There are about 173942 clinical studies being (or have been) conducted in United States. The country of the clinical trial is determined by the location of where the clinical research is being studied. Most studies are often held in multiple locations & countries.
This is a multicentre study carried out in participants living with human immunodeficiency virus type 1 (HIV-1) who have not previously been treated with any antiretroviral therapies. The study will investigate two 2-drug regimens for the treatment of HIV-1: a fixed-dose combination oral tablet of dolutegravir/lamivudine (DTG/3TC) and cabotegravir plus rilpivirine long-acting agents (CAB + RPV LA). All participants will initially receive DTG/3TC once daily, and once virologic suppression is attained (plasma HIV-1 <50 c/mL), participants will be offered a choice to switch to CAB + RPV LA or to continue taking oral DTG/3TC. This study will provide important data on the efficacy, safety, implementation effectiveness, and patient-reported outcomes of these two regimens in a study where participants have the option to choose between them based on individual preference. The aim of the study is to evaluate the antiviral effectiveness at 11 months after switching to CAB+RPV LA following initial virologic suppression on DTG/3TC and to provide data on how long it takes participants to suppress their viral load on DTG/3TC.
Obsessive-compulsive disorder effects approximately 2-3% of the population. The only established first-line treatments for OCD are cognitive-behavioral therapy (CBT) with exposure/response prevention and serotonin reuptake inhibitor medications (SRIs). Approximately 30-40% of patients fail to respond to either modality and few patients experience complete symptom resolution. Up to 25% of patients have difficulty tolerating CBT, and the risk of relapse after therapies remains significant. Symptoms of OCD include unwanted, distressing thoughts and rituals such as excessive washing of hands or other body parts, rechecking things such as locks or switches because of obsessional doubt, and avoidance of anxiety-provoking situations. In some cases, compulsions can consume several hours per day and in the most extreme cases can involve most of the patient's waking hours (e.g. washing hands hundreds of times per day, 18-hour showers). Medical complications may result from repeated washing or other repetitive behaviors. Significant social and occupational impairment can result from this disorder and some patients are housebound or even bed-ridden. Effective evidence-based treatments include behavior therapy and certain medications. Despite these therapies, a significant number of patients are treatment resistant and suffer persistent, debilitating symptoms. In severe cases, neurosurgical intervention is sometimes performed to alleviate symptoms. A common surgical option is deep brain stimulation (DBS), a procedure that involves placing two electrodes in a specific region in the brain and connecting them to a pacemaker-like device implanted under the skin in the upper chest. The clinician adjusts the stimulation parameters on the device to find the settings that best relieve symptoms. One of the challenges of treating a psychiatric disorder is the absence of reliable and valid biomarkers for diagnosing and objectively monitoring treatment outcomes. There is also problem of heterogeneity, which introduces additional barriers to predicting who will respond best to a particular treatment. A better understanding of the dysfunction in key brain circuits underlying OCD symptomatology will allow us to improve outcomes with DBS. The pathophysiology of OCD is associated with dysfunction in prefrontal cortico-basal ganglia circuits. The electrodes of the DBS system are placed at a critical hub within this circuit. This target is called the ventral capsule/ventral striatum (VC/VS). DBS targeting the VC/VS is approved for the treatment of severe OCD under an FDA Humanitarian Device Exemption (HDE). In this project, the investigators will recruit patients treated with DBS for OCD under the standard clinical (HDE) pathway. The FDA/HDE-approved device for these procedures is the Medtronic Percept DBS system. The Percept implanted pulse generator (IPG; pacemaker-like device mentioned above that delivers stimulation) has the ability to not only stimulate, but also record electrical activity measured from the brain electrodes, store the recordings in memory, and wirelessly transmit them to the clinician. The investigators will ask consenting patients to perform and transmit these recordings to the investigators for analysis. The investigators hope that these recordings will help them understand the relationship between electrical network activity in the brain and patient symptoms. A closer understanding of this relationship may eventually enable the investigators to make better informed programming adjustments and therefore achieve better symptom control. The main objective is to obtain recordings from the VC/VS, a key network hub in OCD, in patients already implanted with a DBS system for severe OCD. The Investigators will use these recordings to better understand the relationship between brain activity and OCD symptoms, with the hope that this understanding will lead to more effective utilization of DBS therapy to treat severe OCD.
The objective of this study is to develop a virtual rehabilitation system that can be used to effectively treat Phantom Limb Pain (PLP) within the research setting and for at-home use by individuals with upper and lower extremity amputation. We hypothesize that the system will improve PLP for individuals with upper or lower extremity amputation, as measured through with various outcome measures and questionnaires.
An observational study following up with trigeminal neuralgia patients to understand their comorbid facial pain condition, specifically temporomandibular disorder.
Prospective observational study evaluating the incidence, and qualifying the types, of perioperative pulmonary complications in patients that vape.
The study aims at evaluating the maintenance of virologic suppression of dolutegravir/lamivudine (DTG/3TC) fixed dose combination (FDC) at Week 48 post-switch from bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) in participants living with Human Immunodeficiency Virus Type 1 (HIV-1) who are of at least 50 years of age and above.
Surgical coaching involves the development of a partnership between two surgeons in which one surgeon (coach) guides the other (coachee) in identifying goals, providing feedback and facilitating action planning. Surgical coaching provides an effective means of acquiring new technical and non-technical skills. In this study, the investigators aim to perform a randomized controlled trial to evaluate the impact of a video-based surgical coaching intervention on laparoscopic closure of the vaginal cuff among Obstetrics and Gynecology residents. Obstetrics and Gynecology resident participants will be randomly assigned to the control or intervention groups. Participants will have access to an instructional video related to laparoscopic vaginal cuff suturing and the validated laparoscopic vaginal cuff trainer to practice laparoscopic suturing as desired. The intervention group will receive the same resources as the control group and will also undergo three video-based coaching sessions focused on laparoscopic suturing on the validated laparoscopic vaginal cuff trainer. Our main outcome will consist of participants' change in technical skills of laparoscopic suturing the vaginal cuff, measured by the change in Global Operative Assessment of Laparoscopic Skills Plus score (Vassiliou 2005) from baseline to study completion. Secondary outcomes will include participants' self-reported surgical confidence, operative enjoyment, and plans to incorporate surgery into their career.
Study Description: The investigators propose to extend earlier research conducted during a feasibility study (Strong Foundations 1.0) by enrolling participants who have a greater risk for falling (x4 cohorts of up to 15 individuals) and from a lower socio-economic status (x4 cohorts of up to 15 individuals), and by collecting high quality laboratory based measures of balance, posture, and strength to better determine the effectiveness of the program and its suitability for widespread deployment. Additionally, the investigators hope to showcase it is feasible to sustain programmatic gains with ongoing digitally delivered content by combining cohorts into a larger group that continues to practice the foundational exercises taught during the 12-week initial program.
This Phase 2, randomized, double-blind, multicenter, induction and maintenance study is designed to evaluate the safety and efficacy of RVT-3101 in adult participants with moderate to severe active Crohn's disease.
The purpose of this study is to understand the safety and effects of the study medicine ARV-471 (PF-07850327) given together with palbociclib in advanced breast cancer. In particular, the study will compare the combination of ARV-471 plus palbociclib to standard of care therapy (letrozole plus palbociclib). Both letrozole and palbociclib are medicines already used for treatment of breast cancer. ARV-471 is a new medicine under study. This study is seeking participants who have breast cancer that: - Have a locally advanced or metastatic disease and cannot be fully cured by surgery or radiation therapy. A metastatic disease is when disease has spread to other parts of the body. - Is sensitive to hormonal therapy such as tamoxifen. This is called estrogen receptor positive disease. - Have not received any prior medicine for advanced disease. Example medications include tamoxifen or letrozole or exemestane. The study will have an open-label SLI (study lead-in) before initiation of Phase 3 trial. During SLI, two dose levels of palbociclib in combination with ARV-471 will be explored in parallel. Assignment to the palbociclib dose is by chance. Half of the participant will receive one dose and the other half another palbociclib dose. The purpose of SLI is to determine the recommended Phase 3 dose of palbociclib to be administered in combination with ARV-471. In the Phase 3, half of the participants will take ARV-471 plus palbociclib while the other half will take letrozole plus palbociclib. In both SLI and Phase 3, participants will take the study medicines by mouth, with food, once a day. Participants will take the study medicines until breast cancer increase in size or side effects become too severe. Side effects refer to unwanted reactions to medications. Participants will visit the study clinic about once every 4 weeks.