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Patient informed consent

David J Pulford, Philipp Harter, Anne Floquet, Catherine Barrett, Dong Hoon Suh, Michael Friedlander, José Angel Arranz, Kosei Hasegawa, Hiroomi Tada, Peter Vuylsteke, Mansoor R Mirza, Nicoletta Donadello, Giovanni Scambia, Toby Johnson, Charles Cox, John K Chan, Martin Imhof, Thomas J Herzog, Paula Calvert, Pauline Wimberger, Dominique Berton-Rigaud, Myong Cheol Lim, Gabriele Elser, Chun-Fang Xu, Andreas du Bois
BACKGROUND: The focus on translational research in clinical trials has the potential to generate clinically relevant genetic data that could have importance to patients. This raises challenging questions about communicating relevant genetic research results to individual patients. METHODS: An exploratory pharmacogenetic analysis was conducted in the international ovarian cancer phase III trial, AGO-OVAR 16, which found that patients with clinically important germ-line BRCA1/2 mutations had improved progression-free survival prognosis...
October 21, 2016: BMC Medical Ethics
Srikanth Boddu, Marc Dinkin, Maria Suurna, Kelly Hannsgen, Xem Bui, Athos Patsalides
OBJECTIVE: Evaluate the role of venous sinus stenting in the treatment of pulsatile tinnitus among patients with Idiopathic Intracranial Hypertension (IIH) and significant venous sinus stenosis. SUBJECTS AND METHODS: A written informed consent approved by the Weill Cornell institutional review board was signed and obtained from the study participants. Thirty-seven consecutive patients with IIH and venous sinus stenosis who were treated with venous sinus stenting between Jan...
2016: PloS One
Marilyn J Hammer, Patricia Eckardt, Margaret Barton-Burke
The primary goal of the thousands of registered trials in cancer research is to extend survival. With evaluation of efficacy, safety, and tolerability, healthcare providers must ensure that the principles described in the Belmont Report are upheld and that patients are truly informed when signing a consent form. In this article, two cases are highlighted, and reasons for participating in clinical trials are discussed. Challenges, such as healthcare literacy, patients' dedication to their healthcare providers, and choosing between multiple trials, are also explored...
November 1, 2016: Oncology Nursing Forum
Jayita De, Anne P F Wand, Peter I Smerdely, Glenn E Hunt
OBJECTIVE: To measure the diagnostic accuracy of the 4A's test in screening for delirium in geriatric inpatients from culturally diverse backgrounds. METHODS: A prospective study was conducted with patients admitted to the geriatric and orthogeriatric services of a tertiary teaching hospital. Consenting participants aged 65 years and over were screened for delirium with the 4AT by nursing staff within 72 h of admission. The diagnosis of delirium was made separately by expert assessors, responsible for the participant's clinical care, blinded to the 4AT score, within 30 min of the 4AT assessment using the DSM 5 criteria and the Confusion Assessment Method...
October 20, 2016: International Journal of Geriatric Psychiatry
Salman Razvi, Lorna Ingoe, Vicky Ryan, Simon H S Pearce, Scott Wilkes
BACKGROUND: Hypothyroidism is a common condition, particularly in the older population. Thyroid hormone requirements change with age and serum TSH levels also alter, especially in older patients. However, in practice laboratory reference ranges for thyroid function are not age-specific and treatment in older patients aims to achieve a similar target thyroid function level as younger age groups. METHODS: A dual centre, single blind, randomised controlled trial was conducted to determine the feasibility of a future definitive RCT in hypothyroid individuals aged 80 years or older who were treated with levothyroxine...
2016: Thyroid Research
Ming-Ching Shen, Ming Chen, Gwo-Chin Ma, Shun-Ping Chang, Ching-Yeh Lin, Bo-Do Lin, Han-Ni Hsieh
BACKGROUND: Von Willebrand disease (VWD) is not uncommon in Taiwan. In type 2 or type 3 VWD hemorrhagic symptoms are severer and laboratory data relatively more distinctive. De novo mutation and somatic mosaicism of type 2 VWD gene were rarely reported. Therefore clinical, laboratory and genetic studies of only type 2A, 2B and 2M VWD will be presented and issues of de novo mutation and somatic mosaicism will be explored. METHODS: Fifty-four patients belonging to 23 unrelated families from all around the country in whom type 2 VWD exclusive of type 2N has been diagnosed not only by clinical and routine laboratory studies but also by genetic confirmation during 1990-2015 were investigated...
2016: Thrombosis Journal
Jung Jae Park, Byong Chang Jeong, Chan Kyo Kim, Seong Il Seo, Keumhee C Carriere, Minji Kim, Byung Kwan Park, Seong Soo Jeon, Hyun Moo Lee, Han Yong Choi
PURPOSE: To evaluate postoperative outcome of cystic renal cell carcinoma (RCC) defined on preoperative computed tomography (CT), and to find the optimal cut-off of cystic cystic proportion in association with patients' prognosis. MATERIAL AND METHODS: In this institutional review board-approved study with waiver of informed consent, a total of 1315 patients who received surgery for single RCC with pre-operative CT were enrolled. The cystic proportion of RCC was determined on CT...
October 17, 2016: Journal of Urology
Q A Hill, L C Harrison, A D Padmakumar, R G Owen, K R Prasad, G F Lucas, P Tachtatzis
OBJECTIVE AND IMPORTANCE: Transplantation-mediated alloimmune thrombocytopenia (TMAT) occurs when leukocytes transferred in a donor organ from a patient with immune thrombocytopenia (ITP), mount a response against recipient platelets. We present the first fatal case of TMAT following liver transplantation and review its aetiology and treatment. CLINICAL PRESENTATION: The liver donor had ITP and died from an intracranial haemorrhage. The recipient platelet count fell to 2 × 10(9)/l on post-operative day 2...
October 21, 2016: Hematology (Amsterdam, Netherlands)
Abdunoor M Kabanywanyi, Rita Baiden, Ali M Ali, Muhidin K Mahende, Bernhards R Ogutu, Abraham Oduro, Halidou Tinto, Margaret Gyapong, Ali Sie, Esperanca Sevene, Eusebio Macete, Seth Owusu-Agyei, Alex Adjei, Guillaume Compaoré, Innocent Valea, Isaac Osei, Abena Yawson, Martin Adjuik, Raymond Akparibo, Mwaka A Kakolwa, Salim Abdulla, Fred Binka
The antimalarial drug piperaquine is associated with delayed ventricular depolarization, causing prolonged QT interval (time taken for ventricular de-polarisation and re-polarisation). There is a lack of safety data regarding dihydroartemisinin/piperaquine (DHA/PPQ) for the treatment of uncomplicated malaria, which has limited its use. We created a platform where electrocardiograms (ECG) were performed in public hospitals for the safety assessment of DHA/PPQ, at baseline before the use of dihydroartemisinin/piperaquine (Eurartesim®), and on day 3 (before and after administration of the final dose) and day 7 post-administration...
2016: PloS One
John I Shin, Kevin Phan, Parth Kothari, Jun S Kim, Javier Z Guzman, Samuel K Cho
STUDY DESIGN: This is a retrospective analysis of administrative database. OBJECTIVE: To elucidate the effect of glycemic control on surgical outcomes of middle-aged and elderly idiopathic scoliosis patients undergoing spinal fusion surgery. SUMMARY OF BACKGROUND DATA: Diabetes mellitus (DM) is a condition thought to adversely affect outcomes of spine surgery. However, no study has stratified glycemic control levels and their impact on outcome for idiopathic scoliosis patients receiving a spinal fusion surgery...
October 19, 2016: Clinical Spine Surgery
Lukasz Krokowicz, Adam Bobkiewicz, Maciej Borejsza-Wysocki, Barbara Kuczynska, Aleksandra Lisowska, Urszula Skowronska-Piekarska, Jacek Paszkowski, Jaroslaw Walkowiak, Michal Drews, Tomasz Banasiewicz
The term constipation with regard to patients with a stoma is defined as impaired bowel movements associated with increased stool consistency or long periods without bowel movements that lead to discomfort, flatulence, and abdominal pain. Information about constipation in patients with a stoma is limited. A prospective, descriptive study was conducted among patients attending ostomy and proctology outpatient clinics in Poznan, Poland between January 2011 and December 2014 to assess the role of dietary and pharmacological strategies in the management of constipation in patients with a stoma...
December 2015: Ostomy/wound Management
Rob Stenstrom, Daphne Ling, Eric Grafstein, Rolando Barrios, Chris Sherlock, Reka Gustafson, Farzaneh Osati, Iraj Poureslami, Aslam Anis
OBJECTIVES: The objective of this study was to estimate the seroprevalence of HIV infection and the acceptability of point-of-care HIV testing in an innercity Canadian emergency department. METHODS: We conducted a prospective cohort study in an urban tertiary care emergency department between August 2009 and January 2011. Randomly selected patients were enrolled using probabilistic sampling based on patient volumes. Inclusion criteria were age 19-75 years and ability to provide informed consent...
October 20, 2016: Canadian Journal of Public Health. Revue Canadienne de Santé Publique
Canna Ghia, Shashank Akerkar, Shailaja Sabnis, Urk Rao, Gautam Rambhad
BACKGROUND / OBJECTIVES: Biologic anti-TNFs in India have improved the patient management. Significant proportions of patients lose response over time or do not respond. Possible explanations are suboptimal trough anti-TNFa concentrations or antibodies to anti-TNFs. The aim of this project was to set up and standardize an independent laboratory to test immunogenicity of anti-TNF biologics (infliximab and etanercept). METHODS: Three rheumatologists piloted this project approved by independent ethics committee and carried out in compliance with ICH/GCP guidelines...
September 2016: Journal of the Association of Physicians of India
Shobhit Srivastava, Anil K Saksena, Sanjay Khattri, Santosh Kumar, Raghubendra Singh Dagur
BACKGROUND AND PURPOSE: Curcuma longa L. (CL), an Indian herb, has been used to treat many disorders because of its wide spectrum of pharmacological activities. It has been shown to exhibit anti-oxidant and anti-inflammatory properties, and is being used as herbal remedy since ancient times. Osteoarthritis of knee (KOA) is a chronic painful disorder in which prolong use of non-steroidal anti-inflammatory drugs (NSAIDs) or steroids may result into many serious side effects; hence, there is a need to develop herbal drugs, having good analgesia without side effects...
October 19, 2016: Inflammopharmacology
M Muge Karaman, He Wang, Yi Sui, Herbert H Engelhard, Yuhua Li, Xiaohong Joe Zhou
OBJECTIVES: To demonstrate the feasibility of a novel fractional motion (FM) diffusion model for distinguishing low- versus high-grade pediatric brain tumors; and to investigate its possible advantage over apparent diffusion coefficient (ADC) and/or a previously reported continuous-time random-walk (CTRW) diffusion model. MATERIALS AND METHODS: With approval from the institutional review board and written informed consents from the legal guardians of all participating patients, this study involved 70 children with histopathologically-proven brain tumors (30 low-grade and 40 high-grade)...
2016: NeuroImage: Clinical
Nevzat Dabak, Hasan Göçer, Alper Çıraklı
BACKGROUND: Giant Cell Tumor is considered a benign, local and aggressive tumor. Although considered a benign bone tumor, it is still the subject of discussion and research because of the associated local bone destruction, as well as high rates of recurrence and distant metastases. Options are being developed for both surgical techniques and adjuvant therapies. AIMS: The present study evaluated the administration of cryotherapy via a pressurized-spray technique in giant cell tumors of the bone...
September 2016: Balkan Medical Journal
Kensuke Hori, Tomohiko Tsuruta, Chihiro Odani, Hitomi Ono, Rieko Ohkubo, Kanoko Shimoji, Junko Murakami, Mio Nakagawa, Lina Tashima, Kimihiko Ito
OBJECTIVES: Treatment for ovarian cancer with bevacizumab(Bmab)has been covered by public medical insurance in Japan since November 2013. It is recommended that the use of Bmab is limited to the first treatment for FIGO stage III or IV ovarian cancer. The OCEAN trial for platinum sensitivity in relapsed patients and the AURELIA trial for platinum-resistance in relapsed patients were performed, and both significantly improved progression-free survival. METHOD: We retrospectively studied patients receiving Bmab with an anticancer agent for recurrent ovarian cancer...
October 2016: Gan to Kagaku Ryoho. Cancer & Chemotherapy
Mareike Kroll, Revati Phalkey, Sayani Dutta, Sharvari Shukla, Carsten Butsch, Erach Bharucha, Frauke Kraas
BACKGROUND: Despite the rising impact of non-communicable diseases (NCDs) on public health in India, lack of quality data and routine surveillance hampers the planning process for NCD prevention and control. Current surveillance programs focus largely on communicable diseases and do not adequately include the private healthcare sector as a major source of care in cities. OBJECTIVE: The objective of the study was to conceptualize, implement, and evaluate a prototype for an urban NCD sentinel surveillance system among private healthcare practitioners providing primary care in Pune, India...
2016: Global Health Action
Takanori Masuda, Takeshi Nakaura, Yoshinori Funama, Toru Higaki, Masao Kiguchi, Naoyuki Imada, Tomoyasu Sato, Kazuo Awai
OBJECTIVE: We evaluated the effect of the age, sex, total body weight (TBW), height (HT) and cardiac output (CO) of patients on aortic and hepatic contrast enhancement during hepatic-arterial phase (HAP) and portal venous phase (PVP) computed tomography (CT) scanning. METHODS: This prospective study received institutional review board approval; prior informed consent to participate was obtained from all 168 patients. All were examined using our routine protocol; the contrast material was 600 mg/kg iodine...
October 18, 2016: Journal of Computer Assisted Tomography
John S Halle, Rob J Halle
BACKGROUND: Dry needling (DN) is an evidence based treatment technique that is accepted and used by physical therapists in the United States. This clinical commentary is the second in a two-part series outlining some of the pertinent anatomy and other issues that are needed for optimal utilization of this treatment modality. Part one was an overview of the thorax with a summary of reported adverse effects (AEs) and the underlying anatomy that could be used to minimize patient risk. As is the case with any intervention, the technique of dry needling has some inherent patient risk...
October 2016: International Journal of Sports Physical Therapy
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