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NCT05112237
The objective of this study is to collect information on patients with cardiomyopathy (CM) due to mutations in the MYBPC3 gene, to evaluate their disease course, burden of illness, risk factors for this disease, and the quality of life (QoL). This study will also collect information on treatments, procedures and outcome in infants and children up to 18 yrs who have this mutation.
NCT02783729
This study will be conducted to demonstrate, using polysomnography, that lemborexant 10 milligrams (mg) and 5 mg is superior to placebo on objective sleep onset as assessed by latency to persistent to sleep (LPS) after the last 2 nights of 1 month of treatment in participants 55 years and older with insomnia disorder.
NCT04950166
Peritoneal carcinomatosis (PC) results from the metastasis of a primary cancer of the peritoneum (e.g., appendiceal, ovarian, uterine, colorectal, and gastric cancers) that then disseminates throughout the abdominal cavity. Historically progression to PC was considered terminal and resulted in survival times on the scale of a few months with palliative care being the best option for patients. More recently, cytoreductive surgery (CS) has emerged as a means to prolong and improve patient lives with a median increase in survival of up to \~5 years. It has been reported that for every 10% increase in cytoreduction there is a 5.5% increase in median survival time. In addition to surgical tumor debulking within the peritoneal space, it has also been shown that coupling surgical intervention with hyperthermic intraperitoneal chemotherapy (HIPEC) can have an even greater impact on patient outcomes. Pegsitacianine, a micellar fluorescence agent, exploits the ubiquitous pH differences observed between cancerous and normal tissues. This in turn, provides a highly sensitive and specific fluorescence response after localizing within the tumor microenvironment, thus allowing the detection of primary tumors, their margins, metastatic disease, and tumor-containing lymph nodes.
NCT05048082
This Phase 2 study is an open-label, single-arm trial where each patient is his/her own "intrapatient" control. All patients will receive a single dose of pegsitacianine prior to standard of care surgery.
NCT05103657
This study is open to people aged 18 to 65 who have post-traumatic stress disorder. The purpose of this study is to find out whether a medicine called BI 1358894 improves symptoms in people with post-traumatic stress disorder. Participants are put into 2 groups randomly, which means by chance. Participants take BI 1358894 or placebo as tablets every day for 2 months. Placebo tablets look like BI 1358894 tablets but do not contain any medicine. Participants are in the study for about 3 months. During this time, they visit the study site about 8 times and get about 4 phone calls from the trial staff. During the study, participants answer questions in interviews and complete questionnaires so the doctors can check whether their symptoms change. The doctors also regularly check participants' health and take note of any unwanted effects.
NCT04041375
Patients with diabetes are often challenged by the routine of managing their diabetes, and may experience both stress and medical problems. Diabetes-related medical problems and stress often happen together and affect peoples' ability to live a full, happy and healthy life. Because of this, programs that help with medical problems and stress by teaching ways to better manage diabetes and stress may improve the lives of those with diabetes. Many excellent programs are available in the VA and in the community that help persons with diabetes better manage their medical problems and stress, but often times Veterans have trouble finding these programs. The purpose of the study is to see if a telephone-based coaching program improves the physical and emotional health of Veterans with diabetes more than use of a directory of community and VA resources and no coaching. The Veterans who receive the directory of community and VA resources will be given this at the beginning of the study and will access resources as they see fit. Those in the coaching program will be coached by a Veteran with knowledge of diabetes, mental health and community resources who will help them connect to care in the VA and/or community depending on their preference. Examples of resources available in the VA and community include mental health care and programs to help with diet, exercise and learning about how to better manage diabetes. Veterans who are interested in participating and pass screening will be enrolled in the study for about 6 months. Each enrolled Veteran will have a 50% chance of being enrolled in the coaching group and a 50% chance of being enrolled in the directory group (like the flip of a coin). Both groups will be asked to complete several questionnaires about their health and well-being by telephone. This will occur at the beginning of the study and three and six months later. The questionnaires will take about an hour to complete each time.
NCT04740164
This clinical trial compares the effect of LMA Gastro, a dual channel supraglottic airway (SGA) device, to oxygenation with standard nasal cannula for endoscopic retrograde cholangiopancreatography (ERCP). An ERCP is a combination of imaging scans and endoscopy that helps doctors diagnose and treat conditions of the pancreas and bile ducts that requires general anesthesia or procedural sedation. Anesthesiologists often use SGAs or nasal cannulas to help patients breathe while they are asleep during procedures. An SGA consists of an airway tube that connects to a mask, which is inserted through the mouth and placed at the back of the throat to keep the airway open while patients are under anesthesia or sedation. The nasal cannula is a device that fits in a patient's nostrils and delivers oxygen through a small, flexible tube while they are under anesthesia or sedation. The goal of this trial is to compare the effects of the LMA Gastro to nasal cannula when used to deliver oxygen to patients while they are asleep during their ERCP procedure.
NCT05415683
During the observational, non-interventional study, at Baseline Study Visit (BSV) subjects will be screened and consented. Eligible subjects will undergo imaging with the DeepView device. Pre- and post-debridement images will be obtained (if debridement performed per SOC), as well as reviewing medical history and physical assessments. Additional Study Visits (SVs) will be performed when patient returns to the clinic for Routine Clinic Visit for up to 12 weeks or wound closure. During these visits DeepView imaging will occur pre- and post-debridement, and the status of the subject's treatment will be recorded.
NCT05364021
The objective of this study is to assess the safety, tolerability, efficacy, and pharmacokinetics of adjunctive therapy of LP352 in adults and adolescents with developmental and epileptic encephalopathies.
NCT04959032
This is a multicenter, randomized, double-blind, placebo-controlled, parallel-group, fixed-dose study in adult patients with a primary diagnosis of schizophrenia according to criteria of the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, (DSM-5).
NCT05516927
This protocol is a prospective, case-control multi-center diagnostic study to assess the sensitivity and specificity of blood-based screening tests for the early detection of multiple cancers.
NCT06388616
This study will evaluate the pharmacokinetics (PK), safety, and tolerability of a single oral dose of balcinrenone in patients with mild and moderate hepatic impairment in comparison to a matched healthy control group.
NCT03374917
The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of 4 weeks of continuous infusion with ABBV-951 in adult subjects with Parkinson's Disease (PD).
NCT04292912
The study will be composed of 3 periods for all participants: Screening, 28-day Treatment period, and Follow-up visit (approximately 28 days after the final dose).
NCT03724747
The study medication (BAY 2315497 Injection) is a thorium-227 labeled immuno-conjugate, specific for the prostate-specific membrane antigen (PSMA), which will be evaluated in patients with metastatic castration resistant prostate cancer. In this study, this investigational medication will be administered to patients for the first time. The primary objective of the study is to define the safety and tolerability profile and Maximal Tolerated Dose (MTD) of BAY2315497 Injection alone, or in combination with darolutamide. The secondary objectives are to determine the recommended dose for further clinical development of BAY2315497 Injection alone, or in combination with darolutamide and to investigate how the study drug is distributed and cleared from the body.
NCT03260244
This document is a clinical investigation plan (CIP) for the EnSite Precision Observational Study. This clinical study is intended to quantify and characterize the usage of the EnSite Precision™ Cardiac Mapping System (Software version 2.0.1 or higher) in a real-world environment. This study will be conducted in patients who are indicated for a cardiac electrophysiological (EP) mapping and radio frequency ablation procedure using a three-dimensional system.
NCT01413750
Drugs used in chemotherapy, such as carboplatin and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Vorinostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether giving carboplatin and paclitaxel together is more effective with or without vorinostat in treating non-small cell lung cancer.
NCT04060862
The open-label Phase Ib portion of this study will evaluate the safety and pharmacokinetics of ipatasertib in combination with palbociclib and fulvestrant to identify a dose of ipatasertib that can be combined with palbociclib and fulvestrant in the Phase III portion. The randomized Phase III portion of this study will evaluate the efficacy, safety, and patient-reported outcome (PRO) objectives of ipatasertib + palbociclib + fulvestrant compared with placebo + palbociclib + fulvestrant in patients with HR+ HER2-, locally advanced unresectable or metastatic breast cancer who had relapsed during adjuvant endocrine therapy or progressed during the initial 12 months of first-line endocrine therapy in locally advanced unresectable or metastatic breast cancer.
NCT02004691
Primary Objective: The primary objective of this phase 2/3 study was to evaluate the efficacy of olipudase alfa (recombinant human acid sphingomyelinase) administered intravenously once every 2 weeks for 52 weeks in adult participants with acid sphingomyelinase deficiency (ASMD) by assessing changes in: 1) spleen volume as measured by abdominal magnetic resonance imaging (MRI) (and, for the United States \[US\] only, in association with participant perception related to spleen volume as measured by splenomegaly-related score \[SRS\]); and 2) infiltrative lung disease as measured by the pulmonary function test, diffusing capacity of the lung for carbon monoxide (DLCO). Secondary Objectives: * To confirm the safety of olipudase alfa administered intravenously once every 2 weeks for 52 weeks. * To characterize the effect of olipudase alfa on the participant perception related to spleen volume as measured by the SRS after 52 weeks of study drug administration. (For the US, the effect of olipudase alfa on the SRS is part of the primary objective). * To characterize the effect of olipudase alfa after 52 weeks of study drug administration on the following outcome measures assessed sequentially: * The effect of olipudase alfa on liver volume; * The effect of olipudase alfa on platelet count; * The effect of olipudase alfa on fatigue; * The effect of olipudase alfa on pain; * The effect of olipudase alfa on dyspnea.
NCT00493792
The goal of this clinical trial is to compare two types of polyethylene (Stryker Orthopaedics N2Vac and their X3 polyethylene) prostheses that are used in total knee replacements. The primary outcome will analyze whether or not prostheses require a revision surgery 10 years post knee replacement. Other outcomes such as reoperation rate, complications, radiographic results, and clinical outcomes will be collected. It is hypothesized that X3 would perform equally well to N2Vac at 10 years.