Treatment Trials

9 Clinical Trials for Various Conditions

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COMPLETED
A Study to Evaluate Participant Satisfaction and Natural Outcomes Following Administration of BOTOX Cosmetic Injections in Adult Participants for Treatment of Upper Facial Lines
Description

Facial lines that develop from repeated facial expression, such as glabellar lines (GL), lateral canthal lines (LCL), and forehead lines (FHL), are typically treated by selectively weakening specific muscles with small quantities of botulinum toxin. The purpose of this study is to evaluate participant satisfaction and natural outcomes following the administration of BOTOX Cosmetic in adult participants with upper facial lines (GL, LCL, and FHL). This is an open-label study in which all participants will receive active study treatment. Around 100 adult participants with an assessment of moderate to severe GL, LCL, and FHL, will be enrolled at approximately 10 sites in the United States and Canada. Participants will receive BOTOX Cosmetic as intramuscular injections to the glabellar lines, lateral canthal lines, and forehead lines at Day 1. Participants will attend regular visits during the study. The effect of the treatment will be checked by medical assessments for side effects and questionnaires will be completed during regular study visits.

COMPLETED
Participant Satisfaction With the BUILD Mobile Application
Description

This study explores user satisfaction with the BUILD mobile application.

COMPLETED
Prospective Evaluation of Visual Outcomes With Tecnis One-Piece Multifocal Intraocular Lenses Compared With Patients Previously Implanted With Crystalens Aspheric Optic (AO)
Description

The study is being conducted to collect information about visual outcomes and participant satisfaction with the Tecnis One-Piece Multifocal (MF) Intraocular Lenses (IOLs) compared with participants previously implanted with Crystalens Aspheric Optic (AO) IOLs. The U.S. Food and Drug Administration (FDA) has cleared the Tecnis One-Piece MF IOL for visual correction of aphakia (replacing a removed lens in the eye) in adults.

COMPLETED
Research Participants Perceptions of Their Experience in Clinical Studies
Description

This study will examine how research volunteers experience their participation in studies in order to develop surveys to be used by research centers trying to improve the experience of their participants. People 18 years of age and older who have participated in an NIH research protocol within the past 2 years as someone with a medical condition under study may be eligible for this study. Eight participants will participate in a moderator facilitated focus group in a discussion about being in research studies. An observer audiotapes the discussion and takes written notes. The focus group discussion lasts about 1 to 1 (Omega) hours.

COMPLETED
Evaluating the Quality of Different Methods of Obtaining Informed Consent
Description

This is a sub-study of a drug development study conducted by Pfizer, Inc. It will evaluate how well people who participate in research studies understand from the study consent form what the purpose of the study is, the risks and benefits of participating, the procedures they will undergo and their right to withdraw from the study before it ends. It will compare the understanding and satisfaction of those who are given a standard consent form with those who are given a simpler, concise consent form and examine how their understanding of the information is affected by the length, complexity, format, and reading level of the document. People 18 years of age and older who are participating in a Pfizer drug development study and who are able to read and write English may be eligible for this sub-study. Participants in Pfizer's drug development study who agree to participate in this sub-study are randomized to receive either the standard consent form or the concise consent form. The standard consent consists of a detailed, multiple page consent form. The concise form is simpler, written at a lower reading comprehension level. Both forms contain all of the required elements of informed consent according to federal regulations, and include information needed to make a decision about participating in the study. Each form also contains information regarding participation in this sub-study. The standard group signs the standard consent form; the concise group is given the standard consent after reviewing the concise form and is asked to review and sign it. After reviewing the consent form for the main study, participants complete a 20-minute questionnaire that includes questions that measure understanding of study information such as its purpose, risks and benefits, compensation schemes, and other information. Additional questions ask about how the participants made the decision to enroll in the study. ...

COMPLETED
A Study to Evaluate Treatment Satisfaction With Erenumab in Participants With Migraine
Description

The main purpose of this study is to evaluate the effect of erenumab on medication-specific treatment satisfaction.

Conditions
COMPLETED
HEARTS R34 Feasibility Study, Autistic Participants
Description

The goal of this randomized clinical trial is to test whether the 6 sessions HEARTS Healthy Relationships classes increases the satisfaction that autistic adults feel about their friendships and dating relationships compared to a 6 weeks online discussion group. The 6 HEARTS sessions cover: healthy and unhealthy relationships, launching new relationships, neurohealth, meeting and reconnecting, boundaries, and healthy endings. Participants who take part in this research study will be in this research study for three months. During this time, participants will be asked to complete two 30-minute and six 10-minute online surveys, and participate in two 20-minute interviews over Zoom.

COMPLETED
A Study to Evaluate Patient Preference and Satisfaction of Subcutaneous Administration of the Fixed-Dose Combination of Pertuzumab and Trastuzumab in Participants With HER2-Positive Early Breast Cancer
Description

This is a Phase II, randomized, multicentre, multinational, open-label, cross-over study in adult patients who have completed neoadjuvant chemotherapy with neoadjuvant pertuzumab and trastuzumab and have undergone surgical treatment of human epidermal growth factor receptor 2 (HER2)-positive early breast cancer. The study will consist of two adjuvant treatment periods: a treatment cross-over period and a treatment continuation period. It will evaluate participant-reported preference for a subcutaneously administered fixed-dose combination formulation (FDC SC) of pertuzumab and trastuzumab compared with intravenously (IV) administered pertuzumab and trastuzumab formulations. The study will also evaluate participant-reported satisfaction with pertuzumab and trastuzumab FDC SC and health-related quality of life outcomes; healthcare professionals' perceptions of time/resource use and convenience of pertuzumab and trastuzumab FDC SC compared with pertuzumab and trastuzumab IV formulations; as well as the safety and efficacy of each study regimen.

COMPLETED
Research Participant Perception of Care Project: Part II: Fielding and Validation of the Research Participant Perception Survey Derived From Focus Group-Identified Key Dimensions of the Research Participant Experience
Description

Background: * Understanding participants experiences as research volunteers is critical to improving the effectiveness of human participant protection programs and strengthening public trust in clinical research. Historically, studies that evaluate participants comprehension of the informed consent document or evaluate the informed consent process have only indirectly measured the quality of a participant s experience. * Few studies have assessed the nature, quality and efficiency of the entire clinical research process from the participant s perspective. To address this need, researchers have developed a Clinical Research Participant Perception Survey to evaluate participants overall perceptions of clinical research. Objectives: - To validate the Research Participant Perception Survey questionnaire and revise it accordingly to produce a questionnaire that other researchers can use. Eligibility: - Individuals at least 18 years of age who have participated in at least one research protocol within the past 2 years. Participation may be completed or ongoing. Design: * Eligible participants will receive a survey by mail and will be asked to complete it and return it in the stamped envelope provided. * The survey will ask questions about the research protocol process, including participants positive and negative experiences of participating in the research protocol....