PatSnap/clinical-trial huggingface dataset:
Clinical trial NCT00657280: Study of the Effect of Sitagliptin on Glucose (Sugar) Metabolism in Patients With Heart Failure
Official title: Effect of Sitagliptin on Insulin Resistance and Myocardial Metabolism in Heart Failure
Conditions: Heart Failure, Congestive
Summary: This study will investigate the effects of sitagliptin, a medicine commonly used to treat type 2 diabetes, on the utilization of glucose by the heart in patients with heart failure which is not due to heart attacks. We hope to determine whether improving the heart's ability to use glucose in the blood may help improve the function of the heart as well. If so, this may suggest that even people who do not have frank diabetes but who do have heart failure may benefit from using this medication.
This study will also investigate the effect of sitagliptin on the body's use of sugar, and of the effect of sitagliptin on blood flow to the heart.
Interventions:
description: No one is blinded to the treatments.
name: Sitagliptin
other_name: Januvia
type: Drug
Study arms:
design_group_description: All subjects are aware of what they are taking. Nobody is blinded in this study. study
design_group_title: All subjects recieve Sitagliptin
design_group_type: Experimental
Sponsor: Stanford University
Collaborators: Merck Sharp & Dohme Corp.
Drug name mappings:
name: 磷酸西格列汀
lang: CN
name: Sitagliptin Phosphate
lang: EN
name: シタグリプチンリン酸塩水和物
lang: JP
Clinical trial NCT03445702: Metformin Gastrointestinal Intolerance: Measurement of Mitochondrial Complex I
Official title: Metformin Gastrointestinal Intolerance: Measurement of Mitochondrial Complex I
Conditions: Diabetes Mellitus, Type 2
Metformin Adverse Reaction
Summary: Metformin is associated with a high degree of gastrointestinal intolerance, which limits the effective use of the medication. It is proposed to be an inhibitor of liver mitochondrial glycerophosphate dehydrogenase which results in partial blockade of mitochondrial complex 1 and inhibition of metabolism of lactate to pyruvate. There is also evidence that it is accumulated in gastrointestinal cells, and that there are certain genotypes associated with inclusion or lack of exclusion of the metformin from these cells. To validate this hypothesis investigators propose to give metformin after a standard meal test to see if there is the accumulation of lactic acid in those with gastrointestinal intolerance to metformin, compared to those without intolerance, and to determine if these elevations of lactic acid and GI symptoms are associated with genetic predispositions.
Aims:
1. To determine if the GI intolerance to metformin is associated with post meal elevations of lactic acid.
a. The test will measure the inhibition of mitochondrial complex 1 levels of lactate to pyruvate compared with non- intolerant subjects.
2. To determine if individuals with gastrointestinal symptoms and elevated lactate/pyruvate ratios have genetic variation in the organic cation transporters.
Interventions:
description: Metformin 1000mg once
name: Metformin
other_name: Glucophage
type: Drug
description: Sugar pill manufactured to mimic metformin 1000mg
name: Placebo
type: Drug
Study arms:
design_group_description: Metformin 1000mg once
design_group_title: Metformin intolerant & metformin
design_group_type: Experimental
design_group_description: Placebo 1000mg once
design_group_title: Metformin intolerant & placebo
design_group_type: Placebo Comparator
design_group_description: Metformin 1000mg once
design_group_title: Metformin tolerant & metformin
design_group_type: Active Comparator
design_group_description: Placebo 1000mg once
design_group_title: Metformin tolerant and placebo
design_group_type: Placebo Comparator
Sponsor: St. Louis University
Collaborators: Washington University School of Medicine
Drug name mappings:
name: 盐酸二甲双胍
lang: CN
name: Metformin Hydrochloride
lang: EN
name: メトホルミン塩酸塩
lang: JP
Clinical trial NCT06541405: Safety and Efficacy of NK520 to Treat Pediatric Relapsed/Refractory Acute Myeloid Leukemia
Official title: An Open, Single Center Exploratory Study to Evaluate Safety and Efficacy of NK520 for Pediatric Patients With Relapsed/Refractory Acute Myeloid Leukemia
Conditions: Relapsed/Refractory Acute Myeloid Leukemia
Summary: This study will evaluate the safety and efficacy of NK520 in the treatment of pediatric relapsed/refractory acute myeloid leukemia. NK520 will be administered by intravenous injection. The safety and efficacy of this treatment will be evaluated.
Interventions:
description: The number of NK520 cell infused for each dosing should be calculated base on the body weight of subject. NK520 will be administered through intravenous infusion.
name: NK520
other_name: genetic modified NK cell
type: Drug
Study arms:
design_group_description: NK520: 5x10^7 NK/kg
design_group_title: Group A(low-dose group)
design_group_type: Experimental
design_group_description: NK520: 1.5×10^8NK/kg
design_group_title: Group B(medium-dose group)
design_group_type: Experimental
design_group_description: NK520: 3×10^8NK/kg
design_group_title: Group C(high-dose group)
design_group_type: Experimental
Sponsor: Base Therapeutics (Shanghai) Ltd.
Collaborators: Shanghai Children's Medical Center
Drug name mappings:
name: NK-520
lang: EN
Clinical trial NCT06552260: A Surgical Window of Opportunity Clinical Trial of Troriluzole in Recurrent IDH Wild-Type Glioblastoma
Official title: A Surgical Window of Opportunity Clinical Trial of Troriluzole in Recurrent IDH Wild-Type Glioblastoma
Conditions: Glioblastoma
Recurrent Glioblastoma
Brain Tumor
Summary: This research study is studying troriluzole as a possible treatment for recurrent glioblastoma.
The name of the study drug involved in this research study is:
-Troriluzole (a tripeptide prodrug of riluzole)
Interventions:
description: Tripeptide prodrug of Riluzole, 100 mg capsule, taken orally per protocol.
name: Troriluzole
other_name: 2-Amino-N-({methyl-[(6-trifluoromethoxy-benzothiazol-2-ylcarbamoyl)-methyl]-carbamoyl}-methyl)-acetamide monohydrate monohydrochloride
BHV-4157
C15H16F3N5O4S.HCl.H2O
FC-4157
Trigriluzole
type: Drug
Study arms:
design_group_description: 18 participants will be randomly assigned to this group and with complete:<br/>* Baseline visit with assessments and MRI.<br/>* Cycle 0:<br/>  * Day -6 through Day 0: Predetermined dose of Troriluzole 2x daily.<br/>  * Day 0: pre-op MRI<br/>  * Day 0: standard of care surgical resection of tumor<br/>  * Day 0: post-op MRI<br/>* Cycle 1 through Cycle 3:<br/>  --Days 1 through 28 of 28 day cycle: Predetermined dose of Troriluzole 2x daily.<br/>* Cycle 3 through End of Treatment:<br/>  --Days 1 through 28 of 28 day cycle: Predetermined dose of Troriluzole 2x daily.<br/>* MRIs every 8 weeks while on treatment.<br/>* End of study visit with MRI<br/>* Follow up every 3 months for 1 year, and then every 6 months for the next 3 years.
design_group_title: Group A: Presurgical Troriluzole
design_group_type: Experimental
design_group_description: 9 participants will be randomly assigned to this group and with complete:<br/>* Baseline visit with assessments and MRI<br/>* Day 0: pre-op MRI<br/>* Day 0: standard of care surgical resection of tumor<br/>* Day 0: post-op MRI<br/>* Cycle 1 through Cycle 3:<br/>  --Days 1 through 28 of 28 day cycle: Predetermined dose of Troriluzole 2x daily.<br/>* Cycle 3 through End of Treatment:<br/>  --Days 1 through 28 of 28 day cycle: Predetermined dose of Troriluzole 2x daily.<br/>* MRIs every 8 weeks while on treatment.<br/>* End of study visit with MRI<br/>* Follow up every 3 months for 1 year, and then every 6 months for the next 3 years.
design_group_title: Group B: Surgery + Troriluzole
design_group_type: Experimental
Sponsor: Dana-Farber Cancer Institute, Inc.
Collaborators: Biohaven Pharmaceuticals, Inc.
National Institutes of Health
Drug name mappings:
name: Trigriluzole
lang: EN
Clinical trial NCT02515240: Immune Response to Pneumococcal Vaccination in HIV Infected Individuals
Official title: Immune Response to Pneumococcal Vaccination in HIV Infected Individuals
Conditions: Pneumococcal Infection
Summary: The purpose of the study. To characterize the immune response to the pneumococcal vaccine in HIV positive individuals and to dissect the most appropriate timing and frequency of vaccination.
Interventions:
description: 23 valent pneumococcal polysaccharide vaccine in Healthy adults.
name: PPV23
other_name: 23 valent pneumococcal polysaccharide vaccine
type: Biological
Study arms:
design_group_description: healthy individuals, HIV negative, 19-50 yrs if age, immunized with one shot of PPV23 vaccine.
design_group_title: healthy controls
design_group_type: Active Comparator
design_group_description: Newly diagnosed HIV positive patients with CD4 count >200, immunized with one shot of PPV23 vaccine.
design_group_title: newly diagnosed HIV >200
design_group_type: Active Comparator
design_group_description: Newly diagnosed HIVpositive patients with CD4 count <200, immediately immunized with one shot of PPV23 vaccine.
design_group_title: newly diagnosed HIV <200
design_group_type: Active Comparator
design_group_description: Newly diagnosed HIV positive patients with CD4 count <200 delayed immunization with one shot of PPV23 vaccine, treated for 6-12 months with Highly Active Anti-Retroviral Therapy (HAART) first.
design_group_title: newly diagnosed HIV <200 delayed
design_group_type: Active Comparator
design_group_description: HIV positive, on HAART treatment for 5 years, nadir CD4 count <200, but at present CD4 count is >200, immunized with one shot of PPV23 vaccine.
design_group_title: HAART experienced HIV>200
design_group_type: Active Comparator
design_group_description: HIVpositive, on HAART treatment for 5 years, nadir CD4 count <200, and at present CD4 count is <200, immunized with one shot of PPV23 vaccine.
design_group_title: HAART experienced HIV<200
design_group_type: Active Comparator
Sponsor: University of Toledo
Collaborators: National Institutes of Health
Drug name mappings:
name: 23价肺炎球菌多糖疫苗 (北京科兴)
lang: CN
name: Pneumococcal 23-valent vaccine(Sinovac Biotech Ltd.)
lang: EN
Clinical trial NCT03446651: Mechanism and Effects of Manipulating Chloride Homeostasis in Acute Heart Failure
Official title: Mechanism and Effects of Manipulating Chloride Homeostasis in Acute Heart Failure
Conditions: Heart Failure
Summary: The purpose of this study is to understand the effects of chloride supplementation on volume-overloaded acute heart failure patients concomitantly treated with IV diuretics.
Interventions:
description: Patients will receive 7 days of therapy using 115 mmol/day of lysine chloride. Patients will be given the option of a taste test of both lysine chloride & the placebo powders mixed with various beverages to ensure it is palatable to them. If the patient feels they will not be able to take the study medication twice a day due to taste, they will be withdrawn from the study at this time.
name: Lysine Chloride
type: Drug
description: Patients will receive 7 days of therapy using placebo. Patients will be given the option of a taste test of both lysine chloride & the placebo powders mixed with various beverages to ensure it is palatable to them. If the patient feels they will not be able to take the study medication twice a day due to taste, they will be withdrawn from the study at this time.
name: Placebo
type: Other
Study arms:
design_group_description: Participants will be randomized to 7 days of therapy with either 115 mmol/day of lysine chloride or placebo. People in the Lysine Chloride group will receive the active intervention.
design_group_title: Lysine Chloride
design_group_type: Experimental
design_group_description: Participants will be randomized to 7 days of therapy with either 115 mmol/day of lysine chloride or placebo. People in the Placebo group will receive placebo.
design_group_title: Placebo
design_group_type: Placebo Comparator
Sponsor: Yale University
Collaborators: National Heart, Lung & Blood Institute
Drug name mappings:
name: 盐酸赖氨酸
lang: CN
name: L-Lysine hydrochloride
lang: EN
Clinical trial NCT03145259: Evaluation of Bioavailability of Diclofenac Dermal Products
Official title: Evaluation of Bioavailability of Diclofenac Dermal Products
Conditions: Bioavailability
Summary: The study will utilize already FDA-approved marketed diclofenac products in healthy adults to generate data for establishing rate of drug delivery comparisons between diclofenac epolamine patches and diclofenac sodium solution in healthy adults and to determine skin concentrations.
Interventions:
description: patch
name: Diclofenac Epolamine Patch
other_name: patch
type: Drug
description: solution
name: diclofenac sodium solution
other_name: solution
type: Drug
Study arms:
design_group_description: Study Session 1: diclofenac epolamine patches (PK) [51 h study duration]
design_group_title: Diclofenac patch
design_group_type: Other
design_group_description: Study Session 2: diclofenac sodium solution (PK) [47 h study duration]
design_group_title: Diclofenac solution
design_group_type: Other
design_group_description: Study Session 3: diclofenac epolamine patch pieces and diclofenac sodium solution (no PK, for skin tape stripping) [51 h study duration]
design_group_title: Diclofenac patch and solution
design_group_type: Other
Sponsor: University of Maryland Baltimore
Collaborators: US Food & Drug Administration
Drug name mappings:
name: 双氯芬酸依泊胺
lang: CN
name: Diclofenac Epolamine
lang: EN
name: 双氯芬酸钠
lang: CN
name: Diclofenac Sodium
lang: EN
name: ジクロフェナクナトリウム
lang: JP
Clinical trial NCT02239354: A Safety, Tolerability, and Efficacy Study of VC-01™ Combination Product in Subjects With Type I Diabetes Mellitus
Official title: A Prospective, Multicenter, Open-Label, First-in-Human Phase 1/2 Study With Two Cohorts to Evaluate the Safety, Tolerability, and Efficacy of Various Doses of VC-01™ Combination Product in Subjects With Type 1 Diabetes Mellitus
Conditions: Type 1 Diabetes Mellitus
Summary: The purpose of this trial is to test if VC-01™ combination product can be implanted subcutaneously in subjects with Type 1 Diabetes and maintained safely for two years. It will also test if VC-01 is an effective treatment for subjects with Type 1 Diabetes.
Interventions:
description: Biologic and Device
name: VC-01™ Combination Product
type: Combination Product
Study arms:
design_group_description: 2 VC-01™ Combination Product implants
design_group_title: Cohort 1
design_group_type: Experimental
design_group_description: 4 or 6 VC-01™ Combination Product implants
design_group_title: Cohort 2
design_group_type: Experimental
Sponsor: ViaCyte, Inc.
Collaborators: California Institute for Regenerative Medicine
Drug name mappings:
name: PEC Encap
lang: EN
Clinical trial NCT03008187: MEN1703 (SEL24) in Participants With Acute Myeloid Leukemia
Official title: A Phase I/II Study of SEL24 in Patients With Acute Myeloid Leukemia
Conditions: Acute Myeloid Leukemia
Summary: The purpose of the clinical trial is to identify the maximum tolerated dose of MEN1703 and to further investigate its safety profile in participants with acute myeloid leukemia (AML).
Interventions:
description: MEN1703 given as oral capsules once daily for 14 consecutive days over a 21-day treatment cycle.
name: MEN1703
other_name: SEL24
SEL24-B489
type: Drug
Study arms:
design_group_description: Participants received MEN1703 (25 milligrams [mg]) orally once daily for 14 consecutive days in cycles of 21 days.
design_group_title: Cohort 1 (25 mg)
design_group_type: Experimental
design_group_description: Participants received MEN1703 (50 mg) orally once daily for 14 consecutive days in cycles of 21 days.
design_group_title: Cohort 2 (50 mg)
design_group_type: Experimental
design_group_description: Participants received MEN1703 (75 mg) orally once daily for 14 consecutive days in cycles of 21 days.
design_group_title: Cohort 3 (75 mg)
design_group_type: Experimental
design_group_description: Participants received MEN1703 (100 mg) orally once daily for 14 consecutive days in cycles of 21 days.
design_group_title: Cohort 4 (100 mg)
design_group_type: Experimental
design_group_description: Participants received MEN1703 (125 mg) orally once daily for 14 consecutive days in cycles of 21 days.
design_group_title: Cohort 5 (125 mg)
design_group_type: Experimental
design_group_description: Participants received MEN1703 (150 mg) orally once daily for 14 consecutive days in cycles of 21 days.
design_group_title: Cohort 6 (150 mg)
design_group_type: Experimental
Sponsor: A.Menarini Industrie Farmaceutiche Riunite Srl
Collaborators: Theradex (Europe) Ltd.
Medpace, Inc.
Drug name mappings:
name: Dapolsertib
lang: EN
Clinical trial NCT01518556: Safety and Efficacy Study of Idarubicin Dose Intensification to Treat Acute Myeloid Leukemia
Official title: Phase I/II Clinical Study of Idarubicin Dose Intensification for Remission Induction Therapy in Acute Myeloid Leukemia Patients Age of 65 Years or Less
Conditions: Leukemia, Myeloid, Acute
Summary: The purpose of this study is to determine whether idarubicin dose intensification is safe and effective as a remission induction therapy for acute myeloid leukemia.
Interventions:
description: In the phase I study, idarubicin dose is increased step by step as follows: 12 mg/m2/day for 3 days IV in the 1st step; 15 mg/m2/day for 3 days IV in the 2nd step; 18 mg/m2/day for 3 days IV in the 3rd step.<br/>In the phase II study, idarubicin dose is the maximum tolerated dose that is determined from the phase I study or 18 mg/m2/day for 3 days .
name: Idarubicin
other_name: IDARU INJ
type: Drug
Study arms:
design_group_description: Idarubicin dose intensification for remission induction in acute myeloid leukemia
design_group_title: Idarubicin
design_group_type: Experimental
Sponsor: Konkuk University Medical Center
Collaborators: Jeonbuk National University Hospital
Samsung Medical Center
Seoul National University Hospital
Soon Chun Hyang University
Pusan National University Hospital
Ewha Womans University
Chung-Ang University Hosptial
Drug name mappings:
name: 盐酸伊达比星
lang: CN
name: Idarubicin Hydrochloride
lang: EN
name: イダルビシン塩酸塩
lang: JP
Clinical trial NCT00834678: Bendamustine and Erlotinib in Treating Patients With Stage IIIB, Stage IIIC, or Stage IV Breast Cancer
Official title: Phase I/II Study of Bendamustine and Erlotinib for Metastatic or Locally Advanced Triple Negative Breast Cancer
Conditions: Breast Cancer
Summary: RATIONALE: Drugs used in chemotherapy, such as bendamustine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Giving bendamustine together with erlotinib may kill more tumor cells.
PURPOSE: This phase I/II trial is studying the side effects and best dose of giving bendamustine together with erlotinib in treating patients with stage IIIB, stage IIIC, or stage IV breast cancer.
Interventions:
description: 100 or 120 mg/m2 IV on days 1 and 2
name: bendamustine
other_name: Ribomustin
SDX- 105
Treanda
type: Drug
description: 100 or 150 mg po on days 5 - 21 of each 28 day cycle
name: erlotinib
other_name: Tarceva
type: Drug
description: 150 mg po daily (days 1 - 28 of 28 day cycle)
name: Maintenance erlotinib
other_name: Tarceva
type: Drug
Study arms:
design_group_description: Bendamustine 100 or 120 mg/m2 IV on days 1 and 2 and erlotinib 100 or 150 mg po on days 5 - 21 of each 28 day cycle.
design_group_title: Bendamustine and Erlotinib
design_group_type: Experimental
Sponsor: Ohio State University Comprehensive Cancer Center
Collaborators: Genentech, Inc.
National Comprehensive Cancer Network, Inc.
Drug name mappings:
name: 盐酸苯达莫司汀
lang: CN
name: Bendamustine Hydrochloride
lang: EN
name: ベンダムスチン塩酸塩
lang: JP
name: 盐酸厄洛替尼
lang: CN
name: Erlotinib Hydrochloride
lang: EN
name: エルロチニブ塩酸塩
lang: JP
Clinical trial NCT05240300: A Study of Topical BX005-A in Subjects With Moderate to Severe Atopic Dermatitis
Official title: A Phase 1b/2a, Double-blind (Sponsor Open), Randomized, Vehicle-controlled Study of Topically Administered BX005-A in Subjects With Moderate to Severe Atopic Dermatitis
Conditions: Atopic Dermatitis
Summary: The purpose of study BMX-05-001 is to evaluate the safety, tolerability, efficacy, and pharmacodynamics of BX005-A compared to vehicle administered topically in adult subjects with moderate to severe atopic dermatitis (AD).
Interventions:
description: phage gel
name: BX005-A
type: Biological
description: vehicle gel
name: Placebo
type: Other
Study arms:
design_group_description: twice daily topical application x 8 weeks
design_group_title: BX005-A
design_group_type: Experimental
design_group_description: twice daily topical application x 8 weeks
design_group_title: Vehicle
design_group_type: Placebo Comparator
Sponsor: BiomX, Inc.
Collaborators: Maruho Co., Ltd.
Drug name mappings:
name: BX-005
lang: EN
Clinical trial NCT00867321: Bevacizumab and Sorafenib as First-Line Therapy in Treating Patients With Locally Advanced or Metastatic Liver Cancer
Official title: Phase I/II Randomized Trial of Sorafenib and Bevacizumab as First-Line Therapy in Patients With Locally Advanced or Metastatic Hepatocellular Carcinoma
Conditions: Liver Cancer
Summary: RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Bevacizumab and sorafenib may also stop the growth of liver cancer by blocking blood flow to the tumor.
PURPOSE: This randomized phase I/II trial is studying the best dose of bevacizumab when given together with sorafenib as first-line therapy in treating patients with locally advanced or metastatic liver cancer.(Phase I closed to accrual as of 11/03/2010)
Interventions:
description: Given IV
name: bevacizumab
type: Biological
description: Given orally
name: sorafenib tosylate
type: Drug
Study arms:
design_group_description: Patients receive oral sorafenib tosylate on days 1-28 twice daily and bevacizumab IV on days 1 and 15.
design_group_title: Arm I (Phase II)
design_group_type: Experimental
design_group_description: Patients receive oral sorafenib tosylate twice daily on days 1-28.
design_group_title: Arm II (Phase II)
design_group_type: Experimental
Sponsor: Alliance Foundation Trials LLC
Collaborators: National Cancer Institute
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: 甲苯磺酸索拉非尼
lang: CN
name: Sorafenib Tosylate
lang: EN
name: ソラフェニブトシル酸塩
lang: JP