PatSnap/clinical-trial huggingface dataset:
Clinical trial NCT05355337: Pramipexole for Anhedonic Depression
Official title: Adjunctive Treatment With Pramipexole for Anhedonic Depression Symptoms in Depression - PRIME-PRAXOL
Conditions: Psychiatric Disorders Mood
Anhedonia
Depression
Summary: The heterogeneity of depression suggests that several different neurocircuits and pathophysiological mechanisms are involved. Anhedonia - the inability to experience pleasure from, or the lack of motivation to carry out, usually enjoyable activities - is a promising endophenotype within the depression spectrum, with a distinct pathophysiology involving dopaminergic mesolimbic projections. Anhedonia is common in depression and associated with treatment resistance. Pramipexole, an agonist to the dopamine -receptor 3, is an established treatment of Parkinson's disease. Based on its mechanism of action, pramipexole might be efficacious in a subtype of depression characterized by anhedonia and lack of motivation - symptoms linked to dopaminergic hypofunction. This is supported by animal data, clinical experience, and recent pilot study data, but randomized controlled trials (RCTs) are lacking. In this double-blind placebo-controlled RCT the anti-anhedonic and antidepressant effects of add-on pramipexole will be tested, using an "enriched population study design" including only depressed patients with significant anhedonia. To better understand the neurobiology of anhedonia in depression and to identify treatment predictors, simultaneous assessments of anhedonia-related neurocircuitry using (f)MRI will be done, and anhedonia-related biomarkers in blood and cerebrospinal fluid analyzed. The aim of the study is to confirm the efficacy of pramipexole in this depression subtype, which would be an important step towards personalized medicine in psychiatry.
Interventions:
description: 9 weeks of treatment with Pramipexole
name: Pramipexole
type: Drug
description: 9 weeks of treatment with Placebo
name: Placebo
type: Drug
Study arms:
design_group_description: Pramipexole prolonged-release tablet, 0.26 mg base to 3.15 mg base / day for 9 weeks (individually varying dose titrating during these weeks).
design_group_title: Pramipexole
design_group_type: Active Comparator
design_group_description: Tablets in appearance identical to the active comparator tablets, but without the the active substance (pramipexole).
design_group_title: Placebo
design_group_type: Placebo Comparator
design_group_description: 40 healthy controls who will carry out blood sampling, lumbar puncture and fMRI according to the same protocol as the depressed patients.
design_group_title: Healthy controls
design_group_type: No Intervention
Sponsor: Region Skåne Holding AB
Collaborators: University of Lund
Drug name mappings:
name: 盐酸普拉克索
lang: CN
name: Pramipexole Dihydrochloride
lang: EN
name: プラミペキソール塩酸塩水和物
lang: JP
Clinical trial NCT01085266: An Extension of the HORIZON Protocol Evaluating the Safety of Dimebon (Latrepirdine) in Subjects With Huntington Disease
Official title: HORIZON-Plus: An Open-Label Extension of the HORIZON Protocol (DIM20) Evaluating the Safety of Dimebon (Latrepirdine) in Subjects With Huntington Disease
Conditions: Huntington Disease
Summary: An open-label extension study of the HORIZON protocol evaluating the safety of dimebon (latrepirdine)in subjects with Huntington disease.
Interventions:
name: Dimebon (latrepirdine)
type: Drug
Study arms:
design_group_description: Patients receive dimebon 10mg orally 3 times per day for 1 week and 20 mg orally 3 times per day thereafter.
design_group_title: Dimebon (latrepirdine)
design_group_type: Experimental
Sponsor: MediVation, Inc.
Collaborators: Pfizer Inc.
Drug name mappings:
name: 盐酸地美波林
lang: CN
name: Dimebolin hydrochloride
lang: EN
Clinical trial NCT03403712: A Study to Assess the Safety and the Efficacy of IV Fosnetupitant/Palonosetron (260 mg/0.25 mg) Combination Compared to Oral Netupitant/Palonosetron (300 mg/0.5 mg) Combination for the Prevention of CINV in AC Chemotherapy in Women With Breast Cancer
Official title: A Multicenter, Randomized, Double-blind, Double-dummy, Active-controlled, Parallel Group Phase 3b Study to Assess the Safety and to Describe the Efficacy of IV Fosnetupitant/Palonosetron (260 mg/0.25 mg) Combination (IV NEPA FDC) Compared to Oral Netupitant/Palonosetron (300 mg/0.5 mg) Combination (Akynzeo®) for the Prevention of Chemotherapy-induced Nausea and Vomiting in Initial and Repeated Cycles of Anthracycline-cyclophosphamide (AC) Chemotherapy in Women With Breast Cancer
Conditions: Chemotherapy-induced Nausea and Vomiting
Summary: Multicenter, randomized, double-blind, double-dummy, parallel group, stratified study assessing the safety and describing the efficacy of a single dose of intravenous (IV) fosnetupitant/palonosetron (260 mg/0.25 mg) infusion [test] versus oral netupitant/palonosetron (300 mg/0.5 mg) combination [control]; each administered with oral dexamethasone prior to initial and repeated cycles of AC chemotherapy in female breast cancer patients.
Interventions:
description: intravenous fosnetupitant/ palonosetron (260 mg/0.25 mg) fixed-dose combination
name: fosnetupitant/ palonosetron
other_name: IV NEPA FDC
type: Drug
description: oral netupitant/palonosetron (300 mg/0.50 mg) fixed-dose combination
name: netupitant/palonosetron
other_name: Akynzeo capsules
type: Drug
description: Oral dexamethasone (12 mg)
name: dexamethasone
type: Drug
Study arms:
design_group_description: intravenous fosnetupitant/ palonosetron (260 mg/0.25 mg) fixed-dose combination, administered as a 30-minute infusion of a 50 mL solution, on Day 1 of each cycle.<br/>Oral dexamethasone will be administered on Day 1 of each cycle (12 mg)
design_group_title: Test group
design_group_type: Experimental
design_group_description: oral netupitant/palonosetron (300 mg/0.50 mg) fixed-dose combination on Day 1 of each cycle.<br/>Oral dexamethasone will be administered on Day 1 of each cycle (12 mg)
design_group_title: Control group
design_group_type: Active Comparator
Sponsor: Helsinn Healthcare SA
Collaborators: Physicians' Services, Inc. Foundation
Emerald Clinical Trials Pty Ltd.
Drug name mappings:
name: 地塞米松磷酸钠
lang: CN
name: Dexamethasone Sodium Phosphate
lang: EN
name: デキサメタゾンリン酸エステルナトリウム
lang: JP
name: 奈妥匹坦帕洛诺司琼
lang: CN
name: Netupitant/Palonosetron Hydrochloride
lang: EN
Clinical trial NCT00312195: Safety and Efficacy of Buprenorphine Transdermal System (BTDS) in Subjects With Chronic Nonmalignant Pain
Official title: An Open-label Run-in, Followed by a Randomized, Double-blind, Placebo Controlled, Parallel Group Study to Show the Effectiveness of Buprenorphine Transdermal System in Management of Patients With Chronic Nonmalignant Pain Syndromes
Conditions: Chronic Non-malignant Pain
Summary: The objective of this study is to demonstrate the effectiveness and tolerability of the buprenorphine transdermal system (5, 10 and 20) in comparison to matching placebo transdermal system in subjects with chronic nonmalignant pain syndromes currently controlled by oral opioids. The double-blind treatment intervention duration is 2 weeks during which time supplemental analgesic medication (acetaminophen) will be provided to all subjects in addition to study drug.
Interventions:
description: Buprenorphine transdermal patch 5, 10 or 20 mcg/h applied for 7-day wear.
name: Buprenorphine transdermal patch
other_name: Butrans™
type: Drug
description: Placebo to match buprenorphine transdermal patch applied for 7-day wear.
name: Placebo to match BTDS
type: Drug
Study arms:
design_group_description: Buprenorphine transdermal patch
design_group_title: BTDS (5, 10 or 20)
design_group_type: Experimental
design_group_description: Placebo to match buprenorphine transdermal patch
design_group_title: Placebo to match BTDS
design_group_type: Placebo Comparator
Sponsor: Purdue Pharma LP
Collaborators: Napp Pharmaceuticals Ltd.
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: 丁丙诺啡
lang: CN
name: Buprenorphine
lang: EN
name: ブプレノルフィン
lang: JP
Clinical trial NCT03496298: Effect of Efpeglenatide on Cardiovascular Outcomes
Official title: A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Effect of Efpeglenatide on Cardiovascular Outcomes in Type 2 Diabetes Patients at High Cardiovascular Risk
Conditions: Type 2 Diabetes Mellitus
Summary: Primary Objective:
To demonstrate that efpeglenatide 4 and 6 mg was noninferior to placebo on 3-point major adverse cardiac events (MACE) in Type 2 diabetes mellitus (T2DM) participants at high cardiovascular (CV) risk.
Secondary Objectives:
To demonstrate that efpeglenatide 4 and 6 mg was superior to placebo in T2DM participants with high CV risk on the following parameters:
* 3-point MACE.
* Expanded CV outcome.
* Composite outcome of new or worsening nephropathy.
To assess the safety and tolerability of efpeglenatide 4 and 6 mg, both added to standard of care in T2DM participants at high CV risk.
Interventions:
description: Pharmaceutical form: Solution for injection,<br/>Route of administration: SC
name: Efpeglenatide (SAR439977)
type: Drug
description: Pharmaceutical form: Solution for injection<br/>Route of administration: SC
name: Placebo
type: Drug
Study arms:
design_group_description: Participants received placebo (matched to Efpeglenatide) as subcutaneous (SC) injection once weekly up to end of treatment.
design_group_title: Placebo
design_group_type: Placebo Comparator
design_group_description: Participants received Efpeglenatide as SC injection 2 milligrams (mg) per week for 4 weeks then 4 mg per week up to end of treatment.
design_group_title: Efpeglenatide 4 mg
design_group_type: Experimental
design_group_description: Participants received Efpeglenatide as SC injection 2 mg per week for 4 weeks, then 4 mg per week for 4 weeks and then 6 mg per week up to end of treatment.
design_group_title: Efpeglenatide 6 mg
design_group_type: Experimental
Sponsor: Sanofi
Collaborators: Hanmi Pharmaceutical Co., Ltd.
Drug name mappings:
name: Efpeglenatide
lang: EN
Clinical trial NCT03062839: Melatonin as Adjuvant Treatment for ADHD in Adults
Official title: Melatonin as Adjuvant Treatment for ADHD in Adults
Conditions: Attention Deficit Hyperactivity Disorder
Summary: This study aims to evaluate the effect of melatonin supplementation as adjuvant treatment in ADHD in adults.
Interventions:
description: Melatonin 5 mg taken 30 minutes before bed time
name: Melatonin 5 mg
other_name: Melatonina
type: Drug
Study arms:
design_group_description: Melatonin 5 mg taken 30 minutes before bed time
design_group_title: Melatonin
design_group_type: Experimental
design_group_description: Placebo identical to melatonin capsule taken 30 min before bed time
design_group_title: Placebo
design_group_type: Placebo Comparator
Sponsor: Hospital Israelita Albert Einstein
Collaborators: Fundação de Amparo à Pesquisa do Estado de São Paulo
University of Sao Paulo
Drug name mappings:
name: 褪黑素
lang: CN
name: Melatonin
lang: EN
name: メラトニン
lang: JP
Clinical trial NCT00641056: Efficacy of Exenatide Once Weekly and Once-Daily Insulin Glargine in Patients With Type 2 Diabetes Treated With Metformin Alone or in Combination With Sulfonylurea (DURATION - 3)
Official title: Efficacy of Once-Weekly Exenatide Long-Acting Release and Once-Daily Insulin Glargine in Patients With Type 2 Diabetes Treated With Metformin Alone or in Combination With Sulfonylurea
Conditions: Type 2 Diabetes Mellitus
Summary: The purpose of this study is to compare the effects of 2.0 mg exenatide once weekly and insulin glargine, titrated to glucose targets using the algorithm described by Yki- Järvinen et al.(2007), with respect to glycemic improvements, body weight, fasting lipids, safety, and tolerability.
Interventions:
description: subcutaneous injection, 2.0mcg, once weekly
name: Exenatide Once Weekly
type: Drug
description: subcutaneous injection, variable dose, QD
name: Insulin Glargine
type: Drug
Study arms:
design_group_title: 1
design_group_type: Experimental
design_group_title: 2
design_group_type: Active Comparator
Sponsor: AstraZeneca PLC
Collaborators: Eli Lilly & Co.
Drug name mappings:
name: 艾塞那肽
lang: CN
name: Exenatide
lang: EN
name: エキセナチド
lang: JP
Clinical trial NCT01660893: Comparison of Intranasal Kovacaine Mist, Tetracaine Alone, and Placebo for Anesthetizing Maxillary Teeth
Official title: A Phase III, Multi-Center, Randomized, Double-Blind, Parallel-Groups Clinical Trial Comparing the Efficacy and Safety of Intranasally Administered Kovacaine Mist to Tetracaine Alone and to Placebo for Anesthetizing Maxillary Teeth in Adults
Conditions: Anesthesia
Summary: The purpose of this study is to compare the efficacy of Kovacaine Mist, Tetracaine only, and Placebo for inducing pulpal anesthesia of the maxillary teeth in adults.
Interventions:
description: 3 unilateral intranasal sprays per dose
name: Tetracaine HCl 3% and oxymetazoline HCl 0.05%
other_name: Kovacaine Mist
type: Drug
description: 3 unilateral intranasal sprays per dose
name: Tetracaine HCl 3%
type: Drug
description: 3 unilateral intranasal sprays per dose
name: Placebo
type: Drug
Study arms:
design_group_description: Tetracaine HCl 3% and oxymetazoline HCl 0.05%
design_group_title: Kovacaine Mist, 3 sprays unilateral
design_group_type: Experimental
design_group_description: Tetracaine HCl 3%
design_group_title: Tetracaine Only, 3 sprays unilateral
design_group_type: Experimental
design_group_description: Placebo
design_group_title: Placebo, 3 sprays unilateral
design_group_type: Placebo Comparator
Sponsor: St. Renatus LLC
Collaborators: Triligent International
Rho, Inc.
Drug name mappings:
name: 盐酸羟甲唑啉
lang: CN
name: Oxymetazoline Hydrochloride
lang: EN
name: オキシメタゾリン塩酸塩
lang: JP
name: 盐酸丁卡因
lang: CN
name: Tetracaine Hydrochloride
lang: EN
Clinical trial NCT00003824: S9809, Ciprofloxacin Compared With Cephalexin in Treating Patients With Bladder Cancer
Official title: The Effect of Fluoroquinolones on the Disease-Free Interval in Patients With Stage Ta Transitional Cell Carcinoma of the Bladder
Conditions: Bladder Cancer
Summary: RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer. It is not yet known whether ciprofloxacin is more effective than cephalexin in preventing cancer recurrence in patients who are undergoing surgery to treat bladder cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of ciprofloxacin with that of cephalexin in preventing recurrence of cancer in patients who are undergoing surgery for bladder cancer.
Interventions:
description: 500 mg oral bid for 3 days starting the night before resection
name: cephalexin
other_name: antibiotic
type: Drug
name: surgical procedure
type: Procedure
description: 500 mg oral bid for 3 days starting the night before resection
name: Ciprofloxacin
other_name: cipro
type: Drug
Study arms:
design_group_description: ciprofloxacin
design_group_title: cipro
design_group_type: Experimental
design_group_description: cephalexin
design_group_title: ceph
design_group_type: Experimental
Sponsor: SWOG
Collaborators: National Cancer Institute
Drug name mappings:
name: 头孢氨苄
lang: CN
name: Cephalexin
lang: EN
name: セファレキシン
lang: JP
name: 环丙沙星
lang: CN
name: Ciprofloxacin
lang: EN
name: シプロフロキサシン
lang: JP
Clinical trial NCT01885559: HALT Progression of Polycystic Kidney Disease Study B
Official title: HALT Progression of Polycystic Kidney Disease Study B
Conditions: Kidney, Polycystic
Summary: The efficacy of interruption of the renin-angiotensin-aldosterone system (RAAS) on the progression of cystic disease and on the decline in renal function in autosomal dominant kidney disease (ADPKD) will be assessed in two simultaneous multicenter randomized clinical trials targeting different levels of kidney function: 1) early disease defined by GFR >60 mL/min/1.73 m2 (Study A); and 2) moderately advanced disease defined by GFR 25-60 mL/min/1.73 m2 (Study B). Participants will be recruited and enrolled, either to Study A or B, over the first three years. Participants enrolled in Study B will be followed for five-to-eight years, with the average length of follow-up being six and a half years.
Combination therapy will use angiotensin-converting-enzyme inhibitor (ACE-I) and an angiotensin-receptor blocker (ARB). Monotherapy will use ACE-I alone.
Interventions:
description: Lisinopril titrated to 5mg, 10mg, 20mg, 40mg as tolerated by participants, to achieve standard blood pressure control of 110-130/80 mm Hg.
name: Lisinopril
other_name: ACE
ACE-I
Ace-Inhibitor
type: Drug
description: Telmisartan titrated to 40mg and 80mg, as tolerated by participants, to achieve standard blood pressure control of 110-130/80 mm Hg.
name: Telmisartan
other_name: ARB
type: Drug
description: Placebo titrated to 40mg and 80mg, as tolerated by participants, to achieve standard blood pressure control of 110-130/80 mm Hg.
name: Placebo
other_name: Control
type: Drug
Study arms:
design_group_description: Monotherapy of lisinopril and placebo. Standard blood pressure control of 110-130/80 mm Hg
design_group_title: ACE-I + placebo
design_group_type: Placebo Comparator
design_group_description: Dual therapy of lisinopril and telmisartan treatments. Standard blood pressure control of 110-130/80 mm Hg.
design_group_title: ACE-I + ARB
design_group_type: Active Comparator
Sponsor: National Institute of Diabetes & Digestive & Kidney Diseases
Collaborators: Merck Sharp & Dohme Corp.
Washington University School of Medicine
Boehringer Ingelheim GmbH
University of Pittsburgh
The Polycystic Kidney Disease Research Foundation
Drug name mappings:
name: 赖诺普利
lang: CN
name: Lisinopril
lang: EN
name: リシノプリル水和物
lang: JP
name: 替米沙坦
lang: CN
name: Telmisartan
lang: EN
name: テルミサルタン
lang: JP
Clinical trial NCT00729794: Vasopressin, Epinephrine, and Steroids for Cardiac Arrest
Official title: Vasopressin, Epinephrine, and Corticosteroids for Inhospital Cardiac Arrest: A Multicenter Randomized Controlled Trial
Conditions: Cardiac Arrest
Summary: The simultaneous activation of adrenergic and vasopressin receptors, in conjunction with a potential steroid-mediated enhancement of the vascular reactivity to epinephrine may have beneficial effects in patients with cardiac arrest. This hypothesis is supported by the single-center results of NCT 00411879. The investigators intend to either refute or provide definitive evidence supporting this hypothesis (and its generalizability) by conducting the present multicenter, randomized, controlled clinical trial of in hospital cardiac arrest.
Interventions:
description: Combination Treatment<br/>Administration of vasopressin, epinephrine, and methylprednisolone during CPR, and of stress dose hydrocortisone after CPR
name: Vasopressin, Epinephrine, Methylprednisolone, Hydrocortisone
type: Drug
description: Patients receive advanced life support according to the Guidelines for Resuscitation 2005
name: Standard CPR Protocol with Epinephrine and two Placebos
type: Drug
Study arms:
design_group_description: Patients with refractory, inhospital cardiac arrest, i.e., with asystole, pulseless electrical activity, or ventricular fibrillation/pulseless ventricular tachycardia not responsive to two attempts at defibrillation.
design_group_title: Study Group
design_group_type: Experimental
design_group_description: Patients with refractory, inhospital cardiac arrest, i.e., with asystole, pulseless electrical activity, or ventricular fibrillation/pulseless ventricular tachycardia not responsive to two attempts at defibrillation.
design_group_title: Control Group
design_group_type: Placebo Comparator
Sponsor: National & Kapodistrian University of Athens
Collaborators: University of Thessaly
Drug name mappings:
name: 重酒石酸肾上腺素
lang: CN
name: Epinephrine Bitartrate
lang: EN
name: 甲泼尼龙
lang: CN
name: Methylprednisolone
lang: EN
name: メチルプレドニゾロン
lang: JP
name: 氢化可的松
lang: CN
name: Hydrocortisone
lang: EN
name: ヒドロコルチゾン
lang: JP
name: 精氨加压素
lang: CN
name: Vasopressin
lang: EN
name: 合成バソプレシン
lang: JP
Clinical trial NCT00980876: A Comparative Study Between Two Formulations of the Ciprofloxacin Hydrochloride + Hydrocortisone Otic Suspension
Official title: Multicentric, Double Blind, Randomized, Parallel Comparative Study Between Ciprofloxacin HCl 2 mg/mL + Hydrocortisone 10 mg/mL Ear Suspension and Cipro HC®, for the Assessment of Efficacy and Safety in Patients With Otitis Externa.
Conditions: Otitis Externa
Summary: The objective of this study is to compare the efficacy and safety profiles of the test product containing 2 mg/mL ciprofloxacin hydrochloride associated with 10 mg/mL of hydrocortisone with the reference product Cipro HC®, in patients with acute otitis externa.
Interventions:
description: Cipro HC (Ciprofloxacin HCl and Hydrocortisone)
name: Cipro HC
type: Drug
description: Ciprofloxacin Hydrochloride and Hydrocortisone
name: Ciprofloxacin HCl and Hydrocortisone
other_name: Otociriax
type: Drug
Study arms:
design_group_description: Reference product
design_group_title: Cipro HC
design_group_type: Active Comparator
design_group_description: Test product
design_group_title: Ciprofloxacin HCl and Hydrocortisone
design_group_type: Experimental
Sponsor: Farmoquímica SA
Collaborators: Pharmagenix Projetos em Medicina Farmacêutica Ltda.
Drug name mappings:
name: 醋酸氢化可的松
lang: CN
name: Hydrocortisone Acetate
lang: EN
Clinical trial NCT01384877: Subcutaneous Lidocaine For Cancer-Related Pain
Official title: A Randomized Double Blind Placebo Controlled Crossover Trial of the Use of Subcutaneous Lidocaine Infusion (SCLI) for Chronic Cancer-related Pain
Conditions: Cancer-related Pain
Summary: This study's primary objective is to test the hypothesis that a single infusion of subcutaneous lidocaine can cause a clinically useful reduction in cancer pain within 48 hours of infusion and lasting a minimum of 7 days. A clinically useful reduction in pain is defined by either a 2-point reduction (on a 0-10 scale) in the worst pain experienced over a 24-hour period, or a ≥30% reduction in 24-hour opioid requirement. We will use a composite endpoint of reduction in pain without increase in 24-hr opioid requirement or no decrease in pain with a ≥30% reduction in 24-hour opioid requirement.Subjects will receive either lidocaine or placebo, followed at least 1 week later by the alternate agent.
Interventions:
description: 10mg/kg by subcutaneous infusion over 5.5 hours
name: Lidocaine
other_name: Lignocaine
Xylocaine
type: Drug
description: Same volume as for lidocaine infusion, identical clear liquid in appearance, given in same device over same time period (5.5 hrs)
name: Placebo (D5W)
other_name: 5% dextrose in water
type: Drug
Study arms:
design_group_description: Lidocaine
design_group_title: Lidocaine
design_group_type: Experimental
design_group_description: Placebo first as compared with lidocaine first
design_group_title: Placebo (D5W)
design_group_type: Placebo Comparator
Sponsor: British Columbia Cancer Agency
Collaborators: Bc Cancer Foundation
Drug name mappings:
name: 利多卡因
lang: CN
name: Lidocaine
lang: EN
name: リドカイン
lang: JP