PatSnap/clinical-trial huggingface dataset:
Clinical trial NCT05372315: Efficacy of Dextenza Insert in Upper vs Lower Punctum Following Cataract Surgery With PCIOL.
Official title: A Randomized, Controlled Study to Evaluate the Safety and Effectiveness of Treatment With an Intracanalicular Dexamethasone (0.4mg) Ophthalmic Insert in the Operating Room Following Cataract Surgery/Intraocular Lens Implant (IOL).
Conditions: Cataract
Summary: To assess the safety and effectiveness of treatment with an intracanalicular dexamethasone (0.4mg) insert in the operating room following cataract surgery/intraocular lens implant (IOL) with or without iStent/Hydrus/Goniotomy when placed in the lower punctum compared to the upper punctum.
Interventions:
description: (dexamethasone ophthalmic insert)-for the treatment of ocular inflammation and pain following following ophthalmic surgery.
name: Dextenza 0.4Mg Ophthalmic Insert
type: Drug
Study arms:
design_group_description: DEXTENZA (dexamethasone ophthalmic insert, 0.4mg) for intracanalicular use<br/>Group 1 (up to 40 eyes) will receive the insert in the lower punctum on the day of surgery in the OR.
design_group_title: Lower Punctum Insertion (Group 1)
design_group_type: Other
design_group_description: DEXTENZA (dexamethasone ophthalmic insert, 0.4mg) for intracanalicular use<br/>Group 2 (up to 40 eyes) will receive the insert in the upper punctum on the of surgery in the OR.
design_group_title: Upper Punctum Insertion (Group 2)
design_group_type: Other
Sponsor: Iworks Laser & Vision Center
Collaborators: Ocular Therapeutix, Inc.
Drug name mappings:
name: 地塞米松
lang: CN
name: Dexamethasone
lang: EN
name: デキサメタゾン
lang: JP
Clinical trial NCT01024647: Optimizing Cimzia in Crohn's Patients
Official title: Optimizing Response in Crohn's Disease Patients Who Have Insufficient Initial Response or Who Have Loss of Successful Response to Certolizumab Pegol (Cimzia) Induction Therapy
Conditions: Crohn's Disease
Summary: The purpose of this study is to determine if increasing the dose and/or dosing frequency of certolizumab pegol (Cimzia) is effective in regaining and optimizing response in patients with moderate to severe Crohn's disease.
Interventions:
description: certolizumab pegol 200 mg every 2 weeks
name: certolizumab pegol
other_name: Cimzia
type: Biological
description: certolizumab pegol 400 mg every 2 weeks
name: certolizumab pegol
other_name: Cimzia
type: Biological
description: certolizumab pegol 400 mg every 4 weeks
name: certolizumab pegol
other_name: Cimzia
type: Biological
description: certolizumab pegol 400 mg every 2 weeks
name: certolizumab pegol
other_name: Cimzia
type: Biological
Study arms:
design_group_description: Loss of Response Reinduction Responders:certolizumab pegol (Cimzia) 200 mg every 2 weeks
design_group_title: Loss of Reponse Reinduction Responders
design_group_type: Active Comparator
design_group_description: Response Loss Reinduction Non-Responders:certolizumab pegol(Cimzia) 400 mg every 2 weeks
design_group_title: Response loss Reinduction Non-Responders
design_group_type: Active Comparator
design_group_description: Responders: certolizumab pegol(Cimzia) 400 mg every 4 weeks
design_group_title: Responders
design_group_type: Active Comparator
design_group_description: Non-Responders: certolizumab pegol (Cimzia) 400 mg every 2 weeks
design_group_title: Non-Responders
design_group_type: Active Comparator
Sponsor: Atlanta Gastroenterology Associates LLC
Collaborators: UCB Pharma GmbH
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 NCT05697211: ORal IrON Supplementation with Ferric Maltol in Treating Iron Deficiency and Anaemia in Patients with Heart Failure (ORION-HF)
Official title: A Pilot Study to Explore Safety, Tolerability and Efficacy of ORal IrON Supplementation with Ferric Maltol in Treating Iron Deficiency and Anaemia in Patients with Heart Failure
Conditions: Heart Failure, Left-sided
Anemia, Iron Deficiency
Summary: This is an open-label, single arm, multicenter pilot-study to explore the safety, tolerability and efficacy of oral iron supplementation with ferric maltol in treating iron deficiency and anaemia in patients with heart failure.
Interventions:
description: In this trial Feraccru® 30 mg hard capsules will be used. Each capsule contains 30 mg iron (as ferric maltol), 91.5 mg of lactose, 0.5 mg of Allura Red AC (E129) and 0.3 mg Sunset Yellow FCF (E110) as excipients with known effects.
name: Ferric maltol 30 mg (Feraccru®)
type: Drug
Study arms:
design_group_description: Treatment with Feraccru® 30 mg hard capsules (Ferric maltol 30 mg). One capsule twice daily p.o., morning and evening, on an empty stomach
design_group_title: Feraccru® 30 mg hard capsules
design_group_type: Experimental
Sponsor: Hannover Medical School
Collaborators: Norgine Ltd.
Drug name mappings:
name: 麦芽酚铁
lang: CN
name: Ferric Maltol
lang: EN
Clinical trial NCT06710184: Treatment With Aspirin Alone Versus Aspirin in Combination With Fondaparinux Before Early Coronary Assessment in Patients With Non-ST-Elevation Myocardial Infarction
Official title: Aspirin Versus Aspirin and Fondaparinux Prior to Early Invasive Strategy in Patients With NSTEMI
Conditions: NSTEMI - Non-ST Segment Elevation Myocardial Infarction (MI)
Acute Myocardial Infarction (AMI)
Summary: The main goal of this study is to compare two treatments in patients with a specific type of heart attack called Non-ST-elevation Myocardial Infarction (NSTEMI). The investigators want to find out whether using aspirin alone is as effective and safer than using aspirin together with a second blood thinner called fondaparinux.
Both treatments will be given before a scheduled heart procedure called coronary angiography (CAG), which may include balloon dilation and stent placement (PCI) if needed.
The current guidelines recommend using aspirin in combination with a second blood thinner like fondaparinux before CAG and possible PCI. However, these recommendations are based on studies from the 1990s, a time when invasive procedures were not standard practice for these patients. In contrast, nearly all patients with NSTEMI in Denmark (96%) now undergo CAG within 72 hours. This change in practice raises questions about whether the older studies still provide a valid foundation for today's guidelines.
The study aims to answer two questions:
1. Is aspirin alone as effective as aspirin combined with fondaparinux before early CAG and possible PCI?
2. Is aspirin alone safer, with a lower risk of severe bleeding, compared to the combination treatment?
To answer these questions, the investigators will enroll about 5,000 patients with NSTEMI. Participants will be randomly assigned to receive either aspirin alone or aspirin with fondaparinux. The investigators will monitor them for 30 days to compare outcomes such as death, new heart attacks, the need for urgent CAG before the scheduled, and severe bleeding.
Interventions:
description: Aspirin bolus of 300 mg followed by 75 mg daily until CAG
name: Aspirin
type: Drug
description: Fondaprinux 2.5 mg subcutaneus daily until CAG (1.5 mg for patients with eGFR 20-50 ml/min/1.73m2)
name: Fondaparinux Sodium
type: Drug
Study arms:
design_group_description: Treatment with aspirin alone. The intervention is removal of treatment with fondaparinux
design_group_title: Aspirin alone
design_group_type: Experimental
design_group_description: Standard treatment regime with Aspirin in combination with Fondaparinux.
design_group_title: Standard Treatment - Aspirin and Fondaparinux
design_group_type: Active Comparator
Sponsor: University of Aarhus
Collaborators: Aalborg University Hospital
Odense University Hospital
Randers Regional Hospital
Horsens Regional Hospital
Rigshospitalet
Danske Regioner
Drug name mappings:
name: 阿司匹林
lang: CN
name: Aspirin
lang: EN
name: サリチル酸
lang: JP
Clinical trial NCT02473809: The Effect of Liraglutide on Bone Turnover, Bone Mass and Bone Cell Function
Official title: The Effect of Liraglutide on Bone Turnover, Bone Mass and Bone Cell Function
Conditions: Diabetes Complications
Osteoporosis
Summary: The purpose of this study is to test whether liraglutide, a drug approved and widely used in the treatment of type 2 diabetes, has an effect on bone mass and bone cell function. Type 2 diabetes may cause multiple complications, and it is well known that patients with type 2 diabetes have a higher risk of fractures. If Liraglutide can be demonstrated to have a positive effect on bone, this may be one among other factors to consider before the decision about specific treatment of type 2 diabetes is made for the individual patient.
Interventions:
description: Once daily
name: Liraglutide
other_name: Victoza
type: Drug
description: Once daily
name: Placebo
other_name: Saline
type: Drug
Study arms:
design_group_description: Liraglutide ("Victoza"), subcutaneous 1,8 mg once daily for 180 days
design_group_title: Liraglutide
design_group_type: Experimental
design_group_description: Saline, subcutaneous once daily for 180 days
design_group_title: Placebo
design_group_type: Placebo Comparator
Sponsor: University of Aarhus
Collaborators: Århus Universitetshospital
Novo Nordisk A/S
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 NCT00197639: Pharmacokinetic Study of Indinavir Drug Levels When Boosted With Ritonavir in Thailand
Official title: A Pharmacokinetic Study to Assess the Inter-patient Variability of Indinavir Drug Levels When Boosted With Ritonavir in Thai Patients on Highly Active Antiretroviral Therapy
Conditions: HIV Infection
Summary: This study looks at the ways indinavir drug levels, when boosted with ritonavir, may vary from patient to patient. The study population are HIV+ Thai individuals.
Interventions:
name: Ritonavir-boosted indinavir
type: Drug
Study arms:
Sponsor: Harvard T.H. Chan School of Public Health
Collaborators: National Institute of Child Health & Human Development
Drug name mappings:
name: 利托那韦
lang: CN
name: Ritonavir
lang: EN
name: リトナビル
lang: JP
name: 硫酸茚地那韦
lang: CN
name: Indinavir Sulfate
lang: EN
Clinical trial NCT06002906: The Use of Indocyanine Green to Visualize Blood Flow to the Gastrojejunostomy During Bariatric Surgery.
Official title: The Use of Indocyanine Green to Visualize Blood Flow to the Gastrojejunostomy During Bariatric Surgery
Conditions: Ulcer, Gastric
Obesity, Morbid
Summary: This is an interventional pilot study aimed to evaluate the use of NIF imaging as an intraoperative aid to assess the anastomotic blood flow to the gastric pouch and gastrojejunostomy during Roux-en-Y gastric bypass surgery and to determine its long-term impact on the rate of marginal ulceration, leaks and stricture.
Interventions:
description: Indocyanine green (ICG) is a safe, sterile, water-soluble molecule that binds to plasma proteins and can be injected intravenously. ICG will be injected intravenously based on the patient's weight prior to and after making the GJ anastomosis and a 10 mL bolus of normal saline will be immediately followed the injection of indocyanine green by an anesthesiologist. A subjective score of 1-5 for perfusion will be assigned by operating surgeons. The RYGB will then be completed by the operating surgeon in their routine fashion.
name: Indocyanine green
other_name: SPY AGENT GREEN
type: Drug
description: The Stryker 1688 AIM system used during laparoscopic surgery which is sensitive in the visible and infrared spectrum. ICG (SPY AGENT™ GREEN) is used with the SPY mode in the Stryker 1688 AIM fluorescence imaging system to perform intraoperative fluorescence angiography.
name: Stryker 1688 AIM system
type: Device
Study arms:
design_group_description: The interventional group will receive indocyanine green during bariatric surgery inside the operating room before and after making the gastrojejunostomy.
design_group_title: Interventional group (with drug)
design_group_type: Experimental
Sponsor: University Health Network
Collaborators: Stryker Endoscopy
Drug name mappings:
name: 吲哚菁绿
lang: CN
name: Indocyanine Green
lang: EN
name: インドシアニングリーン
lang: JP
Clinical trial NCT01974817: Study Response of 13-valent Conjugate Pneumococcal Vaccine in Patients With End Stage Renal Disease
Official title: Streptococcus Pneumoniae Colonization and Immunogenicity of 13-valent Conjugate Pneumococcal Vaccine in Patients 50 Years or Older With End Stage Renal Disease on Dialysis.
Conditions: End Stage Renal Disease
Summary: The purpose of the study is to determine the response of 13-valent conjugate pneumococcal vaccine in patients 50 years or older with end stage renal disease on dialysis.
The study will also try to determine Streptococcus pneumoniae colonization in patients 50 years or older with end stage renal disease on dialysis.
Interventions:
description: 0.5ml IM for one dose
name: 13-valent conjugate pneumococcal vaccine
other_name: Prevnar-13
type: Biological
Study arms:
design_group_description: Patients will receive one dose of 0.5 ml 13-valent conjugate pneumococcal vaccine (Prevnar-13) intra-muscularly.
design_group_title: Vaccine
design_group_type: Experimental
Sponsor: Michigan State University
Collaborators: Pfizer Inc.
Drug name mappings:
name: 13价肺炎球菌多糖结合疫苗 (辉瑞制药)
lang: CN
name: Pneumococcal polysaccharide conjugate vaccine
lang: EN
name: 沈降１３価肺炎球菌結合型ワクチン
lang: JP
Clinical trial NCT06752850: A Study to Investigate the Course of Synovial Hypertrophy in Patients With Haemophilia A on Efanesoctocog Alfa Prophylaxis
Official title: A 12-month, Interventional, Open-label, Phase 4 Study in Europe (SHINE) to Investigate the Course of Synovial Hypertrophy as Detected by Joint Ultrasound and MRI in Patients With Haemophilia A on Efanesoctocog Alfa Prophylaxis.
Conditions: Haemophilia A (Moderate or Severe)
Hemophilia, Classic
Haemophilia
Hemophilia
Classic Hemophilia
Synovial Hypertrophy
Summary: The rationale for conducting this open-label phase 4 study is to assess whether once-weekly prophylaxis with efanesoctocog alfa (50 IU/kg) improves the disease course of existing synovial hypertrophy and prevents the risk of joint bleeds in patients with moderate or severe haemophilia A. The use of imaging assessments will allow for objective detection and monitoring of synovial hypertrophy, and thus expand on the previous findings demonstrating positive effects of once-weekly prophylaxis with efanesoctocog alfa (50 IU/kg) on joint health.
Interventions:
description: 50 IU/kg once weekly, Intravenous injection
name: Efanesoctocog alfa
type: Drug
Study arms:
design_group_title: Study Treatment Group
design_group_type: Experimental
Sponsor: Swedish Orphan Biovitrum AB
Collaborators: PSI CRO AG
Drug name mappings:
name: Efanesoctocog alfa
lang: EN
name: エフアネソクトコグ アルファ（遺伝子組換え）
lang: JP
Clinical trial NCT05213156: Concentration of Ofloxacin Into the Aqueous Humour of Patients With Dry Eye Disease
Official title: Concentration of Ofloxacin Into the Aqueous Humour of Patients After Topical Instillation According to the Severity of Dry Eye Disease
Conditions: Dry Eye Disease
Summary: After topical installation of one drop of 0.3% commercially available ofloxacin (Oxatrex®) four times at intervals of 15min in catarract patients with Dry Eye Disease, aqueous humour samples will be collected intraoperatively, one hour after the last installation. Concentration of ofloxacin in aqueous humour will be measured by HPLC-MS/MS.
Interventions:
description: 0.3% ofloxacin eye drops in single doses
name: Oxatrex
type: Drug
Study arms:
design_group_description: Control Group
design_group_title: Patients without Dry Eye Disease
design_group_type: Active Comparator
design_group_description: non severe Dry Eye Disease
design_group_title: Patients with Dry Eye Disease, except the severe Dry Eye Disease
design_group_type: Experimental
design_group_description: severe Dry Eye Disease
design_group_title: Patients with severe Dry Eye Disease
design_group_type: Experimental
Sponsor: University of Patras
Collaborators: University of Patras
Drug name mappings:
name: 氧氟沙星
lang: CN
name: Ofloxacin
lang: EN
name: オフロキサシン
lang: JP
Clinical trial NCT00870311: Investigation of Lithium on Signal Transduction, Gene Expression and Brain Myo-Inositol Levels in Manic Patients
Official title: Investigation of Lithium on Signal Transduction, Gene Expression and Brain Myo-Inositol Levels in Manic Patients
Conditions: Bipolar Disorder
Summary: This study investigates the effects of Lithium treatment on signal transduction pathways, gene expression and brain neurochemistry and structure in patients with Bipolar disorder. It is hypothesized that specific changes in these markers will correlate with lithium treatment responsiveness.
Interventions:
description: 300mg PO, three times daily with dose titrated to obtain a therapeutic plasma level of 0.8 to 1.2meq/L) over the first week of treatment. Total duration is a minimum of 3 weeks. Medication is dispensed in the form of blinded research capsules.
name: Lithium Carbonate
other_name: Eskalith
Lithane
Lithobid
Lithonate
Lithotabs
type: Drug
Study arms:
design_group_description: Bipolar Disorder patients
design_group_title: Blinded Lithium
design_group_type: Experimental
Sponsor: Wayne State University (Michigan)
Collaborators: National Institute of Mental Health
Drug name mappings:
name: 碳酸锂
lang: CN
name: Lithium carbonate
lang: EN
name: 炭酸リチウム
lang: JP
Clinical trial NCT00177216: Characteristics of Sleep Patterns in Young Adults With and Without Insomnia
Official title: Psychobiology and Treatment Response in Primary Insomnia
Conditions: Sleep Disorders
Summary: This study will compare the symptoms, experiences, and laboratory sleep characteristics of young adults with and without insomnia.
Interventions:
description: The benzodiazepine receptor agonist (BzRA), zolpidem was given in an initial dose of 5 mg by mouth every night, 30 minutes prior to bedtime. The dose was increased to a maximum of 10 mg after the first week if there was no improvement in overall symptoms (CGI score of 4 or >). The dose was decreased to 5 mg if side effects occurred.
name: Zolpidem
other_name: Ambien
type: Drug
description: The antidepressant, escitalopram was initiated at 5 mg by mouth every night, 30 minutes prior to bedtime. If there were no side effects, the dose was increased every four days until the target dose of 20 mg (maximum dose) was reached by day 13. If significant side effects appeared, the highest tolerated dose was used.
name: Escitalopram
other_name: Celexa
type: Drug
description: A placebo capsule was given with instructions to take it every night by mouth, 30 minutes prior to bedtime.
name: Placebo
other_name: Placebo control
type: Drug
Study arms:
design_group_description: The benzodiazepine receptor agonist (BzRA), zolpidem was given in an initial dose of 5 mg by mouth every night, 30 minutes prior to bedtime. The dose was increased to a maximum of 10 mg after the first week if there was no improvement in overall symptoms (CGI score of 4 or >). The dose was decreased to 5 mg if side effects occurred.
design_group_title: Zolpidem
design_group_type: Experimental
design_group_description: The antidepressant, escitalopram was initiated at 5 mg by mouth every night, 30 minutes prior to bedtime. If there were no side effects, the dose was increased every four days until the target dose of 20 mg (maximum dose) was reached by day 13. If significant side effects appeared, the highest tolerated dose was used.
design_group_title: Excitalopram
design_group_type: Experimental
design_group_description: A placebo capsule was given with instructions to take it every night by mouth, 30 minutes prior to bedtime.
design_group_title: Placebo
design_group_type: Placebo Comparator
Sponsor: University of Pittsburgh
Collaborators: National Institute of Mental Health
Drug name mappings:
name: 草酸艾司西酞普兰
lang: CN
name: Escitalopram Oxalate
lang: EN
name: エスシタロプラムシュウ酸塩
lang: JP
name: 酒石酸唑吡坦
lang: CN
name: Zolpidem Tartrate
lang: EN
name: ゾルピデム酒石酸塩
lang: JP
Clinical trial NCT01059123: Short Course of Amoxicillin for Erysipelas
Official title: Randomized Non Inferiority Study Comparing Short Course of Oral Amoxicillin to One of the Usual Treatments of Lower Leg Erysipelas
Conditions: Erysipelas
Summary: The propose of this study is to determine whether a 6-day duration of oral amoxicillin treatment of erysipelas is non-inferior to a 14-day standard duration intravenous then oral amoxicillin regimen. This trial will be open but evaluation will be perform by a blind evaluator.
Interventions:
description: 50 mg/kg/24H ; Per Os ; 3 times/day 6 days
name: Amoxicillin
type: Drug
description: 50 mg/kg/24H in I.V. ; 3 times/day ; up to apyrexia then amoxicillin ; 50 mg/kg/24H ; Per Os ; 3 times/day up to day 14.
name: Amoxicillin
type: Drug
Study arms:
design_group_description: amoxicillin ; 50 mg/kg/24H ; P.O. ; 3 times/day 6 days.
design_group_title: 1:Short treatment
design_group_type: Experimental
design_group_description: amoxicillin 50 mg/kg/24H ; I.V. ; 3 times/day ; up to apyrexia then amoxicillin ; 50 mg/kg/24H ; P.O. ; 3 times/day up to day 14.
design_group_title: 2:Usual treatment
design_group_type: Active Comparator
Sponsor: Assistance Publique des Hôpitaux de Paris SA
Collaborators: Société Française de Dermatologie
Drug name mappings:
name: 阿莫西林钠
lang: CN
name: Amoxicillin Sodium
lang: EN
Clinical trial NCT01056497: The Effect of A-lipoic Acid (ALA) on Fatty Acid-induced Impairment of Glucose-stimulated Insulin Secretion
Official title: The Effect of A-lipoic Acid (ALA) on Fatty Acid-induced Impairment of Glucose-stimulated Insulin Secretion
Conditions: Type 2 Diabetes
Prediabetes
Summary: Chronically elevated free fatty acids impair insulin sensitivity and insulin secretion (ie lipotoxicity) by a combination of oxidative stress, endoplasmic reticulum (ER) stress and inflammation. This study will test whether alpha-lipoic acid, which has potent antioxidant and anti-inflammatory properties, prevents or ameliorates lipotoxicity.
Interventions:
description: A 2 week treatment period with either oral ALA tablets or placebo tablets, followed by 30 hour hospital stay to infuse lipid or saline and to test insulin sensitivity and insulin secretion. For two weeks prior to each admission to hospital and during each hospital admission subjects will ingest 3 tablets 2 times per day with breakfast and supper, 1800mg per day
name: alpha lipoic acid
other_name: ALA
lipoic acid
type: Drug
Study arms:
design_group_title: alpha lipoic acid
design_group_type: Experimental
Sponsor: University Health Network
Collaborators: Diabetes Canada
Drug name mappings:
name: 硫辛酸
lang: CN
name: Lipoic acid
lang: EN