Kornimate/medical-research-clean huggingface dataset:
vitamin c for prophylaxis of post-operative atrial fibrillation in on-pump cardiac surgery procedures

Conditions: Atrial Fibrillation

Summary: the purpose of this study is to determine whether vitamin c is effective in the prophylaxis of post-operative atrial fibrillation in on-pump cardiac surgery

atrial fibrillation (af) is the single most common post-operative complication after on-pump cardiac surgery, ranging from roughly 25% in cabg procedures, up to 65% in valve replacement procedures. the presence of af in cardiac surgery patients doubles the morbidity amongst these patients, as well as raising the mortality rates. vitc is an electron donor for a number of enzymatic systems, reducing potentially harmful free radicals. in post-procedural af, there is increased peroxynitrite concentration, which is a target for vitamin c. a randomized, double blind study will be conducted in order to establish the efficiency of vitamin c as prophylaxis for postoperative af.

Eligibility criteria:
inclusion criteria: * patients undergoing on-pump cardiac surgery exclusion criteria: * off-pump cardiac surgery procedure * af before the procedure * recent infection and/or infectious endocarditis * presence of neoplasia * chronic renal failure with creatinine\>2.3 mg/dl * hepatic failure * autoimmune disease and/or disease that brings about a systematic inflammatory response * thyroid disease * systematic use of supplements that contain vitc or carnitine * the use of nsaids other than aspirin for a time period up to one month before the procedure

Keywords: atrial fibrillation cardiac valve repair aneurysm repair cabg on-pump cardiac surgery vitamin c
long-term trial on growth hormone deficiency in adults (ghda)

Conditions: Growth Hormone Disorder; Adult Growth Hormone Deficiency

Summary: this trial is conducted in japan. this protocol describes an extension trial to supply hgh to subjects who wish continuous treatment after the long-term phase 3 trial (ghliquid-1519) until hgh products have been approved for ghda in japan.


Eligibility criteria:
inclusion criteria: * subjects who completed ghliquid-1519. * if the subject has a history of treatment for a tumor of pituitary or peripheral site, two years or more have to be passed since completion of surgery, radiotherapy or other treatment, and recurrence of the underlying disease to be excluded. * appropriate replacement therapy has been administered for more than 24 weeks for the treatment of other pituitary hormone deficiencies. exclusion criteria: * subject with a history of acromegaly. * subject with diabetes mellitus. * subject suffering from malignancy. * several medical conditions
molecular screening for lynch syndrome in southern denmark

Conditions: Colorectal Cancer; Lynch Syndrome; HNPCC

Summary: a clinically applicably strategy for molecular screening for lynch syndrome has been implemented in the region of southern denmark. based on sequential analysis with immunohistochemistry and methylation analysis, patients with possible hereditary colorectal cancer are identified. these patients are offered genetic risk assessment and counselling. the study hypothesis is that molecular screening will identify more patients with lynch syndrome than the family history alone. prospective data collection is performed using established clinical databases.


Eligibility criteria:
inclusion criteria: * histological diagnosis of colorectal adenocarcinoma * diagnosed at one of the five departments of pathology in the region exclusion criteria: * none
intraoperative hypotension and acute kidney injury after off-pump coronary artery bypass grafting surgery

Conditions: Coronary Artery Bypass, Off-Pump; Intraoperative Hypotension; Acute Kidney Injury

Summary: acute renal injury (aki) is a common complication after cardiac surgery and is associated with worse outcomes. hypotension is an important risk factor for the development of aki after noncardiac surgery. however, the association between intraoperative hypotension and aki after cardiac surgery has not been fully investigated. the purpose of this study is to analyze the association between intraoperative hypotension and acute kidney injury after off-pump coronary artery bypass surgery.

acute renal injury (aki) is a common complication after cardiac surgery. cardiac surgery-associated acute kidney injury (csa-aki) is associated with increased in-hospital mortality, prolonged length of stay in the intensive care unit and hospital, and higher costs of care. intraoperative hypotension is an important risk factor for the development of aki after noncardiac surgery. in a retrospective analysis, a mean arterial pressure of less than 55 mmhg predicted the occurrence of adverse cardiac- and renal-related outcomes after noncardiac surgery. other studies also revealed that intraoperative hypotension is associated with increased incidence of aki and 1-year mortality after noncardiac surgery. in patients undergoing cardiac surgery, 30-day mortality is proportionate to the extent of systolic blood pressure excursions outside the range of 75 to 135 mm hg intraoperatively. however, the correlation between intraoperative hypotension and the development of aki after cardiac surgery has not been fully investigated. the purpose of this study is to analyze the association between intraoperative hypotension and the risk of acute kidney injury after off-pump coronary artery bypass surgery.

Eligibility criteria:
inclusion criteria: * age ≥ 50 years; * underwent off-pump cabg surgery. exclusion criteria: * end-stage renal disease requiring renal-replacement therapy; * emergency surgery; * kidney transplantation within 3 months; * missing data.

Keywords: coronary artery bypass, off-pump intraoperative hypotension acute kidney injury
bio-k+ cl1285 for prevention of recurrent clostridium difficile infection

Conditions: Recurrent Clostridium Difficile Infection

Summary: the primary objective of this study is to evaluate the efficacy of bio-k+ cl1285 for prevention of recurrent clostridium difficile infection.


Eligibility criteria:
inclusion criteria: 1. age 18 years or older 2. presence of two or more loose or liquid stools in the 24-hour period prior to initiation of antibiotic therapy 3. hospitalized and starting antibiotic therapy for clostridium difficile infection (cdi) or recurrent clostridium difficile infection (rcdi), diagnosed with a positive stool culture 4. agree to use contraception throughout study period, unless postmenopausal or surgically sterile (females only) 5. understand the nature and purpose of the study including potential risks and side effects 6. willing to comply with the requirements of the study exclusion criteria: 1. history of 2 or more clostridium difficile infections at any time prior to the current episode 2. presence of severe chronic and/or inflammatory condition 3. impaired immunity, e.g. undergoing immunotherapy or chemotherapy 4. major gastrointestinal complication, e.g. crohn's disease or ulcer 5. current treatment with nasogastric tube, ostomy, or parenteral nutrition 6. use of proton pump inhibitors 7. pregnant female or breastfeeding 8. eating disorder 9. history of alcohol, drug, or medication abuse 10. daily consumption of probiotics, fermented milk, and/or yogurt 11. known allergies to any substance in the study product 12. participation in another study with any investigational product within 3 months of screening

Keywords: clostridium difficile diarrhea
hypnosis for patients treated with adjuvant chemotherapy for breast cancer(hypnoval)

Conditions: Breast Cancer

Summary: the main objective is to assess the feasibility of an intervention based on medical ericksonian hypnosis as a complementary therapy in patients treated with surgery after a diagnosis of breast cancer, followed by an indication of adjuvant chemotherapy and radiotherapy

in the field of management of cancer, many approaches have been used since tens of years, particularly in regard of pain management, both in achieving surgical or invasive procedures in the pain induced by the disease itself. the investigators owe the first description in 1829 chapelin and col who used hypnosis in a patient with breast cancer in which a mastectomy should be performed. meta-analysis (2000) showed the positive impact of analgesia obtained through hypnosis on the perception of pain intensity. in children in whom regular venous punctures is performed, using hypnosis seems indisputable on the management of anticipatory anxiety, leading to a better experience of the act itself. regarding the nausea and vomiting induced by chemotherapy, numerous studies are old, not always randomized and performed often before the era of the setrons; but seems favorable impact on anticipated nausea and vomiting, the updated studies should emerge on the issue of delayed emesis which remain a serious adverse event and not completely resolved. mark to improve the eortc validated tools of quality of life measurement widely used for example in ovarian cancer. the impact of hypnosis on the quality of life or the side effects of treatment or rehospitalization for toxicity remains controversial (judson, 2011). a meta-analysis combining the tests carried out before and after the era of setrons (richardson, 2007) concluded that the effectiveness of the anticipated nausea and vomiting. in this context,the investigators proposed to conduct a feasibility study to evaluate the role and impact of medical ericksonian hypnosis on acute and delayed adverse event (incl nausea and vomiting) in female patients treated by adjuvant chemotherapy for breast cancer. the main objective is to assess the feasibility of an intervention based on medical ericksonian hypnosis as a complementary therapy in patients treated with surgery after a diagnosis of breast cancer, followed by an indication of adjuvant chemotherapy and radiotherapy

Eligibility criteria:
inclusion criteria: * • female, age \> 18 years-old * without previous practice of hypnosis * patient with diagnosis of breast cancer * patient receiving an adjuvant chemotherapy for at least 3 months with an indication of radiotherapy after chemotherapy * patient accepting the principle of the study with a signed written informed consent * patient affiliated to french social security exclusion criteria: * • male * age \< 18 years * patient refusing hypnosis * pregnancy, breast-feeding, or lack of effective contraception in female patients with reproductive potential. * patient with psychological or mental disorders under psychotropic treatments (lithium, neuroleptics) * not ability to speak and read french, deaf and/or mute
short-term health benefits of using fresh air filtration system in classroom

Conditions: Airway Morbidity; Cognitive and Attention Disorders and Disturbances; Oxidative Stress

Summary: a randomized crossover trial will be conducted in 90 primary school children in 3 classrooms in shanghai, china. the effects of fresh air ventilation/filtration system, fresh air ventilation system with no filtration and natual ventilation will be compared on the effects of reducing indoor pm2.5 and chilhood health. biological samples of children are going to be collected to investigate the associations between indoor air pollution and biomarkes of certain health effects.

a randomized crossover trial among 90 primary students in 3 classrooms in shanghai, china will be performed. three arms are going to be 1) fresh air filtration system, 2) fresh air system with no filtration and 3) natural ventilation. each arm is going to be in use for five continuous weekdays followed by one week of wash-out. after one-week of wash out, a cross over change between 3 arms is going to be taked. then the 2nd week of intervention is performed followed by the 2nd wash-out week. the same cross-over change between 3 arms is going to be repeated again until each classroom will be applied by all three arms of ventilation. a total of 5 weeks is required for the project. children's biological samples including saliva, urine and skin samples will be collected as well as exhaled no. a questionnaire on children's perception on air quality will be assessed as well.

Eligibility criteria:
inclusion criteria: * all invited primary school children in grade 5 in an artibrarily selected school exclusion criteria: * current airway symptoms (cough, airway infection, asthma et al.) * acute infectious diseases

Keywords: exhaled nitric oxide sick building syndrome indoor air
prospective radiologic evaluation of changes following fat grafting

Conditions: Breast Cancer

Summary: breast implants are currently used for cosmetic breast augmentation and in breast reconstruction following mastectomy for breast cancer. fat grafting is a technique where fat is injected around the periphery of a breast implant to camouflage the transition between implant and the body. the investigators propose to show mammography images of women who have had breast implants with fat grafting to informed and blinded radiologists and evaluate their readings of the images. hypothesis: with mammographic screening, radiologists will be able to distinguish between findings associated with fat grafting and those which are suspicious for breast cancer.


Eligibility criteria:
inclusion criteria: * women with silicone implants and fat grafting exclusion criteria: * procedures performed outside the university of minnesota or clinique spontini paris, france
the mobility toolkit: electronically augmented assessment of functional recovery following lower-extremity trauma

Conditions: Gait

Summary: the study will prospectively enroll and follow 300 participants ages 18-60 surgically treated for a lower-extremity articular injury including fractures of the tibial plateau, pilon, ankle, and calcaneus.

the study will prospectively enroll and follow 300 participants ages 18-60 surgically treated for a lower-extremity articular injury including fractures of the tibial plateau, pilon, ankle, and calcaneus. all participating centers will undergo training to implement the mobility toolkit (mtk). research staff will facilitate a series of performance tests while participants wear the mtk device. mtk assessment will also be conducted on 150 non-injured adults matched to the injured cohort on age and gender. these individuals will be enrolled and assessed once at two participating centers. study flow and data capture are summarized in the figure on the next page.

Eligibility criteria:
inclusion criteria: 1. 18-60 years of age 2. open or closed fractures of the tibial plateau, pilon, ankle or calcaneus requiring surgical fixation. exclusion criteria: 1. gustilo type iiib or iiic injuries 2. no other surgically or non-surgically treated injuries that impact gait (e.g. upper extremity injury proximal to the elbow; spinal cord injury; contralateral or ipsilateral fractures). 3. neurologic impairment or deficit that impairs gait 4. prior injuries or conditions that alter gait (e.g. severe osteoarthritis) 5. severe problems with maintaining follow-up (e.g. participants who are prisoners, who are intellectually challenged without adequate family support, or have documented psychiatric disorders). 6. unable to provide informed consent in english or spanish.
safety and immunogenicity of adch63 me-trap and mva me-trap vaccines in malaria endemic areas

Conditions: Malaria

Summary: the purpose of this trial is to assess the safety and immunogenicity of adch63 me-trap and mva me-trap candidate vaccines in healthy adult volunteers in a malaria endemic region. the regime proposed in this trial has protected non-immune volunteers against sporozoite challenge in clinical trials performed by oxford, and so may be protective against naturally acquired infection in kenya.the study population will comprise 30 healthy adult males aged 18-50. the investigators do not propose to include a placebo group. at this stage the investigators objective is to describe the safety profile in a small number of individuals, and the confidence intervals for the proportion of individuals with a particular event would be too wide for meaningful comparison with a placebo group. immunogenicity will be judged by comparison with baseline.


Eligibility criteria:
inclusion criteria: * consenting adult males aged 18-50 years in good health. * will remain resident in the study area for the study duration exclusion criteria: * clinically significant history of the following conditions; skin disorder (eczema, etc.), allergy, symptomatic immunodeficiency, cardiovascular disease, respiratory disease, endocrine disorder, liver disease, renal disease, gastrointestinal disease, neurological illness. * history of splenectomy * haemoglobin less than 9.0 g/dl * clinically significant abnormalities of laboratory screening tests (full blood count, alt, creatinine levels, urine dipstick examination for blood and protein). * blood transfusion within one month of the beginning of the study * history of vaccination with previous experimental malaria vaccines * administration of any other vaccine or immunoglobulin within two weeks before vaccination. * current participation in another clinical trial, or within 12 weeks of this study * any other finding which in the opinion of the investigators would increase the risk of an adverse outcome from participation in the trial. * likelihood of travel away from the study area * hiv positive. * history of contact dermatitis (due to the use of a potentially irritant disinfectant that may be present in trace amounts in the adch63 me-trap vaccine, see the investigators brochure for details, attached)

Keywords: vaccine immune response
combined afib ablation and ra denervation for the maintenance of sinus rhythm and management of resistant hypertension

Conditions: Afib; Hypertension

Summary: the purpose of this study is to perform renal artery denervation at the same time as atrial fibrillation ablation. ra denervation may reduce blood pressure, increase the chances of a successful atrial fibrillation ablation, and decrease the number of medications required to control blood pressure.


Eligibility criteria:
inclusion criteria: * hypertensive patients scheduled for afib ablation * patient taking one or more bp medication exclusion criteria: -
endovascular stenting of medically refractory icasd (clinical and sonographic study)

Conditions: Stroke, Ischemic

Summary: cerebral endovascular stenting of medically refractory intracranial stenotic blood vessels with recurrent ischemic strokes patients

fifty patients were enrolled with 25 underwent intracranial stenting 25 received optimal medicall treatment without stenting and comparative study of primary outcome was conducted

Eligibility criteria:
inclusion criteria: 1. patients age between 30-80 years. 2. symptomatic icas: presented with tia or stroke, attributed to 70%-99% stenosis of a major intracranial artery: internal carotid artery (ica), middle cerebral artery (mca) \[m1segment\], vertebral artery (va), or basilar artery (ba). 3. patient with recurrent tia or stroke despite medical therapy, including anti-coagulation or antiplatelet and control of all vascular risk factors (dm, htn and hyperlipidemia). exclusion criteria: 1. patients previously stented at the target lesion or had extracranial stenosis. 2. patient with acute stroke (within two weeks from the onset). 3. complete occlusion of the artery on the imaging assessment. 4. massive cerebral infarction (more than half the mca territory), intracranial hemorrhage, epidural or subdural hemorrhage, and intracranial brain tumor on ct or mri scans. 5. contraindications to antithrombotic and/or anticoagulant therapies.
dendritic cell based therapy of metastatic breast cancer

Conditions: Metastatic Breast Cancer

Summary: the study aim to show if vaccination with autologous dendritic cells pulsed with onco-peptides in combination with adjuvant cytokine can induce a measurable immune response in patients with metastatic breast cancer, and to evaluate the clinical effect (objective response rate) of the vaccination regime.

hla a2 positive patients are treated with padre and oncopeptide pulsed dc; p53, survivin and telomerase peptides. each patient is given 6 immunizations with at least 5x106 peptide/lysate pulsed autologous dc. vaccination 1-4 is given weekly and 4-6 at 2-week intervals. those patients who exhibit stable disease, partial response or complete response after 6 injections will be given 4 more vaccinations at 2-week interval. the vaccine is applied by either intranodal or intradermal injection near the inguinal region. for adjuvant used il-2 2 miu sc. day 2-6. scans and re-staging tests are performed at scheduled intervals throughout the study.

Eligibility criteria:
inclusion criteria: * histologically proven progressive metastatic or locally advanced breast cancer * no standard treatment indicated * age: \> 18 * who-performance status 0-1 * at least tone measurable tumor lesions according to the recist criteria. * expression of the hla-a2 tissue type * life expectancy more than 3 months * acceptable cbc and blood chemistry results * written informed consent exclusion criteria: * patients with a history of any other neoplastic disease less than 5 years ago (excepting treated carcinomas in situ of the cervix and basal/squamous cell carcinomas of the skin). * patients with metastatic disease in the central nervous system (cns). * patients with other significant illness including severe allergy, asthma, angina pectoris or congestive heart failure. * patients with acute or chronic infection including hiv, hepatitis and tuberculosis. * patients who are pregnant. * patients who have received antineoplastic therapy including chemotherapy or immunotherapy less than 4 weeks before beginning the trial. * patients who receive corticosteroids or other immunosuppressive agents. * patients with active autoimmune diseases such as lupus erythematosus, rheumatoid arthritis or thyroiditis.

Keywords: breast cancer dendritic cells vaccine
safety and metabolic study of highly active antiretroviral therapy (haart) in malnourished children with hiv

Conditions: Kwashiorkor; Marasmus; Severe Acute Malnutrition; HIV

Summary: it is unclear whether children with hiv and severe acute malnutrition can be started on highly active antiretroviral therapy (haart) safely while they are still malnourished and the manner in which this therapy should start. this study will examine the safety, efficacy, and metabolism of children started on haart while still severely malnourished.


Eligibility criteria:
inclusion criteria: * hiv-infected about to start on haart for the first time * 6-59 months old exclusion criteria: * also being treated for tb * other chronic illness (e.g., congenital heart disease, cerebral palsy)