This research study will include heavy, long-term cannabis users with moderate to severe use desire who want or need to discontinue cannabis use and have previously had symptoms of cannabis withdrawal. Subjects participating in this research study will receive either PP-01 higher dose or lower dose (combination of nabilone and gabapentin in a varied amount), nabilone only, gabapentin only or placebo (inactive substance). This study will assess whether the study drugs help to lessen or alleviate cannabis withdrawal symptoms in study subjects.

This project is an extension of the CDC-funded FORWARD (Fragile X Online Registry With Accessible Research Database) study. From its inception in 2010, the goal of the FORWARD study has been to characterize the natural history of fragile X syndrome (FXS). This current extension project is known as FORWARD-MARCH (Multiple Assessments for Research CHaracterization) because it will include multiple assessments to characterize behavioral, adaptive, and cognitive function in greater depth and thereby further improve understanding of the natural history of FXS. FORWARD-MARCH continues the mission of FORWARD to better understand the natural history of FXS in order to improve the lives of children and adolescents with FXS and the lives of their families. FORWARD-MARCH will also better define trajectories of development in FXS that will be useful in understanding the long-term effects of an intervention relative to the natural history of FXS.

FORWARD-MARCH builds upon the foundation of the FORWARD study. The FORWARD study included 24 participating FXS specialty clinics throughout the US that are members of the FXCRC (Fragile X Clinical & Research Consortium). The FORWARD study worked closely with the Centers for Disease Control and Prevention (CDC), the National Fragile X Foundation (NFXF), and other stakeholders in the FXS community. FORWARD-MARCH will also involve a contractor, Chickasaw Nation Industries (CNI), funded through a contract with the CDC. CNI will assist in data collection and management.

Between September 2022 and August 2026, FORWARD-MARCH expects to enroll at least 600 individuals with fragile X syndrome who were born between 2003-2017. The majority of these individuals will already be FORWARD study participants, enabling researchers to conduct longitudinal analyses incorporating previously collected data. Cognitive, behavioral, and adaptive function will be assessed using parent or caregiver-completed surveys and in-person clinical assessments. After completion of data collection, deidentified data will be securely maintained at CDC and will be an important long-term resource for analyses of the natural history of FXS.

Previous phases of the FORWARD study, conducted between 2012 and 2022, have received IRB review and approval by the institutions of each participating clinic. These previous phases of the study did not require review by a CDC IRB, as CDC had no participant contact and did not have access to personal identifying information (PII). The extension of the FORWARD study covered in this protocol (FORWARD-MARCH, 2022-2026) will continue to be reviewed and approved by the institutions of each participating clinic conducting data collection. However, review and approval are also being sought from the CDC IRB because PII will be maintained on CDC servers and because CDC's contractor, CNI, will regularly have access to PII and interact directly with study participants. A reliance agreement allowing CNI to rely on CDC's IRB is being developed and will be executed before data collection is begun. To clarify which aspects of the protocol involve CDC and CNI staff (rather than just clinic staff), sections 3,4 and 5 of this protocol document each end with a subsection that specifically focuses on the role of CDC and CNI staff.

The purpose of this study is to see if the study drug BOTOX®, is safe and helps to reduce upper limb essential tremor in adults who experience persistent tremor during movement. The study is 38 weeks long and includes 12 clinic visits. Participants will be injected with the study drug or placebo 3 times over the 38 week period. The participant will have to complete a set of questionnaires and assessments at each visit.

This is a low-interventional cohort study to determine cardiac and non-cardiac long-term outcomes of persons <21 years of age with myocarditis/pericarditis after the administration of COMIRNATY, compared with similarly aged persons with myocarditis/pericarditis associated with COVID-19, including MIS-C.

This is a Phase 3 multicenter, single-arm, open-label extension (OLE) study designed to investigate the long-term safety, tolerability, and efficacy of risankizumab 150 mg or 55 mg by weight every 12 weeks (Q12W) in the treatment of moderate to severe plaque Ps in eligible subjects who have completed all assessments in Study M19-977 and elect to participate in Study M19-973. The study is comprised of a 216-week treatment period and a follow-up phone call for safety approximately 140 days (20 weeks) after the last dose of study drug.

In this Phase II trial the efficacy of treatment in patients with clinically significant portal hypertension (CSPH), in compensated alcohol-related cirrhosis, will be assessed. This will be the first trial in the clinical development of the drug BI 685509 where patients will be treated for 24 weeks, and where the portal pressure will be assessed quantitatively via HVPG measurements. The trial will evaluate both short-term and long-term efficacy. The long-term assessment will be used to rule out any adaptation to sGC activation on portal pressure on chronic treatment. The trial will also provide supportive evidence for the planned Phase III development.

This study is for patients that have been diagnosed with locally advanced head and neck squamous cell carcinoma. The purpose of this research study is to evaluate the effectiveness of using a combination of pembrolizumab and olaparib when given before and after standard chemoradiation therapy in treating locally advanced head and neck squamous cell carcinoma. Pembrolizumab and olaparib are drugs that are approved for treatment of different cancers including lung, head and neck, breast and prostate cancer. However, FDA has not approved use of these two drugs together in treating head and neck cancer.

Treatment will be offered in three phases. In the induction phase, participants will receive a single infusion of pembrolizumab and will take olaparib tablets twice daily for total of 21 days. Participants will move to the chemoradiation phase, where they will receive radiation therapy and chemotherapy per routine standard care, for a total of 7 weeks. Chemoradiation therapy is done on a daily basis (excluding weekends), and chemotherapy therapy will involve a cisplatin infusion once weekly. At the conclusion of this phase, participants start the maintenance phase, which involves treatment with pembrolizumab and olaparib in cycles that are 42-days long. Treatment will include a single pembrolizumab infusion during each cycle and taking olaparib tablets twice daily during each cycle. Total number of cycles to be completed in the maintenance phase are 8 cycles. Participants can expect to be in this study for about 6.5 years.

The primary objective of this study is to determine how bictegravir (BIC) plus lenacapvir (LEN) in two different doses affects an HIV-1 infection in the body compared with current standard treatment regimens. Other objectives are to determine which of these treatments are the most effective for treating HIV-1 infection, the safety and tolerability of these two doses for people with HIV, as well as how long it stays in the body using physical exams, laboratory tests, ECG, blood analysis, and any symptoms or problems experienced during the study.

This study is for patients that have been diagnosed with extensive-stage small-cell lung cancer (ES-SCLC). The investigational drug in this study is lurbinectedin. Investigational means it is not yet approved by the Food and Drug Administration (FDA). The purpose of this study is to compare the effects, good or bad, of lurbinectedin in combination with atezolizumab versus atezolizumab alone in participants with ES-SCLC. Atezolizumab is already approved for treatment of ES-SCLC.

There are two phases of treatment. During the induction phase of the treatment, participants will receive 4 cycles of carboplatin, etoposide, and atezolizumab. One treatment cycle is 3 weeks long. During the maintenance phase of the treatment, participants will be placed in one of the following treatment groups: Arm A will receive atezolizumab and lurbinectedin given as an infusion (into the vein) on Day 1 of each 21-day cycle; Arm B will receive atezolizumab given as an infusion (into the vein) on Day 1 of each 21-day cycle.

During this study, participants will have visits approximately every 3 weeks while receiving treatment. Visits may last 3-6 hours. After the final dose, the study doctor will follow up about every 3 months. The total time in the study will depend on how the ES-SCLC responds to treatment. This could range from 1 day to more than 4 years.

Exploring the Burn Wound Microbiome Using Next Generation Sequencing Technology study is designed to learn more about the microorganisms (bacteria and fungi such as yeast) that are present in traumatic burn wounds. We wish to learn how the make up of microbes differ between the wounded and uninjured skin. Currently, if a doctor wants to know which organisms exist in a burn wound, they would need to send a sample of the wound surface to be grown on a petri dish. Ultimately this system takes too long and may not identify all the organisms that may affect wound healing and as a result this method is no longer used for most burn wounds at most burn centers. Our study proposes to bridge this knowledge gap by using newly available techniques collectively referred to as "Next Generation Sequencing technology" or NGS for short. NGS has the potential to provide more detailed and accurate information about the make up of the burn wound and has already been used as a tool in other parts of healthcare. The information gained from this study may potentially improve the care of future burn patients.