Kornimate/medical-research-clean huggingface dataset:
pharmacokinetics of 122-0551 and its effects on adrenal suppression

Conditions: Plaque Psoriasis

Summary: adrenal suppression effects of corticosteroids are among the most important safety concerns for this group of products. this study is designed to determine the adrenal effects of the investigational formulation of 122-0551 and characterize the steady state pharmacokinetics of the formulation.


Eligibility criteria:
inclusion criteria: * subject has a clinical diagnosis of stable plaque psoriasis exclusion criteria: * subject has spontaneously improving or rapidly deteriorating plaque psoriasis * subject has guttate, pustular, erythrodermic or other non-plaque forms of psoriasis * subject has used any phototherapy, photo-chemotherapy or systemic psoriasis therapy within 30 days prior to initiation of treatment * subject has used systemic corticosteroids or topical, inhaled, intranasal corticosteroids within 30 days and 14 days, respectively, prior to study screening * subject has had prolonged exposure to natural or artificial sources of ultraviolet radiation within 30 days prior to initiation of treatment * subject has used topical psoriatic therapy including tar, anthralin, retinoids, vitamin d analogs (e.g., dovonex®) within 14 days prior to initiation of treatment * subject has used emollients/moisturizers on areas to be treated within one day prior to initiation of treatment * subject is currently using lithium or plaquenil (hydroxychloroquine) * subject is currently using a beta-blocking medication (e.g., propranolol) or angiotensin converting enzyme (ace) inhibitors (e.g., lisinopril) at a dose that has not been stabilized * subject is pregnant, nursing or planning a pregnancy during the study period * subject is currently enrolled in an investigational drug, biologic or device study * subject has received an investigational drug, biologic or an investigational device within 30 days prior to study start * subject has been previously enrolled in this study and treated with the test article * subject has an irregular sleep schedule or works night shifts

Keywords: 122-0551 steroid hpa
influence of profound muscle relaxation on muscle trauma and postoperative pulmonary function

Conditions: Profound Muscle Relaxation; Muscle Trauma; Postoperative Analgesic Demand; Postoperative Pulmonary Function

Summary: although deep anesthesia can produce skeleton muscle relaxation,unnecessary deep anesthesia often had adverse cardiac effects and was related to 2-year mortality in cancer patients.the use of muscle relaxants allowed the depth of anesthesia to be optimized.however, for many anesthesiologists,in fear of residual postoperative neuromuscular blockade,intraoprative administration of muscle relaxants had to be minimized in spite of poor surgical conditions. this study, however, is designed to test the hypothesis that profound neuromusclular blockade reduces muscle trauma caused by self-retaining retractor and thus cut down postoperative analgesic requirement.on the other hand,profound muscle relaxation can decrease postoperative diaphragmatic dysfunction and abdominal muscle trauma, which can improve postoperative pulmonary function.


Eligibility criteria:
inclusion criteria: * asa 1\~2,scheduled to undergo upper abdominal surgery by midline incision exclusion criteria: * neuromuscular disorder * history of malignant hyperthemia * allergy to medications used during general anesthesia

Keywords: profound muscle relaxation muscle trauma postoperative analgesic demand postoperative pulmonary function
the efavirenz (efv) central nervous system exposure sub-study of encore1

Conditions: HIV Infection

Summary: persistent hiv infection in the central nervous system (cns) compartment may put subjects at risk of developing hiv-related brain disease. important factors associated with the development of hiv-related brain disease include therapeutic concentrations of antiretroviral drugs in the cns. conflicting evidence regarding the cns exposure of the antiretroviral drug used for the encore1 study, efavirenz (efv) have been described in related studies. there were recent study of two small series assessment of efv exposure in the cerebral spinal fluid (csf); one group reported small detectable efv concentrations, while another observed undetectable efv exposure in the csf. also, in a larger reported series comprising of 80 subjects on efv-containing antiretroviral therapy, a csf to plasma concentration suggested that there is limited movement of efv out of the csf. in hiv-1 infected subjects at steady state, efv plasma level parameters are dose proportional following 200mg, 400mg, and 600mg daily doses. the cns exposure of efv at different daily dosing has not been described.


Eligibility criteria:
inclusion criteria: * all subjects entering into the main study protocol at participating centres will be eligible to enter this sub-study. exclusion criteria: * existing neurological disease which in the opinion of the investigator would be a contra-indication to lumbar puncture examination * cns opportunistic infections in the past 12 weeks of randomisation * bacterial or viral meningitis in the past 12 weeks of randomisation * head injury requiring medical assessment in the past 12 weeks of randomisation

Keywords: hiv efavirenz central nervous system (cns) lumbar puncture dose reduction
bone marrow transplant chart review for ric

Conditions: Myelofibrosis

Summary: we will evaluate the records of 30 patients that have undergone allogeneic transplant, specifically looking at engraftment rate, relapse rate, disease free survival, overall survival, causes of death and other pertinent statistics. we will compare the outcomes to appropriate historical controls.

primary myelofibrosis (pmf) is among the philadelphia chromosome negative myeloproliferative disorders. this diagnosis can be present at a patient's initial diagnosis or it can arise out of preceding polycythemia vera or essential thrombocythemia. while the clinical course is variable, it is defined by varying degrees of splenomegaly, anemia, fatigue and other constitutional symptoms. patients with pmf are at increased risk of acute leukemia, bone marrow failure and thrombosis. currently, the only curative treatment for pmf is allogeneic stem cell transplant. however, as the median age at diagnosis is in the mid to late 60s, most patients are no longer candidates for transplant due to their age and/or other comorbid illnesses. unfortunately, all other treatments for pmf are palliative in nature and often of limited efficacy. over the last several years, many advances have occurred that have increased the safety and improved the outcomes of allogeneic transplants. perhaps most important has been the ongoing refinement of reduced intensity conditioning (ric) regimens prior to transplant. over the last few years, many groups have published data suggesting that these ric transplants can be very effective in the treatment of pmf and it is felt to be a potentially curative procedure. however, the vast majority of these data are reported in persons younger than 65 years old. the current protocol for ric transplant for pmf available at the university of utah excludes patients older than the age of 65. we would like to see if there is sufficient successful experience with transplant in persons older than 60 years old (including many older than 65 years of age) to justify the creation of a clinical trial using ric regimens in this older age group. we will be reviewing the medical records of approximately 30 patients at four different institutions: * university of utah/huntsman cancer hospital * fred hutchinson cancer research center * baylor college of medicine * m.d. anderson cancer centers we will evaluate: engraftment rate, relapse rate, disease free survival, overall survival, causes of death and other pertinent statistics. we will compare the outcomes to appropriate historical controls. we hypothesize that ric regimens may be justifiably safe in older patients with pmf and hope that our data will allow the development of a corollary clinical trial.

Eligibility criteria:
inclusion criteria: * \> 60 years of age * diagnosed with primary myelofibrosis * undergone allogeneic transplant exclusion criteria: * any subjects not meeting the criteria above

Keywords: bone marrow transplant myelofibrosis stem cell transplant allogenic transplant
mean systemic filling pressure and heart performance predicting fluid responsiveness in sepsis

Conditions: Cardiac Output, High

Summary: the purpose of this study is to determine fluid responsiveness in critically ill patients by measuring mean systemic filling pressure on the intensive care unit.

the assessment of the cardiovascular state in critically ill patients is subject to difficulties in terms of the fact that several hemodynamic parameters, for example mean arterial blood pressure (map) and cardiac output (co) supply insufficient information about the circulating volume and cardiac performance. there is a clinical need to adequate determination of intravascular volume status and therefore reliable predictors of fluid responsiveness are highly relevant. however, in determining the fluid status of a patient, the lack of appreciation of the venous side of the circulation persists today, which is greatly due to the inability to appropriately assess the venous side of the circulation. the importance of the venous part of the circulation is moreover reflected by the fact that an increase in venous resistance does reduce co many times more than a similar increase in arterial resistance. mean systemic filling pressure (pms), which is defined as the pressure equal to the pressure which would be measured if the heart should suddenly stop pumping and all (arterial and venous) the pressures in the entire circulatory system should be brought to equilibrium instantaneously, is a good, complete and reliable reflection of the total intravascular fluid compartment. passive leg raising (plr) represents a "self-volume challenge" that predicts preload responsiveness and the transient hemodynamic changes on venous return can be directly monitored in ventilated patients, provided that there is an intact circulation, in order to test the amount of volume responsiveness.

Eligibility criteria:
inclusion criteria: * patients must be older than 18 years, and must be equipped with a pulse-contour cardiac output system with a central venous catheter. * patients will be subsequently connected to the hemodynamic monitoring device navigator™. * in those patients with clinical signs of inadequate tissue perfusion, passive leg raising and standardized fluid challenge will be performed. exclusion criteria: * patients with assist devices (e.g. intra aortic balloon pump, impella®, ecmo), patients with arrhythmias (either atrial of ventricular) will be excluded from the study. * also, patients with inguinal impairment or contraindications for a passive leg raising will be excluded (such as deep venous thrombosis or elastic compression stocking), head trauma, an increase intra-abdominal pressure suspected by clinical context and examination as well as patients with absolute contraindications for fluid challenge.

Keywords: volume responsiveness mean systemic filling pressure
magnetic compression anastomosis for recanalization of biliary stricture

Conditions: Biliary Anastomotic Stricture; Biliary Tract Diseases; Cholestasis, Extrahepatic; Endotoxicosis

Summary: biliary stricture is a common complication after end-to-end biliary anastomosis, especially after liver transplantation. this study is designed to investigate the safety and efficacy of magnetic recanalization technique, a newly clinical method, for treating biliary anastomotic stricture.

biliary anastomotic stricture is a common complication of after end-to-end biliary anastomosis. magnetic recanalization is a promising way to establish connection of biliary tract after stenosis or completed obstruction. this study is designed to investigate the safety and efficacy of magnetic recanalization among patients with severe biliary stricture after biliary anastmosis. patients who failed to undergo stent placement with endoscopic retrograde cholangiopancretography (ercp) would be enrolled for magnetic recanalization treatment. magnetic treatment will be implemented by several steps. firstly, placement of one magnet through the sinus of percutaneous transhepatic cholangio drainage (ptcd) in upper part of the bile duct; second, introduction of another magnet via ercp into the distal part of the bile duct, and making them be mated together; third, after necrosis of the tissue between the two magnets, the magnets will drop off and be taken out together through the thread connected with them out of the mouth. last, a plastic stent should be placed in the bile duct for a lasting support. the time of recanalization (drop off of the magnets), and adverse events (e.g. fever, melena, nausea, vomiting, anorexia, hematemesis, abdominal pain, and gastrointestinal bleeding) will be recorded, and each patient will be followed up for long-term outcomes.

Eligibility criteria:
inclusion criteria: * 1. age ≥ 18 years old and ≤65 years old * 2. patients with biliary stricture after end-to-end biliary anastomosis exclusion criteria: * 1. pregnant woman * 2.have a history of cardiovascular disease, including coronary heart disease (angina pectoris, myocardial infarction, coronary angiogenesis or electrocardiographic abnormal q wave (ecg)), stroke (ischemic or hemorrhagic, including transient ischemic attack) * 3. severe lung diseases such as copd and asthma * 4. patients with acute infection or inflammation (i.e. pneumonia) * 5. any other medical condition considers the longest survival time to be less than 2 years * 7. immunodeficiency or hiv positive * 8. no autonomy, inability to participate in follow-up * 9. illiterate

Keywords: magnetic recanalization biliary anastomotic stricture biliary tract diseases cholestasis, extrahepatic
postoperative pain and analgesic requirements after preoperative methadone for primary tka

Conditions: Osteoarthritis (OA) of the Knee

Summary: the goal of this prospective, randomized study is to compare the outcomes of two cohorts of patients undergoing primary total knee arthroplasty (tka) and to determine whether a single dose of methadone administered preoperatively is effective at reducing postoperative opioid usage and postoperative pain versus a control group of patients receiving standard intraoperative opioids only for primary tka. the main questions it aims to answer are: * what is the efficacy of a single preoperative dose of methadone in reducing opioid consumption and postoperative pain in primary total knee arthroplasty? * will the study results demonstrate the effectiveness and safety of a single preoperative dose of methadone (10 mg) in primary total knee arthroplasty in reducing postoperative opioid usage while maintaining a similar or better level of pain control when compared to a standard pain control regimen? researchers will compare methadone to a standard pain control regimen (oxycodone) to see if methadone is equivalent or more effective at reducing opioid consumption and postoperative pain in primary total knee arthroplasty participants will: * be randomized into one of two groups * undergo a primary tka * complete a tracking sheet documenting daily pain medicine usage and vas pain level for the first 14 days following the tka * return to office at 2 weeks and 6 weeks postop for follow-up * complete additional questionnaires at 2 weeks and 6 weeks postop


Eligibility criteria:
inclusion criteria: 1. patient age is 21-89 at time of surgery 2. patient is scheduled to undergo a unilateral primary tka, secondary to osteoarthritis 3. patient agrees to participate as a study subject and signs the informed consent and research authorization document 4. patient is able to read and speak english. exclusion criteria: 1. patient is under the age of 21 2. patient's primary diagnosis is not osteoarthritis 3. patient is unable to read and speak english 4. history of liver or kidney disease, 5. known or suspected gi obstruction 6. hypersensitivity to methadone 7. patients with significant respiratory depression 8. pregnant or nursing females

Keywords: osteoarthritis knee total knee arthroplasty prospective rct preoperative analgesia methadone
bubble continuous positive airway pressure (cpap) with conventional cpap for extubation in preterm infants

Conditions: Extubation Failure

Summary: the objective of this study is to evaluate whether cpap delivered by bubble cpap resulted in a greater proportion of infants being successfully extubated when compared with management with ventilator derived cpap.

there have been no published randomized trials comparing extubation failure rates of bubble cpap with conventional ventilator derived cpap. infants of gestation \<32 weeks and of birth weight less than 1500 grams considered by the treating team to be ready for the initial extubation within first week of life were screened for enrolment. all eligible neonates were randomly allocated to bubble cpap or conventional cpap.the purpose of this study is to compare whether infants on bubble cpap had more chances of successful extubation as compared to infants put on conventional cpap.

Eligibility criteria:
inclusion criteria: * gestation less than 32 weeks * birth weight less than 1500 g * age less than seven days * first extubation attempt. exclusion criteria: * a neonate having any of the following will be excluded from the study- * severe birth asphyxia defined as need for chest compression for more than 30 seconds * suspected congenital neuromuscular disorder * major congenital malformation * grade 3/4 interventricular haemorrhage * hydrops.

Keywords: extubation failure continuous positive airway pressure bubble cpap
complications in body contouring surgery

Conditions: Bariatric Surgery; Body Contouring Surgery

Summary: the objective of this study is to describe the wound related complication rate in post-bariatric body contouring surgery patients who are treated according to the new dutch guideline and to asses the factors associated with a higher complication rate.

in the recently published guideline of the dutch association of plastic surgeons it is advised that assessment and improvement of the nutritional status should be part of pre-operative work-up of all post-bariatric patients who undergo body contouring surgery (bcs). the assessment should consist of consultation of a dietician and measurement of the nutritional parameters associated with wound healing. it is advised to assess the following parameters: * albumin * hemoglobin * vitamin d (25-hydroxy vitamin d) * ferritin * folic acid * vitamin b12 standard treatment in this study will consist of the pre-operative work-up as advised by the guideline. participants will have a consultation with the dietician to assess (protein) intake. in addition the first blood sample, which is part of standard treatment according to the new protocol, will be obtained to assess foregoing parameters. if there are nutritional deficiencies they will be treated according to the protocol of the department of bariatric surgery of the treating hospital. to evaluate the effect of the treatment of deficiencies and to be sure that there are no deficiencies present during the bcs a second blood sample will be drawn during the body contouring procedure. for study purposes this second sample will be collected in all patients, even if a deficiency was not present at the first blood sample. the dietician will assess current intake of the patients, with special attention the protein intake. based on guidelines on protein-intake in post-bariatric patients and after consultation of experts (dieticians of maastricht university) investigators decided that the aim of the minimum protein intake is 1.5 gram per kilogram bodyweight (calculated with bmi 27kg/m2) per day. the first consultation at the dietician will be eight weeks prior to surgery. patients will be advised to start with the extra protein-intake four weeks prior to surgery and continue this until the wounds are completely healed. six weeks after surgery a questionnaire will be handed-out to the patients, to assess the compliance to the treatment regime.

Eligibility criteria:
inclusion criteria: * post-bariatric patient * undergoing bcs because of skin surplus * contouring in one of the following regions: abdomen, mammae, legs, arms, upper body or lower body. exclusion criteria: * bmi higher than 34.9 kg/m2 * weight unstable in last 12 months * diabetes mellitus defined by currently using either oral medication or insulin * active smoker * using immunosuppressive drugs, e.g. corticosteroids, methotrexate * using anti-coagulants other than acetylsalicylic acid * coagulopathy, vasculitis, connective tissue disorder * kidney failure (gfr\<30) or liver failure

Keywords: nutritional deficiencies plastic surgery post-bariatric protein skin surplus
laparoscopic versus robot-assisted inguinal hernia repair: a single institution randomized controlled trial

Conditions: Hernia, Inguinal

Summary: randomized trial to compare outcomes of laparoscopic and robot assisted inguinal hernia repair.

inguinal hernia repair is a very common surgical operation. both laparoscopic and robot-assisted operations are considered acceptable. however, there is no clear indication for a particular approach. no prospective trial has been conducted so far to establish superiority of one approach over the other. the investigator believes each approach has unique characteristics and may offer advantages over the other in the right population group. the investigator will randomly assign patients in two arms according to the surgical approach, whether laparoscopic or robot-assisted. the investigator will collect preoperative characteristics, intraoperative variables, and postoperative outcomes. the investigator will compare all variables to establish differences between the two groups.

Eligibility criteria:
inclusion criteria: * surgeon determined need for inguinal hernia repair exclusion criteria: * \< 18 years of age * \> 99 years of age * medical indication for open repair

Keywords: robot-assisted
weekly vaccination with copaxone as a potential therapy for dry age-related macular degeneration

Conditions: Dry Age Related Macular Degeneration

Summary: the purpose of the project is to investigate in eyes with dry amd, the efficacy and safety as preventive therapy of the immunomodulatory substance named copaxone which had been proven as safe and effective agent for a neurodegenerative disease, in arresting the progression as well as the conversion of dry amd to wet amd. the hypothesis that the immunomodulatory agent copaxone proven for a neurodegenerative disease may work in the eye is revolutionary and may open a new avenue of preventive treatment for the disease which is the major cause of legal blindness in the industrial world


Eligibility criteria:
inclusion criteria: 1. dry amd in one or both eyes 2. age 50 or above of either gender 3. signed informed consent. exclusion criteria: 1. known sensitivity to mannitol or copaxone. 2. skin disease or active infection of skin. 3. active fever or active treatment for infection. 4. history of other uncontrolled systemic active disease. 5. premenopausal females not using reliable birth control. 6. sensitivity to fluorescein or iodine. 7. inability to comply with study procedures.

Keywords: dry age related macular degeneration dry amd