PatSnap/clinical-trial huggingface dataset:
Clinical trial NCT01324934: Efficacy and Safety of ATG-Fresenius Following a Renal Transplantation, Without Corticosteroids
Official title: Prospective, Randomized, Multi-center, Open Label, Phase III Study to Evaluate the Efficacy and Safety of Immunosuppression Following a Heart-beating Cadaveric Renal Transplantation Based on the Use of Rabbit Anti-T-lymphocyte Serum, Tacrolimus and Mycophenolate, Free of Concomitant Corticosteroids From the Start of Immunosuppression
Conditions: Renal Transplant Rejection
Summary: The main objective of the study is the assessment of the overall graft rejection rate (acute, chronic and subclinical) between a treatment with ATG-Fresenius administered in addition to standard treatment consisting of CellCept® or Myfortic®/TAC and without corticosteroids and a treatment consisting of CellCept® or Myfortic®/TAC and corticosteroids during the first year after renal transplantation.
Interventions:
description: Dosage: Single high-dose of 9 mg/kg pre-operatively, followed by 3 mg/kg/d at day +2 and +4. ATG-Fresenius treatment at Days 0, +2, and +4 is mandatory.<br/>(In case of persisting DGF, the treatment is left to the discretion of the investigator. Treatment options include the continuation of ATG-Fresenius treatment with 3 mg/kg/d at Day +6 and if deemed necessary also at Day +8 - but without corticosteroids).
name: ATG-Fresenius S
type: Drug
Study arms:
design_group_description: immunosuppressive treatment consisting of ATG-Fresenius/TAC/MMF or Myfortic
design_group_title: Study Group
design_group_type: Active Comparator
design_group_description: immunosuppressive treatment consisting of TAC, MMF or Myfortic, and corticosteroids.
design_group_title: Control Group
design_group_type: No Intervention
Sponsor: Neovii Biotech GmbH
Collaborators: Eurotrials Brasil Consultores Científicos Ltda.
PsyConsult VOF
Drug name mappings:
name: 抗人T细胞兔免疫球蛋白
lang: CN
name: Anti-human T Lymphocyte Rabbit Immunoglobulin
lang: EN
Clinical trial NCT03840421: GP Vs PF As Induction Chemotherapy Combined with CCRT for Locoregionally Advanced Nasopharyngeal Carcinoma
Official title: GP Vs PF As Induction Chemotherapy Combined with CCRT for Locoregionally Advanced Nasopharyngeal Carcinoma：a Prospective,Parallel, Randomized, Open Labeled, Multicenter Phase III Clinical Trial
Conditions: Nasopharyngeal Carcinoma
Nasopharyngeal Neoplasms
Nasopharyngeal Diseases
Head and Neck Neoplasm
Summary: The purpose of this study is to compare the survival and toxicity of GP (gemcitabine and cisplatin) vs. PF (cisplatin and fluorouracil) as induction chemotherapy combined with concurrent chemoradiotherapy (CCRT) for locoregionally advanced nasopharyngeal carcinoma( NPC ) patients.
Interventions:
description: Patients receive gemcitabine (1000 mg/m² d1,8) and cisplatin (80mg/m² d1) every 3 weeks for 3 cycles before concurrent chemoradiotherapy.
name: gemcitabine and cisplatin
other_name: gemcitabine and cisplatin (GP)
type: Drug
description: Patients receive fluorouracil (800mg/m2 d1-5) and cisplatin (80mg/m² d1) every 3 weeks for 3 cycles before concurrent chemoradiotherapy.
name: cisplatin and fluorouracil
other_name: cisplatin and fluorouracil (PF)
type: Drug
description: Intensity modulated-radiotherapy (IMRT) is given as 30～33 fraction with five daily fractions per week for 6-7 weeks to a total dose of 68～70 Gy to the primary tumor
name: IMRT
type: Radiation
description: IMRT concurrently with cisplatin 100 mg/m² every 3 weeks for 2 cycles.
name: cisplatin
other_name: cisplatin（DDP）
type: Drug
Study arms:
design_group_description: Patients receive gemcitabine (1000 mg/m² d1,8) and cisplatin (80mg/m² d1) every 3 weeks for 3 cycles before radiotherapy, and then receive intensity modulated-radiotherapy (IMRT), concurrently with cisplatin 100 mg/m² every 3 weeks for 2 cycles.
design_group_title: gemcitabine and cisplatin
design_group_type: Experimental
design_group_description: Patients receive fluorouracil (800mg/m² d1-5) and cisplatin (80mg/m² d1) every 3 weeks for 3 cycles before radiotherapy, and then receive intensity modulated-radiotherapy (IMRT), concurrently with cisplatin 100 mg/m² every 3 weeks for 2 cycles.
design_group_title: cisplatin and fluorouracil
design_group_type: Active Comparator
Sponsor: Sun Yat-Sen University
Collaborators: Guangdong General Hospital
the First Affiliated Hospital of Sun Yat-Sen University
Drug name mappings:
name: 吉西他滨
lang: CN
name: Gemcitabine
lang: EN
name: 顺铂
lang: CN
name: Cisplatin
lang: EN
name: シスプラチン
lang: JP
Clinical trial NCT03155997: Endocrine Therapy With or Without Abemaciclib (LY2835219) Following Surgery in Participants With Breast Cancer
Official title: A Randomized, Open-Label, Phase 3 Study of Abemaciclib Combined With Standard Adjuvant Endocrine Therapy Versus Standard Adjuvant Endocrine Therapy Alone in Patients With High Risk, Node Positive, Early Stage, Hormone Receptor Positive, Human Epidermal Receptor 2 Negative, Breast Cancer
Conditions: Breast Cancer
Summary: The purpose of this study is to evaluate the safety and efficacy of the study drug abemaciclib in participants with high risk, node positive, early stage, hormone receptor positive (HR+), human epidermal receptor 2 negative (HER2-), breast cancer.
Interventions:
description: Administered orally.
name: Abemaciclib
other_name: LY2835219
type: Drug
description: Administered according to label instructions.
name: Standard Adjuvant Endocrine Therapy
type: Drug
Study arms:
design_group_description: Participants received Abemaciclib orally at 150 milligrams (mg) twice daily with at least 6 hours between doses for up to 2 years or until evidence of disease recurrence or other discontinuation criteria were met, whichever occurs first. Endocrine therapy (physicians' choice) standard-of-care was administered according to package label until discontinuation criteria were met.
design_group_title: 150 mg Abemaciclib + Endocrine Therapy
design_group_type: Experimental
design_group_description: Endocrine therapy (physicians' choice) standard-of-care was administered according to package label until discontinuation criteria were met.
design_group_title: Endocrine Therapy
design_group_type: Other
Sponsor: Eli Lilly & Co.
Collaborators: NSABP Foundation, Inc.
Drug name mappings:
name: 阿贝西利
lang: CN
name: Abemaciclib
lang: EN
name: アベマシクリブ
lang: JP
Clinical trial NCT02593773: Safety, Tolerability and Efficacy of ACTIMMUNE® Dose Escalation in Friedreich's Ataxia Study
Official title: Multicenter, Safety and Efficacy, Open-Label Extension Study of ACTIMMUNE® (Interferon γ-1b) in Children and Young Adults With Friedreich's Ataxia
Conditions: Friedreich's Ataxia
Summary: The purpose of this phase 3 multi-center, open-label extension study is to evaluate the long-term safety of ACTIMMUNE® (interferon-γ 1b) in participants with Friedreich's Ataxia.
Interventions:
description: The study drug dose is planned to be escalated on a weekly basis over the first 4 weeks of treatment (from 10 µg/m² to 25, 50, and 100 µg/m²). The dose may be reduced, interrupted, or held based on tolerability. By Week 13, all participants are to be on a stable tolerated dose of study drug in order to continue study participation; the dose may not be further increased after Week 13, however, it may be reduced on a case-by-case basis to manage drug-related adverse events (AEs).
name: Interferon γ-1b
other_name: ACTIMMUNE®
type: Drug
Study arms:
design_group_description: Subcutaneous (SC) doses of ACTIMMUNE® TIW for a total of 26 weeks.
design_group_title: interferon γ-1b
design_group_type: Experimental
Sponsor: Amgen, Inc.
Collaborators: The Friedreich's Ataxia Research Alliance
Drug name mappings:
name: 干扰素γ-1b
lang: CN
name: Interferon gamma-1b
lang: EN
Clinical trial NCT00001127: Study of a Flu Vaccine in Children
Official title: Study of the Influenza Virus Vaccine, Trivalent, Types A & B, Live Cold-Adapted (CAIV-T) in a Community-Based, Non-Randomized, Open-Label Trial in Children to Assess Safety and Herd Immunity for the Control of Epidemic Influenza
Conditions: Influenza
Summary: This study tests the safety and effectiveness of a flu vaccine in school children.
School children are usually the first members of a community to come down with the flu, and they often give the flu to their younger siblings, parents, and grandparents. It is hoped that giving school children a flu vaccine can help prevent the spread of the flu to other members of the community.
Interventions:
name: Influenza virus vaccine (CAIV-T)
type: Biological
Study arms:
Sponsor: National Institute of Allergy & Infectious Diseases
Collaborators: Aviron LLC
Drug name mappings:
name: Influenza virus vaccine(Protein Sciences Corp.)
lang: EN
Clinical trial NCT00336167: Bezafibrate Trial in CPT2 Deficiency
Official title: Clinical Trial on the Effect of Bezafibrate in the Muscular Form of Carnitine Palmitoyltransferase 2 Deficiency
Conditions: Carnitine Palmitoyl Transferase 2 Deficiency
Summary: The purpose of this study is to determine whether bezafibrate is effective in the treatment of the muscular adult form of carnitine palmitoyltransferase 2 deficiency
Interventions:
name: bezafibrate (drug)
type: Drug
Study arms:
Sponsor: Assistance Publique des Hôpitaux de Paris SA
Collaborators: Institut National de la Santé et de la Recherche Médicale
Drug name mappings:
name: 苯扎贝特
lang: CN
name: Bezafibrate
lang: EN
name: ベザフィブラート
lang: JP
Clinical trial NCT00287079: A Prospective Study Looking at the Use of Rebif® in Subjects With Clinically Isolated Syndrome
Official title: A Prospective, Open Label, Multi-centre Study Exploring the Use of Subcutaneous (sc) 44 Microgram Interferon (IFN) Beta - 1a (Rebif®) Once a Week (qw) in Subjects With Clinically Isolated Syndrome (CIS)
Conditions: Clinically Isolated Syndrome
Summary: The primary objective of this initiative is to assess the effectiveness of subcutaneous (sc) interferon (IFN) beta - 1a, (Rebif®), versus No Treatment in delaying the conversion to Clinically Definite Multiple Sclerosis (CDMS) - as defined by the occurrence of a second exacerbation - over 96 weeks in subjects that present with Clinically Isolated Syndrome (CIS) accompanied by an abnormal magnetic resonance imaging (MRI). The secondary objectives are to:
* Assess the effectiveness of sc IFN beta - 1a (Rebif®) therapy in reducing the proportion of patients with CIS converting to CDMS
* Assess the safety of sc IFN beta - 1a (Rebif®) in the patients with CIS
Interventions:
description: 44 microgram (mcg) IFN beta-1a sc once a week (qw) for 96 weeks
name: Rebif®
type: Drug
description: No treatment for 96 weeks
name: No Treatment
type: Other
Study arms:
design_group_title: Rebif®
design_group_type: Experimental
design_group_title: No Treatment
design_group_type: Other
Sponsor: Merck KGaA
Collaborators: EMD Serono Canada Inc.
Drug name mappings:
name: 干扰素β-1a(Merck Serono SA)
lang: CN
name: INTERFERON BETA-1A(Merck Serono SA)
lang: EN
Clinical trial NCT00850343: Long-term Treatment Study of Certolizumab Pegol Without Coadministration of Methotrexate in Japanese Rheumatoid Arthritis (RA) Patients
Official title: A Multicenter, Open-label, Long-term Safety Study of CDP870 to Evaluate the Safety and Efficacy of CDP870 Administered Without Coadministration of Methotrexate (MTX) Over the Long Term in Patients With Active Rheumatoid Arthritis Transferred From the Efficacy Confirmatory Study (Study 275-08-003)
Conditions: Rheumatoid Arthritis
Summary: The objectives of this study are to evaluate the safety and efficacy of certolizumab pegol when administered without coadministration of methotrexate over the long term in Japanese RA patients who transferred from Study 275-08-003 (NCT00791921), and to evaluate the effects of different dosing regimens on the safety and efficacy of certolizumab pegol in American College of Rheumatology 20% (ACR20) responders who completed Study 275-08-003.
Interventions:
description: Subcutaneous (SC) injection
name: Certolizumab pegol
other_name: CDP870
Cimzia
type: Drug
Study arms:
design_group_description: Participants received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
design_group_title: Certolizumab pegol 200 mg
design_group_type: Experimental
design_group_description: Participants received 400 mg certolizumab pegol by subcutaneous injection once every 4 weeks for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
design_group_title: Certolizumab pegol 400 mg
design_group_type: Experimental
Sponsor: Astellas Pharma, Inc.
Collaborators: UCB Japan Co. Ltd.
Drug name mappings:
name: 培塞利珠单抗
lang: CN
name: Certolizumab Pegol
lang: EN
name: セルトリズマブ ペゴル（遺伝子組換え）
lang: JP
Clinical trial NCT00043537: Treatment of Childhood Social Phobia
Official title: Treatment of Childhood Social Phobia
Conditions: Social Phobia
Summary: This 4-year study will compare the long-term effectiveness of behavioral treatment, fluoxetine (Prozac®), and placebo for treatment of social phobia in children and adolescents.
Interventions:
name: Social Effectiveness Therapy for Children (SET-C)
type: Behavioral
name: Fluoxetine
type: Drug
name: Pill Placebo
type: Drug
Study arms:
design_group_description: Social Effectiveness Therapy for Children includes social skills training, peer generalization experiences and exposure therapy
design_group_title: Social Effectiveness Therapy for Children
design_group_type: Experimental
design_group_description: Fluoxetine given in 10mg doses, up to 40 mg as tolerated
design_group_title: Fluoxetine
design_group_type: Experimental
design_group_description: Capsules identical to fluoxetine given in "10 mg." doses up to 40 mg.
design_group_title: Pill placebo
design_group_type: Placebo Comparator
Sponsor: University of Central Florida
Collaborators: National Institute of Mental Health
Drug name mappings:
name: 盐酸氟西汀
lang: CN
name: Fluoxetine Hydrochloride
lang: EN
Clinical trial NCT01625182: Evaluate Efficacy and Safety of Fingolimod 0.5 mg Orally Once Daily Versus Placebo in Chronic Inflammatory Demyelinating Polyradiculoneuropathy Patients.
Official title: A Double-blind, Randomized, Multicenter, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy and Safety of Fingolimod 0.5 mg Administered Orally Once Daily Versus Placebo in Patients With Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)
Conditions: Chronic Inflammatory Demyelinating Polyradiculoneuropathy
Summary: The study was designed to evaluate the efficacy and safety of fingolimod in the treatment of chronic inflammatory demyelinating polyradiculoneuropathy compared with placebo.
Interventions:
description: Fingolimod 0.5 mg capsules
name: Fingolimod
type: Drug
description: Matching placebo capsules
name: Placebo Comparator
type: Drug
Study arms:
design_group_description: Participants received Fingolimod 0.5 mg orally once daily.
design_group_title: Fingolimod (FTY720)
design_group_type: Experimental
design_group_description: Participants received matching placebo to Fingolimod orally once daily.
design_group_title: Placebo
design_group_type: Placebo Comparator
Sponsor: Novartis Pharmaceuticals Corp.
Collaborators: Tanabe Pharma Corp.
Drug name mappings:
name: 盐酸芬戈莫德
lang: CN
name: Fingolimod Hydrochloride
lang: EN
name: フィンゴリモド塩酸塩
lang: JP
Clinical trial NCT04303026: The Effect of Zoledronic Acid on Patients With Osteoarthritis of the Hip
Official title: A Randomized Placebo Controlled Trial Testing The Effect of Zoledronic Acid on Hip Osteoarthritis
Conditions: Osteoarthritis, Hip
Summary: Hip Osteoarthritis (OA) is one of the most common diseases affecting the ageing population. No specific and safe treatment slowing the development of hip OA as reflected in reduced joint space narrowing has been developed so far. Implantation of hip prosthesis has been a great success, but is expensive and puts a great financial pressure on hospitals and national healthcare programs. It also poses risks of serious complications. Current non-surgical treatment options focus on pain management and physiotherapy.
Bisphosphonates have been shown to exert multiple beneficial effects in OA. Animal studies have demonstrated that bisphosphonates protect against subchondral bone degradation and preserve articular cartilage in mice and rats with OA.
In this study 70 participants will be treated with either Zoledronic Acid (a potent Bisphosphonate) or Placebo (Saltwater). Allocation will be random and both parties are blinded. The investigators hypothesis is that participants treated with Zoledronic acid will have less pain, and better function after 12 months. The results will be tested with functional and pain scores, and functional tests. The study team will also measure the effects on disease related quality of life, bone quality measurements and the effect on bone marrow lesions on MRI (magnetic resonance imaging) and histological examination
Interventions:
description: 5mg IV infusion
name: Zoledronic Acid
other_name: Active Treatment
type: Drug
description: Placebo Group. Saline 0.9% 100 ml infusion
name: Saline 0.9%
other_name: Placebo
type: Drug
Study arms:
design_group_description: Participants receiving active treatment with two infusions of Zoledronic Acid 5 mg with 3 months interval mixed in 100 ml 0.9% saline
design_group_title: Treatment Group
design_group_type: Active Comparator
design_group_description: Participants receiving Placebo with two infusions of 100 ml 0.9% saline with 3 months interval.
design_group_title: Placebo Group
design_group_type: Placebo Comparator
Sponsor: Martina Hansens Hospital AS
Collaborators: University of Oslo
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
Clinical trial NCT02028923: Efficacy of Topical Morphine in the Treatment of Severe Local Pain of Chronic Wounds
Official title: Phase III Study Evaluating the Efficacy of Topical Morphine in the Treatment of Severe Local Pain of Chronic Wounds
Conditions: Local Pain
Chronic Wounds
Summary: This phase III study aims to show that topical morphine low doses treats localized pain in chronic wounds, intense and rebellious to systemic analgesics included or not opioids.
Interventions:
description: Topical
name: Morphine gel
type: Drug
description: Topical
name: Neutral gel
type: Other
Study arms:
design_group_description: morphine 30 mg, quantity of gel per application: 15mg (15ml)
design_group_title: Morphine gel
design_group_type: Experimental
design_group_description: water for injection, quantity of gel per application: 15mg (15ml)
design_group_title: Neutral gel
design_group_type: Placebo Comparator
Sponsor: Institut Curie
Collaborators: Assistance Publique des Hôpitaux de Paris SA
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 NCT01722240: Liraglutide in Type 1 Diabetes
Official title: Liraglutide in Type 1 Diabetes
Conditions: Type 1 Diabetes
Summary: The glucose lowering effects of GLP-1 agonists are well established in subjects with type 2 diabetes, however, these have not been studied prospectively in subjects with type 1 diabetes. The investigators have, therefore, designed this study to investigate the central hypothesis that in patients with type 1 diabetes, Liraglutide has a glucose lowering effect. A major secondary objective of this study is to elucidate the mechanisms responsible for its glucose lowering effects and those involved in reducing the insulin dose. The specific aims of this proposal are:
Hypothesis 1: Treatment with Liraglutide in patients with type 1 diabetes decreases HbA1c, fasting, postprandial and the overall mean glucose concentrations while decreasing the dose of insulin required.
Hypothesis 2: Treatment with Liraglutide in patients with type 1 diabetes decreases basal and postprandial glucagon concentrations and increases basal and postprandial C-peptide concentrations.
Hypothesis 3: Treatment with Liraglutide in patients with type 1 diabetes delays gastric emptying.
Interventions:
name: Liraglutide 1.8mg
type: Drug
name: Placebo
type: Drug
Study arms:
design_group_description: Daily Injection
design_group_title: Liraglutide 1.8mg
design_group_type: Active Comparator
design_group_description: Daily Injection
design_group_title: Placebo
design_group_type: Placebo Comparator
Sponsor: State University of New York at Buffalo
Collaborators: National Institute of Diabetes & Digestive & Kidney Diseases
Drug name mappings:
name: 利拉鲁肽
lang: CN
name: Liraglutide
lang: EN
name: リラグルチド（遺伝子組換え）
lang: JP
Clinical trial NCT00361582: A Study to Evaluate the Effectiveness and Safety of Multiple Doses of Tapentadol(CG5503) in Patients Awaiting Joint Replacement Surgery
Official title: A Randomized, Double-Blind, Active- and Placebo-Controlled, Parallel Group, Multicenter Study to Evaluate the Efficacy and Safety of Multiple Doses of CG5503 Immediate Release Formulation in Subjects Awaiting Primary Joint Replacement Surgery for End-Stage Joint Disease
Conditions: Osteoarthritis
Pain Assessment
Arthralgia
Summary: The purpose of this study is to evaluate in patients who are eligible for elective primary total or partial joint replacement of the hip or knee due to chronic osteoarthritis the efficacy (level of pain control) of CG5503 over 5 and 10 days compared with placebo, and to assess the safety and tolerability of multiple doses of CG5503 IR patients.
Interventions:
name: CG5503 IR; tapentadol
type: Drug
Study arms:
Sponsor: Johnson & Johnson Pharmaceutical Research & Development LLC
Collaborators: Grünenthal GmbH
Drug name mappings:
name: 盐酸他喷他多
lang: CN
name: Tapentadol Hydrochloride
lang: EN
name: タペンタドール塩酸塩
lang: JP