PatSnap/clinical-trial huggingface dataset:
Clinical trial NCT06407232: Letermovir (Prevymis) for CMV in Kidney and Pancreas Transplant Recipients
Official title: An Interventional Study of Letermovir for Secondary Prophylaxis After Treatment of Cytomegalovirus Infection in High Risk (D+/R-) Kidney and Kidney/Pancreas Transplant Recipients
Conditions: Cytomegalovirus Infections
Kidney Transplant Infection
Pancreas Transplant
Summary: This study is designed to assess how effective letermovir is in preventing recurrence of cytomegalovirus (CMV) infection in adult kidney or kidney/pancreas transplant recipients who are UW Health patients. Participants will be in the study for about 6 months.
Interventions:
description: 480 mg taken orally once daily, for 84 days
name: Letermovir
other_name: Prevymis
type: Drug
Study arms:
design_group_description: Enrolled participants will be converted from treatment with ganciclovir derivatives to letermovir
design_group_title: Letermovir for CMV in Transplant Patients
design_group_type: Experimental
Sponsor: University of Wisconsin-Madison
Collaborators: Merck Sharp & Dohme LLC
Drug name mappings:
name: 来特莫韦
lang: CN
name: Letermovir
lang: EN
name: レテルモビル
lang: JP
Clinical trial NCT00765206: A Pharmacodynamic Study Comparing Zegerid® and Prilosec OTC® (Study CL2008-02)(P07814)(COMPLETED)
Official title: Randomized, Crossover Pharmacodynamic Study Comparing the Effects of Zegerid® (20 mg Omeprazole/Sodium Bicarbonate) and Prilosec OTC® Tablets (20 Mg-equivalent Omeprazole)
Conditions: Gastric Acid
Human Experimentation
Summary: Open-label randomized crossover design study. 60 participants will be evaluated on Day 1 to compare effects on stomach acid; 30 participants will continue treatment for 7 days and will have repeat evaluations at Day 7.
Interventions:
description: Single dose of omeprazole/sodium bicarbonate per day for either 1 or 7 days.
name: Omeprazole/sodium bicarbonate
other_name: Zegerid
type: Drug
description: Single dose of omeprazole magnesium per day for either 1 or 7 days.
name: omeprazole magnesium (20 mg equivalent)
other_name: Prilosec OTC Tablet
type: Drug
Study arms:
design_group_description: Omeprazole 20 mg /sodium bicarbonate 1100 mg over-the-counter (OTC) Capsule
design_group_title: Zegerid
design_group_type: Experimental
design_group_description: Omeprazole magnesium 20 mg OTC tablet
design_group_title: Prilosec
design_group_type: Active Comparator
Sponsor: Bayer AG
Collaborators: Bausch Health Americas, Inc.
Drug name mappings:
name: 奥美拉唑碳酸氢钠
lang: CN
name: Omeprazole/Sodium Bicarbonate
lang: EN
Clinical trial NCT05060406: A Study to Evaluate the Efficacy and Safety of LY06006 in Postmenopausal Women With Osteoporosis at High Risk for Fracture
Official title: A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of LY06006 in Postmenopausal Women With Osteoporosis at High Risk for Fracture
Conditions: Postmenopausal Osteoporosis
Summary: A multicenter, randomized, double-blind, placebo-controlled phase III clinical study will be conducted to evaluate the efficacy and safety of LY06006 in the treatment of postmenopausal women with osteoporosis at high risk for fracture, as well as an exploratory population pharmacokinetic analysis of LY06006.
Interventions:
description: 60 mg/1 ml, once every 6 months administered subcutaneously, two injections in total
name: LY06006
other_name: recombinant human monoclonal anti-RANKL antibody injection
type: Drug
Study arms:
design_group_description: injection<br/>Interventions:<br/>Drug: LY06006 Injection； Dietary Supplement: Elemental Calcium； Dietary Supplement: Vitamin D
design_group_title: LY06006 60mg
design_group_type: Experimental
design_group_description: injection<br/>Interventions:<br/>Drug: Placebo； Dietary Supplement: Elemental Calcium； Dietary Supplement: Vitamin D
design_group_title: Placebo
design_group_type: Placebo Comparator
Sponsor: Luye Pharma Group Ltd.
Collaborators: Shandong Boan Biotechnology Co., Ltd.
Drug name mappings:
name: 地舒单抗生物类似药 (山东博安生物)
lang: CN
name: Denosumab Biosimilar (Boan Biological)
lang: EN
Clinical trial NCT01460472: Immunotherapy With Racotumomab in Advanced Lung Cancer
Official title: A Prospective, Randomized, Multicenter, Open Label Phase III Study of Active Specific Immunotherapy With Racotumomab Plus Best Support Treatment Versus Best Support Treatment in Patients With Advanced Non-small Cell Lung Camcer.
Conditions: NSCLC
Lung Cancer, Non-small Cell
Summary: This is a prospective, randomized, open label, parallel-group, multicenter phase III study to evaluate the efficacy and safety of active specific immunotherapy with racotumomab plus best supportive care versus best supportive care in patients with advanced NSCLC who have achieved an Objective Response (Partial or Complete Response) or Stable Disease with standard first-line treatment. Also immunological parameters will be evaluated. Best supportive therapy will be administered to all patients in the study according to institutional standards and includes any subsequent onco-specific therapies. 1082 patients will be included in the study, with non-small cell lung cancer in stages IIIA (non-resectable), IIIB or IV.
Interventions:
description: Patients will receive best support treatment and vaccination with racotumomab. The vaccination schedule is as follows: 5 doses (1mg/mL each), intradermally, every 2 weeks (induction period) followed by monthly vaccinations until any criteria for discontinuation are met. If disease progression occurs and further onco-specific therapy is indicated, the patient will be able to continue in the study and vaccination will not be interrupted unless criteria for vaccine discontinuation are met.
name: Racotumomab
other_name: 1E10
type: Biological
description: Patients will receive best support treatment for advanced NSCLC as per each institution's standards, including onco-specific therapies when disease progresses.
name: Best Support Treatment
type: Other
Study arms:
design_group_description: Patients will receive Racotumomab and Best Support Treatment, which includes any further onco-specific therapy for progressive disease.
design_group_title: Racotumomab plus Best Support Treatment
design_group_type: Experimental
design_group_description: Patients will receive best support treatment for advanced NSCLC including onco-specific therapies when disease progresses.
design_group_title: Best Support Treatment
design_group_type: Active Comparator
Sponsor: Recombio SL
Collaborators: Innogene Kalbiotech Pte Ltd.
Eurofarma Laboratórios SA
Laboratorio Elea Phoenix SA
CIMAB SA
Drug name mappings:
name: Racotumomab
lang: EN
Clinical trial NCT07361003: A Phase Ib/III Study of Suvemcitug Plus FTD/TPI in Participants With Refractory Metastatic Colorectal Cancer
Official title: A Phase Ib/III Study of Suvemcitug Plus Trifluridine/Tipiracil Tablets (FTD/TPI) Versus Placebo Plus Trifluridine/Tipiracil Tablets in Participants With Refractory Metastatic Colorectal Cancer
Conditions: Refractory Metastatic Colorectal Cancer
Summary: The primary goal of Phase Ib Study is to evaluate the safety of Suvemcitug in combination with trifluridine/tipiracil tablets in colorectal cancer participants.
The primary goal of Phase III Study is to evaluate the efficacy of Suvemcitug in combination with trifluridine/tipiracil tablets in colorectal cancer participants. Researchers will compare Suvemcitug + trifluridine/tipiracil tablets with placebo (a look-alike substance that contains no drug)+ trifluridine/tipiracil tablets to see if Suvemcitug + trifluridine/tipiracil tablets works better in treating refractory metastatic colorectal cancer.
Interventions:
description: Suvemcitug injection at 1.5mg/kg, Trifluridine/tipiracil tablets at 35 mg/m²
name: Suvemcitug injection, trifluridine/tipiracil tablets
type: Drug
description: Suvemcitug placebo injection, Trifluridine/tipiracil tablets at 35 mg/m².
name: Suvemcitug placebo injection, trifluridine/tipiracil tablets
type: Drug
Study arms:
design_group_description: Participants will receive Suvemcitug injection (at 1.5mg/kg for Phase Ib; and a recommended dose level based on Phase Ib result will be used for Phase III part) on Day 1 and Day 15 of each cycle (28 days), and trifluridine/tipiracil tablets at 35 mg/m² on day 1-5, 8-12 of each cycle (28 days), until disease progression, intolerable adverse event, participant withdrawal, or meet other discontinuation criteria as described by the protocol.
design_group_title: Suvemcitug+ trifluridine/tipiracil tablets
design_group_type: Experimental
design_group_description: Participants will receive Suvemcitug placebo injection on Day 1 and Day 15 of each cycle (28 days), and trifluridine/tipiracil tablets at 35 mg/m² on day 1-5, 8-12 of each cycle (28 days), until disease progression, intolerable adverse event, participant withdrawal, or meet other discontinuation criteria as described by the protocol.
design_group_title: Placebo+ trifluridine/tipiracil tablets
design_group_type: Placebo Comparator
Sponsor: Jiangsu Simcere Pharmaceutical Co., Ltd.
Collaborators: Jiangsu Simcere Pharmaceutical Co., Ltd.
Drug name mappings:
name: 曲氟尿苷替匹嘧啶
lang: CN
name: Tipiracil Hydrochloride/Trifluridine
lang: EN
name: トリフルリジン/チピラシル塩酸塩
lang: JP
name: 苏维西塔单抗
lang: CN
name: Sevacizumab
lang: EN
Clinical trial NCT00192400: Trial to Assess the Safety and Tolerability of the Liquid Formulation of CAIV-T in Healthy Children.
Official title: A Prospective, Randomized, Double-Blind, Placebo-Controlled Trial to Compare the Safety, Tolerability, Immunogenicity and Efficacy of One Dose and Two Doses of a Liquid Formulation of Influenza Virus Vaccine, Trivalent, Types A & B, Live Cold-Adapted (CAIV-T) Compared With Placebo in Healthy Children
Conditions: Healthy
Summary: The purpose of this study is to determine the efficacy of the liquid formulation of CAIV-T against culture confirmed influenza illness in healthy children aged at least 6 months and less than 36 months.
Interventions:
name: CAIV-T
type: Biological
Study arms:
Sponsor: MedImmune LLC
Collaborators: Wyeth AB
Drug name mappings:
name: Influenza vaccine live(MedImmune LLC)
lang: EN
Clinical trial NCT03345095: A Phase III Trial of With Marizomib in Patients With Newly Diagnosed Glioblastoma
Official title: A Phase III Trial of Marizomib in Combination With Standard Temozolomide-based Radiochemotherapy Versus Standard Temozolomide-based Radiochemotherapy Alone in Patients With Newly Diagnosed Glioblastoma
Conditions: Newly Diagnosed Glioblastoma
Summary: The standard of care for newly diagnosed glioblastoma includes surgery, involved-field radiotherapy, and concomitant and six cycles of maintenance temozolomide chemotherapy, however the prognosis remains dismal. Marizomib has been tested in patients with newly diagnosed and recurrent glioblastoma in phase I and phase II studies. In patients with recurrent glioblastoma, marizomib was administered as a single agent or in combination with bevacizumab (NCT02330562). Based on encouraging observations, a phase I/II trial of marizomib in combination with Temozolomide+Radiotherapy(TMZ/RT) followed by Temozolomide (TMZ) in newly diagnosed glioblastoma has been launched (NCT02903069) which explores safety and tolerability of this triple combination and which shall help to determine the dose for further clinical trials in glioblastoma. In this context, given that marizomib has been established as a safe addition to the standard TMZ/RT -->TMZ, a phase III study is considered essential to establishing its impact on overall survival.
Interventions:
description: Intravenous administration of Marizomib
name: Marizomib
type: Drug
description: Oral Administration of Temozolomide
name: Temozolomide
other_name: TMZ
type: Drug
description: 60 Gy in 30 fractions over 6 weeks
name: radiotherapy
other_name: RT
type: Radiation
Study arms:
design_group_description: Radiotherapy + Temozolomide + Marizomib followed by adjuvant Temozolomide + Marizomib
design_group_title: Experimental Arm
design_group_type: Experimental
design_group_description: Radiotherapy + Temozolomide followed by adjuvant Temozolomide
design_group_title: Standard Arm
design_group_type: Active Comparator
Sponsor: European Organisation for Research & Treatment of Cancer
Collaborators: Celgene Corp.
Canadian Cancer Trials Group
Drug name mappings:
name: 替莫唑胺
lang: CN
name: Temozolomide
lang: EN
name: テモゾロミド
lang: JP
name: Marizomib
lang: EN
Clinical trial NCT06051409: A Study of Olverembatinib in Patients With Newly Diagnosed Ph+ALL.
Official title: A Pivotal Registrational Phase 3 Study of Olverembatinib Combined With Chemotherapy Versus Imatinib Combined With Chemotherapy in Patients With Newly Diagnosed Philadelphia Chromosome-positive Acute Lymphoblastic Leukemia (Ph+ALL)
Conditions: Ph+ ALL
Summary: A global multicenter, open-label, randomized and registrational Phase 3 study to evaluate efficacy and safety of Olverembatinib combined with chemotherapy versus Imatinib combined with chemotherapy in subjects with newly diagnosed Ph+ALL.
Interventions:
description: Orally, once every other day (QOD).
name: Olverembatinib
type: Drug
description: Orally, once daily (QD).
name: Imatinib
type: Drug
Study arms:
design_group_description: Olverembatinib in combination with chemotherapy
design_group_title: Olverembatinib
design_group_type: Experimental
design_group_description: Imatinib in combination with chemotherapy
design_group_title: Imatinib
design_group_type: Active Comparator
Sponsor: Ascentage Pharma Group, Inc.
Collaborators: Healthquest Pharma Ltd.
Drug name mappings:
name: 奥雷巴替尼
lang: CN
name: Olverembatinib
lang: EN
Clinical trial NCT00087399: Gabapentin With or Without Antidepressants in Treating Hot Flashes in Women Who Have Had Breast Cancer or Have Concerns About Taking Hormone Therapy
Official title: A Phase III Randomized, Trial of Gabapentin Alone or in Conjunction With an Antidepressant in the Management of Hot Flashes in Women Who Have Inadequate Control With an Antidepressant Alone
Conditions: Breast Cancer
Hot Flashes
Summary: RATIONALE: Gabapentin may be effective in relieving hot flashes in women who have had breast cancer or who have concerns about taking hormone therapy to treat hot flashes. It is not yet known whether gabapentin is more effective with or without antidepressants in treating hot flashes.
PURPOSE: This randomized phase III trial is studying gabapentin and antidepressants to see how well they work compared to antidepressants alone in treating hot flashes in women who have had breast cancer or who have concerns about taking hormones to treat hot flashes.
Interventions:
name: gabapentin
type: Drug
name: antidepressant
type: Drug
Study arms:
design_group_description: Patients continue to receive the same antidepressant (as before study entry) on weeks 1-5. During weeks 2-5, patients also receive oral gabapentin once daily on days 8-10, twice daily on days 11-13, and then three times daily on days 14-35 in the absence of unacceptable toxicity.<br/>Patients complete a hot flash diary at baseline and then daily during study treatment.
design_group_title: gabapentin + antidepressant
design_group_type: Experimental
design_group_description: Patients receive gabapentin once daily on days 8-10, twice daily on days 11-13, and then three times daily on days 14-35 in the absence of unacceptable toxicity. Patients are tapered off their antidepressant over 7-10 days and remain on gabapentin alone.<br/>Patients complete a hot flash diary at baseline and then daily during study treatment.
design_group_title: gabapentin
design_group_type: Experimental
Sponsor: Alliance Foundation Trials LLC
Collaborators: National Cancer Institute
Drug name mappings:
name: 加巴喷丁
lang: CN
name: Gabapentin
lang: EN
name: ガバペンチン
lang: JP
Clinical trial NCT01398072: Development of an Optimal Antibiotic Regime for Long-term Therapy in Stable Chronic Obstructive Pulmonary Disease (COPD)
Official title: A Phase III Single-blind, Randomised Placebo Controlled Trial of Long Term Therapy in Patients With Stable COPD Using Moxifloxacin, Azithromycin and Doxycycline: a Bayesian Decision Analysis, Including Other Criteria, Will be Used to Distinguish the Optimal Antibiotic Treatment
Conditions: Chronic Obstructive Pulmonary Disease (COPD).
Summary: Chronic Obstructive Pulmonary Disease (COPD) is the cause of considerable deaths, and exacerbations (flare up of symptoms) are a major cause of hospital admission in the UK. Bacterial infections play an important role in the development of COPD, however, there is little information available about the use of long term antibiotics in the treatment of this disease. Therefore the purpose of this study is to identify the best antibiotic regime for treating patients with COPD who have persistent bacterial infection in their lung. We will test a variety of approaches including both older and newer regimes prescribed either on a daily basis at a lower dose or in "pulsed" courses (for example, every other day or five days every month). The three antibiotics tested in this study are: moxifloxacin, azithromycin and doxycycline. This is a 13 weeks study conducted at the Royal Free Hospital, London. It is expected that approximately 200 patients will be selected for this study. The information we get from this study may help us to treat future patients with COPD better.
Interventions:
description: An oral dose of 400 mg once daily for 5 consecutive days every 4 weeks.
name: Moxifloxacin
type: Drug
description: An oral dose of 250 mg once daily three times a week (every other day).
name: Azithromycin
type: Drug
description: An oral dose of 100 mg once daily.
name: Doxycycline
type: Drug
description: Oral dose of one table once daily.
name: Placebo
type: Drug
Study arms:
design_group_title: Moxifloxacin
design_group_type: Active Comparator
design_group_title: Azithromycin
design_group_type: Active Comparator
design_group_title: Doxycycline
design_group_type: Active Comparator
design_group_title: Placebo
design_group_type: Placebo Comparator
Sponsor: University College London
Collaborators: Royal Free Hampstead NHS Trust
University of Cambridge
Drug name mappings:
name: 盐酸多西环素
lang: CN
name: Doxycycline Hyclate
lang: EN
name: ドキシサイクリン塩酸塩水和物
lang: JP
name: 阿奇霉素
lang: CN
name: Azithromycin
lang: EN
name: アジスロマイシン水和物
lang: JP
name: 盐酸莫西沙星
lang: CN
name: Moxifloxacin Hydrochloride
lang: EN
name: モキシフロキサシン塩酸塩
lang: JP
Clinical trial NCT01423032: Bendamustine Versus Fludarabine in Chronic Lymphocytic Leukemia (CLL)
Official title: Bendamustine Versus Fludarabine as 2nd-line Treatment in Chronic Lymphocytic Leukemia, Stage BINET B+C / RAI II-IV
Conditions: Chronic Lymphocytic Leukemia
Summary: Bendamustine demonstrated clinical activity in pre-treated hematological malignancies due to its unique mechanism of action distinct from standard alkylating agents. This study assesses its efficacy in patients with chronic lymphocytic leukemia pre-treated with an alkylator, in comparison to fludarabine.
Patients with relapsed chronic lymphocytic leukemia requiring treatment after one previous systemic regimen (usually chlorambucil-based) are randomized to either receive bendamustine 100 mg/m² on days 1 and 2 of a 4-week cycle, or standard fludarabine treatment consisting of 25 mg/m² on days 1 to 5 every four weeks. The primary objective was to achieve non-inferior progression-free survival with bendamustine.
Interventions:
description: 100 mg/m² iv, day 1+2, q4w
name: bendamustine
type: Drug
description: 25 mg/m² iv, days 1-5, q4w
name: Fludarabine
type: Drug
Study arms:
design_group_title: Bendamustine
design_group_type: Experimental
design_group_title: Fludarabine
design_group_type: Active Comparator
Sponsor: WiSP Wissenschaftlicher Service Pharma GmbH
Collaborators: ribosepharm GmbH
Mundipharma Research GmbH & Co. KG
Klinikum Leverkusen gGmbH
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
Clinical trial NCT00533624: Myfortic vs. Cellcept in Kidney Transplant Recipients
Official title: Head to Head Comparison of Myfortic vs. Cellcept in the Treatment of Kidney Transplant Recipients Using Our Current Center Standardized Concomitant Immunosuppressive Protocol
Conditions: End Stage Renal Disease
Summary: The comparison the incidence of G.I. toxicity between Myfortic® vs. Cellcept® in 150 sequential patients, in which 75 will be randomized to Cellcept® and 75 to Myfortic® in first and second living or deceased donor renal transplant recipients.
Interventions:
description: Myfortic® 1,440 mg/day
name: Mycophenolate Sodium Delayed Release Tablets
type: Drug
description: Cellcept® 2,000 mg/day
name: Mycophenolate Mofetil
other_name: Cellcept®
type: Drug
Study arms:
design_group_description: Myfortic Group: Myfortic® 1,440 mg/day in two divided doses (induced with either the IL-2 receptor inhibitors or thymoglobulin). Tacrolimus will be dosed to 12-hour trough levels of 8-10 ng/ml. Methylprednisolone is to be given as per our center protocols, weaning to dose levels of <0.1 mg/kg by 3-6 months post-operatively.
design_group_title: 1: Myfortic
design_group_type: Active Comparator
design_group_description: Cellcept® 2,000 mg/day, in divided doses (induced with either the IL-2 receptor inhibitors or thymoglobulin). Tacrolimus will be dosed to 12-hour trough levels of 8-10 ng/ml. Methylprednisolone is to be given as per our center protocols, weaning to dose levels of <0.1 mg/kg by 3-6 months post-operatively.
design_group_title: 2. Cellcept
design_group_type: Active Comparator
Sponsor: University of Miami
Collaborators: Novartis Pharmaceuticals Corp.
Drug name mappings:
name: 吗替麦考酚酯
lang: CN
name: Mycophenolate Mofetil
lang: EN
name: ミコフェノール酸 モフェチル
lang: JP
Clinical trial NCT00799643: Targeting Inflammation Using Salsalate for Type 2 Diabetes-Stage II
Official title: Targeting Inflammation in Type 2 Diabetes: Clinical Trial Using Salsalate
Conditions: Type 2 Diabetes Mellitus
Summary: Growing evidence over recent years supports a potential role for low grade chronic inflammation in the pathogenesis of insulin resistance and type 2 diabetes. In this study we will determine whether salsalate, a member of the commonly used Non-Steroidal Anti-Inflammatory Drug (NSAID) class, is effective in lowering sugars in patients with type 2 diabetes. The study will determine whether salicylates represent a new pharmacological option for diabetes management. The study is conducted in two stages. Enrollment in the first stage is complete. The primary objective of the first stage was to select a dose of salsalate that is both well-tolerated and demonstrates a trend toward improvement in glycemic control. The primary objective of Stage 2 of the study is to evaluate the effects of salsalate on blood sugar control in diabetes; the tolerability of salsalate use in patients with type 2 diabetes (T2D); and the effects of salsalate on measures of inflammation, the metabolic syndrome, and cardiac risk.
Interventions:
description: Salsalate 3.5 g/d orally, divided dosing
name: Salsalate
other_name: disalsid
type: Drug
name: Salsalate Placebo
type: Drug
Study arms:
design_group_description: Salsalate, 3.5 g/d orally, divided dosing
design_group_title: 1
design_group_type: Active Comparator
design_group_description: Salsalate Placebo, orally, divided dosing
design_group_title: 2
design_group_type: Placebo Comparator
Sponsor: Joslin Diabetes Center, Inc.
Collaborators: National Institute of Diabetes & Digestive & Kidney Diseases
Drug name mappings:
name: 双水杨酯
lang: CN
name: Salsalate
lang: EN