PatSnap/clinical-trial huggingface dataset:
Clinical trial NCT04516057: Nabilone for Agitation Blinded Intervention Trial
Official title: Nabilone for Agitation Blinded Intervention Trial
Conditions: Alzheimer Disease
Agitation
Summary: This study will look at whether nabilone is an effective treatment for agitation in Alzheimer's disease (AD) patients. Agitation is highly prevalent in patients with AD and is one of the most distressing and challenging-to-treat symptoms. Agitation is associated with faster progression to institutionalization, increased caregiver burden, poorer quality of life, and increased risk of death. In addition, current pharmacological options show only modest efficacy and elevated risks of adverse events. Therefore, identifying safer and more effective treatments for agitation in AD is a clinical and research priority.
Nabilone is a synthetic cannabinoid that is Health Canada-approved to treat chemotherapy-induced nausea and vomiting.
The PI's research group completed a 6-week double-blind placebo-controlled randomized cross-over pilot trial in 38 patients with moderate-to-severe AD, providing the first preliminary evidence regarding the safety and efficacy of nabilone in this population. They found that nabilone significantly improved agitation, overall neuropsychiatric symptoms, and caregiver distress. That study was limited by its sample size and questions remain regarding the efficacy of nabilone for nutrition and pain and predictors of response. However, the promising preliminary findings encourage a pivotal, practice-changing phase III trial to inform clinical practice.
Participants in this study will be randomized to receive either nabilone or a placebo for 8 weeks. In addition to looking at the effectiveness of nabilone in treating agitation, the researchers will also look at whether it is beneficial for other relevant outcomes for patients with AD including overall neuropsychiatric symptoms, caregiver distress, cognition, nutritional status, and pain. Participants will also be followed for 8 weeks following completion of the study treatment.
Interventions:
description: After the screening period, participants randomized to the nabilone arm will receive nabilone for 8 weeks. Participants will then be followed for 8 weeks following completion of the study treatment.
name: Nabilone
other_name: Cesamet
type: Drug
description: After the screening period, participants randomized to the placebo arm will receive placebo capsules for 8 weeks. Participants will then be followed for 8 weeks following completion of the study treatment.
name: Placebo
type: Other
Study arms:
design_group_description: Participants randomized to the nabilone arm will be titrated up to a maximum dose of 2 mg/day.
design_group_title: Nabilone Arm
design_group_type: Experimental
design_group_description: Participants randomized to the placebo arm will receive placebo capsules.
design_group_title: Placebo Arm
design_group_type: Placebo Comparator
Sponsor: Sunnybrook Health Sciences Centre
Collaborators: Alzheimers Drug Discovery Foundation
Drug name mappings:
name: 大麻隆
lang: CN
name: Nabilone
lang: EN
Clinical trial NCT03791918: Lenvatinib Plus PD-1 Antibody vs TACE for Intermediate-stage HCC Beyond Up-to-seven Criteria
Official title: Lenvatinib Plus Programmed Cell Death Protein-1 (PD-1) Antibody Versus Transarterial Chemoembolization for Intermediate-stage Hepatocellular Carcinoma Beyond Up-to-seven Criteria
Conditions: Hepatocellular Carcinoma
Summary: The purpose of this study is to evaluate the efficacy and safety of lenvatinib combined with PD-1 antibody compared with transarterial chemoembolization (TACE) for patients with intermediate-stage hepatocellular carcinoma (HCC) beyond up-to-seven criteria
Interventions:
description: 12 mg (or 8 mg) once daily (QD) oral dosing.
name: Lenvatinib
other_name: E7080, Lenvima
type: Drug
description: 3mg/kg intravenously every 2 weeks
name: PD-1 antibody
other_name: Programmed cell death 1 antibody
type: Drug
description: A standard hepatic artery catheter was introduced via the femoral artery percutaneously. Selective catheterization of the proper hepatic artery was performed using standard diagnostic catheters and fluoroscopic guidance. TACE Drug Protocol were injected.
name: TACE
other_name: Transarterial chemoembolization
type: Procedure
description: lipiodol mixed with chemotherapy drugs(EADM , lobaplatin, and MMC) followed by polyvinyl alcohol particles (PVA)
name: TACE Drug Protocol
other_name: Drugs for transarterial chemotherapy and embolization
type: Drug
Study arms:
design_group_description: Participants received lenvatinib capsules 12 milligram (mg) based on the participant's body weight greater than or equal to (>=) 60 kilogram (kg) or 8 mg based on the participant's body weight less than (<) 60 kg at baseline, orally, once daily (QD) in continuous 14-day treatment cycles, and received 3mg/kg PD-1 antibody intravenously every 2 weeks up to documented disease progression, development of unacceptable toxicity, participant request, or withdrawal of consent.
design_group_title: Lenvatinib Plus PD-1
design_group_type: Experimental
design_group_description: Hepatic intra-arterial infusion with lipiodol mixed with chemotherapy drugs (EADM, lobaplatin, and MMC), and embolization with polyvinyl alcohol particles (PVA).
design_group_title: TACE
design_group_type: Active Comparator
Sponsor: Sun Yat-Sen University
Collaborators: KaiPing Central Hospital
Guangzhou No. 12 People's Hospital
Drug name mappings:
name: 甲磺酸仑伐替尼
lang: CN
name: Lenvatinib mesylate
lang: EN
name: レンバチニブメシル酸塩
lang: JP
Clinical trial NCT06127407: Ivosidenib in Participants With Locally Advanced or Metastatic Conventional Chondrosarcoma Untreated or Previously Treated With 1 Systemic Treatment Regimen
Official title: A Phase 3, Multicenter, Double-blind, Randomized, Placebo-controlled Study of Ivosidenib in Participants ≥18 Years of Age With Locally Advanced or Metastatic Conventional Chondrosarcoma With an IDH1 Mutation, Untreated or Previously Treated With 1 Systemic Treatment Regimen
Conditions: Locally Advanced or Metastatic Conventional Chondrosarcoma With an IDH1 Mutation, Untreated or Previously Treated With 1 Systemic Treatment Regimen
Summary: Study CL3-95031-007 (CHONQUER) is a Phase 3, international, multicenter, double-blind, randomized, placebo-controlled study of orally administered ivosidenib. Participants are required to have a histopathological diagnosis consistent with isocitrate dehydrogenase-1 (IDH1) gene-mutated, locally advanced or metastatic conventional chondrosarcoma Grades 1, 2, or 3 and not eligible for curative resection. IDH1 mutant status will be determined during pre-screening/screening phase. Participant must have radiographic progression/recurrence of disease according to Response Evaluation Criteria in Solid Tumors (RECIST v1.1) and have received 0 to 1 prior systemic treatment regimen in the advanced/metastatic setting for conventional chondrosarcoma. The primary endpoint is progression-free survival (PFS) in Grades 1 and 2 participants. Key secondary endpoints are PFS in all randomized participants, overall survival (OS) in Grades 1 and 2 participants, and OS in all randomized participants.
Participants who meet enrollment criteria will be randomized 1:1 to receive oral ivosidenib 500mg once daily, or a matching placebo once daily.
Interventions:
description: Provided as tablets, taken orally as two 250mg tablets once daily.
name: Ivosidenib 500mg
type: Drug
description: Provided as tablets, taken orally once daily.
name: Placebo
type: Drug
Study arms:
design_group_description: Taken continuously until BICR-confirmed disease progression, unacceptable toxicity, confirmed pregnancy, death, withdrawal of consent, lost to follow-up, or the Sponsor ends the study (estimated average treatment duration of two years).
design_group_title: Ivosidenib
design_group_type: Experimental
design_group_description: Taken continuously until BICR-confirmed disease progression, unacceptable toxicity, confirmed pregnancy, death, withdrawal of consent, lost to follow-up, or the Sponsor ends the study (estimated average treatment duration of two years). Participants randomized to the placebo arm who experience BICR-confirmed disease progression and meet the crossover eligibility criteria will be given the opportunity to cross over and receive ivosidenib.
design_group_title: Placebo
design_group_type: Placebo Comparator
Sponsor: Servier Bio-Innovation LLC
Collaborators: Institut de Recherches Intern Servier
Drug name mappings:
name: 艾伏尼布
lang: CN
name: Ivosidenib
lang: EN
name: イボシデニブ
lang: JP
Clinical trial NCT02187471: Treatment of Pain Associated With Fibromyalgia
Official title: A Randomized, Double-Blind, Placebo- and Active-Controlled Study of DS-5565 for Treatment of Pain Associated With Fibromyalgia
Conditions: Pain Associated With Fibromyalgia
Summary: The main objective of this trial is to compare change in weekly average daily pain score (ADPS) from baseline to Week 13 in participants receiving either dose of DS-5565 versus placebo.
Weekly ADPS is based on daily pain scores reported by the subject that best describes his or her worst pain over the previous 24 hours.
Interventions:
description: DS-5565 15 mg QD or BID; tablet for oral use
name: DS-5565
other_name: Mirogabalin
type: Drug
description: Pregabalin capsule for oral use; 75 mg capsule for one week, then 150 mg capsule
name: Pregabalin
other_name: Other treatment - not comparator
type: Drug
description: Placebo tablet for oral use, matching DS-5565 tablet
name: Placebo tablet
other_name: Tablet Control
type: Drug
description: Placebo capsule for oral use, matching pregabalin capsule
name: Placebo capsule
other_name: Capsule Control
type: Drug
Study arms:
design_group_description: Participants take one each of placebo tablet and capsule, twice daily (BID)
design_group_title: Placebo
design_group_type: Placebo Comparator
design_group_description: Participants take one pregabalin capsule and one placebo tablet BID
design_group_title: Pregabalin
design_group_type: Other
design_group_description: Participants take one each of placebo tablet and capsule in the morning and one placebo capsule in the evening with one DS-5565 tablet once daily (QD)
design_group_title: DS-5565 15 mg QD
design_group_type: Experimental
design_group_description: Participants take one placebo capsule with one DS-5565 tablet BID
design_group_title: DS-5565 15 mg BID
design_group_type: Experimental
Sponsor: Daiichi Sankyo Co., Ltd.
Collaborators: Syneos Health, Inc.
Drug name mappings:
name: 苯磺酸美洛加巴林
lang: CN
name: Mirogabalin Besilate
lang: EN
name: ミロガバリンベシル酸塩
lang: JP
Clinical trial NCT06795178: Efficacy, Safety, and Pharmacokinetics of FP-014, 11.25 mg in Patients With Advanced Prostate Cancer
Official title: A Global, Phase 3, Open-Label, Single Arm Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of FP-014, 11.25 mg (Triptorelin Mesylate Injection, 11.25 mg) in Patients With Advanced Prostate Cancer (KATANA E3M)
Conditions: Prostate Cancer
Summary: This is a study in male patients with advanced prostate cancer who are eligible for androgen ablation therapy. The study duration will be up to 26 weeks.
Eligibility will be assessed during a screening period of up to 28 days. Up to 2 doses of a long-acting FP-014, 11.25 mg formulation will be given to the patients by separate SC injections 12 weeks apart in an unblinded manner. The first dose of FP-014, 11.25 mg, will be administered on Day 0 (Visit 2/Week 1). When patients have tolerated the first dose of FP-014, 11.25 mg and have achieved castrate levels of serum testosterone, a second dose will be administered on Day 84 (Visit 13/Week 12) to achieve castrate levels of serum testosterone concentrations (< 50 ng/dL). Patients will be followed for efficacy, safety, tolerability, and ancillary clinical and laboratory markers for an additional 12-week observation period (Day 168/Week 24/ Visit 22).
Blood samples will be collected at Baseline (Day 0/Week 1) at least 30 minutes before the first FP-014, 11.25 mg administration, immediately thereafter and at specified time points through Day 168 (Week 24) to determine pharmacokinetic (PK) (triptorelin) and pharmacodynamic (PD) (testosterone, PSA, and LH) profiles.
Interventions:
description: 11.25 mg in a prefilled, ready-to-use, long-acting formulation
name: FP-014
other_name: Triptorelin Mesylate
type: Drug
Study arms:
design_group_description: Each patient will receive 2 single doses of FP-014, 11.25 mg administered as SC injections. The two injections of the study drug will be administered 12 weeks apart; one injection at Baseline (Visit 2/Day 0/Week 1), and one at Visit 13 (Day 84/Week 12) to achieve castrate serum testosterone level (< 50 ng/dL).
design_group_title: FP-014, 11.25 mg
design_group_type: Experimental
Sponsor: Foresee Pharmaceuticals Co., Ltd.
Collaborators: QPS Holdings LLC
Drug name mappings:
name: 双羟萘酸曲普瑞林
lang: CN
name: Triptorelin Pamoate
lang: EN
Clinical trial NCT03073018: Prevention of Renal and Vascular Endstage Disease Intervention Trial
Official title: Prevention of Renal and Vascular Endstage Disease Intervention Trial
Conditions: Microalbuminuria
Cardiovascular Diseases
Renal Disease
Summary: The Prevention of Renal and Vascular Endstage Disease Intervention Trial (PREVEND IT) was designed to determine whether intervention with the angiotensin-converting enzyme (ACE) inhibitor fosinopril and/or the hydroxymethylglutaryl coenzyme A reductase inhibitor pravastatin reduced cardiovascular and renal events in nonhypertensive, nonhypercholesterolemic subjects with microalbuminuria.
Interventions:
description: oral administration, capsules
name: Fosinopril
other_name: Monopril
type: Drug
description: oral administration, capsules
name: Pravastatin
other_name: Pravachol
type: Drug
description: oral administration, capsules
name: Fosinopril Placebo
type: Drug
description: oral administration, capsules
name: Pravastatin Placebo
type: Drug
Study arms:
design_group_description: Fosinopril (20 mg) + pravastatin (40 mg) once daily for 4 years
design_group_title: Fosinopril + Pravastatin
design_group_type: Experimental
design_group_description: Fosinopril (20 mg) + pravastatin placebo once daily for 4 years
design_group_title: Fosinopril + Placebo
design_group_type: Active Comparator
design_group_description: Pravastatin (40 mg) + fosinopril placebo once daily for 4 years
design_group_title: Pravastatin + Placebo
design_group_type: Active Comparator
design_group_description: Fosinopril placebo and pravastatin placebo once daily for 4 years
design_group_title: Double Placebo
design_group_type: Placebo Comparator
Sponsor: Universitair Medisch Centrum Groningen
Collaborators: Nierstichting Nederland
Drug name mappings:
name: 普伐他汀钠
lang: CN
name: Pravastatin Sodium
lang: EN
name: プラバスタチンナトリウム
lang: JP
name: 福辛普利钠
lang: CN
name: Fosinopril Sodium
lang: EN
Clinical trial NCT00135876: Dalteparin Low Molecular Weight Heparin for Primary Prophylaxis of Venous Thromboembolism in Brain Tumour Patients
Official title: A Trial of Dalteparin Low Molecular Weight Heparin for Primary Prophylaxis of Venous Thromboembolism in Brain Tumour Patients (PRODIGE)
Conditions: Venous Thromboembolism
Brain Tumors
Summary: In patients with malignant glioma, to determine the efficacy of prophylaxis with LMWH (dalteparin) compared to placebo, both commenced beyond the immediate postoperative period, for the prevention of VTE.
Interventions:
name: dalteparin
type: Drug
Study arms:
Sponsor: Ontario Clinical Oncology Group
Collaborators: Pfizer Inc.
Drug name mappings:
name: 达肝素钠
lang: CN
name: Dalteparin Sodium
lang: EN
name: ダルテパリンナトリウム
lang: JP
Clinical trial NCT04656613: A Phase III Clinical Trial of the Immunogenicity and Safety of the Gam-COVID-Vac Vaccine Against COVID-19 in the UAE
Official title: A Phase III, Randomized, Double -Blind, Placebo-controlled Trial to Evaluate Immunogenicity and Safety of the Gam-COVID-Vac Combined Vector Vaccine in Prophylactic Treatment for SARS-СoV-2 Infection in the United Arab Emirates
Conditions: Covid19
SARS-CoV Infection
Summary: This study is randomized, double-blind (blinded for the trial subject and the study physician), placebo-controlled trial in the parallel assignment of the immunogenicity, and safety of the Gam-COVID-Vac combined vector vaccine against the SARS-CoV-2-induced coronavirus infection in adults in the SARS-СoV-2 infection prophylactic treatment.
Interventions:
description: the Gam-COVID-Vac is combined 2 -component vector vaccine against the SARS-СoV-2-induced coronavirus infection
name: Gam-COVID-Vac
other_name: Sputnik V
type: Biological
description: Placebo Comparator
name: placebo
type: Other
Study arms:
design_group_description: a study group of 750 subjects receiving the Gam-COVID-Vac combined vector vaccine against the SARS-СoV-2-induced coronavirus infection
design_group_title: Vaccine
design_group_type: Experimental
design_group_description: a reference group of 250 subjects receiving placebo
design_group_title: Placebo
design_group_type: Placebo Comparator
Sponsor: Gamaleya Research Institute Of Epidemiology And Microbiology, Health Ministry Of The Russian Federation
Collaborators: Pdc Cro
Drug name mappings:
name: Gam-COVID-Vac
lang: EN
Clinical trial NCT04322123: Safety and Efficacy of Hydroxychloroquine Associated With Azithromycin in SARS-Cov-2 Virus (COVID-19)
Official title: An Open-label, Randomized Controlled Trial of Hydroxychloroquine and Azithromycin for COVID-19 Infection on Hospitalized, Noncritical Patients
Conditions: Coronavirus Infections
Summary: Coronavirus (COVID-19) is a somewhat new and recognized infectious disease that is now spreading to several countries in the world, including Brazil. Hydroxychloroquine and azithromycin may be useful for treating those patients.
COALITION I study aims to compared standard of care, hydroxychloroquine plus azithromycin and hydroxychloroquine monotherapy for treatment of hospitalized patients with COVID-19.
COALITION I will recruit 630 patients with infection by COVID-19 (210 per arm). Ordinal endpoint of status at 15 days will be the primary endpoint.
Interventions:
description: Hydroxychloroquine 400 mg BID
name: Hydroxychloroquine Oral Product
type: Drug
description: Hydroxychloroquine 400 mg BID + azithromycin 500 mg once a day
name: Hydroxychloroquine + azithromycin
type: Drug
Study arms:
design_group_description: Hydroxychloroquine after randomization, Hydroxychloroquine [400mg 2x/day, 12/12h] for 07 days.
design_group_title: Hydroxychloroquine
design_group_type: Experimental
design_group_description: Hydroxychloroquine + azithromycin. After randomization, Hydroxychloroquine [400mg 2x/day, 12/12h] + azithromycin [500mg 1x/day]) for 07 days.
design_group_title: Hydroxychloroquine + azithromycin
design_group_type: Experimental
design_group_description: standard treatment protocol for 2019-nCoV infection.
design_group_title: Control
design_group_type: No Intervention
Sponsor: Associacao Beneficente Siria
Collaborators: Hospital Israelita Albert Einstein
EMS SA (Brazil)
Sociedade Beneficiente de Senhoras Hospital Sírio Libanês
Drug name mappings:
name: 硫酸羟氯喹
lang: CN
name: Hydroxychloroquine Sulfate
lang: EN
name: ドロキシクロロキン硫酸塩
lang: JP
Clinical trial NCT02135510: MEtoclopramide, DExamethasone or Axoli to Prevent or Delay Chemotherapy-induced Nausea and Vomiting in Moderately Emetogenic Non-AC-based Chemotherapy
Official title: MEtoclopramide, DExamethasone or Axoli (Palonoseton) for the Prevention of Delayed Chemotherapy-induced Nausea and Vomiting in Moderately Emetogenic Non-AC-based Chemotherapy: the MEDEA-trial
Conditions: Solid Tumors
Summary: In this phase III non-inferiority trial, the aim is to evaluate whether metoclopramide and palonosetron prophylactic antemetic treatment are non-inferior to dexamethasone with regard to its efficacy to prevent delayed chemotherapy-induced nausea and vomiting (CINV) induced by non- anthracyclines plus cyclophosphamide (AC) based moderately emetogenic chemotherapy (MEC).
Interventions:
name: metoclopramide
type: Drug
name: dexamethason
type: Drug
name: palonosetron
type: Drug
Study arms:
design_group_title: metoclopramide
design_group_type: Active Comparator
design_group_title: dexamethason
design_group_type: Active Comparator
design_group_title: palonosetron
design_group_type: Active Comparator
Sponsor: Stichting Onderzoek Cancer Center Amsterdam
Collaborators: Rijnstate
Ziekenhuis Amstelland
Noordwest Ziekenhuisgroep
Drug name mappings:
name: 盐酸甲氧氯普胺
lang: CN
name: Metoclopramide Hydrochloride
lang: EN
name: 塩酸メトクロプラミド
lang: JP
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
name: 地塞米松
lang: CN
name: Dexamethasone
lang: EN
name: デキサメタゾン
lang: JP
Clinical trial NCT01169259: Vitamin D and Omega-3 Trial (VITAL)
Official title: Vitamin D and Omega-3 Trial (VITAL)
Conditions: Cancer
Cardiovascular Disease
Summary: The VITamin D and OmegA-3 TriaL (VITAL) is a randomized clinical trial in 25,871 U.S. men and women investigating whether taking daily dietary supplements of vitamin D3 (2000 IU) or omega-3 fatty acids (Omacor® fish oil, 1 gram) reduces the risk of developing cancer, heart disease, and stroke in people who do not have a prior history of these illnesses. The 5-year intervention phase (study pill-taking, median 5.3 years) has ended; post-intervention observational follow-up of study participants is ongoing.
Interventions:
description: Vitamin D3 (cholecalciferol), 2000 IU per day.
name: vitamin D3
other_name: cholecalciferol
type: Dietary Supplement
description: Omacor, one 1-gram capsule per day. Each capsule of Omacor contains 840 milligrams of marine omega-3 fatty acids (465 mg of eicosapentaenoic acid [EPA] and 375 mg of docosahexaenoic acid [DHA]).
name: omega-3 fatty acids (fish oil)
type: Drug
description: Vitamin D placebo
name: Vitamin D3 placebo
type: Dietary Supplement
description: Fish oil placebo
name: Fish oil placebo
type: Dietary Supplement
Study arms:
design_group_title: Vitamin D + fish oil
design_group_type: Active Comparator
design_group_title: Vitamin D + fish oil placebo
design_group_type: Active Comparator
design_group_title: Vitamin D placebo + fish oil
design_group_type: Active Comparator
design_group_title: Vitamin D placebo + fish oil placebo
design_group_type: Placebo Comparator
Sponsor: The Brigham & Women's Hospital, Inc.
Collaborators: Pharmavite LLC
National Heart, Lung & Blood Institute
National Cancer Institute
National Institute of Neurological Disorders & Stroke
National Center For Complementary & Integrative Health
Pronova BioPharma ASA
BASF Corp.
Office of Dietary Supplements
Drug name mappings:
name: ω-3酸乙酯(Trygg Pharma AS)
lang: CN
name: Omega-3-acid ethyl esters(Trygg Pharma AS)
lang: EN
name: 维生素D3
lang: CN
name: Colecalciferol
lang: EN
Clinical trial NCT02174627: Safety and Efficacy Study of Roxadustat to Treat Anemia in Patients With Chronic Kidney Disease (CKD), Not on Dialysis
Official title: A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Roxadustat for the Treatment of Anemia in Chronic Kidney Disease Patients Not on Dialysis
Conditions: Anemia
Summary: The purpose of the study is to evaluate the safety and efficacy of roxadustat for treatment of anemia in patients with chronic kidney disease not on dialysis
Interventions:
description: The initial study drug dose is 70 mg three times a week (TIW). The dose is subsequently adjusted to achieve and maintain Hb 11±1 g/dL.
name: Roxadustat
type: Drug
description: The initial study drug dose is 70 mg three times a week (TIW). The dose is subsequently adjusted to achieve and maintain Hb 11±1 g/dL.
name: Placebo
type: Drug
Study arms:
design_group_title: Roxadustat
design_group_type: Experimental
design_group_title: Placebo
design_group_type: Placebo Comparator
Sponsor: AstraZeneca PLC
Collaborators: Kyntra Bio, Inc.
Drug name mappings:
name: 罗沙司他
lang: CN
name: Roxadustat
lang: EN
name: ロキサデュスタット
lang: JP