louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00171678: Efficacy and Safety of Diclofenac Sodium Gel in Knee Osteoarthritis
Official title: Efficacy and Safety of Diclofenac Sodium Gel in Knee Osteoarthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Osteearthritis
Keywords: Knee osteoarthritis, Topical NSAID, Diclofenac sodium
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2005-09-15
Enrollment: 480
Sex: ALL
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will test the efficacy and safety of topical diclofenac sodium gel in the treatment of knee osteoarthritis.


Eligibility criteria: Key Inclusion criteria

* OA of the knee Key Exclusion criteria
* Other rheumatic disease, such as rheumatoid arthritis
* Active gastrointestinal ulcer during the last year
* Known allergy to analgesic drugs

Primary outcomes:
measure: WOMAC pain score in target knee at Week 12
measure: WOMAC physical function score in target knee at Week 12
measure: Global rating of disease activity by patient at Week 12
Secondary outcomes:
measure: WOMAC pain and physical function scores in target knee and global rating of disease activity by patient at Weeks 1, 4 and 8
measure: WOMAC stiffness score, pain on movement and spontaneous pain in target knee, and global rating of benefit by patient, at Weeks 1, 4, 8 and 12
measure: Pain on movement in target knee and use of rescue medication recorded in diary
measure: Global evaluation of treatment at final visit
measure: Treatment responder rate according to OARSI criteria
Other outcomes:
Locations:
city: Parsippany
country: United States
facility: Novartis Consumer Health Inc.
state: New Jersey
Study officials:
References:
citation: Baraf HS, Gloth FM, Barthel HR, Gold MS, Altman RD. Safety and efficacy of topical diclofenac sodium gel for knee osteoarthritis in elderly and younger patients: pooled data from three randomized, double-blind, parallel-group, placebo-controlled, multicentre trials. Drugs Aging. 2011 Jan 1;28(1):27-40. doi: 10.2165/11584880-000000000-00000.
Clinical trial NCT06119178: EX-PRESS® P-50 and EX-PRESS® P-200
Official title: EX-PRESS® P-50 and EX-PRESS® P-200
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Glaucoma
Keywords: Glaucoma
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2023-11-07
Enrollment: 122
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Cohorts will be selected from approximately 12 investigative sites located in the United States and/or outside the United States, approximately 4 countries.

Brief summary: The purpose of this Post-Market Clinical Follow-Up (PMCF) study is to assess long term clinical performance and safety outcomes for EX-PRESS Glaucoma Filtration Devices Models P-50 and P-200.

Detailed description: This is a non-interventional/observational study designed as a retrospective chart review. Study sites will identify patient charts within their existing databases in a fair and consistent manner, e.g., reviewing all eligible charts in reverse chronological order by year of baseline visit. Patients meeting the eligibility criteria who have a minimum of 5 years of follow-up data since the implantation of the P-50 or P-200 device will be enrolled, including patients whose 5-year standard of care visit is scheduled during the study enrollment period.

The overall study duration is expected to be approximately 7 months.

Eligibility criteria: Key Inclusion Criteria:

* Able to understand and sign an Institutional Review Board (IRB) / Independent Ethics Committee (IEC) approved informed consent form authorizing data collection prior to the review of any medical records;
* Implanted (one eye or both) with the EXPRESS P-50 or EXPRESS P-200 device per indications for use for at least 5 years;
* Have a minimum of 5 years of recorded follow-up data;
* Other protocol-specified inclusion criteria may apply.

Key Exclusion Criteria:

* Enrolled in any clinical trial within the last 5 years;
* At the time of implantation:

  1. Presence of ocular disease such as uveitis, ocular infection, severe dry eye, severe blepharitis.
  2. Pre-existing ocular or systemic pathology that, in the opinion of the surgeon, is likely to cause postoperative complications following implantation of the device.
  3. Diagnosed with angle-closure glaucoma.
* Other protocol-defined exclusion criteria may apply.

Primary outcomes:
measure: Percentage reduction in intraocular pressure (IOP) from baseline
timeFrame: Baseline (preoperative), up to Year 5 postoperative
Secondary outcomes:
Other outcomes:
Locations:
city: Rogers
country: United States
facility: Boozman Hoff Regional Eye Clinic
state: Arkansas
city: El Paso
country: United States
facility: El Paso Eye Surgeons, PA
state: Texas
Study officials:
affiliation: Alcon Research, LLC
name: Clinical Trial Lead, Vision Care
role: STUDY_DIRECTOR
References:
Clinical trial NCT01461278: Multicenter Investigation of the Glaukos® Suprachoroidal Stent Model G3 In Conjunction With Cataract Surgery
Official title: A Prospective, Randomized, Single-Masked, Controlled, Parallel Groups, Multicenter Clinical Investigation of the Glaukos® Suprachoroidal Stent Model G3 In Conjunction With Cataract Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Primary Open-angle Glaucoma
Keywords: Primary open-angle glaucoma
POAG
Cataract surgery
Suprachoroidal space
Suprachoroidal stent
iStent supra
Lead sponsor: Glaukos Corporation
Sponsor class: INDUSTRY
First posted: 2011-10-28
Enrollment: 505
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Evaluate the safety and efficacy of the Glaukos® Suprachoroidal Stent Model G3 in conjunction with cataract surgery, compared to cataract surgery only, in subjects with mild to moderate primary open-angle glaucoma.

Detailed description: This is an IDE trial to evaluate the safety and efficacy of the Glaukos® Suprachoroidal Stent Model G3 (hereinafter referred to as G3) in conjunction with cataract surgery, compared to cataract surgery only, in subjects with mild to moderate primary open-angle glaucoma.

Eligibility criteria: Inclusion Criteria:

* Mild to moderate open-angle glaucoma
* Characteristics consistent with mild to moderate glaucoma
* Use of one (1) to three (3) medications at time of screening exam

Exclusion Criteria:

* Pigmentary or pseudoexfoliative glaucoma
* Prior incisional glaucoma surgery

Primary outcomes:
measure: ≥ 20% Reduction in Intraocular Pressure (IOP)
timeFrame: Baseline and Month 24
Secondary outcomes:
measure: Diurnal IOP Reduction from Baseline
timeFrame: Baseline and Month 24
Other outcomes:
Locations:
city: Racine
country: United States
facility: Eye Centers of Racine and Kenosha
state: Wisconsin
Study officials:
affiliation: Glaukos Corporation
name: Kerry Stephens, O.D.
role: STUDY_CHAIR
References:
Clinical trial NCT01521078: Web-based Personalized Feedback for University Students
Official title: Randomized Controlled Trial of a Brief Personalized Feedback Intervention in University Students
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Risky Alcohol Consumption
Lead sponsor: Centre for Addiction and Mental Health
Sponsor class: OTHER
Collaborators: name: University of Houston
First posted: 2012-01-30
Enrollment: 425
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Excessive alcohol consumption in university students continues for be a serious public health concern with a variety of negative consequences. There have been a number of different brief interventions developed to address this issue among university students. The current project will add to this literature by evaluating the use of a personalized feedback intervention (www.CheckYourDrinkingU.net; CYDU). Specifically, this trial will examine whether providing access to the CYDU will result in short-term reductions in drinking. This issue is important as use of these interventions is not a mandatory requirement for university students so the issue is whether making materials of this type available leads to any reductions in risky drinking. It is hypothesized that students provided access to the CYDU will display greater reductions in drinking at a six-week follow-up as compared to students who were not provided access to the CYDU.


Eligibility criteria: Inclusion Criteria:

* AUDIT-C score of 4 or more at baseline

Exclusion Criteria:

-

Primary outcomes:
measure: Alcohol Use Disorders Identification Test - Consumption scale (AUDIT-C scale)
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Centre for Addiction and Mental Health
state: Ontario
Study officials:
References:
citation: Cunningham JA, Neighbors C, Bertholet N, Hendershot CS. Use of mobile devices to answer online surveys: implications for research. BMC Res Notes. 2013 Jul 8;6:258. doi: 10.1186/1756-0500-6-258.
citation: Cunningham JA, Hendershot CS, Murphy M, Neighbors C. Pragmatic randomized controlled trial of providing access to a brief personalized alcohol feedback intervention in university students. Addict Sci Clin Pract. 2012 Oct 10;7(1):21. doi: 10.1186/1940-0640-7-21.
Clinical trial NCT00189878: A Study of the Use of Methotrexate in the Treatment of Chronic Idiopathic Urticaria
Official title: Multi-centre Prospective Randomised Double-blind Placebo-controlled Study of Methotrexate in the Treatment of Chronic Idiopathic Urticaria
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Urticaria
Keywords: chronic idiopathic urticaria
methotrexate
Lead sponsor: Barnsley Hospital
Sponsor class: OTHER
First posted: 2005-09-19
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether methotrexate produces significant improvement in chronic idiopathic urticaria, compared with placebo

Detailed description: Chronic idiopathic urticaria is thought to affect approximately 0.1% of the population. It can be very disabling and difficult to treat. Antihistamines are the only drugs licensed for treatment of urticaria, however there is a group of severely affected patients with chronic idiopathic urticaria who fail to respond. Previous trials have shown ciclosporin to be beneficial, and small studies support the use of intravenous immunoglobulins and plasmapheresis. However, not only are these options expensive, but since chronic idiopathic urticaria may persist for years, their prolonged use may be limited by adverse effects. We have previously published a report of 2 patients who responded to methotrexate, and wish to properly evaluate the efficacy of methotrexate in the treatment of CIU.

In the first part of the study patients will be given either placebo or methotrexate for 8 weeks and in the second part of the study, non-responders will be offered open labelled methotrexate for 8 weeks.

Eligibility criteria: Inclusion Criteria:

* severe unremitting chronic idiopathic urticaria
* disease resistant to treatment with antihistamines
* aged 18 years or more

Exclusion Criteria:

* predominant physical urticaria
* urticarial vasculitis
* any contraindication to the use of methotrexate, eg. pregnancy / breast feeding, women wanting to conceive or man wanting to father a child within 12 months of entry, use of drugs which interact, underlying medical conditions
* use of immunosuppressant within 4 weeks of entry

Primary outcomes:
measure: A positive response to treatment (a reduction to <25% of baseline urticaria activity scores)
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Barnsley Hospital NHS Foundation Trust
name: Ruth A Sabroe, FRCP, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06939478: AI Powered Mapping Technology for Identifying Arrhythmias
Official title: vMAP Informed Targeting of Arrythmia Location EP
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Arrhythmias, Cardiac
Lead sponsor: Heart Rhythm Clinical and Research Solutions, LLC
Sponsor class: OTHER
Collaborators: name: Vektor Medical
First posted: 2025-04-22
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: Study population will be derived from subjects scheduled for cardiac ablation who meet inclusion and exclusion criteria for the registry.

Brief summary: Exploratory, hypothesis-generating study evaluating the impact of vMap on procedural efficiency, acute success, and work flow optimization.

Detailed description: The registry is a retrospective and prospective, post-approval, multicenter, single-arm, all-comers registry with two cohorts:

Retrospective Cohort: approximately 60 patients across two sites. Prospective Cohort: approximately 50 patients across two sites. This registry aims to collect real-world data on the clinical utility, safety, and procedural efficiency of vMap-guided ablation procedures.

Eligibility criteria: Inclusion Criteria:

* A cardiac ablation (de novo or repeat) procedure will occur guided by vMap.
* A confirmed cardiac arrythmia has been identified on a 12-lead ECG.
* The patient is greater than or equal to 18 years old.
* The patient can provide written informed consent.

Exclusion Criteria:

* Non-inducible arrhythmia (unless pre-mapped via vMap prior to the procedure).
* Patients in whom no ablation was performed.
* Inability to obtain 12-lead ECG of sufficient quality for vMap analysis.

Primary outcomes:
measure: AF Ablation rate of procedural efficacy
timeFrame: Day of procedure
measure: Focal Arrhythmia Ablation rate of procedural efficiency
timeFrame: Day of procedure
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03341871: Glecaprevir/Pibrentasvir Drug Use Results Survey in Patients Infected With Hepatitis C Virus Genotype 1-6
Official title: Glecaprevir/Pibrentasvir Drug Use Results Survey in Patients Infected With Hepatitis C Virus Genotype 1-6
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatitis C Virus (HCV)
Keywords: chronic hepatitis C virus (HCV)
Genotype
glecaprevir
pibrentasvir
sustained virologic response
chronic hepatitis C virus genotype 1
chronic hepatitis C virus genotype 2
chronic hepatitis C virus genotype 3
chronic hepatitis C virus genotype 4
chronic hepatitis C virus genotype 5
chronic hepatitis C virus genotype 6
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2017-11-14
Enrollment: 1095
Sex: ALL
Minimum age (years): 0
Maximum age (years): 99
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Japan patients infected with hepatitis C virus and treating with glecaprevir plus pibrentasvir per approved Japan label.

Brief summary: This multi-center, post-marketing, observational study evaluates the real world safety and effectiveness of glecaprevir plus pibrentasvir use in participants infected with the hepatitis C virus genotype 1 - 6.


Eligibility criteria: Inclusion Criteria:

* Patients with chronic hepatitis C virus infection and administering glecaprevir plus pibrentasvir.

Exclusion Criteria:

* Patients previously treated with glecaprevir plus pibrentasvir.

Primary outcomes:
measure: Percentage of Participants Achieving Sustained Virological Response 12 Weeks Post-treatment (SVR12)
timeFrame: 12 weeks after last dose of drug
Secondary outcomes:
measure: Percentage of Participants with Post-treatment Relapse
timeFrame: Up to 24 weeks after last dose of drug
measure: Percentage of Participants with On-treatment Virologic Failure
timeFrame: Up to 12 weeks after first dose
measure: Percentage of Participants Achieving SVR4
timeFrame: 4 weeks after last dose
measure: Percentage of Participants Achieving SVR8
timeFrame: 8 weeks after last dose of drug
measure: Percentage of Participants Achieving SVR24
timeFrame: 24 weeks after last dose of drug
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: Abbvie Japan /ID# 161985
Study officials:
affiliation: AbbVie
name: AbbVie Inc.
role: STUDY_DIRECTOR
References:
Clinical trial NCT02933671: Suprainguinal Fascia Iliaca (SIFI) Block Improves Analgesia Following Total Hip Arthroplasty
Official title: Suprainguinal Fascia Iliaca (SIFI) Block Improves Analgesia Following Total Hip Arthroplasty
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Hip Osteoarthritis
Primary Total Hip Arthroplasty
Pain
Keywords: suprainguinal fascia iliaca (SIFI)
nerve block
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2016-10-14
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to learn if using a suprainguinal fascia iliaca (SIFI) injection technique (also called a "nerve block") that numbs the nerves going to the side and front of the upper leg will improve pain control after surgery. The SIFI technique uses a numbing solution (local anesthetics) that is injected next to nerves in the hip to reduce pain. This block may affect movement in the leg and make the legs weak. The amount of leg weakness is not known and assessment of this will be included in the study. Many institutions use the SIFI block for patients having total hip replacements, with the hope of providing good pain relief combined with improved mobility after surgery.


Eligibility criteria: Inclusion Criteria:

* English speaking
* between 18 and 75 years old
* American Society of Anesthesiologists (ASA) 1-3 patients undergoing primary total hip arthroplasty

Exclusion Criteria:

* ASA 4 or 5
* revision hip arthroplasty
* diagnosis of chronic pain
* daily chronic opioid use (over 3 months of continuous opioid use)
* inability to communicate pain scores or need for analgesia
* acute hip fracture
* Infection at the site of block placement
* Age under 18 years old or greater than 75 years old
* Pregnant women
* Intolerance/allergy to local anesthetics
* Weight \<50 kg
* Suspected, or known addiction to or abuse of illicit drug(s), prescription medicine(s), or alcohol within the past 2 years.
* Uncontrolled anxiety, schizophrenia, or other psychiatric disorder that, in the opinion of the investigator, may interfere with study assessments or compliance
* Current or historical evidence of any clinically significant disease or condition that, in the opinion of the investigator, may increase the risk of surgery or complicate the subject's postoperative course.

Primary outcomes:
measure: Numeric Pain Score at 4 Hours Postoperatively, as Measured by Numerical Rating Scale (NRS) 11
timeFrame: 4 hours postoperatively
Secondary outcomes:
measure: Cumulative Opioid Consumption
timeFrame: 24 hours
measure: Motor Strength, as Measured by Dynamometry
timeFrame: 4 hours postoperatively
measure: Numeric Pain Score at 24 Hours, as Measured by NRS 11
timeFrame: 24 hours
measure: Ambulation, as Measured by Distanced Walked
timeFrame: post-op day 0
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Hospital
state: North Carolina
Study officials:
References:
Clinical trial NCT00975871: Correlation of Genetic Polymorphism and Livedo Vasculitis
Official title: Correlation of Genetic Polymorphism and Livedo Vasculitis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Livedo Vasculitis
Livedoid Vasculitis
Livedoid Vasculopathy
Genetic Pleomorphism
Leiden Mutation
Keywords: Livedo vasculitis
Genetic pleomorphism
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2009-09-14
Enrollment: 50
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: General population

Brief summary: Livedo vasculitis is disease with recurrent courses of painful foot or ankle ulcerations, followed by healed white scars. The actual mechanism of its pathophysiology is not yet clear. It has been reported to be associated with some gene mutations, for example, factor V Leiden gene. This study is aimed to find the possible relation of these gene mutations in Taiwanese patients.

Detailed description: Livedo vasculitis is a chronic, recurrent painful ulcerations on the ankles and feet. This chronic disease is characterized by healed white, atrophic scars named atrophie blanche. The histopathological exam on the lesion site reveals fibrin deposition within the vessel walls. It has been reported to be related to factor V Leiden mutation (heterozygous) (22.2%), prothrombin G20210A gene mutation (8.3%), PAI promotor 4G/4G genotype and methylenetetrahydrofolate reductase (MTHFR) C677T mutation in about total 30% livedo vasculitis patients. This study is trying to find the correlation between Taiwanese patients and these four genes.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of livedo vasculitis

Exclusion Criteria:

* No special exclusion criteria

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital
name: Tsen-Fang Tsai, MD
role: PRINCIPAL_INVESTIGATOR
References: