Patient Informed Consent

Three Taiwan’s domestic family cluster infections of coronavirus disease 2019 | 9/6/2020

… or lower respiratory tract aspirates) and (b) Positive molecular biological testing for viral (SARS‐CoV‐2) RNA from a clinical specimen (nasopharyngeal swab, throat swab, expectorated sputum, or lower respiratory tract aspirates). 14 2.1 Patient informed consents and ethic issue This is a retrospective study. Patient information was obtained from the content of CECC’s press conference and the Taiwan CDC website. 12 The authors who do not know the patient’s …

Giant cell tumor stromal cells: osteoblast lineage-derived cells secrete IL-6 and IL-10 for M2 macrophages polarization | 8/24/2020

… The patient’s consent was obtained and informed consent form was signed. The use of all patient-derived materials was approved by the Ethics Committee of the Fourth Military Medical University (IRB-REV-2015005), and patient informed consent was obtained individually. Cell culture Primary GCT stromal cells (GCTSCs) were isolated from fresh GCT. The neoplasm was minced in small pieces and digested with 200 U/ml collagenase (Gibco BRL, Karlsruhe, Germany …

Texas Medical Board Clarifies Access To Ozone Therapy for the Treatment of COVID-19 | PR Newswire | 6/23/2020

… physicians. Board rule 190.8 (1) (A) which reads “ failure to treat a patient according to the generally accepted standard of care” is a violation. Hemphill’s request was to amend the rule by adding, “ without patient informed consent .” Currently the Center for Disease Control states there is no treatment for COVID-19; and, the only standard of care is infection control, supportive oxygen and ventilation. Therefore, any other treatment of COVID …

Texas Medical Board Clarifies Access To Ozone Therapy for the Treatment of COVID-19 | 6/23/2020

… physicians. Board rule 190.8 (1) (A) which reads “ failure to treat a patient according to the generally accepted standard of care” is a violation. Hemphill’s request was to amend the rule by adding, “ without patient informed consent .” Currently the Center for Disease Control states there is no treatment for COVID-19; and, the only standard of care is infection control, supportive oxygen and ventilation. Therefore, any other treatment of COVID …

TISSIUM™ Nerve Coaptation Device First-in-Human Clinical Trial | 3/30/2020

… achieved by flexion of the extremity without excessive tension; Clean surgical wound with sufficient healthy soft tissue that enables primary closure without adjunctive soft tissue procedures; Subject willing and able to provide a signed Patient Informed Consent Form; Subject willing and able to follow the study instructions and likely to complete all required study procedures and visits. Exclusion Criteria: Any patient with a known allergy to the constituent polymer of …

MicroRNA-28-5p Regulates Liver Cancer Stem Cell Expansion via IGF-1 Pathway | 12/1/2019

… samples were collected from patients who underwent the resection of their primary HCC in the Eastern Hepatobiliary Surgery Hospital (EHBH); detailed clinicopathological features of the patients is described in the online supplementary table 1 . Patient informed consent was also obtained, and the procedure of human sample collection was approved by the Ethics Committee of EHBH. Four HCC patients’ tissues were used for isolated primary HCC cells. Forty HCC patients’ tissues …

PD1Hi CD8+ T cells correlate with exhausted signature and poor clinical outcome in hepatocellular carcinoma | 11/29/2019

… from high immune cells infiltrated region in paraffin-embedded tumor and peri-tumor tissue based on the HE staining. Sections (4 μm) were cut and applied to APES- coated slides as previously described [ 4 ]. Patient informed consent was obtained and the study was approved by the institutional ethics committee. Tumor differentiation was graded by the Edmondson grading system [ 4 ]. None of the patients received antitumor or immunosuppressive treatments before surgery …

Aethlon Medical Announces Second Quarter Financial Results and Provides Corporate Update | PR Newswire | 11/1/2019

… to support an initial Early Feasibility Study (EFS) in patients with advanced and/or metastatic head and neck cancer, which was approved by FDA on October 4, 2019 subject to submission of a final patient informed consent form. The Company is currently preparing to initiate a 10 to 12 subject EFS in patients with advanced and/or metastatic head and neck cancer. The EFS will be performed at a major …

Dr. Diana Zuckerman’s Statement on FDA’s Draft Guidance on Labeling for Breast Implants | 10/23/2019

Statement of Dr. Diana Zuckerman, President, Research on October 23 Regarding FDA Labeling Recommendations to Improve Patient Communication Draft Guidance We thank the FDA for proposing a black box warning and a patient Informed Consent check list that provides specific, understandable information about the risks of breast implants. The FDA’s draft includes the types of information that we have proposed to the FDA in recent months in our work with …

The importance of obtaining patient informed consent to intervention Essay | 9/11/2019

The importance of obtaining patient informed consent to intervention in physical therapy practice - Essay Example The process of obtaining informed consent can be conducted as a single event or a series of multiple discussions in hospital wards, for inpatients or outpatients. This paper is determined to provide detailed information about the meaning of informed consent to intervention and the significance of obtaining patient informed consent to intervention in physical therapy …

Field Clinical Submission Specialist 1 Year Fixed Term Contract | 9/3/2019

… standard of quality defined by Company Standard Operating Procedures (SOPs). Focus is preparation of documents for submission to ethics committees (EC)/Institutional Review Boards (IRB) and competent Authorities (CA), especially country and site-specific Patient Informed consent adaptation; obtain and finalize documents required for submission/application, and support the process until review/final vote and approvals are granted. Be responsible for EC/CA communication in close collaboration with other Field …

BMI and specimen weight: impact on personalized risk profiling for optimized informed consent in breast reduction surgery? | Nature | 9/3/2019

… and allergies for wound infections; and patients’ age, resection weight for fat tissue necrosis. The resultant chart of institutionally encountered most common complications based on individual risk factors is a graphical template for obtaining patient informed consent in the future. Whether this approach influences patient information retainment, incidence of filed lawsuits or behavioral change needs to be prospectively tested in future studies. Introduction Women with large breasts, macromastia or even …

(ARE-Dubai) Field Clinical Submission Specialist - 1 Year Fixed Term Contract | 9/2/2019

… standard of quality defined by Company Standard Operating Procedures (SOPs). Focus is preparation of documents for submission to ethics committees (EC)/Institutional Review Boards (IRB) and competent Authorities (CA), especially country and site-specific Patient Informed consent adaptation; obtain and finalize documents required for submission/application, and support the process until review/final vote and approvals are granted. Be responsible for EC/CA communication in close collaboration with other Field …

Assessing the Justification, Funding, Success, and Survival Outcomes of Randomized Noninferiority Trials of Cancer Drugs: A Systematic Review and Pooled Analysis | Oncology | JAMA Network Open | JAMA Network | 8/30/2019

… noninferiority trials, 1 , 2 including in oncology. 3 For example, how much of a possible reduction in efficacy is reasonable? How noninferiority limits are defined may raise ethical issues related to the sufficiency of patient informed consent . 4 In some cases, noninferiority designs have been useful. For example, the standard of care for the use of zoledronic acid for preventing skeletal-related events in patients with cancer and bone metastases …

(USA) Medical - Clinical Research Assoc. II | 8/28/2019

… for assigned sites: Clinical Trial Monitoring Provide input into and/or develop study related materials such as protocols, Clinical Monitoring Plans, Data Management Plans, eCRF forms, data completions guidelines, patient diaries, recruitment plans, and patient informed consent s Ensure proper conduct of clinical trials in accordance with the Monitoring Plan and applicable prevailing laws, Good Clinical Practices, and company standards to achieve project goals, timelines and quality Manage assigned operational aspects …

The importance of obtaining patient informed consent to intervention Essay | 6/16/2019

The importance of obtaining patient informed consent to intervention in natural therapy practice - Essay ExampleThe process of obtaining informed consent can be conducted as a single event or a serial of multiple discussions in hospital wards, for inpatients or outpatients. This paper is determined to provide detailed information about the meaning of informed consent to intervention and the signification of obtaining patient informed consent to intervention in physical therapy practice …

(ARE-Dubai) Field Clinical Submission Specialist | 6/3/2019

Abbott Field Clinical Submission Specialist in Dubai , United Arab Emirates Main Purpose of Job: Support regulatory activities at study start up. Focus is preparation of documents for submission to ethics committees (EC) and competent Authorities (CA), especially country and site-specific Patient Informed consent adaptation; obtain documents required for submission, and support the process until vote or approval is granted. Primary Responsibilities: Prepare documents for Ethics Committee/Competent Authority (EC …

Surmodics, Inc. (SRDX) CEO Gary Maharaj on Q2 2019 Results - Earnings Call Transcript | Seeking Alpha | 5/5/2019

… to the agency seeking guidance on the recommendations and impact on our TRANSCEND trial. Following multiple conversations, we have taken several actions in response to the agency’s recommendations, including updates of investigated communications, the patient informed consent forms as well as safety data review and patient follow-up procedures; this situation required us to briefly pause enrollment in the study. As I mentioned, currently over half of our US trial …

National Cancer Institute

Crwe World | Aethlon Medical Announces Second Quarter Financial Results and Provides Corporate Update | 11/2/2019

… metastatic head and neck cancer, which was approved by FDA on October 4, 2019 subject to submission of a final patient informed consent form. The Company is currently preparing to initiate a 10 to 12 … was awarded a $1.86 million Phase II contract from the National Cancer Institute (NCI) under the Small Business Innovative Research (SBIR) program to develop a benchtop instrument to isolate and characterize exosomes in cancer. This …

Aethlon Medical Announces Second Quarter Financial Results and Provides Corporate Update | PR Newswire | 11/1/2019

… metastatic head and neck cancer, which was approved by FDA on October 4, 2019 subject to submission of a final patient informed consent form. The Company is currently preparing to initiate a 10 to 12 … was awarded a $1.86 million Phase II contract from the National Cancer Institute (NCI) under the Small Business Innovative Research (SBIR) program to develop a benchtop instrument to isolate and characterize exosomes in cancer. This …