Kornimate/medical-research-clean huggingface dataset:
prevention of heartmate ii pump thrombosis

Conditions: HeartMate II Pump Thrombosis

Summary: the purpose of this study is to assess how often blood clots form in the fda-approved heartmate® ii (hm ii) left ventricular assist device (lvad) and to identify risks related to clotting within the pump.

prevent is a prospective, multi-center, non-randomized study that is designed (1) to assess the incidence of hm ii pump thrombosis in the current era when recommended practices for clinical management are adopted, and (2) to identify the risk factors associated with pump thrombosis events. the recommended practices are focused on implantation technique, anticoagulation regimen, pump speed and blood pressure management. all consecutive patients receiving a hm ii implant will be considered for this study.

Eligibility criteria:
inclusion criteria: * subject or legally authorized representative has signed an informed consent form * subject is receiving the heartmate ii as their first left ventricular assist device (lvad) exclusion criteria: * prior mechanical circulatory support (mcs) (except for intra-aortic balloon pump) * participation in any other clinical investigation(s) involving a mcs device, or an investigation(s) that is likely to confound study results or affect study outcome

Keywords: heartmate ii heart assist device pump thrombosis hypercoagulable disorder thrombus thoratec corporation
knowledge and awareness about inflammatory articular diseases

Conditions: Inflammatory Articular Diseases

Summary: the manuscript describes the level of knowledge and awareness about inflammatory articular diseases in a syrian population. we found that awareness of inflammatory articular diseases is mostly bad and very bad in our sample. also, we showed how the level of awareness changes due to the change of many factors such as (sex, age, residency, education, marital status, and others ). our community-based survey was the first conducted in syria. we have included a total of 641 participants who were directed to the first part of the survey to complete questions around socio-demographic data and awareness questions about inflammatory articular diseases. we ranked our participants into five levels: excellent, good, average, bad, and very bad. finally, we compared our results with other 4 original published studies, and we found many boolean points of similarity and many other inspiring points of difference.


Eligibility criteria:
inclusion criteria: * all participants older than 18 years and younger than 70 exclusion criteria: * non-syrians

Keywords: knowledge awareness inflammatory articular diseases syrian population
assess if immune response of gsk biologicals' tritanrix™-hepb/hib-menac given without or with hepatitis b vaccine at birth is at least as good as tritanrix™-hepb/hiberix™ without hepatitis b vaccine at birth, when given to healthy infants

Conditions: Haemophilus Influenzae Type b; Diphtheria; Whole Cell Pertussis; Hepatitis B; Tetanus

Summary: the purpose of this study is to compare the immune response, safety and reactogenicity of tritanrix™-hepb/hib-menac vaccine given either with or without a birth dose of hepatitis b vaccine to tritanrix™-hepb/hiberix™ when given to healthy infants (born to mothers who do not carry hepatitis b virus) at 6, 10 \& 14 weeks of age. this study will also include a small group of infants born to mothers who do carry hepatitis b virus; these infants will receive a birth dose of hepatitis b vaccine and will be vaccinated with tritanrix™ hepb/hib-menac at 6, 10 \& 14 weeks age.

randomized study with three groups (subjects born to mothers who do not carry hepatitis b virus) to receive one of the following vaccination regimens: - gsk biologicals' tritanrix™-hepb/hib-menac and hepatitis b vaccine at birth - gsk biologicals' tritanrix™-hepb/hib-menac and no hepatitis b vaccine at birth - gsk biologicals' tritanrix™-hepb/hiberix™ there will also be a fourth group (subjects born to mothers who do carry hepatitis b virus) to receive: - gsk biologicals' tritanrix™-hepb/hib-menac and hepatitis b vaccine at birth

Eligibility criteria:
inclusion criteria: * healthy infants aged 3 days or less, written informed consent obtained from the parents, born after a gestation period of 36 to 42 weeks. * result of the maternal blood sample (presence/not of hepatitis b virus) is available. exclusion criteria: * any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination. * a family history of congenital or hereditary immunodeficiency. * major congenital defects or serious chronic illness. * history of any neurologic disorders or seizures. * administration of immunoglobulins and/or any blood products since birth or planned administration during the study period (except for immunoglobulins given at birth to infants born to hbsag seropositive mothers). * acute disease at the time of enrolment. * known exposure to diphtheria, tetanus, pertussis, hepatitis b, haemophilus influenzae type b and/or meningococcal disease. * hepatitis b vaccine given at birth outside the study.
coping after breast cancer - a randomized clinical trial with two digital interventions

Conditions: Breast Cancer Patients; Health, Subjective

Summary: 1. breast cancer patients and age-matched controls are first invited to answer questions on hrqol. 2. among responding breast cancer patients, a subset are invited in a randomized clinical trial with two digital interventions for cancer stress management, cognitive based stress management (cbsm) and mindfulness based intervention (mbi), as well as a control group. 3. the goal is to determine whether digital cbsm or mbi can effectively reduce stress levels as compared to a control group. second, whether these interventions can improve hrqol (or avoid onset of hrqol problems) for patients with breast cancer, compared to a control group.

after completing the baseline hrqol assessment, eligible breast cancer patients will be invited to participate in a randomized clinical trial. those who are willing will be randomly allocated to one of the following arms: a) digital cognitive based stress management, b) digital mindfulness based intervention or c) control group. the intervention is based on a revised version of the stressproffen app, which was developed by the oslo university hospital (lise solberg nes, elin børøsund and others). outcome measures include measures of perceived stress and hrqol.

Eligibility criteria:
inclusion criteria: * first occurrence breast cancer diagnosed from jan 1, 2020 * non-metastatic cancer stage 0-iii invasive tumors must be: * her2 positive (regardless of er, pr) or * er negative * (may later include other er+ if not conflict with recruitment for emit/optima) exclusion criteria: * none

Keywords: health related quality of life stress management intervention
comparison of volumen and breeza oral contrast agents in pediatric patients

Conditions: Inflammatory Bowel Diseases

Summary: in this research study, two different oral contrast materials that can be used for ct or mr enterography will be studied. this study is designed to compare which oral contrast material (volumen or breeza) is preferred by pediatric patients and which provides higher quality exams.

volumen, a low hounsfield unit 0.1% barium sulfate suspension that also contains sorbitol and a gum, is the most common oral contrast material used in children and adults undergoing ct and mr enterography (advanced imaging tests used to evaluate the bowel lumen and bowel wall in children and adults, usually with suspected or known crohn disease). this contrast material is typically administered orally to non-sedated patients during the 45-60 minute period prior to imaging. the goal of oral contrast material administration is to completely fill the small bowel with fluid at the time of imaging. benefits of oral contrast material at cross-sectional enterography include: improved delineation of bowel from non-bowel structures in the abdomen and pelvis, improved accuracy when assessing bowel wall thickness, and improved visualization of mucosal hyper-enhancement in the setting of active intestinal inflammation. in some children (and adults), the standard-of-care contrast agent (volumen) is poorly tolerated. this is likely due to a variety of factors, including taste, texture, and the volume that is required to be consumed. recently, a new oral contrast material called "breeza for neutral abdominopelvic imaging" (or simply breeza) has become available for use at ct and mr enterography. this agent contains sorbitol, mannitol, and xantham gum (a thickening agent), and it is marketed as a "flavored beverage" as it contains no active ingredient (e.g., barium sulfate). a single study performed in adult volunteers has shown that this new agent performs similar to volumen, has a superior taste, and is associated with greater willingness for repeat drinking. the objective of our study is to compare our standard-of-care oral contrast material to the newly available contrast material in a prospective, randomized, blinded manner. primary outcomes will include degree of small bowel opacification, distention of the terminal ileum, and patient acceptance/tolerability.

Eligibility criteria:
inclusion criteria: * age \> 8 years and \< 18 years * patients undergoing clinically indicated ct or mr enterography exclusion criteria: * age \< 8 years and ≥ 18 years * requirement for sedation for ct or mri enterography * cannot drink oral contrast (will require tube administration)
safety, tolerability, pharmacokinetics and pharmacodynamics study of vay736 in rheumatoid arthritis patients

Conditions: Rheumatoid Arthritis

Summary: this study investigated the safety and tolerability of vay736 administered as single ascending doses of intravenous infusion, subcutaneous injection and repeated subcutaneous injections in rheumatoid arthritis patients.

this study had three sequential parts which investigated the safety and tolerability of vay736 administered as single ascending doses of intravenous infusion (part 1), single ascending doses of subcutaneous injection (part 2), and repeated subcutaneous injections of fixed doses (part 3), respectively, in rheumatoid arthritis patients. part 1 was double blind, placebo controlled, with 11 cohorts. part 2 was open-label study with 2 dosing cohorts. part 3 was open-label study with 1 fixed-dose cohort.

Eligibility criteria:
inclusion criteria: * active disease despite methotrexate treatment 5 to 20 mg/week for parts 1 and 2; methotrexate treatment 5 to 20 mg/week for part 3 * fulfilled 2010 american college of rheumatolody (acr)/european league against rheumatism (eular) classification criteria for rheumatoid arthritis for part 1 and part 2. for part 3, fulfilled 2010 american college of rheumatolody (acr)/)/european league against rheumatism (eular) classification criteria or/and 1987 american college of rheumatolody (acr) classification criteria for rheumatoid arthritis; * methotrexate ≥ 16 weeks, stable dose ≥ 8 weeks exclusion criteria: * previous treatment with a b cell-depleting biologic agent. * autoimmune disease other than ra except concurrent sjogren's syndrome * adult juvenile rheumatoid arthritis * ara functional class iv disease of acr revised steinbrocker classification

Keywords: rheumatoid arthritis
assessment of minimal residual disease (mrd) after antineoplastic treatment in patients with al amyloidosis

Conditions: Amyloidosis

Summary: in this study, the investigators seek to evaluate bone marrow and blood samples and treatment responses to see if minimal residual disease (mrd) can be used as a predictive method of response to treatment in amyloidosis.

in this study, the investigators seek to evaluate bone marrow and blood samples and treatment responses to see if minimal residual disease (mrd) (as described below), can be used as a predictive method of response to treatment in amyloidosis. minimal residual disease (mrd) is a concept that has gained significant value as a prognostic predictor and has become an emerging constituent of complete response (cr) reassessment in multiple myeloma (mm) patients. studies in mm have demonstrated that up to 30% of patients achieving a cr after high-dose therapy will still have detectable mrd in the bone marrow as measured by standard-sensitivity flow cytometry or by molecular assays. virtually every study examining mrd in mm has reported that among patients achieving a cr, those who were mrd negative (mrd-) had a significantly superior progression-free survival, with some studies reporting superior overall survival. as amyloidosis is a disease that is very similar to multiple myeloma, the investigators wish to evaluate the concept in this disease.

Eligibility criteria:
inclusion criteria: * biopsy-proven systemic al amyloidosis defined as * at least one + congo red stain * proof of a clonal plasma cell dyscrasia by: * immunofixation electrophoresis (ife) of the urine or serum * light chain restriction based on immunohistochemistry (ihc) in bone marrow plasma cells or in the amyloid tissue * must be scheduled to undergo antineoplastic therapy (this may include high dose melphalan and autologous stem cell transplantation) for al amyloidosis (part ii enrollments only) exclusion criteria: * co-existing multiple myeloma * prior antineoplastic treatment for al amyloidosis at time of enrollment. * prior negative bone marrow biopsy showing no identifiable clone

Keywords: al amyloidosis, systemic primary amyloidosis
the effects of various cooking oils on health related biomarkers in healthy subjects

Conditions: Colorectal Neoplasms

Summary: fats and oils play important roles in maintaining human nutrition and health through providing energy, essential fatty acids, and acting as modulators of many biological processes (signal transduction, immunity and inflammation). due to differences in the fatty acid composition and content of antioxidants of individual cooking oils, the degree of oxidative and thermolytic reactions may vary oil by oil. it is lack of human feeding study to investigate the molecular mechanisms on how and which deep-fried oil exerts its adverse effects. the investigators are also lack of biomarkers for monitoring deep-fried oil exposure. therefore, the purpose of this study is to compare how human body responds differently to several popular uncooked and deep-fried oils with varied fatty acid compositions with respect of oxylipin profile, inflammatory markers, non-targeted metabolomics, and transcriptomics. the investigators will recruit 20 volunteers, provided them once a week the milk shakes prepared from 60g of olive oil, soybean oil, palm oil, camellia oil, tallow (butter), and deep-fried oils of the last 4, respectively; in comparison with a no-fat milk shake control. the experiments lasted for 10 weeks.。each time; serum, plasma, whole blood and urine samples were collected at baseline, after 2 hours, and after 4 hours. the investigators anticipate to find biomarker(s) for deep-frying, and contribute to the understanding of molecular mechanisms on how deep-fried oils exert adverse effects toward health through integrative omics or so-called system biology approaches.


Eligibility criteria:
inclusion criteria: * non-smoking, non-drinker, usual dietary intake * bmi : 18.5\~27 kg/m2 exclusion criteria: 1. over the past two weeks have suffered from acute illness. 2. none of the subjects was taking any supplemental vitamins, antioxidants or medication at that time. 3. taking steroids or non-steroidal anti-inflammatory drug, such as aspirin or panadol in the past one week. 4. cancer or other severe diseases was diagnosed.
robotic assistance for tunnel positioning in anterior cruciate ligament reconstruction

Conditions: Anterior Cruciate Ligament Injuries

Summary: accurate ideal graft tunnel positioning is essential for the successful application of anatomic anterior cruciate ligament (acl) reconstruction. the accurate insertion of the tibial tunnel (tt) and femoral tunnel (ft) remain a challenge. a robotic assisted new strategy for drill tt and ft in acl reconstruction will be performed and its efficacy and accuracy will be assess. the investigators will prospectively include 30 patients with acl rupture requiring surgical treatment. the reconstruction will be performed with hamstring tendon graft or patellar tendon graft. the femoral and tibial tunnels placement will be guided by the rosa robot (zimmer®).


Eligibility criteria:
inclusion criteria: * all patients treated at chu amiens-picardie for acl reconstruction by practitioner who has robot experience. * children and adults from 10 to 45 years old exclusion criteria: * patients managed by another acl reconstruction technique * patients under guardianship, curators deprived of liberty * pregnant and nursing women. * patient who refused to participate in the study and to sign informed consent

Keywords: anterior cruciate ligament reconstruction robot tunnel
impact of covid-19 pandemic on headache evaluations in the pediatric emergency department

Conditions: COVID-19; Headache Disorders; Emergency Service, Hospital

Summary: background: to evaluate the impact of covid-19 on evaluations in the pediatric emergency department (ed) because of headache as main symptom. methods: number and clinical features of patients evaluated in the pediatric ed of a single site in milan,italy, were collected between january 2017 and january 2022. the impact of covid-19 on evaluation rates was quantified by using the incidence rate ratio (irr) and 95% confidence intervals (ci) between the pandemic (march 2020 to january 2022) and the prepandemic period (january 2017 to february 2020).


Eligibility criteria:
inclusion criteria: * range of age: 2 - 18 years * sex: all * headache as main symptom exclusion criteria: * headache in the context of head trauma, because of different diagnostic-care in pediatric emergency department
surgical approach for retrorectal tumors cohort

Conditions: Malignant Tumor

Summary: aim of the study : to evaluate postoperative outcomes of all surgical approach for retrorectal tumors. methods : from 2005 to 2020, all consecutive patients who underwent surgery for a retrorectal tumor in two referral tertiary center were prospectively collected. considering our exlusion criterias, data from xx patients were analyzed. the cohort was separated into 2 groups according to tumor localization regarding the third sacral vertebra. short and longterm outcomes were compared between the two groups. primary outcome : 90 days postoperative morbidity rate

retro-rectal tumors are a group of heterogeneous and rare lesions. the actual incidence has been estimated to be approximately one case per 40,000 admissions. it is most often a benign tumor that affects young women and the origin is congenital in 60% of cases. the most common benign lesion is a tailgut cyst. chordoma is the most common malignant lesion. they are mostly asymptomatic or pauci-symptomatic. this is why their diagnosis is regularly accidentaly after a morphological examination such as an abdominal ultrasound or a ct scan. mri is the gold standard for determining the structure of the lesion, its origin, its topography, its extension in relation to adjacent organs, parameters that are essential to define the type of surgery and its approach. when a retro-rectal tumor is diagnosed, the standard treatment is surgical resection. a biopsy is not helpful if there is no suspicion of a degenerate lesion. usually, lesions located under the third sacral vertebra (s3) are approached by dorsal transsacrococcygeal, perineal or combined approach (abdominal and perineal approach) while those located above s3 the approach is abdominal (laparotomy or laparoscopy). as these lesions are, in the majority of cases, benign, the functional impact of surgery is essential. based on our experience in minimally invasive surgery and in particular in retro-rectal tumors, laparoscopy has become our first-line approach regardless of the location of the lesion compared to s3. our hypothesis is that the minimally invasive approach is reliable, safe and allows satisfactory histological results to be obtained while limiting postoperative pain and functional sequelae.

Eligibility criteria:
inclusion criteria: * patient presenting a retrorectal tumor * surgical procedure between 01/01/2005 and 31/12/2020 exclusion criteria: * age \< 18 years old * patients presenting a rectal tumor * patients presenting a rectal duplication

Keywords: retrorectal tumor tail gut cyst benign tumor mini-invasive approach open approach perineal approach
restless legs syndrome in stroke patients

Conditions: Restless Legs Syndrome; Stroke; Transient Ischemic Attack

Summary: our study aimed to examine a possible association between restless legs syndrome and cerebrovascular disease, by examining patients during hospitalization for acute stroke or transient ischemic attack, in a matched case-control design.


Eligibility criteria:
inclusion criteria: * 18 years old or older * hospitalization for stroke or transient ischemic attack exclusion criteria: * 18 years old or younger * no stroke or transient ischemic attack

Keywords: restless legs syndrome stroke transient ischemic attack cerebrovascular risk factors
dose finding study to determine if bez235 alone or in combination with rad001 decreases the incidence of respiratory tract infections in the elderly

Conditions: Respiratory Tract Infections

Summary: the purpose of this study is to evaluate the efficacy, tolerability, and safety of bez235 alone and in combination with rad001 to support further development to reduce the incidence of respiratory tract infections (rtis) in elderly subjects.

this is a randomized, blinded, placebo-controlled, multicenter, parallel-group, dose finding 24-week study to assess the safety, tolerability and efficacy of up to 3 doses of bez235 alone and in combination with rad001 as compared to placebo in elderly subjects who are at increased risk of respiratory tract infection related-morbidity and mortality. the study will be composed of up to a 6-week screening and run-in period, a 16-week treatment period and an 8-week follow-up period.

Eligibility criteria:
inclusion criteria: * male and female subjects * age ≥ 85 years * age ≥ 65 and \< 85 years with one or more of the following conditions: * asthma * chronic obstructive pulmonary disease (copd) * chronic bronchitis * type 2 diabetes mellitus (t2dm) * congestive heart failure (chf) new york heart association (nyha) functional classification i-ii * current smoker * one or more emergency room visits or hospitalizations for a rti during the previous 12 months exclusion criteria: * subjects with medically significant cardiac conditions including nyha functional classification iii-iv * subjects with type i diabetes mellitus. * subjects with clinically significant underlying pulmonary disease other than asthma, gold class i and ii copd or chronic bronchitis * history of malignancy in any organ system within the past 5 years except for the following: * localized basal cell or squamous cell carcinoma of the skin, prostate cancer confined to the gland, cervical carcinoma in situ, breast cancer localized to the breast. * subjects with any one of the following: * hemoglobin \< 10.0 g/dl for males and \< 9.0 for females * white blood cell (wbc) count \< 3,500/mm3, * neutrophil count \< 2,000/mm3 * platelet count \< 125,000/mm3 * subjects with a history of a systemic autoimmune disease or receiving immunosuppressive therapy * recent surgery other than minor skin surgery * liver disease or liver injury * history or presence of impaired renal function * history of immunodeficiency diseases * subjects with active infection * subjects with a mini mental status examination (mmse) score \<24 at screening. * significant illness (based on the subject's medical history and the clinical judgement of the investigator) which has not resolved within two (2) weeks prior to initial dosing.