Kornimate/medical-research-clean huggingface dataset:
study of a strategy to prevent oversedation in intensive care patients under mechanical ventilation

Conditions: ICU Patients Requiring Invasive Mechanical Ventilation

Summary: the purpose of the present study is to determine whether administration of sedation according to a strategy including a bundle of measures to prevent oversedation is associated with a reduction in mortality of intensive care unit patients requiring mechanical ventilation, compared to administration of sedation according to usual practices.

in intensive care unit (icu) patients receiving mechanical ventilation (mv), potent hypnotics and morphinics are frequently administered to increase synchrony with the ventilator, control agitation and decrease discomfort and pain due to the tracheal tube, bed ridding, painful condition and diagnostic or therapeutic procedures. however, administration sedatives or morphinics is often excessive and may result in deep and prolonged alteration of consciousness, delayed weaning from mv and prolonged mv. and exposes the patient to a higher risk of ventilator-associated pneumonia, icu delirium and neuromuscular weakness at awakening. the present randomized multicenter study will compare the day-90 mortality of a group of patients receiving conventional sedation to the mortality of a group of patients receiving sedation administered according to an algorithm aimed to prevent oversedation to the mortality. the algorithm is built on a graduate therapeutic response to increasingly intense symptoms of discomfort, pain, ventilator dyssynchrony and agitation, and includes the use of analgesics, non hypnotic benzodiazepines, neuroleptics, repeated intravenous (iv) boluses of hypnotics and short duration (6 hours) iv hypnotic infusions.

Eligibility criteria:
inclusion criteria: * age 18 and older * admission to icu with expected mechanical ventilation duration \> 48 hrs * mechanical ventilation in icu for less than 12 hours * information provided to the patient or proxy exclusion criteria: * icu admission after cardiac arrest * acute or chronic neuromuscular disease * tracheotomy on icu admission * acute cerebral injury with intracranial hypertension requiring continuous iv sedation with or without neuromuscular blockade * status epilepticus * treatment withdrawal decision * pregnancy, breast feeding * concurrent participation in another interventional study requiring a change in usual practice of sedation or mechanical ventilation

Keywords: intensive care mechanical ventilation sedatives morphinics oversedation mortality midazolam propofol pain agitation
ae05ml device for ml hem-o-lok polymer clip delivery in laparoscopic surgical procedures observational registery study

Conditions: Gall Bladder Disease; Bile Duct Diseases; Acute Cholecystitis; Kidney; Liver; Appendix; Spleen Disease; Prostate

Summary: this clinical registry study aims to evaluate the safety and effectiveness of the ae05ml device for ligating vessels and tissue structures during laparoscopic surgery using hem-o-lok® medium large (ml) polymer clips. the primary objective is to assess the device's safety and performance, with secondary objectives focusing on device performance characteristics and operator feedback.

the objective of this clinical registry study is to evaluate safety and performance of the weck® auto endo5® 5 mm automatic endoscopic 35 cm applier device (teleflex incorporated, morrisville, nc, usa - further referred to as ae05ml) for delivery of hem-o-lok® medium large (ml) polymer clips for the purpose of vessel / tissue structure ligation in laparoscopic surgery. this is a prospective, observational, multi-center, clinical registry study. all subjects will undergo vessel / tissue structure ligation using ae05ml during their indicated laparoscopic procedure as per standard of care and institutional policy and procedure. the primary objective is to evaluate the safety and performance of ae05ml for delivery of ml hem-o-lok polymer clips for the purpose of vessel / tissue structure ligation in adult subjects during laparoscopic procedures. primary endpoints * safety: incidence of device related adverse events (ae) * performance: success / failure of polymer clip delivery attempts the secondary objectives are to evaluate device performance characteristics and operator reported feedback regarding their experience using the device for each case. secondary endpoint • results of device performance and operator feedback questionnaire

Eligibility criteria:
inclusion criteria: * age 18 years or older * scheduled for a laparoscopic procedure in which ae05ml will be used for vessel / tissue structure ligation * capable of providing informed consent for participation exclusion criteria: * imprisoned * cognitively impaired and unable to provide informed consent
safety study of intracerebral topotecan for recurrent brain tumors

Conditions: Brain Neoplasms, Primary Malignant

Summary: this study will evaluate the safety and efficacy of a chemotherapeutic drug (topotecan) as it is given directly into brain tumors by a delivery technique called convection-enhanced delivery. this drug has been used for different types of cancer, but in this study it will be given by an experimental delivery technique designed to maximize the amount of drug delivered to the brain tumor and minimize the side effects in other parts of the body. this study will also evaluate advanced magnetic resonance (mr) imaging techniques. the study will assess quality of life parameters throughout the follow-up period.

clinical efficacy with chemotherapy has been discouraging for malignant brain tumors, mostly because of side effects and delivery limitations. because they are locally invasive and rarely metastasize, malignant gliomas have features that make them uniquely amenable to new strategies of regional drug delivery. intracerebral clysis (convection-enhanced delivery) is a novel drug delivery strategy that uses a microinfusion pump to establish a pressure gradient in the brain via implanted catheters. the pressure gradient produces convective forces that distribute a therapeutic agent throughout the tumor and surrounding brain tissue. non-invasive magnetic resonance imaging (mri) methods of monitoring drug distribution and treatment response have been developed to maximize the clinical applications and minimize complications associated with treatment risks. study participants will be taken to the operating room to have 2 catheters surgically placed into their tumor and surrounding tumor bed. these catheters will then be connected to small infusion pumps which will slowly infuse topotecan continuously over 4-5 days. patients will have daily mri scans while in the hospital. upon completion of the experimental treatment, patients will be discharged and will be followed up in the outpatient clinic.

Eligibility criteria:
inclusion criteria: * single primary malignant brain tumor * previous treatment with external beam radiation * tumor is stereotactically accessible * karnofsky performance score of at least 60 exclusion criteria: * diffuse subependymal or cerebrospinal fluid (csf) disease * tumor involves brainstem, cerebellum or both hemispheres * active infection * systemic disease associated with unacceptable anesthetic/operative risk * previous treatment with topotecan * unable to receive mri scans

Keywords: recurrent primary malignant brain tumors brain tumors neoplasms, brain brain cancer brain cancer treatment topotecan
correlation between body mass index, selective motor control and functional ability in children with cp

Conditions: Diplegic Cerebral Palsy

Summary: purpose: to investigate the correlations between body mass index, spasticity, functional ability and isolated motor control in children with spastic diplegia. background: cerebral palsy is primarily a disorder of movement and posture hypotheses: there is no correlation between body mass index, spasticity, functional ability and isolated motor control in children with spastic diplegia. research question: is there a correlation between body mass index, spasticity, functional ability and isolated motor control in children with spastic diplegia?

this is an observational correlational study. scale will be used to assess selective motor control of lower extremity. gmfm-88 and wee fim will be used to assess functional ability. mas will be used to assess degree of spasticity

Eligibility criteria:
inclusion criteria: * spastic diplegic cp, age from 6 to 9 years, able to follow verbal commands or instructions during testing procedures, 1+ and 2 according to modified ashworth scale (mas), (gmfcs e\&r) selected level ii , iii. exclusion criteria: * patients who had contractures or fixed deformities related to the joints of the lower limbs, injection with botulinium toxin or any orthopaedic surgery in lower limbs within one year before study,

Keywords: isolated motor control functional ability body mass index cerebral palsy
quality of life in patients with congenital afibrinogenemia

Conditions: Afibrinogenemia, Congenital

Summary: the aim of this observational study is to evaluate the quality of life in patients with congenital afibrinogenemia using the haemo-qol sf for kids and the haem-a-qol for adult patients.

in this observational study, children and adults suffering from congenital afibrinogenemia confirmed by biology will be enrolled. all patients will receive a questionnaire on quality of life in their own language during a routine visit and filled out by the patient at home. a general questionnaire will be filled out by the patient's physician.

Eligibility criteria:
inclusion criteria: * congenital afibrinogenemia confirmed by biology (absence of circulating fibrinogen) and genotype exclusion criteria: * lack of participant's consent * patient unable to understand the questionnaire

Keywords: congenital fibrinogen disorders
localvancomycinpowdertopreventperiprostheticjointinfection.

Conditions: Arthroplasty Complications; Periprosthetic Fracture of Hip

Summary: the purpose of this study is to evaluate the efficacy and complication profile of local vancomycin application in primary arthroplasty. the investigators hypothesized that the use of local antibiotics would decrease the rate of infection compared to controls and this will be achieved by applying 1 gm of vancomycin powder intracapsularly.

periprosthetic joint infection is a truly devastating complication of total joint arthroplasty (tja), causing most patients to undergo a revision surgery and to bear significant psychological and financial burden. surveys suggest patients of total joint arthroplasty undergoing revision for infection have poorer functional outcomes and satisfaction levels than patients undergoing revision for other reasons, with negative consequences being more persistent . despite developments in infection prophylaxis and risk factor mitigation, patients with periprosthetic joint infection represent a substantial societal and monetary cost to our value-based health care system. thus, there is significant interest in developing and systematically evaluating new pji prophylaxis measures to reduce this rate. historically, local wound vancomycin powder has been shown to safely reduce infection rates in spine surgery. the earliest and strongest support for local vancomycin powder for primary orthopedic surgery came from the spine literature, and it now has support in the shoulder and elbow and foot and ankle literature. the use of topical vancomycin was first reported in 1989 when the application of topical vancomycin to the sternum in cardio thoracic patients reduced rates of sternal infection from 3.6% to 0.45%). similarly, multiple studies have shown that vancomycin decreases the rate of postoperative infections in patients undergoing spinal surgery. importantly, data on topical vancomycin powder used alone remain inconclusive for tja, with some stating that it may increase aseptic wound complications, and others stating that it reduces pji significantly .

Eligibility criteria:
inclusion criteria: all patients population who will undergo primary total knee or total hip arthroplasty exclusion criteria: * patients with diabetes mellitus inflammatory arthritis diseases smokers bmi \> 40
exploratory study on two different doses of vml-0001 on the effects on vaginal ph in healthy post-menopausal women

Conditions: Vaginal Atrophy

Summary: the study is designed to determine the effect on vaginal ph and the duration of action measured on the ability of the base formulation to reduce the vaginal ph


Eligibility criteria:
inclusion criteria: * be greater than 45 years * no positive findings on screening gynaecological examination * negative smear test within the last 5 years exclusion criteria: * has signs of vaginal infection * has evidence of alcohol abuse * has used hormonal replacement therapy in three months prior to study entry
effect of triflow breathing training

Conditions: Hemodialysis Complication; Haemolyses and Related Conditions

Summary: this study aims to explore whether an 8-week triflow breath training program reduced the anxiety levels and improved the heart rate variability and quality of life of patients receiving hemodialysis. to investigate the effect of the triflow respiration training on the improvement of heart rate variability, anxiety, and the quality of life in hemodialysis patients.

method:this research adapted the cluster randomization design. the participants were divided into the first group of patients undergoing hemodialysis every monday, wednesday, and friday and the second group undergoing dialysis every tuesday, thursday, and saturday. the experimental group and the control group were randomly assigned by a coin toss. the investigators conducted the study for eight weeks and investigated the effects of respiration training on the improvement of heart rate variability, anxiety, and quality of life in hemodialysis patients. patients in the experimental group receive the triaflow respiration training three times a week for eight weeks during hemodialysis. data were collected by a heart rate variability monitor, state-trait anxiety inventory and whoqol-bref at baseline and after a 8-week respiration training.

Eligibility criteria:
inclusion criteria: 1. long-term hemodialysis is required to treat patients with end-stage renal disease diagnosed by a physician. 2. blood older than or equal to 65 years old and under 80 years old with diabetes dialysis patients. 3. hemodialysis has been accepted for more than three months and is still under treatment and half there were no hospitalizations for other comorbidities during the year. 4. those who are conscious and have no serious mental symptoms, can talk and express and agree to subject to respirator training and questionnaires. 5. available country and taiwanese communicators. 6. the average score of the situational trait anxiety scale is greater than 20 points. exclusion criteria: 1. patients with low blood pressure during dialysis can not raise the bed to 30 degrees. 2. blindness and hearing or long-term bedridden. 3. there are cases of irregular heartbeat. 4. the daily activity scale is less than or equal to 60 points (the study uses the barthel index).
a dose-ranging, study of the safety and efficacy of subcutaneous injections of lipo-102 compared with placebo for the reduction of abdominal subcutaneous adiposity

Conditions: Weight

Summary: lipo-102 is under evaluation for treatment of abdominal adiposity


Eligibility criteria:
inclusion criteria: * 18 - 50 years old inclusive * localized area of abdominal subcutaneous adiposity of grade 3 or above on the p-pns or c-pns * bmi \< 25kg/m sq * stable diet and exercise and body weight exclusion criteria: * prior treatment of abdominal subcutaneous adipose tissue * females within 12 months postpardum * known hypersensitivity to the drugs or components

Keywords: treatment of abdominal adiposity
study to characterize the local duration of exposure from fx006 in patients with osteoarthritis of the knee

Conditions: Osteoarthritis of the Knee

Summary: the purpose of this study was to characterize the local duration of exposure of tca for 2 doses of fx006 relative to 40 mg of tca ir in patients with oa of the knee.

this study was an open-label, single administration design, conducted in male and female patients ≥40 years of age with oa of the knee. patients were enrolled sequentially with 8 patients per cohort, as follows: cohort a: fx006 40 mg, final visit at week 20 cohort b: fx006 40 mg, final visit at week 16 cohort c: fx006 10 mg, final visit at week 12 cohort d: fx006 40 mg, final visit at week 12 cohort e: triamcinolone acetonide immediate-release (tca ir) 40 mg, final visit week 12 each patient was evaluated for up to 12, 16, or 20 weeks following a single ia injection depending on the assigned cohort. following the screening visit, safety was evaluated at 3 out-patient visits and synovial fluid was collected at day 1 for baseline measurements and the final visit for drug concentration measurements.

Eligibility criteria:
key inclusion criteria: * written consent to participate in the study * willingness and ability to comply with the study procedures and visit schedules and ability to follow verbal and written instructions * has documented diagnosis of oa of the index knee made at least 6 months prior to screening * currently meets american collage of rheumatology criteria (clinical and radiological) for oa * index knee pain for \>15 days over the last month * body mass index (bmi) ≤ 40 kg/m2 * ambulatory and in good general health key exclusion criteria: * history of reiter's syndrome, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, arthritis associated with inflammatory bowel disease, sarcoidosis or amyloidosis * history of arthritides due to crystals (e.g., gout, pseudogout) * history of infection in the index joint * clinical signs and symptoms of active knee infection or crystal disease of the index knee * presence of surgical hardware or other foreign body in the index knee * unstable joint (such as a torn anterior cruciate ligament) within 12 months of screening * ia corticosteroid (investigational or marketed) in any joint within 6 months of screening * ia hyaluronic acid (investigational or marketed) in the index knee within 6 months of screening * oral corticosteroids (investigational or marketed) within 1 month of screening * inhaled, intranasal and topical corticosteroids (investigational or marketed) within 2 weeks of screening * any other ia investigational drug/biologic within 6 months of screening * prior use of fx006 * prior arthroscopic or open surgery of the index knee within 12 months of screening * planned/anticipated surgery of the index knee during the study period * active or history of malignancy within the last 5 years, with the exception of resected basal cell carcinoma, squamous cell carcinoma of the skin, or resected cervical atypia or carcinoma in situ

Keywords: osteoarthritis knee corticosteroids triamcinolone acetonide synovial fluid
effects of iloprost on hypoxic pulmonary vasoconstriction and exercise capacity at high altitude

Conditions: Hypoxic Pulmonary Vasoconstriction

Summary: the objective of this study is to determine if single dose administration of inhaled iloprost will reduce pulmonary artery pressure, reduce hypoxic pulmonary vasoconstriction and improve arterial oxygenation at rest and during exercise at high altitude.

three major pathways in addition to oxygen modulate pulmonary vascular tone: 1) nitric oxide, 2) endothelin, and 3) prostacyclin. considerable animal data support the role of the prostacyclin pathway in modulating hypoxic pulmonary vasoconstriction. in humans, prostacyclin and its analogs are important therapeutic agents in the treatment of pulmonary arterial hypertension (pah). despite the animal data and human data in pah there is very little information about the use of iloprost to relieve hypoxic pulmonary vasoconstriction in healthy humans. inhaled iloprost is an ideal agent to study the prostacyclin pathway due to its short duration of action (30-90 min) and elimination half-life of only 20-30 min. individuals already participating in the nepal medex 2008 trip will be invited to participate in this research. participants will be healthy active females or males, between 18-80 years of age, without known pregnancy or liver disease, who have a readily measurable tricuspid regurgitant velocity by doppler echocardiography. if possible, we will attempt to identify a cohort of hape susceptible patients. participants will undergo evaluation both at sea level (baseline) and at high altitude. baseline (low altitude) testing will be performed in bangor, north wales, uk, and will include evaluation of pulmonary artery systolic pressures, cardiac output, and oxygen saturation at rest and during submaximal exercise before and after inhalation of iloprost. this strategy will then be repeated at an altitude of approximately 5000 meters in the dhaulagiri region of nepal.

Eligibility criteria:
inclusion criteria: 1. age: 18 - 80 years 2. healthy physically active males or females 3. have readily measurable tricuspid regurgitation (tr) peak systolic velocity by continuous wave doppler ultrasound exclusion criteria: 1. unable to measure tr velocity 2. known liver disease 3. pregnancy 4. nitrates, cyclosporin, glyburide or other medications that in the opinion of the investigators could place subjects at increased risk of complications 5. any other medical condition that in the opinion of the investigators would place the subject at high risk

Keywords: to study the effects of iloprost on hypoxic pulmonary vasoconstriction at high altitude
evaluation of tear film lipid layer thickness change after cataract surgery

Conditions: Cataract Patients

Summary: this study will compare cataract patients before and after phacoemulsification. evaluations will be performed before and 1 and 3 months following cataract surgery, including measurement of tear film lipid layer thickness, tear film break up time, schirmer test, corneal and conjunctival fluorescein staining, examination of lid margins and meibomian glands, and the ocular surface disease index.


Eligibility criteria:
inclusion criteria: * cataract patients with lens opacities classification higher than grade iii and desire to be spectacle independence for distance and near vision exclusion criteria: * previous ocular surgery or trauma and the presence of corneal opacities, fundus abnormalities, glaucoma, uveitis, amblyopia, systemic disease, and posterior capsule rupture during cataract surgery