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NCT02624947
The purpose of this study is to determine the efficacy of maternal immunization during the third trimester of pregnancy with the RSV F vaccine against medically-significant RSV lower respiratory tract infection (LRTI), as defined by hypoxemia or tachypnea at rest, through the first 90, 120, 150, and 180 days of life in infants.
NCT04068103
This phase II/III trial studies how well circulating tumor deoxyribonucleic acid (ctDNA) testing in the blood works in predicting treatment for patients with stage IIA colon cancer after surgery. ctDNA are circulating tumor cells that are shed by tumors into the blood. Finding ctDNA in the blood means that there is very likely some small amounts of cancer that remain after surgery. However, this cancer, if detected, cannot be found on other tests usually used to find cancer, as it is too small. Testing for ctDNA levels may help identify patients with colon cancer after surgery who do benefit, and those who do not benefit, from receiving chemotherapy.
NCT05141006
Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS) is a chronic and debilitating urological complex of disorders characterized by symptoms of bladder pain or discomfort, mostly upon bladder filling, and often accompanied by lower urinary tract symptoms (LUTS). This study will assess how safe and effective BOTOX (onabotulinumtoxinA) is in treating IC/BPS. Adverse events and change in disease symptoms will be evaluated. BOTOX (onabotulinumtoxinA) is an investigational drug being developed for the treatment of Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS). Study doctors randomly assign the participants to 1 of 2 groups, called treatment arms, to receive BOTOX or placebo. There is a 1 in 2 chance that participants will be assigned to placebo. Approximately 80 female participants, aged 18 to 75 years, with a diagnosis of IC/BPS will be enrolled in approximately 40 sites in the United States and Canada. Participants will receive BOTOX or placebo injected into the bladder on Day 1 and will be followed for at least 12 weeks in treatment 1. Eligible participants may request additional dose of BOTOX between Weeks 12 and 24, and will be followed for 12 weeks in treatment period 2. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.
NCT04974528
INHALE-1 is a Phase 3, open-label, randomized clinical study evaluating the efficacy and safety of Afrezza in combination with a basal insulin (i.e., the Afrezza group) versus insulin aspart, insulin lispro or insulin glulisine in combination with a basal insulin (i.e., the Rapid-acting Insulin Analog \[RAA\] injection group) in pediatric subjects with type 1 or type 2 diabetes mellitus. Following 26 weeks of randomized treatment (i.e., Afrezza or RAA injection combined with a basal insulin), all subjects will enter a treatment extension where subjects will receive Afrezza until Week 52. The purpose of the treatment extension is to assess safety and efficacy with continued use of Afrezza. Pediatric subjects ≥4 and \<18 years of age will be enrolled in this study. Subjects will be randomly assigned in a 1:1 ratio to either the Afrezza group or the RAA injection group. The study is composed of: * Up to 5-week screening/run-in period * 26 week randomized treatment period * 26-week treatment extension * 4-week follow-up period
NCT04203641
This study will evaluate the safety and tolerability of escalating doses of L-DOS47 in combination with doxorubicin, as well as preliminary anti-tumor activity in patients with previously treated advanced pancreatic cancer.
NCT05067972
A study to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and antitumor activity of PF-07260437, a B7-H4 x CD3 bispecific mAb, in participants aged ≥18 years of age with advanced or metastatic breast cancer, ovarian cancer or endometrial cancer. Adult participants with other advanced or metastatic high B7-H4 expressing tumors may be considered after discussion with and approval from sponsor.
NCT02040714
Legg-Calvé-Perthes disease is a childhood hip disorder which is common enough to be a significant public health problem (affects 1 in 740 boys between ages 0-14), but uncommon enough to have a sufficient number of patients from a single institution to perform a definitive prospective study comparing the results of current treatments. The present study will establish a database of prospectively identified patients with Legg-Calvé-Perthes (LCP) Disease and collect information regarding their presentation, treatment, and outcomes in the course of receiving currently available treatments. This study seeks to compare the outcomes of current treatments in the management of different age groups (ages 1-6, 6-8, 8-11, \>11) of patients with Perthes disease at two- and five-year followup and at skeletal maturity. For each age group, two to three common treatment regimens currently used by practicing pediatric orthopaedic surgeons will be compared. The intervention a patient receives is determined through physician treatment expertise, and is not pre-determined by the study.
NCT05043090
A clinical trial to compare the effectiveness of savolitinib plus durvalumab versus sunitinib in MET-driven (hepatocyte growth factor receptor), unresectable and locally advanced or metastatic PRCC (Papillary Renal Cell Carcinoma).
NCT05081128
The Placebo-Controlled Efficacy in Idiopathic Normal Pressure Hydrocephalus (iNPH) Shunting (PENS) trial is a multi-center blinded, randomized, placebo-controlled design investigation of cerebrospinal fluid (CSF) shunt surgery to study the shunt efficacy in iNPH patients.
NCT04182620
The purpose of the ULTRA-HFIB Pilot is to determine the role of adjunctive renal denervation (RDN) in the prevention of Atrial Fibrillation (AF) recurrence in patients scheduled for an AF ablation procedure. Patients will be randomized to either i) AF ablation (Control) or ii) AF ablation + renal sympathetic denervation (Intervention).
NCT05892614
This is a 2-Part study with Part A, a double-blind, randomized, placebo-controlled, PoC study to evaluate the efficacy, safety, and tolerability of efzofitimod in patients with SSc-ILD. The primary objective of the study is to evaluate the PoC for efficacy in a population with SSc-ILD. While improvement of ILD is the outcome of interest, the study will also evaluate changes in the skin. After initial screening (up to 4 weeks), approximately 25 eligible participants will be randomized 2:2:1 to 1 of 2 active (experimental) dose arms or placebo, administered every 4 weeks up to and including Week 20. Part B is an optional open-label extension to Part A in which participants can receive 450 mg efzofitimod every 4 weeks for 6 doses.
NCT04591392
Evaluation of the safety and efficacy of the reSept ASD Occluder to treat patients with clinically significant secundum atrial septal defect
NCT06959316
T1D Pregnancy \& Me will partner with pregnant participants living with type 1 diabetes (T1D) in the United States to collect real-world data on management of T1D in pregnancy. This is a remote study where participants can complete online surveys and share device data (continuous glucose monitor (CGM) data and insulin data). Through the collection of CGM, insulin, and pregnancy outcome data, the study will provide important information to understand how diabetes is being managed during pregnancy. These data will provide much needed evidence to guide modern management of diabetes during pregnancy with a goal of improving care and outcomes.
NCT06099730
The primary objective of this clinical investigation is to demonstrate the safety and 12-month effectiveness of pulmonary vein isolation (PVI) and posterior LA wall isolation in the treatment of subjects with symptomatic paroxysmal and persistent atrial fibrillation using the pulsed field ablation with the VARIPULSE™ catheter and the TRUPULSE™ generator.
NCT06725277
This observational protocol is intended to provide long-term follow-up data on patients initiating or continuing treatment with either Spravato® or IV ketamine. This can provide us information on the patient acceptability and satisfaction, patterns of use, long-term effectiveness, and safety of the two approaches. This 5-year, 6-site study will enroll 450 total patients. The sites will comprise 3 academic medical centers and 3 community psychiatric practices.
NCT05721859
Study of the patient's subsidence after revision hip arthroplasty by assessing gross stem subsidence in the femoral canal.
NCT06751576
This is a two arm, randomized, controlled, blinded, multi-case multi reader (MRMC), retrospective study for the evaluation of the efficacy and safety of an AI/ML technology-based CADe/x developed to detect, localize and characterize malignancy score of pulmonary nodules on LDCT chest scans taken as part of a lung cancer screening program. LDCT DICOM images of patients who underwent routine lung cancer screening will be selected and enrolled into the study. Enrolled scans analyzed by radiologists with the assistance of the Median LCS (formerly iBiopsy) device are compared to the analysis by radiologists without the assistance of the Median LCS device. Figures of merit for patient level and lesion level detection and diagnostic efficacy will be calculated and compared, sub-class analysis will be performed to ensure device generalizability.
NCT05761301
To evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of single ascending doses of ALN-KHK and to evaluate the safety, tolerability, efficacy, PK and PD of multiple doses of KHK.
NCT04329221
This clinical trial aims to investigate the efficacy of Calcipotriol ointment combined with 5-fluorouracil cream as an immunotherapy for actinic keratosis in Organ Transplant Recipients (OTRs) before transplantation and determine whether it can prevent cutaneous squamous cell carcinoma (SCC) in OTRs post-transplant.
NCT05087628
The PREVAIL-2 study is designed to assess the safety and potential efficacy of PRV-3279 in flare prevention in systemic lupus erythematosus (SLE) patients with active disease after amelioration induced by corticosteroid treatment.