PatSnap/clinical-trial huggingface dataset:
Clinical trial NCT01842841: Multicenter Extension Study of Velaglucerase Alfa in Japanese Patients With Gaucher Disease
Official title: A Multicenter, Open-label Extension Study of Velaglucerase Alfa Enzyme Replacement Therapy in Japanese Patients With Gaucher Disease
Conditions: Gaucher Disease
Summary: Gaucher disease is an inherited deficiency of the lysosomal enzyme glucocerebrosidase (GCB) that leads to progressive accumulation of glucocerebroside within macrophages and subsequent tissue and organ damage; typically of the liver, spleen, bone marrow, and brain. Type 1 Gaucher disease affects an estimated 30,000 persons worldwide and is the most common. Type 1 Gaucher disease does not involve the central nervous system. Patients with Type 2 Gaucher disease present with acute neurological deterioration, which leads to early death. Those with Type 3 disease typically display a more sub-acute neurological course, with later onset and slower progression.
The primary objective of this study is to evaluate the long-term safety of every other week (EOW) dosing of velaglucerase alfa in Japanese patients with Gaucher disease who completed study HGT-GCB-087 and elected to continue treatment with velaglucerase alfa.
Velaglucerase alfa has been developed and approved as an enzyme replacement therapy for Type 1 Gaucher disease.
Interventions:
description: 15-60 U/kg, EOW
name: velaglucerase alfa
other_name: VPRIV
type: Drug
Study arms:
design_group_description: 15 to 60 U/kg, EOW via intravenous infusion
design_group_title: velaglucerase alfa
design_group_type: Experimental
Sponsor: Shire Plc
Collaborators: Quintiles, Inc. (California)
Drug name mappings:
name: 维拉苷酶α
lang: CN
name: Velaglucerase Alfa
lang: EN
name: ベラグルセラーゼ アルファ（遺伝子組換え）
lang: JP
Clinical trial NCT04762459: Efficacy and Safety of Almonertinib Combined With or Without Chemotherapy as an Adjuvant Treatment for Stage II-IIIA Non-small Cell Lung Carcinoma Following Complete Tumour Resection
Official title: Efficacy and Safety of Almonertinib Combined With or Without Chemotherapy as an Adjuvant Treatment for EGFR Mutation Positive Stage II-IIIA Non-small Cell Lung Carcinoma Following Complete Tumour Resection: A Multicenter, Randomized Controlled, Open-label Clinical Study
Conditions: Non-small Cell Lung Carcinoma
Summary: This is a multicenter, randomized, open label, phase III study.
Interventions:
description: Almonertinib 110mg PO once daily
name: Almonertinib
type: Drug
description: 500 milligrams per square meter (mg/m²) Pemetrexed
name: Pemetrexed
type: Drug
description: 75mg/m² Cisplatin taken intravenously (IV) once every 3 weeks concurrently
name: Cisplatin
type: Drug
Study arms:
design_group_description: Drug: Almonertinib 110 mg A cycle of treatment is defined as 21 days of once daily treatment. Number of Cycles: The patient continues to receive treatment until the disease progresses or reaches termination criteria. The overall treatment last for 3 years.
design_group_title: Almonertinib
design_group_type: Active Comparator
design_group_description: Drug: Almonertinib 110 mg Drug: Pemetrexed 500 mg/m² IV on day 1 of each 21 day cycle. Number of cycles until disease progression or unacceptable toxicity develops.<br/>Drug: Cisplatin 75mg/m2 IV on day 1 of each 21 day cycle. Number of cycles until disease progression or unacceptable toxicity develops.<br/>A cycle of treatment is defined as 21 days of once daily treatment. Number of Cycles: The patient continues to receive treatment until the disease progresses or reaches termination criteria. The overall treatment last for 3 years.
design_group_title: Almonertinib/Pemetrexed/Cisplatin
design_group_type: Experimental
design_group_description: Drug: Pemetrexed 500 mg/m² IV on day 1 of each 21 day cycle. Number of cycles until disease progression or unacceptable toxicity develops.<br/>Drug: Cisplatin 75mg/m2 IV on day 1 of each 21 day cycle. Number of cycles until disease progression or unacceptable toxicity develops.<br/>A cycle of treatment is defined as 21 days of once daily treatment. Number of Cycles: The patient continues to receive treatment until the disease progresses or reaches termination criteria. If disease progresses during the treatment period and conditions required for the cross-treatment are met according to the assessment process, the patient can start to receive the open cross-treatment of Almonertinib. The overall treatment last for 3 years.
design_group_title: Pemetrexed/Cisplatin
design_group_type: Active Comparator
Collaborators: Genecast Biotechnology Co. Ltd.
Jiangsu Hansoh Pharmaceutical Group Co., Ltd.
Drug name mappings:
name: 培美曲塞二钾
lang: CN
name: Pemetrexed Dipotassium
lang: EN
name: 甲磺酸阿美替尼
lang: CN
name: Almonertinib Mesilate
lang: EN
name: 顺铂
lang: CN
name: Cisplatin
lang: EN
name: シスプラチン
lang: JP
Clinical trial NCT00252733: Diabetic Retinopathy Candesartan Trials
Official title: Effects of Candesartan Cilexetil (Candesartan) on Diabetic Retinopathy in Type 1 Diabetic Patients Without Retinopathy.
Conditions: Type 1 Diabetes
Summary: The primary objective is to determine whether candesartan, compared to placebo reduces the incidence of diabetic retinopathy in normotensive, normoalbuminuric type 1 diabetic patients without retinopathy.
The secondary objective is to determine whether candesartan, compared to placebo, beneficially influences the rate of change in urinary albumin excretion rate (UAER).
This study is part of the DIRECT Programme also including secondary prevention studies of diabetic retinopathy in both type 1 and type 2 diabetes. The primary objective for all three pooled studies is to determine whether candesartan, compared to placebo, reduces the incidence of microalbuminuria in type 1 and type 2 diabetic patients.
Interventions:
description: 32 mg once daily oral tablet given over 60 months
name: candesartan cilexetil
other_name: ATACAND
type: Drug
Study arms:
design_group_description: Placebo
design_group_title: 1
design_group_type: No Intervention
design_group_description: candesartan cilexetil
design_group_title: 2
design_group_type: Experimental
Sponsor: AstraZeneca PLC
Collaborators: Takeda Pharmaceutical Co., Ltd.
Drug name mappings:
name: 坎地沙坦酯
lang: CN
name: Candesartan Cilexetil
lang: EN
name: カンデサルタン シレキセチル
lang: JP
Clinical trial NCT04765059: A Study to Evaluate Chemotherapy Plus Osimertinib Against Chemotherapy Plus Placebo in Patients With Non-small Cell Lung Cancer (NSCLC)
Official title: A Phase III, Randomized, Double-Blind, Placebo-Controlled Study of Platinum Plus Pemetrexed Chemotherapy Plus Osimertinib Versus Platinum Plus Pemetrexed Chemotherapy Plus Placebo in Patients With EGFRm, Locally Advanced or Metastatic NSCLC Who Have Progressed Extracranially Following First-Line Osimertinib Therapy (COMPEL)
Conditions: Non-small Cell Lung Cancer
Summary: The study will evaluate the efficacy and safety of treatment with chemotherapy in combination with osimertinib compared to chemotherapy in combination with placebo in patients whose disease has progressed extracranially following first-line osimertinib treatment.
Interventions:
description: Randomized patients will receive oral dose of osimertinib with intravenous (IV) pemetrexed plus either IV cisplatin or IV carboplatin
name: Osimertinib (AZD9291) pemetrexed cisplatin or carboplatin
type: Drug
description: Randomized patients will receive oral dose of placebo matching osimertinib with IV pemetrexed plus either IV cisplatin or IV carboplatin
name: Placebo for osimertinib (AZD9291) pemetrexed cisplatin or carboplatin
type: Drug
Study arms:
design_group_description: All randomized patients will receive osimertinib 80 mg QD with pemetrexed (500 mg/m^2) (with pre-treatment) plus either cisplatin (75 mg/m^2) or carboplatin ([AUC] 5), both administered on Day 1 of 21-day cycles for 4 cycles, followed by osimertinib 80 mg QD plus pemetrexed maintenance (500 mg/m^2) on Day 1 of 21-day cycles
design_group_title: Treatment Arm A
design_group_type: Experimental
design_group_description: All randomized patients will receive placebo QD with pemetrexed (500 mg/m^2) (with pre-treatment) plus either cisplatin (75 mg/m^2) or carboplatin (AUC5), both administered on Day 1 of 21-day cycles for 4 cycles, followed by placebo QD plus pemetrexed maintenance (500 mg/m^2) on Day 1 of 21-day cycles
design_group_title: Treatment Arm B
design_group_type: Placebo Comparator
Sponsor: AstraZeneca PLC
Collaborators: PAREXEL International Corp.
Drug name mappings:
name: 卡铂
lang: CN
name: Carboplatin
lang: EN
name: カルボプラチン
lang: JP
name: 顺铂
lang: CN
name: Cisplatin
lang: EN
name: シスプラチン
lang: JP
name: 培美曲塞二钠
lang: CN
name: Pemetrexed Disodium Hydrate
lang: EN
name: ペメトレキセドナトリウム水和物
lang: JP
name: 甲磺酸奥希替尼
lang: CN
name: Osimertinib mesylate
lang: EN
name: オシメルチニブメシル酸塩
lang: JP
Clinical trial NCT02498301: Trial Evaluating Chemoprophylaxis Against Travelers' Diarrhea - Prevent TD
Official title: A Randomized, Placebo-Controlled, Double-Blind, Clinical Trial Evaluating Two Dose Regimens of Rifaximin (550 mg Daily or 550 mg Twice Daily) for Chemoprophylaxis Against Travelers' Diarrhea (TD) Among Active Duty Deployed U.S. and British Military Personnel
Conditions: Travelers' Diarrhea
Functional Bowel Disorders
Reactive Arthritis
Summary: The purpose of this study is to develop evidence on the relative efficacy of 2 rifaximin chemoprophylaxis regimens for the prevention of Travelers' Diarrhea (TD) in a deployed setting. An additional purpose is to explore the effect of chemoprophylaxis on microbial flora and antimicrobial resistance, and obtain parameter estimates to inform a cost-effectiveness model of chemoprophylaxis in prevention of TD. Information from this study will be used to develop management guidelines for the prevention of TD among deployed (United States (US) and United Kingdom (UK) military personnel.
The study will be a multi-site, randomized, placebo-controlled, double-blind, clinical trial among deployed military personnel. The study will test 2 TD chemoprophylaxis regimens (once daily versus twice daily) of the same antibiotic, rifaximin, compared to a placebo.
For the proposed chemoprophylaxis study described herein, cohorts of military personnel (US and UK) deploying/traveling overseas will be recruited prior to travel to participate and will undergo enrollment procedures as outlined in study appendices. Subjects who are eligible and agree to participate will be randomized to receive one of 3 regimens: (1) rifaximin 550 mg daily; (2) rifaximin 550 mg twice a day; or (3) placebo, to be taken while deployed. Chemoprophylaxis will be maintained for duration of travel or a predetermined period of up to 6 weeks and at least 2 weeks, which may include a period of up to 5 days of use after return to COO for deployments less than 6 weeks in duration. Clinical and laboratory data will be obtained before, during if available and after deployment/chemoprophylaxis.
Interventions:
description: Rifaximin will be provided to subjects either daily with placebo, or twice daily depending on which of the two experimental arms they are randomized to
name: Rifaximin
other_name: Xifaxan
type: Drug
description: Placebo will be administered twice daily or once daily with rifaximin depending on which experimental arm they are randomized to
name: Placebo
type: Drug
Study arms:
design_group_description: rifaximin, 550 mg, once daily, by mouth
design_group_title: Rifaximin 550 mg once/day
design_group_type: Experimental
design_group_description: rifaximin, 550 mg, twice daily, by mouth
design_group_title: Rifaximin 550 mg twice/day
design_group_type: Experimental
design_group_description: Placebo pills, twice daily, by mouth
design_group_title: Placebo
design_group_type: Placebo Comparator
Sponsor: The Henry M. Jackson Foundation
Collaborators: United Kingdom Ministry of Defence
Naval Medical Research Center
Drug name mappings:
name: 利福昔明
lang: CN
name: Rifaximin
lang: EN
name: リファキシミン
lang: JP
Clinical trial NCT00151138: Cognitive/Cerebrovascular Consequences of HTN Treatment
Official title: Cognitive and Cerebrovascular Sequelae of Hypertension
Conditions: Hypertension
Summary: Randomized trial of two antihypertensive drugs of known efficacy to investigate whether one has more favorable effects on brain blood flow and cognitive function.
Interventions:
name: Atenolol (drug), Lisinopril (drug)
type: Drug
Study arms:
Sponsor: University of Pittsburgh
Collaborators: National Heart, Lung & Blood Institute
Drug name mappings:
name: 赖诺普利
lang: CN
name: Lisinopril
lang: EN
name: リシノプリル水和物
lang: JP
name: 阿替洛尔
lang: CN
name: Atendol
lang: EN
name: アテノロール
lang: JP
Clinical trial NCT00878371: Effects of a Surgery-induced Peripheral Inflammatory Response on the Blood Brain Barrier
Official title: Identification and Quantification of the Effects of a Surgery-induced Peripheral Inflammatory Response on Changes in Drug Efflux Transporter Function in the Brain
Conditions: Dissecting Aneurysm of the Thoracic Aorta
Summary: The purpose for this study is to determine if surgery (repair of descending thoracic aneurysm) causes a temporary decrease in the Blood Brain Barrier's ability to remove drugs from the brain back into the blood. The Blood Brain Barrier surrounds the brain and the spinal cord. This Blood Brain Barrier acts as a filter and allows some things to cross into the brain and allows other matter to be removed. Studies have shown the Blood Brain Barrier is affected by inflammation.
Functions of the Blood Brain Barrier in animals have been studied. Human studies with multiple causes of inflammation (e.g. Alzheimer's, Epilepsy, trauma and severe infections in critically
Hypothesis: Surgically-induced inflammation will temporarily reduce blood-brain barrier drug efflux transporter function in proportion to the degree of inflammation. The investigators anticipate that inflammation-mediated reductions in drug transporter function will be reflected by an increased cerebral spinal fluid (CSF) concentration of morphine (a PGP substrate) and M3G and M6G (MRP1 substrates). The corresponding in vitro studies will allow us to elucidate the mechanism(s) by which inflammation alters blood brain barrier efflux transport of morphine, M3G and M6G.
Interventions:
description: All patients treated with Morphine during induction after the lumbar drain inserted. Morphine was prescribed as Standard of care post operatively
name: morphine
type: Drug
Study arms:
design_group_description: All patients treated with Morphine during induction after the lumbar drain inserted. Morphine was prescribed as Standard of care post operatively
design_group_title: morphine
design_group_type: Other
Sponsor: Nova Scotia Health Authority
Collaborators: Dalhousie University
Drug name mappings:
name: 硫酸吗啡
lang: CN
name: Morphine Sulfate
lang: EN
name: モルヒネ硫酸塩水和物
lang: JP
Clinical trial NCT03364725: Toward Elimination of Hepatitis C Virus (HCV): A Pilot Study
Official title: Toward Elimination of Hepatitis C Virus (HCV): A Pilot Study Combining HCV and Addiction Treatment of Young Suburban Heroin Users (SHU) That Addresses Barriers to Care
Conditions: Hepatitis C
Addict Heroin
Summary: To demonstrate that colocation treatment of substance use disorder and Hepatitis C infection concurrently while proving addiction counselling will achieve increased duration of sobriety and elimination of Hepatitis C virus in study participants.
Interventions:
description: Glecaprevir-pibrentasvir will be dispensed to 30 patients recently detoxed off heroin in an acute detox center.
name: Glecaprevir-pibrentasvir
type: Drug
Study arms:
design_group_description: Treatment arm using Glecaprevir-pibrentasvir for treatment of all patients
design_group_title: Open Label Treatment Arm
design_group_type: Experimental
Sponsor: ID Care PA
Collaborators: AbbVie, Inc.
Drug name mappings:
name: 格卡瑞韦/哌仑他韦
lang: CN
name: Glecaprevir/Pibrentasvir
lang: EN
name: グレカプレビル水和物/ピブレンタスビル
lang: JP
Clinical trial NCT05575180: Effect of Acetazolamide and Methazolamide on Hypoxic Exercise Performance
Official title: Effect of Acetazolamide and Methazolamide on Hypoxic Exercise Performance
Conditions: High Altitude Effects
Summary: A single-centered randomized doubled blinded placebo-controlled cross-over trial comparing two the effect of two carbonic anhydrase inhibitors on exercise performance in acute hypoxia. Participants will be young (under 40 years of age), healthy males and females who are regularly physically active.
Interventions:
description: Oral acetazolamide
name: Acetazolamide 250Mg Tab
type: Drug
description: Oral Methazolamide
name: Methazolamide Pill
type: Drug
description: Oral placebo
name: Placebo
type: Drug
Study arms:
design_group_description: Drug: Methazolamide Dose: 100 mg b.i.d Duration: 2 days prior to testing + 1 hr prior to testing start Form: Oral
design_group_title: Methazolamide
design_group_type: Experimental
design_group_description: Drug: Acetazolamide Dose: 250 mg t.i.d Duration: 2 days prior to testing + 1 hr prior to testing start Form: Oral
design_group_title: Acetazolamide
design_group_type: Active Comparator
design_group_description: Drug: Placebo (microcrystalline cellulose) Dose: 250 mg t.i.d Duration: 2 days prior to testing + 1 hr prior to testing start Form: Oral
design_group_title: Placebo
design_group_type: Placebo Comparator
Sponsor: The University of Waterloo
Collaborators: The Wilderness Society
Drug name mappings:
name: 醋甲唑胺
lang: CN
name: Methazolamide
lang: EN
Clinical trial NCT02444234: Pharmacokinetics of Tedizolid Phosphate in Cystic Fibrosis
Official title: Steady-State Pharmacokinetics of Tedizolid in Plasma and Sputum of Patients With Cystic Fibrosis
Conditions: Cystic Fibrosis
Summary: The proposed study is designed to characterize the pharmacokinetics of intravenous and oral tedizolid in patients with Cystic Fibrosis.
Interventions:
description: Participants will be randomized to receive tedizolid oral 200mg once daily for 3 days and crossed over to IV after a 1 week washout.
name: Tedizolid PO
type: Drug
description: Participants will be randomized to receive tedizolid IV 200mg once daily for 3 days and crossed over to PO after a 1 week washout.
name: Tedizolid IV
type: Drug
Study arms:
design_group_description: Tedizolid phophate 200mg tablet
design_group_title: Tedizolid PO
design_group_type: Experimental
design_group_description: Tedizolid phophate 200mg IV
design_group_title: Tedizolid IV
design_group_type: Experimental
Sponsor: University of Southern California
Collaborators: Merck Sharp & Dohme Corp.
Drug name mappings:
name: 磷酸特地唑胺
lang: CN
name: Tedizolid Phosphate
lang: EN
name: テジゾリドリン酸エステル
lang: JP
Clinical trial NCT01373684: PEG-interferon Alfa-2a add-on Study in HBeAg Negative Chronic Hepatitis B Patients
Official title: Induction of HBsAg Decline Using an add-on Treatment of Peginterferon Alfa-2a in HBeAg-negative Chronic Hepatitis B Patients Treated With Nucleos(t)Ide Analogous (PAS)
Conditions: Chronic Hepatitis B
Summary: This study intends to investigate whether addition of PEG-IFN alfa-2a in HBeAg-negative chronic hepatitis B patients who are pretreated with nucleos(t)ide analogues enhances the degree of HBsAg decline.
Interventions:
description: 180 μg per week s.c. for a total duration of 48 weeks.
name: Peginterferon alfa-2a
other_name: Pegasys
type: Drug
description: All patients are all currently being treated with long-term NA treatment and will continue using these during the study. Dosage depends on which Nucleos(t)ide analogue they are using.
name: Nucleos(t)ide analogue
other_name: Adefovir (Hepsera)
Entecavir (Baraclude)
Tenofovir (Viread)
type: Drug
Study arms:
design_group_description: All patients are all currently being treated with long-term NA treatment. PEG-IFN will be given in a dose of 180 μg per week s.c. for a total duration of 48 weeks starting at week 0.
design_group_title: Peginterferon alfa-2a add on
design_group_type: Experimental
design_group_description: All patients are all currently being treated with long-term Nucleos(t)ide analogue treatment and will continue using this medication during the duration of the study.
design_group_title: Nucleoside analogue
design_group_type: Active Comparator
Sponsor: Foundation for Liver Research
Collaborators: Hoffmann-La Roche, Inc.
Drug name mappings:
name: 聚乙二醇干扰素α-2a
lang: CN
name: Peginterferon alfa-2a
lang: EN
name: ペグインターフェロン アルファ‐2a（遺伝子組換え）
lang: JP
Clinical trial NCT02124655: Antiplaque Effect of Essential Oils and 0.2% Chlorhexidine on an in Situ Model of Oral Biofilm Growth.
Official title: Antiplaque Effect of Essential Oils and 0.2% Chlorhexidine on an in Situ Model of Oral Biofilm Growth: a Randomised Clinical Trial.
Conditions: Oral Biofilm
Mouthwash
Periodontitis
Summary: The accumulation and maturation of oral biofilm in the gingival margin is widely recognised to be the primary aetiological factor in the development of chronic gingivitis. Based on this association, the current treatment of gingivitis is focused on biofilm disruption, which will normally include mechanical processes, both professionally and at home. However, for patients, it is not easy to achieve a proper level of plaque control. The efficient plaque control techniques are very time consuming and require a special motivation and skills for their optimum use. It was at this point where mouthwashes become important, due to the fact that they include diverse types of antimicrobial agents to complement the results of mechanical oral hygiene measures.
Chlorhexidine is considered the "gold standard" of oral antiseptics; nevertheless it has not been recommended for long periods of time due to its well-known secondary effects. All of these inconveniences have limited its acceptability among dental professionals and users; in contrast, however, are the exceptional antiseptic properties, promoting the interest of researchers in other alternative antiplaque agents. Mouthwashes containing essential oils in their formulation have received a lot of attention. Their antiplaque activity has been demonstrated in numerous clinical studies, in which they were used in conjunction with mechanical oral hygiene measures.
In order to achieve a better understanding of the clinical effects that antimicrobial agents produce in the interior of the biofilm, it is necessary to apply a methodology in which the biofilm grows directly in the interior of the oral cavity but its three dimensional structure is not distorted by manipulation.
The aim of this study was to evaluate the in situ antiplaque effect of 2 antimicrobial agents (essential oils formulation and 0.2% chlorhexidine) in the short term with a posterior analysis on "non-destructured" biofilm with Confocal Laser Scanning Microscope combined with fluorescence staining.
Interventions:
name: Essential oils
other_name: Listerine
type: Drug
name: 0.2% chlorhexidine
other_name: Oraldine Perio
type: Drug
name: Sterile water
type: Drug
Study arms:
design_group_description: A) 20 ml rinses for 30 seconds with essential oils/2 times daily (1/0/1). -----14 days----- B) 10 mL rinses for 30 seconds with 0.2% chlorhexidine/2 times daily (1/0/1). -----14 days----- C) 20 mL rinses for 30 seconds with sterile water (1/0/1).
design_group_title: Essential oils/0.2% chlorhexidine/Sterile water
design_group_type: Experimental
Sponsor: University of Santiago de Compostela
Collaborators: Johnson & Johnson
Drug name mappings:
name: 葡萄糖氯己定
lang: CN
name: Chlorhexidine gluconate
lang: EN
name: クロルヘキシジングルコン酸塩
lang: JP
name: 水杨酸甲酯
lang: CN
name: Methyl Salicylate
lang: EN
name: サリチル酸メチル
lang: JP