Kornimate/medical-research-clean huggingface dataset:
preoperative imrt for soft tissue sarcoma of the extremities and trunk: low rate of wound complications

Conditions: Sarcoma

Summary: postoperative wound healing complications following preoperative radiotherapy represent a severe problem in the treatment of malignant soft tissue tumors, and are reported to be 34% and more. the literature discusses intensely the advantages and disadvantages of this multimodal treatment concept and there are different opinions. the canadian prospective randomized ncic sr2 trial showed increased wound complication rates in the study arm receiving preoperative radiation. the sarcoma center zurich pursues mainly this treatment concept and the results shall now be analysed and published. the approach is to show that not only the complication rates are comparable to international bench marks, but also the (still intermediate time) local control rates.

introduction: the canadian prospective randomized ncic sr2 trial tested the sequence of radiation and surgery for soft tissue sarcoma of the extremities. similar disease control rates following pre- versus postoperative non-intensity modulated radiation therapy (non-imrt) was found, with increased wound complications (17% vs 35%) in the preoperative radiation arm, \[95% ci 5-30\], p=0·01). the investigators assessed a single center preoperative imrt (or imrt-equivalent highly conformal three dimensional conventional rt (3dcrt)) cohort with respect to the wound complication rate (wcr). the hypothesis was that a lower wcr rate was achieved in the era of imrt as compared to the non-imrt era when the canadian trial was conducted. methods: 67 consecutive patients irradiated with 50gy in 25 fractions between 3/2008-3/2016 with preoperative imrt (n=48, 72%) or highly conformal imrt-equivalent 3dcrt dose distribution (n=19, 28%) were assessed. all patients were previously discussed at the weekly interdisciplinary sarcoma board of the sarcoma center zurich.

Eligibility criteria:
inclusion criteria: * patients with a malignant soft tissue tumour * patients who underwent preoperative radiotherapy at the department of radiation oncology, university hospital zurich (usz) * surgical treatment at balgrist university hospital between 2007 and 2016 exclusion criteria: * vulnerability * previous chemotherapy * previous radiotherapy on the affected site * patient's wish

Keywords: soft tissue sarcoma imrt and sarcoma preoperative highly conformal radiation therapy soft tissue sarcoma and wound healing postoperative complications treatment tolerance of soft tissue imrt
pemetrexed/carboplatin non-small cell lung cancer (nsclc) elderly patients

Conditions: Non Small Cell Lung Cancer

Summary: a phase ii study to evaluate the efficacy and safety profile of the combination of pemetrexed and carboplatin in elderly patients with advanced non-small cell lung cancer


Eligibility criteria:
inclusion criteria: * pathologically confirmed non small cell lung cancer stage iiib (not amenable to radiotherapy treatment) or stage iv * no previous chemotherapy for lung cancer * men and women \> or = 70 years * at least one uni-dimensionally measurable lesion (response evaluation criteria in solid tumors \[recist\]criteria) * eastern cooperative oncology group (ecog) performance status 0 to 1 exclusion criteria: * treatment within the last 30 days with a drug that has not received regulatory approval * serious systemic disorders * inability to discontinue administration of aspirin or anti-inflammatory non steroid * concurrent administration of any other antitumor therapy * brain metastasis
study of int-747 in patients with diabetes and presumed nafld

Conditions: Diabetes Mellitus, Type II; Fatty Liver

Summary: the primary objectives of this study are to assess, in patients with type 2 diabetes mellitus (dm) and presumed nonalcoholic fatty liver disease (nafld), the following: * the safety and tolerability of multiple doses of int 747; * the effects of 2 dose levels (25 mg and 50 mg) of int 747 on insulin resistance and glucose homeostasis; * effects of int-747 on hepatocellular function as measured by assessment of liver enzymes and biochemical markers of hepatic and metabolic function and inflammation, and; * trough concentrations of int-747 and its metabolites, glyco 6-ethyl chenodeoxycholic acid (6-edca) and tauro 6-ecdca.

this is a multi-center, double-blind, randomized, placebo-controlled, multiple-dose, parallel-group study. three (3) cohorts of 12 patients each will receive either placebo, 25 mg int-747, or 50 mg int-747 by mouth daily for 6 weeks. the primary objective of assessing changes in insulin resistance and glucose homeostasis will be attained by performing a euglycemic clamp procedure at baseline (day 0) and at the end of 6 weeks of treatment (day 43). other endpoints will be evaluated by monitoring adverse experiences; vital signs; clinical laboratory values; plasma drug and metabolite concentrations; and general health and well-being.

Eligibility criteria:
inclusion criteria: * type 2 diabetes, defined by the american diabetes association (ada), as one of the following criteria: * symptoms of diabetes plus casual plasma glucose concentration \>200 mg/dl (11.1 mmol/l) or * fasting plasma glucose \>126 mg/dl (7.0 mmol/l) or * 2-hour post-load glucose \>200 mg/dl (11.1 mmol/l) during a 75 g oral glucose tolerance test (gtt). * presumed nafld, defined by one of the following criteria: * alanine aminotransferase (alt) ≥47 u/l for females and ≥56 u/l for males * aspartate aminotransferase (ast) ≥47 u/l for females and ≥60 u/l for males * enlarged liver (demonstrated by ultrasound or other imaging technique) * diagnostic histological findings shown on prior biopsy (in the last 5 years). exclusion criteria: * bilirubin \>2 × uln * alt \>155 u/l for females and \>185 u/l for males. * ast \>155 u/l for females and \>200 u/l for males. * patients taking any antidiabetic medications, with the exception of metformin and sulfonylureas. if the hba1c is \<11%, patients may be enrolled who have been withdrawn from all other diabetic medications as specified in the protocol, at the discretion of the principal investigator.

Keywords: farnesoid x receptor agonist metabolic disorder diabetes nafld
optimal management of extreme obesity and severe knee osteoarthritis feasibility trial

Conditions: Knee Osteoarthritis; Morbid Obesity

Summary: does weight loss surgery in patients with morbid obesity prior to knee replacement surgery improve outcomes from knee replacement surgery

rct involving patients who have severe knee osteoarthritis and have a body-mass index (bmi; the weight in kilograms divided by the square of the height in meters) of 45 to 60 and are randomly assigned to receive dietary and lifestyle counseling for 9 to 13 months followed by total knee replacement (control arm) or sleeve gastrectomy with dietary and lifestyle counseling for 9 to 13 months followed by total knee replacement (treatment arm).

Eligibility criteria:
inclusion criteria: severe knee osteoarthritis body-mass index of 45 to 60 exclusion criteria: previous total replacement of the same knee, a need for bilateral total knee replacement, and knee pain during the previous week that the patient rated at higher than 60 mm on a 100-mm visual-analogue scale. also,prior bariatric or complex foregut surgery, significant cardiovascular, pulmonary, renal, liver, gastrointestinal, psychiatric disorders, pregnancy, malignancy within last 5 years, anemia, coagulopathy requiring anti-coagulation therapy.

Keywords: arthroplasty, replacement, knee bariatric surgery
performance of two different ke0s in the same pharmacokinetic propofol model

Conditions: Unconsciousness

Summary: the aim of this study was to assess the clinical performance of two different ke0s (fast and slow) in terms of propofol effect-site concentration (ce) during the loss and recovery of consciousness, using marsh's pharmacokinetic model.the hypothesis to be tested was that the ce of propofol predicted by the slow ke0 in the loss and recovery of consciousness is similar, differently from the fast ke0.

introduction: the ke0 can be defined as the proportional variation of the gradient of concentration between the plasma and the effect-site in relation to the unit of time. theoretically, the higher the value of the ke0, the faster the drug enters the effect-site. therefore, drugs with short t½ke0 have high ke0s and fast onset of action. the aim of this study was to assess the clinical performance of two different ke0s (fast and slow) in terms of propofol effect-site concentration (ce) during the loss and recovery of consciousness, using marsh's pharmacokinetic model. method: twenty healthy male adult volunteers participated in this study. propofol was first administered to the individual volunteer using marsh's pharmacokinetic target-controlled infusion model with ke0 of 1.21 min-1 and, on another opportunity, with the same pharmacokinetic model but ke0 of 0.26 min-1. propofol was infused in plasma target-concentration of 3.0 µg.ml-1. loss and recovery of consciousness was defined as response of the volunteer to verbal stimulus. the ce was registered at the moments of loss and recovery of consciousness. results: at loss and recovery of consciousness, propofol ce means predicted by the fast ke0 were different (3.64 ± 0.78 and 1.47 ± 0.29 µg.ml-1, respectively, p \< 0.0001), whereas with the slow ke0 the predicted ce means were similar (2.20 ± 0.70 and 2.13 ± 0.43 µg.ml-1, respectively, p = 0.5425). conclusion: it can be concluded that slow ke0 (0.26 min-1) incorporated into marsh's pharmacokinetic model showed better clinical performance than fast ke0 (1.21 min-1), since the predicted effect-site concentrations of propofol at loss and recovery of consciousness were similar.

Eligibility criteria:
inclusion criteria: * healthy * male * adult between 20 and 45 years old exclusion criteria: * use of alcohol or illicit drugs * chronic use of h2 inhibitors and tricyclic antidepressants of calcium channel blockers * hypersensitivity to the drugs used in the experimental protocol.

Keywords: intravenous anesthesia propofol pharmacokinetic model monitoring bispectral index.
sleep-cope: sleep intervention for oppositional children

Conditions: Insomnia Chronic; Oppositional Defiant Disorder

Summary: children with oppositional defiant disorder (odd) are at risk for insomnia, arousal dysfunction, mood problems, and noncompliance. cognitive behavioral treatment for insomnia (cbt-i) holds promise for improving insomnia and related concerns. telehealth delivery will reduce the burden of in-person sessions, particularly in areas where there is low mental healthcare access. telehealth cbt-i is efficacious in adults and children but has not been tested in children with odd. the proposed trial is the next logical step - development and iterative testing of sleep-cope, a brief dyadic telehealth cbt-i for children with odd and their parents.


Eligibility criteria:
inclusion criteria: 1. child ages 8-12 with odd (prior diagnosis) and insomnia 2. child and parent english proficiency. insomnia: 1. complaints of difficulties falling asleep, staying asleep, or early morning awakening by child report or parent observation for 3+ mos 2. daytime dysfunction (mood, cognitive, social, academic) due to insomnia 3. baseline diaries and actigraphy indicate \>30 mins. of sleep onset latency, wake after sleep onset, or early morning awakening (time between last awakening and out of bed time) on 6+ nights exclusion criteria: 1. parent unable to provide informed consent or child unable to provide assent 2. family unwilling to accept random assignment 3. child/parent participation in another randomized research project 4. parent unable to complete forms or implement treatment procedures due to cognitive impairment 5. child untreated medical comorbidity, including other sleep disorders (e.g., apnea, epilepsy, psychotic disorders, suicidal ideation/intent, \[frequent\] parasomnias) 6. child psychotropic or other medications that alter sleep with the exceptions of stimulants, sleep medications, and/or melatonin 7. child participation in non-pharmacological treatment (including cbt) for sleep outside current trial 8. parent report of inability to undergo holter monitoring or actigraphy (e.g., extreme sensitivity, behavioral outbursts) 9. other conditions adversely affecting trial participation
rapid rehabilitation to treat lower extremity trauma

Conditions: Lower Limb Trauma

Summary: the purpose of this study is to find out if an advance balance perturbation training program can enhance the rehabilitation process by increasing weight-bearing strategies on the prosthetic or injured limb, and, help reduce stumbles and falls.


Eligibility criteria:
inclusion criteria: * research participants will be eligible active duty service members and retired veterans. * having lower limb trauma (transtibial and transfemoral amputations, bilateral amputations, and limb salvage). * are enrolled in conventional rehabilitation at the participating military treatment centers. * subjects with dysvascular disease will be excluded because compromised lower limb somatosensation and circulation are independently linked with poor postural stability and a history of frequent falls. * for subjects with amputations, the individual must be a community ambulator (i.e., k-level 3 or 4). * for subjects with limb salvage, they will need to have an ideo and be entered into the return-to-run training program. exclusion criteria: - subjects must not have excessive pain or other neuromuscular problems that preclude them from performing the test protocol.
aspiration risk assessment by gastric ultrasound in emergency surgery and anesthetic decision-making: the argument study

Conditions: Pulmonary Aspiration; Emergency Surgery

Summary: pulmonary aspiration of gastric contents is a serious patient safety problem accounting for 50% of anesthesia-related mortality. the risk is higher in patients undergoing emergency surgery as the gastric content is uncertain which poses a challenge to anesthetic decision-making. standard clinical assessment to identify at-risk patients primarily relies on preoperative fasting guidelines and is not adequate for patients undergoing emergency surgeries. point-of-care gastric ultrasound (gus) has emerged as an accurate bedside tool providing information regarding the type and volume of gastric contents. when gus was added to standard clinical assessment, anesthetic management plan changed in 71% of adult elective and 37% of pediatric emergency surgical procedures. such data is lacking in adult patients undergoing emergency surgeries. the investigators propose a multicentre mixed-method study to evaluate the impact of gus on aspiration risk assessment and subsequent anesthetic plan before emergency surgeries. the evidence from this study will improve patient safety by accurately identifying patients at risk of aspiration and tailoring anesthetic techniques and airway management to prevent pulmonary aspiration in patients undergoing emergency surgeries.

the proposed trial design is a mixed-method, multicenter study that includes a randomized controlled trial (rct) and a qualitative assessment component. the rct will evaluate the impact of adding gus to the standard clinical assessment on the incidence of changes in the anesthetic plan for adult patients undergoing emergency surgery. the qualitative assessment will gather attending anesthesiologists' opinions on the addition of gus in an emergency surgical setting.

Eligibility criteria:
inclusion criteria: * age \>18 years * american society of anesthesiologists' (asa) physical status i-iii * patients scheduled for non-elective non-cardiac surgery. exclusion criteria: * abnormal anatomy of the upper gastro-intestinal tract (including hiatus hernia, gastric tumors, and previous surgeries of the upper gastrointestinal tract). * extrinsic gastric compression obtained from the medical history or during the actual ultrasound examination. * pregnancy. * attending anesthesiologist refusal to include the patient for participation in the study
turoctocog alfa in haemophilic italian patients: protection and engagement in recreational activities

Conditions: Haemophilia A

Summary: this is a study on italian patients with haemophilia a in prophylaxis treatment with turoctocog alfa under routine clinical conditions. the purpose of the study is to investigate the therapeutic scheme in a population of patients treated with turoctocog alfa and to investigate the participation in recreational activities, the level of physical activity, and quality of life. participants will get novoeight® (turoctocog alfa) as prescribed to them by the study doctor. the study will last for about 12 months. participants will be requested to fill in the questionnaires investigating the participation in recreational activities, the level of physical activity, and quality of life.


Eligibility criteria:
inclusion criteria: * informed consent obtained before any study-related activities. study-related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study. * male or female, age above or equal to 12 years at the time of signing informed consent. * haemophilia a (any severity), needing prophylactic therapy (with the usual recommended doses). * decision to treat with turoctocog alfa, made by the treating physician and the subject/legally acceptable representative (lar) based on local label before and independently from the decision to include the subject in this study. exclusion criteria: * previous participation in this study, defined as previously signed informed consent; * presence of other coagulation disorders; * presence of any inhibitor; * mental problems, poor compliance, linguistic barriers or other conditions which can impede the understanding of the study aims and the participation to it.
effects and mechanisms of specific trunk exercises in low back pain

Conditions: Low Back Pain

Summary: low back pain affects 80% of americans at some time during their lives. although recovery usually occurs within 6 months, there is a 50% recurrence within one year's time. it has long been thought that poor control of trunk muscle may lead to abnormal forces across the spine, which then damage local spinal structures, thus, leading to low back pain. however, the investigators know little about the function of specific trunk muscles in healthy subjects during various activities of daily life. furthermore, the precise muscle dysfunction associated with low back pain has not been well characterized at all. in addition, the investigators know little about which exercise protocol is most beneficial for particular subgroups of people with low back pain. thus, the purposes of this study are to learn more about: 1) how trunk muscles are affected by low back pain; 2) which exercises might be most beneficial for people with certain kinds of low back pain; and 3) how these exercises influence trunk muscle function. by having a better understanding of which trunk muscles are affected by low back pain, rehabilitation specialists can design exercise programs and therapeutic interventions that are more specific and more effective.


Eligibility criteria:
inclusion criteria: * a history of chronic lbp with or without recurrences for a minimum of 12 months * between 21 - 55 years of age * able to stand and walk without assistance * have an oswestry disability score of 19% or higher exclusion criteria: * any major structural spinal deformity including scoliosis, kyphosis, or stenosis * spinal fracture or dislocation * osteoporosis * ankylosing spondylitis * rheumatoid arthritis * disc herniation with corroborating clinical signs and symptoms * serious spinal complications such as tumor or infection * previous spinal surgery * frank neurological loss, i.e., weakness and sensory loss * pain or paresthesia below the knee * etiology of lbp other than the lumbar spine, e.g., hip joint * history of neurological disease which required hospitalization * active treatment for cancer * history of unresolved cancer * pregnancy or less than 6 months post-partum or less than 6 months post weaning * magnified symptom-behavior * worker's compensation or disability case * in litigation for the lbp problem * have a bmi ≥ 30

Keywords: stabilization exercise strength and conditioning exercise physical therapy rehabilitation
comparison of two botulinum type a products in the treatment of blepharospasm

Conditions: Blepharospasm

Summary: this pilot study estimates the treatment effects of two different types of botulinum toxin type a in the treatment of blepharospasm. blepharospasm is characterised by excessive contraction of the muscles around the eye and can lead to repetitive blinking or sustained closure of the eyelids.


Eligibility criteria:
inclusion criteria: * diagnosed with benign essential blepharospasm * received ≥20u/eye of botox® for at least one visit prior to study entry and required, in the investigators opinion, the same dose at the study injection visit. * combined jankovic rating score of \>2 exclusion criteria: * female subjects who were pregnant, breastfeeding, or who were of childbirth potential and not practicing birth control. * profound atrophy of the muscles in the target area(s) of injection. * myasthenia gravis, lambert-eaton syndrome, amyotrophic lateral sclerosis or any other disease that might interfere with neuromuscular function. * known significantly impaired renal and/or hepatic function