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NCT02308085
The best available evidence suggests that pregnancy after breast cancer does not increase a woman's risk of developing a recurrence from her breast cancer. In particular, the most recent data suggest that this is the case also in women with a hormone receptor-positive breast cancer. There is also no indication of increased risk for delivery complications or for the newborn. The aim of the study is to investigate if temporary interruption of endocrine therapy, with the goal to permit pregnancy, is associated with a higher risk of breast cancer recurrence.The study aims also to evaluate different specific indicators related to fertility, pregnancy and breast cancer biology in young women. A psycho-oncological companion study on fertility concerns, psychological well-being and decisional conflicts will be conducted in interested Centers.
NCT04701203
During the first 26 weeks of the trial, participants were randomly assigned to one of two groups: one group received TransCon PTH and one group received placebo. All participants started with study drug at a dose of 18 mcg/day and were individually and progressively titrated to an optimal dose in dose increments of 3 mcg/day. TransCon PTH or placebo were administered as a subcutaneous injection using a pre-filled injection pen. Neither trial participants nor their doctors knew who had been assigned to each group. After the 26 weeks, participants continued in the trial as part of a long-term extension study. During the extension, all participants received TransCon PTH, with the dose adjusted to their individual needs. This was a global trial that was conducted in the United States, Canada, Germany, Denmark, Norway, Italy, and Hungary.
NCT06274801
This open-label extension study will evaluate the long-term safety, tolerability and efficacy of orally inhaled seralutinib in subjects who have completed a previous seralutinib study
NCT05234567
In this prospective observational sub-study, participants with pediatric-onset hypophosphatasia (HPP) (perinatal/infantile- or juvenile-onset) of any age will be followed for a minimum of 5 years at sites in the United States and potentially 1 or 2 other countries.
NCT03375047
This Phase 1/2, first-in-human study evaluated the safety and tolerability of single and multiple escalating doses of MRT5005 administered by nebulization to the respiratory tract of adult subjects with cystic fibrosis (CF).
NCT05265520
The investigators aim to prospectively evaluate the efficacy and mechanism of benefit of His-bundle pacing enhanced cardiac resynchronization therapy (His-CRT) vs. cardiac resynchronization therapy (BIV-CRT) in patients with heart failure and right bundle branch block (RBBB).
NCT06706076
This Phase1/2, open label, multicenter study will assess the safety, tolerability, pharmacokinetics (PK), pharmacodynamics and preliminary anti-tumor activity of BH-30643 in patients with NSCLC having EGFR and/or HER2 mutations. Phase 1 will determine the recommended Phase 2 dose (RP2D) and, if applicable, the maximum tolerated dose (MTD) of BH-30643. Phase 2 will further evaluate the antitumor efficacy and safety in specified cohorts determined by EGFR/HER2 mutation subtypes and/or treatment history at the RP2D, as well as the population PK.
NCT06617572
The purpose of this expanded access protocol (EAP) is to provide controlled access to Afamitresgene autoleucel, suspension for intravenous infusion that does not meet the commercial release specification (NC afami-cel). This EAP will be conducted at authorized treatment centers where TECELRA® is being administered and where the EAP is approved to be conducted. Patients who are prescribed TECELRA® , sign the informed consent form, and meet all entry criteria will be eligible to participate in this protocol.
NCT04557748
The purpose of this study is to define and characterize important subtypes of patients with urinary urgency to improve our understanding of the pathophysiology, risk factors, experiences, and comorbidities to lay the foundation for more effective treatment by focusing on the most bothersome and difficult to treat symptoms of urinary urgency and urgency urinary incontinence.
NCT04948268
This is a feasibility trial of a personalized 8-week text messaging intervention aimed at young adults (ages 18-25) with depression and anxiety who are not interested in -- or experience barriers to -- receiving traditional face-to-face psychological treatments. The trial will consist of a pilot test of (1) an 8-week adaptive (personalized) messaging intervention relative to (2) a non-personalized digital mental health intervention, or (3) an active control which will send weekly psychoeducation information by way of Uniform Resource Locators (URLs). The adaptive intervention will uses machine learning to tailor Short Message Service (SMS) messages to an individual's needs and preferences, and URL links to provide access to psychoeducational content to contextualize messages, when the length of that content exceeds the limitations of messages. The primary goals of the project are to conduct a feasibility trial using a sequential multiple assignment randomized treatment (SMART) design, which will evaluate (a) the effectiveness of an adaptive, personalized messaging intervention in reducing engagement relative to a non-personalized version; and (b) whether human coaching results in greater symptom reduction and engagement, relative an unguided implementation.
NCT01658787
Prospective, observational Registry to obtain data on device performance and clinical outcomes.
NCT05785624
The main purpose of the study is to evaluate the efficacy of vixarelimab compared with placebo on lung function in participants with idiopathic pulmonary fibrosis (IPF) and in participants with systemic sclerosis-associated interstitial lung disease (SSc-ILD). Participants who complete 52-weeks of treatment in the Double-blind Treatment (DBT) period can choose to enroll in the optional Open-label Extension (OLE) period to receive treatment with vixarelimab for another 52 weeks. Cohort 1 has completed enrollment and has been closed for further enrollment. Cohort 2 is enrolling participants.
NCT04044859
This study will investigate the safety and tolerability of ADP-A2M4CD8 T-cell therapy in subjects who have the appropriate human leukocyte antigen (HLA) and MAGE-A4 tumor antigen. Tumor indications include endometrial, esophageal, esophagogastric junction (EGJ), gastric, head and neck, melanoma, non-small cell lung (NSCLC), ovarian or urothelial cancer.
NCT06129240
Study LTI-401 is an open-label, multicenter study which will evaluate the safety and tolerability of LIQ861 in subjects who have WHO Group 1 \& 3 PH.
NCT05551117
Study CP-MGC018-03 is an open-label, two-part, Phase 2 study. Part 1 of the study will enroll participants with metastatic castration-resistant prostate cancer (mCRPC) previously treated with one prior androgen receptor axis-targeted therapy (ARAT). ARAT includes abiraterone, enzalutamide, or apalutamide. Participants may have received up to 1 prior docetaxel-containing regimen, but no other chemotherapy agents. This part of the study will assess the efficacy and tolerability of vobramitamab duocarmazine (MGC018) in two experimental arms (2.0 mg/kg every 4 weeks \[Q4W\] and 2.7 mg/kg Q4W) . Approximately 100 participants will be randomized 1:1. Part 2 of the study will enroll participants with locally advanced or metastatic solid tumors. Participants must have progressive following at least 1 prior line of standard chemotherapy for advanced or metastatic disease. Participants will receive vobramitamab duocarmazine at a dose of 2.7 mg/kg every 4 weeks. Up to 200 participants may be enrolled in Part 2. In both parts, vobramitamab duocarmazine will be administered intravenously (IV) in clinic on Day 1 of each 4-week cycle. Vobramitamab duocarmazine will be administered until criteria for treatment discontinuation are met. Participants will undergo regular testing for signs of disease progression using computed tomography (CT) scans, magnetic resonance imaging (MRI), bone scans, and prostate-specific antigen (PSA) blood tests. Routine examinations and blood tests will be performed and evaluated by the study doctor.
NCT02917993
The purpose of this study is to evaluate the safety and tolerability of itacitinib in combination with osimertinib in subjects with locally advanced or metastatic non-small cell lung cancer (NSCLC).
NCT05104710
The specific aims of this study are to: 1. Determine if a painless and quick measurement of muscle activity using surface electrodes can help with the diagnosis of ALS. Specifically, we ask if a measure of intermuscular coherence (IMC-βγ), when added to current diagnostic criteria (Awaji criteria), can differentiate ALS from mimic diseases more accurately and earlier than currently possible. 2. Characterize IMC-βγ in neurotypical subjects by age, sex, race, and ethnicity. 3. Follow a cohort of ALS patients longitudinally to determine if IMC-βγ changes with ALS disease progression and whether such changes correlate with functional and clinical scores, or survival.
NCT07398417
The study is a Phase 3, double-blind, placebo-controlled, randomized withdrawal study to assess the efficacy and safety of AXS-14 in the management of fibromyalgia.
NCT03516617
This phase II trials studies how well acalabrutinib with or without obinutuzumab works in treating patients with early-stage chronic lymphocytic leukemia or small lymphocytic lymphoma. Acalabrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as obinutuzumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. It is not yet known whether giving acalabrutinib with or without obinutuzumab will work better in treating patients with early-stage chronic lymphocytic leukemia or small lymphocytic lymphoma.
NCT07055854
The goal of this study is to plan for a large scale evaluation of a program called Mindful After Cancer, or MAC. The MAC Program provides training in mindfulness, educational material about sexual health after cancer, and support to cancer survivors experiencing sexual and body image concerns. The main study aims are to: 1. Develop effective plans for recruiting participants across multiple sites 2. Evaluate participation in the program and surveys 3. Develop plans to train and supervise the professionals who will deliver the program. Researchers will compare study recruitment across three sites, aiming to identify the most efficient approach for a larger future trial. Participants who are randomly assigned to receive the MAC program will receive access to the 8-week program delivered by a trained mindfulness coach using videoconference and online materials. They will asked to participate in an interview about their experiences at the end of the program. Participants who are not randomly assigned to the MAC program will receive access to the program's educational materials after completing the final survey. All study participants will be asked to complete 3 online surveys. Participants randomly assigned to the MAC Program will also be asked to complete a one-on-one interview about their experience in the program.