetanus or pertussis, any component of the vaccine and any residual component of the manufacturing process such as formaldehyde and glutaraldehyde that may be present in trace amounts. 2. encephalopathy of unknown origin within 7 days after a prior immunisation with a vaccine against pertussis. 3. progressive neurological disorder, uncontrolled epilepsy, progressive encephalopathy if no treatment has been established and the condition is not stable. 4. acute severe febrile illness or acute infection.
arsenic trioxide in treating patients with stage iv prostate cancer that has not responded to previous hormone therapy

Conditions: Prostate Cancer

Summary: rationale: drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. purpose: phase ii trial to study the effectiveness of arsenic trioxide in treating patients who have stage iv prostate cancer that has not responded to hormone therapy.

objectives: * determine the efficacy of arsenic trioxide in patients with metastatic stage iva or ivb hormone-refractory prostate cancer. * determine the toxicity of this drug in this patient population. * assess, in a preliminary manner, the effect of this drug on pain control in these patients. * assess the potential value of serial quantitative prostate-specific antigen (psa) and prostate-specific membrane antigen (psma) mrna determinations in rna from peripheral blood mononuclear cells as surrogate markers of disease response in patients treated with this drug. * assess the pharmacokinetics and pharmacodynamics of this drug in these patients. * assess the feasibility of using pretreatment bone marrow evaluation of psa and pmsa mrna levels and pi class glutathione s-transferase expression (i.e., eliminate glutathione levels) as potential correlates of disease response in patients treated with this drug. outline: patients receive arsenic trioxide iv over 2 hours on days 1-5 and 8-12 for one course. treatment continues as biweekly infusions for at least 14 additional weeks in the absence of disease progression, unacceptable toxicity, or excessive increase in serum prostate-specific antigen. pain is assessed at baseline and then before each biweekly treatment. projected accrual: a total of 17-37 patients will be accrued for this study within 12-24 months.

Eligibility criteria:
eligibility criteria: * diagnosis of stage iva or ivb hormone-refractory prostate cancer * obstructive uropathy and/or hydronephrosis allowed if adequate renal function and urinary drainage * wbc at least 2,500/mm\^3 * absolute neutrophil count at least 1,500/mm\^3 * platelet count at least 100,000/mm\^3 * hemoglobin at least 9.0 g/dl * bilirubin less than 2 mg/dl exclusion criteria: * no significant active infectious disease * no grade 2 or greater peripheral neuropathy * no other debilitating acute or chronic co-morbid medical, neurological, or psychiatric condition that would preclude study compliance * no concurrent amphotericin b or other agent that prevents restoration of potassium or magnesium to normal levels and/or correction of qt interval to under 500 milliseconds

Keywords: stage iv prostate cancer recurrent prostate cancer
biennial cem in women with a personal history of breast cancer

Conditions: Breast Cancer; Breast Neoplasms; Breast Cancer Female; Neoplasms

Summary: this is a prospective clinical trial that will examine if biennial contrast-enhanced mammography added to annual 3d mammography (tomosynthesis) substantially improves breast cancer detection with minimal increase in false-positives, in women with a personal history of breast cancer.

the investigators seek to determine if improved breast cancer detection is maintained with biennial contrast-enhanced mammography (cem) added to annual digital breast tomosynthesis (dbt) with overall fewer false positives than from annual dbt plus cem. the investigators will offer biennial cem exams for eligible patients. enrolled participants will have a baseline cem exam with their routine dbt exam, and then have another cem exam 24 months after their baseline cem exam and then again at 48 months. participants will continue to have their annual dbt exams during this time as a part of their usual care. two radiologists (one primary) will evaluate each pair of examinations by sequentially interpreting each of dbt and cem in opposing order (primary reader dbt then cem and secondary reader cem then dbt), initially blinded to the other modality. we expect that with biennial screening, at least a similar number of cancers will be detected with cem (and possibly more that were occult on the dbt-only screen 12 months prior), with a similar incremental false-positive rate and at least similar (if not improved) overall positive predictive value (ppv1).

Eligibility criteria:
inclusion criteria: * asymptomatic women, ages 30-79, with a personal history of breast cancer who are at least one year out from any breast cancer surgery and/or treatment and are scheduled to have a routine annual mammogram with tomosynthesis (dbt). exclusion criteria: * women with a history of prior moderate or severe iodinated contrast reaction \[only those with a prior mild reaction that can be managed by pre-medication and with and a strong desire to participate will be allowed to participate. however, among these women with a mild sensitivity, if they are allergic to benadryl (one of the premedications), they will be excluded\]. * women with implant(s) in the breasts to be screened (as this creates artifacts and diagnostic performance of imaging in women with implants likely does not generalize to those without implants, and the sample size with implants would be too small to infer conclusions. * women who have had bilateral mastectomy * women with a history of kidney failure or estimated glomerular filtration rate (egfr) \< 45 ml/min * pregnancy or lactation * women actively being treated for cancer of any type with chemotherapy * having only one kidney * women with stage 4 metastasis to visceral areas or brain * women who have a screening breast mri exam within 24 months prior to the current round of cem. * women who had a cem exam within the prior 23 months

Keywords: breast cancer screening digital breast tomosynthesis contrast-enhanced mammogram
effectiveness and safety of antibiotherapy in diabetic patients treated for a diabetic foot infection.

Conditions: Diabetic Foot Infection

Summary: diabetes is a frequent and serious disease, with many complications. diabetic foot ulcers are a frequent complication. infection of diabetic foot ulcers is common, and requires heavy medical and/or surgical treatments. antibiotherapy is one of the main options for the treatment of the diabetic foot ulcers, but it has many side effects. the aim of this study is to evaluate effectiveness and safety of medical treatments, in this population of patients.


Eligibility criteria:
inclusion criteria: * adults men and women * followed for diabetic foot infection (grades 2 to 4 of iwgdf classification) * that accepted to take part in the study exclusion criteria: * legal safeguard * pregnant women * patient that can't accept to take part in the study because can't be informed * exclusive surgical treatment