The goal of this study is to utilize prospectively collected information from a multisite single-arm trial of 300 HIV uninfected people assigned female gender at birth with lower genital tract neoplasia ("WLGTN") to conduct a unique multidisciplinary study that will clarify issues surrounding anal cancer screening tests in this population as well as help to comprehend the natural history of anal dysplasia among WLGTN. This single arm clinical trial will evaluate screening (diagnostic) tests for anal cancer screening in a population that is not currently routinely screened, determine the prevalence and incidence of aHSIL and
collect data regarding the acceptability of different anal cancer screening approaches. The initial screening interventions will include the collection of (1) anal cytology, obtained by clinician using a water moistened cytobrush; (2) self-collected HPV testing specimens (by subjects, using a Dacron swab); (3) a clinician collected HPV specimen. Anal specimens will be collected by insertion of the cytobrush or moistened Dacron swab into the anal canal until resistance is not met; approximately 5 cm. These tests are followed by a brief standardized exam to determine any external anogenital lesions or pathology, performed by the investigator conducting anoscopy. A digital rectal exam will also be done on all patients. Results of these tests will be confirmed in all patients using high resolution anoscopy (HRA) with biopsy of suspicious lesions. Following standard practices, subjects are treated with 3% acetic acid and Lugol's iodine.
This trial will be a randomized controlled trial designed to determine if women with overactive bladder (OAB), treated with the prescription digital therapeutic (PDTx) demonstrate greater improvement in OAB-related health as compared to standard behavioral education with informational handouts.
To evaluate the efficacy of two different dwell times (3 hours and 4 hours) of i.p. VS-01, administered once daily for up to 4 days on top of SOC compared to SOC alone in treating OHE in patients with AD of liver
cirrhosis or ACLF grade 1 measured by time to improvement of OHE.
This research is being done to see if the drug suvorexant is effective as treatment for insomnia in people who have opioid use disorder and who are utilizing stable medications for opioid use disorder (MOUD). It is a 13-week study, and the study drug will be compared to a placebo.
This study will evaluate the efficacy and safety of RO7790121 compared with placebo in patients with moderately to severely active CD. Data on currently available treatments highlights the need for new medications in addressing the high unmet need in CD. The total maximum duration of study participation for an individual is expected to be approximately 70 weeks without OLE participation. With OLE participation, treatment will continue until RO7790121 is commercially available in that region or until the Sponsor decides to terminate the study, whichever is earlier. Approximately 600 patients will be enrolled in the study.
This study aims to look at injury rates experienced during a club travel volleyball season as correlated with self reported scores on the GRIT scale, Brief Resiliency Scale (BRS), and Athlete Burnout Questionnaire (ABQ) in male and female high school age volleyball players. The GRIT asks questions about passion and perseverance to achieve goals.
The BRS asks questions about resiliency after stress.
The ABQ asks questions to understand the determinants and consequences of athlete burnout. Completion of these surveys will take approximately 20 minutes.
Upon receiving and compiling all survey data, appropriate statistical analysis will be performed to assess for trends in the development of injuries and inform best practice on training.
J2T-MC-B002 (B002) examines the effectiveness of lebrikizumab in treating moderate-to-severe atopic dermatitis (AD). This study involves adult and adolescent patients suffering from eczema, which is characterized by inflammation, redness, and irritation of the skin. Participants will complete symptom assessments during their visits and will schedule appointments within specific timeframes. The study will also observe skin lesions using clinical measures. Participants will remain in the study for up to two years, even if their therapies change, to track disease progression with or without lebrikizumab. This observational study aims to record real-world treatment outcomes for the analysis of lebrikizumab in AD therapy.
Subjects prescribed with the LibAirty system will be instructed to perform daily therapy sessions per standard device use recommendations. During the study period, subjects will be followed according to standard of care procedures and timelines for Bronchiectasis management. Clinical outcomes and healthcare resource utilization during the study period will be collected and compared to the 12-month period prior to study enrollment. Adherence to therapy will be evaluated by device recorded logs. Health related quality of life and subject satisfaction with the system will be evaluated by designated questionnaires, collected during clinic visits. Subjects will be followed for 12 months after starting therapy. Each subject will be required to complete a screening and enrollment visit, and any scheduled follow up visits according to standard of care timelines through 12 months (with data expected to be collected at 6 and 12 (±1m) months at minimum). Up to one hundred (100) subjects older than 21 years of age, with bronchiectasis who meet the entry criteria will be enrolled to the study, in up to ten (10) sites.
This study will evaluate whether a 5-day, 6-hours-per-day therapy camp called Camp Hand to Hands can help children with hemiplegic cerebral palsy improve their walking ability, stair climbing, and involvement in daily life. During the camp, children will wear a resting hand splint covered by a soft puppet glove on their stronger arm to encourage use of the more affected arm while participating in fun, play-based activities such as obstacle courses and crafts. The study team will conduct daily assessments of each child's walking endurance and stair navigation using the 6-Minute Walk Test (6MWT) and the Timed Up and Down Stairs (TuDS) test during the 5-day camp. Parents will also complete a brief questionnaire about their child's participation at home and in the community before and after the camp. The study seeks to determine whether this short CIMT program leads to improvements in mobility and daily function.
Apathy is a common set of symptoms seen in many people following a stroke. Apathy occurs when a person has lost motivation, becomes withdrawn, and stops doing things that used to be important to them. Apathy has a large negative impact on a person's quality of life, and can also have a large impact the people who take care of individuals with apathy. There are currently no FDA-approved treatments to help with apathy, and other services like therapy may be difficult to access for people who have had a stroke. To address this problem, we are conducting a study to find out if a form of treatment called repetitive transcranial magnetic stimulation (rTMS) can be safe and helpful for people struggling with apathy after a stroke. Our study will apply a new form of rTMS which can be delivered quickly to a part of the brain called the medial prefrontal cortex (mPFC). Our study will help establish whether this treatment is safe, comfortable, and effective for people with apathy after a stroke, and will help researchers develop new forms of treatment.