PatSnap/clinical-trial huggingface dataset:
Clinical trial NCT05816785: Pilot Study of Imatinib Cetuximab Combo for H & N Cancer
Official title: A Pilot Window of Opportunity Study of Imatinib in Combination With Cetuximab in Patients With Squamous Cell Carcinomas of the Head and Neck
Conditions: Head and Neck Cancer
Squamous Cell Carcinoma of Head and Neck
Summary: The goal of this clinical trial is to find if levels of a protein called AXL in tumor cells relate to how tumors respond to cetuximab (CTX) combined with imatinib in participants with head and neck cancer. This interventional study will occur in the time between diagnosis of your cancer and surgery to remove your tumor or radiation or chemoradiation treatment of your primary cancer.
Participants will undergo a research blood draw and a research biopsy as part of the screening process, and will be in this research study for approximately 13 to 16 months.
Interventions:
description: Week 1: loading dose of 400mg/m2; Week 2: 250mg/m2
name: Cetuximab
type: Drug
description: 400 mg orally daily
name: Imatinib
type: Drug
Study arms:
design_group_description: Participants will receive two doses of CTX and a minimum of an 8 day (maximum 14 day) course of imatinib prior to definitive surgery or definitive radiation/chemoradiation.
design_group_title: Imatinib Cetuximab Combination
design_group_type: Experimental
Sponsor: University of Wisconsin-Madison
Collaborators: National Cancer Institute
Drug name mappings:
name: 西妥昔单抗
lang: CN
name: Cetuximab
lang: EN
name: セツキシマブ（遺伝子組換え）
lang: JP
name: 甲磺酸伊马替尼
lang: CN
name: Imatinib mesylate
lang: EN
name: イマチニブメシル酸塩
lang: JP
Clinical trial NCT05008146: Imaging CRF X NOP Interactions in CUD
Official title: Imaging Corticotrophin-releasing Factor (CRF) X Nociceptive Opioid Peptide (NOP) Interactions in Cocaine Use Disorders (Aim 1)
Conditions: Cocaine Use Disorder
Summary: This study uses [11C]NOP-1A positron emission tomography (PET) and a hydrocortisone challenge to image the interaction between nociceptive opioid peptide (NOP) receptors and cortisol/corticotrophin releasing factor (CRF) in subjects with cocaine use disorders (CUD) and matched healthy controls (HC). It will also examine whether alterations in CRF x NOP interactions predict relapse in subjects with CUD.
Interventions:
description: Radiotracer
name: Baseline [C-11]NOP-1A PET Scan
type: Radiation
description: Intravenous, 1mg/Kg
name: Hydrocortisone
type: Drug
description: Radiotracer
name: Post-hydrocortisone [C-11]NOP-1A PET Scan
type: Radiation
Study arms:
design_group_description: [C-11]NOP-1A
design_group_title: PET
design_group_type: Experimental
Sponsor: University of Pittsburgh
Collaborators: National Institute on Drug Abuse
Drug name mappings:
name: 氢化可的松
lang: CN
name: Hydrocortisone
lang: EN
name: ヒドロコルチゾン
lang: JP
Clinical trial NCT05478863: The Pharmacodynamics of Cannabinoid-Caffeine Combinations
Official title: A Double-Blind, Randomized, Placebo-Controlled, Within-Subject Crossover Study of the Effects of Combinations of Cannabinoids and Caffeine
Conditions: Behavioral Pharmacology of Cannabinoids
Summary: Cannabis and caffeine are two of the most commonly consumed psychoactive substances in the world, with many consumers reporting positive impacts on energy, alertness, and focus. Preliminary evidence has suggested that cannabidiol (CBD), the non-intoxicating cannabinoid found in cannabis, may mitigate the negative side effects of caffeine (e.g., feeling jittery) without impacting positive or desired effects. CBD also shows potential in reducing undesirable acute effects (e.g., anxiety) of delta-9-tetrahydrocannabinol (THC), the primary intoxicating cannabinoid found in cannabis. Despite these promising findings, little is known about the potential effects of THC, caffeine, and CBD in combination. This double-blind, randomized, placebo-controlled, within-subject crossover study will assess the effects of combinations of THC, CBD, and caffeine (i.e., THC only; THC + caffeine; THC + CBD + caffeine) on subjective energy, arousal, and cognitive performance.
Interventions:
description: Placebo will be orally self-administered by study participants.
name: Oral Placebo
type: Drug
description: THC will be orally self-administered by study participants.
name: Oral THC
type: Drug
description: CBD will be orally self-administered by study participants.
name: Oral CBD
type: Drug
description: Caffeine will be orally self-administered by study participants.
name: Oral Caffeine
type: Drug
Study arms:
design_group_description: Acute administration of oral placebo three times in study session (Time 0, 60, and 120).
design_group_title: Oral placebo
design_group_type: Placebo Comparator
design_group_description: Acute administration of oral THC (2.5 mg) three times in study session (Time 0, 60, and 120).
design_group_title: Oral administration of 2.5 mg THC
design_group_type: Experimental
design_group_description: Acute administration of oral THC (2.5 mg) and oral caffeine (60 mg) three times in study session (Time 0, 60, and 120).
design_group_title: Oral administration of 2.5 mg THC + 60 mg caffeine
design_group_type: Experimental
design_group_description: Acute administration of oral THC (2.5 mg), oral caffeine (60 mg), and oral CBD (35 mg) three times in study session (Time 0, 60, and 120).
design_group_title: Oral administration of 2.5 mg THC + 60 mg caffeine + 35 mg CBD
design_group_type: Experimental
Sponsor: The Johns Hopkins University
Collaborators: Canopy Growth Corp.
Drug name mappings:
name: 大麻二酚
lang: CN
name: Cannabidiol
lang: EN
name: 咖啡因
lang: CN
name: Caffeine
lang: EN
name: カフェイン水和物
lang: JP
name: 屈大麻酚
lang: CN
name: Dronabinol
lang: EN
Clinical trial NCT05472818: SV2A Density Cannabis Use Disorder
Official title: SV2A Density Cannabis Use Disorder
Conditions: Cannabis Use Disorder
Healthy
Summary: The main purpose of this study is to determine whether hippocampal synaptic vesicle density estimated by hippocampal [11C]APP-311/[11C]UCB-J binding in individuals diagnosed with cannabis use disorder (CUDs) improves with at least 4 weeks of confirmed abstinence from cannabis, in comparison to healthy controls (HCs). Furthermore, any change in synaptic vesicle density will be placed in functional context by measuring verbal memory, which is sensitive to hippocampal function, before and after at least 4 weeks of confirmed abstinence. Finally, the relationship between hippocampal [11C]UCB-J binding in CUDs with measures of cannabis exposure (e.g., age of initiation, cumulative lifetime dose) will be explored.
Interventions:
description: For each [11C]APP311 (UCB-J) PET scan, up to 20 mCi of [11C]APP311 (UCB-J) will be administered by infusion pump. All participants will receive at least two [11C]APP311 (UCB-J) PET scans approx. 4 weeks days apart. Approximately 8 CUD participants will be asked to return for a third [11C]APP311 (UCB-J) PET scan after an additional 4 weeks following their second scan.
name: [11C]APP311
type: Drug
Study arms:
design_group_description: Participants will be scanned using anatomical magnetic resonance imaging (MRI) and PET. All participants will receive two PET scans, 4 weeks apart. CUD participants will be asked to abstain from cannabis for the 4 week period.
design_group_title: CUD Group
design_group_type: Active Comparator
design_group_description: Participants will be scanned using anatomical magnetic resonance imaging (MRI) and PET. All participants will receive two PET scans, 4 weeks apart.
design_group_title: Healthy Controls
design_group_type: Active Comparator
Sponsor: Yale University
Collaborators: National Institute on Drug Abuse
Drug name mappings:
name: 11C-UCB-J
lang: EN
Clinical trial NCT06273852: A Study of the Intratumoral Microdose Administration of PBA-0405 in Patients With Solid Tumors
Official title: A Phase 0 Multicenter Study of the Pharmacodynamic Effects of Intratumoral Microdose Administration of PBA-0405 in Patients With Solid Tumors
Conditions: Head and Neck Squamous Cell Carcinoma
Soft Tissue Sarcoma Adult
Triple Negative Breast Cancer
Summary: This is a multi-center, single arm, open-label, localized pharmacodynamic biomarker Phase 0 trial designed to study the biological effects within the tumor microenvironment of PBA-0405 when administered intratumorally in microdose quantities via the CIVO device.
Interventions:
description: Intratumoral microdose injection by the CIVO device.
name: PBA-0405
other_name: PB004.22.0405.aF
type: Drug
Study arms:
design_group_description: Patients who are scheduled for surgical biopsy or tumor resection surgery will be injected at 1-2 days prior to surgery using the CIVO device. Each needle of the CIVO device will deliver up to 8.3 microliters of solution, including a vehicle control (sterile saline) or subtherapeutic microdoses of PBA-0405, as single agents. Each microdose is simultaneously injected in a columnar fashion through each of 8, or 5, (in a device configuration determined by tumor dimensions) into a single solid tumor or effaced metastatic lymph node.
design_group_title: PBA-0405
design_group_type: Experimental
Sponsor: Pure Biologics SA
Collaborators: Presage Biosciences, Inc.
Drug name mappings:
name: PBA-0405
lang: EN
Clinical trial NCT07458659: Clinical Study of BCMA-Targeted CAR T-Cell Injection in the Treatment of Patients With Relapsed/Refractory Multiple Myeloma
Official title: Phase Ib Clinical Study of BCMA-Targeted Chimeric Antigen Receptor T-Cell Injection (CART-BCMA) in the Treatment of Patients With Relapsed/Refractory Multiple Myeloma
Conditions: Relapsed/Refractory Multiple Myeloma (MM)
Summary: A Phase 1b clinical trial to evaluate the safety and efficacy of BCMA-targeted CAR T-cell therapy in Thai patients with relapsed or refractory multiple myeloma.
Interventions:
description: This product is a CAR T-cell therapy utilizing the participant's own autologous T-lymphocytes, which are collected via apheresis, processed in a laboratory setting, and subsequently reinfused intravenously through a peripheral vein at a rate of 2-5 mL/min. Participants will undergo cell collection via apheresis for product preparation, followed by lymphodepleting chemotherapy. This process includes pre-chemotherapy and pre-infusion assessments prior to the administration of CART-BCMA cells.
name: Chimeric Antigen Receptor T Cells (CAR-T)
type: Biological
Study arms:
design_group_description: Chimeric antigen receptor T-cell injection targeting BCMA (CART-BCMA) Dose level: 0.5×10e7 cells/Kg
design_group_title: CART-BCMA in multiple myeloma
design_group_type: Experimental
Sponsor: University of Chulalongkorn
Collaborators: University of Chulalongkorn
King Chulalongkorn Memorial Hospital
Drug name mappings:
name: BCMA-Targeted CAR T-Cell(Chulalongkorn University)
lang: EN
Clinical trial NCT04380831: TBI Using IMRT and Cyclophosphamide Prior to Stem Cell Transplant for the Treatment of Severe Systemic Sclerosis
Official title: Pilot Study of Total Body Irradiation Using Intensity Modulated Radiation Therapy (IMRT) and Cyclophosphamide Conditioning Regimen Prior to Autologous Hematopoietic Cell Transplantation in Patients With Severe Systemic Sclerosis
Conditions: Systemic Scleroderma
Summary: This early phase I trial studies the side effects and feasibility of total body irradiation using intensity modulation radiation therapy (IMRT) when given in combination with cyclophosphamide prior to stem cell transplant to treat severe systemic sclerosis. IMRT delivers total body radiation therapy more precisely and may reduce radiation exposure to sensitive normal organs. Giving chemotherapy, such as cyclophosphamide, and total body irradiation before a donor stem cell transplant helps kill cancer cells in the body and helps make room in the bone marrow for new blood-forming cells (stem cells) to grow. Giving IMRT and cyclophosphamide prior to stem cell transplant may work better in treating severe systemic sclerosis and reduce radiation doses to lung and kidneys compared to cyclophosphamide alone.
Interventions:
description: Undergo HSCT
name: Allogeneic Hematopoietic Stem Cell Transplantation
other_name: Allogeneic Hematopoietic Cell Transplantation
HSC
HSCT
Stem Cell Transplantation, Allogeneic
allogeneic stem cell transplantation
type: Procedure
description: Undergo HSCT
name: Cyclophosphamide
other_name: (-)-Cyclophosphamide
2H-1,3,2-Oxazaphosphorine, 2-[bis(2-chloroethyl)amino]tetrahydro-, 2-oxide, monohydrate
CP monohydrate
CTX
CYCLO-cell
Carloxan
Ciclofosfamida
Ciclofosfamide
Cicloxal
Clafen
Claphene
Cycloblastin
Cycloblastine
Cyclophospham
Cyclophosphamid monohydrate
Cyclophosphamide Monohydrate
Cyclophosphamidum
Cyclophosphan
Cyclophosphane
Cyclophosphanum
Cyclostin
Cyclostine
Cytophosphan
Cytophosphane
Cytoxan
Fosfaseron
Genoxal
Genuxal
Ledoxina
Mitoxan
Neosar
Revimmune
Syklofosfamid
WR- 138719
type: Drug
description: Undergo TBI using IMRT
name: Intensity-Modulated Radiation Therapy
other_name: IMRT
Intensity Modulated RT
Intensity-Modulated Radiotherapy
Radiation, Intensity-Modulated Radiotherapy
type: Radiation
description: Undergo TBI using IMRT
name: Total-Body Irradiation
other_name: TBI
Total Body Irradiation
Whole Body Irradiation
Whole-Body Irradiation
type: Procedure
Study arms:
design_group_description: Patients undergo TBI using IMRT BID on days -5 and -4 in the absence of disease progression or disease progression. Patients then receive cyclophosphamide on days -3 and -2 and undergo HSCT on day 0 in the absence of disease progression or unacceptable toxicity.
design_group_title: Treatment (TBI using IMRT, cyclophosphamide, HSCT)
design_group_type: Experimental
Sponsor: City of Hope National Medical Center
Collaborators: National Cancer Institute
Drug name mappings:
name: 环磷酰胺
lang: CN
name: Cyclophosphamide
lang: EN
name: シクロホスファミド水和物
lang: JP
Clinical trial NCT03380936: Pilot Study of Treatment for Subclinical AMR (Antibody-mediated Rejection) in Kidney Transplant Recipients
Official title: A Randomized Pilot Study of Treatment for Subclinical Antibody-Mediated Rejection in Kidney Transplant Recipients
Conditions: Kidney Transplant Rejection
Summary: This is a pilot study to determine if extended release Envarsus at an optimal level is just as effective as more invasive standard therapies for subclinical (mild) AMR (antibody mediated rejection) in kidney transplant patients. Subjects will be randomized to either conversion to Envarsus XR (extended release); or, to a standard of care regimen of plasma exchange/IVIG (intravenous immunoglobulin)/rituximab treatments.
Interventions:
description: Switching from current version of tacrolimus to the extended release, once a day version (Envarsus) and titrating dose to achieve an optimal trough level. Goal trough tac level > 8 ng/ml, MPA at 720 mg bid unless medically contraindicated, prednisone at current dose (5mg) or continue taper to 5mg per center standard of care protocol.
name: Tacrolimus Extended Release Oral Tablet [Envarsus]
other_name: Envarsus XR
type: Drug
description: Plasma exchange x 5 treatments, each followed by IVIG 200 mg/kg except last dose of 1 gm/kg. Rituximab 375 mg/m2 following final plasma exchange treatment.
name: Plasma Exchange and IVIG (Intravenous Immunoglobulin )
type: Other
Study arms:
design_group_description: Optimize: conversion to Envarsus XR (Tacrolimus Extended Release Oral Tablet [Envarsus]) with goal trough tac level > 8 ng/ml, MPA at 720 mg bid unless medically contraindicated, prednisone at current dose (5mg) or continue taper to 5mg per center standard of care protocol
design_group_title: Arm 1 - conversion to Envarsus XR
design_group_type: Active Comparator
design_group_description: Treat clinical AMR: Plasma exchange x 5 treatments, each followed by IVIG 200 mg/kg except last dose of 1 gm/kg. Rituximab 375 mg/m2 following final plasma exchange treatment.
design_group_title: Arm 2 - plasma exchange and IVIG
design_group_type: Active Comparator
Sponsor: University of Colorado Denver
Collaborators: Veloxis Pharmaceuticals A/S
Drug name mappings:
name: 他克莫司
lang: CN
name: Tacrolimus
lang: EN
name: タクロリムス水和物
lang: JP
name: 利妥昔单抗
lang: CN
name: Rituximab
lang: EN
name: リツキシマブ（遺伝子組換え）
lang: JP
Clinical trial NCT03837470: Evaluation of Renal Sodium Excretion After Salt Loading in Heart Failure With Preserved Ejection Fraction
Official title: Evaluation of Renal Sodium Excretion After Salt Loading in Heart Failure With Preserved Ejection Fraction
Conditions: Heart Failure With Preserved Ejection Fraction
Summary: Heart failure (HF) affects 2-3% of the population, and is characterized by impaired sodium balance which results in fluid overload. Ejection fraction, a measure of systolic function, is reduced in only about half of all HF patients. Incidence of heart failure with preserved ejection fraction (HFpEF) has increased in the last 20 years making it a growing public health problem. Currently, most patients admitted to the hospital with heart failure have preserved rather than reduced ejection fractions. However, to date it remains unknown why patients with HFpEF retain salt and water. The hypothesis is that patients with clinical HFpEF have an impaired renal response to salt loading, intravascular expansion and diuretics. Characterization of the salt and water excretory renal response to intravascular salt, fluid and diuretic load in patients with HFpEF will provide insight into the pathophysiology of HFpEF, and may help in the development of novel strategies to target renal sodium handling in patients with HFpEF. This characterization is the primary objective of this pilot project.
Interventions:
description: Intravenous infusion of 0.25ml/kg/min of 0.9% sodium chloride intravenously for a total of 60 minutes
name: 0.9% Sodium Chloride
other_name: normal saline
type: Drug
description: Bolus intravenous injection of 40 mg furosemide
name: Furosemide 40 mg
type: Drug
Study arms:
design_group_description: Subjects receive intravenous infusion of 0.9% Sodium Chloride, followed by diuretic challenge with bolus injection of Furosemide 40 mg
design_group_title: Saline Loading and Diuretic Challenge
design_group_type: Experimental
Sponsor: University of Utah
Collaborators: University of Utah
Drug name mappings:
name: 呋塞米
lang: CN
name: Furosemide
lang: EN
name: フロセミド
lang: JP
name: 氯化钠
lang: CN
name: Sodium Chloride
lang: EN
name: 塩化ナトリウム
lang: JP
Clinical trial NCT07275736: A Study of CNCT19 in the Treatment of Relapsed or Refractory Neurological Autoimmune Diseases
Official title: An Exploratory Clinical Study on the Safety and Efficacy of CNCT19 Cell Injection in the Treatment of Relapsed or Refractory Autoimmune Neurological Diseases
Conditions: Neurological Autoimmune Diseases
Summary: This study is a single-arm, open-label, non-randomized clinical trial aimed at evaluating the safety, tolerability and preliminary efficacy of CNCT19 cell injection in the treatment of patients with relapsed/refractory Neurological Autoimmune Diseases.
Interventions:
description: A conditioning chemotherapy regimen of fludarabine and cyclophosphamide will be administered followed by investigational treatment, CNCT19.
name: CNCT19 cell injection
type: Biological
Study arms:
design_group_title: Single dose of CNCT19
design_group_type: Experimental
Sponsor: Juventas Cell Therapy Ltd.
Collaborators: Beijing Tiantan Hospital
Drug name mappings:
name: 纳基奥仑赛
lang: CN
name: Inaticabtagene Autoleucel
lang: EN
Clinical trial NCT00663910: Topical Aminolevulinic Acid in Patients With Nonmelanoma Skin Cancer
Official title: Evaluation of Protoporphyrin Formation in Non-Melanoma Skin Cancers After Topical Application of 5-Aminolevulinic Acid: A Pilot Study
Conditions: Non-melanomatous Skin Cancer
Summary: RATIONALE: Studying samples of tumor tissue in the laboratory from patients with nonmelanoma skin cancer that has been treated with topical aminolevulinic acid may help doctors predict how patients will respond to photodynamic therapy.
PURPOSE: This clinical trial is studying topical aminolevulinic acid in patients with nonmelanoma skin cancer.
Interventions:
description: On Day 1, ALA will then be applied topically to the center of the tumor surface (at the location of its greatest diameter) in a standardized manner with great care not to include normal skin. The solution will be applied directly to the lesions by dabbing gently with a wet applicator tip. Enough solution will be applied to uniformly wet the exposed lesion surface. Once the initial application has dried, the ALA will be applied again in the same manner. The ALA will be left on for 2 hours under occlusion with Duoderm Extra Thin®.
name: Aminolevulinic Acid
other_name: ALA
type: Drug
description: Then local anesthesia, lidocaine 1% with epinephrine 1:100,000, will be administered and before the tumor is excised by one of the Cleveland Clinic MOHS surgeons, a 2mm punch biopsy will be taken from the area where the ALA was previously applied. The punch biopsy will be full thickness, extending to the subcutaneous fat.
name: biopsy
type: Procedure
description: Two hours after the amniolevlulenic acid was applied, the measurements of surface fluorescence will be repeated with the hand held dosimeter.
name: diagnostic imaging technique
other_name: Aurora dosimeter
type: Procedure
description: The non-melanoma skin cancer will be excised using the MOHS procedure.
name: therapeutic conventional surgery
type: Procedure
Study arms:
Sponsor: The Cleveland Clinic Foundation
Collaborators: National Cancer Institute
Drug name mappings:
name: 盐酸氨酮戊酸
lang: CN
name: Aminolevulinic Acid Hydrochloride
lang: EN
name: アミノレブリン酸塩酸塩
lang: JP
Clinical trial NCT04939337: A Study of TH-SC01 for Treating Complex Perianal Fistula in Perianal Crohn's Disease.
Official title: Study to Assess the Safety and Efficacy of Allogeneic Umbilical Cord-derived Mesenchymal Stem Cells(TH-SC01), for Treatment of Complex Perianal Fistulas in Perianal Crohn's Disease.
Conditions: Crohn's Disease
Summary: The purpose of this study is to asses the efficacy and Safety of Allogeneic Umbilical Cord-derived Mesenchymal Stem Cells in the Treatment of Complex Perianal Fistula in Perianal Crohn's Disease.
Interventions:
description: Allogeneic Umbilical Cord-derived Mesenchymal Stem cells perilesional injection. Human TH-SC01 cell injection (human umbilical cord mesenchymal stem cells for injection, 5 million cells / ml, 6.0-10.0ml / bottle)
name: TH-SC01
type: Drug
Study arms:
design_group_description: TH-SC01 24 mL suspension of 120 million cells as a perilesional injection, once on Day 0.
design_group_title: TH-SC01
design_group_type: Experimental
Sponsor: Nanjing General Hospital of Nanjing Military Command
Collaborators: Jiangsu Tuohong Kangheng Pharmaceutical Co., Ltd.
Drug name mappings:
name: 人源TH-SC01细胞(江苏拓弘康恒医药)
lang: CN
name: Human umbilical cord mesenchymal stem cells(Jiangsu Topcel-KH Pharmaceutical)
lang: EN
Clinical trial NCT04508660: CGB-400 for the Reduction of Facial Redness
Official title: Effectiveness of CGB-400 (Cosmetic) for the Reduction of Facial Redness
Conditions: Rosacea
Summary: Open-label multicenter study using CGB-400 Gel (cosmetic) to reduce facial redness
Interventions:
description: BID application
name: CGB-400
type: Drug
Study arms:
design_group_description: Topical application twice daily for 4 weeks
design_group_title: Subjects with facial redness
design_group_type: Experimental
Sponsor: CAGE Bio, Inc.
Collaborators: ethica Clinical Research Inc.
Drug name mappings:
name: CGB-400
lang: EN
Clinical trial NCT04928508: Advanced or Recurrent Solid Tumors Treated With SHetA2
Official title: Phase 1 Trial of OK-1 (SHetA2) in Patients With Advanced or Recurrent Solid Tumors
Conditions: Solid Tumor, Adult
Summary: The purpose of this research is to test the safety of the study drug (OK-1) and see what effects (good and bad) this drug has on patients with recurrent solid tumors.
Interventions:
description: OK-1 orally in the form of 50 mg capsules. Four dose levels will be evaluated:<br/>5.4mg/kg 7.0mg/kg 9.0mg/kg 12mg/kg
name: OK-1
other_name: NSC 726189
type: Drug
Study arms:
design_group_description: OK-1 (oral, BID) within a 21-days cycle
design_group_title: OK-1 capsule
design_group_type: Experimental
Sponsor: University of Oklahoma
Collaborators: National Cancer Institute
Drug name mappings:
name: SHetA2
lang: EN