Kornimate/medical-research-clean huggingface dataset:
metaxa hospital thromboprophylaxis program in oncological & surgical patients

Conditions: Thrombosis; Solid Cancer

Summary: during methos study will be collected real world data the clinical practice regarding thromboprophylaxis in high thrombotic risk solid tumors patients undergoing surgical and /or chemotherapeutical treatment, for one year following the protocol initiation date. specifically focus will be on the following: * number of thrombotic events * anti-thrombotic management dosage \& duration * any bleedings related to anticoagulation * patients' adherence and compliance


Eligibility criteria:
inclusion criteria: 1. patients who were diagnosed with histological confirmed high thrombotic risk cancers (gi, thoracic, gynecologic and genitourinary) undergoing surgery 2. age ≥ 18 years 3. eastern cooperative oncology group (ecog) performance status 0-2 4. life expectancy \>6 months 5. signed informed consent exclusion criteria 1. patients who were not diagnosed with histological confirmed high thrombotic risk cancers (gi, thoracic, gynecologic and genitourinary) undergoing surgery 2. age \< 18 years 3. ecog performance status \>2 4. life expectancy \<6 months 5. not signed informed consent

Keywords: thrombosis cancer heparin, low molecular weight
effect of bevel position of the artery needle on puncture pain and post-puncture bleeding time

Conditions: Pain; Bleeding Time; Arteriovenous Fistula

Summary: a patient with an arteriovenous fistula (avf) receiving chronic hemodialysis (hd) treatment is cannulated 312 times a year on average. the patients cannot comply with dialysis treatment and the quality of life is decreased by pain when the fistula cannot be accessed with a single attempt. sharp pain depends on the tear in the skin, the tissue where the sensitive nerve ends receptive to pain are located, and it is particularly important during avf puncture. also, punctures are accompanied by haemorrhages and frequent loss of blood.

the repeated puncture of the avf leads to a considerable degree of pain, due to the calibre and length of the bevel of fistula needles. when the fistula needle is removed, the small punctures that occur in the entrance area are closed with a thrombus. as a result, scar tissue forms in the entrance area and the surrounding skin, which can lead to the development of stenosis and aneurysm. for this reason, the needle conical tip direction is important in terms of delaying the loss of tissue elasticity and prolonging the use of the intervention area. there are very few studies investigating the effect of the conical tip being up or down on the pain that develops during cannulation in the patient.

Eligibility criteria:
inclusion criteria: * 18 years of age or older * on maintenance hemodialysis three times per week for four hours per session * receiving hemodialysis therapy for a least six moths at the time of the study * pain level of one or more measured by the visual analogue scale during cannulation * able to communicate in turkish * willing to participate to the study exclusion criteria: * known to be difficult to enter the fistula (with more than one cannulation) * history of hematoma or stenosis in fistula * having an infection in the fistula area * taking painkillers 3 hours before treatment
the detection of circulating tumor cells (ctcs) in patients with renal cancer undergoing cryosurgery combined with dc-cik treatment

Conditions: Neoplastic Cells, Circulating

Summary: circulating tumor cells (ctcs) have the potential to provide a surrogate for'real-time biopsy' of tumor biological activity. enumeration and molecular characterization of ctcs in renal cancer could play an important role in diagnosis, predicting the risk for tumor recurrence, and providing novel target therapy biomarkers. in view of these facts, the investigators wanted to demonstrate the value of multiparameter flow cytometry in detecting human tumor cells of renal cancer in normal peripheral blood after cryosurgery with or without dendritic cell(dc)-cytokine-induced killers(cik) treatment, and the investigators also compared the specificity with reverse transcriptase polymerase chain reaction (rt-pcr) method.

1 day before and 2 days after cryosurgery with or without dc-cik treatment，approximately 17-ml ethylene diamine tetraacetic acid(edta)-blood was drawn by vein puncture from patients with renal cancer and healthy volunteers. the blood of the healthy volunteers will be used to evaluate the sensitivity and specificity and as negative control cells. to avoid contamination with skin cells, 2 ml blood will be discarded before the study samples will be taken.briefly, the mononucleate cells will be separated from the blood over ficoll- paque for 20 min with 1800g at 4℃. the interface cells will be removed and washed, and the red blood cells(rbcs) will be removed using a lysis buffer followed by a repeated wash. the mononuclear cells will be counted and aliquot for rt-pcr and multiparameter flow cytometry on the basis of at least 2-3×106 cells for each methodology. the cell pellet will be resuspended in phosphate-buffered saline for multiparameter flow cytometry and in trizol reagent for rt-pcr. aim : identification of ctcs may lead to better diagnosis and prognosis and could help to choose an adequate therapy.

Eligibility criteria:
inclusion criteria: 1. age:18-75 2. karnofsky performance status \>60 3. diagnosis of renal cancer based on histology or the current accepted radiological measures. 4. classification tumor,nodes,metastasis-classification(tnm) stage: ⅱ,ⅲ,ⅳ 5. will receive cryosurgery and/or dc-cik treatment 6. life expectancy: greater than 3 months 7. patients' routine blood test, liver function and kidney function have no obvious abnormalities 8. ability to understand the study protocol and a willingness to sign a written informed consent document exclusion criteria: 1. patients with other primary tumor except renal cancer 2. history of coagulation disorders or anemia

Keywords: renal neoplasms circulating tumor cells
outcome prediction in cochlear implant recipients

Conditions: Hearing Loss

Summary: the ability to predict post-operative outcomes after implantation is important for a number of reasons, including being able to advise candidates of appropriate expectations using evidence based guidance. the approved study involves investigation of the ability to predict outcomes in the implanted ear alone and in the best-aided binaural listening conditions, examining a number of measured factors both pre-, peri- and post-operatively. the study incorporates a range of functional outcome measures through questionnaires to ascertain social, functional and demographic factors that may be predictive of outcomes. questionnaires are also administered to determine the degree of benefit obtained after implantation for each individual, since this forms a key component of providing pre-operative counselling to candidates.


Eligibility criteria:
inclusion criteria: 1. clinical suitability for first side implantation, i.e. not undergoing assessment for second side cochlear implant surgery 2. willing and able to attend the study visits 3. able to provide informed consent for participation in the study, with an understanding of the requirements, risks and benefits of participation in the investigation 4. able to read and understand study documents and follow investigator instructions 5. able to understand and follow study personnel instructions during audiological measurements 6. native speaker in the language used to assess clinical speech perception performance exclusion criteria: 1. unrealistic expectations on the part of the subject regarding the possible benefits, risks, and limitations that are inherent to enrolment in the clinical investigation.

Keywords: cochlear implants hearing loss
evaluation of skin tests in biotherapy allergies

Conditions: Locally Advanced Cutaneous Squamous Cell Carcinoma of the Head and Neck; Melanoma Neoplasms; Small Cell Bronchial Carcinomas; Bronchial Carcinoma; Pleural Mesothelioma; Hodgkin&#39;s Lymphoma; Chronic Lymphocytic Leukemia; Follicular Lymphoma; Myeloma; AL Amyloidosis; Hepatocarcinoma; Colorectal Cancer; Esophageal Squamous Cell Carcinoma; Heart Cancer; Cholangiocarcinoma; Colorectal Adenocarcinoma

Summary: biotherapies are biological (extracted from an organism or living tissue) or biotechnological drugs used in the treatment of multiple conditions, such as autoimmune inflammatory diseases, cancers, and hematologic diseases. in recent years, these biotherapies have notably emerged in the treatment of cancers and hematologic disorders. as such, most patients with cancers or hematologic diseases will likely receive a biotherapy as part of their care pathway. these biotherapies are associated with various side effects, including hypersensitivity or allergic reactions, which are often poorly characterized in clinical trials. these reactions manifest as symptoms without specific dermatologic or allergologic semiology (such as itching, erythema, shortness of breath, sometimes digestive issues, or discomfort, and in some cases, an anaphylactic reaction). unlike other treatments, such as antibiotics and neuromuscular blockers, there are currently no guidelines on the concentrations to use in skin tests for biotherapies. we propose conducting prospective clinical research to scientifically establish the concentrations to be used when investigating hypersensitivity to a biotherapy, in line with best practice recommendations for drug skin testing.


Eligibility criteria:
inclusion criteria : * patient treated with one of the biotherapies under study (atezolizumab 1200 mg, nivolumab 480 mg, obinutuzumab 100 mg, durvalumab 1500 mg, pembrolizumab 200 mg, daratumumab 1800 mg, cemiplimab 3500 mg) and who has received at least two injections of the biotherapy without suspected allergic side effects. * subjects covered by or having the rights to medical care assurance * written informed consent obtained from subject * if applicable, treatment with corticosteroids and h1 antihistamines by systemic route (iv or oral) which may be discontinued at least one week before performing the tests (inhaled corticosteroids are allowed). exclusion criteria: * presence of local or diffuse dermatological lesions (e.g., psoriasis, eczema, ...) that could interfere with the interpretation of skin tests. * poor understanding of the french language * pregnancy, breastfeeding * persons in detention by judicial or administrative decision * person admitted to a health or social establishment for purposes other than research * person subject to a legal protection measure
acute normovolemic hemodilution on rotem in cardiac surgery

Conditions: Mitral Regurgitation; Mitral Stenosis; Tricuspid Regurgitation

Summary: impact of acute normovolemic hemodilution (anh) using hydroxyethyl starch before initiating cardiopulmonary bypass (cpb) on whole blood viscoelastic profile after cpb has not been well established. patients undergoing cardiac surgery employing moderate hypothermic cpb (n=40) are randomly allocated into one of two groups: in group-anh(n=20), anh is applied by using a balanced hydroxyethyl starch (hes 130/0.6); and in group-c, anh is not applied. after weaning from cpb, intergroup differences of intem, extem, fibtem and aptem profiles are analyzed. as a primary outcome, inter-group difference between maxiaml clot firmness of extem will be determined at 10 min after anh in group-anh and that at control.

background: impact of acute normovolemic hemodilution (anh) using hydroxyethyl starch before initiating cardiopulmonary bypass (cpb) on whole blood viscoelastic profile after cpb has not been well established. method: patients undergoing cardiac surgery employing moderate hypothermic cpb (n=40) are randomly allocated into one of two groups: in group-anh(n=20), anh is applied by using a balanced hydroxyethyl starch (hes 130/0.6); and in group-c anh is not applied. intergroup differences of intem, extem, fibtem and aptem profiles are analyzed. after anesthesia induction (control) and after weaning form cpb and protamine neutralization (after-cpb) in both groups. in group-anh, those are determined after anh (after-anh). as a primary outcome, inter-group difference between maxiaml clot firmness of extem is determined at 10 min after anh in group-anh and that at control. as secondary outcomes, intergroup differences of hematocrit (hct), na+, k+, hco3-, ca2+, osmolarity, s-cr are determined intergroup difference of data at t2 are performed.

Eligibility criteria:
inclusion criteria: * patients undergoing cardiac surgery with cardiopulmonary bypass who signed written informed consent exclusion criteria: * preoperative renal failure requiring reran replacement therapy * preoperative liver disease * preoperative low cardiac output (ef \< 50%) * preoperative iabp application, atrial fibrillation, pacemaker, * contraindication for applying tee * intraoperative withdrawal

Keywords: rotational thromboelastometry cardiac surgery acute normovolemic hemodilution
bay81-8973 pediatric safety and efficacy trial

Conditions: Haemophilia A

Summary: the primary objective was to evaluate the safety and efficacy of the treatment with bay81-8973 for prophylaxis and treatment of breakthrough bleeds in children with severe hemophilia a. the secondary objectives were * to assess the safety and efficacy of bay81-8973 during surgeries. * to assess incremental recovery of bay81-8973. * to assess pharmacokinetic (pk) parameters in a subset of children (previously treated patients \[ptps\] and previously untreated patients \[pups\] / minimally treated patients \[mtps\] - participation in pk sampling was voluntary and required consent).


Eligibility criteria:
inclusion criteria: * male * ptps (previously treated patients): aged \<= 12 years * pups (previously untreated patients) / mtps (minimally treated patients): aged \< 6 years * severe hemophilia a defined as \< 1% fviii concentration (fviii:c) * ptps: \>= 50 exposure days (eds) with any fviii concentrate, no current evidence of inhibitory antibody, and no history of fviii inhibitor formation * pups: no prior exposure to any fviii product * mtps: having no more than 3 eds with any fviii product, no current evidence of inhibitory antibody and no history of fviii inhibitor formation exclusion criteria: * with another bleeding disorder that is different from hemophilia a * with thrombocytopenia (platelet count \< 100 000/mm\^3) * creatinine \> 2x upper limit of normal or aspartate aminotransferase (ast)/alanine aminotransferase (alt) \> 5x upper limit of normal * without a negative inhibitor testing at screening (except for pups) * receiving chemotherapy, immune modulatory drugs, has received another investigational fviii product within the last month, or received another experimental drug within the last 3 months * requires any pre-medication to tolerate fviii treatment * known hypersensitivity to active substance, mouse, or hamster protein

Keywords: recombinant factor viii pediatric use
occult carbon monoxide poisoning detection by pulsated carboxymetry in an emergency department

Conditions: Carbon Monoxide Poisoning

Summary: in france, the carbon monoxide is one of the first causes of the accidental poisonings with approximately 8000 cases a year, among which 500 deaths. the severe forms are translated by neurological disorders even a coma or the death straight away. the more insidious forms with a little carboxyhémoglobine level give rise to frustrate clinical pictures, mimicking flu or intestinal syndromes. the syndrome post--intervallaire corresponds to the appearance of remote neuropsychiatric disorders of the poisoning. its appearance and its gravity are not correlated in the gravity of the initial poisoning, however the precocity of the treatment tends to decrease its frequency. carbon monoxide elimination is made under unchanged form in the expired air. in a spontaneous way, the half-life in ambient air is of the order of 4 hours. in ventilation in isobaric pure oxygen, the half-life is shortened at 80 minutes and in hyperbaric oxygen at 23 minutes. this imposes a fast diagnosis for two reasons: * for poisonings with low level, the more the investigators wait to measure the carboxyhémoglobine (hbco), the more they risk not to detect it. * the oxygen therapy decreases the duration of the poisoning and thus the tissular suffering. actually the risk is important to pass next to the diagnosis and to let leave a patient without adapted care and without technical intervention to eliminate the source of the poisoning. presently, to make the diagnosis, the investigators possess the analysis of the blood hbco by realization of gas of the venous blood, which are taken in emergencies, but very often a few hours after the end of the exposure at the source of poisoning, what is translated by a disappearance of the symptoms and an underestimate of the initial blood hbco. since 2005, masimo laboratory commercialize a pulse carboxymètre, the rad 57, which allows to estimate the carboxyhémoglobinémie in a not invasive way. lot of studies showed the interest of its use in the early screening of carbon monoxide poisonings, allowing a faster dosage of the blood hbco, and thus an also faster adapted care.


Eligibility criteria:
inclusion criteria: patients over 18 years old consult in ed for : * cephalalgia * syncope * weakness * nausea * vomiting * asthenia exclusion criteria: * temperature over 38.5 °c

Keywords: device assessment
prediction of the risks of cardiovascular mortality

Conditions: Cardiovascular Diseases; Cardiovascular Morbidity; Stroke; Embolism; Cardiac Arrest

Summary: monitoring risks of cardiovascular diseases in working population (18 - 65 years old) by monitoring their bmi, ankle-brachial index with pulse wave velocity, cholesterol and glycemia.

monitoring working population in their workplace by measuring their ankle-brachial index with pulse wave velocity, bmi, glycemia and cholesterol. putting acquired data in correlation to their work habits, type of employment, work demands, job type, activity levels. trying to find common predictors of cardiovascular disease. all assessed subjects must understand written and spoken czech, must be employed in a company that consents with our data collections, must be older than 18 year old, doesn't have any bleeding disorder, doesn't have deep vein thrombosis (as it produces inaccurate data with ankle brachial index). study will be conducted in ustecky region in the czech republic on approximately 200 subjects.

Eligibility criteria:
inclusion criteria: * employed in ustecky region czech republic * adult * understands spoken and written czech * consents with assessment * works in a company that consents to assessments of their employees exclusion criteria: * deep vein thrombosis * not currently employed * on sick leave * bleeding disorder

Keywords: ankle-brachial index cardiovascular mortality prevention
comparative usability evaluation of sustained acoustic medicine (sam) devices and topical gel for oa knee pain

Conditions: Knee Osteoarthritis

Summary: the purpose of this study is to evaluate the usability of the ultrasound devices and common pain relief gel. the ability of the three treatment approaches to reduce pain, stiffness, and functionality as measured by nrs scale and the western ontario and mcmaster universities arthritis index (womac) will be evaluated.


Eligibility criteria:
inclusion criteria: * physician-diagnosed mild to moderate knee osteoarthritis (kl grade 2-3) based on fixed-flexion x-ray radiological findings for osteophytes and joint space narrowing within the past 12 months * fulfill the american college of rheumatology clinical and radiological diagnostic criteria for knee oa * 35-80 years of age * report a frequent pain score between 4-7 (nrs range: 0-10) during the week preceding enrollment * report that knee pain negatively affects quality of life * willing not to use any cream, gel, or topical solution during the administration of treatment other than the approved ultrasound gel provided to the subject at the initiation of the study * deemed appropriate by their physician or by the study site physician to participate * willing and able to self-administer treatment daily within their place of residence or during normal daily activity, excluding bathing, showering, or other water activities which may result in submersion of the study device * not initiate use of opioid and/or non-opioid analgesic medications * willing to discontinue any other interventional treatment modalities on the knee during the study period exclusion criteria: * cannot successfully demonstrate the ability to put on and take off the device * display any condition which, in the judgment of the investigator, would make participation in the study unacceptable, including, but not limited to, the subject's ability to understand and follow instructions * have severe oa or have little to no cartilage in the knee * have knee replacement, other surgical intervention, or hyaluronidase injection in the affected knee in the past 6 months * is non-ambulatory (unable to walk) * is pregnant * is a prisoner * has a pacemaker * has a malignancy in the treatment area * has an active infection, open sores, or wounds in the treatment area * has impaired sensation in the treatment area, such as caused by chemotherapy or anesthesia * has known neuropathy * has a hereditary disposition (tendency) for excessive bleeding (hemorrhage) * participated in a clinical trial for an investigational drug and/or agent within 30 days prior to screening * modify their medications during the course of the study (medications and doses must remain constant throughout the study) * currently taking steroids * have contraindication to radiograph * have a secondary cause of arthritis (metabolic or inflammatory)

Keywords: non-steroidal anti-inflammatory drugs sustained acoustic medication low-intensity continuous ultrasound
a study to determine the number of patients who reach optimal cholesterol levels on each of three different treatments (0653a-121)

Conditions: Hypercholesterolemia

Summary: to evaluate the percentage of patients with either established cardiovascular disease (cvd), at "high risk" of developing cvd or with diabetes who are on simvastatin 40mg, with fasting ldl-c \> 2mmol/l, who are able to attain the recommended ldl-c target of \< 2mmol/l following 6 weeks treatment with either ezetimibe/simvastatin 10/40mg, atorvastatin 40mg or rosuvastatin 10mg.


Eligibility criteria:
inclusion criteria: * patient is male or female and aged over 18 * patient provides written informed consent * patient has a fasting ldl-c level \>2mmol/l at both visit 1 and again at visit 2 * patient has established cvd, diabetes or at "high risk" of cvd (\>20 % risk over 10 years, framingham scale) * patient has taken simvastatin 40mg continuously for the past 6 weeks * patient has a fasting triglyceride level of \<3.7mmol/l * patient has hba1c \<9% at visit 1 * patient is 75% compliant with medication between visit 1 and visit 2 exclusion criteria: * patient is hypersensitive to any of the study medications or their components * patient has a history of, or active liver disease (persistent elevation of alt / ast (\>3xuln) * patient is pregnant, lactating, or a female patient of childbearing potential not using adequate contraception * patient has severe renal impairment: creatinine clearance \<30ml/min (cockcroft-gault equation) (in patients with moderate renal impairment: \<60ml/min, the dose of rosuvastatin will be 5mg in line with the spc) * patient has uncontrolled endocrine or metabolic disease known to influence serum lipids or lipoproteins (i.e. secondary causes of hyperlipidaemia such as hypothyroidism or hyperthyroidism) * patient has a recent history of, or current, alcohol abuse * patient has ck \>10 x uln at visit 1 or visit 2 * patient has fasting ldl-c \>4.2mmol/l * patient has any acute or serious condition, or history suggestive of myopathy or predisposing to the development of renal failure secondary to rhabdomyolysis (e.g. sepsis, hypotension, major surgery, trauma, severe metabolic, severe endocrine and electrolyte disorders or uncontrolled seizures)