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NCT03067181
This phase III trial studies how well active surveillance help doctors to monitor subjects with low risk germ cell tumors for recurrence after their tumor is removed. When the germ cell tumor has spread outside of the organ in which it developed, it is considered metastatic. Chemotherapy drugs, such as bleomycin, carboplatin, etoposide, and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. The trial studies whether carboplatin or cisplatin is the preferred chemotherapy to use in treating metastatic standard risk germ cell tumors.
NCT04863495
This is a longitudinal study with regular quantitative assessments of all participants every six months for 3 years. The quantitative portion of the study will recruit couples, consisting of individuals over the age of 65 who are in a committed relationship. Both members of the couple must be willing to participate at baseline. The assessment is in two parts. In the first part, each member of the couple will be asked the following: demographic information, mental health history, self-reported physical and emotional health, measures of emotional and mental health, personality, relationship and attachment style, social support and self-efficacy. Then each member of the study couple will be asked a series of questions to determine whether they consider themselves a caregiver. If they do, individuals will be asked to respond to additional caregiver questionnaires. Follow-ups will occur every six months for the study couples for a total of three years from the baseline visit. Each visit, the entire assessment except for demographic questions, will be re-administered to each individual in the couple. At the end of each questionnaire battery, individuals will be screened for cognitive impairment and those who are in the middle to advanced stages of dementia will no longer participate. Recruitment will end when 600 individuals (300 couples,150 couples at each site) are enrolled in the longitudinal portion of the study. All study visits will be conducted virtually via Zoom or WebEx video conferencing. Analyses will be conducted to determine the association between changes in dyadic relationship and changes in mental health and cognitive outcomes, to elucidate how relationship characteristics impact health and well-being as perceived by each member of the dyad.
NCT07434843
The purpose of this study is to determine how effective the drug pemigatinib is as a treatment option for advanced succinate dehydrogenase (SDH)-deficient gastrointestinal stromal tumors(GIST). This study will also assess the side effects associated with pemigatinib and evaluate its tolerability. The name of the study drug involved in this study is: • Pemigatinib (INCB054828)
NCT07440303
This split-mouth randomized controlled clinical trial will test whether a ready-to-use collagen membrane (Star Matrix) can widen the protective band of gum tissue (keratinized gingiva) as effectively as the standard free gingival graft harvested from the palate. Central question Can Star Matrix provide the same or better gain in keratinized tissue width-with less patient discomfort and chair-time-than an autogenous graft? Primary objectives Compare the 6-month increase in keratinized tissue width between Star Matrix and autogenous graft sites. Assess patient-reported pain and morbidity associated with each treatment. Secondary objectives Measure operative time, early healing scores, esthetic outcomes, and (optional) histologic quality of the regenerated tissue. Methods Twelve adults with ≤ 2 mm keratinized tissue on contralateral lower-jaw teeth will be enrolled. Each participant receives Star Matrix on one side and a conventional free gingival graft on the other. Follow-up visits at 2, 4, 8, 12 and 24 weeks include clinical measurements, standardized photographs, and a 7-day postoperative pain diary. An optional 2 mm punch biopsy at 6 months is analyzed microscopically.
NCT07441265
This study will test whether biological sex influences how the body responds to circadian misalignment-a mismatch between the internal body clock and the timing of sleep and eating (as can occur with shift work or jet lag). Researchers will examine how circadian misalignment affects appetite regulation (hunger/fullness) and glucose metabolism (blood sugar control), and whether these effects differ between females and males. Findings may help inform more personalized shift work schedules and targeted strategies to reduce metabolic health risks and sex-related differences in clinical care.
NCT00003809
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Monoclonal antibodies can locate cancer cells and either kill them or deliver tumor-killing substances to them without harming normal cells. It is not yet known whether cisplatin plus monoclonal antibody therapy is more effective than cisplatin alone for metastatic or recurrent head and neck cancer. PURPOSE: Randomized double-blinded phase III trial to compare the effectiveness of cisplatin with or without monoclonal antibody in treating patients who have metastatic or recurrent head and neck cancer.
NCT01712490
This open-label, randomized, 2-arm, multicenter, phase 3 study has the primary objective of comparing the modified progression-free survival (mPFS) obtained with brentuximab vedotin (ADCETRIS®) plus AVD (doxorubicin \[Adriamycin\], vinblastine, and dacarbazine; abbreviated A+AVD) versus that obtained with ABVD (doxorubicin \[Adriamycin\],bleomycin, vinblastine, and dacarbazine) for the frontline treatment of advanced classical Hodgkin lymphoma(HL)
NCT03830320
The purpose of the study is to evaluate a new radiotracer called 64Cu-FBP8 for PET-MR imaging of thrombosis. The tracer has the potential of detecting thrombosis anywhere in the body, for instance in the left atrial appendage of patients with atrial fibrillation, and thereby may provide a non-invasive alternative to the current standard-of-care methods.
NCT03940703
This study was to assess the antitumor activity, safety, tolerability, and pharmacokinetics (PK) of the Mesenchymal-epithelial Transition Factor (MET) inhibitor tepotinib combined with the 3rd generation EGFR inhibitor osimertinib in participants with advanced or metastatic non-small cell lung cancer (NSCLC).
NCT04089358
This phase III trial compares a multi-component mobile health and social media physical activity intervention versus wearing a physical activity tracker alone among adolescent and young adult childhood cancer survivors. Regular physical activity helps maintain healthy weight, energy levels, and health. Adolescents and young adults who complete treatment for cancer are often less active. They may gain weight and have more health problems compared to people the same age who have not had treatment for cancer. Comparing the 2 programs will help researchers learn how to increase physical activity levels over time and also how changes in physical activity levels affect health and quality of life over time.
NCT04485286
The goal of this study is to investigate the efficacy of \[68Ga\]CBP8 to detect collagen deposition in radiation induced tissue injury.
NCT04514653
This interventional study is being conducted with an investigational gene therapy treatment called ABBV-RGX-314 (also known as RGX-314) and is being developed as a potential one-time gene therapy treatment for neovascular (wet) age-related macular degeneration (wet AMD or nAMD). The typical treatment for nAMD is frequent injections of anti-VEGF therapy. Researchers are testing ABBV-RGX-314 to see if it has similar effects as the current approved standard of care, such as Lucentis® or Eylea® injections. The duration of this study will be up to 52 weeks or for ranibizumab control participants who cross over to ABBV-RGX-314 after week 52, up to 80 weeks post-randomization. The primary outcome measure for this investigational study is to evaluate the mean change in best-corrected visual acuity (BCVA) for ABBV-RGX-314 compared with ranibizumab monthly at the Week 40 visit.
NCT04526106
This is a Phase 1/2, open-label, FIH study designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PDy), and antineoplastic activity of RLY-4008, a potent and highly selective FGFR2 inhibitor, in patients with unresectable or metastatic cholangiocarcinoma (CCA) and other solid tumors. The study consists of 4 parts: a dose escalation (Part 1), a dose expansion (Part 2), and an extension (Part 3) and a rollover (Part 4).
NCT04693533
The main goal of this study is to determine whether there is a relationship between fremanezumab's ability to prevent migraine and improved sleep quality in migraine patients (fremanezumab is a FDA-approved humanized CGRP monoclonal antibody for the treatment of migraine). This is a within-person study design that examines treatment effects (changes) using high-resolution assessments. To complete the study, each participant will be observed using daily assessments of migraine and sleep outcomes before treatment (baseline: 0 to 30 days), and at 1, 2, and 3 months after treatment (injection 1: days 31-60, injection 2: days 61-90, injection 3: days 91-120). In essence, this creates an interrupted time-series design where repeated interventions are introduced at fixed intervals.
NCT07442266
The goal of this clinical trial is to examine how repeated memory retrieval changes visual representations in the brain in healthy adult participants. Specifically, the study aims to determine whether repeated recall strengthens or transforms neural representations in visual cortex compared to a time-matched control condition. The main questions it aims to answer are: 1) Does repeated retrieval produce cumulative changes in visual cortical representations compared to a control condition matched for elapsed time? 2) Do these representational changes differ for simple spatial stimuli and complex natural images? Researchers will compare neural activity patterns during repeated retrieval to those during a control retrieval condition to determine whether repeated recall leads to systematic changes in representational structure beyond those attributable to the passage of time. Participants will: 1) complete two fMRI sessions. 2) Undergo a localizer session including anatomical imaging, population receptive field (pRF) mapping, and a visual category localizer task. 3) Study cue-stimulus pairs consisting of either simple spatial patterns or natural images. 4) Recall previously studied stimuli multiple times during repeated and control retrieval conditions while undergoing fMRI scanning. Brain activity patterns during study and recall will be compared to assess how repeated retrieval influences the structure and tuning of visual representations.
NCT07290569
This is a multicenter, randomized, double-blinded, placebo-controlled, dose-range finding study to evaluate the efficacy and safety of ORKA-001 in adult participants with moderate-to-severe plaque psoriasis.
NCT03633708
This is a phase 3 trial of etelcalcetide in pediatric participants with secondary hyperparathyroidism (SHPT) and chronic kidney disease (CKD) on hemodialysis.
NCT07227415
This study is testing a new medicine called PF-08634404 and how it works in adults with advanced Renal Cell Carcinoma (RCC)- a type of kidney cancer that is either locally advanced (spread to nearby tissues) or metastatic (spread to other parts of the body). The study will look at the safety of the study medicine, when given alone or with other anticancer medicines, and how this type of cancer responds to them. To join the study, participants must be adults; with locally advanced or metastatic RCC; who have not received treatment for their advanced kidney cancer. Participants will receive study medicine either alone or with other anticancer medicines. The medicine will be given through intravenous (IV) infusions, which means it will be injected directly into a vein. All treatments will take place at clinical study sites, where trained medical staff will take care of participants during and after each visit.
NCT03992430
Part 1 (dose escalation) will evaluate the safety and tolerability of 2 doses (100 milligrams/kilogram \[mg/kg\] and 200 mg/kg) of eteplirsen in approximately 10 participants with DMD; Part 2 (dose finding and dose comparison) will evaluate the efficacy and safety of the high doses (100 mg/kg and 200 mg/kg) of eteplirsen compared with that of the 30 mg/kg dose of eteplirsen, in approximately 144 participants with genetically confirmed deletion mutations amenable to treatment by skipping exon 51.
NCT07443670
VAPP-HF is a prospective, multi-center, observational study assessing whether daily voice recordings analyzed by a machine learning algorithm can detect changes in pulmonary arterial (PA) pressure in heart failure patients with implanted PA pressure sensors (e.g., CardioMEMS, Cordella). Patients across three sites in Germany and the United States provide daily voice recordings via a mobile app for 12 weeks while continuing standard PA pressure monitoring and heart failure care. Voice data is analyzed retrospectively after study completion; no clinical decisions are based on voice analysis during the study. The primary endpoint is the sensitivity and specificity of the AI-based voice analysis in detecting PA pressure changes at defined thresholds.