louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00732225: DisCoVisc Comparative Evaluation
Official title: A Prospective, Non-randomized Comparison of DisCoVisc to Dispersive and Cohesive Ophthalmic Viscosurgical Devices (OVDs) in Non-eventful Cataract Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Cataracts
Keywords: DisCoVisc OVD
Ophthalmic Viscosurgical Device
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2008-08-11
Enrollment: 173
Sex: ALL
Minimum age (years): 49
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A comparison of the ability of DisCoVisc to that of other Opthalmic Viscosurgical Devices (OVDs) (DuoVisc®, BioVisc®, Healon5®, or Amvisc PLUS) regarding endothelial protection and anterior chamber space maintenance during non-eventful cataract surgery.


Eligibility criteria: Inclusion Criteria:

* Unilateral operable cataracts

Exclusion Criteria:

* Preoperative Endothelial Cell Count (ECC) ≤1500 cells/mm2
* Intraocular Pressure (IOP) \> 21
* History of ocular inflammation
* Systemic or ocular diseases affecting corneal endothelium

Primary outcomes:
measure: Percent Loss of Endothelial Cells
timeFrame: 2 months following surgery
Secondary outcomes:
measure: Aqueous Signs - Corneal Edema
timeFrame: 1 day after surgery
measure: Aqueous Signs - Aqueous Flare
timeFrame: 1 day following surgery
measure: Aqueous Signs - Aqueous Cells
timeFrame: 1 day following surgery
measure: Intraocular Pressure (IOP)
timeFrame: 1 day following surgery
measure: Physician Survey - Anterior Chamber Dome Maintenance During Anterior Capsulotomy
timeFrame: Time of Surgery
measure: Physician Survey - Anterior Chamber Dome Maintenance During Phacoemulsification
timeFrame: Time of Surgery
measure: Physician Survey - Anterior Chamber Dome Maintenance During IOL Insertion
timeFrame: Time of Surgery
Other outcomes:
Locations:
city: Fort Worth
country: United States
facility: Alcon Call Center for Trial Locations
state: Texas
Study officials:
References:
Clinical trial NCT01348425: Zilver PTX Drug-Eluting Peripheral Stent Study
Official title: Evaluation of the Zilver PTX Drug-Eluting Peripheral Stent
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Peripheral Arterial Disease
Keywords: PAD
Lead sponsor: Cook Group Incorporated
Sponsor class: INDUSTRY
First posted: 2011-05-05
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This randomized, post-market clinical study is intended to evaluate the delivery and deployment of longer Zilver PTX stents (≥ 100 mm) compared to shorter Zilver PTX stents (≤80 mm) for treatment of lesions of the above-the-knee femoropopliteal artery.


Eligibility criteria: Inclusion Criteria:

* One de novo or restenosed artherosclerotic lesion with \> 50% diameter stenosis
* Reference vessel diameter of 4 - 9 mm
* Rutherford category ≥ 2
* Resting ankle brachial index \< 0.9

Exclusion Criteria:

* Prior stent in the study vessel
* Significant stenosis (\> 50%) or occlusion of inflow tract not successfully treated before the study procedure
* Lacks at least one patent runoff vessel
* Lesions requiring atherectomy, cutting balloons, cryoplasty balloons, or any other advanced device to facilitate stent delivery

Primary outcomes:
measure: Percent Change in Stent Length Upon Deployment
timeFrame: During Procedure (day 1) (Prior to Stent Deployment and after Stent Deployment)
Secondary outcomes:
Other outcomes:
Locations:
city: Bad Krozingen
country: Germany
facility: Herz-Zentrum
city: Berlin
country: Germany
facility: Evangelische Krankenhaus Königin Elisabeth Herzberge
city: Magdeburg
country: Germany
facility: Universitätsklinikum Magdeburg A.ö.R.
city: Berne
country: Switzerland
facility: INSELSPITAL, Universitätsspital Bern
Study officials:
affiliation: Universitätsklinikum Magdeburg A.ö.R., Department for Radiology and Nuclear Medicine
name: Prof. Dr. med. Jens Ricke
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02515825: Angiographic Comparison in an Observational Study of CADence (The AMBIENCE Study)
Official title: Angiographic Comparison in an Observational Study of CADence (The AMBIENCE Study)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Artery Disease
Lead sponsor: AUM Cardiovascular, Inc.
Sponsor class: INDUSTRY
First posted: 2015-08-05
Enrollment: 101
Sex: ALL
Minimum age (years): 41
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects already scheduled for coronary angiography who meet study inclusion and exclusion criteria.

Brief summary: This is a prospective, multi-center study to capture information on sensitivity and specificity of CADence using coronary angiogram as the gold standard, on subjects who are already scheduled for coronary angiography.

Detailed description: CADence is an ECG and acoustic tool to assess coronary artery disease. This study's goal is to collect patient CADence information and compare it to the results of angiogram to determine performance: sensitivity and specificity. The CADence is not used to direct patient care. This is observational only.

Eligibility criteria: Inclusion Criteria:

* Age \>40 years
* Clinical indication for coronary angiogram
* Willing and able to give informed consent

Exclusion Criteria:

* Body Mass Index (BMI) \<18.5 or \>40
* Prior bypass surgery or coronary stenting
* Presence of pacemaker/defibrillator
* Presence of artificial valve
* Presence of obvious cyanotic or pre-diagnosed congenital heart defect and coarctation of the aorta
* Presence of murmurs, including valve lesions, ventricular septal defects and arteriovenous fistulae
* Presence of moderate-severe valve disease
* Left Ventricular Assist Device (LVAD)
* Presence of scars on the site thorax areas
* Participation in trial within 30 days prior to collecting CADence data except participation in registry studies.
* Asthma or chronic obstructive pulmonary disease (COPD) with active wheezing
* Inability to lie in supine position
* Heart Transplant

Primary outcomes:
measure: Percent of Participants With Positive Agreement of CADence Device Under Normal Use Conditions as Compared to Coronary Angiograms as Accurate and Appropriate
timeFrame: 24 hours or discharge from hospital, whichever is sooner
Secondary outcomes:
measure: Number of Participants With CADence-related Adverse Events
timeFrame: 24 hours or discharge from hospital, whichever is sooner
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: Heart Center Research, LLC
state: Alabama
city: Baltimore
country: United States
facility: MedStar Union Memorial Hospital
state: Maryland
city: Saint Paul
country: United States
facility: St. Joseph's Hospital
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Carmelo Panetta, MD
role: STUDY_CHAIR
References:
Clinical trial NCT00157625: Automatic Stop Orders for Urinary Catheters
Official title: A Randomized Controlled Trial of Automatic Stop Orders for Urinary Catheterization in Hospitalized Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Urinary Tract Infections
Keywords: urinary infections, catheters, bacteriuria, trial
Lead sponsor: McMaster University
Sponsor class: OTHER
Collaborators: name: The Physicians' Services Incorporated Foundation
First posted: 2005-09-12
Enrollment: 630
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Urinary tract infections are the most common type of hospital-acquired infection. The majority of these infections result from the use of indwelling urinary catheters. Often caregivers leave them in unnecessarily. The purpose of this study is to assess the effectiveness of an automatic stop order (automatic removal or urinary catheters when they no longer needed) in reducing urinary infections.

Detailed description: We will randomize patients with urinary catheters to either automatic stop orders or to usual care. The primary outcome will be urinary tract infection. Secondary outcomes will include days of indwelling urinary catheterization, symptomatic urinary tract infection, isolation of antimicrobial-resistant bacteria from catheterized urine, antimicrobial use, bacteremia (blood-stream) infection secondary to urinary tract infection, and cost. We hypothesize that use of the automatic stop order will significantly reduce hospital-acquired urinary tract infection.

Eligibility criteria: Inclusion Criteria:

* Urinary catheter for less than 48hrs

Exclusion Criteria:

* Patient with symptomatic urinary tract infection
* Latex allergy

Primary outcomes:
measure: Urinary tract infections
Secondary outcomes:
measure: days of indwelling urinary catheterization,
measure: symptomatic urinary tract infection,
measure: isolation of antimicrobial-resistant bacteria from catheterized urine,
measure: antimicrobial use,
measure: bacteremia (blood-stream) infection secondary to urinary tract infection,
measure: cost
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: McMaster University Medical Centre
state: Ontario
city: Hamilton
country: Canada
facility: Henderson Hospital
state: Ontario
city: Hamilton
country: Canada
facility: Hamilton General Hospital
state: Ontario
Study officials:
affiliation: McMaster University
name: Mark B Loeb, MD MSc FRCPC
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ellahi A, Stewart F, Kidd EA, Griffiths R, Fernandez R, Omar MI. Strategies for the removal of short-term indwelling urethral catheters in adults. Cochrane Database Syst Rev. 2021 Jun 29;6(6):CD004011. doi: 10.1002/14651858.CD004011.pub4.
Clinical trial NCT01367925: Stryker Triathlon® Cruciate Substituting vs. Posterior Stabilized Outcomes Study
Official title: A Prospective, Randomized, Comparison of Total Knee Arthroplasty With the Triathlon® CS Tibial Insert vs. the Triathlon® PS Tibial Insert.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Osteoarthritis, Knee
Keywords: Osteoarthritis
Total Knee Replacement
TKA
Knee
PS
CS
Lead sponsor: Spokane Joint Replacement Center
Sponsor class: OTHER
First posted: 2011-06-07
Enrollment: 125
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult patients undergoing total knee arthroplasty

Brief summary: This study compares the clinical and radiographic outcomes obtained with the use of the Stryker Triathalon® Cruciate Substituting (CS) and Posterior Stabilized (PS) tibial inserts.


Eligibility criteria: Inclusion Criteria:

* Adults ages 20-80 years old
* Body mass index \<40
* Undergoing primary total knee arthroplasty for osteoarthritis of the knee

Exclusion Criteria:

* Inflammatory arthritis
* Revisions

Other criteria may apply

Primary outcomes:
measure: Clinical outcomes, Knee Society Score
timeFrame: Pre-operative, 6 weeks, 6 months, 1, 2, 3, 4, and 5 years post-operative
Secondary outcomes:
Other outcomes:
Locations:
city: Spokane
country: United States
facility: Spokane Joint Replacement Center
state: Washington
Study officials:
affiliation: Spokane Joint Replacement Center
name: David F Scott, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00040625: ALIMTA (Pemetrexed) Alone or in Combination With Cisplatin for Patients With Malignant Mesothelioma.
Study type: EXPANDED_ACCESS
Overall status: APPROVED_FOR_MARKETING
Conditions: Mesothelioma
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2002-07-04
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: This study is to evaluate the effects (good and bad) of ALIMTA and Cisplatin or ALIMTA alone on you and your malignant pleural mesothelioma as well as make ALIMTA available to patients who qualify for treatment.


Eligibility criteria: Inclusion Criteria:

* Have a proven diagnosis of malignant mesothelioma in patients not candidates for curative surgery
* Prior chemotherapy for your disease is allowed
* Measurable lesion is not required
* Have a adequate performance status
* Sign an informed consent form

Exclusion Criteria:

* You are excluded from this trial if you have received any investigational agent within 4 week before enrolling in this study
* You are excluded from this trial if you have received radiation within the previous 2 weeks
* You are excluded from this trial if you are a candidates for curative surgery

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Basking Ridge
country: United States
facility: For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY(1-877-285-4559) or speak with your personal physician.
state: New Jersey
city: Porto Alegre
country: Brazil
facility: For additional information regarding investigative sites for this trial, contact the Clinical Trials support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician
state: RS
city: Sao Paulo
country: Brazil
facility: For additional information regarding investigative sites for this trial, contact the Clinical Trials support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician
city: Cairo
country: Egypt
facility: "For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician."
city: Cairo
country: Egypt
facility: For additional information regarding investigative sites for this trial, contact the Clinical Trials support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician
city: Jeddah
country: Saudi Arabia
facility: For additional information regarding investigative sites for this trial, contact the Clinical Trials support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician
Study officials:
References:
Clinical trial NCT04376125: Suboccipital Inhibition in Tension Headache
Official title: Suboccipital Inhibition in Tension Headache
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Tension Headache
Keywords: tension headache
suboccipital inhibition
Lead sponsor: Universidad de León
Sponsor class: OTHER
Collaborators: name: Sanidad de Castilla y León
First posted: 2020-05-06
Enrollment: 30
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The researchers will carry out a randomized experimental study. Participants in the experimental group will receive a treatment based on suboccipital inhibition technique in addition to conventional treatment. Participants in the control group will only receive the conventional treatment. The existence of significant differences in both groups will be analyzed.

Detailed description: Conventional therapy will consist of microwaves, interference currents, and manual therapy.

Eligibility criteria: Inclusion Criteria:

* pathology tension headache associated with cervicalgia

Exclusion Criteria:

* pathology of nervous system

Primary outcomes:
measure: Change in Visual Analogue Scale for Pain
timeFrame: immediately before starting the intervention and after the last session of the intervention, that is, 2 weeks from the start
Secondary outcomes:
measure: Change in Six-item Headache Impact Text
timeFrame: immediately before starting the intervention and after the last session of the intervention, that is, 2 weeks from the start
Other outcomes:
Locations:
city: León
country: Spain
facility: Cristina Blanco Ortega
Study officials:
affiliation: Universidad de León
name: Cristina Blanco Ortega, physiotherap
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06491225: Autologous Tumor-Infiltrating Lymphocyte (GTE-001 Injection ) for Treatment of Patients with Advanced Lung Adenocarcinoma
Official title: A Phase I, Open Label, Multicenter Study Evaluating the Safety and Efficacy of Autologous Tumor-Infiltrating Lymphocyte (GTE-001 Injection ) for Treatment of Patients with Advanced Lung Adenocarcinoma
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Advanced Lung Adenocarcinoma；Adult
Lead sponsor: Grit Biotechnology
Sponsor class: INDUSTRY
First posted: 2024-07-09
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is a Multiple centers, open design aimed at evaluating the safety,efficacy and Production feasibility of Autologous Tumor-Infiltrating Lymphocyte (GTE-001 injection ) for treatment of patients with Advanced lung adenocarcinoma,And evaluate potential biomarkers related to GTE-001 activity.


Eligibility criteria: Inclusion Criteria:

* 1. Voluntarily join the study, signed informed consent form， willing and able to comply with the study protocol;
* 2. Age ≥18 years old;
* 3. Advanced lung adenocarcinoma that progresses after recurrence or first-line chemotherapy；
* 4. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1;
* 5. Expected survival time of ≥ 3 months;
* 6. Good function of vital organs;
* 7. At least one measurable target lesion that meets the definition of RECIST v1.1 after tumor sampling.

Exclusion Criteria:

* 1.Subject has previously received an allogeneic stem cell transplant or organ allograft,Subject has previously received engineered cell therapy,Prior FOLR1 directed therapy is not allowed unless it had been with an approved agent in the indication;
* 2.Subject has undergone surgery or received radiotherapy, immunotherapy, targeted therapy agents, anticancer vaccines, systemic steroids, or chemotherapy within 2 weeks of enrolment. Targeted agents, such as tyrosine kinase inhibitors, may be continued until 5 half-lives before enrolment;
* 3.Pregnant or lactating women; or women who are pregnant, breastfeeding, or planning to become pregnant within 12 months after cell infusion;
* 4.History of central nervous system (CNS) disorder,History of autoimmune disease,History of primary immunodeficiency;

Primary outcomes:
measure: Objective response rate
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing GoBroad Hospital
state: Beijing
Study officials:
References:
Clinical trial NCT01361048: Neo-Penotran Forte Vaginal Suppository for Vaginal Trichomoniasis
Official title: Neo-Penotran Forte Vaginal Suppository for Vaginal Trichomoniasis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Trichomonas Vaginitis
Keywords: trichomonas
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: Embil Pharmaceutical Co. Ltd
First posted: 2011-05-26
Enrollment: 40
Sex: FEMALE
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators are trying a combination vaginal product of higher dose metronidazole combined with miconazole to see if it is effective in treating vaginal trichomonas.


Eligibility criteria: Inclusion Criteria:

* presence of trichomonas

Exclusion Criteria:

* pregnant or nursing
* known immunodeficiency
* allergy to study drugs
* concurrent yeast infection
* history of seizures or peripheral neuropathy
* unwillingness to abstain from alcohol during treatment period and for 48 hrs after concurrent lithium
* anticoagulation therapy, and abuse
* patient expected to have menses within 8 days of enrollment

Primary outcomes:
measure: Percentage of Participants Cured of Vaginal Trichmonas
timeFrame: day 12-15
Secondary outcomes:
measure: Tolerability of the Study Product as Measured by Participant Self-report
timeFrame: day 12-15 day 30-35
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Personal Health Clinic UAB
state: Alabama
Study officials:
References:
Clinical trial NCT04021030: Building Collaborations to Address Drug Problems in the United States and China
Official title: Building Collaborations to Address Drug Problems in the United States and China
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Pain
Keywords: Cognitive Behavioral Therapy
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: Michigan Medicine - PKUHSC Joint Institute for Translational and Clinical Research
name: Peking University
name: Meridian Health Services
First posted: 2019-07-16
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the impact of a Cognitive Behavioral Therapy (CBT) intervention on the distribution and variability of pain level before and after intervention receipt among people with co-occurring chronic pain and Substance Use Disorders (SUDs) over a three-month follow-up period.

Detailed description: The project is an open trial of the CBT intervention for 20 adults receiving detoxification treatment with comorbid pain. Participants will be screened for pain and other conditions by completing a self-report survey questionnaire. Eligible participants will be asked to complete a baseline assessment. A trained research therapist will conduct individual therapy with participants twice a week for 2-4 weeks. Participants will be re-assessed at 1- and 3-month post-intervention follow-ups to track changes in their pain, functioning, and substance use.

Eligibility criteria: Inclusion Criteria:

* At least 18 years of age
* Currently receiving detoxification treatment
* Report pain of at least moderate or greater intensity over the three months prior to baseline assessment as indicated by an average score of four or greater on the Numeric Rating Scale (NRS)
* Have access to a phone for confidential personal therapy after the completion of detoxification treatment. For individuals who enter the residential treatment at the facility following the detoxification treatment, a research therapist will meet with them in person at a private office at the facility during their stay due to program's restriction on phone usage.

Exclusion Criteria:

* Inability to speak and understand English
* Inability to give informed, voluntary, written consent

Primary outcomes:
measure: Proportion of participants with decrease in pain level ≥ 18 % (or two points) on the Numeric Rating Scale (NRS)
timeFrame: 3 months post-intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Waterford
country: United States
facility: Meridian Health Services
state: Michigan
Study officials:
affiliation: University of Michigan
name: Mark Ilgen, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: