PatSnap/clinical-trial huggingface dataset:
Clinical trial NCT00323804: Interest of Ribavirin in the Maintenance Treatment of Liver Fibrosis Using Low Dose Pegylated Interferon alpha2b in Patients With Chronic Hepatitis C Non Responders to Previous Antiviral Therapy.
Official title: Randomized, Double-blind, Placebo-controlled Multicenter Study Evaluating the Interest of a Long-term (3 Years) Treatment With Peginterferon Alfa-2b and Ribavirin on Liver Fibrosis in Non-responder Chronic Hepatitis C Patients.
Conditions: Hepatitis C, Chronic
Liver Fibrosis
Summary: Patients with chronic hepatitis C who did not respond to previous antiviral treatment develop liver fibrosis leading to cirrhosis. Maintenance low dose pegylated interferon therapy of fibrosis is currently under investigation in large multicenter trials. The aim of our study is to assess if peginterferon alpha2b plus ribavirin is more efficient than peginterferon alpha2b alone. 454 patients will be randomized between the 2 arms and the efficacy will be assessed, after 3 years of treatment, on Metavir liver fibrosis score improvement.
Interventions:
description: PegIFN alfa 2b in addition to ribavirin or ribavirin-placebo, from day 0 to M36
name: Peginterferon alfa-2b
type: Biological
description: Ribavirin in addition to PegIFN alfa 2b, from day 0 to M36
name: Ribavirin
type: Drug
description: Ribavirin-placebo in addition to PegIFN alfa 2b, from day 0 to M36
name: Ribavirin-Placebo
type: Drug
Study arms:
design_group_description: Combination of ribavirin capsules 200 mg, weight-based daily dose ( <75 kg : 1000 mg ; ≥ 75 kg : 1200 mg), and low-dose PegIFN alfa 2b by subcutaneous injection 0.5 μg / kg / week, from day 0 to M36
design_group_title: Randomised PegIFN alfa 2b + ribavirin (RBV) arm
design_group_type: Experimental
design_group_description: Combination of ribavirin-placebo capsules 200 mg, weight-based daily dose ( <75 kg : 1000 mg ; ≥ 75 kg : 1200 mg), and low-dose PegIFN alfa 2b by subcutaneous injection 0.5 μg / kg / week, from day 0 to M36
design_group_title: Randomised PegIFN alfa 2b + ribavirin-placebo arm
design_group_type: Placebo Comparator
Sponsor: France Recherche Nord & Sud SIDA HIV-Hepatites
Collaborators: Centre Hospitalier Universitaire de Rennes
Merck Sharp & Dohme Corp.
Drug name mappings:
name: 聚乙二醇干扰素α-2b注射(Merck & Co)
lang: CN
name: Peginterferon alfa-2b(Merck & Co)
lang: EN
name: 利巴韦林
lang: CN
name: Ribavirin
lang: EN
name: リバビリン
lang: JP
Clinical trial NCT05378698: Effects of Tralokinumab in the Skin: an Immunologic and Molecular Investigation
Official title: Effects of Tralokinumab in the Skin: an Immunologic and Molecular Investigation (TRALIS)
Conditions: Atopic Dermatitis
Summary: The clinical efficacy of tralokinumab has been demonstrated in the treatment of AD; its MOA however remains insufficiently understood. A better understanding of the mechanisms underlying the clinical effects of tralokinumab would be of great clinical benefit since it may ultimately help us to identify more precisely candidate patients who may benefit from a therapy with tralokinumab.
Interventions:
description: 2 Arms 20 patients 5 healthy controls
name: Application of Tralokinumab
type: Drug
Study arms:
design_group_description: Healthy controls
design_group_title: Healthy arm
design_group_type: No Intervention
design_group_description: Patients with AD
design_group_title: Tralokinumab
design_group_type: Active Comparator
Sponsor: University of Zurich
Collaborators: Hochgebirgsklinik Davos
Drug name mappings:
name: 曲罗芦单抗
lang: CN
name: Tralokinumab
lang: EN
name: トラロキヌマブ（遺伝子組換え）
lang: JP
Clinical trial NCT01021696: Pain in Patients With Dementia and Behavioural Disturbances
Official title: The Impact of Pain on Behavioural Disturbances in Patients With Moderate and Severe Dementia. A Cluster Randomized Trial
Conditions: Dementia
Pain
Agitation
Summary: In nursing homes (NHs) 80% of the patients have dementia, between 60%-80% exhibit behavioural disturbances (BPSD), and more than 60% have pain. Both pain and BPSD is more common in those with severe dementia. Since older persons with dementia have less communicative skills, suffer from more pain and exhibit more agitation, pain may be a contributing factor in these patients. More than 40% of patients with BPSD are treated with neuroleptics despite described side-effects. There is an urgent need to investigate the impact of individual pain management on BPSD in patients with dementia.
It was hypothesized that
* pain increase BPSD in patients with dementia
* individual pain treatment decrease BPSD in patients with dementia
Interventions:
description: Paracetamol Max. dose: 3g/d
name: Paracetamol
other_name: Individual pain treatment
type: Drug
description: Morphine ret. Tab. 5mgx2/d; max. dose:10mgx2/d
name: Morphine
other_name: Individual pain treatment
type: Drug
description: 5ųg/h, change each 7.day; max. dose: 10ųg/h
name: Buprenorphine plaster
other_name: Individual pain treatment
type: Drug
description: 25mgx1/d; max 300mg/d
name: Pregabalin
other_name: individual pain treatment
type: Drug
Study arms:
design_group_description: Control group
design_group_title: Treatment as usual
design_group_type: No Intervention
design_group_description: Intervention group
design_group_title: Paracetamol
design_group_type: Active Comparator
design_group_description: Intervention group, individual pain treatment
design_group_title: Morphine
design_group_type: Active Comparator
design_group_description: Intervention group, individual pain treatment
design_group_title: Buprenorphine plaster
design_group_type: Active Comparator
design_group_description: Intervention group, individual pain treatment
design_group_title: Pregabalin
design_group_type: Active Comparator
Sponsor: University of Bergen
Collaborators: Noregs forskingsråd
Drug name mappings:
name: 盐酸丁丙诺啡
lang: CN
name: Buprenorphine Hydrochloride
lang: EN
name: ブプレノルフィン塩酸塩
lang: JP
name: 普瑞巴林
lang: CN
name: Pregabalin
lang: EN
name: プレガバリン
lang: JP
name: 对乙酰氨基酚
lang: CN
name: Acetaminophen
lang: EN
name: アセトアミノフェン
lang: JP
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 NCT06549634: Biomarkers of AKI in Patients Receiving Daratumumab
Official title: Biomarkers of AKI in Patients With Multiple Myeloma Receiving Daratumumab: A Pilot Study
Conditions: Acute Kidney Injury
Multiple Myeloma
Light Chain Nephropathy
Summary: The goal of this prospective observational study is to understand changes in urinary and blood biomarkers associated with acute kidney injury (AKI) in patients newly diagnosed with multiple myeloma and being treated with Daratumumab SC. The aims of the study are:
To measure changes in plasma and urinary biomarkers of AKI before initiation of Daratumumab therapy and 30 days after initiation of therapy.
To establish whether these biomarkers serve to aid in early detection and prevention of AKI
Participants will give urine and blood samples at their normally scheduled lab appointments.
Interventions:
description: Daratumumab is not being administered as part of the study. Patients will receive daratumumab as part of their clinical care, and blood and urine will be collected in order to measure biomarkers pre- and post-daratumumab administration
name: Daratumumab
type: Drug
Study arms:
design_group_description: Patients with multiple myeloma being newly initiated on daratumumab
design_group_title: Patients with multiple myeloma
Sponsor: The Brigham & Women's Hospital, Inc.
Collaborators: Janssen Pharmaceuticals, Inc.
Drug name mappings:
name: 达雷妥尤单抗
lang: CN
name: Daratumumab
lang: EN
name: ダラツムマブ（遺伝子組換え）
lang: JP
Clinical trial NCT00001024: The Effects of Anti-HIV Drugs in HIV-Infected Patients Who Do Not Have AIDS
Official title: A Multicenter, Open-Label Study of Viral Burden in Peripheral Blood Versus Lymphoid Tissue Before and After Antiretroviral Therapy in HIV-Infected Individuals Without AIDS (NOTE: One Arm Receives no Treatment)
Conditions: HIV Infections
Summary: Immunopathogenesis objectives: To compare and quantitatively determine HIV burden and HIV replication in peripheral blood (PB) and lymphoid tissue (LT). To determine the degree to which antiretroviral therapy alters HIV replication in LT.
Clinical objectives: To gain insight into the degree of correlation between immunologic surrogate markers for HIV disease (e.g., CD4, beta-2 microglobulin) as compared to measures of HIV replication in PB and LT. To assess changes in PB and LT viral burden after antiretroviral therapy and to determine its ability to predict an antiviral response.
One of the major problems in defining the immunopathogenic changes in HIV infections has been the inability to correlate the extent of loss of immunologic function with the number of HIV-infected CD4+ cells in the peripheral blood. Few studies exist that measure viral burden in lymph nodes of HIV-infected individuals. Researchers hope to find out whether the amount of HIV virus or markers for the virus in the body's lymph tissue is a better measure of disease progression than the amount of virus or markers for the virus in the blood.
Interventions:
name: Zidovudine
type: Drug
name: Didanosine
type: Drug
Study arms:
Sponsor: National Institute of Allergy & Infectious Diseases
Collaborators: Glaxo Wellcome SA
Bristol Myers Squibb Co.
Drug name mappings:
name: 齐多夫定
lang: CN
name: Zidovudine
lang: EN
name: ジドブジン
lang: JP
name: 去羟肌苷
lang: CN
name: Didanosine
lang: EN
Clinical trial NCT00280215: Renal Protective Effect of ACEI and ARB in Primary Hyperoxaluria
Official title: Renal Protective Effect of ACEI and ARB in Primary Hyperoxaluria
Conditions: Hyperoxaluria
Summary: This study will test the effectiveness of two medications: ACEI (angiotensin converting enzyme inhibitor)and ARB (angiotensin receptor blocker) in reducing the renal injury induced by hyperoxaluria in patients with Primary Hyperoxaluria.
Hypothesis: Calcium oxalate crystal deposition in the kidney causes inflammation and resulting injury to kidney tissue. Angiotensin blockade will improve these changes, thus slowing the progression of renal insufficiency in patients with Primary Hyperoxaluria.
Interventions:
description: Patients will be randomized to a combination of Angiotensin Converting Enzyme Inhibitor and Angiotensin Receptor Blocker, Patients will be randomized to a combination of ARB(losartan 50 mg daily in adult patients, 0.7 mg/kg/day in patients < 40 kg) ACE-I (lisinopril 10 mg daily in adult patients, 0.15 mg/kg/day in pediatric patients < 40 kg) to be taken for 24 months.
name: ACEI / Angiotensin converting enzyme inhibitor
other_name: Lisinopril
type: Drug
description: Patients will be randomized to a combination of Angiotensin Converting Enzyme Inhibitor and Angiotensin Receptor Blocker,Patients will be randomized to a combination of ARB(losartan 50 mg daily in adult patients, 0.7 mg/kg/day in patients < 40 kg) ACE-I (lisinopril 10 mg daily in adult patients, 0.15 mg/kg/day in pediatric patients < 40 kg) to be taken for 24 months.
name: ARB /Angiotensin Receptor Blocker
other_name: Losartan
type: Drug
description: Patients will receive placebo for 24 months
name: Placebo
type: Drug
Study arms:
design_group_description: Patients will be randomized to a combination of Angiotensin Converting Enzyme Inhibitor and Angiotensin Receptor Blocker. Patients will be randomized to a combination of ARB(losartan 50 mg daily in adult patients, 0.7 mg/kg/day in patients < 40 kg) ACE-I (lisinopril 10 mg daily in adult patients, 0.15 mg/kg/day in pediatric patients < 40 kg) to be taken for 24 months.
design_group_title: 1
design_group_type: Active Comparator
design_group_description: Patients will take placebo for 24 months.
design_group_title: 2
design_group_type: Placebo Comparator
Sponsor: Mayo Clinic
Collaborators: National Institute of Diabetes & Digestive & Kidney Diseases
Drug name mappings:
name: 氯沙坦钾
lang: CN
name: Losartan Potassium
lang: EN
name: ロサルタンカリウム
lang: JP
Clinical trial NCT02670330: Open Label Extension Study to Evaluate the Long-term Safety of Zorblisa (SD-101-6.0) in Patients With Epidermolysis Bullosa
Official title: An Open Label Multi-Center Extension Study to Evaluate the Long-term Safety of Zorblisa™ (SD-101-6.0) in Patients With Epidermolysis Bullosa
Conditions: Epidermolysis Bullosa
Summary: The study aimed to assess the long-term safety of topical use of Zorblisa (SD-101-6.0) in participants with Epidermolysis Bullosa (EB).
Interventions:
description: SD-101 is a white, crystalline powder that is formulated within an odorless, soft, white cream base. SD-101-6.0 cream contains allantoin, a diureide glyoxylic acid, at a concentration of 6% and other excipients.
name: SD-101-6.0 cream
other_name: SD-101
Zorblisa
type: Drug
Study arms:
design_group_description: All participants (or their caregivers) applied SD-101-6.0 cream topically once a day to the entire body for a period of up to 36 months.
design_group_title: Experimental: SD-101-6.0 cream
design_group_type: Experimental
Sponsor: Scioderm, Inc.
Collaborators: Amicus Therapeutics, Inc.
Drug name mappings:
name: 尿囊素
lang: CN
name: Allantoin
lang: EN
Clinical trial NCT00672373: Extract of Ginkgo Biloba and Tardive Dyskinesia
Official title: A Double-Blind, Randomised, Parallel-Group Comparison of Extract of Ginkgo Biloba(EGB-761) Versus Placebo as Add-on Medication in Patients With Established Tardive Dyskinesia
Conditions: Tardive Dyskinesia
Schizophrenia
Summary: The purpose of this study is to determine whether Extract of Ginkgo Biloba is effective in the treatment on Tardive dyskinesia
Interventions:
description: EGb-761 240mg/d, 1 capsule(80mg) tid,po,12 weeks; Each capsule contains 19.6mg flavonol glycosides and 4.8mg terpene lactones.
name: Extract of Ginkgo Biloba (EGb-761 capsules)
other_name: YiKangNing
type: Drug
description: Wheat flour placebo capsule,1 capsule tid, po,12 weeks
name: Placebo
type: Drug
Study arms:
design_group_description: Active treatment with EGb-761 capsules (80mg each capsule), 3 capsules each day for 12 weeks
design_group_title: A
design_group_type: Experimental
design_group_description: Matching placebo treatment
design_group_title: B
design_group_type: Placebo Comparator
Sponsor: Beijing HuiLongGuan Hospital
Collaborators: Peking University
Drug name mappings:
name: 银杏叶
lang: CN
name: Ginkgo Biloba leaves Extract
lang: EN
Clinical trial NCT00321464: A Study Comparing Denosumab vs. Zoledronic Acid for the Treatment of Bone Metastases in Breast Cancer Subjects.
Official title: A Randomized, Double-Blind, Multicenter Study of Denosumab Compared With Zoledronic Acid (Zometa®) in the Treatment of Bone Metastases in Subjects With Advanced Breast Cancer
Conditions: Bone Metastases
Summary: The purpose of this study is to determine if denosumab is non-inferior to zoledronic acid in the treatment of bone metastases in subjects with advanced breast cancer.
Interventions:
description: Q4W 120 mg denosumab SC injection and 4 mg zoledronic acid (Zometa) placebo IV over a minimum of 15 minutes
name: Denosumab
type: Biological
description: Q4W 4 mg zoledronic acid IV over minimum 15 minutes and 120 mg denosumab placebo SC
name: Zoledronic Acid
other_name: Zometa
type: Drug
Study arms:
design_group_title: zoledronic acid
design_group_type: Active Comparator
design_group_title: denosumab
design_group_type: Experimental
Sponsor: Amgen, Inc.
Collaborators: Daiichi Sankyo Co., Ltd.
Drug name mappings:
name: 地舒单抗
lang: CN
name: Denosumab
lang: EN
name: デノスマブ（遺伝子組換え）
lang: JP
Clinical trial NCT01864915: Prucalopride + Prucalopride Booster vs. Prucalopride + Picosalax Booster for the Colon Capsule
Official title: Prucalopride + Prucalopride Booster vs. Prucalopride + Picosalax Booster for the Colon Capsule
Conditions: Bowel Cleansing
Colon Capsule Completion Times
Summary: Colon capsule endoscopy is a new technology that is a noninvasive method of examining the large bowel. The bowel preparation required for this test differs from colonoscopy in that it needs to clean the colon but also needs to provide propulsion. Most published studies have used medications as part of their regime that are not available in parts of North America (ex. sodium phosphate) and have shown poor test completion, bowel preparation and polyp detection rates.
Objective: In this study a bowel preparation for the colon capsule is proposed that uses medications approved for use in Canada that may provide a better preparation quality and better completion rates.
Methods: Patients who are being referred for a colonoscopy will be recruited to participate in the study. They will all receive split-dose polyethylene glycol (PEG) for bowel preparation. They will be randomized to receive either 1) Prucalopride 2mg daily for four days, 2) Prucalopride 2mg daily for four days plus a Prucalopride booster, or 3) Prucalopride 2mg for four days plus 1 and 1/2 sachets of Picosalax boosters for the colon capsule study. The day after the colon capsule they will drink PEG ( 2 Liters) at 5am -or approx 4hrs prior to procedure time and return for a colonoscopy. The colon capsule results will be reviewed by two endoscopists experienced in video capsule endoscopy who will assess the bowel preparation using a previously defined scale and examine for polyps. We propose that administering Prucalopride daily for 4 days will increase intestinal motility and improve colon capsule completion rates and a booster dose of Picosalax will improve colon capsule completion rates compared to prucalopride by itself.
Interventions:
description: Prucalopride 2mg daily starting three days before the colon capsule study (total of 4 doses with the last at 0800hrs on day of colon capsule study)
name: Prucalopride
other_name: RESTORAN
type: Drug
description: Colon capsule procedure performed day prior to colonoscopy, at 0800 hrs on day 4.
name: Colon Capsule
type: Procedure
Study arms:
design_group_description: low dose prucalopride booster arm
design_group_title: No Booster-low dose prucalopride booster
design_group_type: Experimental
design_group_description: additional 2mg prucalopride at time of capsule ingestion
design_group_title: Prucalopride Booster-high dose prucalopride booster
design_group_type: Experimental
design_group_description: One sachet of Picosalax 2hrs after capsule ingestion and 1/2 sachet at 4 hrs after swallowing colon capsule.
design_group_title: Picosalax Booster Arm
design_group_type: Experimental
Sponsor: Queen's University
Collaborators: Religious Hospitallers of St. Joseph of Cornwall Ontario
Janssen, Inc.
Drug name mappings:
name: 琥珀酸普芦卡必利
lang: CN
name: Prucalopride Succinate
lang: EN
Clinical trial NCT00397839: The Effect Of Oral Ibandronate In Male Osteoporosis
Official title: A Parallel, Placebo-controlled, Randomized (2:1) Double-blind Study of One Year Duration to Assess the Effect of Oral Ibandronate 150 mg Given Once-monthly Versus Placebo on LS BMD in Men With Osteoporosis
Conditions: Male Osteoporosis
Summary: Male osteoporosis is a common and important clinical problem, associated with significant morbidity, mortality and societal expense. Approximately 10% of men =65 years of age are osteoporotic. The proposed study will evaluate efficacy and safety of oral ibandronate given 150 mg once-monthly for 12 months versus placebo in men with primary osteoporosis. Less frequent, once monthly, dosing is expected to improve patient's treatment adherence compared to a weekly dosing regimen.
Interventions:
description: Ibandronate orally (tablet) at a dose of 150 mg once per month
name: Ibandronate
type: Drug
description: Placebo orally (tablet) at a dose of 150 mg once per month
name: placebo
type: Drug
Study arms:
design_group_title: Placebo
design_group_type: Placebo Comparator
design_group_title: Ibandronate
design_group_type: Experimental
Sponsor: Hoffmann-La Roche, Inc.
Collaborators: GSK Plc
Drug name mappings:
name: 伊班膦酸钠
lang: CN
name: Ibandronate Sodium
lang: EN
name: イバンドロン酸ナトリウム水和物
lang: JP
Clinical trial NCT06517173: Y-3 for Injection in the Treatment of Acute Ischemic Stroke
Official title: A Multicenter, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Y-3 in Chinese Subjects with Acute Ischemic Stroke
Conditions: Acute Ischemic Stroke
Summary: This trial aims to evaluate the effectiveness and safety of Y-3 for injection in the treatment of patients with acute ischemic stroke within 48 hours of onset
Interventions:
description: Qualified subjects were randomly divided into groups in a 1:1 ratio and received continuous treatment with Y-3 injection (40 mg/dose, qd) or placebo control drug. The treatment was performed 10 times for 10 days.
name: Y-3 for injection
type: Drug
description: Qualified subjects were randomly divided into groups in a 1:1 ratio and received continuous treatment with Y-3 injection (40 mg/dose, qd) or placebo control drug. The treatment was performed 10 times for 10 days.
name: Placebo control group
type: Drug
Study arms:
design_group_description: The special solvent Y-3 for injection was extracted with a sterile syringe and injected into a Y-3 lyophilized powder vial for injection. The vial was artificially vibrated until the powder was completely dissolved, and then injected into 250mL 0.9% sodium chloride injection with a sterile syringe for dilution, gently shaken and mixed, and intravenous infusion was performed for 60min±10min. The treatment was performed 10 times for 10 days. The first dose should be completed as soon as possible after randomization; The time from the second dose to the first dose shall not be less than 12h, but not more than 24h+1h. The time interval of each subsequent administration is 24h±1h
design_group_title: Y-3 for injection test group
design_group_type: Experimental
design_group_description: The special solvent Y-3 for injection was extracted with a sterile syringe and injected into the lyophilized powder vial of Y-3 simulant for injection. The vial was artificially vibrated until the powder was completely dissolved, and then injected into 250mL 0.9% sodium chloride injection with a sterile syringe for dilution, gently shaken and mixed, and intravenous infusion was performed for 60min±10min. The treatment was performed 10 times for 10 days. The first dose should be completed as soon as possible after randomization; The time from the second dose to the first dose shall not be less than 12h, but not more than 24h+1h. The time interval of each subsequent administration is 24h±1h
design_group_title: Placebo control group
design_group_type: Placebo Comparator
Sponsor: Beijing Tiantan Hospital
Collaborators: Neurodawn Pharmaceutical Co., Ltd.
Drug name mappings:
name: 洛贝米柳
lang: CN
name: Y-3(Neurodawn)
lang: EN