Patient Recruitment. 3.3.3 před vstupem způsobilých účastníků do studie zkoušející se způsobilými účastníky projedná všechny podrobnosti a požadavky protokolu a formuláře souhlasu.
Patient Recruitment. Twelve adult patients with PD will initially be recruited during months 3-9 (Milestone 4,5) of this proposal (statistical justification in section 3.5). Pending acceptable initial findings, an additional 18 patients will be Figure 5: The new trajectory guide is shown. It includes a base with MR fiducials (arrow) a vertical alignment indicator and articulation knobs that can be precisely manipulated remotely. [***] Indicates portions of this exhibit that have been omitted and filed separately with the Securities and Exchange Commission pursuant to a request for confidential treatment. recruited (statistical justification in Section 3.5). Patients will be recruited from the UCSF surgical movement disorders clinic referred for DBS surgery for PD. Our center is the busiest DBS surgical center on the West coast and currently evaluates over 75 new patients a year for DBS candidacy. Patients with disabling symptoms of advanced PD that are inadequately controlled with medical therapy will be considered for the study. Inclusion/exclusion criteria will be identical to the criteria for patients undergoing surgical treatment for PD by standard methods. Inclusions are: (1) diagnosis of bilateral, idiopathic PD with clinically significant motor fluctuations despite maximized antiparkinsonian therapy (2) at least 5 years’ duration, relative to the date of surgery, since diagnosis of PD, (3) age >21 inclusive, on date of surgery, (4) the subject is ambulatory in their best on time (not wheelchair bound), (5) the subject is medically able to undergo the surgery as determined by clinical and laboratory evaluations (e.g., subjects will have normal coagulation tests and normal platelet levels), and (6) the subject is expected to be able to comply with and understand the required visit schedule and all required tests and procedures. Exclusions will include: (1) a history of any clinically significant medical, psychiatric, or laboratory abnormality for which participation in the study would, in the opinion of a mental health expert (CR), pose a safety risk to the subject, (2) history of treatment of PD by any procedure involving intracranial surgery or implantation of a device, (3) MR of the brain within 12 months before the surgery which demonstrates an intracranial abnormality that would contraindicate surgery (e.g. stroke, tumor, vascular abnormality affecting the DBS target area), (4) any disorder that precludes a surgical procedure (e.g., signs of sepsis or inadequately tr...
Patient Recruitment. A total of 12 patients will be recruited from the UCSF surgical movement disorders clinic referred for DBS surgery for dystonia (Milestone 9) statistical justification in section 3.5). Our busy DBS surgical center currently evaluates over 20 new dystonia patients a year for DBS candidacy. The following inclusion criteria will be applied: (1) Severe idiopathic or secondary dystonia diagnosed by a movement disorders neurologist (JO), (2) severe functional impairment despite optimal medical management, including failed botulinum toxin therapy if appropriate, (3) age >7 inclusive, on date of surgery, (4) the subject is medically able to undergo the surgery as determined by clinical and laboratory evaluations, and (5) the subject is able to comply with and understand the required visit schedule and all required tests and procedures. Exclusions will include: (1) medical contraindications to surgery, stimulation, or magnetic resonance imaging, (2) active alcohol or drug abuse, (3) pregnancy and (4) Inability to follow-up with post-operative study visits. Written consent will be obtained prior to the surgical procedure and the investigators will extensively discuss with patients and their families the study rationale, protocol, risks, and potential benefits.
Patient Recruitment. Nabi and Kedrion will both recruit patients into the Phase II Study. Kedrion will recruit patients from the Territory into the study. Nabi will recruit patients from the USA into the study. Each Party shall notify the other in writing on a weekly basis as to the number of patients recruited and retained in the Phase II Study and recruitment shall cease when the number of patients specified in the protocol for the Phase II Study have been enrolled. Kedrion will reimburse Nabi on a quarterly basis within thirty days of presentation of a report providing the details for each patient in the USA for such quarter for Nabi’s costs incurred to recruit and treat patients in the Phase II Study up to a maximum aggregate amount per patient not to exceed [*****] inclusive of the cost of clinical supplies of the Licensed Product used to treat such patients valued in accordance with Section 4.2. Upon conclusion of the Phase II Study, Kedrion shall have the right to audit the books and records of Nabi for purposes of verifying the patient costs claimed by Nabi pursuant to this Section 3.6. [*****] A CONFIDENTIAL PORTION OF THE MATERIAL HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
Patient Recruitment. Reference: “Connections and channels of communication with prospective patients for whom XX-XX/RH Program services can have beneficial impact on their health.” (Page 124) Describe the keys ways in which this Essential Performance Area (EPA) is organized and conducted. Describe any steps to increase or enhance performance in this EPA. The GYT (Get Yourself tested) campaign information is at the two Nicolet College campuses and other local establishments to create an awareness of the total scope of services available at the Oneida County Health Department’s Reproductive Health Clinic. Information on the WI FPOS insurance coverage is also shared. Area phone books and STD websites have our contact information listed. Most new client referrals come from family and friends and/or the internet. We have created business cards and matchbook covers to promote our services. GYT posters and flyers have been printed and posted in the community and in the Public Health Dept.’s WIC program. The PNCC nurse will provide post-partum contraception education during the third trimester and provide contact information on RHC services. The RH staff follows up on all referrals to potential clients by letter or phone calls.
Patient Recruitment. Reference: “Connections and channels of communication with prospective patients for whom XX-XX/RH Program services can have beneficial impact on their health.” (Page 124) Describe the keys ways in which this Essential Performance Area (EPA) is organized and conducted. Describe any steps to increase or enhance performance in this EPA. The Xxxxx County Health Department/ FP program has continued a trend of growth over the past 5 years. We hope that this year will again show increases in total clients served. In looking at client numbers thus far, we appear to be on target to do so. We see much of our growth through client referrals to their friends and see this as the highest compliment possible. Actively reaching out to PNCC clients in the third trimester and contacting them after delivery continues to be a focus for client retention, as does outreach as previously mentioned.
Patient Recruitment. The Investigator shall use his or her best efforts to recruit only Qualified Participants and shall not knowingly enroll any participants, which in his or her best professional judgment do not adequately meet the criteria for Qualified Participants. The Principal Investigator will use his/her best efforts to recruit approximately 10 patients. The increase of the number of patients to be enrolled will require written approval from the Sponsor, but not an amendment to this Agreement. 3.5
Patient Recruitment. Reference: “Connections and channels of communication with prospective patients for whom XX-XX/RH Program services can have beneficial impact on their health.” (Page 124) Describe the keys ways in which this Essential Performance Area (EPA) is organized and conducted. Describe any steps to increase or enhance performance in this EPA. Patient Recruitment: We plan to meet with Memorial Medical Center staff and Marshfield Clinic-Greenwood site staff to inform the providers of the Family Planning Clinic’s role and services. The goal is to create a strong partnership and ultimately increase the frequency of referrals to and from the Family Planning Clinic. Using Facebook (and possibly other social media channels) to advertise the Clinic’s mission and objectives will be an appropriate avenue to reach the younger demographic. We also plan to meet with local tavern owners/operators about the Program as well as school leadership about referral opportunities. Also, as a geographically expansive county, we plan to explore the need and feasibility of opening clinic in the Northern and Southern parts of the county.
Patient Recruitment. Reference: “Connections and channels of communication with prospective patients for whom XX-XX/RH Program services can have beneficial impact on their health.” (Page 124) Describe the keys ways in which this Essential Performance Area (EPA) is organized and conducted. Describe any steps to increase or enhance performance in this EPA. KCDOH has been able to integrate reproductive life planning concepts and principles at all three clinic sites since 2012, as well as within our home visiting programs. Many families that visit one of our clinics for immunizations self-refer themselves to the RH-FP program after learning about its availability and services while on site. One example is the physical location of our Wellness Center within the WIC agency office. Since our clinics provide so many varying services simultaneously, it helps to maintain privacy. Nurse supervisors xxxxxx community awareness through regular outreach education, community partnerships, and a Community Advisory Board. For example, KCDOH staff facilitates health and wellness educational outreach programming through the Living Free Rehabilitation Program to persons who have been detained for non-violence alcohol or other drug charges. This program promotes our RH- FP services to a high risk population of men and women who reside in Kenosha County. In addition, KCDOH has two open Public Health Nurse positions that provide support to the KC RH-FP program and are working diligently to hire staff in the Kenosha area that are immersed in the community and various events and activities within the county. Patient referrals to friends and family (i.e. word of mouth) have also been a large source of program referrals.
Patient Recruitment. Reference: “Connections and channels of communication with prospective patients for whom XX-XX/RH Program services can have beneficial impact on their health.” (Page 124) Describe the keys ways in which this Essential Performance Area (EPA) is organized and conducted. Describe any steps to increase or enhance performance in this EPA. RH Nurses continually outreach through many avenues, one of the primary methods of patient recruitment is through our educational presentations to local area school districts and universities/colleges. The educational presentations primarily review the current available birth control methods and their effectiveness, STI prevention, transmission and treatment, as well as our Reproductive Health program services & WI- FPOS. In addition to our educational presentations, Xxxxxx County Health Department (PCHD) offers services for the WIC program, Prenatal Care Coordination/Families First program, and Reproductive Health services at both River Falls and Xxxxxxxxx. PCHD is offered space at numerous Health/Community Wellness/Business Fairs where PCRH outreach and education are provided. A large portion of clientele at PCRH is through the UW-River Falls, and a large portion of recruitment has come from our service contract with active UWRF students. Throughout the academic year PCRH has set up tables in UW-Student Center, as well as worked with student health services to speak at parent educational sessions during new student registration/orientation..
