louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02481115: Validation of the PreSchool Confusion Assessment Method for the Intensive Care Unit (psCAM-ICU)
Official title: Pediatric Delirium in Infants and Young Children: Validation of the PreSchool Confusion Assessment Method for the Intensive Care Unit (psCAM-ICU)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Delirium
Cognitive Impairment
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
First posted: 2015-06-25
Enrollment: 300
Sex: ALL
Minimum age (years): 6
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Critically ill pediatric patients at least 6 months to children 5 years of age, both on and off mechanical ventilation

Brief summary: The investigators hypothesize that critical care trained registered nurses and physicians can perform measurements of cognitive impairment in critically ill pediatric patients in a reliable and valid manner. To test this hypothesis, the investigators will incorporate an instrument (psCAM-ICU) to assess both components of consciousness, arousal and content, in critically ill pediatric patients at least 6 months to children 5 years of age, both on and off mechanical ventilation, and compare these assessments to those of the reference standard.


Eligibility criteria: Inclusion Criteria:

* All patients admitted to the Pediatric Critical Care Unit regardless of admitting diagnosis aged at least 6 months of age up to 5 years of age.
* Patients ventilated or non-ventilated.

Exclusion Criteria:

* Non-English speaking patients.
* Children with visual or hearing impairments.
* Patient/surrogate or physician refusal
* Moribund and not expected to survive \>48 hours
* Patients in whom comfort care orders have been instituted
* Patients who are identified for transfer to floor or home regardless of placed orders or bed availability

Primary outcomes:
measure: Validation of psCAM-ICU
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Secondary outcomes:
measure: Inter-rater reliability of diagnosing delirium
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 2 weeks
measure: Validation of the Richmond Agitation Sedation Scale (RASS)
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 2 weeks
measure: Validation of the Withdrawal Assessment Tool-1 (WAT-1)
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 2 weeks
measure: Long-term cognitive impairment composite
timeFrame: 1 year
Other outcomes:
Locations:
Study officials:
affiliation: Vanderbilt University School of Medicine
name: Heidi Smith, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00497315: Evaluation of Pemetrexed Combined With Cisplatin and Radiotherapy for Unresectable Locally Advanced Non-Small Cell Lung Cancer (NSCLC)
Official title: A Randomized Multicenter Phase II Study Of Induction Therapy With Pemetrexed And Cisplatin Followed By Chemoradiation With Pemetrexed Versus Chemoradiation With Pemetrexed Followed By Consolidation Therapy With Pemetrexed And Cisplatin In Patients With Stage III Non-Small Cell Lung Cancer: Paccora Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Non-Small Cell Lung Cancer
Keywords: Non-Small Cell Lung Cancer
NSCLC
Chemoradiation
locally advanced NSCLC
pemetrexed
lung cancer
Lead sponsor: University Hospital, Antwerp
Sponsor class: OTHER
Collaborators: name: Universiteit Antwerpen
name: Eli Lilly and Company
First posted: 2007-07-06
Enrollment: 30
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 aim of this study is to evaluate if the multi modality treatment pemetrexed combined with cisplatin and radiotherapy can lead to a better tumor control and/or a better side-effect profile in patients with locally advanced NSCLC. Patients will be randomized between 3 cycles of induction chemotherapy followed by concurrent chemoradiotherapy or concurrent chemoradiotherapy followed by 3 cycles of adjuvant combination chemotherapy.


Eligibility criteria: Inclusion Criteria:

* cytological or histological proven NSCLC
* unresectable stage III NSCLC
* presence of at least one measurable lesion (RECIST criteria)
* adequate haematological, renal and hepatic function
* adequate lung function reserve
* good condition, weight loss \<10 % over previous 6 months, life expectancy \> 3 months

Exclusion Criteria:

* previous chemo- or radiotherapy for NSCLC
* distant metastasis or a malignant pleural or pericardial effusion
* second active primary malignancy or serious concomitant medical disease
* interstitial lung disease
* auto-immune systemic disease with potential involvement of the lungs
* inability to interrupt aspirin or other non-steroidal anti-inflammatory agents for a 5-day period
* concomitant use of amiodarone

Primary outcomes:
measure: Response rate
timeFrame: after each treatment modality and 5 year follow-up
Secondary outcomes:
measure: Toxicity
timeFrame: at the end of each cycle and 5 year follow-up
measure: Time to progression
timeFrame: 5 year follow-up
measure: Overall survival
timeFrame: median survival and 2-year survival
Other outcomes:
Locations:
city: Antwerpen
country: Belgium
facility: ZNA Middelheim
state: Antwerp
city: Edegem
country: Belgium
facility: University Hospital Antwerp
state: Antwerp
city: Wilrijk
country: Belgium
facility: St Augustinus Ziekenhuis
state: Antwerp
Study officials:
affiliation: Universiteit Antwerpen
name: Paul R Germonpre, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00805415: Ovulation Inhibition of Two 4-phasic Oral Contraceptive Regimens
Official title: Multicenter, Open-label, Randomized, Comparative Study to Evaluate Ovulation Inhibition With Two 4-phasic Oral Contraceptive Regimens Containing Estradiol Valerate and Dienogest Applied Daily for Three Cycles to 200 Healthy Female Volunteer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Ovulation Inhibition
Keywords: Oral Contraceptive
Ovulation Inhibition
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2008-12-09
Enrollment: 209
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of the study is to investigate the ovulation inhibition of two 4-phasic oral contraceptive regimens.


Eligibility criteria: Inclusion Criteria:

* Healthy women willing to use non-hormonal methods of contraception

Exclusion Criteria:

* Women with any contraindication for oral contraceptive use, for example but not limited to: presence or history of venous or arterial thrombotic / thrombembolic events, hypertension, presence or history of severe hepatic disease

Primary outcomes:
measure: Proportion of subjects with a Hoogland score of 5-6 (luteinized unruptured follicle [LUF] or ovulation)
timeFrame: Treatment cycles 2 and 3
Secondary outcomes:
measure: Proportion of subjects with a Hoogland score of 5-6 (LUF or ovulation)
timeFrame: Treatment cycles 2 or 3
measure: Measurements of endometrial thickness
timeFrame: Treatment cycles 2 and 3
measure: Visibility of cervical mucus
timeFrame: Treatment cycles 2 and 3
measure: Ovarian activity (Hoogland score)
timeFrame: Posttreatment cycle (only subjects from center 2)Treatment cycles 2 and 3
measure: Measurements of follicle size
timeFrame: Treatment cycles 2 and 3
measure: Measurements of hormone levels (follicle-stimulating hormone [FSH], luteinizing hormone [LH], progesterone and estradiol)
timeFrame: Treatment cycles 2 and 3
measure: Compliance
timeFrame: Throughout whole study
measure: Medical, surgical and medication history, concomitant medication, general physical and gynecological examination, cervical smear, pregnancy test, adverse events, safety laboratory determinations, cycle control, vital signs
timeFrame: Various timepoint throughout the study
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Dinox GmbH Berlin
city: Groningen
country: Netherlands
facility: Dinox B.V.
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT01994915: Effects of Occupational Therapy in COPD
Official title: Effects on Functionality of Occupational Therapy Added to Physiotherapy in Severe COPD Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: exacerbation
functionality
occupational therapy
chronic obstructive pulmonary disease
Lead sponsor: Universidad de Granada
Sponsor class: OTHER
First posted: 2013-11-26
Enrollment: 35
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: Chronic obstructive pulmonary disease is a chronic condition involving an impairment in functionality and in the execution of activities of daily life. The hypothesis of this study is that an occupational therapy intervention added to a physiotherapy program and a medical treatment increase the functionality and the quality of life of patients with chronic obstructive pulmonary disease.

Detailed description: The evolution of chronic obstructive pulmonary disease can be aggravated in some periods by an increase of the symptoms (above all, the cough, the dyspnea and the quantity of sputum purulence). This is known as exacerbation, and it is the most frequent reason for hospital stay, urgences services and death in this condition. A physiotherapy program and an occupational therapy intervention are carrying out in patients attending to the Hospital because of an exacerbation.. Participants will be assessed at baseline and again at the end of the study.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of chronic obstructive pulmonary disease with exacerbation.
* No contraindication of physiotherapy.
* Signed written consent.
* Medical approval for inclusion

Exclusion Criteria:

* Heart disease.
* Neurological patients.
* Contraindications of physiotherapy.
* Nursing home residents.
* Cognitive impairments.

Primary outcomes:
measure: Functionality
timeFrame: Baseline, 12 months
measure: Quality of life
timeFrame: Baseline, 12months
Secondary outcomes:
measure: Anxiety and depression
timeFrame: Baseline, 12 months
measure: Activity levels
timeFrame: Baseline, 12 months
measure: Dyspnoea
timeFrame: baseline, 12 months
Other outcomes:
Locations:
city: Granada
country: Spain
facility: Department of Physical Therapy
Study officials:
affiliation: Universidad de Granada
name: Marie Carmen Valenza, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02063815: A Trial of Caries Prevention Effect of Fissure Sealants
Official title: A Randomized Controlled Trial of Caries Prevention Effect of a Glass Ionomer Sealant Versus a Resin Sealant
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Caries Prevention
Fissure Sealant
Fluoride Concentration
Glass Ionomer Cement
Resin
Lead sponsor: Marmara University
Sponsor class: OTHER
First posted: 2014-02-14
Enrollment: 40
Sex: ALL
Minimum age (years): 6
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this randomized clinical trial was to compare caries prevention of a conventional resin-based sealant and a glass-ionomer sealant placed on occlusal pits and fissures over a one year period in a high caries children group. Additionally the concentration of Fluoride in saliva was evaluated.


Eligibility criteria: Inclusion Criteria:

* 1.Age range of 6 to 10 years 2.Having caries free, fully erupted first permanent molars 3.Deep and/or intermediate pits or fissures 4.dft ≥ 2

Exclusion Criteria:

* 1.Having any systemic disease 2.Topical fluoride was applied last six months 3.dft = 0

Primary outcomes:
measure: Change from Baseline in Fluoride concentration of saliva
timeFrame: 1 week, 6. months, 12. months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03086915: Myorelaxation Practice in Paediatric Anesthesia
Official title: Myorelaxation Practice in Paediatric Anesthesia: Retrospective Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neuromuscular Blockade
Keywords: neuromuscular blockade
muscle relaxation
muscle relaxant
Lead sponsor: Brno University Hospital
Sponsor class: OTHER
Collaborators: name: Masaryk University
First posted: 2017-03-22
Enrollment: 1650
Sex: ALL
Maximum age (years): 20
Standard ages: CHILD
ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Paediatric anesthesiology patients who underwent surgery with neuromuscular blocking agent administered during surgery in tertiary center paediatric anesthesiology department

Brief summary: In retrospective data search the investigators will identified the percentage of patients with muscle relaxants administered during perioperative period. The block reversal, typ of drug, percentage of cases with and without reversal will be identified.

Detailed description: The actual percentage of surgeries with the muscle relaxants administered during perioperative period in paediatric patients remain unclear because many surgeries are being performed without muscle relaxation. In this retrospective study, the anesthesiology perioperative data from January 2016 till December 2016 in the tertiary center od Pediatric anesthesia will be searched for the percentage of surgeries with muscle relaxants administered. Type of surgery, age, weight, duration u surgery, muscle relaxants drug and percentage of block reversal will be identified.

Eligibility criteria: Inclusion Criteria:

* paediatric patients
* the study period (1/2016-12/2016)
* neuromuscular blocking agent administration during surgery

Exclusion Criteria:

* surgery without neuromuscular blockade

Primary outcomes:
measure: Percentage of neuromuscular block reversal
timeFrame: 1 year
Secondary outcomes:
measure: Percentage of surgeries without muscle relaxant administration
timeFrame: 1 year
measure: Type of neuromuscular blocking agent in paediatric anesthesiology practice
timeFrame: 1 year
Other outcomes:
Locations:
city: Brno
country: Czechia
facility: Brno University Hospital
Study officials:
References:
Clinical trial NCT06762015: Nursing Practice Environment and Patient Safety in Primary Health Care
Official title: Practice Environment for Nursing and Patient Safety in Primary Health Care
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Healthy Work Environment
Patient Safety
Primary Health Care
Keywords: Healthy Work Environment
Patient Safety
Primary Health Care
Nurses
Lead sponsor: Rio de Janeiro State University
Sponsor class: OTHER
Collaborators: name: CINTESIS - Center for Health Technology and Services Research, Porto
name: Universidade do Porto
First posted: 2025-01-07
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The goal of this study is to conduct an experimental, controlled, and randomized study, which will involve two data collection points - pre-intervention, post-intervention and a follow-up to asses the impact of the program. The study will be carried out with two groups - an intervention group and a control group, consisting of nurses interested in participating in the Positive Nursing Practice Environments Promotion Program (PAPEP), a multi-component intervention program aimed at promoting positive nursing practice environments. Participant allocation will be conducted randomly, using software to ensure stratified randomization of participants between the two groups.


Eligibility criteria: Inclusion Criteria:

* Nurses working in primary health care units

Exclusion Criteria:

* Nurses in primary health care who refuse to participate in the study

Primary outcomes:
measure: Work Environment
timeFrame: 6 months
measure: Safety climate
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Santa Maria da Feira
country: Portugal
facility: ULS Entre Douro e Vouga
state: Aveiro
Study officials:
References:
Clinical trial NCT04160715: Korean Idiopathic Pulmonary Fibrosis Registry
Official title: Korean Idiopathic Pulmonary Fibrosis Registry
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Idiopathic Pulmonary Fibrosis
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2019-11-13
Enrollment: 3000
Sex: ALL
Minimum age (years): 30
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients with IPF

Brief summary: This is a multicenter prospective registry of IPF patients in South Korea. The Seoul National University Bundang Hospital is the coordination center for the Korean IPF Registry built by a collaboration of the Korean Interstitial Lung Diseases (ILD) Study Group.

Detailed description: Korean ILD Study Group includes investigators of 30 hospitals. Demographic, pulmonary function, laboratory data, chest CT findings and hospital course of IPF patients are collected.

Eligibility criteria: Inclusion Criteria:

* IPF patients diagnosed by multidisciplinary discussion

Exclusion Criteria:

* Other interstitial lung diseases except for IPF
* connective tissue disease-related ILD
* exposure-related ILD

Primary outcomes:
measure: survival of IPF
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: survival
timeFrame: through study completion, an average of 1 year
measure: acute exacerbation
timeFrame: through study completion, an average of 1 year
measure: incidence of comorbidity
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
Study officials:
affiliation: Samsung Medical Center
name: Man Pyo Chung, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Moon SW, Kim SY, Chung MP, Yoo H, Jeong SH, Kim DS, Song JW, Lee HL, Choi SM, Kim YW, Kim YH, Park CS, Park SW, Park JS, Jegal Y, Lee J, Uh ST, Kim TH, Lee JH, Kim YH, Shin B, Lee HK, Yang SH, Lee H, Kim SH, Lee EJ, Choi HS, Shin H, Park YB, Shin JW, Park MS. Longitudinal Changes in Clinical Features, Management, and Outcomes of Idiopathic Pulmonary Fibrosis. A Nationwide Cohort Study. Ann Am Thorac Soc. 2021 May;18(5):780-787. doi: 10.1513/AnnalsATS.202005-451OC.
Clinical trial NCT05269615: Exercise-induced Erythropoiesis: the Mechanistic of Angiotensin II
Official title: Exercise-induced Erythropoiesis: the Mechanistic of Angiotensin II
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Exercise Physiology
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
First posted: 2022-03-08
Enrollment: 80
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The major aims are to determine the effect of acute (single dose) blockade of ANGII receptor 1 (AT1) on the EPO response to a single session of endurance exercise, as well as determine the effect of chronic (8-week) blockade of AT1 on ET-induced adaptations in total circulating red blood volume and hemoglobin.

Detailed description: Physical activity, particularly when comprised of endurance training (ET) leading to cardiovascular adaptations, is considered the most effective intervention to augment life expectancy. Major health benefits induced by ET are closely associated (independently of traditional risk factors) with improvements in maximal oxygen consumption (VO2max), a hallmark of aerobic exercise capacity. The higher the VO2max the greater the likelihood to be free of cardiovascular disease, the main cause of mortality worldwide. Understanding the mechanisms explaining the improvement in VO2max with ET can provide sound basis for highly effective lifestyle and pharmacological interventions aimed to enhance cardiovascular health in the general population. So far, the essential role of ET-induced increased formation of red blood cells, i.e., erythropoiesis, has been firmly established for any improvement in VO2max. Yet, the underlying mechanism remains elusive. Clinical studies and recent investigations by the PI point towards the endocrine effects of key hormones that regulate blood volume (BV). Notably, the impact of ET-induced changes in angiotensin II (ANGII), a multifaceted hormone that modulates erythropoiesis through its effects on kidney erythropoietin (EPO) production, has to be experimentally elucidated in humans.

Eligibility criteria: Inclusion Criteria:

* Healthy status, absence of current medical symptoms or medication limiting incremental exercise testing
* No history of cardiac, pulmonary or kidney disease.

Exclusion Criteria:

- Individuals fulfilling the above criteria but currently involved in regular exercise training (\> 5 hr/week)

Primary outcomes:
measure: stroke volume in ml/m2
timeFrame: 10 weeks
measure: maximal oxygen consumption in ml/kg/min
timeFrame: 10 weeks
measure: Blood volume (BV)-regulating hormone: Plasma ANGII in ng/dL
timeFrame: 10 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: School of Public Health
Study officials:
References: