Search Clinical Trials
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Nivolumab in Treating Patients With Autoimmune Disorders and Advanced, Metastatic, or Unresectable Cancer
National Cancer Institute (NCI)
Advanced Malignant Neoplasm
Autoimmune Disease
Crohn Disease
Dermatomyositis
Inflammatory Bowel Disease
This phase Ib trial studies the side effects of nivolumab and to see how well it works in
treating patients with autoimmune disorders and cancer that has spread to other places in the
body or cannot removed by surgery. Immunotherapy with monoclonal antibodies, such as
nivolumab,... expand
This phase Ib trial studies the side effects of nivolumab and to see how well it works in treating patients with autoimmune disorders and cancer that has spread to other places in the body or cannot removed by surgery. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Type: Interventional Start Date: Apr 2019 |
AZD6738 for Patients With Progressive MDS or CMML
Massachusetts General Hospital
Leukemia
Myelodysplastic Syndrome
This research study is studying a research drug called AZD6738 as a possible treatment for
Myelodysplastic Syndrome or Chronic Myelomonocytic Leukemia .
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This research study is studying a research drug called AZD6738 as a possible treatment for Myelodysplastic Syndrome or Chronic Myelomonocytic Leukemia . Type: Interventional Start Date: Aug 2019 |
Study of Pembrolizumab (MK-3475) Versus Placebo in Combination With Neoadjuvant Chemotherapy & Adjuvant...
Merck Sharp & Dohme Corp.
Breast Cancer
The purpose of this study is to assess the efficacy and safety of pembrolizumab (MK-3475)
versus placebo in combination with neoadjuvant (pre-surgery) chemotherapy and adjuvant
(post-surgery) endocrine therapy in the treatment of adults who have high-risk early-stage
estrogen... expand
The purpose of this study is to assess the efficacy and safety of pembrolizumab (MK-3475) versus placebo in combination with neoadjuvant (pre-surgery) chemotherapy and adjuvant (post-surgery) endocrine therapy in the treatment of adults who have high-risk early-stage estrogen receptor-positive, human epidermal growth factor receptor 2-negative (ER+/HER2-) breast cancer. The primary study hypotheses are: 1) pembrolizumab is superior to placebo, both in combination with the protocol-specified neoadjuvant anticancer therapy, as assessed by pathological Complete Response (pCR) rate defined by the local pathologist, and 2) pembrolizumab is superior to placebo (both in combination with the protocol-specified neoadjuvant and adjuvant anticancer therapies) as assessed by Event-Free Survival (EFS) as determined by the investigator. The study is considered to have met its primary objective if pembrolizumab is superior to placebo with respect to either pCR (ypT0/Tis ypN0) or EFS. Type: Interventional Start Date: Dec 2018 |
A Dose Escalation and Expansion Study of RO7121661, a PD-1/TIM-3 Bispecific Antibody, in Participants...
Hoffmann-La Roche
Solid Tumors
Metastatic Melanoma
Non-small Cell Lung Cancer (NSCLC)
Small Cell Lung Cancer (SCLC)
Esophageal Squamous Cell Carcinoma (ESCC)
This is a first-in-human, open-label, multicenter, Phase I multiple-ascending dose (MAD)
study of single agent RO7121661, an anti PD-1 (programmed death-1) and TIM-3 (T-cell
immunoglobulin and mucin domain 3) bispecific antibody, for participants with advanced and/or
metastatic... expand
This is a first-in-human, open-label, multicenter, Phase I multiple-ascending dose (MAD) study of single agent RO7121661, an anti PD-1 (programmed death-1) and TIM-3 (T-cell immunoglobulin and mucin domain 3) bispecific antibody, for participants with advanced and/or metastatic solid tumors. The study consists of 2 parts: Dose Escalation (Part A) and Expansion (Parts B1, B2, B3, B4, and B5). The Dose Escalation part will be conducted first to determine the maximum tolerated dose (MTD) and/or recommended dose for expansion (RDE) based on safety, tolerability, pharmacokinetic, and/or the pharmacodynamic profile of escalating doses of RO7121661. The Expansion part will enroll tumor-specific cohorts to evaluate anti-tumor activity of the MTD and/or RDE of RO7121661 from Part A (Q2W) and to confirm safety and tolerability in participants with selected tumor types. Recruitment into the Expansion Part B4: SCLC Cohort is now closed. Type: Interventional Start Date: Oct 2018 |
Rucaparib in Combination With Nivolumab in Patients With Advanced or Metastatic Biliary Tract Cancer...
University of Michigan Rogel Cancer Center
Biliary Tract Cancer
Investigators hypothesize that following first-line platinum based chemotherapy, rucaparib in
combination with nivolumab, will improve progression-free survival and overall survival in
BTC patients.
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Investigators hypothesize that following first-line platinum based chemotherapy, rucaparib in combination with nivolumab, will improve progression-free survival and overall survival in BTC patients. Type: Interventional Start Date: Mar 2019 |
A Phase 3 Efficacy, Safety and Tolerability Study of Zolbetuximab (Experimental Drug) Plus mFOLFOX6 Chemotherapy...
Astellas Pharma Global Development, Inc.
Locally Advanced Unresectable Gastroesophageal Junction (GEJ) Adenocarcinoma or Cancer
Locally Advanced Unresectable Gastric Adenocarcinoma or Cancer
Metastatic Gastric Adenocarcinoma or Cancer
Metastatic Gastroesophageal Junction (GEJ) Adenocarcinoma
A study of zolbetuximab (IMAB362) plus mFOLFOX6 versus placebo plus mFOLFOX6 in subjects with
Claudin 18.2 positive, HER2-negative, locally advanced unresectable or metastatic gastric or
gastroesophageal junction adenocarcinoma.
Why is this study being done?
SPOTLIGHT... expand
A study of zolbetuximab (IMAB362) plus mFOLFOX6 versus placebo plus mFOLFOX6 in subjects with Claudin 18.2 positive, HER2-negative, locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma. Why is this study being done? SPOTLIGHT is a new clinical study for adult patients who have any of: - advanced unresectable gastric or GEJ cancer - metastatic gastric or GEJ cancer These types of cancers have a unique set of proteins (called Claudin 18.2). We may be able to use a treatment that targets the proteins to kill the cancer cells. For patients with one of the types of cancer listed above, mFOLFOX6 (a combination of three chemotherapies known as Oxaliplatin, Leucovorin, and Fluorouracil) is a current treatment option. This study is testing an experimental medicine called zolbetuximab (IMAB362). Zolbetuximab attaches itself to Claudin 18.2 on the cancer cells causing cancer cell death. Patients will be assigned to one of two groups by chance and given either: - zolbetuximab with mFOLFOX6; or - a placebo with mFOLFOX6 A placebo is a treatment that looks like the experimental medicine, but contains no medicine. The goal of the study is to find out if zolbetuximab with mFOLFOX6 helps patients to live longer by stopping the cancer from getting worse. Type: Interventional Start Date: Jun 2018 |
Stroke Motor Rehabilitation and Recovery Study
Massachusetts General Hospital
Stroke, Ischemic
SMaHRT (Stroke Motor reHabilitation and Recovery sTudy) is a longitudinal study aimed at
understanding the natural history of upper extremity motor recovery after ischemic stroke.
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SMaHRT (Stroke Motor reHabilitation and Recovery sTudy) is a longitudinal study aimed at understanding the natural history of upper extremity motor recovery after ischemic stroke. Type: Observational Start Date: Jun 2017 |
Study of Efficacy and Safety of Novel Spartalizumab Combinations in Patients With Previously Treated...
Novartis Pharmaceuticals
Melanoma
The primary purpose of this study is to evaluate the efficacy of novel spartalizumab (PDR001)
combinations in previously treated unresectable or metastatic melanoma
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The primary purpose of this study is to evaluate the efficacy of novel spartalizumab (PDR001) combinations in previously treated unresectable or metastatic melanoma Type: Interventional Start Date: Sep 2018 |
Benefits of µCor in Ambulatory Decompensated Heart Failure
Zoll Medical Corporation
Heart Failure
Subjects meeting the inclusion/exclusion criteria will wear the µCor for at least 90 days.
During the study, clinic follow up will occur every 30 days. For all subjects, each scheduled
clinic visit will include assessment of cardiac symptoms and any relevant clinically
actionable... expand
Subjects meeting the inclusion/exclusion criteria will wear the µCor for at least 90 days. During the study, clinic follow up will occur every 30 days. For all subjects, each scheduled clinic visit will include assessment of cardiac symptoms and any relevant clinically actionable events. The subject will be given a daily diary to track symptoms, unplanned hospital visits, medication changes, and all other heart failure related clinical events. Weekly phone calls to the subject will be given throughout the duration of the study to remind the patient to use the subject diary and to collect and record heart failure related clinical events. Subjects will be contacted six months and one year from initial enrollment to assess the vital status of the subject, any heart failure related clinical events since the end of µCor wear, and any health care utilization since the end of µCor wear. Type: Interventional Start Date: Jun 2018 |
A Study Comparing Adjuvant Alectinib Versus Adjuvant Platinum-Based Chemotherapy in Patients With ALK...
Hoffmann-La Roche
Carcinoma, Non-Small-Cell Lung
This randomized, active-controlled, multicenter, open-label, Phase III study is designed to
investigate the efficacy and safety of alectinib compared with platinum-based in the adjuvant
setting. Participants in the experimental arm will receive alectinib at 600 mg orally twice... expand
This randomized, active-controlled, multicenter, open-label, Phase III study is designed to investigate the efficacy and safety of alectinib compared with platinum-based in the adjuvant setting. Participants in the experimental arm will receive alectinib at 600 mg orally twice daily (BID) taken with food for 24 months. Participants in the control arm will receive one of the protocol specified platinum based chemotherapy regimens for 4 cycles. Following treatment completion, participants will be followed up for their disease until disease recurrence. At the time of disease recurrence, participants will enter a survival follow-up until death, withdrawal of consent or study closure, whichever occurs earlier. Type: Interventional Start Date: Aug 2018 |
Long-Term Follow-up Protocol for Subjects Treated With Gene-Modified T Cells
Celgene
Neoplasms
This is a prospective study for the long-term follow-up (LTFU) of safety and efficacy for all
pediatric and adult subjects exposed to Gene-modified (GM) T cell therapy participating in a
previous Celgene sponsored or Celgene alliance partner sponsored study.
Subjects who... expand
This is a prospective study for the long-term follow-up (LTFU) of safety and efficacy for all pediatric and adult subjects exposed to Gene-modified (GM) T cell therapy participating in a previous Celgene sponsored or Celgene alliance partner sponsored study. Subjects who received at least one GM T cell infusion, will be asked to roll-over to this LTFU protocol upon either premature discontinuation from, or completion of the prior parent treatment protocol. Type: Interventional Start Date: Jun 2018 |
A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study to Evaluate the Efficacy...
AbbVie
Ulcerative Colitis (UC)
The objectives of Sub-Study 1 are to evaluate the efficacy, safety, and pharmacokinetics of
risankizumab as induction treatment in subjects with moderately to severely active ulcerative
colitis (UC), and to identify the appropriate induction dose of risankizumab for further... expand
The objectives of Sub-Study 1 are to evaluate the efficacy, safety, and pharmacokinetics of risankizumab as induction treatment in subjects with moderately to severely active ulcerative colitis (UC), and to identify the appropriate induction dose of risankizumab for further evaluation in Sub-Study 2. The objective of Sub-Study 2 is to evaluate the efficacy and safety of risankizumab compared to placebo in inducing clinical remission in subjects with moderately to severely active UC. Type: Interventional Start Date: Mar 2018 |
Olaparib In Metastatic Breast Cancer
Dana-Farber Cancer Institute
Metastatic Breast Cancer
Invasive Breast Cancer
Somatic Mutation Breast Cancer (BRCA1)
Somatic Mutation Breast Cancer (BRCA2)
CHEK2 Gene Mutation
This research study is for patients with metastatic breast cancer.
- Metastatic means that the cancer has spread beyond the breast. In addition, through
genetic testing of the blood or tumor, an altered gene has been found that suggests the
tumor may not be... expand
This research study is for patients with metastatic breast cancer. - Metastatic means that the cancer has spread beyond the breast. In addition, through genetic testing of the blood or tumor, an altered gene has been found that suggests the tumor may not be able to repair its genetic material (DNA) when it becomes damaged. - This aspect of the cancer may cause it to be more sensitive - that is, more effectively killed by certain types of drugs such as the study agent being evaluated in this trial, Olaparib. - Olaparib is a type of drug known as a PARP inhibitor. Some types of breast cancer and ovarian cancer share some basic features that make them sensitive to similar treatments. Information from those other research studies suggests that this drug may help to treat metastatic breast cancer. - This study will evaluate whether olaparib is effective in breast cancer patients whose tumor has a mutation in one of the other genes that function with BRCA1 and BRCA2 to repair damaged DNA .This mutation may have been inherited from a parent, or may have developed only in the tumor. - This study will also evaluate whether olaparib is effective in breast cancer patients whose tumor has a mutation in BRCA1 or BRCA2 that was acquired by the tumor, but not inherited. Type: Interventional Start Date: Apr 2018 |
Evaluation of Patient Outcomes From the Kidney Allograft Outcomes AlloSure Registry
CareDx
Kidney Transplant Rejection
This is an observational study to evaluate safety and efficacy outcomes in renal transplant
recipients in whom post-transplant care is managed using AlloSure®. AlloSure® is a
non-invasive test to measure donor-derived cell-free DNA (dd-cfDNA). The AlloSure test is
intended... expand
This is an observational study to evaluate safety and efficacy outcomes in renal transplant recipients in whom post-transplant care is managed using AlloSure®. AlloSure® is a non-invasive test to measure donor-derived cell-free DNA (dd-cfDNA). The AlloSure test is intended to assess the probability of allograft rejection in kidney transplant recipients with clinical suspicion of rejection and to inform clinical decision-making regarding the necessity of renal biopsy in such patients at least 2 weeks post-transplant in conjunction with standard clinical assessment. Amendment 1 (A1): Is an observational study to develop and validate the clinical use of KidneyCare®. Type: Observational Start Date: Jan 2018 |
Magrolimab Monotherapy or Magrolimab in Combination With Azacitidine in Participants With Hematological...
Gilead Sciences
Hematological Malignancies
The primary objectives of this study are:
- To confirm the safety and tolerability of magrolimab monotherapy in a
relapsed/refractory (R/R) acute myeloid leukemia (AML) and myelodysplastic syndrome
(MDS) population, and of magrolimab in combination with azacitidine... expand
The primary objectives of this study are: - To confirm the safety and tolerability of magrolimab monotherapy in a relapsed/refractory (R/R) acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS) population, and of magrolimab in combination with azacitidine in previously untreated participants with AML or MDS and participants with R/R AML and MDS - To evaluate the efficacy of magrolimab monotherapy in R/R AML/MDS, and of magrolimab in combination with azacitidine in previously untreated participants with AML/MDS, or R/R AML/MDS as measured by complete remission (CR) rate for participants with AML and higher-risk MDS, and duration of complete response for participants with AML and higher-risk MDS, and duration of CR for participants with AML and higher-risk MDS - To evaluate the safety, tolerability, and efficacy of magrolimab monotherapy or combination with azacitidine in low-risk MDS participants as measured by red blood cell (RBC) transfusion independence rate Type: Interventional Start Date: Sep 2017 |
A Study of Repotrectinib (TPX-0005) in Patients With Advanced Solid Tumors Harboring ALK, ROS1, or NTRK1-3...
Turning Point Therapeutics, Inc.
Locally Advanced Solid Tumors
Metastatic Solid Tumors
Phase 1 dose escalation will determine the first cycle dose-limiting toxicities (DLTs), the
maximum tolerated dose (MTD), the biologically effective dose and recommended Phase 2 dose
(RP2D) of repotrectinib given to adult subjects with advanced solid malignancies harboring an... expand
Phase 1 dose escalation will determine the first cycle dose-limiting toxicities (DLTs), the maximum tolerated dose (MTD), the biologically effective dose and recommended Phase 2 dose (RP2D) of repotrectinib given to adult subjects with advanced solid malignancies harboring an ALK, ROS1, NTRK1, NTRK2, or NTRK3 gene rearrangement. Midazolam DDI substudy will examine effect of of repotrectinib on CYP3A induction. Phase 2 will determine the confirmed Overall Response Rate (ORR) as assessed by Blinded Independent Central Review (BICR) of repotrectinib in each subject population expansion cohort of advanced solid tumors that harbor a ROS1, NTRK1, NTRK2, or NTRK3 gene rearrangement. The secondary objective will include the duration of response (DOR), time to response (TTR), progression-free survival (PFS), overall survival (OS) and clinical benefit rate (CBR) of repotrectinib in each expansion cohort of advanced solid tumors that harbor a ROS1, NTRK1, NTRK2, or NTRK3 gene rearrangement. Type: Interventional Start Date: Feb 2017 |
A Study of PDR001 in Combination With LCL161, Everolimus or Panobinostat
Novartis Pharmaceuticals
Colorectal Cancer, Non-small Cell Lung Carcinoma (Adenocarcinoma), Triple Negative Breast Cancer, Renal Cell Carcinoma
The purpose of this study is to combine the PDR001 checkpoint inhibitor with several agents
with immunomodulatory activity to identify the doses and schedule for combination therapy and
to preliminarily assess the safety, tolerability, pharmacological and clinical activity of... expand
The purpose of this study is to combine the PDR001 checkpoint inhibitor with several agents with immunomodulatory activity to identify the doses and schedule for combination therapy and to preliminarily assess the safety, tolerability, pharmacological and clinical activity of these combinations. Type: Interventional Start Date: Oct 2016 |
Reduced Craniospinal Radiation Therapy and Chemotherapy in Treating Younger Patients With Newly Diagnosed...
Children's Oncology Group
Medulloblastoma
This phase II trial studies how well reduced doses of radiation therapy to the brain and
spine (craniospinal) and chemotherapy work in treating patients with newly diagnosed type of
brain tumor called WNT)/Wingless (WNT)-driven medulloblastoma. Recent studies using
chemotherapy... expand
This phase II trial studies how well reduced doses of radiation therapy to the brain and spine (craniospinal) and chemotherapy work in treating patients with newly diagnosed type of brain tumor called WNT)/Wingless (WNT)-driven medulloblastoma. Recent studies using chemotherapy and radiation therapy have been shown to be effective in treating patients with WNT-driven medulloblastoma. However, there is a concern about the late side effects of treatment, such as learning difficulties, lower amounts of hormones, or other problems in performing daily activities. Radiotherapy uses high-energy radiation from x-rays to kill cancer cells and shrink tumors. Drugs used in chemotherapy, such as cisplatin, vincristine sulfate, cyclophosphamide and lomustine, 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. Giving reduced craniospinal radiation therapy and chemotherapy may kill tumor cells and may also reduce the late side effects of treatment. Type: Interventional Start Date: Oct 2017 |
Combination Chemotherapy With or Without Temsirolimus in Treating Patients With Intermediate Risk Rhabdomyosarcoma
National Cancer Institute (NCI)
Alveolar Rhabdomyosarcoma
Botryoid-Type Embryonal Rhabdomyosarcoma
Embryonal Rhabdomyosarcoma
Rhabdomyosarcoma
Sclerosing Rhabdomyosarcoma
This randomized phase III trial studies how well combination chemotherapy (vincristine
sulfate, dactinomycin, cyclophosphamide alternated with vincristine sulfate and irinotecan
hydrochloride or vinorelbine) works compared to combination chemotherapy plus temsirolimus in
treating... expand
This randomized phase III trial studies how well combination chemotherapy (vincristine sulfate, dactinomycin, cyclophosphamide alternated with vincristine sulfate and irinotecan hydrochloride or vinorelbine) works compared to combination chemotherapy plus temsirolimus in treating patients with rhabdomyosarcoma (cancer that forms in the soft tissues, such as muscle), and has an intermediate chance of coming back after treatment (intermediate risk). Drugs used in chemotherapy 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. Combination chemotherapy and temsirolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether combination chemotherapy or combination chemotherapy plus temsirolimus is more effective in treating patients with intermediate-risk rhabdomyosarcoma. Type: Interventional Start Date: May 2016 |
Carotid Revascularization and Medical Management for Asymptomatic Carotid Stenosis Trial
Thomas G. Brott, M.D.
Carotid Stenosis
Carotid revascularization for primary prevention of stroke (CREST-2) is two independent
multicenter, randomized controlled trials of carotid revascularization and intensive medical
management versus medical management alone in patients with asymptomatic high-grade carotid... expand
Carotid revascularization for primary prevention of stroke (CREST-2) is two independent multicenter, randomized controlled trials of carotid revascularization and intensive medical management versus medical management alone in patients with asymptomatic high-grade carotid stenosis. One trial will randomize patients in a 1:1 ratio to endarterectomy versus no endarterectomy and another will randomize patients in a 1:1 ratio to carotid stenting with embolic protection versus no stenting. Medical management will be uniform for all randomized treatment groups and will be centrally directed. Type: Interventional Start Date: Dec 2014 |
A Study of Cytisinicline for Smoking Cessation in Adult Smokers
Achieve Life Sciences
Smoking Cessation
This placebo-controlled Phase 3 study is being conducted at sites within the United States to
evaluate 3 mg cytisinicline TID for treatment duration of 42 days/6 weeks as well as
repeating that duration for a total of 84 days/12 weeks treatment.
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This placebo-controlled Phase 3 study is being conducted at sites within the United States to evaluate 3 mg cytisinicline TID for treatment duration of 42 days/6 weeks as well as repeating that duration for a total of 84 days/12 weeks treatment. Type: Interventional Start Date: Oct 2020 |
PPMI 2.0 Clinical -Establishing a Deeply Phenotyped PD Cohort
Michael J. Fox Foundation for Parkinson's Research
Parkinson Disease
The Parkinson Progression Marker Initiative 2.0 (PPMI 2.0) is a longitudinal, observational,
multi-center natural history study to assess progression of clinical features, digital
outcomes, and imaging, biologic and genetic markers of Parkinson's disease (PD) progression
in... expand
The Parkinson Progression Marker Initiative 2.0 (PPMI 2.0) is a longitudinal, observational, multi-center natural history study to assess progression of clinical features, digital outcomes, and imaging, biologic and genetic markers of Parkinson's disease (PD) progression in study participants with manifest PD, prodromal PD, and healthy controls The overall goal of PPMI 2.0 is to identify markers of disease progression for use in clinical trials of therapies to reduce progression of PD disability. Type: Observational Start Date: Jul 2020 |
TAK-676 as Single Agent (SA) and in Combination With Pembrolizumab in Advanced or Metastatic Solid Tumors
Millennium Pharmaceuticals, Inc.
Solid Neoplasms
The purpose of this study is to determine the safety and tolerability of TAK-676 administered
as an SA or in combination with pembrolizumab in participants with advanced or metastatic
solid tumors.
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The purpose of this study is to determine the safety and tolerability of TAK-676 administered as an SA or in combination with pembrolizumab in participants with advanced or metastatic solid tumors. Type: Interventional Start Date: Jul 2020 |
Study of Safety, Pharmacokinetics, and Antitumor Activity of BGB-3245 in Participants With Advanced or...
MapKure, LLC
Solid Tumor
B-Raf Mutation-Related Tumors
The purpose of this study is to evaluate the safety, tolerability, and antitumor activity of
BGB-3245 in participants with advanced or refractory tumors harboring specific v-RAF murine
sarcoma viral oncogene homolog B (B-RAF) genetic mutations.
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The purpose of this study is to evaluate the safety, tolerability, and antitumor activity of BGB-3245 in participants with advanced or refractory tumors harboring specific v-RAF murine sarcoma viral oncogene homolog B (B-RAF) genetic mutations. Type: Interventional Start Date: Feb 2020 |
2019-06 TRISCEND Study
Edwards Lifesciences
Tricuspid Valve Regurgitation
Heart Valve Diseases
Cardiovascular Diseases
Early feasibility study to assess safety and performance of the Edwards EVOQUE Tricuspid
Valve Replacement System
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Early feasibility study to assess safety and performance of the Edwards EVOQUE Tricuspid Valve Replacement System Type: Interventional Start Date: May 2020 |