louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02856399: Long-term Effects of Methadone for Cancer Pain
Official title: Long-term Effects of Methadone for Cancer Pain
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cancer Pain
Keywords: methadone
cancer pain
long term effect
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2016-08-04
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing a methadone treatment for cancer pain

Brief summary: The methadone is an useful opioid for the cancer pain treatment, mostly used in second or last line during the opioid rotation. The Methadone had an anti-MNDA effect, and clinicians agree that the methadone could have an effect in neuropathic cancer pain. During a previous study the investigators find that the pain was still improving after the week 2, but they had only a small number of patients still included at this stage and they cannot conclude.

The investigators decide to follow up systematically all the patients undergoing a methadone treatment for cancer pain, at day 28, to study the hypothesis about the long-term pain improvement.


Eligibility criteria: Inclusion Criteria:

* Patients with t methadone for cancer pain in opioid rotation
* Able to fill the questionnaire
* Performance status (PS) from 0 to 2

Exclusion Criteria:

* Patients PS 3
* Unable to sign the informed consent

Primary outcomes:
measure: Difference between EVA pain score at Day 28 and Day 0
timeFrame: pain score measure at Day 0 and Day 28
Secondary outcomes:
measure: Change in score of neuropathic pain intensity NPSI
timeFrame: Day 0 and Day 28
measure: Change in depression and anxiety score HADS
timeFrame: Day 0 and Day 28
measure: Change in quality of life score QOL C30
timeFrame: Day 0 and Day 28
measure: Side effect record
timeFrame: up to Day 28
Other outcomes:
Locations:
city: Pierre-Bénite
country: France
facility: Unité de Soins Palliatifs - Hospices Civils de Lyon - Centre Hospitalier Lyon Sud, 165 Chemin du Grand Revoyet
Study officials:
affiliation: Hospices Civils de Lyon
name: Marilene FILBET, Pr Associate
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01363999: A Formulation Screening Study of Dalcetrapib and Atorvastatin in Healthy Volunteers
Official title: A Single-center, Randomized, Open-label, Four Treatments, Four Periods, Four Sequence, Four-way Crossover Study to Explore the Pharmacokinetic Performance of Dalcetrapib and Atorvastatin Fixed Dose Combination Prototype Formulations in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2011-06-02
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: A single-center, crossover study to evaluate the pharmacokinetics of dalcetrapib and atorvastatin from prototype fixed dose combination formulations in healthy volunteers. Volunteers will receive a single dose of dalcetrapib with atorvastatin in each of four treatment periods.


Eligibility criteria: Inclusion Criteria:

* Healthy volunteers, 18 to 55 years of age, inclusive

Exclusion Criteria:

* Any concomitant disease or ongoing condition that in the investigator's opinion could interfere with the study or could pose an unacceptable risk to the patient
* Clinically significant abnormal laboratory values

Primary outcomes:
measure: Plasma Concentration of Dalcetrapib Active Form
timeFrame: 3 days
measure: Plasma Concentration of Atorvastatin
timeFrame: 3 days
Secondary outcomes:
measure: Plasma Concentration of Atorvastatin Metabolites
timeFrame: 3 days
measure: Safety: Incidence of Serious Adverse Events
timeFrame: 9 weeks
Other outcomes:
Locations:
city: Christchurch
country: New Zealand
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT05683899: A Study of Emergency Department AI Prediction Impact
Official title: Evaluation of Emergency Department AI Prediction Algorithm
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hospital Admission
Length of Stay
Keywords: AI Prediction Algorithm
Emergency Department
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2023-01-13
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The group being surveyed will consist of Hospital Internal Medicine (HIM) clinicians, (physicians, nurse practioners, and physician assistants) at the Mayo Clinic- Rochester site, who are all adults. The patients which are triaged by this group are only adults, and accordingly, the AI score will never be shown for pediatric patients, or patients undergoing psychiatric evaluation.

Brief summary: The purpose of this study is to evaluate the impact of an AI admission prediction tool on the number of preventable hospital admissions, emergency department (ED) length of stay, when the predictions are displayed only to a dedicated ED triage team. Also, to evaluate user perceptions of the AI tool among the triage team users and medical officer of the day users. Additionally, to evaluate any impact of the AI tool on the number of interventions performed by the triage team, and to evaluate the impact of the tool on time-to-admission after an admission order is placed.


Eligibility criteria: Inclusion Criteria:

* For the survey component, any HIM clinician that works a shift in the triage area, ED physicians, and the medical officer of the day will be included.
* For length of stay data, adult patients registered in the Mayo Clinic-Rochester St. Mary's Emergency Department will be included.

Exclusion Criteria:

* For the survey, clinicians not working a triage shift during the study period will be excluded.
* For the length of stay analysis, only adult ED patients will be included, who do not triaged to the behavioral health/psychiatry pathway, nor patients who are triaged to the Emergency Department observation pathway.

Primary outcomes:
measure: Hospital Admissions
timeFrame: 282 days
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic Minnesota
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Alexander Ryu, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04532099: Clinical Comparison of Two Daily Wear Frequent Replacement Silicone Hydrogel Soft Contact Lenses
Official title: Clinical Comparison of Two Daily Wear Frequent Replacement Silicone Hydrogel Soft Contact Lenses
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Refractive Errors
Ametropia
Keywords: Contact Lenses
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2020-08-31
Enrollment: 132
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Part A is a crossover study. Part B is a single group study.
Primary purpose: TREATMENT

Brief summary: The primary objective of this study is to evaluate the overall performance of an investigational silicone hydrogel lens when compared to ACUVUE OASYS® with HYDRACLEAR® PLUS (AOHP).

Detailed description: Part A of this study is a randomized, double masked, crossover study comparing 2 contact lens products. The expected duration of subject participation in Part A is approximately 8 weeks with 5 scheduled visits.

Part B of this study is a non-randomized, single masked, single group study with 1 contact lens product. The expected duration of subject participation in Part B is approximately 4 weeks with 3 scheduled visits.

Eligibility criteria: Key Inclusion Criteria:

* Sign an approved Informed Consent Form.
* Wear spherical contact lenses in both eyes for a minimum of 5 days per week and 10 hours per day during the past 3 months.
* Willing to wear habitual spectacles for vision correction when study lenses are not worn, as needed.
* Other protocol-defined inclusion criteria may apply.

Key Exclusion Criteria:

* Any eye condition or use of medication that contraindicates contact lens wear, as determined by the Investigator.
* History of refractive surgery or plan to have refractive surgery during the study.
* Current or history of dry eye in either eye that, in the opinion of the Investigator, would preclude contact lens wear.
* Routinely sleeps in contact lenses at least 1 night per week.
* Part A: Current wearer of ACUVUE OASYS® with HYDRACLEAR® PLUS.
* Part B: Current wearer of Biofinity family of contact lenses (comfilcon A).
* Other protocol-defined exclusion criteria may apply.

Primary outcomes:
measure: Distance Visual Acuity (VA) (Part A)
timeFrame: Day 30, each study lens type
Secondary outcomes:
Other outcomes:
Locations:
city: Longwood
country: United States
facility: Alcon Investigator 6356
state: Florida
city: Maitland
country: United States
facility: Alcon Investigator 6565
state: Florida
city: Warwick
country: United States
facility: Alcon Investigator 6401
state: Rhode Island
city: Memphis
country: United States
facility: Alcon Investigator 6353
state: Tennessee
Study officials:
affiliation: Alcon Research, LLC
name: Sr. Clinical Trial Lead, CDMA Vision Care
role: STUDY_DIRECTOR
References:
Clinical trial NCT01318499: Nepafenac 0.3% Two Study
Official title: Clinical Evaluation of Nepafenac Ophthalmic Suspension, 0.3% Compared to Nepafenac Ophthalmic Suspension 0.1% and Vehicle for Prevention and Treatment of Ocular Inflammation and Pain Associated With Cataract Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cataract
Keywords: cataract
inflammation
pain
inflammatory cells
aqueous flare
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2011-03-18
Enrollment: 1342
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: The purpose of this study was to assess the safety and efficacy of Nepafenac Ophthalmic Suspension, 0.3% for the prevention and treatment of inflammation (swelling and redness) and pain in the eye after cataract extraction.


Eligibility criteria: Inclusion Criteria:

* Planned cataract extraction by phacoemulsification with the implantation of a posterior chamber intraocular lens;
* Patients who, in the opinion of the Investigator, would have improvement in best-corrected visual acuity after surgery;
* Able to understand and sign an informed consent;
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Use of topical ocular, inhaled or systemic nonsteroidal anti-inflammatory drugs within 7 days of surgery, with the exception of the allowed low dose of aspirin (up to 100 mg) prior to surgery and through study exit;
* Use of topical ocular, inhaled or systemic steroids within 14 days prior to surgery and through study exit;
* History of chronic or recurrent inflammatory eye disease (eg, iritis, scleritis, uveitis, iridocyclitis, rubeosis iridis) in the operative eye;
* Diabetic retinopathy in the operative eye;
* Known or suspected allergy or hypersensitivity to non-steroidal anti-inflammatory drugs (NSAIDs), or to any component of the test article;
* Other protocol-defined exclusion criteria may apply.

Primary outcomes:
measure: Percentage of Patients Cured at Day 14, Nepafenac 0.3% vs. Nepafenac Vehicle 0.3%
timeFrame: Day 14 postoperative
Secondary outcomes:
measure: Percentage of Patients Cured at Day 7, Nepafenac 0.3% vs. Nepafenac 0.1%
timeFrame: Day 7 postoperative
Other outcomes:
measure: Cumulative Percentage of Patients Cured by Visit
timeFrame: Day 1, Day 3, Day 7, Day 14
measure: Cumulative Percentage of Patients Pain Free by Visit
timeFrame: Day 1, Day 3, Day 7, Day 14
Locations:
city: Fort Worth
country: United States
facility: Contact Alcon Call Center for Trial Locations
state: Texas
Study officials:
References:
Clinical trial NCT03902899: Increasing Serrated Polyp Detection With a Brief Awareness Training
Official title: The Influence of a Short Training in the Detection Rate of Proximal Serrated Polyps in an Asymptomatic Patient Population
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Serrated Polyp
Colorectal Neoplasms
Lead sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Sponsor class: OTHER
Collaborators: name: National Institute for Public Health and the Environment (RIVM)
First posted: 2019-04-04
Enrollment: 138
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a non-randomized controlled trial with two arms. The intervention-arm consists of all endoscopists employed by 9 semi-randomly chosen Dutch hospitals hospitals who receive an educational training. The control-arm consists of a specific number of randomly chosen endoscopists.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: In this non-randomized controlled trial, a semi-random group of Dutch endoscopist receive an oral training about the significance of serrated polyps. The primary aim of this training is to improve the endoscopist's awareness of the significance of serrated polyps, ultimately leading to increased detection. In addition, a random group of endoscopists that will not receive this training will be used as a reference group.

Data will be collected as part of routine care within the Nationwide Dutch Bowel cancer screening program. The serrated polyp detectionrate of each endoscopist will be extracted from anonymized data that will be prospectively collected as part of routine care within the Dutch Nationwide bowel cancer screening program. Data will be anonymized and provided by Rijksinstituut voor Volksgezondheid en Milieu (RIVM) and ScreenIT.


Eligibility criteria: Inclusion criteria:

- Endoscopists accredited to perform colonoscopies within the Dutch Nationwide colorectal cancer screening program

Exclusion criteria:

- Absent during both training sessions while employed in one of the trained hospitals

Primary outcomes:
measure: Proximal serrated polyp detection rate (PSPDR)
timeFrame: Up to five years (between 2014 and 2018)
Secondary outcomes:
measure: Adenoma detection rate (ADR)
timeFrame: Up to five years (between 2014 and 2018)
Other outcomes:
Locations:
Study officials:
References:
citation: Bleijenberg AGC, van Leerdam ME, Bargeman M, Koornstra JJ, van Herwaarden YJ, Spaander MC, Sanduleanu S, Bastiaansen BAJ, Schoon EJ, van Lelyveld N, Dekker E, IJspeert JEG. Substantial and sustained improvement of serrated polyp detection after a simple educational intervention: results from a prospective controlled trial. Gut. 2020 Dec;69(12):2150-2158. doi: 10.1136/gutjnl-2019-319804. Epub 2020 Mar 5.
Clinical trial NCT05171699: Effect of Electroacupuncture in Patients With Sepsis Associated Brain Injury
Official title: Effect of Electroacupuncture in Patients With Sepsis Associated Brain Injury
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Electroacupuncture
Sepsis
Sepsis-associated Brain Injury
Lead sponsor: Tianjin Nankai Hospital
Sponsor class: OTHER
First posted: 2021-12-29
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: To investigate the effect of electroacupuncture on patients with sepsis-associated brain injury.


Eligibility criteria: Inclusion Criteria:

1. Age is between 20 and 80 years.
2. Patients meeting the diagnosis of sepsis-associated brain injury.
3. Patients who agreed to accept this trial and signed the informed consent form.

Exclusion Criteria:

1. Patients with a history of brain injury, stroke, epilepsy, cognitive impairment, or mental illness prior to admission.
2. Patients who were also involved in any other interventional study.
3. Due to hearing or vision loss, or any other situation that may seriously interfere with study data collection.
4. Patients who refused to participate in this study.
5. The pregnancy test was positive or is currently breastfeeding.
6. Any other situation that the investigator believed might be detrimental to participant in the study.

Primary outcomes:
measure: neuron specific enolase,NSE
timeFrame: Change of NSE from Baseline at 7 days
measure: sTREM2
timeFrame: Change of sTREM2 from Baseline at 7 days
measure: soluble protein-100β,S100β
timeFrame: Change of S100β from Baseline at 7 days
Secondary outcomes:
measure: Acute Physiology and Chronic Health Evaluation，APACHE II
timeFrame: Change of APACHE II from Baseline at 7 days
measure: Glasgow Coma Scale，GCS
timeFrame: Change of GCS from Baseline at 7 days
measure: Montreal Cognitive Assessment (MoCA) scale
timeFrame: Change of MoCA from Baseline at 7 days
Other outcomes:
measure: length of stay in hospital
timeFrame: 2 months
measure: fatality rate at 28 days after discharge
timeFrame: 2 months
Locations:
city: Tianjin
country: China
facility: Tianjin Nankai Hospital
state: Tianjin
Study officials:
References:
Clinical trial NCT06482099: SPECIAL INVESTIGATION FOR ABRYSVO IN PREGNANT WOMEN AND INFANTS
Official title: Special Investigation for ABRYSVO Intramuscular Injection -Investigation in Pregnant Women and Infants-
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Respiratory Tract Infection
Keywords: Respiratory Tract infection
RSV Vaccine
Maternal
Infant
Post Marketing Study
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2024-07-01
Enrollment: 490
Sex: ALL
Minimum age (years): 0
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Pregnant women who have been vaccinated with Abrysvo for the first time and their infants.

Brief summary: This post-marketing study is a multicenter cohort study in pregnant women vaccinated with Abrysvo (RSV vaccine）designed to confirm the safety in pregnant women and their infants under actual clinical practice in Japan.


Eligibility criteria: Inclusion Criteria:

1. Pregnant women who have been vaccinated with Abrysvo for the first time after Abrysvo is launched. Pregnant women who have previously participated in the clinical trials of Abrysvo will be excluded.
2. Vaccinated participants who have provided written consent regarding their participation in the study and entry of symptoms to ePRO with the use of their devices (smartphones, tablets PC, etc.) (or paper-PRO if there is any compelling reason) upon understanding the explanatory document. For a minor vaccinated participant, the parent(s) or legally acceptable representatives shall provide written consent.
3. Pregnant women who have provided written consent to the participation of their infants in the study. For a minor vaccinated participant, the parent(s) or legally acceptable representatives shall provide written consent.

Exclusion Criteria:

* There are no exclusion criteria for this study.

Primary outcomes:
measure: Percentage of pregnant women reporting Adverse Reactions for 28 days after vaccination
timeFrame: up to 28 days after vaccination
measure: Percentage of pregnant women reporting Serious Adverse Reactions from the day of vaccination up to 28 days after delivery
timeFrame: up to 28 days after delivery
measure: Percentage of pregnant women reporting reactogenicity events (local reactions and systemic events) from day of vaccination up to 7 days after vaccination
timeFrame: up to 7 days after vaccination
measure: Percentage of infants reporting Adverse Reactions from the birthday up to 28 days after birth
timeFrame: up to 28 days after birth
measure: Percentage of infants reporting Serious Adverse Reactions from the birthday up to 28 days after birth
timeFrame: up to 28 days after birth
Secondary outcomes:
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: Pfizer
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT03304899: Fibrinogen Concentrate in Isolated Traumatic Brain Injury
Official title: Early Fibrinogen Concentrate in Isolated Traumatic Brain Injury and the Effect on Post Bleeding & Complications
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Traumatic Brain Injury
Hemorrhage
Lead sponsor: Isfahan University of Medical Sciences
Sponsor class: OTHER
First posted: 2017-10-09
Enrollment: 50
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: Fibrinogen is a unique precursor of fibrin and cannot be compensated for by other coagulation factors. If plasma fibrinogen concentrations are insufficient, hemostatic clots cannot be formed with the appropriate firmness. In severe traumatic brain injury(TBI) patients, plasma fibrinogen concentrations decrease earlier and more frequently than other coagulation factors,predicting massive bleeding and death.

The purpose of this study is to try early injection of fibrinogen concentrate in severe isolated traumatic brain injury and investigation the effect of it on post bleeding and complications.


Eligibility criteria: Inclusion Criteria:

* Patients with severe isolated traumatic brain injury.

Exclusion Criteria:

* Severe abdomen or extremities trauma.
* Severe bleeding from abdomen or extremities.
* Congenital coagulopathy (Hemophilia, protein S and C deficiency, Factor 5 Leiden deficiency and ...).
* Warfarin, Heparin, Enoxaparin, Dabigatran and other anticoagulation drugs consumption.

Primary outcomes:
measure: Mortality rate.
timeFrame: Until 90 days after admission.
measure: Average of serum fibrinogen level.
timeFrame: Immediately after admission.
measure: The effect of early fibrinogen on post trauma bleeding (Intracranial hemorrhage).
timeFrame: 2, 6, 24, 72 hours and 30 , 90 days after admission.
Secondary outcomes:
measure: The complications that related to fibrinogen concentrate.
timeFrame: until 90 days after admission.
Other outcomes:
Locations:
city: Isfahan
country: Iran, Islamic Republic of
facility: Isfahan university of medical science.
Study officials:
References: