PatSnap/clinical-trial huggingface dataset:
Clinical trial NCT00455156: Study of the Safety, Efficacy and Cycle Control of a Contraceptive Vaginal Ring
Official title: A Multicenter, Open-label Study on the Efficacy, Cycle Control and Safety of a Contraceptive Vaginal Ring Delivering a Daily Dose of 150µg of Nestorone® and 15µg of Ethinyl Estradiol (150/15 NES/EE CVR)
Conditions: Contraception
Summary: The purpose of this study is to evaluate the one-year data on the contraceptive efficacy and safety of the 150/15 NES/EE CVR as the basis for regulatory approvals of this CVR as a new delivery system for contraception.
Interventions:
description: 150 mg of Nestorone and 15 mg of ethinyl estradiol (150/15 NES/EE CVR), administered via vaginal ring, used on a 21/7 days in/out schedule for no more than one year.
name: 150 mg of Nestorone and 15 mg of ethinyl estradiol (150/15 NES/EE CVR)
type: Drug
Study arms:
design_group_description: 150 mg of Nestorone and 15 mg of ethinyl estradiol (150/15 NES/EE CVR), administered via vaginal ring, used on a 21/7 days in/out schedule for no more than one year.
design_group_title: 150/15 NES/EE CVR
design_group_type: Experimental
Sponsor: Premier Research
Collaborators: The Population Council, Inc.
National Institute of Child Health & Human Development
Drug name mappings:
name: 醋酸烯诺孕酮/炔雌醇
lang: CN
name: Ethinyl Estradiol/Segesterone Acetate
lang: EN
Clinical trial NCT00629135: Moxifloxacin Plus Metronidazole Versus Piperacillin/Tazobactam for the Treatment of Patients With Intra-abdominal Abscesses
Official title: Single Centre, Prospective, Comparative, Open-label, Randomised Study to Evaluate the Efficacy and Tolerability of the Combination of Moxifloxacin Plus Metronidazole Versus Piperacillin/Tazobactam for the Treatment of Patients With Intra-abdominal Abscesses
Conditions: Abscess, Intra-Abdominal
Summary: The study is contemplating the antibiotic therapy of intraabdominal abscesses. These abscesses are a serious problem in surgical practice. Associated pathophysiologic effects as for example peritonitis may become life threatening or may lead to extended periods of morbidity with prolonged hospitalization.
The objective of the sudy is to evaluate whether the combination of Moxifloxacin and Metronidazole is equivalent to Piperacillin / Tazobactam with regard to clinical outcome and eradication of aerobe and anaerobe pathogens in patients with intra-abdominal abscesses.
Interventions:
description: Antibiotic therapy for patients with intra-abdominal abscesses; Intervention consists of antibiotic treatment of the patients with intraabdominal abscess with either the combination of Moxifloxacin and Metronidazole or Piperacillin/Tazobactam.1. Moxifloxacin 400 mg, administered intravenously once daily in combination with Metronidazole 500 mg, administered two times daily intravenously, followed by an oral medication with Moxifloxacin 400 mg once daily and Metronidazole 500 mg twice daily. 2. Piperacillin / Tazobactam 4,5 g administered intravenously three times daily.
name: Moxifloxacin/Metronidazole or Piperacillin/Tazobactam
type: Drug
Study arms:
design_group_description: For adult patients with intra-abdominal abscesses matching the criteria to be included will and enrolled in the study arm 1: Moxifloxacin 400 mg, administered intravenously once daily in combination with Metronidazole 500 mg, administered two times daily intravenously, followed by an oral medication with Moxifloxacin 400 mg once daily and Metronidazole 500 mg twice daily.
design_group_title: 1
design_group_type: Experimental
design_group_description: For adult patients with intra-abdominal abscesses matching the criteria to be included will and enrolled in the study arm 2: Piperacillin / Tazobactam 4,5 g administered intravenously three times daily
design_group_title: 2
design_group_type: Active Comparator
Sponsor: Hannover Medical School
Collaborators: Bayer AG
Drug name mappings:
name: 甲硝唑
lang: CN
name: Metronidazole
lang: EN
name: メトロニダゾール
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
name: 哌拉西林钠他唑巴坦钠
lang: CN
name: Piperacillin Sodium/Tazobactam Sodium
lang: EN
name: タゾバクタム・ピペラシリン
lang: JP
Clinical trial NCT07181382: Efficacy and Safety of Seralutinib in Adult Subjects With Pulmonary Hypertension Associated With Interstitial Lung Disease (PH-ILD)
Official title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Oral Inhalation of Seralutinib for the Treatment of Pulmonary Hypertension Associated With Interstitial Lung Disease (PH-ILD) Followed by a Long-Term Extension Evaluating Safety and Efficacy
Conditions: Pulmonary Hypertension Associated With Interstitial Lung Disease
Summary: This Phase 3 study is designed as a 24-week randomized, double-blind, placebo-controlled period (PCP) followed by a 144-week long-term extension (LTE) period. The primary objective of the PCP is to evaluate the effect of seralutinib on improving exercise capacity in subjects with World Health Organization (WHO) Group 3 pulmonary hypertension associated with interstitial lung disease. The primary objective of the LTE is to evaluate the long-term safety and tolerability of seralutinib.
Interventions:
description: Matching capsule containing placebo
name: Placebo
type: Drug
description: Capsule containing seralutinib
name: Seralutinib
type: Drug
description: Generic dry powder inhaler for seralutinib or placebo delivery
name: Generic Dry Powder Inhaler
type: Device
Study arms:
design_group_description: Placebo inhaled orally twice daily (BID) for 24 weeks in PCP. Subjects randomized to the placebo treatment group in the PCP will receive seralutinib in LTE.
design_group_title: Placebo
design_group_type: Placebo Comparator
design_group_description: Seralutinib inhaled orally BID for 24 weeks in PCP. Seralutinib inhaled orally BID up to 144 weeks in LTE.
design_group_title: Seralutinib 90 mg
design_group_type: Experimental
design_group_description: Seralutinib inhaled orally BID for 24 weeks in PCP. Seralutinib inhaled orally BID up to 144 weeks in LTE.
design_group_title: Seralutinib 120 mg
design_group_type: Experimental
Sponsor: Gossamer Bio, Inc.
Collaborators: CHIESI Farmaceutici SpA
Drug name mappings:
name: Seralutinib
lang: EN
Clinical trial NCT03277313: Efficacy, Safety, Tolerability, Immunogenicity and Pharmacokinetic Evaluation of HYQVIA in Pediatric PIDD Subjects
Official title: Efficacy, Safety, Tolerability, Immunogenicity and Pharmacokinetic Evaluation of HYQVIA in Pediatric Subjects With Primary Immunodeficiency Diseases
Conditions: Primary Immunodeficiency Diseases (PID)
Summary: The purpose of the study is to acquire additional data on efficacy, safety, tolerability, immunogenicity, pharmacokinetic (PK) and other parameters of HYQVIA in pediatric (age ≥ 2 to <16 years) participants with primary immunodeficiency disease (PIDD).
Interventions:
description: Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase (IGI, 10% with rHuPH20)
name: HYQVIA
other_name: IGI 10% with rHuPH20
type: Biological
Study arms:
design_group_description: Pediatric participants with PIDD who were on IV or non-HYQVIA SC treatment with immunoglobulin were enrolled and treated with HYQVIA SC with a dose or interval ramp-up period of up to six weeks. HYQVIA dose was planned to be equivalent to 100% (± 5%) of pre-study treatment. Dose frequency was one treatment interval of one week, then one treatment interval of two weeks for participants who were planned to be treated every three weeks, and one more treatment interval of three weeks for participants who were planned to be treated every four weeks.
design_group_title: Epoch 1
design_group_type: Experimental
design_group_description: Epoch 1 was followed by Epoch 2 with HYQVIA treatment infusions given once every 3 or 4 weeks, depending on the participant's previous IV dosing schedule (for IV pretreated participants) and at the discretion of the investigator and participant (for SC-pretreated participants) up to approximately 36 months.
design_group_title: Epoch 2
design_group_type: Experimental
Sponsor: Baxalta, Inc.
Collaborators: Baxalta Innovations GmbH
Drug name mappings:
name: 人免疫球蛋白 (Takeda)
lang: CN
name: Human normal immunoglobulin(Takeda)
lang: EN
name: 人免疫グロブリン (Takeda)
lang: JP
Clinical trial NCT00002545: Radiation Therapy Plus Chemotherapy in Treating Patients With Supratentorial Glioblastoma Multiforme
Official title: A PHASE III TRIAL COMPARING THE USE OF RADIOSURGERY FOLLOWED BY CONVENTIONAL RADIOTHERAPY WITH BCNU TO CONVENTIONAL RADIOTHERAPY WITH BCNU FOR SUPRATENTORIAL GLIOBLASTOMA MULTIFORME
Conditions: Brain and Central Nervous System Tumors
Summary: RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Chemotherapy uses different ways to stop tumor cells from dividing so they stop growing or die. Combining radiation therapy with chemotherapy may kill more tumor cells.
PURPOSE: Randomized phase III trial to study the effectiveness of radiation therapy and carmustine in treating patients who have supratentorial glioblastoma multiforme.
Interventions:
name: carmustine
type: Drug
name: low-LET photon therapy
type: Radiation
Study arms:
Sponsor: Radiation Therapy Oncology Group
Collaborators: National Cancer Institute
Drug name mappings:
name: 卡莫司汀
lang: CN
name: Carmustine
lang: EN
name: カルムスチン
lang: JP
Clinical trial NCT00252720: DIabetic Retinopathy Candesartan Trials.
Official title: DIRECT: DIabetic Retinopathy Candesartan Trials. Effects of Candesartan Cilexetil (Candesartan) on Diabetic Retinopathy in Type 1 Diabetic Patients With Retinopathy.
Conditions: Type 1 Diabetes
Summary: The primary objective is to determine whether candesartan, compared to placebo reduces the progression of diabetic retinopathy in normotensive, normoalbuminuric type 1 diabetic patients with retinopathy.
The secondary objective is to determine whether candesartan, compared to placebo, reduces the incidence of clinically significant macular oedema (CSME) and/or proliferative diabetic retinopathy (PDR) and beneficially influences the rate of change in urinary albumin excretion rate (UAER).
This study is part of the DIRECT Programme also including a primary prevention study of diabetic retinopathy in type 1 diabetes and a secondary prevention study in 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 oral tablet
name: candesartan
other_name: ATACAND
type: Drug
Study arms:
design_group_description: candesartan cilexetil 32 mg once daily
design_group_title: candesartan
design_group_type: Experimental
design_group_description: control
design_group_title: placebo
design_group_type: No Intervention
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 NCT03128905: Trial of Colchicine Versus Prednisone for the Treatment of Acute CPPD Arthritis
Official title: Colchicine or Prednisone for the Treatment of Acute Calcium Pyrophosphate Deposition (CPPD) Arthritis: Open-label, Randomized, Multicenter, Equivalence Trial of Efficacy and Safety
Conditions: Chondrocalcinosis
Summary: Chondrocalcinosis, recently renamed the calcium pyrophosphate deposition (CPPD) disease, is a very frequent affection of the elderly and causes very painful arthritis.
International recommendations for the treatment of patients suffering from CPPD are based upon rare studies, not randomized, with small samples, and thus very weak scientific evidence.
The treatment of CPPD arthritis is extrapolated from the experience of gout treatment, another crystal deposition disease.
Among recommended treatments, colchicine and oral steroids are recommended as first-line treatments, while NSAIDs are used with caution in elderly populations of patients.
Colchicine utilization is not risk-free, in particular with old patients and patients with renal impairment.
Drug interactions of colchicine can have serious consequences, especially in a polymedicated old patient's population.
Oral steroids are an interesting alternative in this indication with a potential of being better tolerated, but comparative efficacy with colchicine needs to be studied.
From a broader point of view, colchicine and oral steroids have never been compared in any crystal related arthritis.
This is the first large randomized controlled trial for CPPD acute arthritis.
Interventions:
description: International non-proprietary name: Colchicine<br/>Molecule owner: Mayoly-Spindler Laboratory, 1mg scored tablet for oral administration, authorized 03/02/1995.<br/>Composition :<br/>Active principle : Crystallized colchicine Excipients: Erythrosine aluminium lake, lactose, saccharose, magnesium stearate and povidone.
name: Colchicine opocalcium 1mg
other_name: Mayoly-Spindler laboratory
type: Drug
description: International non-proprietary name: Prednisone<br/>Molecule owner : SANOFI AVENTIS France 20 mg scored tablet for oral administration, authorized since 02/05/1990, generic drug available.<br/>Composition :<br/>Active principle : Prednisone Excipients: Maize starch, lactose, talc, magnesium stearate.
name: Prednisone : Cortancyl 20mg
other_name: Sanofi Aventis France
type: Drug
Study arms:
design_group_description: Patients assigned to this group will receive the Colchicine opocalcium 1mg treatment.
design_group_title: Colchicine
design_group_type: Active Comparator
design_group_description: Patients assigned to this group will receive Prednisone : Cortancyl 20mg.
design_group_title: Prednisone (corticoids)
design_group_type: Experimental
Sponsor: Université Catholique de Lille
Collaborators: Hopital Lariboisière
Bichat-Claude Bernard Hospital
Centre Hospitalier d'Armentières
Centre Hospitalier Universitaire de Lille
Drug name mappings:
name: 泼尼松
lang: CN
name: Prednisone
lang: EN
Clinical trial NCT00026286: Hormone Replacement Therapy for Hot Flashes and/or Vaginal Symptoms in Postmenopausal Women Receiving Tamoxifen for Breast Cancer
Official title: A Phase III Prospective, Randomized, Double-Blind Clinical Trial of Hormone Replacement Therapy In Postmenopausal Women With A History Of Node-Negative Or Ductal Carcinoma In Situ Who Are Receiving Adjuvant Tamoxifen
Conditions: Breast Cancer
Hot Flashes
Menopausal Symptoms
Summary: RATIONALE: Hormone replacement therapy may be effective in managing the hot flashes and/or vaginal symptoms in postmenopausal women who are receiving tamoxifen for breast cancer.
PURPOSE: Randomized phase III trial to determine the effectiveness of hormone replacement therapy in managing hot flashes and/or vaginal symptoms in postmenopausal women who are receiving tamoxifen for breast cancer.
Interventions:
name: conjugated estrogens
type: Drug
name: medroxyprogesterone
type: Drug
Study arms:
Sponsor: Eastern Cooperative Oncology Group
Collaborators: National Cancer Institute
Drug name mappings:
name: 醋酸甲羟孕酮
lang: CN
name: Medroxyprogesterone Acetate
lang: EN
name: メドロキシプロゲステロン酢酸エステル
lang: JP
name: 结合雌激素
lang: CN
name: Estrogens, Conjugated
lang: EN
name: 結合型エストロゲン
lang: JP
Clinical trial NCT02914535: Filgotinib in Long-Term Extension Study of Adults With Ulcerative Colitis
Official title: A Long-Term Extension Study to Evaluate the Safety of Filgotinib in Subjects With Ulcerative Colitis
Conditions: Ulcerative Colitis
Summary: The primary objective of this study is to observe the long-term safety of filgotinib in adults who have completed or met protocol specified efficacy discontinuation criteria in a prior filgotinib treatment study in ulcerative colitis (UC).
Interventions:
description: Tablet(s) administered orally once daily
name: Filgotinib
other_name: GLPG0634
GS-6034
type: Drug
description: Tablet(s) administered orally once daily
name: Placebo
type: Drug
Study arms:
design_group_description: Filgotinib 200 mg + placebo to match filgotinib 100 mg for up to 336 weeks
design_group_title: Filgotinib 200 mg (blinded dosing)
design_group_type: Experimental
design_group_description: Filgotinib 100 mg + placebo to match filgotinib 200 mg for up to 336 weeks
design_group_title: Filgotinib 100 mg (blinded dosing)
design_group_type: Experimental
design_group_description: Placebo to match filgotinib 200 mg + placebo to match filgotinib 100 mg for up to 336 weeks
design_group_title: Placebo (blinded dosing)
design_group_type: Placebo Comparator
design_group_description: Filgotinib 200 mg for up to 336 weeks
design_group_title: Filgotinib 200 mg (open-label)
design_group_type: Experimental
design_group_description: Filgotinib 100 mg for up to 336 weeks
design_group_title: Filgotinib 100 mg (open-label)
design_group_type: Experimental
Sponsor: Alfasigma SpA
Collaborators: Gilead Sciences, Inc.
Drug name mappings:
name: 非戈替尼
lang: CN
name: Filgotinib Maleate
lang: EN
name: フィルゴチニブマレイン酸塩
lang: JP
Clinical trial NCT05171049: A Study Comparing Abelacimab to Apixaban in the Treatment of Cancer-associated VTE
Official title: A Multicenter, Randomized, Open-label, Blinded Endpoint Evaluation, Phase 3 Study Comparing the Effect of Abelacimab Relative to Apixaban on Venous Thromboembolism (VTE) Recurrence and Bleeding in Patients With Cancer Associated VTE
Conditions: Venous Thromboembolism
Deep Venous Thrombosis
Pulmonary Embolism
Summary: This is a Phase 3,multicenter, randomized, open-label, blinded endpoint evaluation study comparing the effect of abelacimab relative to apixaban on venous thromboembolism (VTE) recurrence and bleeding in patients with cancer associated VTE (ASTER)
Interventions:
description: Abelacimab 150 mg
name: Abelacimab
other_name: MAA868
type: Biological
description: Apixaban 10 mg followed by 5 mg
name: Apixaban
other_name: Eliquis
type: Drug
Study arms:
design_group_description: Abelacimab intravenous administration followed by monthly administration of the same dose subcutaneously
design_group_title: Abelacimab
design_group_type: Experimental
design_group_description: Apixaban administered orally twice a day
design_group_title: Apixaban
design_group_type: Active Comparator
Sponsor: Anthos Therapeutics, Inc.
Collaborators: Novartis Pharmaceuticals Canada, Inc.
Drug name mappings:
name: Abelacimab
lang: EN
Clinical trial NCT02580591: Empagliflozin as Adjunctive to Insulin Therapy Over 26 Weeks in Patients With T1DM (EASE-3)
Official title: A Phase III, Randomised, Double Blind, Placebo-controlled, Parallel Group, Efficacy, Safety and Tolerability Trial of Once Daily, Oral Doses of Empagliflozin as Adjunctive to Insulin Therapy Over 26 Weeks in Patients With Type 1 Diabetes Mellitus (EASE-3)
Conditions: Diabetes Mellitus, Type 1
Summary: The study will investigate the efficacy, safety, tolerability and Pharmacokinetic(PK) of 3 doses of empagliflozin compared with placebo over 26 weeks in 960 patients with type 1 diabetes mellitus as adjunctive therapy to insulin
Interventions:
name: Empagliflozin
type: Drug
description: For blinding purposes
name: Placebo
type: Drug
Study arms:
design_group_title: Empagliflozin low dose
design_group_type: Experimental
design_group_title: Empagliflozin high dose
design_group_type: Experimental
design_group_title: Empagliflozin medium dose
design_group_type: Experimental
design_group_title: Placebo
design_group_type: Placebo Comparator
Sponsor: Boehringer Ingelheim GmbH
Collaborators: Eli Lilly & Co.
Drug name mappings:
name: 恩格列净
lang: CN
name: Empagliflozin
lang: EN
name: エンパグリフロジン
lang: JP
Clinical trial NCT00791921: Efficacy Confirmation Trial of CDP870 Without Coadministration of Methotrexate (MTX) in Japanese Rheumatoid Arthritis (RA)
Official title: A Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel-group Trial to Assess the Efficacy, Pharmacokinetics, and Safety of CDP870 Without Coadministration of MTX in Japanese Active RA Patients in Whom MTX Cannot be Administrated.
Conditions: Rheumatoid Arthritis
Summary: The objectives of this study are to verify the superiority in efficacy (American College of Rheumatology 20%: ACR20) and investigate the pharmacokinetics and safety of CDP870 versus placebo without coadministration of MTX in active RA patients in whom MTX cannot be administrated.
Interventions:
description: 400mg CDP870 given at Week0, 2, 4 and thereafter 200mg CDP870 given every 2weeks until Week22 subcutaneously(SC)
name: CDP870
type: Drug
description: Placebo given every 2 weeks until Week22 (SC)
name: Placebo of CDP870
type: Drug
Study arms:
design_group_description: 400mg CDP870 given at Week0, 2, 4 and thereafter 200mg CDP870 given every 2weeks
design_group_title: CDP870 200mg
design_group_type: Experimental
design_group_description: Placebo of CDP870
design_group_title: Placebo
design_group_type: Placebo Comparator
Sponsor: Otsuka Pharmaceutical Co., Ltd.
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 NCT00217230: Trial To Assess Safety And Efficacy Of Influenza Virus Vaccine, Trivalent, Types A & B, Live Cold-Adapted (CAIV-T) In Adults Aged 60 Years And Older
Official title: A Prospective, Randomized, Double-Blind, Placebo-Controlled Trial To Assess Safety And Efficacy Of Influenza Virus Vaccine, Trivalent, Types A & B, Live Cold-Adapted (CAIV-T) In Adults Aged 60 Years And Older CAIV-T, Liquid Formulation
Conditions: Influenza
Summary: The purpose of this study is to determine the efficacy, safety and tolerability of the liquid formulation of CAIV-T against culture confirmed influenza illness in adults aged 60 years and older. In addition this study aims to demonstrate superiority of CAIV-T when compared with placebo and the effect on economic resources.
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 NCT06497556: A Study Evaluating the Efficacy and Safety of Divarasib Versus Sotorasib or Adagrasib in Participants With Previously Treated KRAS G12C-positive Advanced or Metastatic Non-Small Cell Lung Cancer
Official title: A Phase III, Randomized, Open-Label, Multicenter Study Evaluating the Efficacy and Safety of Divarasib Versus Sotorasib or Adagrasib in Patients With Previously Treated KRAS G12C-Positive Advanced or Metastatic Non-Small Cell Lung Cancer
Conditions: Non-Small Cell Lung Cancer
KRAS G12C Lung Cancer
Summary: The purpose of this study is to assess the safety and efficacy of divarasib compared to locally approved KRAS G12C inhibitors (sotorasib or adagrasib) in participants with KRAS G12C-positive (KRAS G12C +) advanced or metastatic non-small cell lung cancer (NSCLC).
Interventions:
description: Divarasib will be administered orally QD
name: Divarasib
type: Drug
description: Sotorasib will be administered orally QD
name: Sotorasib
type: Drug
description: Adagrasib will be administred orally BID
name: Adagrasib
type: Drug
Study arms:
design_group_description: Participants will receive divarasib orally, once daily (QD).
design_group_title: Divarasib
design_group_type: Experimental
design_group_description: Participants will receive sotorasib orally QD or adagrasib orally twice a day (BID)
design_group_title: KRAS G12C inhibitor
design_group_type: Active Comparator
Sponsor: Roche Holding AG
Collaborators: Chugai Pharmaceutical Co., Ltd.
Drug name mappings:
name: Divarasib
lang: EN