Kornimate/medical-research-clean huggingface dataset:
evaluation of lucanthone to whole brain radiation therapy in patients with brain metastases from non-small cell lung cancer

Conditions: Brain Metastases; Non-small Cell Lung Cancer

Summary: this is a randomized, double blind placebo controlled study to evaluate safety and efficacy of lucanthone administered as an adjunct to patients receiving whole brain radiation therapy (wbrt) as primary treatment for brain metastases secondary to non-small cell lung cancer.

eligible patients for this trial will be randomized to lucanthone or placebo in a ratio of 1:1. the treatment will consist of wbrt given in a dose of 30 gy in ten fractions. lucanthone/placebo will be given as an adjunct to the wbrt on days that wbrt is administered. tumor assessments will be done with a brain mri. radiological assessments on the tumor will be made periodically throughout the study and will be discontinued at the time of tumor progression. safety will be evaluated for one year during the study period and survival data will be collected thereafter.

Eligibility criteria:
inclusion criteria: * the patient has given informed consent. * the patient is willing and able to abide by the protocol. * the patient is between age 18 and 70 (between 19 and 70 in alabama). * the patient has histologically proven nsclc with radiologically documented brain metastases. * newly diagnosed or stable systemic disease, on or off systemic therapy. * if receiving systemic therapy for nsclc, at least two weeks since patient received systemic therapy. * able to withhold systemic therapy for duration of wbrt therapy. * if the patient is of childbearing potential, he/she is using an acceptable/effective method of contraception. * the patient's karnofsky score is greater than or equal to 70%. exclusion criteria: * patient has a diagnosis of recurrent brain metastases. * the patient has an absolute neutrophil count less than or equal to 1.5 x 10 9/l. * the patient has a screening platelet count less than 100,000/ul. * the patient has a screening bilirubin greater than 1.6 mg/dl. * the patient has a screening creatinine greater than 2.25 mg/dl in men and 1.8 mg/dl in women. * the patient has a screening alt/ast greater than 2.5 times the upper limit of the laboratory reference range. * the patient has an unstable medical condition or significant comorbid pathophysiology (e.g. active infection, poorly controlled diabetes, unstable angina, severe heart failure) that would interfere with his/her participation in the study. * the patient is enrolled, or plans to enroll, in a concurrent treatment protocol with another investigational product. * the patient has received prior chemotherapy or radiation therapy within two weeks of beginning wbrt on protocol. * the patient is allergic to gadolinium contrast. * more than 21 days has or will elapse between the brain mri documenting the brain metastases and the initiation of wbrt.

Keywords: brain metastases non-small cell lung cancer whole brain radiation therapy lucanthone
influence of human albumin supplementation on kidney dysfunction after liver transplantation

Conditions: Liver Transplantation; Acute Kidney Injury

Summary: to verify whether albumin administration to achieve serum concentration above 30g/l (treated group) and its maintenance within plasmatic physiologic range (above 30 g/l) for five days diminishes rate of aki at day 7 after liver transplantation as compared to restrained albumin administration (when serum concentration is at 20 g/l or below (control)).


Eligibility criteria:
inclusion criteria: * male and female subjects equal or above 18 yrs old. * recipients of primary liver allografts from a deceased donor (including after cardiac death) and as a single organ (liver only). * capability of understanding the purpose and risks of the study. * written informed consent exclusion criteria: * fulminant hepatitis * kidney injury at baseline (estimated glomerular filtration rate \< 50 ml/min in modification of diet in renal disease-6) including hepatorenal syndrome * use of an induction agent basiliximab at liver transplantation * protected person (adults legally protected, under judicial protection, guardianship, or supervision), person deprived of their liberty * at the time of randomisation, participation to another interventional study

Keywords: liver transplantation albumin acute kidney injury
study to understand pain experiences in relationships

Conditions: Chronic Pain

Summary: chronic pain is a highly prevalent and costly health care problem. yet, little is known about the optimal ways for health care providers and family members to respond to the distress expressed by people with chronic pain. the aim of the current study is to compare two models of responsiveness to identify responses that result in better functioning and adjustment. an experimental design will be used to test the extent to which emotional validation (e.g., an empathic response to distress) increases or decreases pain behaviors during physical activity. romantic partners of individuals with chronic pain will be randomly assigned to receive validation or control training. following training, people with chronic pain and their partners will engage in a discussion about pain and complete household tasks to examine the effects of partner training on communication, pain intensity, and pain behavior. additionally, each individual in the couple will complete self-report measures after the discussion, after the household tasks, and one-month following the laboratory visit.


Eligibility criteria:
inclusion criteria: * romantic couples who are married or living with each other for 6 months or longer or have been in a romantic relationship 2+ years. * one individual in the couple must have chronic muscoskeletal pain, lasting 3 months or longer. participants may have multiple pain sites. * the individual with chronic pain must report that their pain occurs nearly daily. * the individual with chronic pain must have an average pain intensity of 3 or greater on an 11-point scale (from 0: no pain to 10: worst pain imaginable) * the individual with chronic pain must have an average pain interference of 3 or greater on an 11-point scale (from 0: does not interfere to 10: completely interferes) exclusion criteria: * one or both individuals in the couple are unable to speak, read, or write in english. * both individuals in the couple have chronic pain. couples may consist of one individual with chronic pain and one individual with "minimal pain", which we define as having some aspects of chronic pain but not all (e.g., has had nearly daily pain for 4 months but rates their pain below 3 in regards to interference and intensity) * one or both individuals in the couple have widespread pain (e.g., fibromyalgia)

Keywords: chronic pain pain validation couples romantic relationships emotional validation
compare the safety & efficacy of rosuvastatin 40mg in combination with ezetimibe 10mg

Conditions: Hypercholesterolemia; Coronary Heart Disease; Atherosclerosis

Summary: the purpose of this study is to compare 6 weeks of treatment with rosuvastatin alone compared with 6 weeks of treatment of rosuvastatin combined with ezetimibe in achieving low density lipoprotein level goals.


Eligibility criteria:
inclusion criteria: * a history of chd or clinical evidence of atherosclerosis or multiple risk factors that confer a high risk as defined in the protocol. * fasting ldl-c concentrations at visit 1 as defined in the protocol. * discontinuation of all lipid lowering therapy at visit 1. exclusion criteria: * history of statin induced serious side effects, or serious hypersensitivity reaction to other statins. * subjects considered to be unstable by the investigator after the following events: a myocardial infarction (heart attack), unstable angina, myocardial revascularisation or another revascularisation procedure or a transient ischaemic attack (tia) or stroke. * severe congestive cardiac failure (as defined by the protocol - appendix i). * subjects awaiting a planned myocardial revascularisation prior to starting the study (i.e. planned prior to visit 1)..

Keywords: low density lipoproteins hypercholesterolemia coronary heart disease rosuvastatin crestor ezetimibe
safety and efficacy of acute normovolemic hemodilution in pediatric cardiac surgery patients

Conditions: Cardiac Defect

Summary: the investigators primary objective is to determine if acute normovolemic hemodilution (anh) for pediatric cardiac surgical patients decreases the volume of blood products transfused during surgery and the immediate post-operative period as compared to usual care. this study will enroll 24 pediatric heart surgery patients, aged 6 months to 3 years old undergoing either anh prior to initiating cardiopulmonary bypass or the standard of care procedures for the use of cardiopulmonary bypass.

blood transfusion has been associated with worse outcomes in pediatric cardiac surgical patients. the major complications associated with it include increased blood loss during and after surgery, kidney disease requiring dialysis, abnormal coagulation profile, increased vasopressor use, and increased time spent on the ventilator and in the intensive care unit. one strategy to minimize blood product administration is acute normovolemic hemodilution (anh). the investigators primary aim is to determine if anh for pediatric cardiac surgical patients decreases the volume of blood products transfused during surgery and the immediate post-operative period, compared to usual care. the investigators designed a randomized, controlled, open label study that equally assigns 24 pediatric cardiac surgery patients aged 6 months to 3 years into two groups to receive either anh prior to initiating cardiopulmonary bypass or usual standard of care. participants in the anh arm of the study will have 10 ml/kg of blood removed following anesthetic induction. in order to maintain normal circulating volume, the collected blood will be replaced with an equal volume of 5% albumin. all participants will be treated with a standardized protocol aimed at blood conservation including the use of retrograde arterial and antegrade venous perfusion, small circuit size, intraoperative red blood cell salvage, and low hemoglobin targets to trigger transfusion.

Eligibility criteria:
inclusion criteria: * informed signed consent must be obtained by a legally authorized representative. * must be undergoing an elective surgical repair or palliation of a cardiac defect with the use of the cardiopulmonary bypass machine. * must be clinically stable at the time of evaluation for eligibility and on the day of randomization. exclusion criteria: * patients who carry a diagnosis of a bleeding disorder. * patients who have an abnormal coagulation profile as evidenced by a preoperative coagulation screen. * patients who have received a blood transfusion in the preceding 120 days. * patients who have a diagnosis of a chromosomal abnormality. * patients whose participation in the study is deemed unsafe by their primary care team.

Keywords: pediatric cardiac surgery
evaluation of accuvein in obese patients

Conditions: Primary Care

Summary: the objective of this study is to evaluate the effectiveness of accuvein to facilitate placement of peripheral intravenous catheters in obese patients. this clinical protocol is designed to determine whether using accuvein increases the ease and efficiency of venous cannulation (as perceived by the operator), decreases the time to effective cannulation, and decreases the patient's perception of the pain.


Eligibility criteria:
inclusion criteria: * obese adults ( bmi equal or greater 35) requiring a venous blood sampling or the placement of a venous peripheral catheter exclusion criteria: * pregnant woman
study to evaluate the efficacy and safety of tocilizumab versus corticosteroids in hospitalised covid-19 patients with high risk of progression

Conditions: COVID-19

Summary: this study aims to compare the efficacy and safety of methylprednisolone versus tocilizumab in improving clinical outcomes and reducing the need for ventilator support in covid-19 patients with moderate covid-19 disease at risk for complications of cytokine storm. approximately 310 participants hospitalized with covid-19 in ummc, hospital sungai buloh, hospital kuala lumpur and hospital tuanku jaafar will be enrolled into this study. eligible participants will be selected based on a set of clinical, laboratory and radiological parameters indicative of early stages of crs and lung function decline prior to being randomized at a ratio of 1:1 to receive either tocilizumab or methylprednisolone. participants will be monitored daily for clinical and laboratory parameters, and at 48 hours, switched to the alternate study arm should they manifest signs and symptoms indicative of decompensation.


Eligibility criteria:
inclusion criteria: 1) hospitalised symptomatic covid-19 patients 2( presence of clinical and radiological signs of progressive disease, and laboratory evidence indicative of risk for cytokine storm complications. all patients participating in this clinical trial must meet the following inclusion criteria: 1. hospitalised symptomatic covid-19 patients 2. presence of clinical and radiological signs of progressive disease, and laboratory evidence indicative of risk for cytokine storm complications: clinical: dyspnoea or rr\>20 breaths/min and o2 sat \ 95% on ra with radiological: cxr or ct indicative of pneumonia or worsening findings over time and laboratory: crp levels \>60 or an increase of crp \>20 over 12 hours with an increasing ferritin level or declining lymphocyte counts 3. age \> 18 years and able to give consent exclusion criteria: patients will be excluded if any of the following conditions apply: 1. known sensitivity/allergy to tcz or other monoclonal antibodies 2. ast/alt\>5 times unl, platelet counts \<50,000 or neutrophil counts \<500 3. active tb 4. pregnant 5. receipt of mechanical ventilation 6. has received other immunomodulatory drugs (including tcz) in the past for the treatment of other conditions 7. individuals, in the opinion of the investigator, where progression to death is imminent and inevitable in the next 24 hours irrespective of treatment provision or who have signed a dnr. 8. participating in other clinical trials (subject to approval) 9. any serious medical condition or abnormal clinical laboratory tests which in the judgement of the investigator may compromise patient safety should he/she participate in the study.

Keywords: covid-19
advanced image guidance utilized in liver surgery

Conditions: Carcinoma, Hepatocellular

Summary: advanced image guidance for this study was used during laparoscopic microwave ablation surgery to help the surgeon accurately place the ablation needle into the tumor of patients diagnosed with liver cancer.

hepatocellular carcinoma (hcc) is diagnosed in over 19,000 americans annually and responsible for 17,000 deaths. worldwide, (hcc) is the third leading cause of cancer death. hepatocellular carcinoma recurs frequently due to its multi-centric nature, which requires repeated treatments and often results in progressively fewer treatment options because of severe underlying liver dysfunction. while surgery offers the best prognosis for such tumors and lesions, only 10-15% of all patients are candidates for removal by surgical means, necessitating the exploration of other treatment options. inneroptic's aim guidance system is designed to alleviate the difficulty in using ultrasound to place a needle. aim shows the needle and the ultrasound slice in their locations in 3d on a stereo monitor, making the spatial relationship between them obvious. aim also displays the needle trajectory and where the needle will intersect with the ultrasound image, providing the surgeon with an indication of where the needle will go, if inserted along the needle shaft. aim can also render an ablation volume guide, providing the surgeon with further confirmation that the needle is placed accurately and providing a volumetric guide regarding the power settings of the ablation.

Eligibility criteria:
inclusion criteria: * individuals who have hepatocellular carcinoma. * individuals who are candidates for microwave ablation surgery. exclusion criteria: * individuals who do not have hepatocellular carcinoma. * individuals who are not a candidate for laparoscopic microwave ablation surgery.

Keywords: hepatocellular cancer hepatocellular carcinoma hepatoma liver cancer, adult liver cell carcinoma, adult
impact of pandemic covid-19 on surgical specialities residents in italy

Conditions: COVID

Summary: the coronavirus emergency has severely affected italian healthcare national system. this event made it necessary to adopt extraordinary containment measures and to allocate extraordinary resources in italian hospitals. in many centers routinely elective surgical activity has been decreased or even completely abolished. we believe that this exceptional condition is being consequently having a significant impact on surgical training programs.

purpose of this investigation, organized by the italian polispecialistic society of young surgeons (s.p.i.g.c.), is to establish the impact of covid-19 emergency in the work and training activities of italian surgical residents. there will be collected the residents' impressions by completing a survey on this topic. a sub-analysis for each pandemic wave (first, second, third) will be done.

Eligibility criteria:
inclusion criteria: - residents in the following surgical specialities: cardiothoracic surgery, colon and rectal surgery, general surgery, gynecology and obstetrics, gynecologic oncology, neurological surgery, ophthalmic surgery, oral and maxillofacial surgery, orthopaedic surgery, otorhinolaryngology, pediatric surgery, plastic and maxillofacial surgery, urology, and vascular surgery exclusion criteria: * undergratuated and postgraduated students * consultants in surgical areas

Keywords: resident wellness surgical residency
conservative treatment of rectosigmoid endometriosis monitored by transvaginal ultrasound

Conditions: Bowel Endometriosis

Summary: background: endometriosis is a disease affecting 8-15 % of fertile women and is a cause of abdominal pain and suffering during women's menstrual periods. a subgroup of patients with die has an infiltration into the rectosigmoid bowel wall (4-37%). knowledge of the growth pattern of rectosigmoid lesions related to subjective symptoms is mandatory in order to assess the need for follow-up with transvaginal ultrasound during medical treatment. hypotheses: symptoms will follow growth of rectosigmoid endometriosis. material and methods: two different cohorts of women, based on time of diagnosis of rectosigmoid endometriosis and treatment with hormonal intrauterine device or continuous oral contraceptives will receive a questionnaire and a transvaginal ultrasound scan (measuring size and volume) at inclusion, (6) and 12 months later. perspectives: patients treated conservatively may be followed by questionnaires, thereby reducing the need for time consuming clinical controls.


Eligibility criteria:
inclusion criteria: * medically treated bowel endometriosis exclusion criteria: * age below 18 years * bowel resection of any kind * cancer
the effect of web-based training and counseling given to caregivers on the pressure injury risk, level of dependence-independence, and caregivers' burden of care in bedridden patients

Conditions: Pressure Injury Prevention

Summary: education and counseling of patients and caregivers, either face-to-face or using various communication technologies, are reported to have significant effects. nurses are in a key position in the education and counseling of patients and their relatives for the prevention of pressure injury. although the share of health technologies in the management of pressure injury is important, it is also important for nurses to use these technologies. web-based education, which is a part of health technologies, is defined as an education and training program created by using the features of internet and computer technologies.

to prevent pressure injuries; it has been determined that there are a limited number of studies in which training, telephone monitoring and counseling are provided to caregivers the originality of this study, which was conducted to evaluate the effect of web-based training given to caregivers on the pressure injury development of bedridden patients, addiction independence level and care burden of caregivers; the training is designed as web-based and creates a guide that caregivers can use during the care process.

Eligibility criteria:
inclusion criteria: the patient; * being over 18 years of age * being open to communication (mini mental test score \&gt;25 points), * medium or high risk according to the braden pressure injury assessment scale (score ≤14 according to the braden pressure injury risk assessment scale) * being at least a moderately dependent patient according to the barthel index (score ≤90 according to the barthel index) the caregiver; * being primarily responsible for patient care, * being over 18 years of age * having a family bond with the patient, * no monthly fee for providing care, (except for those receiving a monthly care pension from the state) * lack of healthcare workers (physician, midwife, nurse), * ability to read and write, * having a smartphone and internet access, * accepting a home visit, * there is no physical or psychiatric obstacle that prevents communication, exclusion criteria: the patient; * having cancer, * having an active skin disease, * blood glucose and blood pressure are not under control, * use of medication that may be associated with pressure injury (corticosteroid, immunosuppressive, sedative medication, antineoplastic medication, norepinephrine) is an exclusion criterion from the study. criteria for exclusion from the study the patient; * the patient is hospitalized, * the patient\&#39;s exitus is a criterion for exclusion from the study.

Keywords: pressure injury prevention
aspheric monofocal intraocular lens in pediatric patients

Conditions: Cataract in Child

Summary: to evaluate the performance a new aspheric monofocal intraocular lens (iol) with higher order aspheric optic for far, intermediate, and near vision, in pediatric patients after monolateral cataract surgery.

thirteen patients (mean age 7.6±3.8 years) who underwent cataract surgery and simultaneous implantation of the tecnis eyhance icb00 iol were evaluated. visual acuity was assessed three months after surgery for distance (cdva), intermediate (civa) and near visual acuity (cnva).

Eligibility criteria:
inclusion criteria: * monolateral cataract exclusion criteria: * other ocular diseases * systemic diseases
study of liraglutide in individuals with type 2 diabetes using insulin

Conditions: Type 2 Diabetes

Summary: liraglutide is a glp1 agonist used in the treatment of type 2 diabetes and is is asociated with improved blood glucose control, weight loss and low rates of hypoglycemia when used alone or in combination with metformin. liraglutide has not been extensively tested in people with type 2 diabetes who are taking relatively large doses of insulin (\>50 u/day). often these patients are insulin resistant and despite using large doses of insulin are not able to achieve glucose targets. the rationale for this study is to assess if the addition of liraglutide in addition to usual care versus placebo can improve blood glucose levels in people not achieving a target hba1c of less than 7.0%.


Eligibility criteria:
inclusion criteria: * type 2 diabetes * bmi≤45 kg/m2 * a1c ≥7.5% and ≤10.5% exclusion criteria: * type 1 diabetes * symptoms of poorly controlled diabetes * egfr \<50 ml/min/1.73m2

Keywords: diabetes insulin