PatSnap/clinical-trial huggingface dataset:
Clinical trial NCT00536939: Trial of Paclitaxel, Bevacizumab, and Enzastaurin Versus Paclitaxel, Bevacizumab and Placebo for Breast Cancer
Official title: A Randomized, Double-Blind, Phase 2 Trial of Paclitaxel Plus Bevacizumab and Enzastaurin Versus Paclitaxel Plus Bevacizumab and Placebo for Locally Recurrent or Metastatic Breast Cancer
Conditions: Breast Cancer
Summary: The purpose of this study is to determine efficacy and safety of paclitaxel, bevacizumab and enzastaurin versus paclitaxel, bevacizumab, and placebo in participants who are diagnosed with locally recurrent or metastatic breast cancer.
Interventions:
description: 1125 milligrams (mg) loading dose on Day 1 of Cycle 1 only then 500 mg oral once daily, until disease progression
name: Enzastaurin
other_name: LY317615
type: Drug
description: 10 milligrams per kilogram (mg/kg) intravenously, Days 1 and 15 every 28 days, until disease progression
name: Bevacizumab
type: Drug
description: 90 milligrams per square meter (mg/m^2), intravenously, Days 1 ,8, and 15 every 28 days until disease progression
name: Paclitaxel
type: Drug
description: Oral, daily, until disease progression
name: Placebo
type: Drug
Study arms:
design_group_description: Participants randomized to this arm (Arm A) will receive enzastaurin, paclitaxel and bevacizumab until disease progression.<br/>Prior to randomization, a safety lead-in will be conducted in 6 participants who will be treated according to Arm A for 2 cycles (1 cycle = 28 days). Only after an acceptable safety analysis of the safety lead-in, will other participants be randomized to Phase 2 (either Arm A or Arm B). In Phase 2, participants from the safety lead-in will continue treatment according to Enzastaurin + Bevacizumab + Paclitaxel (Arm A).
design_group_title: Enzastaurin + Bevacizumab + Paclitaxel
design_group_type: Experimental
design_group_description: Participants randomized to this arm (Arm B) will receive bevacizumab, paclitaxel and placebo until disease progression.
design_group_title: Bevacizumab + Paclitaxel + Placebo
design_group_type: Placebo Comparator
Sponsor: Eli Lilly & Co.
Collaborators: Genentech, Inc.
Drug name mappings:
name: 盐酸恩扎妥林
lang: CN
name: Enzastaurin Hydrochloride
lang: EN
name: 紫杉醇
lang: CN
name: Paclitaxel
lang: EN
name: パクリタキセル
lang: JP
name: 贝伐珠单抗
lang: CN
name: Bevacizumab
lang: EN
name: ベバシズマブ（遺伝子組換え）
lang: JP
Clinical trial NCT05913180: Vitamin C Effectiveness in Preventing Urinary Tract Infections After Gynecological Surgeries
Official title: Vitamin C for the Prevention of Catheter-associated Urinary Tract Infections in Women Who Undergo Elective Gynecological Surgeries: a Randomized Double-blinded Controlled Trial
Conditions: Catheter-Associated Urinary Tract Infection
Summary: Double-blind placebo-controlled randomized trial aiming to assess the role of Vitamin C supplementation in the prevention of catheter-associated urinary tract infections in women undergoing elective gynecological surgeries.
Interventions:
description: 1000mg Ascorbic acid orally daily started on the day of elective gynecological surgery for 10 days
name: Ascorbic Acid 1000 MG
other_name: Vitamin C
type: Drug
description: Placebo tablet daily starting day of elective gynecological surgery for 10 days
name: Placebo
type: Drug
Study arms:
design_group_description: 1000mg Ascorbic acid daily starting the day of elective gynecological surgery for 10 days
design_group_title: Vitamin C
design_group_type: Active Comparator
design_group_description: Placebo daily starting the day of elective gynecological surgery for 10 days
design_group_title: Placebo
design_group_type: Placebo Comparator
Sponsor: American University of Beirut Medical Center
Collaborators: Yevdokimov MSUMD
Drug name mappings:
name: 维生素C
lang: CN
name: Ascorbic Acid
lang: EN
name: アスコルビン酸
lang: JP
Clinical trial NCT06670521: Corticosteroids for Post-Extubation Dysphagia
Official title: Randomized Trial of Corticosteroids for Post-Extubation Aspiration
Conditions: Dysphagia
Laryngeal Edema
Summary: This is a placebo-controlled, double-blind randomized trial of a short course of intravenous corticosteroids for Acute Respiratory Failure Survivors with Fiberoptic Endoscopic Evaluation of Swallowing (FEES) documented laryngeal edema. Study was leveraged using the existing R01 grant infrastructure COMIRB # 21-3873, study design, and research methods. Patients for the study proposed will have already been enrolled in the R01 longitudinal cohort study. The sites to perform this study include Colorado, BU, Yale, and Stanford. Those R01-enrolled patients with laryngeal edema on their initial FEES examination: defined as the revised Patterson edema score greater than zero, will be approached for enrollment.
Interventions:
description: 50 mg methylprednisolone IV every 6 hours for 4 doses to reduce laryngeal edema
name: Methylprednisolone
type: Drug
description: Normal Saline placebo IV every 6 hours for 4 doses
name: Normal Saline
type: Drug
Study arms:
design_group_description: 50 mg Methylprednisolone IV every 6 hours for 4 doses (total dose 200mg)
design_group_title: Corticosteroid Intervention
design_group_type: Experimental
design_group_description: Normal Saline placebo dose IV every 6 hours for 4 doses
design_group_title: Placebo Control
design_group_type: Placebo Comparator
Sponsor: University of Colorado Denver
Collaborators: National Institute on Aging
Drug name mappings:
name: 甲泼尼龙
lang: CN
name: Methylprednisolone
lang: EN
name: メチルプレドニゾロン
lang: JP
Clinical trial NCT00959894: Evaluating Once Daily Etravirine in Treatment-Naive Adults With HIV Infection
Official title: Antiretroviral Activity and Tolerability of Once Daily Etravirine in Treatment-Naïve Adults With HIV-1 Infection
Conditions: HIV Infections
Summary: The main study is a single arm, open-label, prospective study to assess antiretroviral activity and tolerability of etravirine (TMC-125) 400 mg once daily, given with fixed-dose tenofovir/emtricitabine, in treatment-naïve HIV-1-infected men and women. There are also a genital secretions pharmacokinetic (PK) sub-study and a metabolic sub-study. The purpose of the genital secretions PK sub-study is to gain information about drug levels and HIV-1 RNA in genital secretions when subjects are taking etravirine. The purpose of the metabolic sub-study is to learn about the effects of etravirine on body composition, as well as lipid and glucose levels.
Interventions:
description: Etravirine 400 mg (four 100 mg or two 200 mg tablets) taken orally once a day with one pill of Truvada (200 mg of emtricitabine and 300 mg of tenofovir) taken orally once a day
name: Etravirine (Intelence)
other_name: Intelence
TMC-125
type: Drug
description: Etravirine 400 mg (four 100 mg or two 200 mg tablets) taken orally once a day with one pill of Truvada (200 mg of emtricitabine and 300 mg of tenofovir) taken orally once a day
name: Truvada
other_name: Tenofovir/emtricitabine
type: Drug
Study arms:
design_group_description: Etravirine 400 mg once daily with fixed dose tenofovir/emtricitabine (Truvada) one tablet once daily
design_group_title: Etravirine 400 mg once daily
design_group_type: Experimental
Sponsor: The University of North Carolina at Chapel Hill
Collaborators: Janssen Pharmaceuticals, Inc.
Drug name mappings:
name: 依曲韦林
lang: CN
name: Etravirine
lang: EN
name: エトラビリン
lang: JP
name: 恩曲他滨替诺福韦
lang: CN
name: Emtricitabine/Tenofovir Disoproxil Fumarate
lang: EN
name: エムトリシタビン/テノホビル ジソプロキシルフマル酸塩
lang: JP
Clinical trial NCT03453489: AMT-PET in Monitoring Telotristat Etiprate Treatment in Participants With MetastaticNeuroendocrine Neoplasm
Official title: Monitoring Telotristat Ethyl Inhibition of Tryptophan Hydroxylase (TPH) in Neuroendocrine Tumors Using ?-[11C]Methyl-L-tryptophan (AMT)-PET
Conditions: Carcinoid Syndrome
Metastatic Nonfunctional Well Differentiated Neuroendocrine Neoplasm
Summary: This pilot trial studies how well telotristat etiprate works in treating participants with well differentiated neuroendocrine neoplasm that has spread to other places in the body and monitored by carbon C 11 alpha-methyltryptophan (AMT)-emission tomography (PET). Telotristat etiprate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Studying the changes within the tumor cells via AMT-PET may help doctors better understand how tumors respond to treatment with telotristat etiprate.
Interventions:
description: Undergo AMT-PET
name: Carbon C 11 Alpha-methyltryptophan
other_name: 11C-AMT
11C-alpha-methyltryptophan
[11C] AMT
alpha-[11C]methyl-L-tryptophan
type: Other
description: Correlative studies
name: Laboratory Biomarker Analysis
type: Other
description: Undergo AMT-PET
name: Positron Emission Tomography
other_name: Medical Imaging, Positron Emission Tomography
PET
PET Scan
Positron Emission Tomography Scan
Positron-Emission Tomography
proton magnetic resonance spectroscopic imaging
type: Procedure
description: Given PO
name: Telotristat Etiprate
other_name: LX1032 Hippurate
LX1606
LX1606 Hippurate
TPH Inhibitor LX1606
Tryptophan Hydroxylase Inhibitor LX1032
Tryptophan Hydroxylase Inhibitor LX1606
type: Drug
Study arms:
design_group_description: Participants undergo AMT-PET within 7 days prior to, and 9-14 days after start of telotristat etiprate treatment. Participants receive telotristat etiprate PO TID for 9-14 days.
design_group_title: Treatment (AMT-PET, telotristat etiprate)
design_group_type: Experimental
Sponsor: Barbara Ann Karmanos Cancer Institute
Collaborators: National Cancer Institute
Drug name mappings:
name: 特罗司他乙酯
lang: CN
name: Telotristat Etiprate
lang: EN
Clinical trial NCT05069051: Belimumab in Patients with Chronic Lymphocytic Leukemia
Official title: BeliVeR a Phase II Trial of Belimumab in Combination with Rituximab/venetoclax in Patients with Refractory or Relapsed Chronic Lymphocytic Leukemia
Conditions: Chronic Lymphoid Leukemia in Relapse
Summary: This study is a phase II trial of belimumab in combination with rituximab/venetoclax in patients with refractory or relapsed chronic lymphocytic leukemia (CLL). Treatment of CLL has drastically changed in the past years as new therapeutic agents have gained clinical approval. The combination rituximab/venetoclax over a course of two years is approved as second line therapy especially in patients with high risk CLL (del17p), showing high remission rates and achievement of MRD (minimal residual disease) negativity. The next goals in CLL therapy are now to increase the rate of MRD negativity and to achieve an earlier MRD negativity during the course of treatment to allow for a reduction of treatment time and therefore treatment-induced toxicities. In line with other hematologic diseases, progression free survival depends on remission status, especially MRD negativity, after last treatment as MRD positivity after therapy indicates the persistence of treatment resistant CLL cells. One mechanism of therapy resistance has been described as reduced sensitivity to rituximab-induced antibody dependent cell-mediated cytotoxicity (ADCC) by natural killer (NK) cell production of B-lymphocyte stimulator (BlyS, also called BAFF), which can be bound by belimumab, a human anti-BAFF antibody. Moreover, recombinant human (rh)BAFF can dose dependently reverse cytotoxic effects of venetoclax, which could also be restored by the application of belimumab. This led to the conceptualization of this clinical trial, in which belimumab is applied as a weekly subcutaneous injection in combination with standardrituximab/venetoclax treatment for up to 24 months in relapsed and refractory CLL patients. By removing BAFF from the CLL microenvironment we aim to increase the efficacy of rituximab/venetoclax treatment to achieve higher and earlier MRD negativity rates and allow for an abbreviated treatment.
Interventions:
description: Patients obtain belimumab treatment in combination with rituximab and venetoclax
name: Belimumab 200 MG/ML [Benlysta]
type: Drug
description: Patients obtain the standard of care: combination rituximab and venetoclax
name: standard of care
type: Drug
Study arms:
design_group_description: Patients obtain belimumab in combination with rituximab/venetoclax
design_group_title: Belimumab
design_group_type: Experimental
design_group_description: Patients obtain the combination rituximab/venetoclax
design_group_title: Standard of Care
design_group_type: Active Comparator
Sponsor: University Hospital Tübingen
Collaborators: GSK Plc
Drug name mappings:
name: 贝利尤单抗
lang: CN
name: Belimumab
lang: EN
name: ベリムマブ（遺伝子組換え）
lang: JP
name: 维奈克拉
lang: CN
name: Venetoclax
lang: EN
name: ベネトクラクス
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 NCT05363709: BALSTILIMAB on Viral Clearance in HPV+ Oropharyngeal Cancer Patients
Official title: A Phase 2 Study to Assess the Effect of BALSTILIMAB (AGEN2034) on Viral Clearance in HPV-positive Oropharyngeal Cancer Patients With Persistent HPV Detection in Plasma cfDNA After Definitive Therapy
Conditions: HPV
Oropharyngeal Cancer
Summary: This study aims to leverage this unique property of HPV+ OPC to detect possible minimal residual disease represented by persistent viral detection after the completion of definitive treatment. The study will offer adjuvant immune therapy to patients with persistent viral detection and evaluate the clearance of viral load. It will evaluate the rate of viral clearance with immune therapy and establish the link between viral clearance and long-term disease control.
Interventions:
description: Given by Vein (IV)
name: Balstilimab
other_name: Balstilimab IB
type: Drug
Study arms:
design_group_description: Participants will receive Balstilimab by vein over about 30 minutes on Days 1 and 15 of each cycle (every 2 weeks)
design_group_title: Balstilimab
design_group_type: Experimental
Sponsor: The University of Texas MD Anderson Cancer Center
Collaborators: Agenus, Inc.
Drug name mappings:
name: 巴替利单抗
lang: CN
name: Balstilimab
lang: EN
Clinical trial NCT03650894: Nivolumab, Ipilimumab, and Bicalutamide in Human Epidermal Growth Factor (HER) 2 Negative Breast Cancer Patients
Official title: A Phase II Study of Nivolumab Combined With Bicalutamide and Ipilimumab in Metastatic HER2-negative Breast Cancer
Conditions: Breast Neoplasm Female
Breast Cancer
Breast Carcinoma
Breast Tumor
Summary: The goal of this protocol is to evaluate the safety and efficacy of an alternative systemic combination approach that omits or delays the use of chemotherapy in metastatic disease, while improving efficacy and durability of response. The approach combines two potentially effective and previously studied strategies: androgen receptor blockade and immune checkpoint therapy.
Interventions:
description: Nivolumab 240 mg IV every 2 weeks
name: Nivolumab
other_name: Opdivo
type: Drug
description: Ipilimumab 1 mg/kg IV every 6 weeks.
name: Ipilimumab
other_name: Yervoy
type: Drug
description: Oral bicalutamide 150mg (3 x 50mg tablets) daily
name: Bicalutamide
other_name: Casodex
type: Drug
Study arms:
design_group_description: Participants will receive nivolumab plus ipilimumab combination therapy. Participants should receive nivolumab at a dose of 240 milligrams (mg) fixed dose as a 30-minute intravenous (IV) infusion prepared in 50 milliliter (ml) normal saline (NS) every 2 weeks until progression. Participants should receive ipilimumab at a dose of 1 mg/kilogram as a 30-minute IV infusion prepared in 50 ml NS every 6 weeks. All subjects will take bicalutamide 150mg (3 x 50mg tablets) daily.
design_group_title: Nivolumab, Ipilimumab, and bicalutamide
design_group_type: Experimental
Sponsor: Providence Health & Services
Collaborators: Memorial Sloan Kettering Cancer Center
Bristol Myers Squibb Co.
Drug name mappings:
name: 伊匹木单抗
lang: CN
name: Ipilimumab
lang: EN
name: イピリムマブ（遺伝子組換え）
lang: JP
name: 纳武利尤单抗
lang: CN
name: Nivolumab
lang: EN
name: ニボルマブ（遺伝子組換え）
lang: JP
name: 比卡鲁胺
lang: CN
name: Bicalutamide
lang: EN
name: ビカルタミド
lang: JP
Clinical trial NCT00167544: Randomized Trial of Hydrocortisone in Very Preterm High-Risk Infants
Official title: A Randomized Trial of Hydrocortisone in Very Preterm Infants at High Risk for Neurologic and Pulmonary Impairments
Conditions: Bronchopulmonary Dysplasia
Encephalomalacia
Premature Birth
Summary: The purpose of this study is to determine whether treatment of very preterm infants at high-risk for lung and brain injury with low dose hydrocortisone results in improved pulmonary and neurologic outcomes.
Interventions:
description: Hydrocortisone 3 mg/kg/d divided q 12h IV/PO tapered over 7 days
name: Hydrocortisone
type: Drug
description: Saline
name: Placebo
type: Drug
Study arms:
design_group_description: 1. Tapering dose of hydrocortisone every 12 h over 7 day period
design_group_title: 1
design_group_type: Experimental
design_group_description: 2. Identical-appearing saline placebo
design_group_title: 2
design_group_type: Placebo Comparator
Sponsor: Nationwide Children's Hospital
Collaborators: National Institute of Neurological Disorders & Stroke
National Institutes of Health
Drug name mappings:
name: 醋酸氢化可的松
lang: CN
name: Hydrocortisone Acetate
lang: EN
Clinical trial NCT01390402: Alloreactive Haploidentical Natural Killer (NK) Cells With Busulfan and Fludarabine/ATG
Official title: Natural Killer (NK) Cells and Nonmyeloablative Stem Cell Transplantation for Chronic Myelogenous Leukemia (CML)
Conditions: Leukemia
Chronic Myelogenous Leukemia
Summary: The goal of this clinical research study is to learn if giving a kind of immune cell called natural killer (NK) cells after chemotherapy will improve the response to a stem cell transplant in patients with CML. The safety of this treatment will also be studied.
Interventions:
description: 40 mg/m2 intravenous over one (1) hour on each of four (4) consecutive days, Days -13 to -10.
name: Fludarabine
other_name: Fludara
Fludarabine Phosphate
type: Drug
description: 130 mg/ m2 by vein for 2 doses on Days -11 to -10.
name: Busulfan
other_name: Busulfex
Myleran
type: Drug
description: Natural killer cell infusion will be administered by vein on Day -8.
name: NK cell infusion:
type: Procedure
description: 0.5 million units subcutaneously daily for 5 days on Day -8 to day -4.
name: Interleukin-2
other_name: Aldesleukin
IL-2
Proleukin
type: Drug
description: 2.5 mg/kg by vein for 3 doses on Days -3 to -1.
name: Anti-Thymocyte Globulin
other_name: ATG
Thymoglobulin
type: Drug
description: Allogeneic related stem cell transplant by vein on day 0.
name: Allogeneic related Stem Cell Transplant
type: Procedure
description: Starting dose of 0.015 mg/kg (ideal body weight) as a 24 hour continuous infusion daily adjusted to achieve a therapeutic level of 5-15 ng/ml.
name: Tacrolimus
other_name: Prograf
type: Drug
description: 5 mg/m2 by vein Days 1, 3 and 6 post transplant.
name: Methotrexate
type: Drug
description: 5 mcg/kg/day subcutaneously beginning on Day + 7, and continuing until the absolute neutrophil count (ANC) is > 500 x 10/L for 3 consecutive days.
name: G-CSF
other_name: Filgrastim
Neupogen
type: Drug
Study arms:
design_group_description: Fludarabine 40 mg/m2 intravenous (IV) daily for 4 days, immediately followed by Busulfan 130 mg/ m2 IV every 24 hours and NK cell infusion IV.
design_group_title: NK Infusion + Chemotherapy
design_group_type: Experimental
Sponsor: The University of Texas MD Anderson Cancer Center
Collaborators: National Cancer Institute
Drug name mappings:
name: 磷酸氟达拉滨
lang: CN
name: Fludarabine Phosphate
lang: EN
name: フルダラビンリン酸エステル
lang: JP
name: 白消安
lang: CN
name: Busulfan
lang: EN
name: ブスルファン
lang: JP
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
name: 他克莫司
lang: CN
name: Tacrolimus
lang: EN
name: タクロリムス水和物
lang: JP
name: 阿地白介素
lang: CN
name: Aldesleukin
lang: EN
name: 甲氨蝶呤
lang: CN
name: Methotrexate
lang: EN
name: メトトレキサート
lang: JP
Clinical trial NCT00354640: Simvastatin and Anastrozole in Treating Postmenopausal Women With Ductal Carcinoma In Situ or Invasive Breast Cancer
Official title: A Trial Assessing the Effect of Simvastatin on the Pharmacokinetics of Anastrozole
Conditions: Breast Cancer
Summary: RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming, growing, or coming back. The use of simvastatin and anastrozole may stop cancer from forming, growing, or coming back in patients with invasive breast cancer, ductal carcinoma in situ, or a high risk of breast cancer.
PURPOSE: This phase II trial is studying how well giving simvastatin together with anastrozole works in treating postmenopausal women with invasive breast cancer, ductal carcinoma in situ, or a high risk of breast cancer.
Interventions:
description: 1 milligram tablet PO QD for 14 days
name: anastrozole
other_name: Arimidex
type: Drug
description: 40 milligram tablet PO QD for 14 days
name: simvastatin
other_name: Zocor
type: Drug
description: laboratory analysis
name: pharmacological study
type: Other
description: laboratory analysis
name: adjuvant therapy
type: Procedure
Study arms:
design_group_description: This is a pharmacological study for women on anastrozole as adjuvant therapy for breast cancer to receive concurrent simvastatin for up to 14 days.
design_group_title: Anastrozole and Simvastatin
design_group_type: Experimental
Sponsor: The Sidney Kimmel Comprehensive Cancer Center
Collaborators: National Cancer Institute
Drug name mappings:
name: 辛伐他汀
lang: CN
name: Simvastatin
lang: EN
name: シンバスタチン
lang: JP
name: 阿那曲唑
lang: CN
name: Anastrozole
lang: EN
name: アナストロゾール
lang: JP
Clinical trial NCT00138138: Psychostimulants for Fatigue in Prostate Cancer
Official title: Psychostimulants for Fatigue in Advanced Prostate Cancer
Conditions: Fatigue
Prostate Cancer
Summary: Fatigue is one of the most common symptoms of prostate cancer. Fatigue is a lack of energy that makes it harder to do the things you normally do every day. Some symptoms of fatigue are:
* feeling tired and/or weak;
* having less interest in activities;
* having trouble concentrating;
* feeling "down";
* feeling exhausted for no clear reason.
There are not many drugs that are helpful in treating fatigue. However, one group of medications does seem to be useful. In this study, we, the investigators at Memorial Sloan-Kettering Cancer Center, will be using a psychostimulant called Ritalin. The aim of this study is to see if this drug is helpful in treating fatigue in prostate cancer. We are also studying the side effects of this medication.
Interventions:
name: Ritalin
type: Drug
Study arms:
Sponsor: Memorial Sloan Kettering Cancer Center
Collaborators: Fordham University
Drug name mappings:
name: 盐酸哌甲酯
lang: CN
name: Methylphenidate Hydrochloride
lang: EN