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Cerebral Hemorrhage Risk in Hereditary Hemorrhagic Telangiectasia
Unity Health Toronto
Hereditary Hemorrhagic Telangiectasia
This study is one of the three projects of an NIH Rare Disease Clinical Research
Consortium. A "consortium" is a group of centres sharing information and resources to
perform research. The consortium research focuses on brain blood vessel malformations in
three different rare diseases.
The focus o1 expand
This study is one of the three projects of an NIH Rare Disease Clinical Research Consortium. A "consortium" is a group of centres sharing information and resources to perform research. The consortium research focuses on brain blood vessel malformations in three different rare diseases. The focus of this specific study is on Hemorrhagic Telangiectasia (HHT). HHT is a condition characterized by blood vessel malformations, called telangiectasia and arteriovenous malformations (AVMs), occurring in the brain, nose, lungs, stomach, bowels and liver. Brain AVMs (BAVMs) in HHT are difficult to study because they are rare, affecting approximately 10% of people with HHT. While other types of BAVMs have been studied in depth, studies in the HHT population have been very small. Here, we propose the first large-scale collaboration by joining with 12 HHT Centers of Excellence in North America to perform a large study of risk factors for bleeding from BAVMs, called intracranial hemorrhage (ICH) in HHT patients. The current standard of clinical practice across North America, is to screen all HHT patients for BAVMs with magnetic resonance imaging (MRI). If BAVMs are detected, patients are referred to a multidisciplinary neurovascular team for consideration for treatment. Treatment decisions are made on a case by case basis, balancing risks of complications from the BAVM with risks of therapy, but are limited by the few studies available in HHT. We hope that the knowledge we obtain about the risk factors for intracranial bleeding in these patients from this larger study will help us to improve the care of HHT patients. We plan to study risk factors for rupture of BAVMs, including primarily genetics and imaging characteristics of the BAVMs. Knowledge about risk factors will help in the care and management of HHT patients. This will be achieved through the collection of health information to construct a HHT database, blood sampling and banking (through the National Institute of Neurological Disorders and Stroke [NINDS]), and through genetic analysis at the University of California San Francisco. Type: Observational Start Date: Apr 2010 |
Strength and Muscle Related Outcomes for Nutrition and Lung Function in CF
Jaeb Center for Health Research
Cystic Fibrosis
The goal of the study is to examine multiple markers of anthropometrics, body
composition, sarcopenia and frailty and compare them to dual energy X-ray absorptiometry
(DXA) output, which is considered the current clinical gold-standard tool to measure body
composition. The result of this study will1 expand
The goal of the study is to examine multiple markers of anthropometrics, body composition, sarcopenia and frailty and compare them to dual energy X-ray absorptiometry (DXA) output, which is considered the current clinical gold-standard tool to measure body composition. The result of this study will provide detailed data regarding the nutrition and body composition within this Cystic Fibrosis population and also provide a baseline evaluation for use of these biomarkers in the future studies including evaluation of nutritional intervention. Further, the study will also include psychosocial and other patient-reported outcomes and medical contributors to understand their contributions to the nutritional failure in the adult advanced lung disease population. Finally, the study will evaluate both established and emerging nutritional and body composition parameters and link them to clinical outcomes in adults with CF across the spectrum of pulmonary function. Type: Observational Start Date: Apr 2023 |
Comparing Proton Therapy to Photon Radiation Therapy for Esophageal Cancer
NRG Oncology
Clinical Stage I Esophageal Adenocarcinoma AJCC v8
Clinical Stage I Esophageal Squamous Cell Carcinoma AJCC v8
Clinical Stage I Gastroesophageal Junction Adenocarcinoma AJCC v8
Clinical Stage II Esophageal Adenocarcinoma AJCC v8
Clinical Stage II Esophageal Squamous Cell Carcinoma AJCC v8
This trial studies how well proton beam radiation therapy compared with intensity
modulated photon radiotherapy works in treating patients with stage I-IVA esophageal
cancer. Proton beam radiation therapy uses a beam of protons (rather than x-rays) to send
radiation inside the body to the tumor wit1 expand
This trial studies how well proton beam radiation therapy compared with intensity modulated photon radiotherapy works in treating patients with stage I-IVA esophageal cancer. Proton beam radiation therapy uses a beam of protons (rather than x-rays) to send radiation inside the body to the tumor without damaging much of the healthy tissue around it. Intensity modulated photon radiotherapy uses high-energy x-rays to deliver radiation directly to the tumor without damaging much of the healthy tissue around it. It is not yet known whether proton beam therapy or intensity modulated photon radiotherapy will work better in treating patients with esophageal cancer. Type: Interventional Start Date: Mar 2019 |
Left vs Left Randomized Clinical Trial
Baylor College of Medicine
Heart Failure
Heart Failure With Reduced Ejection Fraction
AV Block
LBBB
RBBB
The investigators aim to prospectively test the comparative effectiveness of His or Left
bundle branch pacing in relation to patient centered outcomes (quality of life, physical
activity, heart failure hospitalization, mortality) and comparative safety in relation to
device-related complications an1 expand
The investigators aim to prospectively test the comparative effectiveness of His or Left bundle branch pacing in relation to patient centered outcomes (quality of life, physical activity, heart failure hospitalization, mortality) and comparative safety in relation to device-related complications and re-interventions (e.g., lead dislodgement, infection) relative to standard of care biventricular pacing in patients with heart failure due to left ventricular systolic dysfunction (LVEF≤50%) and with either a wide QRS (≥130 ms) or with/anticipated >40% pacing who are already receiving current standard heart failure pharmacological therapy. Type: Interventional Start Date: Sep 2023 |
Safety and Efficacy of Polymyxin B Hemoperfusion (PMX) for Endotoxemic Septic Shock in a Randomized1
Spectral Diagnostics (US) Inc.
Septic Shock
Endotoxemia
Prospective, multicenter, randomized, open-label study of standard of care plus the PMX
cartridge versus standard of care alone in patients with endotoxemic septic shock expand
Prospective, multicenter, randomized, open-label study of standard of care plus the PMX cartridge versus standard of care alone in patients with endotoxemic septic shock Type: Interventional Start Date: Oct 2019 |
Thromboelastographic Profile in Healthy Newborns and Infants of Diabetic Mothers Using TEG6s
Arkansas Children's Hospital Research Institute
Thromboelastography
Coagulation; Fetus or Newborn
Diabetes Mellitus, Type 2
Diabetes Mellitus, Type 1
Diabetes, Gestational
Thromboelastography (TEG) is a laboratory technique used to examine the process of clot
formation and degradation by measuring and reporting the kinetic changes, the rate of
clot formation, clot strength, and clot stability. TEG provides numeric values and a
graphical representation of the primary1 expand
Thromboelastography (TEG) is a laboratory technique used to examine the process of clot formation and degradation by measuring and reporting the kinetic changes, the rate of clot formation, clot strength, and clot stability. TEG provides numeric values and a graphical representation of the primary and secondary hemostatic systems and fibrinolysis more quickly and with a smaller blood sample than routine coagulation studies. TEG6s, the newest TEG platform, simplifies and standardizes TEG technique and is currently available at only four US children's hospitals. Normative values of TEG6s results have not been established in healthy neonates. There are a number of well-established perinatal risk factors for thrombosis in the newborn; however, maternal diabetes has been the most frequently identified risk factor in the newborn since 1965. Despite the well-established hypercoagulable state observed in infants of diabetic mothers (IDMs), there have been no studies evaluating TEG in IDMs. To establish normative data and investigate the hypercoagulable state of IDMs, this observational prospective cohort study will evaluate TEG6s in these two populations: a control group that will include neonates ≥37 weeks gestational age born to mothers with uncomplicated pregnancies and a comparison group that will include neonates ≥37 weeks born to mothers with gestational diabetes or a history of Type 1 or Type 2 diabetes prior to pregnancy, either requiring insulin or diet controlled. We hypothesize that cord blood TEG6s results will differ between healthy newborns and IDMs reflecting a hypercoagulable state in IDMs with an increased coagulation index (CI) in the IDM group. A sample size calculation was performed for a two-sample t-test using the POWER procedure in SAS version 9.4. Based on a two-tailed alpha of 0.05 and a standard deviation of 0.9, the total N was determined to be 40 (i.e., 20 in each group). This yields a power of 0.84 to detect a difference of 1.25 units in the mean CI between IDMs and healthy controls. To avoid blood loss and skin breaking procedures in the subjects, umbilical cord blood obtained from the umbilical cord will be used for analysis. To assure appropriate dilution, a hematocrit will be measured at the time of blood collection using a blood gas machine for prompt results. Sample blood will immediately be taken by the investigators from the delivery hospital to the children's hospital, where the following clotting studies will be performed: PT, aPTT, fibrinogen, platelet count, platelet mapping, and TEG6s. Statistical analyses will be performed on the results of these studies and will provide normative data in healthy newborns and infants of diabetic mothers. Having data on the coagulation profile of neonates will help guide management techniques and help explain the propensity to clot among IDMs and guide further research into prevention and treatment of this complication. Type: Observational Start Date: Aug 2021 |
Study BT8009-230 in Participants With Locally Advanced or Metastatic Urothelial Cancer (Duravelo-2)
BicycleTx Limited
Metastatic Urothelial Cancer
This is a global, multicenter, randomized, open-label study, with an adaptive design. The
main objective of the study is to measure the efficacy and safety of BT8009 (zelenectide
pevedotin) as monotherapy and in combination with pembrolizumab in participants with
locally advanced or metastatic urot1 expand
This is a global, multicenter, randomized, open-label study, with an adaptive design. The main objective of the study is to measure the efficacy and safety of BT8009 (zelenectide pevedotin) as monotherapy and in combination with pembrolizumab in participants with locally advanced or metastatic urothelial cancer (UC). The study includes a dose selection phase followed by an adaptive design continuation. The study is comprised of 2 cohorts. Cohort 1 will include participants who have not received any prior systemic therapy for locally advanced or metastatic UC and are eligible to receive platinum-based chemotherapy, whereas Cohort 2 will include participants who have received ≥ 1 prior systemic therapy for locally advanced or metastatic UC. Type: Interventional Start Date: Jan 2024 |
A Study to Test an Oral Medicine, Belumosudil, in Combination With Corticosteroids in Participants1
Sanofi
Chronic Graft Versus Host Disease
This is a parallel, Phase 3, two-arm study for the treatment of newly diagnosed moderate
or severe chronic GVHD.
The study duration for a participant includes up to 4 weeks for screening; a treatment
period until clinically meaningful cGVHD progression (defined as progression requiring
addition of1 expand
This is a parallel, Phase 3, two-arm study for the treatment of newly diagnosed moderate or severe chronic GVHD. The study duration for a participant includes up to 4 weeks for screening; a treatment period until clinically meaningful cGVHD progression (defined as progression requiring addition of new systemic treatment for cGVHD), relapse/recurrence of the underlying disease, participant starts new systemic treatment for cGVHD or experiences an unacceptable toxicity, at the request of the participants or the investigators, or until the end of study is reached, whichever comes first; at least 30 days follow-up of adverse events (AEs) after the last dose until resolution or stabilization, if applicable; and long-term follow-up until death or study close-out, whichever comes first. Type: Interventional Start Date: Jan 2024 |
Pyruvate Kinase Deficiency Global Longitudinal Registry
Agios Pharmaceuticals, Inc.
Pyruvate Kinase Deficiency
This study is an observational (ie, noninterventional), longitudinal, multicenter, global
registry for patients with pyruvate kinase (PK) deficiency, a rare nonspherocytic
hemolytic anemia.
This Registry will be open for enrollment for 7 years and all enrolled participants will
be followed prospec1 expand
This study is an observational (ie, noninterventional), longitudinal, multicenter, global registry for patients with pyruvate kinase (PK) deficiency, a rare nonspherocytic hemolytic anemia. This Registry will be open for enrollment for 7 years and all enrolled participants will be followed prospectively for a minimum of 2 years, and up to 9 years. Data will be collected from participating Registry Physicians, participants, and, where appropriate, parents/guardians who have provided informed consent or assent (where relevant) and authorization pursuant to applicable laws and regulations. Data should include demographic, clinical, and treatment data; and other data of relevance to the management of patients with PK deficiency. Annual chart review and data entry are expected in order to enhance longitudinal understanding of PK deficiency; however, no specific protocol schedule of assessment is required by this Registry protocol. Type: Observational [Patient Registry] Start Date: Apr 2018 |
Study of BMS-986393 a GPRC5D-directed CAR T Cell Therapy in Adult Participants With Relapsed or Ref1
Juno Therapeutics, Inc., a Bristol-Myers Squibb Company
Multiple Myeloma
The purpose of this study is to evaluate the effectiveness and safety of BMS-986393 in
participants with relapsed or refractory multiple myeloma. expand
The purpose of this study is to evaluate the effectiveness and safety of BMS-986393 in participants with relapsed or refractory multiple myeloma. Type: Interventional Start Date: Mar 2024 |
AMX0035 and Progressive Supranuclear Palsy
Amylyx Pharmaceuticals Inc.
Progressive Supranuclear Palsy
PSP
Neurodegenerative Diseases
Atypical Parkinsonism
A35-009 (ORION) is a Phase 2b/3 trial to evaluate the efficacy and safety of AMX0035 in
participants with Progressive Supranuclear Palsy (PSP), consisting of randomized, double
blind placebo controlled phases, followed by an optional open-label extension phase. expand
A35-009 (ORION) is a Phase 2b/3 trial to evaluate the efficacy and safety of AMX0035 in participants with Progressive Supranuclear Palsy (PSP), consisting of randomized, double blind placebo controlled phases, followed by an optional open-label extension phase. Type: Interventional Start Date: Dec 2023 |
RECOVER-AUTONOMIC Platform Protocol
Kanecia Obie Zimmerman
Long COVID
Long Covid19
Long Covid-19
This study is a platform protocol designed to be flexible so that it is suitable for a
wide range of settings within health care systems and in community settings where it can
be integrated into COVID-19 programs and subsequent treatment plans.
This protocol is a prospective, multi-center, multi-a1 expand
This study is a platform protocol designed to be flexible so that it is suitable for a wide range of settings within health care systems and in community settings where it can be integrated into COVID-19 programs and subsequent treatment plans. This protocol is a prospective, multi-center, multi-arm, randomized, controlled platform trial evaluating various interventions for use in the treatment of autonomic dysfunction symptoms, including cardiovascular complications and postural orthostatic tachycardia syndrome (POTS), in PASC participants. The interventions tested will include non-pharmacologic care and pharmacologic therapies with study drugs. Type: Interventional Start Date: Mar 2024 |
Phase 2/3 Adaptive Study of VX-147 in Adult and Pediatric Participants With APOL1- Mediated Protein1
Vertex Pharmaceuticals Incorporated
Proteinuric Kidney Disease
The purpose of this study is to evaluate the efficacy, safety, tolerability, and
pharmacokinetics (PK) of VX-147 in adult and pediatric participants with apolipoprotein
L1 (APOL1)-mediated proteinuric kidney disease. expand
The purpose of this study is to evaluate the efficacy, safety, tolerability, and pharmacokinetics (PK) of VX-147 in adult and pediatric participants with apolipoprotein L1 (APOL1)-mediated proteinuric kidney disease. Type: Interventional Start Date: Mar 2022 |
A Phase 2 Study of Firi-cel in Patients With Relapsed/Refractory Large B-cell Lymphoma
CARGO Therapeutics
Cancer
Relapsed/Refractory Large B-cell Lymphoma (LBCL)
This is a prospective, open-label, multi-center clinical study designed to evaluate the
safety, tolerability, efficacy, pharmacokinetics, pharmacodynamics, and immunogenicity of
firicabtagene autoleucel (firi-cel), a CD22-directed autologous Chimeric Antigen Receptor
(CAR) T-cell therapy for the tr1 expand
This is a prospective, open-label, multi-center clinical study designed to evaluate the safety, tolerability, efficacy, pharmacokinetics, pharmacodynamics, and immunogenicity of firicabtagene autoleucel (firi-cel), a CD22-directed autologous Chimeric Antigen Receptor (CAR) T-cell therapy for the treatment of relapsed or refractory large B-cell lymphoma (LBCL). Type: Interventional Start Date: Aug 2023 |
A Clinical Trial of Four Medicines (Elranatamab Plus Carfilzomib and Dexamethasone or Maplirpacept)1
Pfizer
Multiple Myeloma
The main purpose of the study is to evaluate the safety and tolerability of the
combination of elranatamab and carfilzomib and dexamethasone or elranatamab and
maplirpacept.
There are 2 parts to this study. Part 1 will evaluate the safety and tolerability of
elranatamab when given in combination w1 expand
The main purpose of the study is to evaluate the safety and tolerability of the combination of elranatamab and carfilzomib and dexamethasone or elranatamab and maplirpacept. There are 2 parts to this study. Part 1 will evaluate the safety and tolerability of elranatamab when given in combination with carfilzomib plus dexamethasone. Part 2 has 2 arms. The first will evaluate the safety and tolerability of elranatamab when given in combination with maplirpacept. The second will identify the optimal dose(s) of elranatamab plus maplirpacept. All study medicines are given over 4-week cycles. Everyone taking part in this study will receive elranatamab as a shot under the skin. Participants in Part 1 will also receive weekly carfilzomib as an IV infusion (given directly into a vein) and dexamethasone either by mouth (as a pill) or by IV infusion. Participants in Part 2 will receive elranatamab in combination with maplirpacept as an IV infusion (given directly into a vein) The investigators will examine the experiences of people receiving the study medicines. This will help determine if the study medicines are safe and can be used for multiple myeloma treatment. Participants will take part in this study for about 2 years after the first dose. Type: Interventional Start Date: Dec 2022 |
A Study of CYP-001 in Combination With Corticosteroids in Adults With High-risk aGvHD
Cynata Therapeutics Limited
Graft Versus Host Disease, Acute
This study is a prospective randomized placebo-controlled phase 2 study to compare
CYP-001 plus corticosteroids (CS) to placebo plus CS in allogeneic hematologic stem cell
transplant recipients with HR-aGvHD. Severity of GvHD will be assessed at screening and
throughout the study using Mount Sinai1 expand
This study is a prospective randomized placebo-controlled phase 2 study to compare CYP-001 plus corticosteroids (CS) to placebo plus CS in allogeneic hematologic stem cell transplant recipients with HR-aGvHD. Severity of GvHD will be assessed at screening and throughout the study using Mount Sinai Acute GvHD International Consortium (MAGIC) guidelines. Eligible subjects will be randomized to receive either CYP-001 IV infusion on Days 0 and 4 or placebo on the same days. All subjects will receive ongoing CS therapy as appropriate per institutional guidelines. Subjects will have study visits up to Day 100 during the Primary Evaluation Period. During the Follow-Up Period, subjects will have study visits up to 24 months. Type: Interventional Start Date: Mar 2024 |
T-DM1 and Tucatinib Compared With T-DM1 Alone in Preventing Relapses in People With High Risk HER2-1
Alliance for Clinical Trials in Oncology
Anatomic Stage IA Breast Cancer AJCC v8
Anatomic Stage II Breast Cancer AJCC v8
Anatomic Stage IIA Breast Cancer AJCC v8
Anatomic Stage IIB Breast Cancer AJCC v8
Anatomic Stage III Breast Cancer AJCC v8
This phase III trial studies how well trastuzumab emtansine (T-DM1) and tucatinib work in
preventing breast cancer from coming back (relapsing) in patients with high risk, HER2
positive breast cancer. T-DM1 is a monoclonal antibody, called trastuzumab, linked to a
chemotherapy drug, called DM1. Tra1 expand
This phase III trial studies how well trastuzumab emtansine (T-DM1) and tucatinib work in preventing breast cancer from coming back (relapsing) in patients with high risk, HER2 positive breast cancer. T-DM1 is a monoclonal antibody, called trastuzumab, linked to a chemotherapy drug, called DM1. Trastuzumab is a form of targeted therapy because it attaches to specific molecules (receptors) on the surface of cancer cells, known as HER2 receptors, and delivers DM1 to kill them. Tucatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving T-DM1 and tucatinib may work better in preventing breast cancer from relapsing in patients with HER2 positive breast cancer compared to T-DM1 alone. Type: Interventional Start Date: Jan 2021 |
Standard Systemic Therapy With or Without Definitive Treatment in Treating Participants With Metast1
SWOG Cancer Research Network
Castration Levels of Testosterone
Metastatic Prostatic Adenocarcinoma
Stage IV Prostate Cancer AJCC v8
Stage IVA Prostate Cancer AJCC v8
Stage IVB Prostate Cancer AJCC v8
This phase III trial studies how well standard systemic therapy with or without
definitive treatment (prostate removal surgery or radiation therapy) works in treating
participants with prostate cancer that has spread to other places in the body. Addition
of prostate removal surgery or radiation the1 expand
This phase III trial studies how well standard systemic therapy with or without definitive treatment (prostate removal surgery or radiation therapy) works in treating participants with prostate cancer that has spread to other places in the body. Addition of prostate removal surgery or radiation therapy to standard systemic therapy for prostate cancer may lower the chance of the cancer growing or spreading. Type: Interventional Start Date: Sep 2018 |
Behavioral Pharmacology of Cannabis in Older Adults
University of Arkansas
Health Services for the Aged
This study examines the effects of cannabis on mood, cognitive and psychomotor
performance, balance and vital signs in older adults. expand
This study examines the effects of cannabis on mood, cognitive and psychomotor performance, balance and vital signs in older adults. Type: Interventional Start Date: Dec 2024 |
A Study to Evaluate the Safety and Tolerability of SAGE-718 in Participants With Huntington's Disea1
Sage Therapeutics
Huntington's Disease
The primary purpose of the study is to evaluate the safety and tolerability of SAGE-718
softgel lipid capsule in participants with Huntington's Disease (HD) expand
The primary purpose of the study is to evaluate the safety and tolerability of SAGE-718 softgel lipid capsule in participants with Huntington's Disease (HD) Type: Interventional Start Date: Dec 2022 |
Testing Cabozantinib With or Without Atezolizumab in Patients With Advanced Papillary Kidney Cancer1
National Cancer Institute (NCI)
Metastatic Papillary Renal Cell Carcinoma
Stage IV Renal Cell Cancer AJCC v8
This phase II trial compares the effect of atezolizumab in combination with usual
treatment with cabozantinib to cabozantinib alone in patients with papillary renal cell
carcinoma that has spread to other places in the body (metastatic). Papillary renal cell
carcinoma (PRCC) is a type of kidney can1 expand
This phase II trial compares the effect of atezolizumab in combination with usual treatment with cabozantinib to cabozantinib alone in patients with papillary renal cell carcinoma that has spread to other places in the body (metastatic). Papillary renal cell carcinoma (PRCC) is a type of kidney cancer that forms in the lining of the tiny tubes in the kidney that return filtered substances that the body needs back to the blood and remove extra fluid and waste as urine. Most papillary tumors look like long, thin finger-like growths under a microscope. It is also called papillary kidney cancer or PRCC. Immunotherapy with monoclonal antibodies, such as atezolizumab, may help body's immune system attack the cancer and may interfere with the ability of tumor cells to grow and spread. Cabozantinib is in a class of medications called kinase inhibitors. It works by blocking the action of an abnormal protein that signals cancer cells to multiply and may also prevent the growth of new blood vessels that tumors need to grow. By these actions it may help slow or stop the spread of cancer cells. Combination therapy with atezolizumab and cabozantinib may shrink the cancer and allow a longer survival time in patients with metastatic renal cell carcinoma. Type: Interventional Start Date: Mar 2023 |
Optimizing the Use of Ketamine to Reduce Chronic Postsurgical Pain
NYU Langone Health
Chronic Postsurgical Pain
The study utilizes a 3-arm placebo-controlled RCT to study the effectiveness of ketamine
in reducing chronic post-mastectomy pain. Participants randomized to the first arm will
receive a 0.35 mg/kg dose after induction, followed by a 0.25 mg/kg/hr infusion during
surgery (up to a maximum of 6 hours1 expand
The study utilizes a 3-arm placebo-controlled RCT to study the effectiveness of ketamine in reducing chronic post-mastectomy pain. Participants randomized to the first arm will receive a 0.35 mg/kg dose after induction, followed by a 0.25 mg/kg/hr infusion during surgery (up to a maximum of 6 hours) and continued for 2 hours postoperatively. Participants in the second arm will receive a single dose of 0.6 mg/kg of ketamine in the post-anesthesia care unit, and the final group will serve as the control group and receive saline (no ketamine). Type: Interventional Start Date: Jan 2022 |
Using Biomarkers to Help Guide Safe Immunotherapy Discontinuation in Patients With Unresectable Sta1
ECOG-ACRIN Cancer Research Group
Advanced Melanoma
Clinical Stage III Cutaneous Melanoma AJCC v8
Clinical Stage IV Cutaneous Melanoma AJCC v8
Melanoma of Unknown Primary
Pathologic Stage IIIB Cutaneous Melanoma AJCC v8
This phase II trial investigates how well biomarkers on PET/CT imaging drive early
discontinuation of anti-PD-1 therapy in patients with stage IIIB-IV melanoma that cannot
be removed by surgery (unresectable). Anti-PD-1 therapy has become a standard therapy
option for patients with unresectable mel1 expand
This phase II trial investigates how well biomarkers on PET/CT imaging drive early discontinuation of anti-PD-1 therapy in patients with stage IIIB-IV melanoma that cannot be removed by surgery (unresectable). Anti-PD-1 therapy has become a standard therapy option for patients with unresectable melanoma. This trial is being done to determine if doctors can safely shorten the use of standard of care anti-PD1 therapy for melanoma by using biomarkers seen on PET/CT imaging and tumor biopsy. Type: Interventional Start Date: Feb 2021 |
International Penile Advanced Cancer Trial (International Rare Cancers Initiative Study)
Institute of Cancer Research, United Kingdom
Squamous Cell Carcinoma of the Penis, Usual Type
This is an international phase III trial, with a Bayesian design, incorporating two
sequential randomisations. It efficiently examines a series of questions that routinely
arise in the sequencing of treatment. The study design has evolved from lengthy
international consultation that has enabled us1 expand
This is an international phase III trial, with a Bayesian design, incorporating two sequential randomisations. It efficiently examines a series of questions that routinely arise in the sequencing of treatment. The study design has evolved from lengthy international consultation that has enabled us to build consensus over which questions arise from current knowledge and practice. It will enable potential randomisation for the majority of patients with inguinal lymph node metastases and will provide data to inform future clinical decisions. InPACT-neoadjuvant patients are stratified by disease burden as assessed by radiological criteria. Treatment options are then defined according to the disease burden strata. Treatment is allocated by randomisation. Patients may be allocated to one of three initial treatments: A. standard surgery (ILND); B. neoadjuvant chemotherapy followed by standard surgery (ILND); or C. neoadjuvant chemoradiotherapy followed by standard surgery (ILND). After ILND, patients are defined as being at low or high risk of recurrence based on histological interpretation of the ILND specimen. Patients at high risk of relapse are eligible for InPACT-pelvis, where they are randomised to either: P. prophylactic PLND Q. no prophylactic PLND Type: Interventional Start Date: May 2017 |
Neural Enabled Prosthesis for Upper Limb Amputees
University of Arkansas, Fayetteville
Amputation Arm and Hand, Unilateral Right
Amputation Arm and Hand, Unilateral Left
Prosthesis User
This study is designed to evaluate the feasibility of The Adaptive Neural Systems
Neural-Enabled Prosthetic Hand (ANS-NEPH) system. expand
This study is designed to evaluate the feasibility of The Adaptive Neural Systems Neural-Enabled Prosthetic Hand (ANS-NEPH) system. Type: Interventional Start Date: Dec 2017 |
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