louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01518244: Assessing the Efficacy and Tolerability of AZARGA® (Brinzolamide 1%/Timolol 0.5% Fixed Combination) as Replacement Therapy in Patients on Brimonidine 0.2%/Timolol 0.5% Fixed Combination Therapy (COMBIGAN®) in Latin America
Official title: Assessing the Efficacy and Tolerability of AZARGA® (Brinzolamide 1%/Timolol 0.5% Fixed Combination) as Replacement Therapy in Patients on Brimonidine 0.2%/Timolol 0.5% Fixed Combination Therapy (COMBIGAN®) in Latin America
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Glaucoma
Keywords: Primary open angle-glaucoma
Ocular hypertension
Pigment dispersion glaucoma
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2012-01-25
Enrollment: 50
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 was to assess the efficacy and tolerability of changing to AZARGA® from prior COMBIGAN® pharmacotherapy in participants with open-angle glaucoma or ocular hypertension.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of ocular hypertension, exfoliative open-angle glaucoma, or pigment dispersion glaucoma in at least one eye (study eye).
* On a stable IOP (intra-ocular pressure) lowering regimen within 30 days of Screening Visit.
* IOP considered safe in both eyes in order to assure clinical stability of vision and optic nerve throughout the study period.
* Best corrected visual acuity of 6/60 (20/200 Snellen; 1.0 LogMAR) or better in each eye.
* IOP between 19 and 35 mmHG in at least one eye (which would be the study eye) while on brimonidine/timolol fixed combination therapy.
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Presence of other primary or secondary glaucoma.
* History of ocular herpes simplex.
* Any abnormality preventing reliable applanation tonometry.
* Corneal dystrophies.
* Concurrent infectious/noninfectious conjunctivitis, keratitis, or uveitis in either eye. Blepharitis or non-clinically significant conjunctival injection is allowed.
* Intraocular conventional surgery or laser surgery in study eye(s) less than three months prior to Screening Visit.
* Risk of visual field or visual acuity worsening as a consequence of participation in the study, in the opinion of the investigator.
* Progressive retinal or optic nerve disease from any cause.
* Use of systemic medications known to affect IOP which have not been on a stable course for 7 days prior to Screening Visit or an anticipated change in the dosage during the course of the study.
* Pregnant or lactating.
* Other protocol-defined exclusion criteria may apply.

Primary outcomes:
measure: Mean Change in Intraocular Pressure (IOP) From Baseline (Prior Therapy) at Week 8
timeFrame: Baseline, Week 8
Secondary outcomes:
measure: Percentage of Subjects Who Reach Target IOP (≤18 mmHg) at Week 8
timeFrame: Week 8
Other outcomes:
Locations:
Study officials:
affiliation: Alcon Research
name: Doug Hubatsch
role: STUDY_DIRECTOR
References:
Clinical trial NCT04486144: Impact Nerium Oleander on Immune Function
Official title: Impact of a Proprietary Extract of Nerium Oleander on Immune Function as Evidenced by Clinical Symptoms and Mortality :A Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Covid19 Positive Patient
Covid19 Close Contact
Immune Function
Keywords: Covid19
Nerium oleander
Clinical symptoms
Mortality
Immune Function
Lead sponsor: HealthQuilt
Sponsor class: OTHER
First posted: 2020-07-24
Enrollment: 82
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Assess the impact of a proprietary extract of Nerium oleander on immune function as evidenced by COVID-19 symptoms and mortality in COVID-19 positive patients and their close contacts compared to controls that did not receive the extract.

Detailed description: This is an exploratory study based on positive in-vitro, and in-vivo (humans) that appear to support an immune function benefit. Up to 100 patients that are COVID-19 positive in the ambulatory setting will be invited to participate. After informed consent is obtained, patients will be in either the Intervention Group (receive extract) or Comparison Group (did not receive extract). A baseline assessment and record review will be conducted to assure eligibility criteria. Patients in the Intervention Group will be given .5 ml (6.25 mg of extract) every 6 hours for 5 days, total of 25 mg per day / 125 mg for 5 days. Patient vital signs (temperature, pulse oximetry, blood pressure) and CDC symptoms / side effects will also be tracked. A dedicated medical oversight team with 24 / 7 access to care will be provided to monitor safety and tolerance. Patients will be followed for 10 days. Baseline antibody, RT-PCR, and live virus will be collected on Day 1, Day 5, and Day 10. A Data Monitoring Committee at the Schull Institute will meet weekly to review data.

Eligibility criteria: Inclusion Criteria:

* Age 18
* COVID 19 positive or close contact of COVID 19 positive
* No use of cardiac glycosides or other antiarrhythmic medications

Exclusion Criteria:

* No use of cardiac glycosides or other antiarrhythmic medications
* No allergy to coconut oil

Primary outcomes:
measure: COVID19 symptoms
timeFrame: Every 6 hours for 10 days
measure: Mortality
timeFrame: 10 days from enrollment into the Study, e.g. Day 10
Secondary outcomes:
measure: COVID19 Live Virus
timeFrame: Day 1, Day 5, Day 10
measure: RT-PCR COVID19 Test
timeFrame: Day 1, Day 5, Day 10
Other outcomes:
Locations:
city: Houston
country: United States
facility: KDunn and Associates, PA, dba Healthquilt
state: Texas
Study officials:
affiliation: KDunn and Associates, PA dba Healthquilt
name: Kim Dunn, MD, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04061044: A Study to Evaluate the Long Term Safety of OTX-TP (Sustained Release Travoprost) Intracanalicular Insert
Official title: A Prospective, Multicenter, Open Label Extension Study to Evaluate the Long Term Safety of OTX-TP
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Open Angle Glaucoma and Ocular Hypertension
Lead sponsor: Ocular Therapeutix, Inc.
Sponsor class: INDUSTRY
First posted: 2019-08-19
Enrollment: 40
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: To evaluate the long term safety of repeat dose OTX-TP, a sustained release travoprost drug product, placed in the canaliculus of the eyelid in the treatment of subjects with open-angle glaucoma or ocular hypertension.


Eligibility criteria: Inclusion Criteria:

* Had prior bilateral treatment and completion, through a minimum of week 12, of the OTX-16-002 trial
* Are informed of the nature of the study and subject is able to comply with study requirements and visit schedule for one year
* Have provided written informed consent, approved by the appropriate Institutional Review Board

Exclusion Criteria:

* Had more than 1 replacement, per eye, during participation in the OTX-16-002 trial
* Had punctal or canaliculi related adverse events during the OTX-16-002 trial which required discontinuation (e.g., canaliculitis)
* Used prohibited medications during the OTX-16-002 study, or the period between OTX-16-002 and this trial (with the exception of short term medication used to treat an adverse event or rescue therapy)
* Missed more than 2 visits during participation in the OTX-16-002 trial

Primary outcomes:
measure: Incidence of Treatment-Related Adverse Events (Safety and Tolerability)
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: ApexEye
state: Ohio
Study officials:
References:
Clinical trial NCT00196144: FFS - Far Field Sensing Test Study in Cardiac Dual Chamber Pacemakers
Official title: Far Field Sensing Test Study in Patients With Implanted Cardiac Dual Chamber Pacemakers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Atrial Fibrillation
Lead sponsor: Deutsches Herzzentrum Muenchen
Sponsor class: OTHER
First posted: 2005-09-20
Enrollment: 207
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: The purpose of this study is to evaluate the effect of individual adjustment of the postventricular atrial blanking period in avoiding inappropriate mode switch of dual chamber pacemakers.

Detailed description: Far-field R-wave sensing (FFS) in the atrial channel of dual chamber pacemakers is a relevant source for inappropriate mode switch from the DDD mode to the DDI or VDI mode. Inappropriate loss of atrioventricular synchrony due to false positive mode switch is hemodynamically disadvantageous, may induce atrial tachyarrhythmias, can lead to pacemaker syndrome, and impairs the reliability of pacemaker Holter data. The aim of the study is to determine whether individual adjustment of the postventricular atrial blanking period (PVAB) based on an additional test is effective in avoiding inappropriate mode switch due to FFS when compared to standard programming of the PVAB

Eligibility criteria: Inclusion Criteria:

* Indication for dual chamber pacing
* Implantation of an Identity DR pacemaker (St. Jude Medical)
* Bipolar atrial pacing electrode

Exclusion Criteria:

* Heart failure NYHA III and IV
* Unstable angina pectoris
* Indication for the implantation of an ICD
* Cardiac surgery within previous 6 months
* Cardiac surgery planed for the next 3 months

Primary outcomes:
measure: Incidence of inappropriate mode switch due to far field R-wave sensing
timeFrame: 3 months
Secondary outcomes:
measure: Incidence of inappropriate mode switch due to far field R-wave sensing in relation to the lead position
timeFrame: 3 months
Other outcomes:
Locations:
city: Munich
country: Germany
facility: Deutsches Herzzentrum Muenchen
Study officials:
affiliation: Deutsches Herzzentrum Muenchen
name: Claus Schmitt, MD
role: STUDY_CHAIR
affiliation: Deutsches Herzzentrum Muenchen
name: Christof Kolb, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kolb C, Wille B, Maurer D, Schuchert A, Weber R, Schibgilla V, Klein N, Hummer A, Schmitt C, Zrenner B; FFS-Test Study Group. Management of far-field R wave sensing for the avoidance of inappropriate mode switch in dual chamber pacemakers: results of the FFS-test study. J Cardiovasc Electrophysiol. 2006 Sep;17(9):992-7. doi: 10.1111/j.1540-8167.2006.00545.x.
Clinical trial NCT06506344: Syncing Screening and Services for Suicide Prevention Across Health and Justice Systems
Official title: Project 1 (Signature): Syncing Screening and Services for Suicide Prevention Across Health and Jail Systems
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Suicide Prevention
Lead sponsor: Henry Ford Health System
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
name: Michigan State University
name: HealthPartners Institute
name: Brown University
First posted: 2024-07-17
Enrollment: 60000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This study aims to harmonize jail release record data with electronic health record data in order to connect patients to an evidence-based suicide prevention and clinical care pathway upon jail release.

Detailed description: This study is designed to test the effectiveness of a care pathway delivered at the time of jail release, to increase behavioral health services engagement and prevent suicide attempt. There are 3 primary aims of this study: (1) Examine the effectiveness of the intervention on suicide attempt outcomes. (2) Evaluate the impact of the intervention on behavioral health utilization mechanisms. (3) Evaluate implementation outcomes and processes to guide future implementation and research, including: cost and cost-effectiveness; scalability; sustainability; feasibility, acceptability, and appropriateness to providers/systems; and implementation strategies.

Eligibility criteria: Inclusion Criteria:

* 18 years of age or older
* Released from jail between February 2021 and July of 2028
* Had a prior primary care visit or behavioral health visit at a participating health system in the past 3 years

Exclusion Criteria:

* Does not currently reside in the same state as the study site (i.e.- Michigan, Minnesota)
* Would require a translator to participate in the research according to EHR data
* Previously requested to be excluded from research

Primary outcomes:
measure: Composite measures of suicide attempt and death
timeFrame: 6-months from jail release date
Secondary outcomes:
Other outcomes:
Locations:
city: Detroit
country: United States
facility: Henry Ford Health
state: Michigan
city: Bloomington
country: United States
facility: HealthPartners Institute
state: Minnesota
Study officials:
affiliation: Henry Ford Health
name: Brian Ahmedani, PhD, MSW
role: PRINCIPAL_INVESTIGATOR
affiliation: Brown University
name: Lauren Weinstock, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: HealthPartners Institute
name: Rebecca Rossom, MD, MS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06675240: Meditative Neurofeedback for Depression
Official title: Meditative Neurofeedback for Depression
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Depression - Major Depressive Disorder
Depression Disorders
Keywords: meditation
neurofeedback
rumination
EEG
anxiety
depression
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
First posted: 2024-11-05
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The goal of this open-label single-arm study is to test a meditative neurofeedback intervention for depressed mood.

Detailed description: The goal of this open-label single-arm study is to test whether a 10-session meditative neurofeedback intervention significantly alleviates depressive symptons as well as improves secondary outcomes of rumination and mindfulness.

Eligibility criteria: Inclusion Criteria:

* moderate depression per PHQ9 symptom ratings

Exclusion Criteria:

* active substance abuse/dependence
* psychotic disorders
* bipolar disorder
* displaying acutely suicidal behaviors

Primary outcomes:
measure: PHQ9
timeFrame: 8 weeks
Secondary outcomes:
measure: MAAS
timeFrame: 8 weeks
measure: RRQ
timeFrame: 8 weeks
measure: GAD7
timeFrame: 8 weeks
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: University of California San Diego
state: California
Study officials:
References:
Clinical trial NCT06143540: Clinical Study of 18F-FAPI-RGD in Interstitial Lung Disease Associated With Connective Tissue Disease
Official title: Clinical Study of 18F Labeled Probe Targeting Fibroblast Activating Protein and Integrin avβ3 (FAPI-RGD) in Interstitial Lung Disease Associated With Connective Tissue Disease
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Interstitial Lung Disease
Lead sponsor: Sichuan Provincial People's Hospital
Sponsor class: OTHER
First posted: 2023-11-22
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with clinically suspected or diagnosed connective tissue disease-associated interstitial lung disease

Brief summary: The goal of this observational study is to examine clinical utility of 18F-FAPI-RGD PET/CT imaging in evaluating connective tissue disease-associated interstitial lung disease. Participants will undergo clinical evaluation and 18F-FAPI-RGD PET/CT examination.

Detailed description: Interstitial lung disease is an overarching term for a wide range of disorders characterized by inflammation and/ or fibrosis in the lungs. Interstitial lung disease associated connective tissue diseases(CTD-ILD) is one of the most common types.The goal of this study is to explore the feasibility of using 18F-FAPI-RGD, a dual-targeting heterodimeric PET tracer that recognizes both fibroblast activation protein (FAP) and integrin αvβ3 for detecting connective tissue disease associated interstitial lung disease (CTD-ILD), and analyze the relationship between 18F- FAPI-RGD PET/CT images and related parameters of lung function, clinical laboratory indicators and HRCT scores.

Eligibility criteria: Inclusion Criteria:

* Age 18 and above
* Patients who have been diagnosed with, or are clinically highly suspected of ILD
* Patients who have been diagnosed with, or are clinically highly suspected of CTD-ILD

Exclusion Criteria:

* Pregnant or breastfeeding
* Patients with tumor, other respiratory diseases, and lung surgery
* Abnormal cardiopulmonary function or mental state, unable tolerate PET/CT

Primary outcomes:
measure: Correlation between clinical indicators and PET/CT results
timeFrame: 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Chengdu
country: China
facility: Sichuan Provincial People's Hospital
state: Sichuan
Study officials:
References:
Clinical trial NCT03847740: Safety and Feasibility of a New Neuromuscular Monitoring Device
Official title: Safety and Feasibility of a New Neuromuscular Monitoring Device
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: General Anesthesia
Lead sponsor: Poitiers University Hospital
Sponsor class: OTHER
First posted: 2019-02-20
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The aim of the study is to compare, during general anesthesia using neuromuscular blocking agent, the feasibility of a new mechanographic device (ITF handle and Visual ITF software) with a standard acceleromyographic device (TOF Watch SX) and also to assess its safety during the first 24 hours after surgery.

The two devices will be studied simultaneously in each patient.


Eligibility criteria: Inclusion Criteria:

* Adult patients,
* ASA class 1 to 3,
* Scheduled for elective surgery requiring general anesthesia and muscle paralysis

Exclusion Criteria:

* Age inferior to 18 years,
* ASA class 4,
* Emergency surgery,
* Prone position on the operating table

Primary outcomes:
measure: Delay of block installation between the injection and the disappearance of all the muscular contractions to stimulation by train of four
timeFrame: Usefulness of non depolarizing muscle relaxant-induced muscle paralysis is limited at the surgery period and should be avoided once the surgery is completed. Therefore, all measurements are done during this time.
Secondary outcomes:
measure: Clinical examination
timeFrame: the first 24 postoperative hours
measure: Clinical examination
timeFrame: the first 24 postoperative hours
measure: Characteristics of maintenance curarization
timeFrame: Usefulness of non depolarizing muscle relaxant-induced muscle paralysis is limited at the surgery period and should be avoided once the surgery is completed. Therefore, all measurements are done during this time.
measure: Characteristics of decurarization during spontaneous recovery phase
timeFrame: Usefulness of non depolarizing muscle relaxant-induced muscle paralysis is limited at the surgery period and should be avoided once the surgery is completed. Therefore, all measurements are done during this time.
measure: When the TOF ratio will be greater than 0.9 on the TOF Watch side, the degree of residual paralysis will be assessed on the ITF side using 100 Hz tetanus stimulation repeated 5 times at 2 minutes interval
timeFrame: Usefulness of non depolarizing muscle relaxant-induced muscle paralysis is limited at the surgery period and should be avoided once the surgery is completed. Therefore, all measurements are done during this time.
Other outcomes:
Locations:
city: Poitiers
country: France
facility: Chu de Poitiers
Study officials:
References:
Clinical trial NCT01418144: Effect of Transversus Abdominis Plane (TAP) Block After Laparoscopic Colon Surgery
Official title: Effect of Transversus Abdominis Plane (TAP) Block as Postoperative Pain Management After Laparoscopic Colon Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Laparoscopic Colon Surgery
Lead sponsor: Copenhagen University Hospital at Herlev
Sponsor class: OTHER
First posted: 2011-08-16
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate the effectiveness of Transversus Abdominis Plane (TAP) block as a part of a multimodal postoperative pain management after laparoscopic surgery on colon.


Eligibility criteria: Inclusion Criteria:

* Age 18 - 80
* BMI 18 - 40
* ASA 1 - 3
* Written consent
* Can cooperate

Exclusion Criteria:

* Mb Chron and Collitis Ulcerosa
* Drug and alcohol abuse
* Pregnancy
* Consumption of opioids
* Drug allergy

Primary outcomes:
measure: Pain during cough
timeFrame: 6 hours
Secondary outcomes:
measure: Pain during rest
timeFrame: 1,2,4,6,12 and 24 hours
measure: Total opioid consumption
timeFrame: 0-24 hours
measure: Postoperative nausea and vomiting
timeFrame: 1,2,4,6,12,18 and 24 hours
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Herlev University Hospital, Department of anaesthesia
state: Herlev
Study officials:
References:
citation: Torup H, Hansen EG, Bogeskov M, Rosenberg J, Mitchell AU, Petersen PL, Mathiesen O, Dahl JB, Moller AM. Transversus abdominis plane block after laparoscopic colonic resection in cancer patients: A randomised clinical trial. Eur J Anaesthesiol. 2016 Oct;33(10):725-30. doi: 10.1097/EJA.0000000000000510.