Sep 24th, 2021 - PRIMARY OBJECTIVES: I. To assess the safety of dabrafenib mesylate (dabrafenib) in combination with uprosertib (GSK2141795) and select the optimal dose of GSK2141795 for the phase II portion in patients with BRAF mutant cancer. (Effective November 15, 2014, this trial will not proceed to the Phase II study of dabrafenib and GSK2141795, but will move to an evaluation of triple therapy). (Phase I...

Sep 24th, 2021 - This is a Phase I, open-label, dose escalation and dose expansion study with BID (suspension) and TID (tablet) oral dose of tazemetostat. Subjects will be screened for eligibility within 14 days of the planned first dose of tazemetostat. A treatment cycle will be 28 days. Response assessment will be evaluated after 8 weeks of treatment and subsequently every 8 weeks while on study. The study ha...

Sep 24th, 2021 - This is a Phase II, multicenter, open-label, single arm, 2-stage study of tazemetostat 800 mg BID (twice daily) and 1600 mg QD (once daily). Subjects will be screened for eligibility within 21 days of the planned date of the first dose of tazemetostat and enrolled into one of 8 cohorts: Cohort using tazemetostat 800 mg BID Cohort 1 (Closed for enrollment): MRT, RTK, ATRT, and selected tumors wi...

Sep 24th, 2021 - See report: Honore H, Eggertsen K, Sondergaard S: A study into the feasibility of using HRV variables to guide treatment in patients with paroxystic sympathetic hyperactivity in a neurointensive step-down unit. NeuroRehabilitation 2019, 44(1):141-155.

Sep 24th, 2021 - PRIMARY OBJECTIVES: I. To identify, using next generation sequencing, rare variants of large effect size that impact the risk of hypertension in patients from the clinical trial Eastern Cooperative Oncology Group (ECOG)-5103 (E5103). OUTLINE: Previously collected germline DNA samples are analyzed via whole exome sequencing.

Sep 24th, 2021 - The study is a prospective, randomized multicenter trial. Approximately 200 subjects will be enrolled at 12 sites throughout the United States and Canada. Up to 250 subjects may be enrolled to account for screen failures. Rutgers, New Jersey Medical School is the coordinating center for the study. The purpose of this study is to determine whether there is an advantage to using autograft (bone m...

Sep 24th, 2021 - Primary objective: To evaluate the safety and tolerability of the nutritional drink in gastroparesis patients. Secondary objective: To evaluate the efficacy of the nutritional drink in gastroparesis patients. Study Procedures This study will be a pilot, open-label, trial in gastroparesis patients. A total of 20 patients will be recruited from the gastroenterology gastroparesis clinic. If the vo...

Sep 24th, 2021 - This trial will evaluate the safety and efficacy of pembrolizumab (MK-3475) in combination with platinum doublet neoadjuvant chemotherapy (NAC) before surgery [neoadjuvant phase], followed by pembrolizumab alone after surgery [adjuvant phase] in participants with resectable stage II, IIIA, and resectable IIIB (T3-4N2) non-small cell lung cancer (NSCLC). The primary hypotheses of this study are ...

Sep 24th, 2021 - Objectives To explore the feasibility and benefits of a 'Nurse-led Family and Network Consultation' (FNC) that seek to identify and address patients' symptoms/concerns and caregiver burden on one side and identify the resources and opportunities to ease their burdens on the other side. To explore the impact of these nurse consultations on the nurses' perception of autonomy, self-esteem, and con...

Sep 24th, 2021 - This is a randomized, open label, multicenter phase III trial comparing the efficacy, safety, and tolerability of tisagenlecleucel to Standard Of Care in adult patients with aggressive B-cell Non-Hodgkin Lymphoma after failure of rituximab and anthracycline containing frontline immunochemotherapy.

Sep 24th, 2021 - 1, Consent patients undergoing sports orthopaedic surgery in clinic or in pre-operative holding area and also administer first questionnaire, opioid risk tool, and pain catastrophizing scale(research) 2. Sports orthopaedic surgery (standard of care) 3. Post-op pain control regimen (standard of care) 4. Call or email patient with questionnaire every day for a week followed by weekly for 7 more w...

Sep 24th, 2021 - This Phase II stratified randomized prevention trial will assess the efficacy of a behavioral economic theory-based financial incentive drawing program versus a control regimen to promote early childhood caries (ECC) preventive health behaviors (toothbrushing performance) for young children of predominantly Latino parents/caregivers in Early Head Start (EHS) and day care center programs.

Sep 24th, 2021 - See above

Sep 24th, 2021 - This research study is a Phase I clinical trial, which tests the safety and effect of personalized neoantigen vaccines for pancreatic tumors. It is known that pancreatic tumors have various mutations (changes in genetic material) that are specific to an individual patient and tumors. These mutations can cause the tumor cells to produce proteins that appear very different from the body's own cel...

Sep 24th, 2021 - The objective of this study is to evaluate the efficacy and safety of sacituzumab govitecan-hziy in participants with metastatic urothelial cancer (mUC).

Sep 24th, 2021 - Multi-center trial, Phase II, non-randomized, open-label, single-arm study with combined therapy of rituximab plus MG4101 in patients with indolent CD20-positive NHLs who has relapsed or refractory to prior chemotherapy or chemo-radiotherapy.

Sep 24th, 2021 - PRIMARY OBJECTIVES: I. To identify, using next generation sequencing, rare variants of large effect size that impact the risk of congestive heart failure (CHF) in patients from the clinical trial ECOG-5103 (E5103). OUTLINE: Previously collected germline DNA samples are analyzed via whole exome sequencing.

Sep 24th, 2021 - The primary purpose of this study is to determine the impact of maximizing patient and primary care provider (PCP) activation on breast cancer surveillance rates among women previously treated with chest radiotherapy (RT) for a childhood cancer. This is an 18-month, 3-arm randomized controlled trial using a smartphone intervention with data being collected at baseline and 18-months through pati...

Sep 24th, 2021 - The primary objective of this study is to assess the overall safety profile of idelalisib monotherapy in patients with refractory follicular lymphoma (FL).

Sep 24th, 2021 - This pilot study will use a descriptive case series design with repeated measures to assess the feasibility of an adapted form of strategy training for people with communication impairments after acute stroke. The investigators will recruit people with aphasia due to stroke admitted to the inpatient rehabilitation units and administer the adapted form of strategy training one session per day 5 ...

Sep 24th, 2021 - PRIMARY OBJECTIVES: I. To determine whether veliparib (ABT-888), when added to radiotherapy (RT) and temozolomide, is efficacious for the treatment of patients with newly-diagnosed high-grade glioma (HGG) whose tumors' molecular profile are wild-type for H3 K27M, BRAF, and IDH1/2. II. To determine whether veliparib (ABT-888), when added to RT and temozolomide, is efficacious for the treatment o...

Sep 24th, 2021 - This multicenter screening study will be conducted in order to determine a subject's tumor antigen expression profile and HLA subtype, and subsequent eligibility for Adaptimmune sponsored clinical treatment trials studying the safety and efficacy of autologous genetically modified T-cells engineered with enhanced TCRs targeting specific antigens. No treatment intervention will occur as part of ...

Sep 24th, 2021 - PRIMARY OBJECTIVES: I. To evaluate 68Ga-RM2 (formerly known as DOTA bombesin or BAY 86-7548) PET/MRI for detection of recurrent prostate cancer after initial therapy in patients with elevated prostate-specific antigen (PSA) and non-contributory computed tomography (CT). OUTLINE: Patients receive 68Ga-RM2 intravenously (IV) and beginning 45 minutes later undergoing PET/MRI scan. The 68Ga-RM2 PET...

Sep 24th, 2021 - This study will evaluate the safety and efficacy of AXS-05 in a randomized, double-blind, active-controlled study in patients diagnosed with major depressive disorder (MDD) experiencing an acute episode.

Sep 24th, 2021 - EGFR exon 20 insertion-mutant NSCLCs are generally resistant to 1st-generation EGFR tyrosine kinase inhibitors (TKIs) as well as 2nd-generation EGFR TKIs (overall response rates of 0-8.7%). Osimertinib is an oral, potent, irreversible EGFR-TKI selective for sensitizing EGFR and EGFR T790M resistance mutations with a significant selectivity margin against wild-type EGFR. Osimertinib is potent wi...

Sep 24th, 2021 - PRIMARY OBJECTIVES: I. Compare the progression-free survival rate at 4 months (PFS4) of patients with ocular melanoma treated with cabozantinib-s-malate (cabozantinib) or temozolomide (or dacarbazine). SECONDARY OBJECTIVES: I. Estimate the distribution of progression-free survival (PFS) times. II. Estimate the distribution of overall survival (OS) times. III. Estimate the confirmed response rat...

Sep 24th, 2021 - Group 1 will consist of low-risk participants with cHL Stages IA, IB and IIA without bulky disease. Group 2 will consist of high-risk participants with cHL Stages IIEB, IIIEA, IIIEB, IIIB, IVA and IVB.

Sep 24th, 2021 - Patients will be identified and enrolled by the Mayo Clinic St. Marys Emergency Department staff as they are undergoing medical care in the Emergency Department. The investigators will calculate the difference in oxygen saturation pre- and post-deep inspiration (ΔSpO2 at 1 minute, 2 minutes and 4 minutes), and then correlate these values with the CT result. In cases of PE, The investigators exp...

Sep 24th, 2021 - This is a population screening study to undertake (with prospective consent) additional testing of the newborn screening blood to identify children at increased genetic risk of type 1 diabetes. This study will enrol newborn babies whose mothers have given consent to additional testing for the newborn blood screening (routinely performed when the baby is approximately 5 days old). Women will be ...

Sep 24th, 2021 - Sunitinib malate is designed to block pathways that control important events such as the growth of blood vessels that are essential for the growth of cancer. Hormonal treatment is used to lower testosterone levels in the body because prostate cancer cells need testosterone to survive. Before you can start treatment on this study, you will have what are called "screening tests." These tests will...

Sep 24th, 2021 - Ventricular tachycardia (VT) or fast heart rhythm is a condition where the lower chambers (ventricles) of the heart beat too fast. This condition can be life threatening because these ventricles are the main pumping chambers of the heart. The fast heartbeat is caused by electrical impulses that travel incorrectly in your heart. One way to treat VT is to have a catheter ablation procedure. A cat...

Sep 24th, 2021 - The primary objective of this study is to study the safety and efficacy of the BiOSS LIM C with respect to Patient oriented Composite Endpoint (PoCE) at 12 months in a "real world" left-main bifurcation population and as compared with a prespecified performance goal.

Sep 24th, 2021 - An association between Gaucher disease and parkinsonism has been demonstrated by the concurrence of parkinsonian manifestations in patients with Gaucher disease and an increased incidence of glucocerebrosidase (GBA) mutations in subjects with parkinsonism of various ethnicities. Furthermore, there is a significant number of obligate and confirmed Gaucher carriers with parkinsonian manifestation...

Sep 24th, 2021 - This is a phase 2, single-center, prospective, randomized, double-blind, placebo-controlled, study in patients with well-controlled celiac disease. Patients with confirmed CD diagnosis (biopsy) will be recruited to participate in the study. Informed consent must be obtained prior to performing any screening procedures. Patients who meet Visit 1 protocol enrollment criteria will be enrolled and ...

Sep 24th, 2021 - This is a study to compare the efficacy of bimekizumab versus secukinumab in subjects with moderate to severe chronic plaque psoriasis (PSO).

Sep 24th, 2021 - This study is designed to identify the target Non-Small Cell Lung Cancer (NSCLC) population(s) that over express c-Met (c-Met+) best suited for telisotuzumab vedotin therapy in the second line or third line setting (Stage 1) and then to expand the group(s) to further evaluate efficacy in the selected population(s) (Stage 2).

Sep 24th, 2021 - A study designed to evaluate the safety and efficacy of venetoclax plus dexamethasone (VenDex) compared with pomalidomide plus dexamethasone (PomDex) in participants with t(11;14)-positive Relapsed or Refractory Multiple Myeloma.

Sep 24th, 2021 - Many chemotherapeutic agents compromise the integrity of the mucosal barrier in the gut, allowing translocation of gram-positive bacteria in secondary lymphoid organs. While this has, until recently, been considered an undesirable side-effect, it may also represent one mechanism by which chemotherapy stimulates an effective anti-cancer immune response. The purpose of this research is to test wh...

Sep 24th, 2021 - This protocol results from a funded 2005 Bench-to-Bedside Award and explores the genetic basis of disease severity in neurofibromatosis type 1 (NF1) and the evaluation of three methods to measure disease progression of dermal neurofibromas. NF1 is a common multisystem genetic disorder associated with the development of benign and malignant tumors, primarily of the nervous system. NF1 is 100% pe...

Sep 24th, 2021 - The purpose of this study is to explore the use of off-label CFTR modulators that may affect CFTR function in patients with CFTR mutations that are not currently approved for these drugs. Symdeko (Tezacaftor/Ivacaftor), Orkambi (Ivacaftor and Lumacaftor), correctors of CFTR misfolding and Kalydeco (Ivacaftor), a potentiator of abnormal CFTR gating, will be explored as a treatment for patients w...

Sep 24th, 2021 - Gestational diabetes (GDM) complicates approximately 400,000 pregnancies in the United States annually and is associated with significant adverse pregnancy outcomes, including increasing the lifetime risk of type 2 diabetes. The American College of Obstetricians and Gynecologists (ACOG) recommends that all pregnant women undergo GDM screening between 24-28 weeks gestation utilizing a 1-hour ora...

Sep 24th, 2021 - Child motor development is a complex process which results from the interaction between genetics and the environment. The role of the home as the first environment for child experiences is very important for motor development, especially during infancy. Thus, a more supportive and stimulating environment is associated with more affordances and challenges for infant motor development that may le...

Sep 24th, 2021 - To determine the feasibility and acceptability of using immersive virtual reality technologies to impact clinical outcomes (e.g., pain and anxiety) and medication utilization (e.g., narcotics) in pediatric patients with acute and chronic pain.

Sep 24th, 2021 - With the advances in technology and medical fields, the rate of cerebral palsy is increasing worldwide with the increase in the survival rate of preterm, low birth weight babies and neurodevelopmentally risky babies living in neonatal intensive care units. The International Classification of Health, Function and Disability - Child and Youth version (ICF-CY), developed by the World Health Organi...

Sep 24th, 2021 - Background: Gastrointestinal stromal tumors (GISTs) are the most common gastrointestinal soft tissue sarcoma, but remain a rare disease entity. Most GISTs are characterized by KIT or PDGFRA mutations, making them susceptible to tyrosine kinase inhibitor (TKI) therapy. Wild-type (WT) GISTs are rarer tumors, usually characterized by SDH mutations and/or lack of KIT or PDGFRA mutations; paragangli...

Sep 24th, 2021 - New York esophageal antigen-1 (NY-ESO-1) and LAGE-1a antigens are tumor-associated proteins that have been found in several tumor types. Clinical trials using adoptively transferred T-cells directed against NY-ESO-1 have shown objective responses. GSK3901961 and GSK3845097 are next generation engineered T-cell receptor (TCR) T-cells, co-expressing the CD8α cell surface receptor, targeting NY-ES...

Sep 24th, 2021 - Approximately 2 billion people worldwide are infected with Mycobacterium tuberculosis (TB), with 90% of individuals having latent infection (LTBI). The control of TB requires clearly delineated helper T cell (Th) 1 responses and, to a lesser extent, Th17 responses, which both play important roles in the induction and maintenance of protective immune responses in mouse models of TB infection and...

Sep 24th, 2021 - This is an open-label, randomized, multi-site, Phase II, interventional trial designed to evaluate the efficacy, tolerability, and safety of BNT111 + cemiplimab in anti-PD1-refractory/relapsed patients with unresectable Stage III or IV melanoma. The contributions of BNT111 and cemiplimab will be delineated in single agent calibrator arms. Patients in single agent calibrator arms, who experience...

Sep 24th, 2021 - The safety and effectiveness of the microwave ablation treatment system produced by Suzhou Hengrui Hongyuan Medical Technology Co., Ltd. for the ablation treatment of primary liver cancer is verified through the implementation of prospective, multi-center, single-group target value research. According to the requirements of the trial, 139 patients who were diagnosed with primary liver cancer be...

Sep 24th, 2021 - VOH is a widely used diagnostic method and seems to be getting more into outpatient clinics. Despite its huge contribution to clinical practice, pain during the procedure is an important limiting factor. We aimed to investigate the effect of the trendelenburg lithotomy position to the pain and procedural time.However, there is a scarcity of research on this subject. Therefore, the rationale of ...