PatSnap/clinical-trial huggingface dataset:
Clinical trial NCT02313272: Hypofractionated Stereotactic Irradiation (HFSRT) With Pembrolizumab and Bevacizumab for Recurrent High Grade Gliomas
Official title: A Phase I Trial of Hypofractionated Stereotactic Irradiation (HFSRT) With Pembrolizumab and Bevacizumab in Patients With Recurrent High Grade Gliomas
Conditions: Malignant Glioma
Summary: The purpose of this study is to see if the addition of the investigation drug called pembrolizumab (Keytruda®) to radiation therapy and bevacizumab (Avastin®) is safe and can help with controlling the growth of tumors, in participants with recurrent high grade glioma.
Interventions:
description: Radiation therapy treatment (FSRT) which will be given to participants over 5 days.
name: Hypofractionated Stereotactic Irradiation (HFSRT)
type: Radiation
description: Dose Escalation: The dose of pembrolizumab will be escalated per schema in a 3+3 fashion. The starting dose (i.e., dose level 1) will be 100 mg.<br/>Dose Expansion: The pembrolizumab dose used in the dose expansion cohort will be maximum tolerated dose (MTD) determined from the dose escalation phase.
name: Pembrolizumab
other_name: Keytruda®
MK-3475
type: Drug
description: Initial cycle of bevacizumab must start within 10 days of registering to the trial. It will be given concurrent with radiation therapy. Bevacizumab will be administered intravenously at a dose of 10 mg/kg every 2 weeks. Doses will be adjusted if there is a > 10% change in weight.
name: Bevacizumab
other_name: Avastin®
type: Drug
Study arms:
design_group_description: Hypofractionated Stereotactic Irradiation (HFSRT). Pembrolizumab intravenous (IV) infusion every 3 weeks. Bevacizumab administered intravenously every 2 weeks.
design_group_title: HFSRT with Pembrolizumab and Bevacizumab
design_group_type: Experimental
Sponsor: H. Lee Moffitt Cancer Center & Research Institute, Inc.
Collaborators: Merck Sharp & Dohme Corp.
Drug name mappings:
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
name: 帕博利珠单抗
lang: CN
name: Pembrolizumab
lang: EN
name: ペムブロリズマブ（遺伝子組換え）
lang: JP
Clinical trial NCT01039233: Bioequivalence Study of Bicalutamide 50 mg Tablet and Casodex 50 mg Tablet in Healthy Subjects Under Fasting Conditions
Official title: Randomized, Bioequivalence Study of Bicalutamide 50 mg Tablet and Casodex 50 mg Tablet Following a 50 mg Dose in Healthy Subjects Under Fasting Conditions
Conditions: Bioequivalency
Summary: The objective of this study is to compare the rate and extent of absorption of bicalutamide 50 mg tablet (test) versus Casodex (reference), administered as 1 x 50 mg tablet under fasting conditions
Interventions:
name: Bicalutamide 50 mg Tablet vs Casodex® 50 mg Tablet
type: Drug
Study arms:
design_group_title: Bicalutamide 50 mg Tablet
design_group_type: Experimental
design_group_title: Casodex® 50 mg Tablet
design_group_type: Active Comparator
Sponsor: Kremers Urban Development Co.
Collaborators: Watson Laboratories, Inc.
Drug name mappings:
name: 比卡鲁胺
lang: CN
name: Bicalutamide
lang: EN
name: ビカルタミド
lang: JP
Clinical trial NCT00614978: Lapatinib and Temozolomide for the Treatment of Progressive Brain Disease in HER-2 Positive Breast Cancer
Official title: Phase 1 Study of the Combination of Lapatinib and Temozolomide for the Treatment of Progressive Brain Disease in HER-2 Positive Breast Cancer
Conditions: Metastatic Breast Cancer
Brain Metastases
HER2 Positive
Summary: Objectives:
Primary - Determine the maximum tolerated dose (MTD) and evaluate the dose limiting toxicities (DLT) of combining lapatinib and temozolomideSecondary - Obtain preliminary information on the clinical anti-tumor activity of lapatinib plus temozolomide on brain metastases secondary to HER-2 positive breast cancer including Objective Response Rate (ORR), Clinical Benefit (CB) and Duration of Response (DR)
Methodology:
Phase I, single-centre, open-label, dose-escalation study of combining lapatinib and temozolomide in HER-2 positive breast cancer patients with progressive brain metastases after surgery or radiotherapy or radiosurgery
Treatment:
Temozolomide will be given orally for 5 days of every 28 days, at doses of either 100mg/m2/day or 150mg/m2/day or 200mg/m2/day AND Lapatinib will be given orally every day at either 1000mg/day or 1250mg/day or 1500mg/day.Sequential cohorts will be escalated in increments according to the dose escalation scheme, and determined by dose limiting toxicities.
Interventions:
description: Temozolomide will be given orally for 5 days of every 28 days, at doses of either 100mg/m2/day or 150mg/m2/day or 200mg/m2/day AND Lapatinib will be given orally every day at either 1000mg/day or 1250mg/day or 1500mg/day.
name: lapatinib and temozolomide
other_name: Tykerb
type: Drug
Study arms:
design_group_description: Lapatinib plus temozolomide
design_group_title: I
design_group_type: Experimental
Sponsor: Jules Bordet Institute
Collaborators: Schering-Plough Corp.
GSK Plc
Drug name mappings:
name: 替莫唑胺
lang: CN
name: Temozolomide
lang: EN
name: テモゾロミド
lang: JP
name: 二甲苯磺酸拉帕替尼
lang: CN
name: Lapatinib Ditosylate Hydrate
lang: EN
Clinical trial NCT01205178: G6PD (Glucose-6-phosphate Dehydrogenase) Study to Evaluate Hemolysis Potential of TFQ (Tafenoquine)
Official title: A Phase I Study to Investigate the Hemolytic Potential of Tafenoquine in Healthy Subjects With Glucose-6-phosphate Dehydrogenase Deficiency and the Safety and Tolerability of Tafenoquine in Acute Plasmodium Vivax Malaria Patients With Glucose-6-phosphate Dehydrogenase Deficiency
Conditions: Malaria
Summary: SB-252263 (Tafenoquine, TQ) is an 8-aminoquinoline (8-AQ) antimalarial drug being developed by GlaxoSmithKline (GSK), the U.S. Army Medical Research and Materiel Command (USAMRMC) and Medicines for Malaria Venture (MMV). TQ is currently being developed for the radical cure of acute P. vivax malaria in combination with standard doses of CQ, which is 1500 mg over 3 days.
The current gold standard for radical cure of P. vivax malaria in many areas of the world is chloroquine (CQ) for clearance of the acute parasitemia immediately followed by primaquine (PQ) to clear the liver stages of the parasite and prevent disease relapse. The 8-AQ class of drugs, including PQ, is hemolytic in subjects with glucose-6-phosphate dehydrogenase (G6PD) deficiency. The current study will identify a dose of TQ within the target efficacious dose range that has a hemolytic effect similar to or less than PQ 15 mg OD x 14 days (i.e. ≤ 25-30% hemoglobin decline in WHO class III G6PD-deficient subjects).
Interventions:
description: The current gold standard for radical cure of P. vivax malaria in many areas of the world is chloroquine (CQ); typically 600 mg day 1, 600 mg day 2, 300 mg day 3 for clearance of the acute parasitemia. After this Tafenoquine will be given and subject will be followed up.
name: Chloroquine
type: Drug
description: Primaquine (PQ) is another 8 aminoquinoline drug available for Malaria treatment
name: Primaquine
type: Drug
description: Once daily on Day 1 only. For Part B and C of this study Chloroquine will be given to treat Malaria
name: Tafenoquine
type: Drug
Study arms:
design_group_description: Tafenoquine, TQ is an 8-aminoquinoline (8-AQ) antimalarial drug being developed for the radical cure of acute P. vivax malaria. Chloroquine will be given for the first 3 days in second and third part of this study to treat Malaria.
design_group_title: Tafenoquine
design_group_type: Active Comparator
design_group_description: Dose for first 3 days for Part B & C of the study
design_group_title: Chloroquine
design_group_type: Active Comparator
design_group_description: once daily for first 14 days
design_group_title: Primaquine
design_group_type: Active Comparator
Sponsor: GSK Plc
Collaborators: MMV Medicines for Malaria Venture
Drug name mappings:
name: 琥珀酸他非诺喹
lang: CN
name: Tafenoquine Succinate
lang: EN
name: 磷酸氯喹
lang: CN
name: Chloroquine Phosphate
lang: EN
name: 磷酸伯氨喹
lang: CN
name: Primaquine Phosphate
lang: EN
name: プリマキンリン酸塩
lang: JP
Clinical trial NCT05945160: Vestibular Function Using Mitochondrial Antioxidant Therapy
Official title: A Randomized Controlled Study Using Alpha Lipoic Acid and CoQ-10 to Determine if Vestibular Function Can be Improved or Maintained Over the Course of One Year
Conditions: Vestibular Function Disorder
Summary: To determine if supplementation with known mitochondrial antioxidants (alpha lipoic acid (ALA) and CoQ-10) will stabilize or improve vestibular function in older adults.
Interventions:
description: A naturally occuring mitochondrial antioxidant
name: Alpha Lipoic Acid 300mg
other_name: ALA
type: Drug
description: A naturally occuring mitochondrial antioxidant
name: Coenzyme Q10 200mg
other_name: CoQ10
type: Drug
Study arms:
design_group_description: Alpha Lipoic Acid will be administered as two 300 mg capsules taken once daily CoQ-10 will be administered as two 200mg capsules daily.
design_group_title: Nutritional Supplements Group
design_group_type: Experimental
design_group_description: Standard of care treatment for vestibular function.
design_group_title: Standard of Care Group
design_group_type: No Intervention
Sponsor: University of Texas Health Science Center At San Antonio
Collaborators: National Institute on Aging
Drug name mappings:
name: 硫辛酸
lang: CN
name: Lipoic acid
lang: EN
name: 辅酶Q10
lang: CN
name: Ubidecarenone
lang: EN
name: ユビデカレノン
lang: JP
Clinical trial NCT05105919: Assessing Pharmacokinetics and Pharmacodynamics of Daily Enteric-coated Aspirin in Patients With StablE Diabetes
Official title: Assessing Pharmacokinetics and Pharmacodynamics of Daily Enteric-coated Aspirin in Patients With StablE Diabetes: APPEASED Study Phase 1
Conditions: Diabetes Mellitus, Type 2
Summary: This phase 1 study will include patients suffering from type 2 diabetes mellitus and will study their response to enteric coated aspirin at a dose of 80 mg per day for a 7-day period. The aims are to determine the feasibility of a phase 2 larger scale trial, and to characterize the prevalence of incomplete platelet inhibition after exposure to EC aspirin at doses of 80 mg once daily. Platelet function will be assessed at baseline and a day 7.
Interventions:
description: Participants will receive a 7 day supply of Aspirin 80 mg EC Tab and will be instructed to take the drug at the same time every day for 7 days.
name: Aspirin 80 mg EC Tab
type: Drug
Study arms:
design_group_description: All participants will be assigned to aspirin therapy. Participants will receive 80 mg of enteric coated aspirin per day for a 7 day period.
design_group_title: Aspirin therapy
design_group_type: Experimental
Sponsor: Montréal Heart Institute
Collaborators: Institut de recherches cliniques de Montréal
Drug name mappings:
name: 阿司匹林
lang: CN
name: Aspirin
lang: EN
name: サリチル酸
lang: JP
Clinical trial NCT02774512: Predictive Biomarkers of Biological Activity and Efficacy of Nilotinib on ZAK Target in Non-metastatic Colon Cancer
Official title: Phase 0 Study Aiming at Identifying Predictive Biomarkers of Biological Activity and Efficacy of Nilotinib on ZAK Target in Non-metastatic Colon Cancer
Conditions: Colon Cancer
Summary: This is a monocentric prospective non randomized phase 0 clinical trial targeting patients with colon cancer for whom an upfront surgery has been advised by the pluridisciplinary team.
Interventions:
description: Each patient will receive nilotinib 800 mg/day every day for 7 days. Study treatment will be taken twice a day (400 mg - 2 capsules) by oral route with an interval of approximately 12 hours between two doses and should not be taken with food. The entire capsule should be swallowed with water. No food should be consumed for 2 hours before taking the drug and for at least 1 hour after it.
name: Nilotinib
type: Drug
Study arms:
design_group_description: A specific colonoscopy is performed in order to take biopsy for biological studies to determine the ZAK-0 expression status. Then the patient receives nilotinib orally at the dose of 800 mg/day (400 mg twice a day) for 7 days. The patient is scheduled for surgery the morning after the last take of the nilotinib (12 hours). When the colectomy is performed, the surgeon collects different tumoral samples which are immediately delivered to the laboratory.
design_group_title: Nilotinib
design_group_type: Experimental
Sponsor: Institut Bergonié
Collaborators: Novartis Pharmaceuticals Corp.
Drug name mappings:
name: 尼洛替尼
lang: CN
name: Nilotinib Hydrochloride
lang: EN
name: ニロチニブ塩酸塩水和物
lang: JP
Clinical trial NCT05789173: Interaction of CYP2B6 Genotype and Efavirenz With Methadone and Tizanidine PK
Official title: Effect of CYP2B6 Genotype and Efavirenz on the Disposition and Pharmacodynamic of Methadone and Tizanidine in Healthy Volunteers
Conditions: Drug-Drug Interaction
Summary: The main goal of this clinical study is to test how CYP2B6 genetic variations and efavirenz (cornerstone in HIV-1 therapy) dictate the disposition (PK) of CYP2B6 substrate (methadone) and PK and effect (PD) of CYP1A2 substrate (tizanidine). Specifically, the investigators will test whether efavirenz produces CYP2B6 genotype dependent unanticipated DDIs with CYP2B6 (methadone) and CYP1A2 (tizanidine), leading to lack of efficacy or increased toxicity. Healthy volunteers genotyped for CYP2B6*6 and *18 alleles will be grouped in to three genotype predicted phenotype groups: 20 normal metabolizer (NM) (CYP2B6*1/*1); 20 intermediate metabolizer (IM) (*1/*6, or *1/*18); and 20 poor metabolizer (PM) (*6/*6, *6/*18 or *18/*18). Each phenotype group will receive methadone and tizanidine (separated by a washout period) on two occasions: at baseline (control) and after treatment with efavirenz (600 mg/day for 17 days).
Interventions:
description: Each CYP2B6 genotype predicted phenotypes will receive methadone (10 mg) and tizanidine (4 mg) by mouth at baseline (control)
name: Methadone and Tizanidine
type: Drug
description: Each CYP2B6 genotype predicted phenotypes will receive methadone (10 mg) and tizanidine (4 mg) by mouth after pretreatment with efavirenz (600 mg PO for 16 days)
name: Efavirenz, Methadone and Tizanidine
type: Drug
Study arms:
design_group_description: Each CYP2B6 normal metabolizer (NM) (*1/*1), intermediate metabolizer (IM) (*1/*6), and poor metabolizer (PM) (*6/*6, *6/*18, or *18/*18) group will receive a single dose of methadone (10 mg) and a single dose of tizanidine (4 mg) orally simultaneously at baseline (control).
design_group_title: Baseline (control)
design_group_type: Experimental
design_group_description: Each CYP2B6 normal metabolizer (NM) (*1/*1), intermediate metabolizer (IM) (*1/*6), and poor metabolizer (PM) (*6/*6, *6/*18, or *18/*18) group will be administered a single dose of methadone (10 mg) and a single dose of tizanidine (4 mg) orally simultaneously after 16-day oral treatment with 600 mg/day efavirenz
design_group_title: Efavirenz (treatment)
design_group_type: Experimental
Sponsor: Indiana University
Collaborators: National Institute of General Medical Sciences
Drug name mappings:
name: 依非韦伦
lang: CN
name: Efavirenz
lang: EN
name: エファビレンツ
lang: JP
name: 盐酸美沙酮
lang: CN
name: Methadone Hydrochloride
lang: EN
name: メサドン塩酸塩
lang: JP
name: 盐酸替扎尼定
lang: CN
name: Tizanidine Hydrochloride
lang: EN
name: チザニジン塩酸塩
lang: JP
Clinical trial NCT00993642: ERB-B4 After Treatment With HDAC Inhibitor in ER+ Tamoxifen Refractory Breast Cancer
Official title: Pilot Study Evaluating the Expression of ERB-B4 After Treatment With HDAC Inhibitor in ER+ Tamoxifen Refractory Breast Cancer
Conditions: Breast Cancer
Summary: The long-term objective of this research is to understand the molecular mechanisms of acquired endocrine resistance in breast cancer. Identifying these mechanisms is critical to the implementation of novel therapeutic strategies that can target and overcome altered gene networks involved in controlling breast cancer progression. While patients with tumors over expressing HER1, 2, or 3 have been shown to have reduced survival, patients with those tumors which overexpressed HER4 (erbB4) had increased survival (Witton 2003).
This is a non-randomized, single-arm, proof of principle trial. Selected are patients with advanced-stage breast cancer whose tumors are ER+, tamoxifen refractory. Histologically proven diagnosis of recurrent or metastatic breast cancer is advanced cancer for which there is no treatment available which would have a reasonable chance of cure. Treatment failure is defined as tumor progression after chemotherapy and tamoxifen therapy. Patients will be given five 30mg doses of HDAC inhibitor (LBH) over a period of two weeks. A dose will be taken on Days 1,3,5,8 and 10. Patients will have a diagnostic tumor biopsy prior to drug administration and a diagnostic biopsy within 48 hours (2 days) of the last dose. Primary endpoints are measured by biopsy of palpable tumor with immunohistochemical staining for ERBB4. Secondary end points include the evaluation of cell death, apoptosis, with immunohistochemical staining for DNA breaks by TUNEL assay.
Interventions:
description: Patients will be given five 30mg doses of HDAC inhibitor (LBH) over a period of two weeks. A dose will be taken on Days 1,3,5,8 and 10. Patients will have a diagnostic tumor biopsy prior to drug administration and a diagnostic biopsy within 48 hours (2 days) of the last dose.
name: Panobinostat (LBH589)
type: Drug
Study arms:
design_group_title: All Participants
design_group_type: Experimental
Sponsor: Tulane University Health Sciences Center
Collaborators: Novartis AG
Drug name mappings:
name: 乳酸帕比司他
lang: CN
name: Panobinostat lactate
lang: EN
name: パノビノスタット乳酸塩
lang: JP
Clinical trial NCT03145207: PK and DPK of Lidocaine Dermal Products
Official title: Evaluation of Bioavailability of Lidocaine Dermal Products
Conditions: Heat Effect
Summary: This is a bioequivalence study to compare lidocaine release between a brand name and generic skin patches in healthy adults.
Interventions:
description: lidocaine patch
name: Lidocaine patch
other_name: skin patch
type: Drug
Study arms:
design_group_description: name brand lidocaine patch
design_group_title: name brand patch
design_group_type: Other
design_group_description: generic lidocaine patch
design_group_title: generic patch
design_group_type: Other
design_group_description: name brand lidocaine patch-early
design_group_title: name brand patch-early
design_group_type: Other
design_group_description: name brand lidocaine patch-late
design_group_title: name brand patch-late
design_group_type: Other
design_group_description: generic lidocaine patch-early
design_group_title: generic patch-early
design_group_type: Other
design_group_description: generic lidocaine patch-late
design_group_title: generic patch-late
design_group_type: Other
design_group_description: brand name and generic lidocaine patch
design_group_title: both patches
design_group_type: Other
Sponsor: University of Maryland Baltimore
Collaborators: US Food & Drug Administration
Drug name mappings:
name: 利多卡因
lang: CN
name: Lidocaine
lang: EN
name: リドカイン
lang: JP
Clinical trial NCT03749369: Adjunctive Use of Salvadora Persica in Chronic Periodontitis
Official title: Effect of Salvadora Persica on Clinical, Radiographic and Microbiological Parameters of Chronic Periodontitis: A Triple-Blind Randomized Controlled Clinical Trial
Conditions: Chronic Periodontitis
Summary: A randomized controlled triple blinded study to evaluate the effectiveness of Salvadora Persic (SP) as an adjunct to Scaling and Root Planing (SRP) in chronic periodontitis by comparing the basic parameters of periodontitis, radiographs and bacterial levels with a controlled group (SRP only).
Interventions:
description: Salvadora Persica Gel
name: Salvadora Persica Root
other_name: SP gel
type: Drug
description: Thorough scaling and root planing (SRP) will be performed by a single clinician. The SRP procedure will be carried out in two sittings, comprising of ultrasonic scaling in the first, and manual instrumentation and root debridement in the second.
name: Scaling and root planing
other_name: SRP
type: Procedure
Study arms:
design_group_description: Subjects receiving salvadora gel in addition to scaling and root planing
design_group_title: SRP plus salvadora persica root
design_group_type: Active Comparator
design_group_description: Subjects receiving scaling and root planing only
design_group_title: SRP only
design_group_type: Placebo Comparator
Sponsor: King Saud University
Collaborators: Ziauddin University
Drug name mappings:
name: 山柑藤根提取物
lang: CN
name: Salvadora Persica Root Extract
lang: EN
Clinical trial NCT03943498: Fingolimod in Treating Patients With Chemotherapy-Induced Neuropathy
Official title: Treatment of Established Chemotherapy-Induced Neuropathy With Fingolimod: A Pilot Trial
Conditions: Chemotherapy-Induced Peripheral Neuropathy
Numbness
Pain
Tingling
Summary: This early phase I trial studies how well fingolimod works in treating patients with chemotherapy-induced nerve pain (neuropathy). Fingolimod acts by suppressing immune reactions in the brain. This study is being done to see if fingolimod can reduce neuropathy caused by chemotherapy.
Interventions:
description: Given PO daily for 4 weeks
name: Fingolimod
type: Drug
description: Given PO
name: Fingolimod Hydrochloride
other_name: FTY-720
FTY720
Gilenya
type: Drug
description: Ancillary studies
name: Questionnaire Administration
type: Other
Study arms:
design_group_description: Patients receive 0.5 mg dose of Fingolimod PO QD for 4 weeks.<br/>Take your Fingolimod approximately every 24 hours
design_group_title: Treatment (Fingolimod)
design_group_type: Experimental
Sponsor: Mayo Clinic
Collaborators: National Cancer Institute
Drug name mappings:
name: 盐酸芬戈莫德
lang: CN
name: Fingolimod Hydrochloride
lang: EN
name: フィンゴリモド塩酸塩
lang: JP
Clinical trial NCT06010472: An Exploratory Clinical Study of Anti-CD19 CAR NK Cells in the Treatment of Systemic Lupus Erythematosus
Official title: An Exploratory Clinical Study of the Safety and Efficacy of Anti-CD19 Chimeric Antigen Receptor (CAR) Nature Killer Cells (KN5501) in the Treatment of Moderate to Severe Refractory Systemic Lupus Erythematosus (SLE)
Conditions: Systemic Lupus Erythematosus (SLE)
Summary: A single arm, open-label pilot study is designed to determine the safety and effectiveness of anti-cluster of differentiation antigen 19 (CD19) chimeric antigen receptor (CAR) natural killer (NK) cells (KN5501) in patients with moderate to severe refractory systemic lupus erythematosus (SLE). 36 patients are planned to be enrolled in the dose-escalation trial. The primary objective of the study was to evaluate the safety of allogeneic anti-CD19 CAR-NK cells (KN5501) for the treatment of patients with moderate to severe refractory active SLE. The secondary objective is to evaluate the efficacy of anti-CD19 CAR NK cells (KN5501) in patients with moderate to severe refractory SLE, including British Isles Lupus Assessment Group 2004 (BILAG-2004) index, Systemic Lupus Erythematosus Responder Index (SRI)-4 response rate, Lupus Low Disease Activity State (LLDAS) rate, and Definitions Of Remission In SLE (DORIS) remission rate.
Interventions:
description: Patients will receive Fludarabine (25 mg/m2 per day) and Cyclophosphamide (300mg/m2 per day) on day -5, -4, and -3. Multiple doses of anti-CD19 CAR NK cells (KN5501) will infused in each group using the "3 + 3" dose-escalation strategy.
name: anti-CD19 CAR NK cells (KN5501)
type: Drug
Study arms:
design_group_description: To evaluate the safety and effectiveness of anti-CD19 CAR NK cells (KN5501) in patients with moderate to severe refractory SLE. All subjects will receive fludarabine/cyclophosphamide lymphodepletion followed by anti-CD19 CAR NK cells infusion.
design_group_title: anti-CD19 CAR NK cells
design_group_type: Experimental
Sponsor: Changhai Hospital of Shanghai
Collaborators: Rui Therapeutics Co., Ltd
Drug name mappings:
name: KN-5501
lang: EN