Looking for alternative treatment options for your older dog? Today we are looking at 6 alternative treatment options for senior dogs that you can consider.
Special diet:. Diet therapy is one of the important ADHD alternative treatment methods. Changes in the diet may help your child to deal with allergy symptoms or migraine headaches.. Biofeedback: This ADHD alternative treatment method helps your child to control their own responsibilities. This therapy involves a large commitment from your whole family.. This ADHD alternative treatment option helps children learn coping skills and that give them a sense of control and mastery. This therapy helps to reduce stress and anger that can accompany with ADHD.. Herbal medicine: Herbs act as ADHD alternative treatment method. You can find a number of "all natural" herbal treatments sold in the United States for the control of ADHD in children. Herbs can help to calm your child and they play important role in memory and thinking.. Make sure that herbs you are using are pure, safe, and nontoxic. Herbs can cause side effects and can interact with other medications.. Some of the herbs as ADHD alternative ...
As Table 3 shows, Case 1 presented with significant clinical improvement in rule following and working memory overtime, Case 2 presented with significant clinical improvement in cognitive flexibility, and rule following, while Case 3 presented with significant clinical improvement in cognitive flexibility, inhibition response and speed processing. As can be seen in Table 3, Case 1 presented a significant clinical improvement in social skills and behavior regulation, Case 2 presented with significant clinical improvement in emotional regulation and social skills, while Case 3 presented significant clinical deterioration in behavior regulation, emotional regulation and social skills over time.. DiscussionCognitive functions. Cognitive function domains included verbal comprehension, perceptual reasoning and IQ. Case 1 who had a cavernous angioma on the right frontal lobe showed an improvement followed by a decrease in verbal comprehension and perceptual reasoning, the results obtained in the last ...
Medication is the most important treatment for bipolar disorders. I will outline the medication listed in the textbook and state their potential side effects and limitations in point form.Drug: LithiumLithium is the first choice of treatment for bipola...
Of 242 patients in CT group and 215 patients in no CT group, stage I to IV disease were 1.7%, 38.4%, 58.7%,1.2% and 5.6%, 46%, 47%, 1.4%, respectively. Pretreatment imaging found lymph node and/or distant metastases in 43.4% and upstaged in 27.6% of patients, according to the 7th AJCC system. Treatment modifications were elicited in 21.9% of patients; RT (13.2%), CMT (4.1%) and both (4.5%). At median follow-up time of 35 months, progression-free survival (PFS) and overall survival (OS) at 3 years in CT and no CT group were 70.1% vs 74.7% (p = 0.135) and 68.3% vs 76.4% (p = 0.016). Subgroup analysis by stage showed that patients with stage II disease in CT and no CT group had no significant difference in 3-year PFS and OS; 80.3% vs 83.3% (p = 0.673) and 81.3% vs 79.7% (p = 0.802), respectively. In stage III disease, patients in both groups had no significant difference in 3-year PFS, 64.1% in CT group and 68.4% in no CT group (p = 0.187). However, the 3-year OS was significantly worse in CT ...
Women now have the choice to be given epidural anesthesia to help with pain during active labor. Local anesthetic will be administered into the epidural space of the spine which will be given continuously through a small catheter that is left taped to the womans back. It normally takes about five to thirty minutes for the effects to be felt, at which time the legs may begin to feel heavy and pain should subside. While it is generally safe for both the woman and baby when having an epidural, there are potential side effects they should be aware of.. Low blood pressure is one of the most common effects. Intravenous fluids will be administered at the same time in order to prevent this from occurring. Another common side effect is uncontrollable shivering. However, shivering is something that can happen to a woman during labor even without receiving an epidural, so getting an warm blanket is often enough to help control the shivers.. A loss of bladder control during labor can sometimes happen ...
BACKGROUND: Myocardial infarction (MI) in the absence of electrocardiographic ST-segment elevation or new bundle branch block is the cause of hospitalization for a large and steadily increasing proportion of patients with acute ischemic chest pain. Despite its prevalence, the common demographic features, current hospital-based management, and short-term clinical outcome among patients with non-ST-segment elevation MI remain poorly defined. METHODS: A total of 183 113 patients with non-ST-segment elevation MI were identified in the National Registry of Myocardial Infarction database. Using a validated model, 43 928 patients (24.0%) were retrospectively placed in major, 34 917 (19.1%) in intermediate, and 104 268 (56.9%) in minor severity clinical event categories that included hospital death, recurrent myocardial ischemia, and nonfatal recurrent MI. RESULTS: The administration of widely available and universally recommended pharmacologic therapies, including aspirin and beta-adrenergic blocking agents,
Myself and certain member(s) of the AM community wondered if there were any potential side effects to be concerned with (or to look out for) when
Downloadable! Recently there has been a surge in econometric work focusing on estimating average treatment effects under various sets of assumptions. One strand of this literature has developed methods for estimating average treatment effects for a binary treatment under assumptions variously described as exogeneity, unconfoundedness, or selection on observables. The implication of these assumptions is that systematic (e.g., average or distributional) differences in outcomes between treated and control units with the same values for the covariates are attributable to the treatment. Recent analysis has considered estimation and inference for average treatment effects under weaker assumptions than typical of the earlier literature by avoiding distributional and functional form assumptions. Various methods of semiparametric estimation have been proposed, including estimating the unknown regression functions, matching, methods using the propensity score such as weighting and blocking, and combinations of
This study compared two doses of pembrolizumab (MK-3475) versus docetaxel in participants with non-small cell lung cancer (NSCLC) who had experienced disease progression after platinum-containing systemic therapy. Participants were assigned randomly to receive either pembrolizumab 2 mg/kg once every three weeks (Q3W), pembrolizumab 10 mg/kg Q3W or docetaxel 75 mg/m^2 Q3W. This study used an adaptive trial design so that the total number of participants randomized depended upon demonstration of sufficient objective responses at an interim analysis.. Based on the positive outcome of the Overall Survival (OS) analysis, Protocol Amendment 12 (effective date: 09 Dec 2015) enabled eligible participants who were allocated to docetaxel and experienced disease progression, to be permitted to crossover to receive pembrolizumab 2 mg/kg Q3W as long as Inclusion/Exclusion criteria were met. These participants were participating in the Cross-Over Phase.. The primary study hypotheses are that pembolizumab ...
Duration of response was defined as progression-free survival in responders, i.e. as the time between the start of a complete response (CR) or partial response (PR) and the start of progressive disease (PD) or patient death from any cause, whichever occurred first. Participants who did not have progression or had not died were censored at the last known time the participant was progression free. Participants who had initiated other anticancer therapy prior to progression were censored at the time when new anticancer therapy was initiated. Complete response (CR) and partial response (PR) were defined in outcome #1. Progressive disease was defined as at least a 20% increase in the sum of the longest diameters of target lesions; or the appearance of one or more new lesions; or the unequivocal progression of a non-target lesion. Response was evaluated using Response Evaluation Criteria in Solid Tumors (RECIST ...
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The 12 groups, recognized by CDRRMO, are not affiliated with any barangay and do not receive any regular funding for their efforts and operations. Disaster responders of barangays are funded from their DRRM or five percent of the internal revenue allotment.. "They are vital to the CDRRMO because they augment our resources and capacity during the implementation of some programs like the City Wide Simulation Exercises and especially during times of disasters," said Lyndon Leovic Ancajas, CDRRMO training officer.. Ancajas added that volunteer responders go through trainings and drills to improve their skills and capacity.. Carlo Danilo de Leon, president of the EAGLES Disaster Rescue Group, one of the largest volunteer responder groups in the city with over 600 members, welcomed the support given to them by the CDRRMO.. "These equipment will enable us to respond better and keep us safe during operations," de Leon said.. Raniel Nocom, president of another volunteer responder group called Darcom, ...
Background. Minimally invasive surgery is increasingly applied because of the proven better outcome and benefits for the patient such as less pain, shorter hospital stay, and less injury. Examples of such minimally invasive procedure include Endovascular Aortic Repair (EVAR), endovascular coiling of intracranial aneurysms, and Transcatheter Aortic Valve Implantation (TAVI). These procedures have in common that a device is transported through the iliac and aortic artery after an incision in the groin to the problematic location in the body. Unfortunately, these percutaneous procedures are associated with vascular complications of the iliac artery. These vascular complications include bleeding, vascular rupture, aneurysm spurium, ateriorvenous fistula, dissection, and embolism. There are various clinical and technical procedural parameters associated with these vascular complications. Next to these parameters, the morphology and disease of the vasculature also influence the risk of vascular ...
What are the alternative options for kidney disease with 30% kidney function ? Are dialysis and renal transplant are the only options for them ?
This Phase IIIb study was conducted to evaluate the safety, efficacy and pharmacokinetics of darunavir/cobicistat 800/100 mg once daily in HIV-1-infected adults with no darunavir RAMs who also received two fully active N[t]RTIs. We showed that darunavir/cobicistat 800/150 mg once daily was well tolerated, and the pharmacokinetics, virologic and immunologic responses were consistent with previously published data for darunavir/ritonavir 800/100 mg once daily.. Through Week 24, the onset of any grade 3 or 4 AEs regardless of causality was low (6% in the overall population). Five out of 313 patients (2%), all of whom were treatment-naïve, experienced any study drug-related grade 3 AE through Weeks 24 and 48. No patients experienced grade 4 drug-related AEs. The most commonly reported AEs of all grades during the study, diarrhea, nausea, upper respiratory tract infection and headache, have all been reported previously for darunavir and cobicistat [5-8, 15, 16]. Renal laboratory assessments showed ...
DALLAS and TOKYO, Nov. 19, 2013- Daiichi Sankyos Once-Daily Edoxaban Meets Primary Efficacy Endpoint for Stroke Prevention and Superiority for the Principal Safety Endpoint Compared to Warfarin for Patients with Atrial Fibrillation in a Phase 3 Clinical Trial.
Question - Took all the possible treatment for sinus. Should i go for sinus surgery? . Ask a Doctor about diagnosis, treatment and medication for Allergic rhinitis, Ask an ENT Specialist
Generally, Diabetes easily causes Kidney Failure if patients do not take timely treatments. Well then, what is the comprehensive treatment for stage 4 kidney failure caused by diabetes?
Effectiveness at end of January 2013 was estimated to be 92%.. Coverage at end of January was estimated (using SQUEAC) to be 63%.. Impact can be estimated as:. Impact = Effectiveness x Coverage = 92% x 63% = 58%. Data courtesy of ACF (Pakistan). Coverage also depends indirectly on:. Thorough case-finding and early treatment seeking: This ensures that the majority of admissions are uncomplicated incident cases, which leads to good outcomes (Figure 1). Late admission is associated with the need for inpatient care, longer treatment, defaulting, and poor treatment outcomes (e.g. nonresponse after long stays in programme or death). These can lead to poor opinions of the programme circulating in the host population, which may lead to more late presentations and admissions and a cycle of negative feedback may develop (Figure 2). A high level of compliance by both the beneficiary and the provider: This ensures that the beneficiary receives a treatment of proven efficacy leading to good outcomes and good ...
Cancer 101 is a source for all the information related to cancer. Know about the common types of cancer, diagnosis, possible treatments and prevention tips.
Question - Pain in back gums, treated with salt water. Gums swollen, throbbing, itchy. Possible treatment? . Ask a Doctor about diagnosis, treatment and medication for Back pain, Ask a Dentist
Comprehensive treatment is undertaken for the majority of patients during the early teens. Treatment aims to create a beautiful, balanced and functional
therapy. Treatment was continued until disease progression, discontinuation due to adverse events, or withdrawal of consent. Randomization was stratified according to PSA doubling time (≤ 6 months or , 6 months) and use of osteoclast-targeted therapy at randomization. The primary endpoint was metastasis-free survival in the intention-to-treat population, with the presence of metastasis identified by independent central review of radiographic imaging every 16 weeks.. For the darolutamide vs placebo groups, the median age was 74 years in both, most patients were from European countries, PSA doubling time was up to 6 months in 70% vs 67%, the Eastern Cooperative Oncology Group performance status was 0 or 1 in 100% in both, 97% vs 94% were not using a bone-sparing agent at baseline, and 76% of both groups had received at least 2 previous hormonal therapies.. Metastasis-Free Survival. On independent central review, metastasis was found at baseline in 5.2% of the darolutamide group and 7.0% of the ...
The purpose of the study is to compare safety and efficacy of a single dose of empegfilgrastimt a dose of 3 or 6 mg versus daily administration of filgrastim at
Purpose: This multicenter, open-label, phase II study evaluated the safety and clinical activity of axitinib, a potent and selective second-generation inhibitor of vascular endothelial growth factor receptors (VEGFR)-1, 2, and 3, in patients with metastatic melanoma.. Experimental Design: Thirty-two patients with a maximum of one prior systemic therapy received axitinib at a starting dose of 5 mg twice daily. The primary endpoint was objective response rate.. Results: Objective response rate was 18.8% [95% confidence interval (CI), 7.2-36.4], comprising one complete and five partial responses with a median response duration of 5.9 months (95% CI, 5.0-17.0). Stable disease at 16 weeks was noted in six patients (18.8%), with an overall clinical benefit rate of 37.5%. Six-month progression-free survival rate was 33.9%, 1-year overall survival rate was 28.1%, and median overall survival was 6.6 months (95% CI, 5.2-9.0). The most frequently (,15%) reported nonhematologic, treatment-related adverse ...
A national, multi-center, open-label, phase IIIb trial to determine the efficacy and safety of treatment with ribociclib (LEE011) plus letrozole in women and
Randomised, double-masked, sham-controlled Phase 3b/4 study. All patients received 3 monthly IVT-AFL 2 mg injections. At Week 12, patients were randomised 1:1 into IVT-AFL plus sham PDT (IVT-AFL monotherapy) or IVT-AFL plus active PDT arms. Patients in both arms who did not qualify for rescue treatment received IVT-AFL 2 mg every 8 weeks (2q8); patients who qualified for rescue treatment received IVT-AFL 2q4 plus active or sham PDT, according to the randomisation arm, until visual and anatomical outcomes allowed for extension of the treatment interval. The primary efficacy endpoint was the mean change in BCVA in the study eye from baseline to Week 52. The secondary efficacy endpoint was the proportion of patients avoiding a moderate vision loss (≥15 letters) from baseline to Week 52. Exploratory endpoints included but were not limited to: (1) change in central subfield thickness ([CST] thickness of the central 1 mm of retina) over time; (2) proportion of patients with active polyps; (3) ...
A clinical trial of the Guardian implantable heart attack monitor made by Angel Medical Systems failed to meet its efficacy endpoint, but suggested that the device could be used to help detect "silent" heart attacks.. Wilmington, Del.-based AngelMed won FDA clearance a year ago for the Guardian device for patients with prior acute coronary syndrome events including myocardial infarctions or unstable angina at high risk for further ACS events. Its 907-patient Alerts study randomized patients implanted with Guardian to either six months with the alert function active for the treatment group or six months without activation for the control arm; both groups had the alert function activated after the six-month randomized stage.. The primary efficacy endpoint, a confirmed occlusive event within 7 days, was not significantly reduced for the treatment arm at 3.8%, compared with 4.9% for the control arm. The primary safety endpoint was met a 96.7% rate of freedom from device-related complications, ...
This pragmatic cluster RCT implemented in CHSs in urban China found no differential treatment effect in the primary outcome measure, HbA1c, with intervention and control groups both improving significantly. However, significant treatment effects favouring the intervention group were evident in psychological distress, systolic BP, waist circumference in men and SDSCA-Specific Diet. Two of these outcomes (psychological distress and systolic BP) were robust outcomes consistent with significant treatment effects, as supported in sensitivity analyses.. In addition to being statistically significant, the greater psychological distress observed in the control group compared with that in the intervention group is of clinical significance. The shift in the mean score for the control group at baseline from 14.97±6.24 to 17.45±8.12 at 12 months translates clinically to a shift in the mean from low risk of psychological distress (scores 10-15) to moderate risk of psychological distress (16-21).27 This ...
Background: Superiority clinical trials hold promises of impactful interventions for the future of evidence-based medicine but require extensive resources and may place study patients at risk. Advances made through cardiovascular (CV) trials in past decades have drastically improved patient outcomes, but little is known about the modern landscape of CV superiority trials and how it has evolved over time.. Methods: We performed a comprehensive search in PubMed using keywords and MeSH terms to identify all superiority CV trials with a primary clinical endpoint from January 1, 2006 to December 31, 2011 in the New England Journal of Medicine (NEJM), JAMA, and the Lancet. We used chi-square and Cochran-Armitage Trend tests to assess for statistical significance.. Results: We identified 188 trials (108 drug trials, 20 device trials and 60 others). Overall, 69 trials (36.7%) had positive results, demonstrating superiority of the new intervention for the primary endpoint, while 119 trials (63.3%) showed ...
... from Stem Cell Therapy 21 Jan 2016 by Maren Auxier Lung Institute White Paper A new white paper released by the Lung Institute shows an increase of 10 percent or more in pulmonary function for 48 percent of patients tested after receiving stem cell therapy for COPD, with an overall average increase of 16 percent. TAMPA, Fla. January 26, 2016: Lung Institute doctor Jack Coleman, Jr., M.D. recently
ONGLYZA® (saxagliptin) achieves primary safety endpoint, demonstrating no increased risk for cardiovascular death, heart attack or stroke in SAVOR cardiovascular outcomes trial
The emphasis on evidence-based medical practice emerged in response to the potential hazards and inconsistencies of empirical clinical decision making and reinforced the importance of critical data interpretation. Randomized controlled trials (RCTs) remain the gold standard when performed by trained investigators blinded to treatment arms in multiple centers, with predetermined endpoints and adjudicated through independent core labs and clinical events committees (CECs). RCTs provide the most rigorous and unbiased answers for the safety and effectiveness of a study treatment versus a predefined control group in a specified population. However, there are criticisms of RCTs, including their applicability to real-world populations because of the inclusion/exclusion criteria used to limit confounding variables that would ultimately create heterogeneity in study arms and potentially drive confounding results. Additionally, RCTs are generally costly given the rigorous inclusion/exclusion requirements, ...
Wagner went on to report, "Blood clotting is an intricately balanced process. Blood clots in the heart or brain can result in a heart attack or stroke. Our studies in mouse models have shown that inhibition of P-selectin reduces atherosclerosis (hardening of the arteries) and the work of our collaborators shows that the events leading to deep vein thrombosis are reduced. P-selectin inhibitors have also been shown to be anti-thrombotic in early human trials ...
This article deals with the dependency(ies) of noninferiority test(s) when the two confidence interval method is employed. There are two different definitions of the two confidence interval method. One of the objectives of this article is to sort out some of the confusion in these two different definitions. In the first definition the two confidence interval method is considered as the fixed margin method that treats a noninferiority margin as a fixed constant after it is determined based on historical data. In this article the method is called the two confidence interval method with fixed margin. The issue of the dependency(ies) of noninferiority test(s) does not occur in this case. In the second definition the two confidence interval method incorporates the uncertainty associated with the estimation for the noninferiority margin. In this article the method is called the two confidence interval method with random margin. The dependency(ies) occurs, because the two confidence interval method(s) with
Clinical response was assessed by the investigator as Cure, Failure or Indeterminate at End of treatment (EOT) and Test of Cure (TOC). Favorable clinical response was defined as clinical response of Cure, defined as resolution of all acute signs and symptoms of Late-onset sepsis (LOS) or improvement to such an extent that no further antibacterial therapy is required. Eradication defined as absence of the original baseline pathogen from the source specimen; presumed eradication was defined when source specimen was not available to culture and the subject was assessed as a clinical cure (resolution of all acute signs and symptoms of LOS or improvement to such an extent that no further antibacterial therapy was required) EOT visit occurred within 24 hours after the end of last infusion. Modified ITT analysis set: subjects who received ceftaroline fosamil and met minimal disease criteria of late-onset sepsis ...
Data Dictionary - Survey ACS 2009 (1-Year Estimates); Social Explorer Tables: ACS 2009 (1-Year Estimates) (SE); T3. Sex By Age [27]
Head and neck cancer (HNC) patients often present with advanced metastatic disease. Whilst there have been improvements in the management of locoregional disease, distant metastatic spread remains a challenge in the field [1-3]. Palliative chemotherapy is platinum based and for patients who progress after first line treatment or are refractory, therapeutic options are limited. Numerous agents including cetuximab, paclitaxel, gemcitabine and docetaxel have been assessed prospectively in the treatment of platinum refractory patients and the time to progression ranged from 2 to 6 months [4]. These systemic treatments produce a significant degree of morbidity and new therapeutic options are therefore a need in these patients. Once there is an established role in metastatic disease, translation into the curative setting is appropriate.. The programmed cell death-1/programmed cell death-1 ligand (PD-1/PD-L1) pathway has shown to play a crucial role in tumour immune invasion. Recent literature suggests ...
A total of 873 men were randomized to receive sunitinib (n = 584) or placebo (n = 289). Median age was 68 years, and 49% of patients had a Gleason score ≥ 8. The trial was stopped after a second futility analysis in September 2010. In data collected through February 2011, the median treatment duration was 3.7 months (range, 0−23.2) on the sunitinib arm and 3.4 months (range, 0−22.1) on the placebo arm. Progression-free survival was significantly greater on the sunitinib arm than the placebo arm (5.6 vs 3.7 months; HR = 0.74; P = .0022), although overall survival was not significantly different (13.1 vs 11.7 months; HR = 0.91; P = .1630, stratified log-rank test for both). The overall response rate with sunitinib was also significantly higher compared with placebo (6.1% vs 1.8%; P = .04).. The safety profile for sunitinib was consistent with that previously reported in castrate-resistant prostate cancer and other tumor types, Dr. Michaelson noted. Leading treatment-related grade 3/4 adverse ...
High creatinine level is commonly experienced in people with kidney disease. High creatinine level makes patients suffer from a series of symptoms and complications, therefore, patients are eager to know what is a good treatment to lower hi
The PROOF registry collects data from a real-world cohort of patients with IPF in Europe. Unlike clinical trials, which have strict inclusion/exclusion criteria relating to disease severity, comorbidities and prescribed medications, the PROOF registry provides an opportunity to characterise a real-world population of patients. Compared with clinical trials, registry data are more likely to reflect the range of disease severities and complex medical histories that clinicians observe in clinical practice. In the present manuscript, we report a comprehensive summary of baseline data from patients enrolled in the PROOF registry, including patient demographics and clinical data such as lung function and HRQoL. In addition, we present data demonstrating the high burden of comorbidities and prescribed medication in this population.. Further to providing comprehensive clinical data, the PROOF registry also provides an opportunity to collect information on the diagnosis of IPF in a real-world population. ...
Call centres (CCs) are one of the most rapidly growing forms of workplaces in Sweden. The overall aim of this thesis was to describe work characteristics, physical and psychosocial exposures, and health related outcomes, for CC operators in selected CC in Sweden. The purpose was also to study the test-retest reliability and internal consistency of questions, and the inter-rater reliability of observations and measurements in studies of CCs.. This thesis is based on two projects, where study I was a cohort study and studies II-V were a cross-sectional survey. Fifty-seven CC operators were compared with a reference group of 1459 professional computer users from other occupations, study I, and 1183 operators (848 women and 335 men) (response rate 77%) from 28 CCs were studied in studies II-V . Questionnaires covering organisation and work characteristics, physical and psychosocial exposures, individual characteristics and symptoms during the previous month was used, studies I-V. Structured ...
Colorectal carcinoma (CRC) is the third most common cancer worldwide with the highest incidence in Central Europe. It is the fourth leading cause of cancer related deaths mainly due to the late diagnosis and low efficacy of treatment. CRC diagnosed in early stage has a five-year survival rate about 90% which drops to near 12% once distant metastases occur. It is a heterogenous disease with different molecular and clinicopathological features depending on the tumor location. Therefore, different treatment strategies are required. A standard treatment of locally advanced rectal cancer includes neoadjuvant chemoradiotherapy followed by surgery, whereas colon cancer treatment consists of surgical resection of the tumor and/or subsequent adjuvant chemotherapy based on disease characteristics. 5-fluorouracil (5-FU) alone or in combination with other compounds is the most used treatment in CRC. The mechanism of 5-FU on molecular level is either its incorporation into DNA or it imbalances the synthesis ...
TY - JOUR. T1 - Prediction of treatment outcome of chemotherapy using perfusion computed tomography in patients with unresectable advanced gastric cancer. AU - Lee, Dong Ho. AU - Kim, Se Hyung. AU - Lee, Sang Min. AU - Han, Joon Koo. PY - 2019/4. Y1 - 2019/4. N2 - Objective: To evaluate whether data acquired from perfusion computed tomography (PCT) parameters can aid in the prediction of treatment outcome after palliative chemotherapy in patients with unresectable advanced gastric cancer (AGC). Materials and Methods: Twenty-one patients with unresectable AGCs, who underwent both PCT and palliative chemotherapy, were prospectively included. Treatment response was assessed according to Response Evaluation Criteria in Solid Tumors version 1.1 (i.e., patients who achieved complete or partial response were classified as responders). The relationship between tumor response and PCT parameters was evaluated using the Mann-Whitney test and receiver operating characteristic analysis. One-year survival was ...
Study Identifies Optimal Treatment Approach for Late-Stage Development Circassia Ltd, a specialty biopharmaceutical company focused on allergy, today announced
Excerpt:. "GTx, Inc. (Nasdaq: GTXI) today announced that enobosarm achieved the pre-specified primary efficacy endpoint in the 9 mg dose cohort from patients in both stage 1 and the ongoing stage 2 of its Phase 2 clinical trial in women with advanced, estrogen receptor positive (ER+), androgen receptor positive (AR+) breast cancer. The primary efficacy endpoint requires at least nine patients (out of a total of 44 evaluable patients) to achieve clinical benefit, defined as either a complete response, partial response or stable disease, as measured by Response Evaluation Criteria in Solid Tumors (RECIST) at 24 weeks of treatment. In this ongoing trial, the efficacy endpoint was achieved in the first 22 confirmed evaluable patients, and the trial will continue enrolling and treating eligible patients with enobosarm until 44 evaluable patients have completed the trial. Enobosarm has been well tolerated among patients treated to date in the 9 mg dose cohort with the majority of adverse events being ...
Background Breastfeeding has clear short-term benefits, but its long-term effects on human capital are yet to be established. crude and adjusted analyses, the durations of total breastfeeding and predominant breastfeeding (breastfeeding as the main form of nutrition with some other foods) were positively associated with IQ, educational attainment, and income. We recognized dose-response associations with breastfeeding duration for IQ and educational attainment. In the confounder-adjusted analysis, participants who were breastfed for 12 months or more experienced higher IQ scores (difference of 376 points, 95% CI 220C533), more years of education (091 years, 042C140), and higher monthly incomes (3410 Brazilian reals, 938C5883) than did those who were breastfed for less than 1 month. The results of our mediation analysis suggested that IQ was responsible for 72% of the effect on income. Interpretation Breastfeeding is usually associated with improved overall performance in intelligence assessments ...
Antifungal mouth rinse, lozenges and topical medicines are good treatments for thrush, according to WebMD. The medicine type and prescribed amount are based on a persons age and the severity of the...
We conducted a randomised controlled trial of mandated five-channel physiological monitoring vs standard care, in acute medical and surgical wards in a single UK teaching hospital. In all, 402 high-risk medical and surgical patients were studied. The primary outcome was the proportion of patients experiencing one or more major adverse events, including urgent staff calls, changes to higher care levels, cardiac arrests or death, in 96 h following randomisation. Secondary outcomes were the proportion of patients requiring acute treatment changes, and the 30-day and hospital mortality. In the 96 h following randomisation, 113 (56%) patients in the monitored arm and 116 (58%) in the control arm (OR 0.94, 95% CI 0.63-1.40, p = 0.76) had a major event. An acute change in treatment was necessary in 107 (53%) monitored patients and 101 (50%) control patients (OR 0.55, 95% CI 0.87-1.29). Thirty-four (17%) monitored patients and 35 (17%) control patients died within 30 days. Thirteen patients in the control group
The current clinical trial is an investigator-initiated one, and it is conducted under the multi-center, randomized, open-label, prospective design. The subjects meeting inclusion/exclusion criteria will be assigned to the treatment group or the control group. The randomization ratio is 1:1. The subjects of the treatment group will receive a 2-day hypothermia therapy followed by the process of recovery of temperature within 30 hours (the recovery phase). After 3 months of the onset of symptoms, mRS scores are measured. This is followed by the closure of the clinical trial. ...
Sahih International And We have enjoined upon man, to his parents, good treatment. His mother carried him with hardship and gave birth to him with hardship, and his gestation and weaning [period] is thirty months. [He grows] until, when he reaches maturity and reaches [the age of] forty years, he says, My Lord, enable me…
Published on April 23, 2015 at 4:01 AM. Data revealed today at The International Liver Congress™ 2015 highlights the impact of delaying treatment for the hepatitis C virus (HCV). Researchers found that treatment delays have a serious detrimental effect on treatment efficacy, increasing the risk of morbidity and mortality among patients.. The study was conducted using retrospective patient data from the Veterans Administration in the USA to estimate the impact on risk of morbidity and death depending on whether treatment was initiated before or after a patients FIB4 levels became elevated. The FIB4 index is a simple formula used to predict liver damage (fibrosis) based on standard biochemical values and age.. Researchers found that delaying treatment until after a patients FIB4 level exceeds 3.25 has a clear detrimental effect on treatment effectiveness. Delaying therapy until after the patients FIB4 level exceeds 1.45 or 1.00 has a smaller detrimental effect on treatment ...
E2100 showed an improvement in progression-free survival in patients with HER2-negative metastatic breast cancer, but did not show improvements in disease-related symptoms or survival. However, researchers conducted genomic studies within E2100 and identified markers that conferred longer survival and protection against drug-induced hypertension. Specifically, in E2100, researchers uncovered preliminary PGx data linking VEGF-1154 AA and -2578 AA genotypes to an improvement in median overall survival. Additionally, E2100 showed that patients with VEGF-634 CC and -1498 TT genotypes had protection from grade 3-4 hypertension, a common side effect of Avastin. . . . that patients with high levels of plasma VEGF-A who received standard doses of Avastin had a progression-free survival hazard ratio of 0.49. Meanwhile, patients with low levels of VEGF-A had a PFS hazard ratio of 0.86. This finding suggests that patients with high levels of VEGF-A may be more likely to derive a more substantial benefit ...
Introduction: Obesity significantly increases morbidity and mortality, impairs quality of life and brings serious socio-economic problems.. Aim of the research: Evaluate the effectiveness of non-pharmacological treatment of obesity in patients who underwent the two-week reduction stay in Bardejov Spa a.s. in years 2012-2016. We intended to find out whether the non-pharmacological treatment of obesity will positively affect values of total cholesterol (CHOL), triglycerides (TG), HDL cholesterol (high density lipoprotein), LDL-cholesterol (low density lipoprotein), uric acid (KM) and glycemia and whether the changes reach statistical significance. We have also been interested in the question of possible correlation between severity of obesity and the presence of liver fibrosis. Methodology: Bardejov Spa a. s. has developed a complex specialized two-week spa stay aimed at weight reduction, which was put into practice in May 2012 (Belovicova M, Belovicova L, Svirkova H, Niemasikova G, Bachulak V, ...
If you look at the third point, overall survival, the median overall survival in this study was 9.3 months at a follow-up for 15 months. The [?? 4:24] overall survival rates were 41% in one year, 22% at two years and three years which again suggests that there is a form of tail as we have seen in other diseases.. What we analysed then was survival, depending on whether patients had a benefit of this treatment or not. As you can see in green, those patients who had a complete or partial response on the left according to RECIST, on the right to IR RECIST. All patients were still alive at the time of the analysis with 100% one year and 100% two year overall survival rates. If you look on the left side patients with stable disease one year overall survival was 69%, patients with progressive disease one year overall survival was 33%. Of interest, if you look on the left side you see two year overall survival 11% and three year overall survival 11%. These were patients who had pseudoprogression. ...
A phase I study to determine the maximum tolerable dose (MTD) and to evaluate pharmacokinetic, safety/tolerability and efficacy profiles of antroquinono
June 05,2010- Denosumab Demonstrated Superiority Over Zometa(R) in Delay of Complications
Due to Bone Metastases in Advanced Prostate Cancer.
The high failure rate (e.g., 50%-60%) of phase III trials in oncology presents a major obstacle to the drug discovery process (1). Understanding and addressing the potential reasons for these high failure rates are crucial to making progress. Possible reasons for the high failure rate in phase III trials include (i) suboptimal choice of patient population and (ii) inaccurate predictions of effectiveness from the hypothesis generating prior phase II trials. The focus of this work is on the second of these reasons, and focuses on the choice of the endpoints used for phase II trials in patients with measurable disease to identify agents worthy of further evaluation. Our goal was to consider alternative phase II endpoints to the standardly used endpoint of tumor response, and in particular the use of endpoints based on continuous tumor measurements.. Historically, phase II trials have used tumor response rate as the primary endpoint, where response is assessed via the Response Evaluation Criteria in ...
It is difficult to ensure that treatment comparison groups are sufficiently similar in terms of prognostic variables in non-randomized studies, particularly prognostic variables that remain undiscovered ...
GONADOTROPINS (GONAL-F): These are the actual fertility hormones used to stimulate egg growth from your ovaries, resulting in multiple eggs. Gonadotropins are all very similar- they consist of the hormone FSH with some preparations containing the hormone LH. There are different trade names for these medications in Canada, the United States and Europe, include the following: Pergonal, Humegon, Fertinorm, Fertinex, Metrodin, Puregon, or Gonal-F. Some of the side effects may include: ...
Patients with moderate or occasional acne may have the ability to treat themselves without using prescription drugs. Such treatments may contain an alteration in exercise and diet habits, routine cleanse to remove build-up and deposits on the skin, selecting the right make-up and removing pressure.
To our knowledge, this is the first prospective interventional study that evaluated the safety and effectiveness of RTX in patients with RA who had discontinued their first TNF-α inhibitor and that was conducted in 2 countries with a comparable approach to the management of RA.. There is always a concern that the safety profile of a drug might be different from the one observed in randomized controlled trials (RCT) when tested in real-life clinical situations, where some patients might have not qualified for an RCT based on the inclusion/exclusion criteria. When compared to the REFLEX trial14, patients in our study had slightly less severe disease, measured by DAS28, CRP levels, and HAQ score, despite longer disease duration. Interestingly, the safety profiles were comparable during both the primary treatment period and the retreatment phase. No new signals were seen. RTX was well tolerated during the study, with no serious infusion reactions and a low incidence of serious infections. Fewer ...
REHOVOT, Israel, March 22, 2017 /PRNewswire/ -- CE Mark Granted to Nucleixs Bladder EpiCheck - Announcing Superior Results Over All Other Non-Invasive...
The unadjusted 3-year all-cause mortality was higher in the PCI group as compared with the CABG group (3.8% vs. 2.5%; log-rank p = 0.03), although there was no significant difference in the composite outcome (7.5% vs. 9.4%; log-rank p = 0.07). After adjustment for differences in baseline risk factors, PCI was associated with significantly higher risk of all-cause mortality (HR, 1.71; 95% confidence interval [CI], 1.32-2.21; p < 0.001), but similar risk of the composite outcome (HR, 0.94; 95% CI, 0.82-1.09; p = 0.43). These differences were not statistically significant among patients with low or intermediate SYNTAX (Synergy Between PCI With Taxus and Cardiac Surgery) score (≤32) or diabetes; however, PCI was associated with an increased risk among those with a high SYNTAX score (>32), with HRs of 3.10 (95% CI, 1.84-5.22; p < 0.001) for all-cause mortality and 1.82 (95% CI, 1.36-2.45; p < 0.001) for the composite outcome. CABG was associated with lower risk of repeat revascularization, but ...
In the current study, we set out to understand whether PRO metrics assessed at 3 months postoperatively were accurately predictive of outcomes at 12 months postoperatively. Although there was a significant correlation between absolute outcome scores at 3 and 12 months postoperatively in aggregate via linear regression analysis, we observed a wide variation in the extent of change between 3 and 12 months after surgery. Nearly as many patients demonstrated worsening PROs as reported improving PROs between 3 and 12 months. Furthermore, the extent of 3- to 12-month improvement or worsening also varied widely among patients. Even at its peak reliability in ROC analysis, the 3-month PRO score remained with greater than 10% inaccuracy. Whether one defines surgical treatment response as 12-month MCID improvement or any degree of PRO improvement at 12 months, 3-month scores did not reliably identify treatment responders from nonre-sponders. In the assessment of postoperative improvement in disability ...
The truth is this - we doctors want the most successful treatment for patients - one that will achieve the highest level of function, while restoring each patient to long-term, pain-free living.
Practicing with a partner leads to a better improvement in performance compared to people who practice on their own, a new study reveals.
Rating of Evidence: I = One or more randomized trials in children† with clinical outcomes and/or validated endpoints; I* = One or more randomized trials in adults with clinical outcomes and/or validated laboratory endpoints with accompanying data in children† from one or more well-designed, nonrandomized trials or observational cohort studies with long-term clinical outcomes; II = One or more well-designed, nonrandomized trials or observational cohort studies in children† with long-term outcomes; II* = One or more well-designed, nonrandomized trials or observational studies in adults with long-term clinical outcomes with accompanying data in children† from one or more similar nonrandomized trials or cohort studies with clinical outcome data; III = Expert opinion ...
Our findings of lack of improvement in HRQOL despite improvements in primary clinical outcomes are consistent with RCTs (4,5) in diabetes with nonminorities that found that SF-36 scores deteriorated or remained stable following interventions demonstrating improved clinical outcomes. These findings raise important issues regarding conceptualization of HRQOL and resulting implications for use, analysis, and interpretation of the SF-36 in diabetes RCTs.. One conceptualization of HRQOL in diabetes is disease burden, including patient distress due to diabetes symptoms, complications, or treatment. Weak associations between SF-36 and diabetes markers, in cross-sectional studies, have been discussed in light of this conceptualization, and use of diabetes-specific HRQOL scales assessing troublesome diabetes-specific symptoms and experiences (6) have been recommended for better sensitivity to burden than the SF-36.. A second conceptualization of HRQOL, impact of disease on physical health, social health, ...
When patients who had Botox injections also used the Obagi Nu-Derm skin care regimen, they were more satisfied with their results, compared to patients who had a Botox treatment with placebo, Obagi reports. The results also found there was a greater improvement in overall facial appearance among those that used the Obagi products.. Obagi Nu-Derm works at the cellular level by exfoliating and stimulating cell turnover, so skin "behaves" and looks younger.. Lead researcher Joel Schlessinger, MD, a dermatologist, said that often his patients have skin that doesnt always look markedly improved with Botox or other injectables alone.. "Many practitioners are not aware of the potential benefits associated with incorporating this system with other non-invasive procedures in the practice," he said. "This data clearly highlights the fact that by adding Condition & Enhance [Nu-Derm] to injectable patients treatment regimen, patients are addressing multiple aspects of aging skin for optimal results. The ...
Background: Patients with refractory NHL experience poor outcomes to currently available therapies. In the SCHOLAR-1 pooled analysis of patients with refractory aggressive NHL, the objective response rate (ORR) was 26% (complete response [CR] rate was 7%), and the median overall survival (OS) was 6.3 months (Crump et al. Blood. In press). The primary analysis of ZUMA-1 demonstrated positive results with an ORR of 82% and a CR rate of 54% after a single infusion of axi-cel. The safety profile was manageable: grade ≥ 3 cytokine release syndrome and neurologic events were generally reversible and reported for 13% and 28%, respectively (Locke et al. AACR 2017. #9986). With a median follow-up of 8.7 months, 44% of patients in ZUMA-1 were in ongoing response. We plan to present the 1-year follow-up of ZUMA-1 to confirm the stability of response following anti-CD19 CAR T cell therapy as previously suggested (Locke et al. Mol Ther. 2016; Kochenderfer et al. Mol Ther. 2017). Additionally, exploratory ...
The invention features an assembly for taking a biopsy sample from a site within the body of a patient. The assembly includes a resecting device having a cutter near its distal end for resecting and containing a tissue sample and a sheath exterior to the resecting device and sized to be present within the body with the resecting device. The sheath includes an electrode element electrically isolated from the resecting device and disposed on the sheaths outer surface for cauterizing tissue. The electrode element may reside on the outer sheath, the distal end or both the outer sheath and the distal end of the assembly. The resecting device and the sheath cooperate to permit sequential resecting of a tissue sample from a resecting site and cauterizing of the site with the cutter sufficiently spaced from the electrode element to avoid heat damage to the tissue sample.
Li Yw, Fakhara A, Shadan A, et al. Cancer Res August 1, 2005 65; 6934. doi: 10.1158/0008-5472.CAN-04-4604 Cancer chemotherapeutic strategies commonly require multiple agents. However, use of multiple agents contributes to added toxicity resulting in poor treatment outcome. Thus, combination chemotherapy must be optimized to increase tumor response and at the same time lower its […]. read more ...
A resecting device for use in tissue removal is disclosed. The resecting device includes a cannula having a hollow and which is sized for introduction into a body. The cannula is formed with at least one, preferably a plurality of, cutting openings each having a cutting edge. The resecting device further includes a rotating mechanism which is connectable through a shaft to the cannula and which serves for rotating the cannula around a longitudinal axis thereof. As a result of such rotation and the cannulas construction, when the cannula is contacted with a tissue, the cutting edges of the cutting openings dissect the tissue and direct the dissected tissue through the openings into the hollow of the cannula.
Millions of patients worldwide are admitted for acute heart failure (AHF) each year and physicians caring for these patients are confronted with the short-term challenges of reducing symptoms while preventing end organ dysfunction without causing additional harm, and the intermediate-term challenges of improving clinical outcomes such as hospital readmission and survival. There are limited data demonstrating the efficacy of any currently available therapies for AHF to meet these goals. After diuretics, vasodilators are the most common intravenous therapy for AHF, but neither nitrates, nitroprusside, nor nesiritide have robust evidence supporting their ability to provide meaningful effects on clinical outcomes, except perhaps early symptom improvement ...
Screened means that assessed for eligibility for the study. If the investigator must interact with the subject to obtain information to compare against the inclusion/exclusion criteria then informed consent must be obtained before screening commences. If the investigator simply informs the prospective subject about the trial, this is recruitment not screening. Review of CHOP medical records for potentially eligible subjects may be permissible without consent.. Enrolled means all subjects who have consented to screening or participation in the study. If the subject is a screen failure (ineligible), they are still enrolled. Subjects who fail to get the study intervention or to complete the required study procedures are still enrolled.. Evaluable means all subjects whose data can be used in the final analysis data set. Subjects may be evaluable for some endpoints but not others. For example, if 4 blood samples are needed per subject to be considered evaluable in a PK study, all those who get the ...
In our current analysis of nearly 350,000 PCI procedures performed in the United Kingdom, we found that use of TRA was independently associated with a reduction in 30-day mortality outcomes and that the magnitude of this mortality effect was related to baseline bleeding risk, with those at highest risk of bleeding complications gaining the greatest benefit from adoption of TRA for PCI. Furthermore, our analysis suggests that in a national setting, access site choice does not seem to be influenced by baseline bleeding risk and, paradoxically, that TRA utilization rates are lower in those patients at highest risk of bleeding complications.. Peri-procedural major bleeding complications are among the most powerful independent predictors of mortality (1-3,13,19,20), with a greater impact on mortality than peri-procedural MI (13,20). Our data also suggest that baseline bleeding risk is one of the strongest predictors of 30-day mortality for those patients at highest baseline risk from bleeding ...
TY - JOUR. T1 - Comparison of continuous versus categorical tumor measurement-based metrics to predict overall survival in cancer treatment trials. AU - An, Ming Wen. AU - Mandrekar, Sumithra J. AU - Branda, Megan E.. AU - Hillman, Shauna L.. AU - Adjei, Alex. AU - Pitot, Henry Clement. AU - Goldberg, Richard M.. AU - Sargent, Daniel J.. PY - 2011/10/15. Y1 - 2011/10/15. N2 - Purpose: The categorical definition of response assessed via the Response Evaluation Criteria in Solid Tumors has documented limitations. We sought to identify alternative metrics for tumor response that improve prediction of overall survival. Experimental Design: Individual patient data from three North Central Cancer Treatment Group trials (N0026, n = 117; N9741, n = 1,109; and N9841, n = 332) were used. Continuous metrics of tumor size based on longitudinal tumor measurements were considered in addition to a trichotomized response [TriTR: response (complete or partial) vs. stable disease vs. progression). Cox ...
Summary: A major new antiretroviral has been approved, for patients resistant to more than one protease inhibitor. There is no information yet on ...
Since even small improvements in control seem to have long term benefits, getting tested for diabetes is wise if you have any reason to suspect you have the disease. Americans have become more aware of the threat of diabetes, but 24 percent of diabetes is undiagnosed. That number is an improvement on the past, however, down 30 percent in 2005 and from 50 percent 10 years ago ...
Results 455 subjects (average age 60.3 [±8.7], female 58.9%, average BMI 29.9 [±4.6] kg/m2, KL 3 [64.4%], and bilateral OA [64.0%]) were enrolled. SM04690 appeared well tolerated. In the ITT population clinically meaningful improvements in all clinical outcomes compared to baseline were seen for all groups and placebo at weeks 13 and 26 (Table). Moreover, clinically meaningful improvements in clinical outcomes were also seen in multiple groups over several outcomes at various time points compared to placebo. In the unilateral knee OA subgroup, PTGA (0.03 mg) and MDGA (0.07 mg) were significantly improved compared to placebo. In the WPI≤4 subgroup, WOMAC Pain (0.07 mg), PTGA (0.03 mg) and MDGA (0.07 mg) were significantly improved compared to placebo. ...
Our study compared exacerbation and lung function outcomes of benralizumab treatment with outcomes for other IL-5-directed biologics for severe, uncontrolled asthma. Results of the comparison between benralizumab and mepolizumab demonstrated comparable efficacy in reducing the annual rate of clinically significant exacerbations and exacerbations leading to ED visits or hospitalisation and improving pre-bronchodilator FEV1. In most comparisons, benralizumab was numerically better than mepolizumab after matching adjustment balanced baseline characteristics between the two populations, although there were no significant differences. This analysis extends findings from recent systematic review methods [26] and expands upon evidence from a recent ITC of IL-5-directed monoclonal antibody treatments by Cabon et al. [15] that did not include the key benralizumab phase 3 SIROCCO [9] and CALIMA [11] trials used in our analysis and did not adjust for differences in baseline patient characteristics. Cabon ...
For several years the Medical Research Council has encouraged the performance of multicentric clinical trials in cancerology, as well as the publication of their results. Recent methodological progress in the organisation and analysis of these trials are the objective of this article. Edited by a group of British and American statisticians it is, in fact, addressed to non-statisticians. The first part deals with the programme. The second, which is concerned with the analysis, gives the methods for establishing the curves of survival and for comparing them by the logrank test, methods that are illustrated by a numerical example. The way to interpret the results of a therapeutic trial is discussed with reference to 2 concrete examples. This article is applicable to all clinical trials in which a study is made of the survival, that is to say, the time gap up to the death, but it could also apply to trials studying some other event such as: the first relapse, metastasis, recurrence, and, apart from cancer,
The reliable detection of moderate differences in major health outcomes that arise as a result of treatment requires large-scale randomized evidence (and the appropriate interpretation of this evidence once it has been generated). This may take the form of a single mega-trial or, exceptionally, a meta-analysis of many smaller randomized trials may provide worthwhile information. Small or non-randomized studies cannot generally be trusted to distinguish reliably between a moderate benefit, a moderate hazard, and a negligible difference in major outcomes. Simple design, streamlined data collection, and use of the uncertainty principle to guide eligibility would all encourage the recruitment of larger samples in randomized trials. Future trials need to adopt these methods in order to detect any moderate improvements in major outcomes that may await discovery.
Although interventions varied in the emphasis that they placed on physical activity, all groups showed some increase in physical activity. The typical participant did no moderate or vigorous activity (which does not include walking) at baseline and was doing 50-60 minutes a week at 12 weeks and about half that at one year follow-up. Those in the exercise only comparator group were doing a similar amount to participants in other arms. All interventions therefore seemed to act as a spur for people to do what they already knew they should be doing, a conclusion that is supported by qualitative feedback from participants (data not shown). This activity was probably insufficient to account for weight loss in the comparator group, and this weight loss probably represents what might be achieved by people responding to a spur to action. We believe that the comparator group was therefore a true control group. The comparator group achieved statistically significant weight loss from baseline to follow-up ...
A pair of studies by researchers at the Hospital for Special Surgery demonstrate that newly discovered subsets of cells found in joint tissue among patients with rheumatoid arthritis, and how they interact, could potentially explain why only certain individuals respond to current treatments, according to a press release.“Right now, the standard approach for treating patients is a trial and
A new study sheds new light on the risks associated with the growing popularity of endoscopic resection in the treatment of localized, early-stage esophageal cancer.
TY - JOUR. T1 - Symptom monitoring with patient-reported outcomes during routine cancer treatment. T2 - A randomized controlled trial. AU - Basch, Ethan. AU - Deal, Allison M.. AU - Kris, Mark G.. AU - Scher, Howard I.. AU - Hudis, Clifford A.. AU - Sabbatini, Paul. AU - Rogak, Lauren. AU - Bennett, Antonia V.. AU - Dueck, Amylou. AU - Atkinson, Thomas M.. AU - Chou, Joanne F.. AU - Dulko, Dorothy. AU - Sit, Laura. AU - Barz, Allison. AU - Novotny, Paul. AU - Fruscione, Michael. AU - Sloan, Jeff A. AU - Schrag, Deborah. PY - 2016/2/20. Y1 - 2016/2/20. N2 - Purpose There is growing interest to enhance symptom monitoring during routine cancer care using patientreported outcomes, but evidence of impact on clinical outcomes is limited. Methods We randomly assigned patients receiving routine outpatient chemotherapy for advanced solid tumors at Memorial Sloan Kettering Cancer Center to report 12 common symptoms via tablet computers or to receive usual care consisting of symptom monitoring at the ...
This is a multi-center, randomized, double-blind, controlled, Phase 2 study to assess the safety, tolerability, and efficacy of PB1046 at the optimally titrated dose after 16 weeks of treatment. Subjects will be randomized in a 2:1 ratio to one of two parallel dose groups: a) high-dose group where PB1046 will be up-titrated from a 0.2 mg/kg minimally effective starting dose to a target high dose level of at least 1.2 mg/kg or higher to a maximally tolerated dose (MTD), or b) a low-dose group that will start at 0.2 mg/kg and remain at this minimally effective dose (MED) level with sham up-titration. The total treatment period will be comprised of 2 phases: 1) an initial 10 week dose titration phase in which weekly doses of PB1046 will be titrated (or sham titrated) up to a target dose level of at least 1.2 mg/kg or higher to the MTD, and 2) a maintenance of treatment phase that begins when subjects reach week 11 and continues for 6 weeks during which no further up-titration should occur.. ...
Best Overall Response (BOR) - The best overall response was calculated, based upon the disease assessments recorded during the study visits, and summarized with the number and percentage of participants for the following categories: CRc, PR, HA, SD, PD, and not evaluable. Overall best response is the best response observed for a participant during the study based on International Working Group (IWG) Response Criteria for malignant lymphoma. Complete response (CR) as per IWG is complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy. PR is a minimum of 50% decrease in sum of the product of the diameters (SPD) of up to 6 of the largest dominant nodes or nodal masses and no increase in the size of other nodes and in size of liver or spleen. Stable disease (SD) is when a participant fails to attain the criteria needed for a CR or PR, but does not fulfill those for PD. ...
In this Phase 3, open-label, multicentre, global study, 720 patients with PD-L1+ and PD-L1− R/M SCCHN will be randomised (1:1:1) to receive durvalumab (10 mg/kg IV for up to 12 months); tremelimumab (1 mg/kg IV) plus durvalumab (20 mg/kg IV for up to 12 months); or SoC (cetuximab, taxane, methotrexate, or fluoropyrimidine). Stratification factors include PD-L1 status, human papillomavirus status and smoking history. Eligible patients have progressed with a platinum-containing regimen for R/M disease or within 6 months of multimodality therapy containing platinum. Co-primary endpoints are progression-free survival (RECIST v1.1) based on independent central review and overall survival. Secondary outcomes will assess objective response rate, disease control rate, duration of response, and proportion of patients alive and progression free at 6 and 12 months (using RECIST v1.1 and immune-related RECIST); safety (CTCAE v4.03) and tolerability; and health-related quality of life. Exploratory outcomes ...
In patients with hypertension and Type 2 diabetes, relatively modest improvements in fitness status -- significantly with walking just 30 minutes a day --
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/PRNewswire/ -- Data confirms consistency of IMBRUVICA as an effective treatment option for patients with these challenging blood cancers Note: This press...
Health,...Viable treatment is still a long way off researchers say ...WEDNESDAY June 16 (HealthDay News) -- Researchers report theyve move...The study published in the June 16 issue of the journal Science Tr...Still we demonstrated that we could make this happen said study le...,Gene,Therapy,for,HIV,Inches,Forward,medicine,medical news today,latest medical news,medical newsletters,current medical news,latest medicine news
Our staff is well-trained in all aspects of conducting a rigorous systematic review. They assist clinical faculty in developing key questions and inclusion/exclusion criteria, coordinating with medical librarians for comprehensive searches, performing abstract and full-text review of the scientific literature, quality assessment, data abstraction, meta analysis, and drafting review findings for publications and dissemination. Our team skillfully uses various tools to facilitate the review process, including Endnote, Abstrackr, REDCap, and Distiller. CHPR is proud to contribute to the evidence base that informs clinician, patient, and payer decision making ...
Philadelphia, PA (PRWEB) April 30, 2013 -- Researchers from The Childrens Hospital of Philadelphia and the Perelman School of Medicine at The University of
DRIVE-AHEAD is an ongoing Phase 3 multicenter, double-blind, randomized, active comparator-controlled clinical trial evaluating the safety and efficacy of a once-daily, single-tablet, fixed-dose combination consisting of DOR/3TC/TDF (100mg/300mg/300mg) versus a once daily, single-tablet, fixed-dose combination of EFV/FTC/TDF (600mg/200mg/300mg) in treatment-naïve HIV-1 infected adults. The primary endpoint of the clinical trial was the proportion of participants with HIV-1 RNA less than 50 copies/mL at Week 48. The primary safety endpoint was the proportion of participants with neuropsychiatric adverse events through Week 48 in the following pre-specified categories: dizziness, sleep disorders and disturbances, and the inability to think clearly or concentrate. Secondary endpoints included an evaluation of the effects of DOR/3TC/TDF and EFV/FTC/TDF on fasting serum lipids, change from baseline in CD4+ T-cell count, and evaluation of safety and tolerability. The trial consists of a 96-week ...