Kornimate/medical-research-clean huggingface dataset:
artegraft versus propaten dialysis grafts

Conditions: ESRD; Renal Failure

Summary: compare artegraft and propaten grafts for use in dialysis access to see if one performs better than the other. how long each one lasts until a complication arises or until the graft is no longer used will be compared. the study hypothesis is that the artegraft, being an actual blood vessel, will work better than the manufactured propaten graft.

approximately 50 eligible patients with end stage renal disease (esrd) requiring hemodialysis will be randomized to receive one of these two grafts as part of their standard care. patients will be assessed at 2-3 weeks post-operatively and again at 6 and 12 months for flow characteristics, dialysis adequacy and graft associated complications such as stenosis, infection and thrombosis. data on urea reduction ratio (urr), kinetic modeling (kt/v), and access flow (qb) will be collected at 3, 6, 9 and 12 months via phone call to the hemodialysis center in order to evaluate patency and function. access complications (stenosis, thrombosis, infection) will be treated per our standard protocol. these data will be recorded and then primary, assisted primary and secondary patency rates will be calculated and the graft arms compared using life table analysis.

Eligibility criteria:
inclusion criteria: * \> 18 years of age * candidate for hemodialysis * not a candidate for native av fistula * in need of a new av graft in the upper arm location * artery and vein \> 3mm. * medically stable and have a life expectancy of ≥ 12 months * the patient or legal guardian understands the study and is willing to comply with the requirements. exclusion criteria: * \< 18 years of age * current history or within 6 months of iv drug abuse * chronic hypotension (\<100 mm systolic pressure) not responsive to treatment * pregnant or lactating * known hypercoagulable state * requires only a revision of an existing graft * receiving artery or vein is less than 3 mm in diameter at the time of implantation * known axillary/subclavian occlusion or stenosis that has not been treated * known or suspected systemic infection * heparin sensitivity (known hit) * enrolled in another investigational study. * subject has more than 1 graft in target limb.
intraoperative analysis of cortisol during adrenal vein sampling

Conditions: Primary Hyperaldosteronism

Summary: aldosterone is a hormone produced in the adrenals that helps regulate the salt balance and blood pressure. primary hyperaldosteronism is one of the main endocrine causes of secondary hypertension. the overproduction of aldosteron might in some cases be due to unilateral hyperplasia of the adrenal cortex or a unilateral aldosterone-producing adenoma. in these cases the adrenal can be removed and the patient cured of hypertension. the clinical evaluation of patients with confirmed primary hyperaldosteronism therefore includes selective sampling of blood from the adrenal veins to determine lateralization of overproduction. this is executed as an interventional radiological procedure. the adrenal vein sampling is challenging, and success is determined by measuring another adrenal hormone named cortisol in the blood samples as a marker of a correctly drawn sample. by routine laboratory assays the procedure is evaluated after the patient has been discharged from the hospital. in the study a rapid assay of cortisol will be evaluated, allowing the radiologist to draw new samples during the same procedure if the first set of samples is unsuccessful. the study hypothesis is that intraoperative measurement of cortisol is a useful tool to evaluate successful sampling, and that fewer patients will need a repeated procedure.


Eligibility criteria:
inclusion criteria: * primary hyperaldosteronism * motivated for surgery if applicable * able to give informed consent exclusion criteria: * not able to give informed consent * severe kidney failure
characterization of the iatrogenic drug risk in elderly patients with chronic pain who consult the pain assessment and treatment centre at the nimes university hospital

Conditions: Iatrogenic Drug Risk; Chronic Pain

Summary: chronic pain may be an additional risk factor for drug iatrogeny due to its management and also drug non-compliance in the geriatric population. it seems interesting to carry out an inventory of the iatrogenic risk before and after the consultation at the pain centre to enable us to identify the patients most at risk. this study would make it possible to characterize elderly patients with chronic pain, in order to consider, in a future study, setting up a pharmaceutical consultation.


Eligibility criteria:
inclusion criteria: * the patient must be affiliated or beneficiary of a health insurance * patient ≥ 65 years old * having an outpatient consultation at the pain centre of the nîmes university hospital of for chronic pain * available for pharmaceutical consultation about 30 minutes exclusion criteria: * it is impossible to give information * the patient objects to participating in this study
a study to learn more about how radium-223 affects the quality of life of colombian patients with prostate cancer that has not responded to testosterone lowering treatment and has spread to the bones, and to better understand its safety

Conditions: Prostate Cancer

Summary: the study drug, radium-223, gives off radiation that helps to kill cancer cells in the prostate. it is already available for patients to receive as a treatment for prostate cancer that has not responded to testosterone lowering treatment and has spread to the bones. this type of cancer is called metastatic castration-resistant prostate cancer, also called mcrpc. sometimes, researchers continue studying an available treatment to learn more about how it affects patients' daily lives. in this study, the researchers want to learn more about how radium-223 affects the patients' ability to do their daily tasks. the patients in this study will already be receiving treatment with radium-223 as part of their routine care. the tests and measurements in this study will be done by the patients' own doctors. the researchers will collect information about the patients' treatment and results. the study will include patients with mcrpc who have at least 2 tumors in their bones. these patients will have recently started treatment with radium-223. the patients will have also had surgery or treatment to lower their testosterone levels. but, the treatment did not help their cancer. the study will include about 105 men in colombia who are at least 18 years old. all of the patients will receive radium-223 through a needle put into the vein, also called an intravenous injection. they will visit their doctor's office up to 8 times during 28 weeks. at these visits, their doctors will ask how they are feeling and what medications they are taking, and will take blood samples. the doctors will also give the patients surveys about their physical, social, and emotional health and about the symptoms of their prostate cancer.


Eligibility criteria:
inclusion criteria: * male adult patients (\> 18 years) * label xofigo * signed informed consent * no participation in an investigational program with interventions outside of routine clinical practice. * decision to initiate treatment with radium-223 made as per investigator's routine treatment practice, as treatment option for mcrpc either as first line (naïve), second line (after progression during treatment with enzalutamide or abiraterone) or third line (post-docetaxel). exclusion criteria: * patients with contraindications to the use of radium-223 according to the local label. * patients and who refused to sign the informed consent form.

Keywords: bone metastatic castration resistant prostate cancer radium-223 mcrpc phase iv advance prostate cancer quality of life bone cancer
continuous spinal anesthesia versus combined spinal epidural block

Conditions: Hip Fractures; Knee Arthroplasty; Femur Fracture

Summary: in major orthopaedic surgery of the lower extremities both continuous spinal anesthesia (csa) and combined spinal epidural anesthesia (cse) are safe and reliable anaesthesia methods. our results suggest that both continuous spinal anesthesia and combined spinal epidural anesthesia provide good surgical conditions with a low incidence of complications. the sensory block level and hemodynamic changes were lesser with csa.

240 patients scheduled for hip, knee arthroplasty or fracture of the femur were randomly assigned to receive either csa or cse. blocks were performed in the lateral position at l3-l4 interspace. puncture success, technical difficulties, paresthesia, highest level of sensory and motor block, need for complementary doses of local anesthetic, degree of technical difficulties, cardiocirculatory changes and post dural puncture headache were registered. at the end of the surgery, the catheter was removed and csf leak was evaluated.

Eligibility criteria:
inclusion criteria: * fractures repair of femur, or arthroplasty of either knee or hip exclusion criteria: * hypovolemia * preexisting neurologic disease * coagulation disorders and/or administration of thromboprophylaxis less than eight hours before the start of surgery * infection at the puncture site * agitation or delirium and the presence of a urinary bladder catheter.

Keywords: spinal anesthesia epidural anesthesia orthopedic procedures
prospective randomized trial of moderate vs deep neuromuscular blockade during laparoscopic ventral hernia repair

Conditions: Hernia, Ventral; Neuromuscular Blockade; Pneumoperitoneum

Summary: the proposed study aims to assess the effect of different levels of muscle relaxation on the success of low-pressure insufflation, surgical conditions and patient recovery following laparoscopic repair of a ventral hernia (vhr) between 2 and 10cm in diameter. patients will be randomized to moderate (tof 1-2) or deep (post tetanic count 1-2) relaxation. specific aim 1. compare two different modes of neuromuscular blockade (moderate and deep) on the ability to maintain low insufflation pressure during laparoscopic vhr. all procedures will start with low-pressure insufflation (8 mm hg). surgeon assessment of the conditions will be serially performed during surgery on an established visual scale. if conditions are deemed less than adequate (score 1-2), insufflation pressure will incrementally increase up to 15 mm hg. outcome for this specific aim will be the mean insufflation pressure during each procedure, and the ability to perform low-pressure laparoscopic vhr. specific aim 2. evaluate the success of moderate neuromuscular blockade on the ability to maintain good conditions (visual scale grade 4 or 5) for each. surgical conditions will be considered successful when scores are maintained at 4 or 5 throughout the duration of the procedure. outcome for this aim will be the mean score for surgical condition assessment for each procedure, using a previously published surgeon-driven scoring system (score 4-5 will be used as a surrogate of good visualization). specific aim 3. assess patient recovery with low and high insufflation pressures during laparoscopic vhr. patient overall satisfaction with recovery, pain level, pain medication requirement, ponv incidence and severity will be assessed in multiple time points following surgery. outcomes for this aim will be mean pain (visual scale), ponv severity (analogue score) and incidence (binary outcome), and patient satisfaction using the qor-15 survey. assessments will be performed at 30 minutes, 1, 12 and 24 hours following surgery.


Eligibility criteria:
inclusion criteria: * patients age 18-75 years old * umbilical, ventral, epigastric, spigelian or incisional hernia * plan for laparoscopic ventral hernia repair with mesh * estimated fascial defect between 2-10 cm in maximum diameter exclusion criteria: * allergy to medications delineated in the protocol (muscle blockade, anesthetics, reversal agents) * inability to provide informed consent * body mass index of 35 or over * multiple recurrent hernias (\>1) * creatinine clearance \< 30 ml/min (using the cockcroft-gault calculation)
a study of oral lbh589 in adult patients with advanced hematological malignancies

Conditions: Lymphoma; Leukemia; Multiple Myeloma

Summary: this study evaluated safety, tolerability, pharmacokinetics and preliminary anti-leukemic or anti-tumor activity of lbh589b in adult patients with advanced hematological malignancies


Eligibility criteria:
inclusion criteria: * adult patients (≥18 years old) with advanced hematological malignancies who relapsed after or are refractory to standard therapy, or for which no standard therapy existed; or, were considered inappropriate candidates for standard therapy * world health organization (who) performance status ≤ 2 * patients who met protocol-specified hematologic and non-hematologic laboratory values * patients with adequate liver and renal function exclusion criteria: * concurrent brain metastases or leukemic infiltration of the cerebrospinal fluid * peripheral neuropathy ≥ ctcae grade 2 * unresolved diarrhea ≥ ctcae grade 2 * concurrent severe and/or uncontrolled medical conditions which could compromise participation in the study, including impaired heart function or clinically significant heart disease, and impaired gastrointestinal function or disease that significantly altered aborption of lbh589 * female patients who were pregnant or breast feeding * patients who were unwilling to use an effective method of birth control * patients who took medications specified by the protocol as prohibited for administration in combination with lbh589 * patients with another primary malignancy that required active intervention or were clinically significant

Keywords: hdac inhibitor oral lbh589 lymphoma leukemia multiple myeloma
role of dienogest in the treatment of patient with symptomatic adenomyosis

Conditions: Adenomyosis

Summary: adenomyosis was first described as endometrial glands in the myometrium of the uterus. the current definition of adenomyosis is provided in 1972 'the benign invasion of endometrium into the myometrium, producing a diffusely enlarged uterus which microscopically exhibits ectopic non-neoplastic, endometrial glands and stroma surrounded by the hypertrophic and hyperplastic myometrium


Eligibility criteria:
inclusion criteria: * symptomatic adenomyosis * irregular menstrual bleeding and dysmenorrhea . exclusion criteria: * asymptomatic patients - * non-lactating patient * not desire for pregnancy * no hormonal treatment more than 6 month even contraception e.g iud * no focal lesion of uterus (malignancy ,fibroid or adenxal mass )
mobile phone daily alarm to improve compliance of intranasal corticosteroid among allergic rhinitis patients.

Conditions: Rhinitis, Allergic; Compliance, Medication

Summary: this is a randomized controlled trial to compare the compliance of allergic rhinitis patients towards intranasal steroids between those who use mobile daily alarm reminder and those who do not.

in this single blinded rct, adults with allergic rhinitis are randomized into either he intervention or control arm. the intervention involves installing an alarm with a prerecorded nmessage "have you take your intranasal steroids" which will automatically ring every day on the patients mobile phone. the control arm do not have any alarm set up. both groups are offered counseling and education regarding the importance of compliance to intranasal steroid upon recruitment. daily reminder to take medication may eliminate reason for forgetting medication schedule, hence, improve compliance towards incs among patients with allergic rhinitis. this study aims to assess the effectiveness of using daily mobile alarm on patient's compliance towards incs.

Eligibility criteria:
inclusion criteria: * • patients aged 15 years old to 60 years old with persistent ar * positive spt towards df, dp, bt, cockroach, aspergillus, cat fur * own and able to operate functioning mobile smartphone with built in alarm * able to understand simple instructions * patients who can read in english and malay * newly diagnosed ar or previous patients who only take intranasal corticosteroid less than 4 times per week exclusion criteria: * • patients on immunotherapy * patients with mild intermittent ar * pregnant patients * patient with psychiatric illness * patients with gross anatomical obstruction (severe dns, gross polyposis, nasal tumour) * chronic rhinosinusitis(crs) with or without nasal polyposis * patients who have adverse reaction towards incs * patients with severe hearing loss

Keywords: allergic rhinitis intranasal steroid spray compliance mobile alarm
selenium, as sodium selenite, in the treatment of septic shock

Conditions: Septic Shock; Severe Sepsis

Summary: septic shock is a frequent syndrome with a 45% mortality rate despite intensive care unit (icu) care, where free radicals may play a key role, and a \>40% decrease in plasma selenium concentration is observed. selenium is a trace element with both indirect enzymatic anti-oxidant, and direct oxidant properties. high dose of sodium selenite administration could increase antioxidant cells capacities, and reduce inflammation by a direct paradoxical pro-oxidative effect. we conduct a study to evaluate the effects of selenium treatment in comparison to placebo, in septic shock patients. efficacy will be evaluated by the weaning time of catecholamines.

septic shock - an uncontrolled systemic host response to invasive infection -, leading to multiple organ failure, is a public health issue because of its frequency (\> 1/1000 inhabitants per year), its cost and its 45% mortality rate, remaining high despite all the improvements made in icu for the past 20 years. his physiopathology is better understood with increasing data supporting the key role of free radicals, and a more than 40% plasma selenium concentration decrease that maybe associated with increased morbidity and mortality. meanwhile, for the past 30 years, researches have been conducted on the essential trace element selenium for its requirement for key antioxidant enzymes, through the 21st aa selenocystein, and also for its potentially toxic, pro-oxidant properties. in septic shock, both properties may be useful, antioxidant enzymatic to increase cell defense especially endothelial cells, and direct pro-oxidant action to decrease the genomic response, especially on phagocytic cells. the objective of this study is to evaluate the effects of a high dose of selenium administration, such as selenite, at pro-oxydant initial dose followed by anti-oxidant dose in severe septic shock patients with documented infection. the initial dose was chosen as the highest dose of selenium, as sodium selenite, estimated without severe adverse effects in healthy people for a one-day ingestion. the patients are randomized to receive either the placebo or the selenite at this high initial dose followed by lower doses on a 9-day period. the efficacy will be evaluated by the weaning time of catecholamines, with a special attention to the 6-month mortality rate as first secondary end point.

Eligibility criteria:
inclusion criteria: * hospitalization in icu * severe documented infection * ventilation * circulatory failure requiring high dose of catecholamine * igs ii score \>25 at inclusion * informed written consent exclusion criteria: * pregnancy * end phase chronic disease * limitation of care * shock due to an urinary infection without bacteriemia * peritonitis related to peritoneal dialysis or trauma * preliminary circulatory failure * participating to another clinical trial

Keywords: selenium oxidative stress septic shock sodium selenite
roflumilast versus methotrexate in psoriasis

Conditions: Psoriasis

Summary: roflumilast is a phosphodiesterase-4 (pde-4) inhibitor, which is approved in its oral form for chronic obstructive pulmonary disease, and in its topical form in the treatment of plaque psoriasis. methotrexate is one of the conventional systemic treatments of psoriasis, so the aim of this study is to compare the efficacy and safety of roflumilast and methotrexate in the treatment of psoriasis

phosphodiesterase (pde-4) activity was found to be greater in psoriatic skin than in healthy skin. inhibition of pde-4 inhibits the hydrolysis of cyclic amp in inflammatory cells, which increases intracellular camp and results in down-regulation of immune modulators, including tumor necrosis factor (tnf)- α, interferon-γ, interleukin (il)-17, and il-23. roflumilast is a potent and selective inhibitor of pde-4 which is already approved in its oral form for chronic obstructive pulmonary disease. regarding roflumilast's topical form, it is currently also approved in the treatment of psoriasis. lebwohl et al., 2020 found that roflumilast cream was efficacious in reducing the severity of psoriasis in a 12-week, randomized, double-blind, placebo vehicle-controlled trial.

Eligibility criteria:
inclusion criteria: 1. patients with psoriasis vulgaris 2. psoriatic patients not receiving any relevant systemic treatment for at least 4 weeks before initiation of our study 3. psoriatic patients not receiving any relevant topical treatment for at least 2 weeks before initiation of our study exclusion criteria: 1. erythrodermic or pustular psoriasis 2. pregnant and lactating females 3. patients with autoimmune diseases e.g. systemic lupus erythematosus 4. patients with solid or hematological malignancies e.g., breast cancer, leukemia, etc.