louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04127162: Heart Failure Decompensation And In-Hospital Mortality
Official title: Short-Period Temporal Dispersion Repolarization Markers and In-Hospital Mortality in Decompensated Heart Failure: A Pilot Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Chronic Heart Failure
Decompensated Heart Failure
Morality
Keywords: Temporal Dispersion of Repolarization Phase
proBNP
QTVI
QT
Tpeak-Tend
Lead sponsor: University of Roma La Sapienza
Sponsor class: OTHER
First posted: 2019-10-15
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: decompensated heart failure patients admitted to the emergency department with dyspnea and other clinical signs of heart failure.

Brief summary: Background and objectives Heart failure is a leading cause of morbidity and mortality worldwide and it is a major cause of emergency department access for cardiovascular disease patients. Aim of this study is to identify the markers, based on short-term temporal repolarization dispersion, capable to individuate decompensated chronic heart failure (CHF) patients at high mortality risk.

Method: We will obtain the following variables from ECG monitor, via mobile phone, during 5-minute recordings in decompensated CHF patients: RR, QT end (QTe), QT peak (QTp) and T peak to T end (Te) and we calculated mean, standard deviation (SD) and normalized index (N).


Eligibility criteria: Inclusion Criteria:

* at least one symptom or sign compatible with a decompensation and/or a previous documented history of CHF

Exclusion Criteria:

* pneumonia
* pulmonary embolism

Primary outcomes:
measure: Mortality
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Piccirillo G, Moscucci F, Bertani G, Lospinuso I, Sabatino T, Zaccagnini G, Crapanzano D, Diego ID, Corrao A, Rossi P, Magri D. Short-period temporal repolarization dispersion in subjects with atrial fibrillation and decompensated heart failure. Pacing Clin Electrophysiol. 2021 Feb;44(2):327-333. doi: 10.1111/pace.14158. Epub 2021 Jan 12.
citation: Piccirillo G, Moscucci F, Bertani G, Lospinuso I, Mastropietri F, Fabietti M, Sabatino T, Zaccagnini G, Crapanzano D, Di Diego I, Corrao A, Rossi P, Magri D. Short-Period Temporal Dispersion Repolarization Markers Predict 30-Days Mortality in Decompensated Heart Failure. J Clin Med. 2020 Jun 16;9(6):1879. doi: 10.3390/jcm9061879.
Clinical trial NCT05069662: Impact of the COVID-19 Pandemic on Drug Use and Monitoring of Cancer Patients
Official title: Assessment of the Impact of the COVID-19 Pandemic on Drug Use and on the Perception of Remote Monitoring by Cancer Patients Followed in the ONCORAL Program
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cancer
Keywords: remote monitoring
oral anticancer drugs
drug intake
COVID-19 pandemic
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2021-10-06
Enrollment: 120
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 treated with oral cancer drugs included in the Oncoral multidisciplinary outpatient / hospital program of the Hospices Civils de Lyon and having benefited from remote monitoring during the COVID-19 pandemic-related containment period between March 16, 2020 and May 11, 2020.

Brief summary: The COVID-19 pandemic has profoundly changed the organisation of care. Teleconsultation has replaced hospital medical consultations in order to reduce the risk of patient exposure to the virus.

Within the framework of the Oncoral multidisciplinary outpatient / hospital program of follow-up, carried out by the Hospices Civils de Lyon for ambulatory patients treated with oral anticancer drugs, interviews with the pharmacist and/or nurse, which were previously organised face-to-face, have been replaced by telephone interviews, ensuring continuity of follow-up for patients without having to come to the hospital.

This study focuses on a telephone survey to describe the impact of the COVID-19 pandemic health crisis on the drug exposure of cancer patients followed in the Oncoral program, their treatment management, their perception of teleconsultation and their IT resources for remote monitoring.


Eligibility criteria: Inclusion Criteria:

* Adult patients aged 18 and over
* Ambulatory patients treated with oral anticancer drugs and benefiting from the ONCORAL multidisciplinary outpatient / hospital program
* Having benefited from a remote monitoring between March 16, 2020 and May 11, 2020 (the COVID-19 pandemic-related containment period)
* Patients who do not object to participating in the survey and to the use of the data collected

Exclusion Criteria:

* Patients who do not speak French
* Patients living in an institution
* Patients protected by law
* Patients included in a drug clinical trial
* Patients refusing to participate in the survey and / or not responding to the 2 telephone calls requesting their participation and / or not responding to any of these calls
* Patients choosing to stop the interview and no longer answering to the questions asked

Primary outcomes:
measure: Percentage of patients reporting a change in drug use during the COVID-19 pandemic-related containment period.
timeFrame: Inclusion
Secondary outcomes:
Other outcomes:
Locations:
city: Pierre-Bénite
country: France
facility: Service Pharmaceutique, Hospices Civils de Lyon
Study officials:
References:
Clinical trial NCT00004429: Randomized Study of Recombinant Human Growth Hormone in Patients on Chronic Hemodialysis or Peritoneal Dialysis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Kidney Failure, Chronic
Keywords: end stage renal disease
rare disease
renal and genitourinary disorders
Lead sponsor: FDA Office of Orphan Products Development
Sponsor class: FED
Collaborators: name: Vanderbilt University
First posted: 1999-10-19
Enrollment: 25
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: OBJECTIVES:

I. Assess the clinical safety and long term effects of recombinant human growth hormone on a defined range of nutritional indices in malnourished chronic hemodialysis and continuous ambulatory peritoneal dialysis patients.

Detailed description: PROTOCOL OUTLINE: This is a randomized, double blind, placebo-controlled, cross-over study.

Prior to randomization each patient's protein and calorie intake is assessed and optimized as possible. Patients are randomized to receive either placebo or recombinant human growth hormone subcutaneously every other day for 6 months. At the end of this 6 month period, patients undergo a 4 week washout period. After the washout period, patients are crossed-over to the alternate regimen for an additional 6 months followed by another 4 week washout period.

Eligibility criteria: PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

* On hemodialysis or peritoneal dialysis for more than 3 months
* Optimally dialyzed (urea reduction ratio greater than 65%)
* Suboptimal nutritional status identified by one of the following criteria: -Protein catabolic rate less than 0.85 g/kg/d calculated by three point urea kinetic modeling on at least 2 occasions over the past 6 months -Progressive unintentional weight loss of more than 2.5% of the initial or ideal body weight and/or patient weighs less than 90% of ideal body weight -Biochemical parameters of malnutrition defined by two or more of the following measurements over the past 3 months: Serum albumin no greater than 3.7 g/dL Serum transferrin concentration less than 250 mg/dL Serum prealbumin concentration less than 30 mg/dL Serum IGF-1 concentration less than 0.250 mg/mL

--Patient Characteristics--

* No active autoimmune, inflammatory, or infectious disease At least 6 months since any documented malignancy
* No unusual dietary restrictions At least 3 months since peritonitis

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: Vanderbilt University Medical Center
name: Talat Alp Ikizler
role: STUDY_CHAIR
References:
Clinical trial NCT06584929: Rural Smoking Cessation
Official title: Evaluating Population-Based Strategies for Rural Smoking Cessation
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Smoking Cessation
Lead sponsor: Masonic Cancer Center, University of Minnesota
Sponsor class: OTHER
First posted: 2024-09-05
Enrollment: 272
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Understanding ways to help people who live in rural areas quit smoking is a public health priority. quitting smoking among rural people who smoke is a critical public health concern. People in rural areas smoke at higher rates than those in urban areas, experience high rates of smoking caused cancers and deaths. We are recruiting rural people from around the country to better understand how different quit smoking methods can improve a person's chances of successfully quitting smoking.

Detailed description: This is a SMART, where eligible rural people who smoke (RPWS) can be randomized up to two times to different resources/ways to help quit smoking. For each randomization, participants will use the assigned resources for 3 months, and partake in surveys at baseline, 1, and 3 months, during which they will be asked several questions related to use of resources, and smoking behavior. Carbon monoxide (CO) in exhaled breath will be collected at 3 months using iCO™ Smokerlyzer® (https://www.icoquit.com/us/) to determine biochemically confirmed abstinence.

Eligibility criteria: Inclusion Criteria:

* ≥ 21 years
* smoke ≥ 5 cigarettes per day
* daily access to their own iPhone/Android smartphone or tablet

Exclusion Criteria:

* past 30-day NRT use or contraindications listed on the NRT labels
* currently pregnant/breastfeeding

Primary outcomes:
measure: Number of participants abstinent from all combustible tobacco products
timeFrame: 3 months
Secondary outcomes:
measure: Cigarettes per day (CPD)
timeFrame: 1 and 3 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04199429: Relationship-based Care Model in Pediatrics
Official title: Relationship-based Care Model in Pediatrics: a Randomized Controlled Trial to Implement the Parents' Perception of Quality of Nursing Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression, Anxiety
Nurse-Patient Relations
Keywords: Relationship-based care
Pediatric
Caregiver anxiety
Nurse job satisfaction
Nurse
Lead sponsor: University of Urbino "Carlo Bo"
Sponsor class: OTHER
Collaborators: name: University of Padova
First posted: 2019-12-13
Enrollment: 180
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Aim: To evaluate whether the application of the Relationship-based Care (RBC) model as a treatment called "Take 5 minutes" (T5M) affects the level of anxiety and depression of the parent, the level of the parent perceived quality of nursing care and the work satisfaction of the nursing staff.

Design: Single-blind randomized controlled trial.

Methods: The trial was performed from February to July 2016. The trial was conducted with one intervention (N=101) and one control group (N=90). Nurses applied the RBC model as a treatment, named "Take 5 Minutes", that consisted of dedicating some short time (from 5 to 10 minutes) to the relationship with the parents, using specifically designed communication strategies. The primary outcome was the evaluation of anxiety and depression of parents, the secondary was the parent perceived quality of nursing care.


Eligibility criteria: Inclusion Criteria:

* the parents of the children admitted to two Pediatric Units in a nationally renowned university hospital in the North-East of Italy
* had knowledge of the Italian language spoken and written
* were available for participation in the study by signing the informed consent

Exclusion Criteria:

* Parents of hospitalized patients for a duration of less than 4 days

Primary outcomes:
measure: Change from T0 to T1 and T2 of the Hospital Anxiety and Depression Scale (HADS) scores
timeFrame: T0: admission of the patient; T1: 4th day after the admission; T2: at discharge (expected mean value = 6.2 days after admission [standard deviation = 2.0])
Secondary outcomes:
measure: Caring Behaviors Inventory (CBI)
timeFrame: T2: at discharge of the patient (expected mean value = 6.2 days after admission [standard deviation = 2.0])
measure: Change of the job satisfaction of the nurses
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
affiliation: University of Urbino "Carlo Bo"
name: Davide Sisti, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: De Barbieri I, Sisti D, Di Falco A, Galeazzo M, Amatori S, Rocchi MBL, Perilongo G. Relationship-based care model in paediatrics: A randomized controlled trial to implement the parents' perception of the quality of nursing care. J Adv Nurs. 2020 Dec;76(12):3597-3608. doi: 10.1111/jan.14585. Epub 2020 Oct 3.
Clinical trial NCT01244529: Comparison of Lens Fit and Lens Power of a New Contact Lens to Two Marketed Contact Lenses in a Population of Soft Contact Lens Wearers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myopia
Lead sponsor: Johnson & Johnson Vision Care, Inc.
Sponsor class: INDUSTRY
First posted: 2010-11-19
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: The purpose of this study is to evaluate the comparability of lens fit and lens power of a new contact lens to the lens fit and lens power of two marketed lenses.


Eligibility criteria: Inclusion Criteria:

* Must be at least 18 years of age and no more than 55 years of age.
* Must sign written informed consent.
* Optimal spherical equivalent distance correction must be between -1.00 and -6.00 diopters.
* Have spectacle astigmatism ≤ -0.75 diopter cylinder in both eyes.
* Must have visual acuity best correctable to 20/25+3 or better for each eye.
* Must appear able and willing to adhere to the instructions set forth in this clinical protocol.
* Have normal eyes with no evidence of abnormality or disease. For the purposes of this study a normal eye is defined as one having: No evidence of lid abnormality or infection; No conjunctival abnormality or infection; No clinical significant slit lamp findings, (i.e., oedema, staining, scarring, vascularization, infiltrates or abnormal opacities); No other active ocular disease.
* The subject is a current spherical soft contact lens wearer (defined as a minimum of 6 hours of daily wear for a minimum of 1 month prior to the study) and willing to wear the study lenses on a daily wear basis (defined as a minimum of 6 hours of wear per day at least five days of the week) for the duration of the study.

Exclusion Criteria:

* Any systemic illness which would contraindicate lens wear or the medical treatment of which would affect vision or successful lens wear.
* Any previous eye surgery involving the anterior segment.
* Pre-existing ocular disease that would preclude contact lens fitting.
* Abnormal lacrimal secretions.
* Keratoconus or other corneal irregularity.
* Pregnancy, lactating or planning a pregnancy at the time of enrollment.
* Participation in any concurrent clinical trial.
* Subject's habitual contact lens type is toric or multifocal.
* Require any concurrent ocular medication.

Primary outcomes:
measure: Lens Centration Acceptance
timeFrame: after 15 minutes of contact lens wear
measure: Primary Gaze Lens Movement
timeFrame: after 15 minutes of contact lens wear
measure: Fit Acceptability
timeFrame: after 15 minutes of contact lens wear
Secondary outcomes:
measure: New Lens Power Fit Match to Control Lenses
timeFrame: after 15 minutes of contact lens wear
Other outcomes:
Locations:
city: Farnham
country: United Kingdom
state: Surrey
city: Birmingham
country: United Kingdom
Study officials:
References:
Clinical trial NCT01357629: Observational Follow-up Extension Study of AFF002 and AFF004A in Patients With Alzheimer's Disease
Official title: Observational Follow-up Extension Study to Evaluate Long-term Safety and Tolerability of Immunizations With AFFITOPE AD02 Applied During AFFiRiS002 and AFF004A in Patients With Alzheimer's Disease
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Alzheimer´s Disease
Keywords: Vaccination follow-up
Lead sponsor: Affiris AG
Sponsor class: INDUSTRY
First posted: 2011-05-23
Enrollment: 11
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with Alzheimer´s Disease

Brief summary: This study examines the long term Safety Follow-up of first patients vaccinated with AD02.

Detailed description: Patients who have received AD02 during AFF002 and AFF004A will be observed.

Eligibility criteria: Inclusion Criteria:

* participation in AFF002 and AFF004A

Exclusion Criteria:

* no vaccination with AD02

Primary outcomes:
measure: Safety
timeFrame: up to 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Studienzentrum der PROSENEX Ambulatoriumsbetriebs GmbH
city: Wien
country: Austria
facility: Univ. Klinik für Psychiatire und Psychotherapie
Study officials:
affiliation: Sponsor GmbH
name: Achim Schneeberger, MD
role: STUDY_DIRECTOR
affiliation: Medical University Vienna
name: Siegfried Kasper, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05281029: Observational Study Gemigliptin in Patients Aged ≥ 65 Years With Type 2 Diabetes Mellitus
Official title: A Multicenter, Single-arm, Prospective Observational Study to Evaluate the Safety and Effectiveness of Gemigliptin (as Monotherapy or as Single Pill Combinations) in Patients Aged ≥ 65 Years With Type 2 Diabetes Mellitus
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Type 2 Diabetes Mellitus
Lead sponsor: LG Chem
Sponsor class: INDUSTRY
First posted: 2022-03-15
Enrollment: 3000
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Primary care clinic, secondary and tertiary hospital

Brief summary: The aim of this study is to evaluate safety and effectiveness of treatment with gemigliptin for 24 weeks in Korean patients aged ≥ 65 years with type 2 diabetes mellitus in routine clinical settings


Eligibility criteria: Inclusion Criteria:

* Patients who have been started on gemigliptin in accordance with the approved label and who have signed on the consent form

Exclusion Criteria:

* Patients with previous exposure to gemigliptin and current participation in clinical trials

Primary outcomes:
measure: Change from Baseline of HbA1c at 24 weeks
timeFrame: Baseline, 24 weeks
Secondary outcomes:
measure: Change from Baseline of HbA1c at 12 weeks
timeFrame: Baseline, 12 weeks
measure: The rate of subjects who reached the target value of less than 7% (reasonable HbA1c goal) of HbA1c.
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Severance Hospital
Study officials:
References:
Clinical trial NCT01482429: Evaluation of a Systematic Approach to Weaning From Mechanical Ventilation
Official title: Implantation of a Multidisciplinary Ventilator-weaning Protocol in a Intensive Care Unit of Teaching Hospital of Federal University of Uberlandia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Weaning Failure
Complication of Respirator [Ventilator]
Keywords: ventilator weaning
protocol
Lead sponsor: Federal University of Uberlandia
Sponsor class: OTHER
First posted: 2011-11-30
Enrollment: 235
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: Prolongation of mechanical ventilation poses serious personal and financial threats to healthcare consumers.

The investigators objectives are create and implement an multidisciplinary evidenced-based ventilator-weaning protocol to assess whether a systematic approach compared with the physician's judgment only decreases time spent on the ventilator, complications of mechanical ventilation and length of stay in critical care unit.


Eligibility criteria: Inclusion Criteria:

* remain in mechanical ventilation for more than 24 hours
* begin weaning from mechanical ventilation

Exclusion Criteria:

* admitted in the unit already in weaning from mechanical ventilation

Primary outcomes:
measure: Mortality
timeFrame: length of ICU stay (days)
measure: Duration of Weaning From Mechanical Ventilation
timeFrame: days
measure: Duration of Mechanical Ventilation
timeFrame: days
measure: Length of Intensive Care Unit Stay
timeFrame: days
Secondary outcomes:
Other outcomes:
Locations:
city: Uberlandia
country: Brazil
facility: Federal University of Uberlandia
state: Minas Gerais
Study officials:
affiliation: Federal University of Uberlandia
name: Liliane Barbosa da Silva Passos
role: PRINCIPAL_INVESTIGATOR
affiliation: Federal University of Uberlandia
name: Thulio Marquez Cunha
role: STUDY_CHAIR
affiliation: Federal University of Uberlandia
name: Carlos Henrique Alves de Rezende, MD
role: STUDY_CHAIR
References: