Kornimate/medical-research-clean huggingface dataset:
acceptability and writing frequency of advanced directives in onco-dermatology patients

Conditions: Advance Directives; Oncology; Skin Cancer; Melanoma; Skin Lymphoma; Skin Squamous Cell Carcinoma; Metastatic Basal Cell Carcinoma

Summary: the law about advance directives is evolving but, in france, few people write it. te main endpoint of this research is to estimate the proportion of patients who have written their advance directives or considering doing so in onco-dermatologic population. if this rate remains low, some insights on the reasons will be able to be advanced looking at the point of view and opinion of patients about this topic. seconds endpoints are : for patients against or not planning to write it, understand their reasons estimate the proportion of patients requesting information and understand how they would like to receive it. investigate a possible association between the stage of the oncological disease and the positioning of the patient concerning advance directives.


Eligibility criteria:
inclusion criteria: \> 18 ya with one of the diagnoses below: * melanoma * skin lymphoma * meckel carcinoma * localy advanced or metastatic basal cell carcinoma or squamous cell carcinoma exclusion criteria: patients not in possession of all of its cognitive abilities patients who can't read patients who don't speak french

Keywords: advance directives advance care planning patient's informed treatment preferences skin cancer dermatology
the evarrest® fibrin sealant patch liver study

Conditions: Hemorrhage

Summary: to evaluate the safety and hemostatic effectiveness of evarrest® fibrin sealant patch (evarrest) versus standard of care treatment (soc) in controlling parenchymal bleeding during hepatic surgery.


Eligibility criteria:
inclusion criteria: * subjects ≥ 18 years of age, requiring elective or urgent, open hepatic surgery. * presence of an appropriate bleeding hepatic parenchymal target bleeding site (tbs) as identified intra-operatively by the surgeon * subjects or legally authorized representatives must be willing to participate in the study, and provide written informed consent. (note: this criteria does allow for hospital translators to be used where approved by ethics committees/institutional review boards) exclusion criteria: * subjects with any intra-operative findings identified by the surgeon that may preclude conduct of the study procedure; * tbs is from large defects in arteries or veins where the injured vascular wall requires repair with maintenance of vessel patency and which would result in persistent exposure of evarrest® to blood flow and pressure during healing and absorption of the product; * tbs with major arterial bleeding requiring suture or mechanical ligation; * subjects admitted for trauma surgery; * subject is a transplant patient for fulminant hepatic failure * subject with tbs within an actively infected field; * bleeding site is in, around, or in proximity to foramina in bone, or areas of bony confine; * subjects with known intolerance to blood products or to one of the components of the study product or is unwilling to receive blood products; * subjects who are known, current alcohol and / or drug abusers; * subjects who have participated in another investigational medical device or investigational drug trial within 30 days of surgery or are expected to participate in another medical device or investigational drug trial during the course of the study; * female subjects who are pregnant or nursing.

Keywords: hepatobiliary surgery
use of dynamic arm supports to promote activities of daily living in individuals with dmd

Conditions: Duchenne Muscular Dystrophy

Summary: this study is a longitudinal, randomized control trial evaluating the use of two commercially available dynamic arm support devices (1) armon ayura-kinova and 2) jaeco wrex) to promote participation in activities of daily living (adls) in non-ambulatory individuals with duchenne muscular dystrophy (dmd) with upper extremity weakness.

this study is a longitudinal, randomized control trial evaluating the use of two commercially available dynamic arm support devices (1) armon ayura-kinova and 2) jaeco wrex) to promote participation in activities of daily living (adls) in non-ambulatory individuals with duchenne muscular dystrophy (dmd) with upper extremity weakness. up to 30 individuals will be enrolled to participate in this research study, which includes a two-week baseline data collection period, a four-week device trial and a two-week post device data collection period. participants will be randomly assigned to trial one of the dynamic arm support devices during the four week in-home trial. the actigraph gt9x (name of device), a wrist worn activity monitoring device, will be worn during the baseline period, the device trial and the post device data collection period to capture upper extremity (ue) movement patterns. ue performance will be further quantified with use of a physical motor assessment, the performance of upper limb (pul) assessment and patient reported outcomes. data gleaned will provide important knowledge and objective results regarding the potential benefit of dynamic arm supports in individuals with dmd with limited functional use of their upper extremities.

Eligibility criteria:
inclusion criteria: 1. 14 years of age or older 2. self-report diagnosis of duchenne muscular dystrophy (dmd) 3. use a wheelchair for mobility 4. score 3-5 on the brooke upper extremity (ue) scale 5. self-report of needs assistance/unable to achieve independently on at least 10 items on the upper limb activities of daily living (ul adl) self-report questionnaire 6. able to follow instructions 7. informed consent provided by self (18 and over) or by parent or legal guardian (if under the age of 18) exclusion criteria: 1. does not have minimum level of ue function to operate the assigned dynamic arm support (score of 6 on the brooke ue scale or any other impairment limiting use) 2. the assigned dynamic arm support is unable to be mounted to wheelchair (mounts will vary based on manufacturer/model of wheelchair)

Keywords: dynamic arm support mobile arm support rehabilitation occupational therapy
effect of muscular relaxation and breathing technique on blood pressure in pregnancy

Conditions: Blood Pressure in Pregnancy

Summary: gestational hypertension is the main cause of maternal and fetal mortality, however, it has no definite effective treatment. nowadays, the stress management approaches are use for essential hypertension. so, this study aimed is study the effect of progressive muscular relaxation and breathing control technique on blood pressure during pregnancy. this 3-groups clinical trial has been done in mashhad health centers and governmental hospitals. 60 pregnant women with systolic blood pressure less than 135 mm hg or diastolic blood pressure more than 85 mm hg who met inclusion criteria were assigned into three groups of progressive muscular relaxation, breathing control and control. in tow experiment groups, exercises were controlled by one day personally and the rest by cd, bp before and after interventions was controlled for 4 weeks. in control group blood pressure was measured before and after 15 minutes with no intervention.


Eligibility criteria:
inclusion criteria: * systolic blood pressure ≥ 135mmhg or * diastolic blood pressure ≥ 85mmhg * absence of severe preeclampsia condition * eclampsia * absence chronic hypertension * gestational age 20-36w * single pregnancy * have not contraction or bleeding * absence of underlying disease and mental disorders * absence of polihydramnios * hydatiform mole and placenta previa * not addicted to drugs, alcohol, mood-altering medicine and cigarette * not to use similar relaxation methods and breathing techniques during pregnancy * reading and writing literacy * have contact number exclusion criteria: * using antihypertensive drugs(for experimental groups) * cbr * bleeding * contraction or watering during study * deteriorating of preeclampsia to severe form * hospitalization * start medical treatment for experiment groups * changing mind for continuing with study * to be absent in one session of personal instruction for experiment groups do not exercises more than 3 sessions of relaxation and breathing control at home * delivery during 4- week interventions and presence of symptoms such as confusion, fatigue, feeling of suffocation, pain, blurred vision during doing exercises
safety and efficacy evaluation of by post-marketing surveillance

Conditions: Dovprela

Summary: dovprela tablets (pretomanid) is the only treatment approved for the treatment of drug-resistant tuberculosis on a wider scale. this non-interventional post-marketing surveillance (pms) study is one of the obligations that must be followed under the ministry of food and drug safety (mfds). in accordance with the pharmaceutical affairs act and the re-examination criteria for new drugs, etc. notified by the mfds, this study will be conducted with the purpose to collect and review required information on the safety and efficacy of drugs requiring re-examination for appropriate use. safety and efficacy information will be provided for a minimum of 100 subjects who receive treatment in general clinical settings for a period of 4 years following approval. this survey is an open, non-comparative, non-interventional, prospective, multicenter study conducted by certified physicians (i.e., the investigator) at a korean medical institution.


Eligibility criteria:
inclusion criteria: * to be eligible for participation in this study, subjects must meet the following inclusion criteria: 1. patients who have been administered dovprela tablets according to the current local labelling after the study is initiated at the study institution 2. subjects who have consented to participate in this study by signing the data privacy statement exclusion criteria: * patients falling under any of the following criteria are not included in the study: 1. cases with duplicated studies (in the event of duplicated cases, the case that has been collected first will be recognized.) 2. patients with hypersensitivity to active substance (pretomanid) or components. the list of components is as follows: \*components: lactose monohydrate, microcrystalline cellulose, povidone, sodium starch glycolate, magnesium stearate, colloidal silicon dioxide, sodium lauryl sulfate 3. patients with contraindications to use bedaquiline and/or linezolid as dovprela tablets are used as a combination treatment with bedaquiline and linezolid 4. patients with genetic problems such as galactose intolerance, lapp lactase deficiency or glucose-galactose malabsorption 5. other patients whom the investigator decides not to prescribe under general practice, considering the overall balance of risks and benefits, such as those who are pregnant or breastfeeding if data of the subjects that have not been used within the scope of permitted items is collected, it shall be analysed as a separate item.

Keywords: pretomanid tuberculosis
mild hypothermia and supplemental magnesium sulfate infusion in severe traumatic brain injury (tbi) subjects

Conditions: Traumatic Brain Injury

Summary: the investigators hypothesize that hypothermia (body cooling) and additional magnesium sulfate will improve the outcome of severe traumatic brain injury (tbi) patients. this is a study to compare the outcomes of patients with severe traumatic brain injury who have been allocated to one of the following three groups: group 1 - conventional therapy following traumatic brain injury group 2 - subjects will have their core body temperature lowered to 34c group 3 - subjects will have their core body temperature lowered to 34c and will receive a supplemental intravenous infusion of magnesium sulfate.


Eligibility criteria:
inclusion criteria: 1. adult males or females ≥ 18 years of age 2. subjects with traumatic brain injury and a post-resuscitation glasgow coma score (gcs) ≤ 8 3. in-hospital and screened within 7 hours of injury. 4. able to obtain legally effective written consent from authorized representative 5. patients who are intubated and on mechanical ventilation 6. admitted to icu exclusion criteria: 1. bladder or rectal core temperature below 32c (89.6f) upon admission 2. clinical brain death 3. patients with open abdomens. 4. multiple orthopedic injuries (\> 2 long bone fractures) 5. persistent hypotension (systolic blood pressure \< 90mmhg) 6. persistent hypoxia (o2 saturation \< 94%) 7. persistent metabolic acidosis (lactic acid \> 5 mmol/l, arterial ph \< 7.25) 8. positive serum pregnancy test 9. cardiac arrhythmia with deleterious hemodynamic effects; heart block or myocardial damage (as shown on ecg) 10. history of abnormal renal function 11. significant co-morbidity (i.e. cad;copd; severe coagulopathy) 12. pediatric patients (\< 18 years old)

Keywords: traumatic brain injury
a clinical trial to assess the efficacy and safety of mk-0653c in japanese participants with hypercholesterolemia (mk-0653c-383)

Conditions: Hypercholesterolemia

Summary: this study will evaluate the efficacy and safety of mk-0653c (ezetimibe \[ez\] 10 mg/atorvastatin \[atora\] 10mg or 20 mg) compared to ez 10 mg, atora 10 mg, or atora 20 mg alone when administered to japanese participants with hypercholesterolemia. the primary hypothesis is that mk-0653c (ez 10 mg/atorva 10 mg) is superior to ez 10 mg and is superior to atorva 10 mg and that mk-0653c (ez 10 mg/atorva 20 mg) is superior to ez 10 mg and is superior to atorva 20 mg in percent change from baseline in low-density lipoprotein cholesterol (ldl-c) after 12 weeks of treatment.


Eligibility criteria:
inclusion criteria: * japanese outpatient with hypercholesterolemia. * females must be non-reproductive potential or agree to remain abstinent or use (or partner use) two acceptable methods of birth control from date of signed informed consent to the 14 days after the last dose of study drug * agree to maintain a stable diet that is consistent with the japan atherosclerosis society guideline 2012 (jas2012) for prevention of atherosclerotic cardiovascular diseases for the duration of the study exclusion criteria: * uncontrolled hypertension * type 1 or uncontrolled type 2 diabetes mellitus (treated or untreated) * history of coronary artery disease (cad) homozygous familial hypercholesterolemia or has undergone ldl apheresis * had a gastrointestinal tract bypass, or other significant intestinal malabsorption * history of cancer within the past 5 years except for successfully treated dermatological basal cell or squamous cell carcinoma or in situ cervical cancer * human immunodeficiency virus (hiv) positive * history of drug/ alcohol abuse within the past 5 years or psychiatric illness not adequately controlled and stable on pharmacotherapy * consumes more than 25 g of alcohol per day * consumes more than 1l of grapefruit juice per day * currently following an excessive weight reduction diet * engaging in a vigorous exercise regimen (e.g.; marathon training, body building training etc.) or intends to start training during the study * hypersensitivity or intolerance to ezetimibe or atorvastatin * history of myopathy or rhabdomyolysis with ezetimibe or any statin * pregnant or lactating * taking any other investigational drugs and/or has taken any investigational drugs within 30 days
a registry of patients undergoing cellvizio endomicroscopy and endoscopic retrograde cholangiopancreatography(ercp) imaging procedures for diagnosing pancreatic and bile duct cancers

Conditions: Pancreatic Cancer; Bile Duct Cancer

Summary: this registry will collect data from patients routinely undergoing an ercp and cellvizio endomicroscopy procedure (and optionally an additional cholangiopancreatoscopy procedure) due to suspected pancreatic or bile duct cancer. the objective is to determine if endomicroscopy images collected using the marketed cellvizio device may help endoscopists more accurately diagnose, in conjunction with traditional tissue sampling techniques, whether a suspected lesion is malignant or benign.

this is a registry study to collect high quality longitudinal data from patients with suspected or indeterminate pancreaticobiliary pathology who are undergoing an ercp with cellvizio probe-based endomicroscopy procedure, with or without supplemental direct cholangiopancreatoscopy. the hypothesis is that ercp with cellvizio probe-based endomicroscopy improves differentiation of biliary and pancreatic duct lesions versus ercp alone. direct measures of accuracy (sensitivity, specificity, etc.) in the differentiation of malignant versus benign biliary and/or pancreatic duct lesions will be compared for the combination of endomicroscopy and ercp imaging and ercp alone. these presumptive diagnoses will be compared against a 12-month follow-up confirmed histopathologic endpoint (an initially-benign pathologic diagnosis will be confirmed by a 12-month follow-up). secondary objectives include collecting various safety and technical performance parameters.

Eligibility criteria:
inclusion criteria: 1. male or female \> 18 years of age 2. willing and able to comply with registry procedures and provide written informed consent to participate in the registry 3. indicated for ercp and/or cholangiopancreatoscopy 4. indeterminate or suspected biliary and/or pancreatic stricture, mass, or neoplasm exclusion criteria: 1. subjects for whom ercp procedures are contraindicated 2. known allergy to fluorescein dye

Keywords: endoscopic retrograde cholangiopancreatography ercp bile duct cancer pancreatic duct cancer gall bladder pancreas duodenoscope cellvizio endomicroscopy cholangiopancreatoscopy biliary tract neoplasms (suspected) biliary tract mass (suspected) biliary tract stricture (suspected) pancreatic duct neoplasms (suspected) pancreatic duct mass (suspected) pancreatic duct stricture (suspected)
impact of covid-19 pandemic on orthopaedic practice

Conditions: Covid19; Trauma; Orthopedic Disorder; Anesthesia; Morality

Summary: the covert collaborative is led by a group of academic surgeons that is looking into the impact of the unprecedented covid-19 pandemic on trauma and orthopaedic practice. this will involve both trauma and elective procedures, as well as mortality rates, operative and anaesthetic case mix. the information will help to shape service reconfiguration and enhance patient-specific treatment especially in the threat of potential subsequent waves and future pandemics.

in response to the health crisis, it is the responsibility of clinicians to audit and collaborate in order to observe the impact of the pandemic on clinical practice. with the restructure of the health infrastructure, there is likely to be changes to the nature of acute referrals to trauma and orthopaedics, operative and anaesthetic casemix, polytrauma and open fractures as well as the role of technology to reduce viral transmission. patient safety ought to be prioritised at all times but a national narrative is required to equip healthcare services to counter the pandemic at various time intervals post-social distancing and lockdown at 1.5, 3, 6, 12, 18 and 24 months. this will act as an audit to compare and contrast if the reconfiguration of healthcare services is abiding by the governmental, doh, nhs, who, rcs and boa (boast) policies and guidelines.

Eligibility criteria:
inclusion criteria: * anyone presenting with orthopaedic trauma to the emergency department who has been referred to the on-call trauma and orthopaedic team for further management. exclusion criteria: * spinal trauma
a study of ipatasertib (gdc-0068) in combination with paclitaxel as neoadjuvant treatment for participants with early stage triple negative breast cancer

Conditions: Breast Cancer

Summary: this is a randomized, double-blind, placebo-controlled, multicenter, pre-operative phase ii study designed to estimate the efficacy of ipatasertib combined with paclitaxel chemotherapy versus placebo combined with paclitaxel chemotherapy in women with stage ia - iiia triple-negative breast adenocarcinoma. the anticipated time on study treatment is 12 weeks.


Eligibility criteria:
inclusion criteria: * premenopausal or postmenopausal women * eastern cooperative oncology group (ecog) performance status of 0 or 1 * histologically documented, stage ia to operable stage iiia, triple-negative carcinoma of the breast with primary tumor greter than or equal to (\>/=) 1.5 centimeters (cm) in largest diameter (ct1-3) by mri * adequate hematologic and organ function within 14 days before the first study treatment * availability of tumor tissue from formalin-fixed, paraffin-embedded (ffpe) core biopsy of breast primary tumor * for female participants of childbearing potential, agreement to use highly effective form(s) of contraception for the duration of the study and for at least 6 months after last dose of study treatment exclusion criteria: * known human epidermal growth factor 2 (her2)-positive, estrogen receptor (er)-positive, or progesterone receptor (pgr)-positive breast cancer * any prior treatment for the current primary invasive breast cancer * participants with ct4 or cn3 stage breast tumors * metastatic (stage iv) breast cancer * bilateral invasive breast cancer * multicentric breast cancer * any disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that contraindicates the use of an investigational drug or that may affect the interpretation of the results or render the participant at high risk from treatment complications