PatSnap/clinical-trial huggingface dataset:
Clinical trial NCT02361112: Study Evaluating Pyrotinib in Combination With Capecitabine In Patients With HER2 Positive Metastatic Breast Cancer
Official title: A Phase I Study of Pyrotinib In Combination With Capecitabine In Patients With HER2 Positive Metastatic Breast Cancer
Conditions: Metastatic Breast Cancer
Summary: Pyrotinib is an oral tyrosine kinase inhibitor targeting both EGFR and HER-2 receptors. This study is designed to evaluate the safety and tolerability of Pyrotinib in combination with capecitabine in patients with HER2 positive metastatic breast cancer:
To evaluate the safety and tolerability of pyrotinib, and the maximum tolerated dose (MTD) To determine the dose-limiting toxicity (DLT) To determine the pharmacokinetic profile of Pyrotinib To assess preliminary antitumor activity To determine preliminary regimen dose for phase II study
Interventions:
name: pyrotinib combined with capecitabine
type: Drug
Study arms:
design_group_title: pyrotinib combined with capecitabine
design_group_type: Experimental
Sponsor: Jiangsu Hengrui Pharmaceuticals Co., Ltd.
Collaborators: Cancer Hospital Chinese Academy of Medical Sciences
Drug name mappings:
name: 马来酸吡咯替尼
lang: CN
name: Pyrotinib Maleate
lang: EN
name: 卡培他滨
lang: CN
name: Capecitabine
lang: EN
name: カペシタビン
lang: JP
Clinical trial NCT00004895: Octreotide as Palliative Therapy for Cancer-Related Bowel Obstruction That Cannot Be Removed by Surgery
Official title: Octreotide for Palliation of Inoperable Bowel Obstruction: A Phase II Study
Conditions: Colorectal Cancer
Constipation, Impaction, and Bowel Obstruction
Extrahepatic Bile Duct Cancer
Gastric Cancer
Gastrointestinal Stromal Tumor
Nausea and Vomiting
Ovarian Cancer
Pancreatic Cancer
Peritoneal Cavity Cancer
Small Intestine Cancer
Summary: RATIONALE: Palliative therapy with octreotide may help patients who have bowel obstruction that cannot be removed by surgery to live longer and more comfortably.
PURPOSE: Phase II trial to study the effectiveness of octreotide as palliative therapy in treating patients who have cancer-related bowel obstruction that cannot be removed by surgery.
Interventions:
name: octreotide acetate
type: Drug
Study arms:
Sponsor: Northwestern University
Collaborators: National Cancer Institute
Drug name mappings:
name: 醋酸奥曲肽
lang: CN
name: Octreotide Acetate
lang: EN
name: オクトレオチド酢酸塩
lang: JP
Clinical trial NCT02251912: Oxytocin Treatment of Alcohol Dependence
Official title: Oxytocin Treatment of Alcohol Dependence: A Randomized, Placebo-Controlled Trial
Conditions: Alcohol Dependence
Summary: Purpose: Test whether oxytocin treatment decreases drinking in people who have been consuming alcohol heavily for long periods and are physically and psychologically dependent on alcohol.
Participants: 50 adults with alcohol dependence
Procedures (methods): Oxytocin or placebo will be administered three times a day for the first 2 days followed by twice daily intranasal doses for the rest of the 12 weeks. Before, during and at the end of the trial, each subject will undergo evaluations including breathalyzer readings, rating withdrawal symptoms, interviews about amount of alcohol consumed since last clinic visit, subject self-ratings of anxiety, alcohol craving and, at some visits, laboratory measures (blood and urine) to monitor safety and alcohol/drug use. Following the active phase of the trial, subjects will be followed up at 4 weeks and 12 weeks to evaluate for post-medication safety and efficacy
Interventions:
description: 10 insufflations (40IU of oxytocin total) given 3 initially then 2 times daily for 12 weeks
name: Intranasal Oxytocin
other_name: Syntocinon spray
type: Drug
description: 10 insufflations (same solution as active treatment minus oxytocin) given 3 initially and then 2 times daily for 12 weeks
name: Placebo
type: Drug
Study arms:
design_group_description: Intranasal oxytocin doses 2-3 times/day for 12 weeks
design_group_title: Active
design_group_type: Experimental
design_group_description: Intranasal placebo doses 2-3 times/day for 12 weeks
design_group_title: Control
design_group_type: Placebo Comparator
Sponsor: The University of North Carolina at Chapel Hill
Collaborators: National Institute on Alcohol Abuse & Alcoholism
Drug name mappings:
name: 缩宫素
lang: CN
name: Oxytocin
lang: EN
name: オキシトシン
lang: JP
Clinical trial NCT07167966: Alzheimer's Tau Platform: Regimen A - AADvac1
Official title: Alzheimer's Tau Platform (ATP): Regimen Specific Appendix for AADvac1
Conditions: Preclinical Alzheimer's Disease
Prodromal Alzheimer's Disease
Alzheimer Disease
Summary: The Alzheimer's Tau Platform (ATP) is a multi-center platform trial to evaluate the safety and effectiveness of tau-directed therapies, alone or in combination with donanemab, in adults aged 50-80 with late preclinical or early prodromal Alzheimer's disease.
Regimen A will evaluate the safety and efficacy of AADvac1, alone or in combination with donanemab.
Interventions:
description: Subcutaneous injection of AADvac1
name: AADvac1
type: Drug
description: Active comparator: intravenous infusion of donanemab
name: Donanemab
other_name: Kisunla
type: Drug
Study arms:
design_group_description: Intravenous infusions of donanemab for 6 months, followed by subcutaneous injections of AADvac1 over 24 months (n = 150)
design_group_title: AADvac1 monotherapy
design_group_type: Experimental
design_group_description: Intravenous infusions of donanemab for 6 months, combination donanemab and subcutaneous injections of AADvac1 for 6 months, followed by 18 months of AADvac1 injections alone (n = 150)
design_group_title: Combination AADvac1 therapy with donanemab
design_group_type: Experimental
design_group_description: Intravenous infusions of donanemab for 6 months, combination donanemab and AADvac1-matched placebo subcutaneous injections for 6 months, followed by 18 months of AADvac1-matched placebo injections alone (n = 150).
design_group_title: Donanemab active control
design_group_type: Active Comparator
Sponsor: University of Southern California
Collaborators: The Massachusetts General Hospital
National Institute on Aging
The University of California, San Francisco
Alzheimer's Disease Research Center
AXON Neuroscience SE
Drug name mappings:
name: Alzheimer's disease vaccine(Axon Biochemicals BV)
lang: EN
name: 多奈单抗
lang: CN
name: Donanemab-AZBT
lang: EN
name: ドナネマブ（遺伝子組換え）（JAN）
lang: JP
Clinical trial NCT04757090: 89Zr-Trastuzumab PET/CT in Subjects With Previously Treated HER2-Positive Solid Tumors Scheduled to Receive Treatment With MT-5111
Official title: A Pilot Study of 89Zr-Trastuzumab PET/CT in Subjects With Previously Treated HER2-Positive Solid Tumors Scheduled to Receive Treatment With MT-5111
Conditions: HER2-positive Solid Tumor
HER-2 Positive Cancer
Summary: This is an open-label, single center, pilot study to assess the feasibility of baseline 89Zr-trastuzumab PET/CT to predict response to treatment with monotherapy MT-5111
Interventions:
description: -To minimize uptake of the 89Zr-trastuzumab in normal tissues, immediately prior to planned 89Zr-trastuzumab injection patients will receive a 50 mg dose of "cold" unlabeled trastuzumab intravenously (IV). The administration of a fixed small dose of unlabeled antibody to improve tumor-to-normal-tissue (T/N) uptake of the radiolabeled antibody is standard in this type of imaging procedure.
name: 89Zr-trastuzumab
type: Drug
Study arms:
design_group_description: * Enrolled subjects will be asked to undergo 18F-FDG PET/CT imaging (if not performed within the previous 90 days) and 89Zr-trastuzumab PET/CT imaging at baseline prior to the start of monotherapy MT-5111 treatment. Standard of care 18F-FDG PET/CT examinations performed within 90 days of 89Zr-trastuzumab administration can be used in place of a study specific 18F-FDG PET/CT scan. Baseline 89Zr-trastuzumab imaging should be completed no more than 30 days prior to initiating treatment with MT-5111.<br/>* Cold trastuzumab and 89Zr-trastuzumab will be administered at Visit 1 and the 89Zr-trastuzumab PET/CT (Visit 2) will take place 4 days (+/-1 day) after administration of 89Zr-trastuzumab.
design_group_title: 89Zr-trastuzumab PET/CT imaging
design_group_type: Experimental
Sponsor: Washington University School of Medicine
Collaborators: Molecular Templates, Inc.
Drug name mappings:
name: 89Zr-trastuzumab
lang: EN
Clinical trial NCT04576793: Longitudinal Imaging of Microglial Activation in Different Clinical Variants of Alzheimer's Disease
Official title: Longitudinal Imaging of Microglial Activation in Different Clinical Variants of Alzheimer's Disease
Conditions: Alzheimer Disease
Summary: The purpose of this study is to determine how inflammation is related to other changes in the brain that occur during the progression of Alzheimer's disease. The investigators are also studying how inflammation is related to the symptoms that first occur in patients with Alzheimer's disease (AD). For this reason, the investigators are asking people with different versions of Alzheimer's disease and/or other related dementias to participate. This includes patients with:
* Mild Cognitive Impairment
* Posterior cortical atrophy - a version of Alzheimer's disease with vision difficulties
* Logopenic variant primary progressive aphasia - a version of Alzheimer's disease with language difficulties
* Amnestic Alzheimer's disease - a "typical" version of Alzheimer's disease with memory difficulties
* The investigators are also enrolling older adults with normal visual, language, and memory function.
Interventions:
description: 11C-ER176 sticks to parts of the brain where there is inflammation. Past studies have shown that inflammation is present in the brains of patients with Alzheimer's disease. The purpose of this study is to determine if 11C-ER176 is able to accurately measure inflammation in patients with Alzheimer's disease. 11C-ER176 will be administered at activity up to 20 millicurie (mCi) per injection.
name: 11C-ER176
other_name: [11C] ER176
type: Drug
description: MK-6240 measures a protein called in the brain. MK-6240 is experimental but has been used in several human studies before and has been proven to accurately measure tau in the brain.
name: 18F-MK6240
other_name: [18F-MK6240]
type: Drug
description: Florbetaben has been approved by the FDA to help diagnose Alzheimer's disease. florbetaben measures amyloid in the brain.
name: 18F-Florbetaben
other_name: [18F] Florbetaben
type: Drug
description: Inflammation can also be measured by looking at certain proteins in the spinal fluid. In order to measure these proteins in the spinal fluid, the investigators will perform a lumbar puncture (spinal tap).
name: Lumbar Puncture
other_name: Spinal Tap
type: Procedure
Study arms:
design_group_description: * Mild Cognitive Impairment<br/>* Posterior cortical atrophy - a version of Alzheimer's disease with vision difficulties<br/>* Logopenic variant primary progressive aphasia - a version of Alzheimer's disease with language difficulties<br/>* Amnestic Alzheimer's disease - a "typical" version of Alzheimer's disease with memory difficulties
design_group_title: Cognitive impairment
design_group_type: Experimental
design_group_description: Healthy controls
design_group_title: No cognitive impairment
design_group_type: Active Comparator
Sponsor: Columbia University
Collaborators: National Institute on Aging
Drug name mappings:
name: Florquinitau F18
lang: EN
name: 氟[¹⁸F]贝他苯
lang: CN
name: Florbetaben F-18
lang: EN
name: [11C]ER-176
lang: EN
Clinical trial NCT00004157: Interleukin-11 Plus Filgrastim Prior to Peripheral Stem Cell Transplantation in Patients With Non-Hodgkin's Lymphoma, Hodgkin's Disease, Breast Cancer, or Other Solid Tumors
Official title: Combination of Interleukin 11 (Neumega) With G-CSF to Mobilize Autologous Peripheral Blood Stem Cells (PBSC)
Conditions: Breast Cancer
Gestational Trophoblastic Tumor
Kidney Cancer
Lymphoma
Neuroblastoma
Ovarian Cancer
Sarcoma
Testicular Germ Cell Tumor
Summary: RATIONALE: Interleukin-11 and filgrastim stimulate the production of blood cells. Giving these drugs to stimulate peripheral stem cells that can be collected for peripheral stem cell transplantation may result in fewer side effects after transplant.
PURPOSE: Phase II trial to study the effectiveness of interleukin-11 plus filgrastim prior to peripheral stem cell transplantation in patients who have non-Hodgkin's lymphoma, Hodgkin's disease, breast cancer, or other solid tumors.
Interventions:
name: filgrastim
type: Biological
name: recombinant interleukin-11
type: Biological
Study arms:
Sponsor: Fred Hutchinson Cancer Research Center
Collaborators: National Cancer Institute
Drug name mappings:
name: 非格司亭 （安进）
lang: CN
name: Filgrastim (Amgen)
lang: EN
name: フィルグラスチム（遺伝子組換え）
lang: JP
Clinical trial NCT03207334: iCare4: Genomic Signatures With Midostaurin in Acute Myeloid Leukemia (UF-HEM-004)
Official title: A Phase II, Open-Label Clinical Efficacy Study Defining Genomic Signatures That Correlate With Midostaurin Response in Relapsed or Refractory Acute Myeloid Leukemia (AML)
Conditions: Acute Myeloid Leukemia
Summary: This is an open label, single arm study of midostaurin in patients with relapsed or refractory AML.
Interventions:
description: Induction Phase: 50 mg orally twice daily beginning on day 7 and ending 48 hours prior to beginning the consolidation phase<br/>Consolidation Phase: 50 mg orally twice daily beginning on Day 6 and ending 48 hours prior to either the start of the next cycle or beginning conditioning therapy for allogenic stem cell transplant.
name: Midostaurin
other_name: PKC412
Rydapt
type: Drug
description: Induction Phase: 3 g/m2 (patients 18-65 years old) or 1 g/m2 (patients > 65 years old or those with co-morbidities precluding a higher dose) by vein over 3 hours every 12 hours on Days 1-6.<br/>Consolidation Phase: 3 g/m2 (patients 18-65 years old) or 1 g/m2 (patients > 65 years old or those with co-morbidities precluding a higher dose) by vein over 3 hours every 12 hours on Days 1, 3, and 5 of each cycle.
name: Cytarabine
other_name: Depocyt
type: Drug
Study arms:
design_group_description: Treatment will consist of 3 phases: induction (a 28-42 day cycle), followed by consolidation (up to 4 cycles). Each cycle in the consolidation phase will last 28 days. Subjects will proceed from one phase to the next if they have achieved or maintained a complete remission or complete remission with incomplete blood count recovery by International Working Group 2003 response criteria. Patients may receive a allogeneic hematopoietic stem cell transplant between the end of the induction phase.
design_group_title: Midostaurin and Cytarabine
design_group_type: Experimental
Sponsor: University of Florida
Collaborators: Novartis Pharmaceuticals Corp.
Drug name mappings:
name: 米哚妥林
lang: CN
name: Midostaurin
lang: EN
name: ミドスタウリン
lang: JP
name: 阿糖胞苷
lang: CN
name: Cytarabine
lang: EN
name: シタラビン
lang: JP
Clinical trial NCT00831649: A Phase II, Multicenter, Open-Label, Long-Term Study of the Safety, Tolerability, and Efficacy of Intravenous Natalizumab in Subjects With Rheumatoid Arthritis Who Have Previously Participated in Study ELN100226-RA201
Official title: A Phase II, Multicenter, Open-Label, Long-Term Study of the Safety, Tolerability, and Efficacy of Intravenous Natalizumab in Subjects With Rheumatoid Arthritis Who Have Previously Participated in Study ELN100226-RA201
Conditions: Rheumatoid Arthritis
Summary: The purpose of this study is to evaluate the long-term safety, tolerability, and efficacy of natalizumab in subjects with active rheumatoid arthritis (RA) receiving concomitant methotrexate (MTX)
Interventions:
name: natalizumab
other_name: TYSABRI
type: Drug
Study arms:
design_group_title: natalizumab
design_group_type: Experimental
Sponsor: Biogen, Inc.
Collaborators: Elan Corp. Plc
Drug name mappings:
name: 那他珠单抗
lang: CN
name: Natalizumab
lang: EN
name: ナタリズマブ（遺伝子組換え）
lang: JP
Clinical trial NCT02270814: Cisplatin, Nab-Paclitaxel, and Cetuximab (CACTUX) in Patients With Incurable Head and Neck Squamous Cell Carcinoma
Official title: Phase 2 Single Arm Trial of Cisplatin, Nab-Paclitaxel, and Cetuximab (CACTUX) in Patients With Incurable Head and Neck Squamous Cell Carcinoma (HNSCC)
Conditions: Head and Neck Cancer
Head and Neck Squamous Cell Carcinoma
Cancer of the Head and Neck
Summary: The purpose of this research study is to look at the effect of a treatment regimen called CACTUX on head and neck cancer. The CACTUX regimen is a combination of three drugs called cisplatin, nab-paclitaxel, and cetuximab (although carboplatin may be given in place of cisplatin if participants have previously had problems receiving cisplatin). The use of nab-paclitaxel in this combination is different from routine care, in which a drug called 5FU is often given instead, but the investigators group has conducted previous research where the investigators incorporated nab-paclitaxel into routine treatment with cisplatin, 5FU, and cetuximab. The investigators are looking at the incidence of side effects with the CACTUX regimen as well as response of the disease and health status.
Interventions:
name: nab-paclitaxel
other_name: Abraxane
Albumin-bound paclitaxel
Paclitaxel protein-bound
type: Drug
name: Cisplatin
other_name: CDDP
Cisplatinum
DDP
cis-DDP
cis-Diamminedichloroplatinum
cis-Platinum II
type: Drug
name: Carboplatin
other_name: CBDCA
Paraplatin®
type: Drug
name: Cetuximab
other_name: Erbitux®
type: Biological
Study arms:
design_group_description: Up to 6 cycles of CACTUX may be given. The CACTUX regimen consists of:<br/>* nab-paclitaxel given intravenously over 30 minutes on an outpatient basis on Days 1, 8, and 15 of each 21-day cycle followed by<br/>* cisplatin given intravenously over 60 minutes on an outpatient basis OR carboplatin AUC5 given intravenously over 30 minutes on an outpatient basis on Day 1 of each 21-day cycle followed by<br/>* cetuximab given intravenously on an outpatient basis of Days 1, 8, and 15 of each 21-day cycle<br/>* Cisplatin or carboplatin may be given at the discretion of the investigator.<br/>After the completion of 6 cycles of CACTUX, maintenance therapy will be given and consists of:<br/>* nab-paclitaxel given intravenously over 30 minutes on an outpatient basis on Days 1 and 8 of each 21-day cycle<br/>* cetuximab given intravenously on an outpatient basis on Days 1, 8, and 15 of each 21-day cycle
design_group_title: CACTUX: nab-paclitaxel, cisplatin (or carboplatin), cetuximab
design_group_type: Experimental
Sponsor: Washington University School of Medicine
Collaborators: Celgene Corp.
Drug name mappings:
name: 白蛋白结合型紫杉醇
lang: CN
name: Albumin-Bound Paclitaxel
lang: EN
name: パクリタキセル(JAN)
lang: JP
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: 卡铂
lang: CN
name: Carboplatin
lang: EN
name: カルボプラチン
lang: JP
name: 顺铂
lang: CN
name: Cisplatin
lang: EN
name: シスプラチン
lang: JP
Clinical trial NCT01816594: NeoPHOEBE: Neoadjuvant Trastuzumab + BKM120 in Combination With Weekly Paclitaxel in HER2-positive Primary Breast Cancer
Official title: NeoPHOEBE: Pi3k Inhibition in Her2 OverExpressing Breast cancEr: A Phase II, Randomized, Parallel Cohort, Two Stage, Double-blind, Placebo-controlled Study of Neoadjuvant Trastuzumab Versus Trastuzumab + BKM120 in Combination With Weekly Paclitaxel in HER2-positive, PIK3CA Wild-type and PIK3CA Mutant Primary Breast Cancer
Conditions: HER2-positive Newly Diagnosed, Primary Breast Cancer
Summary: This randomized, parallel cohort, two stage, double-blind, placebo-controlled study evaluated the oral PI3K inhibitor BKM120 in combination with trastuzumab and paclitaxel in HER2-positive, PIK3CA wild-type and PIK3CA mutant primary breast cancer prior to surgery (neo-adjuvant setting).
Interventions:
description: Neo-adjuvant BKM120 (oral pan-class I PI3K inhibitor, continuous daily dosing). BKM120 was administered orally 100 mg/day.
name: BKM120
other_name: Buparsilib
type: Drug
description: Trastuzumab is a humanized monoclonal antibody directed against the extracellular juxtamembrane domain of the HER2 receptor. Administered 4mg/kg i.v. load followed by 2mg/kg i.v. weekly.
name: Trastuzumab
type: Drug
description: Paclitaxel is a cytotoxic agent with proven antitumor activity in a variety of solid tumors. The antitumor activity of paclitaxel is based on tubulin-binding and stabilization of non-functional microtubule bundles, thereby blocking normal mitotic spindle development and subsequent cell division. Administered weekly 80mg/m2 i.v.
name: Paclitaxel
type: Drug
description: Neoadjuvant BKM120 placebo Administered orally 100 mg/day.
name: BKM120 Placebo
type: Drug
Study arms:
design_group_description: BKM120 (oral, pan-class I PI3K inhibitor) in combination with trastuzumab and paclitaxel.
design_group_title: BKM120 + Trastuzumab + paclitaxel
design_group_type: Experimental
design_group_description: BKM120 placebo in combination with trastuzumab and paclitaxel
design_group_title: BKM120 PBO + Trastuzumab + paclitaxel
design_group_type: Placebo Comparator
Sponsor: Novartis Pharmaceuticals Corp.
Collaborators: Grupo SOLTI
Breast International Group
GBG Forschungs GmbH
Drug name mappings:
name: 曲妥珠单抗
lang: CN
name: Trastuzumab
lang: EN
name: トラスツズマブ（遺伝子組換え）
lang: JP
name: 白蛋白结合型紫杉醇
lang: CN
name: Albumin-Bound Paclitaxel
lang: EN
name: パクリタキセル(JAN)
lang: JP
name: Buparlisib
lang: EN
Clinical trial NCT00486291: Study of VI-0521 Compared to Placebo in the Glycemic Management of Obese Diabetics
Official title: A Phase 2, Randomized, Double Blind, Parallel Design Study Comparing the Efficacy and Safety of VI-0521 to Placebo in the Glycemic Management of Obese Diabetic Adults
Conditions: Type 2 Diabetes Mellitus
Summary: The purpose of this study is to evaluate the efficacy and safety of VI-0521 compared to placebo in the glycemic management of obese diabetic adults.
Interventions:
description: phentermine 15mg/topiramate 100mg
name: VI-0521
type: Drug
description: matched placebo
name: Placebo
type: Drug
Study arms:
design_group_description: Phentermine 15mg/topiramate 100mg
design_group_title: 1
design_group_type: Experimental
design_group_description: Matched placebo
design_group_title: 2
design_group_type: Placebo Comparator
Sponsor: VIVUS, Inc.
Collaborators: Synteract, Inc.
Drug name mappings:
name: 盐酸芬特明/托吡酯
lang: CN
name: Phentermine Hydrochloride/Topiramate
lang: EN
Clinical trial NCT04414514: Topical Ruxolitinib 1.5% for Hidradenitis Suppurativa Treatment
Official title: Exploratory Trial of Ruxolitinib 1.5% Cream for the Treatment of Early Stage Hidradenitis Suppurativa
Conditions: Hidradenitis Suppurativa
Summary: Investigators hypothesize that ruxolitinib 1.5% cream is an effective therapy for HS participants through inhibition of inflammatory activity.
Investigators aim to:
* Demonstrate the clinical efficacy of ruxolitinib 1.5% cream in decreasing the clinical disease activity after 16 weeks of treatment.
* Investigate the impact of ruxolitinib 1.5% cream on skin inflammation through translational analyses of skin biopsy samples.
Interventions:
description: Topical Ruxolitinib 1.5% Cream
name: Ruxolitinib 1.5% Cream
type: Drug
Study arms:
design_group_description: Topical Ruxolitinib 1.5% Cream, twice daily for 16 weeks
design_group_title: Open-label
design_group_type: Experimental
Sponsor: Hershey Medical Center
Collaborators: Incyte Corp.
Drug name mappings:
name: 磷酸芦可替尼
lang: CN
name: Ruxolitinib  Phosphate
lang: EN
name: ルキソリチニブリン酸塩
lang: JP