PatSnap/clinical-trial huggingface dataset:
Clinical trial NCT03500848: Sirolimus-based Immunosuppression Treatment Regimen for Liver Transplantation
Official title: Sirolimus-based Immunosuppression Treatment Regimen for Liver Transplantation: A Multicenter, Open-label, Randomized, Controlled Clinical Trial in Liver Transplant Recipients With Hepatocellular Carcinoma
Conditions: Liver Transplantation
Summary: This is a multicenter, open-label, randomized, controlled clinical trial, in order to compare sirolimus-based (tacrolimus-free) versus tacrolimus-based (sirolimus-free) immunosuppression regimen for Hepatocellular Carcinoma (HCC) patients after liver transplantation.
Interventions:
description: Tacrolimus will be started between 3 and 7 days post-transplantation and continued after randomization at a dose of 1.0 mg twice a day (bid, 2 mg daily dose). The tacrolimus trough level is measured twice a week for 1 month, followed by trough level once a month thereafter. Tacrolimus trough levels are targeted to be maintained at 8-15ng/ml until Month 6. After Month 6, the dose will be adjusted over time to maintain steady-state tacrolimus trough blood levels of approximately 5-10 ng/mL.
name: Tacrolimus
other_name: Advagraf
FK-506
Fujimycin
Prograf
Protopic
type: Drug
description: Tacrolimus will be started between 3 and 7 days post-transplantation at a dose of 1.0 mg twice a day (bid, 2 mg daily dose) for 30 (± 5) days and eliminated when randomization is done.
name: Tacrolimus (Tacrolimus elimination)
other_name: Advagraf
FK-506
Fujimycin
Prograf
Protopic
type: Drug
description: Within 24 hours of randomization, sirolimus will be started at a dose of 2.0 mg once a day. The sirolimus trough level is measured twice a week for 1 month, followed by trough level once a month thereafter. The dose will be adjusted over time to maintain steady-state sirolimus trough blood levels of approximately 4-10 ng/mL.
name: Sirolimus
other_name: Rapamune
type: Drug
description: For patients in both groups, MMF and/or steroids are initiated at or prior to the time of liver transplantation according to local practice. Steroids reduction is encouraged by 3 months post liver transplantation.
name: MMF and/or steroids
other_name: Mycophenolate mofetil
type: Drug
Study arms:
design_group_description: Tacrolimus-based immunosuppression regimen: Tacrolimus+MMF and/or steroids
design_group_title: Tacrolimus-based group
design_group_type: Active Comparator
design_group_description: Sirolimus-based immunosuppression regimen: Tacrolimus (Tacrolimus elimination 30 (± 5) days post LT)+Sirolimus+MMF and/or steroids
design_group_title: Sirolimus-based group
design_group_type: Experimental
Sponsor: Southern Medical University
Collaborators: the First Affiliated Hospital of Sun Yat-Sen University
Nanfang Hospital
Drug name mappings:
name: 他克莫司
lang: CN
name: Tacrolimus
lang: EN
name: タクロリムス水和物
lang: JP
name: 西罗莫司
lang: CN
name: Sirolimus
lang: EN
name: シロリムス
lang: JP
Clinical trial NCT06696248: Carvedilol and Alverine in Portal Hypertension
Official title: The Efficacy of Carvedilol Combined with Compound Alverine Citrate Soft Capsules in the Treatment of Portal Hypertension in Patients with Liver Cirrhosis: a Prospective, Open-label, Multicentre, Randomised Controlled Trial
Conditions: Hypertension, Portal
Summary: Brief summaries of CZXH-PH-ALV-2403 The goal of this clinical trial is to learn if the combination of alverine and carvedilol works to treat portal hypertension in adult patients with liver cirrhosis. It will also learn about the safety of alverine.
The main question it aims to answer is:
For patients with liver cirrhosis and portal hypertension who have been treated with carvedilol at a dose of up to 15 mg/day or at a lower dose that is the maximum tolerated for at least 3 months, and still have a hepatic venous pressure gradient (HVPG) of 12 mmHg or higher and up to and including 20 mmHg, can the addition of alverine help to reduce portal hypertension? On the basis of maintaining unchanged routine hepatoprotective and symptomatic supportive treatments and the original dose of carvedilol, participants will be administered with compound alverine citrate capsules (Le Jian Su; specification: each capsule contains alverine citrate 60 mg and simeticone 300 mg; manufactured by Laboratoires MAYOLY SPINDLER), at a dosage of 180 mg/day (1 capsule orally, 3 times a day), for a continuous period of 24 weeks.
Interventions:
description: On the basis of maintaining unchanged routine hepatoprotective and symptomatic supportive treatments and the original dose of carvedilol, participants will be administered with compound alverine citrate capsules (Le Jian Su; specification: each capsule contains alverine citrate 60 mg and simeticone 300 mg; manufactured by Laboratoires MAYOLY SPINDLER), at a dosage of 180 mg/day (1 capsule orally, 3 times a day), for a continuous period of 24 weeks.
name: Carvedilol and alverine
type: Drug
Study arms:
design_group_description: On the basis of maintaining unchanged routine hepatoprotective and symptomatic supportive treatments and the original dose of carvedilol, participants will be administered with compound alverine citrate capsules (Le Jian Su; specification: each capsule contains alverine citrate 60 mg and simeticone 300 mg; manufactured by Laboratoires MAYOLY SPINDLER), at a dosage of 180 mg/day (1 capsule orally, 3 times a day), for a continuous period of 24 weeks.
design_group_title: Carvedilol + Alverine Group
design_group_type: Experimental
Sponsor: Shanghai Changzheng Hospital
Collaborators: Shanghai East Hospital
Drug name mappings:
name: 枸橼酸阿尔维林
lang: CN
name: Alverine Citrate
lang: EN
name: 卡维地洛
lang: CN
name: Carvedilol
lang: EN
name: カルベジロール
lang: JP
Clinical trial NCT03040726: Netupitant and Palonosetron Hydrochloride in Preventing Chronic Nausea and Vomiting in Patients With Cancer
Official title: Fixed-Dose Netupitant and Palonosetron for Chronic Nausea and Vomiting in Cancer Patients
Conditions: Malignant Neoplasm
Nausea
Vomiting
Summary: This randomized phase II/III trial studies how well netupitant and palonosetron hydrochloride works in preventing chronic nausea and vomiting in patients with cancer. Netupitant and palonosetron hydrochloride may reduce nausea and vomiting.
Interventions:
description: Given PO
name: Netupitant
other_name: CID6451149
D05152
RO 67-3189/000
type: Drug
description: Given PO
name: Palonosetron
type: Drug
description: Given PO
name: Palonosetron Hydrochloride
other_name: Aloxi
RS 25259-197
type: Drug
description: Given PO
name: Placebo
other_name: PLCB
placebo therapy
sham therapy
type: Other
description: Ancillary studies
name: Questionnaire Administration
type: Other
Study arms:
design_group_description: Patients receive netupitant orally (PO) and palonosetron hydrochloride PO on days 1, 6, and 11 in the absence of disease progression or unacceptable toxicity.
design_group_title: Group I (netupitant, palonosetron hydrochloride)
design_group_type: Experimental
design_group_description: Patients receive placebo PO on days 1, 6, and 11.
design_group_title: Group II (placebo)
design_group_type: Placebo Comparator
Sponsor: The University of Texas MD Anderson Cancer Center
Collaborators: National Cancer Institute
Helsinn Healthcare SA
Drug name mappings:
name: 奈妥吡坦
lang: CN
name: Netupitant
lang: EN
name: 盐酸帕洛诺司琼
lang: CN
name: Palonosetron hydrochloride
lang: EN
name: パロノセトロン塩酸塩
lang: JP
Clinical trial NCT00002930: PET Scan in Patients With Lung and Esophageal Cancers That May Be Removed by Surgery
Official title: Whole-Body 18F-Fluorodeoxyglucose Positron Emission Tomography to Measure the Response to Induction Chemotherapy of Potentially Resectable Lung and Esophageal Carcinomas
Conditions: Esophageal Cancer
Lung Cancer
Summary: RATIONALE: Imaging procedures, such as fludeoxyglucose F 18 positron emission tomography (PET) scans, may improve the ability to detect lung and esophageal cancer or their recurrence.
PURPOSE: Phase II/III trial to study the effectiveness of fludeoxyglucose F 18 PET scans in measuring response to induction chemotherapy in patients with esophageal and lung cancer that may be removed by surgery.
Interventions:
name: positron emission tomography
type: Procedure
name: fludeoxyglucose F 18
type: Radiation
Study arms:
Sponsor: Memorial Sloan Kettering Cancer Center
Collaborators: National Cancer Institute
Drug name mappings:
name: 氟[18F]脱氧葡糖
lang: CN
name: Fludeoxyglucose F-18
lang: EN
name: フルデオキシグルコース(18F)
lang: JP
Clinical trial NCT03979976: Ramipril, Endothelial Function and Endothelial Progenitor Cells in Patients With Systemic Lupus Erythematosus
Official title: Ramipril Improves Endothelial Function and Endothelial Progenitor Cells in Patients With Systemic Lupus Erythematosus: a Randomized and Controlled Study.
Conditions: Systemic Lupus Erythematosus
Summary: The aim of this study was to evaluate the effect of ramipril on the endothelial function and on the number of endothelial progenitor cells (EPCs) in systemic lupus erythematosus (SLE) patients.
Interventions:
description: Use of ramipril 10mg/day per 12 weeks. Telephone contact was made in the second and sixth week, to ask about possible side effects and ensure adherence
name: Ramipril
other_name: angiotensin-converting enzyme inhibitor (ACEI)
type: Drug
Study arms:
design_group_description: Use of ramipril 10mg/day per 12 weeks
design_group_title: ramipril group
design_group_type: Active Comparator
design_group_description: Without ramipril
design_group_title: Control Group
design_group_type: No Intervention
Sponsor: Universidade Federal De Sao Paulo
Collaborators: Fundação de Amparo à Pesquisa do Estado de São Paulo
Drug name mappings:
name: 雷米普利
lang: CN
name: Ramipril
lang: EN
Clinical trial NCT00430001: Vinorelbine Plus (+) Trastuzumab vs Docetaxel Plus (+) Trastuzumab as 1 Line Treatment for HER2 Positive (+) Metastatic Breast Cancer
Official title: A Randomised Phase III Study of Trastuzumab-Docetaxel vs Trastuzumab-Vinorelbine as 1. Line Therapy for Patients With Metastatic HER2 Positive Breast Cancer
Conditions: Breast Cancer
Summary: In an open-label randomised phase III-trial patients with metastatic HER2-positive breast cancer naive to chemotherapy with normal organ function and WHO performance status < 3 are randomised to receive either docetaxel 100 mg/m2 i.v. plus trastuzumab 6 mg/kg (8 mg/kg loading dose) q 3 weeks or vinorelbine 30 or 35 mg/m2 days 1+8 plus trastuzumab 6 mg/kg (8 mg/kg loading dose) q 3 weeks. Primary endpoint is time to progression. Secondary endpoints include overall survival, time to treatment failure, response rate, duration of response and toxicity. The study hypothesis is that docetaxel is more efficient than vinorelbine but also more toxic.
Interventions:
name: docetaxel
type: Drug
name: vinorelbine
type: Drug
name: trastuzumab
type: Drug
Study arms:
Sponsor: Danish Breast Cancer Cooperative Group
Collaborators: Hoffmann-La Roche, Inc.
Sanofi
Drug name mappings:
name: 曲妥珠单抗
lang: CN
name: Trastuzumab
lang: EN
name: トラスツズマブ（遺伝子組換え）
lang: JP
name: 长春瑞滨双酒石酸盐
lang: CN
name: Vinorelbine Tartrate
lang: EN
name: ビノレルビン酒石酸塩
lang: JP
name: 多西他赛
lang: CN
name: Docetaxel
lang: EN
name: ドセタキセル
lang: JP
Clinical trial NCT00213083: Efficacy Study of the Vaginal Gel Carraguard to Prevent HIV Transmission
Official title: Phase 3 Study of the Efficacy and Safety of the Microbicide Carraguard® in Preventing HIV Seroconversion in Women
Conditions: HIV Infections
AIDS
Sexually Transmitted Diseases
HIV Seroconversion
Summary: The purposes of this study are to determine whether Carraguard® Gel can prevent the transmission of HIV when used during vaginal intercourse, and to confirm that the gel is safe for vaginal use.
Interventions:
name: Carraguard (PC-515)
type: Drug
Study arms:
Sponsor: The Population Council, Inc.
Collaborators: Gates Foundation (United States)
Drug name mappings:
name: PC-515
lang: EN
Clinical trial NCT00690573: Safety, Efficacy, and Pharmacokinetics of Adalimumab in Japanese Children With Juvenile Rheumatoid Arthritis
Official title: A Multicenter, Open-label Study of the Safety, Efficacy, and Pharmacokinetics of the Human Anti-TNF Monoclonal Antibody Adalimumab in Children With Polyarticular Juvenile Rheumatoid Arthritis
Conditions: Juvenile Rheumatoid Arthritis
Summary: To evaluate efficacy, safety and pharmacokinetics of adalimumab in Japanese children with Polyarticular Juvenile Rheumatoid Arthritis
Interventions:
description: Adalimumab administered subcutaneously every other week, with dosage determined by body weight at study entry (20 mg for children weighing less than 30 kg, 40 mg for children weighing 30 kg or more).
name: Adalimumab
other_name: adalimumab, ABT-D2E7, Humira
type: Biological
Study arms:
design_group_title: Adalimumab
design_group_type: Experimental
Sponsor: Abbott Laboratories
Collaborators: Eisai Co., Ltd.
Drug name mappings:
name: 阿达木单抗
lang: CN
name: Adalimumab
lang: EN
name: アダリムマブ（遺伝子組換え）
lang: JP
Clinical trial NCT00116220: Study of External Beam Radiation Therapy With and Without Hormonal Therapy to Treat Prostate Cancer
Official title: A Phase III Trial of External Beam of Radiotherapy +/- Total Androgen Suppression for High Risk Clinically Organ-Confined Prostate Cancer
Conditions: Prostate Cancer
Summary: This clinical study was to determine if the use of 6 months of total androgen suppression (hormonal therapy) when added to radiation therapy for localized-high risk prostate cancer would improve overall survival.
Interventions:
description: Androgen suppression therapy
name: Flutamide (Eulexin) and Lupron or Zoladex
type: Drug
description: Once a day, 4-5 days per week for approximately 2 months
name: External Beam Radiotherapy
type: Radiation
Study arms:
design_group_description: External beam radiation therapy + 6 months total androgen ablation
design_group_title: Treatment 1
design_group_type: Active Comparator
design_group_description: External beam radiation therapy
design_group_title: Treatment 2
design_group_type: Active Comparator
Sponsor: Dana-Farber Cancer Institute, Inc.
Collaborators: The Brigham & Women's Hospital, Inc.
Beth Israel Deaconess Medical Center, Inc.
West Metro Medical Center
Drug name mappings:
name: 唑来膦酸
lang: CN
name: Zoledronic Acid
lang: EN
name: ゾレドロン酸水和物
lang: JP
name: 氟他胺
lang: CN
name: Flutamide
lang: EN
name: フルタミド
lang: JP
name: 醋酸亮丙瑞林
lang: CN
name: Leuprolide Acetate
lang: EN
name: リュープロレリン酢酸塩
lang: JP
Clinical trial NCT05345639: Chest Wall Block After Sternotomy: Randomized Controlled Trial in Cardiac Surgery: (PABLOS Study)
Official title: Chest Wall Block After Sternotomy: Randomized Controlled Trial in Cardiac Surgery: (PABLOS Study)
Conditions: Pain, Postoperative
Cardiac Surgery
Summary: The main objective is to compare the effectiveness of LocoRegional Anesthesia (LRA) (bilateral transverse thoracic block or bilateral parasternal block) in addition to standard management compared to standard management alone (general anesthesia without LRA) on the FQoR-15 (French Quality of Recovery - 15 score) at H+24 after cardiac surgery by sternotomy.This is a phase III monocentric superiority study , comparative, with three parallel groups, randomized with a ratio (1:1:1), controlled versus standard management, single-blind.
Interventions:
description: Bilateral parasternal block or transverse thoracic block are performed ultrasound-guided, at the end of surgery in the operating room. Once in the desired plane depending on the randomisation (transverse or parasternal), a volume of 20 ml of ropivacaine at 2 mg/ml is injected on each side of the sternum.<br/>The intervention (TTP or PSB) is performed by the anesthetist-resuscitator investigator.
name: LRA Loco-regional anesthesia
other_name: 40ml Ropivacaine 0.2%
type: Drug
description: The pain management protocol in intensive care is as follows:<br/>* paracetamol 1g x 4 per day systematically (apart from the usual contraindications), IV then PO;<br/>* PCA (Patient Controlled Analgesia) with oxycodone or morphine: 1mg bolus, 7min refractory period, maximum 4h dose 20mg.<br/>The PCA is usually maintained until 24-48h after the intervention then relayed by oxycodone 5mg every 4h if EVA > 3 sublingual and addition of oxycodone LP 10mg x 2 per day if daily intake on PCA > 20mg.<br/>Remedy molecules in case of ineffective analgesia:<br/>ketoprofen 100mg q12h IV, or 50mg q8h PO; nefopam 20mg every 6h IV or PO; ketamine 1 to 1.5 mg/kg/24H IVSE.
name: Standardized post-operative analgesia protocol
type: Procedure
Study arms:
design_group_description: At the end of the surgery, realisation of a bilateral transverse thoracic block. (20ml of Naropeine 0.2%, each side) Followed by standard analgesic treatment.
design_group_title: TTP group (= Transversus Thoracic Plane block = Deep PIP = Deep parasternal intercostal plane block)
design_group_type: Experimental
design_group_description: At the end of the surgery, realisation of a bilateral parasternal block (20ml of Naropeine 0.2%, each side).<br/>Followed by standard analgesic treatment.
design_group_title: PSB group (=ParaSternal Block = Superficial PIP = Superficial parasternal intercostal plane block)
design_group_type: Experimental
design_group_description: Standard analgesic treatment alone (without LRA) .
design_group_title: Control group
design_group_type: Sham Comparator
Sponsor: Centre Hospitalier Universitaire d'Angers
Collaborators: Fondation APICIL
Drug name mappings:
name: 盐酸罗哌卡因
lang: CN
name: Ropivacaine Hydrochloride
lang: EN
name: ロピバカイン塩酸塩水和物
lang: JP
Clinical trial NCT04695860: Anti-FGF23 (Burosumab) in Adult Patients With XLH
Official title: An Investigator-sponsored Phase 3b Open-label Study of Anti- FGF23 Antibody Burosumab (KRN23) in Adult Patients With Xlinked Hypophosphatemia (XLH) in GERmany - BurGER
Conditions: X-linked Hypophosphatemia
Summary: X-linked hypophosphatemia (XLH) rare genetic disorder due by inactivating mutations in the PHEX gene leading to increased levels in FGF-23. Elevated FGF-23 reduces renal phosphate reabsorbtion and and limits 1-alpha hydroxylase driven Vitamin D activation, eventually leading to phosphate wasting, defective bone mineralization and additional health issues.
Burosumab is a recombinant fully human IgG1 monoclonal antibody developed to treat XLH by binding FGF23, thereby restoring normal phosphate homeostasis.
BUR03 is a Phase 3b open-label, single-arm, single-center study to confirm the efficacy and safety of Burosumab treatment in adult (age ≥18 years) XLH patients without upper age limit and irrespective of baseline pain level and to further evaluate the efficacy in this cohort and the assocaited effect of treatment on physical functioning, mobility and activity.
The study aims at enrolling and treating 34 subjects with a confirmed diagnosis of XLH with q4w s.c. injection of Burosumab 1mg/kg body weight over 48 weeks.
Primary objective is to attiain normal serum phosphorus levels, secondary objectives include key parameters of physical function and activity, mobility and mineral homeostasis.
Interventions:
description: Q4w, 1mg/kg Body weight, s.c.
name: Burosumab
type: Drug
Study arms:
design_group_description: Burosumab Q4W, 1mg/kg body weight s.c.
design_group_title: Open label Burosumab
design_group_type: Experimental
Sponsor: Universitätsklinikum Würzburg
Collaborators: Kyowa Kirin, Inc.
Drug name mappings:
name: 布罗索尤单抗
lang: CN
name: Burosumab-TWZA
lang: EN
name: ブロスマブ （遺伝子組換え）
lang: JP
Clinical trial NCT03141073: Long-term Efficacy and Safety of HMS5552 add-on to Metformin in T2DM Subjects
Official title: A 24-week Multi-center, Randomized, Double-blind, Placebo-controlled, Phase III Study to Evaluate the Efficacy and Safety of HMS5552 add-on to Metformin With Additional 28-week Open-label Treatment to Evaluate the Safety in T2DM Subjects
Conditions: Diabetes Mellitus, Type 2
Summary: This study evaluates the efficacy and safety and population PK of HMS5552 add-on to Metformin in adult type 2 diabetic subjects. There will be 2 groups in the first 24 weeks, one group will receive HMS5552 plus Metformin, while the other group will receive placebo plus Metformin; after 24 weeks, all subjects will receive HMS5552 plus Metformin for 28 weeks.
Interventions:
description: BID oral administration
name: HMS5552
other_name: Glucokinase Activator (GKA)
type: Drug
description: BID oral administration
name: Placebo
type: Drug
Study arms:
design_group_description: 75mg BID
design_group_title: HMS5552
design_group_type: Experimental
design_group_description: BID
design_group_title: Placebo
design_group_type: Placebo Comparator
Sponsor: Hua Medicine (Shanghai) Co., Ltd.
Collaborators: Labcorp Drug Development, Inc.
Drug name mappings:
name: 多格列艾汀
lang: CN
name: Dorzagliatin
lang: EN
Clinical trial NCT02449070: Effects of Nicorandil on Cardiac Infarct Size in Patients With ST-segment Elevation Acute Myocardial Infarction
Official title: Effects of Nicorandil on Cardiac Infarct Size in Patients With ST-segment Elevation Acute Myocardial Infarction : A Randomized Clinical Trial
Conditions: Myocardial Infarction
Summary: The purpose of this study is to determine whether nicorandil reduce cardiac infarct size in patient with ST-segment elevation acute myocardial infarction.
Interventions:
description: 4 mg iv after randomization, 2 mg ic just before ballooning, 2 mg ic just before stenting
name: Nicorandil
other_name: Nicrodandil
type: Drug
Study arms:
design_group_description: Receive nicorandil before primary PCI and thereafter for 6 months along with the standard therapy.
design_group_title: Nicorandil
design_group_type: Experimental
design_group_description: Receive primary PCI and the standard therapy.
design_group_title: Control
design_group_type: No Intervention
Sponsor: Pusan National University Hospital
Collaborators: JW PHARMACEUTICAL Corp.
Drug name mappings:
name: 尼可地尔
lang: CN
name: Nicorandil
lang: EN
name: ニコランジル
lang: JP