18F-Fluciclovine PET Imaging for Detecting High Grade Glioma Recurrence After Radiochemotherapy...
Grade III or Grade IV GliomaThis study will examine whether positron emission tomography (PET) imaging with fluciclovine can reliably differentiate true progression from pseudoprogression months earlier than the conventional MRI methods.
Virtual Reality for GI Cancer Pain to Improve Patient Reported Outcomes
Cancer PainVisceral Pain90 morePatients with digestive tract malignancy often experience severe and unremitting abdominal pain that negatively affects physical, emotional, and social function, as well as health related quality of life (HRQOL). Therapeutic virtual reality (VR) has emerged as a promising and evidence-based treatment modality for cancer pain. Users of VR wear a pair of goggles with a close-proximity screen in front of the eyes that creates a sensation of being transported into lifelike, three-dimensional worlds. To date, VR has been limited to short-term clinical trials for cancer pain. Moreover, limited research exists on theory-based VR modalities beyond mere distraction, such as VR that employs acceptance and commitment therapy (ACT) with components of biofeedback and mindfulness. To bridge these gaps, this study seeks to: (1) assess the impact of immersive VR on patient-reported outcomes (PROs), including pain, activity metrics, and opioid use among patients with visceral pain from a digestive tract malignancy; (2) assess differences in PROs, activity metrics, and opioid use between skills-based VR therapy vs. distraction VR therapy; and (3) determine patient-level predictors of VR treatment response in visceral cancer pain. To address these aims, the study will measure PROs and opioid use in 360 patients randomized among 3 groups and follow them for 60 days after enrollment: (1) an enhanced VR group receiving skills-based VR; (2) a distraction-based VR group receiving patient-selected VR videos; and (3) a VR sham control group using a VR headset with 2-D content. The results will inform best practices for the implementation of VR for visceral cancer pain management and guide selection of patient-tailored experiences.
Aerobe Cycling Training in Women With Unexplained Recurrent Pregnancy Loss
Recurrent Pregnancy LossIn 50% of women with recurrent pregnancy loss (RPL) miscarriages are unexplained, therefore no therapeutic intervention is possible. In a pilot study, women with unexplained RPL showed less endometrial NK cells (eNK) compared to women with a previously uncomplicated pregnancy. It is known that eNK cells are important for embryo implantation during early pregnancy. Investigators presume that high sympathetic activity in these women is related to eNK cell number, function and phenotype and that exercise is an effective intervention to lower sympathetic activity and to influence the immune system, as especially peripheral NK cells have been assumed to be responsive to physical training. The investigators hypothesize that moderate exercise can lower the adrenergic tone of the sympathetic nervous system hereby influencing endometrial NK cells in women with RPL and eventually pregnancy outcome.
Haloperidol and Lorazepam in Controlling Symptoms of Persistent Agitated Delirium in Patients With...
DeliriumLocally Advanced Malignant Neoplasm2 moreThis phase II/IIII trial studies how well haloperidol and lorazepam work in controlling symptoms of persistent agitated delirium in patients with cancer that has spread to other places in the body undergoing palliative care. Haloperidol and lorazepam may help in controlling symptoms of agitated delirium in patients with cancer and may lessen any distress that their caregivers may be experiencing.
Antibody CC-1 in Men With Biochemical Recurrence of Prostate Cancer
Prostate Cancer RecurrentThis trial is a phase I open-label, single center study designed to evaluate the safety, tolerability and preliminary efficacy of the bispecific prostate specific membrane antigen (PSMA) and cluster of differentiation protein 3 (CD3) antibody CC-1 in men with biochemical recurrence (BCR) of prostate cancer (PC). The PSMA binder in CC-1 reacts with tumor cells and also binds to tumor vessels, thereby allowing for a dual mode of anti-cancer action. CC-1 was developed in a novel format, which not only prolongs serum half-life, but most importantly reduces off-target T-cell activation with accordingly reduced side effects. The study entails a part I (dose escalation part) to identify the maximally tolerated dose of CC-1, which then will be further evaluated in part II of the study (dose expansion part). After application of two low doses as safety steps in the first cycle, CC-1 will be applied twice weekly for three consecutive weeks within 4 week cycles as a short-term intravenous infusion (3 hours). The planned trial ultimately shall define the recommended phase II dose (RP2D) of CC-1 in the disease setting of BCR of PC.
Biweekly Follow-Up and At-Home Ultrasound Reduce Anxiety in Women With Recurrent Pregnancy Loss...
Recurrent Pregnancy LossSpontaneous pregnancy loss is a relatively common phenomenon, with 10-15% of clinically recognized pregnancies ending in miscarriage.1 Recurrent pregnancy loss (RPL) is a disorder defined by two or more failed pregnancies2. According to various studies, pregnancy loss has been described as a traumatic event for couples even if the loss occurs at a very early stage of pregnancy. Few controlled studies dealt with the effects of the miscarriage on the psychological condition of women during a subsequent pregnancy, 4,6-8. This study aimed to evaluate the effectiveness of "at home ultrasound" in addition to routine prenatal care in reducing maternal anxiety during pregnancy for patients with history of recurrent pregnancy loss. i. Inclusion criteria: Patients with recurrent pregnancy losses in first trimester Current pregnancy gestational age 12-14 week of gestation Singleton pregnancy ii. Exclusion criteria: 1. Female subjects who refuse to participate 2. Female subjects who don't speak Hebrew Device details: Pulsenmore Specifications: Compatible with: Android mobile phones with USB type C connector (Samsung S8+, Nokia 8, Nokia 7.1) ApplicatThe aim of this study is to evaluate the effectiveness of "at home ultrasound" in addition to routine prenatal care in reducing maternal anxiety during pregnancy for patients with history of recurrent pregnancy loss.ion: PulseNmore ES™, downloadable from Google Play™ Store.
Low-dose Bevacizumab With HSRT vs BVZ Alone for GBM at First Recurrence
GliomaRecurrent GliomaThis randomized phase II trial studies how well lose dose bevacizumab with Hypofractionated Stereotactic Radiotherapy (HSRT) works versus bevacizumab alone in treating patients with glioblastoma at first recurrence. The primary endpoint is 6-month progress-free survivaloverall survival after the treatment. Secondary endpoints included overall survival, objective response rate, cognitive function, quality of life and toxicity.
KL-A167 Injection Combined With Cisplatin and Gemcitabine vs Placebo Combined With Cisplatin and...
Nasopharyngeal CarcinomaRecurrent or MetastaticThe study is to evaluate the efficacy of KL-A167 combined with cisplatin and gemcitabine vs placebo combined with cisplatin and gemcitabine in the treatment of recurrent or metastatic nasopharyngeal carcinoma, as measured by progression-free survival (PFS) per the Response Evaluation Criteria in Solid Tumors RECIST Version 1.1
A Study to Evaluate Camrelizumab Plus Rivoceranib (Apatinib) Versus Camrelizumab as Adjuvant Therapy...
Adjuvant Therapy in Patients With Hepatocellular Carcinoma (HCC) at High Risk of Recurrence After Curative Resection or AblationA Trial to Evaluate the Efficacy and Safety of Camrelizumab Plus Rivoceranib (Apatinib) Versus Camrelizumab as Adjuvant Therapy in Patients with Hepatocellular Carcinoma (HCC) at High Risk of Recurrence After Curative Resection or Ablation.
A Phase I Clinical Study of JS004 in Subjects With Recurrent/Refractory Malignant Lymphoma of China...
Recurrent/Refractory Malignant LymphomaA First-in-human, dose-escalation, dose-expansion phase I clinical study of JS004 in subjects with recurrent/refractory malignant lymphoma in China, to evaluate the safety, tolerbility, PK, immunogenicity,antitumor activity and biomarkers of JS004, to define MTD and RP2D of JS004. A cycle is 21 days(3 weeks) which includes JS004 being administered IV Q3W and JS004 combine with JS001 being administered IV Q3W. All patients will be treated until disease progression per Lugano response critieria 2014 for Lymphoma or intolerable toxicity per CTCAE 5.0, withdrawal of consent, or end of the study, whichever occurs first. Disease progression must be confirmed at least 4 weeks but no longer than 8 weeks after initial documentation of progression.