louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00258518: Respiratory Mechanics and Pleural Effusion
Official title: Estimation of Respiratory Mechanics (Respiratory System, Chest Wall and Lung Elastance) and Pleural Effusion at the Bedside With CT Scan.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Critically Ill
Acute Lung Injury
ARDS
Keywords: Critically ill patients
Lead sponsor: Policlinico Hospital
Sponsor class: OTHER
First posted: 2005-11-24
Enrollment: 60
Sex: ALL
Minimum age (years): 16
Maximum age (years): 90
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: ALI/ARDS patients

Brief summary: The investigators aim to compare the respiratory mechanics in acute lung injury (ALI)/acute respiratory diseases syndrome (ARDS) patients with and without pleural effusion.

Detailed description: In ALI/ARDS we evaluated the respiratory mechanics (respiratory system, chest wall and lung elastance) at the bedside while pleural effusion was evaluated with CT scan. Thus we will be able to estimate any possible role of pleural effusion on the respiratory mechanics.

Eligibility criteria: Inclusion Criteria:

* ALI/ARDS patients underwent invasive mechanical ventilation

Exclusion Criteria:

* Haemodynamic instability
* Chronic obstructive pulmonary disease (COPD) patients

Primary outcomes:
measure: Role of pleural effusion and respiratory mechanics
timeFrame: 1 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Milano
country: Italy
facility: Policlinico Hospital
Study officials:
affiliation: Policlinico Hospital
name: Davide Chiumello, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04761718: Covid-19 Epidemic Lockdown Impact on Psychomotor Performance
Official title: Covid-19 Epidemic Lockdown Impact on Psychomotor Performance in Egyptian Children
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Covid19 Epidemic Lockdown Impact
Lead sponsor: Delta University for Science and Technology
Sponsor class: OTHER
First posted: 2021-02-21
Enrollment: 300
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Participants will be randomly selected from all provinces in Egypt.

Brief summary: PURPOSE:

To detect the Covid-19 Epidemic Lockdown impact on Psychomotor performance in Egyptian Children.

BACKGROUND:

The corona virus disease (COVID-19) affected virtually all countries including Egypt as records showed 156,397 subjects including all age groups, Adolescents and children represent sector in the records, lockdown can contribute to widespread psychological distress and an increased risk of physical inactivity consequences shortly. Psychomotor disorders are expected during and aftermath of the pandemic. Validated Questionnaires are tools to assess the psychomotor condition during and after pandemic lockdown as safe and valid assessment tool.

HYPOTHESES:

Covid-19 Epidemic Lockdown has an impact on Psychomotor performance in Egyptian Children.

RESEARCH QUESTION:

Does Covid-19 Epidemic Lockdown impact on Psychomotor performance in Egyptian Children?


Eligibility criteria: Inclusion Criteria:

100 participants will be chosen according to the following criteria : subject in both sexes and their age will ranged between

1. 6-9 years.
2. 10-13 years.
3. 14-18 years All subjects should be clinically and medically stable

Exclusion Criteria:

Subjects with psychological or Motor impairment will be excluded from the study.

Primary outcomes:
measure: pre lockdown assessment for physical activity
timeFrame: up to 24 weeks
measure: post lockdown assessment for physical activity
timeFrame: up to 24 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: AAA
Study officials:
References:
Clinical trial NCT01076218: Navigator 1.5 Accuracy Study
Official title: In Clinic Evaluation of the FreeStyle Navigator® Continuous Glucose Monitoring System Version 1.5
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus
Keywords: Continuous Glucose Monitoring
Accuracy
Continuous Glucose Error-Grid Analysis
Lead sponsor: Abbott Diabetes Care
Sponsor class: INDUSTRY
First posted: 2010-02-26
Enrollment: 57
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 with type 1 diabetes requiring multiple daily insulin injections or using an insulin pump

Brief summary: The purpose of the study is to confirm that the accuracy and safety of Version 1.5 of the FreeStyle Navigator Continuous Glucose Monitoring System are not impacted by the updates to the system algorithm and minor changes to the user interface and sensor delivery unit, such as adhesive sterilization method. It is anticipated that information collected will be submitted as a supplement to Premarket Approval Application (P050020) to the US Food and Drug Administration for approval to market this version of the system.


Eligibility criteria: Inclusion Criteria:

* History consistent with Type 1 diabetes for at least 2 years prior to enrollment;
* For at least 6 months prior to enrollment, insulin pump user or multiple daily insulin injections;
* At least 18 years of age;
* Available and capable of following the protocol instructions provided by the healthcare professional;
* Signed and dated Informed Consent form.

Exclusion Criteria:

* Pregnancy;
* Type 2, gestational, or secondary diabetes;
* Known allergy to medical grade adhesives or skin disinfectant;
* Skin abnormalities at the insertion sites that would confound the assessment of the effect of the device on the skin;
* Blood donation within 6 weeks prior to beginning study activities;
* Within past 6 months, severe hypoglycemic episode(s) resulting in hospitalization or loss of consciousness;
* Active myocardial ischemia;
* Previous history of stroke;
* Any other concomitant medical condition that in the opinion of the principal investigator would likely affect the evaluation of device performance and/or safety;
* Current participation in another clinical trial.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Walnut Creek
country: United States
facility: Diablo Clinical Research
state: California
city: Renton
country: United States
facility: Rainier Clinical Research
state: Washington
Study officials:
affiliation: Abbott Diabetes Care
name: Shridhara K Alva
role: STUDY_DIRECTOR
References:
Clinical trial NCT03442218: Use of Antiseptic Solution for Vaginal Wash Before Cesarean Section
Official title: Use fo Antiseptic Solution for Vaginal Wash Before Cesarean Section in Patients With Premature Rupture of Membranes. A Randomized, Double Blind, Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Operation Wound; Infection
Endometritis
Keywords: Cesarean
Operative site infection
Vaginal wash
Clorhexidine
Endometritis
Lead sponsor: Saint Thomas Hospital, Panama
Sponsor class: OTHER
Collaborators: name: Sistema Nacional de Investigación (SNI) - Panamá
First posted: 2018-02-22
Enrollment: 203
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: To evaluate the rate of infections after cesarean sections in patients with premature rupture of membranes after vaginal wash either with an antiseptic solution (clorhexidine solution) vs. saline solution (placebo).


Eligibility criteria: Inclusion Criteria:

* Women with gestation between 34 and 41 6/7 weeks.
* Premature rupture of membranes (\> 6 hours).
* Use of prophylactic antibiotic 1 hour previous to cesarean section.

Exclusion Criteria:

* Any source of infection diagnosed previous to surgery.
* Fever of unknown origin previous to surgery.

Primary outcomes:
measure: Number of cases of endometritis after cesarean section
timeFrame: 15 days
Secondary outcomes:
measure: Number of cases of cesarean site infection
timeFrame: 15 days
measure: Number of cases of fever (38°C or above) in the puerperium
timeFrame: 15 days
Other outcomes:
Locations:
city: Panama
country: Panama
facility: Saint Thomas Maternity Hospital
Study officials:
References:
citation: Urena N, Reyes O. Preoperative vaginal cleansing with chlorhexidine vs placebo in patients with rupture of membranes: a prospective, randomized, double-blind, placebo-control study. Am J Obstet Gynecol MFM. 2022 Mar;4(2):100572. doi: 10.1016/j.ajogmf.2022.100572. Epub 2022 Jan 17.
citation: Haas DM, Morgan S, Contreras K, Kimball S. Vaginal preparation with antiseptic solution before cesarean section for preventing postoperative infections. Cochrane Database Syst Rev. 2020 Apr 26;4(4):CD007892. doi: 10.1002/14651858.CD007892.pub7.
Clinical trial NCT01518218: Effectiveness of Laying-on-of-hands for Sickle Cell Disease
Official title: Effectiveness of Laying-on-of-hands for Patients With Sickle Cell Disease in Africa
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Sickle Cell Disease
Pain Crisis Recurrent
Anemia
Infection
Death
Keywords: Sickle cell disease
laying-on-of-hands
morbidity
mortality
Lead sponsor: MOA Health Science Foundation
Sponsor class: OTHER
First posted: 2012-01-25
Enrollment: 40
Sex: ALL
Minimum age (years): 3
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The objective of this study is to evaluate the effectiveness of 1-year administration of laying-on-of-hands on the morbidity and mortality of patients with sickle cell disease in Africa.

Detailed description: Patients with sickle cell disease (SCD) have a high risk of premature death in Africa, mainly due to insufficient medical services. SCD patients often visit emergency department and need hospitalization when they suffer from severe pain; however, they manage most of painful episodes at home. Appropriate pain management at home is, therefore, crucial to improve their clinical course and quality of life. Laying-on-of-hands may be a good candidate for home care management, because family member(s) can become a practitioner of laying-on-of-hands without difficulty and administer it to their loved one as an initial treatment whenever necessary. There are no reports concerning the effectiveness of laying-on-of-hands for the outcomes of SCD patients, as far as we have investigated.

Eligibility criteria: Inclusion Criteria:

* patients with symptoms associated with sickle cell disease
* those able to receive laying-on-of-hands every weekday for 1 year
* those able to receive conventional medical treatment whenever necessary
* those able to receive blood test at the beginning, after 6 month and after 1 year

Exclusion Criteria:

* those who wish to use other complementary and alternative therapies along with laying-on-of-hands

Primary outcomes:
measure: disease-related episodes and mortality
timeFrame: 3 years and 9 months
Secondary outcomes:
measure: blood data
timeFrame: 1 year
Other outcomes:
Locations:
city: Kinshasa
country: Congo, The Democratic Republic of the
facility: The national medical center for sickle cell disease
Study officials:
affiliation: The Institute of Scientific Research for Health, Kinshasa
name: Kodondi K Koto, MD, PhD
role: STUDY_DIRECTOR
References:
citation: Minga TM, Koto FK, Egboki H, Suzuki K. Effectiveness of biofield therapy for individuals with sickle cell disease in Africa. Altern Ther Health Med. 2014 Jan-Feb;20(1):20-6.
Clinical trial NCT05576818: Effect of Synbiotic as an Adjuvant Therapy in the Treatment of Parkinson's Disease
Official title: Clinical Study Evaluating the Efficacy and Safety of Synbiotic as an Adjuvant Therapy in the Treatment of Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Parkinson's Disease
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2022-10-13
Enrollment: 66
Sex: ALL
Minimum age (years): 45
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to investigate the possible efficacy and safety of synbiotic preparation of Lactobacillus acidophilus probiotic with prebiotic fibers as an adjuvant therapy in the treatment of Parkinson's disease


Eligibility criteria: Inclusion Criteria:

* Age between 45 and 65 years old
* Both sexes
* Patients with Parkinson's disease on dopamine replacement therapy
* Modified Hoehn and Yahr stage, MHY 1-4

Exclusion Criteria:

* Patients who are currently using or used antibiotics therapy in the preceding month
* Patients who are currently using or used other probiotic products in the preceding two weeks
* Patients scheduled to undergo GIT surgery or those underwent GIT surgery
* Patients with Known allergy to probiotics
* Patients receiving artificial enteral or intravenous nutrition
* Patients with depression and/or psychosis
* Patients taking antioxidant and/or anti-inflammatory medications
* Patients with Hyperthyroidism
* Patients with inflammatory condition and/or condition involving oxidative stress
* Smokers
* Modified Hoehn \& Yahr stage MHY 5

Primary outcomes:
measure: The change in MDS-Unified Parkinson's Disease Rating Scale.
timeFrame: 3 months
Secondary outcomes:
measure: The change in the serum level of α-Synuclein
timeFrame: 3 months
measure: The change in the serum level of Tumor necrosis factor α (TNF α )
timeFrame: 3 months
measure: The change in the serum level of Brain derived neurotrophic factor ( BDNF)
timeFrame: 3 months
measure: The change in the serum level of Malondialdehyde (MDA)
timeFrame: 3 months
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Tanta University
state: El Gharbia
Study officials:
References:
Clinical trial NCT05741918: Cardiac Output Measurement in Pediatric Intensive Care Unit by Metabolic Monitor (Fick Method) (PEDIA-FICK-ICU)
Official title: Cardiac Output Measurement in Pediatric Intensive Care Unit by Metabolic Monitor (Fick Method) : Prospective Feasibility Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Intensive Care Units, Pediatric
Keywords: Cardiac output
Oxygen Consumption (VO2)
Fick
Pediatric Intensive Care Unit
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2023-02-23
Enrollment: 20
Sex: ALL
Minimum age (years): 28
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: Cardiac output measurement is one of the most frequently used haemodynamic parameter used for intensive care unit (ICU) patients. In pediatric ICU, it is often measured with echocardiography that is a non-invasive method but is operator dependant and can't provide continuous monitoring.

The goal of this clinical trial is to evaluate the feasibility of cardiac output measurement by Fick's method, non-invasive and allowing continuous monitoring, in comparison to echocardiography in pediatric intensive care unit.


Eligibility criteria: Inclusion Criteria:

* Patient under 18 years old
* Patient over 10 kg
* Patient requiring intubation or intubated with a cuffed tube
* Patient requiring a central venous line in superior vena cava territory

Exclusion Criteria:

* Mechanical ventilation with leak
* Bad echogenicity preventing echocardiography
* Absence of written informed consent
* Patient not affiliated to French Health Insurance or not covered by public health insurance
* Patient with a legal protection

Primary outcomes:
measure: Intra-class correlation (or concordance) between the measurement of cardiac output (in ml/min) by Fick's method and by echocardiography
timeFrame: Up to day 3
Secondary outcomes:
measure: Variations of cardiac output before and after Leg Raise Test
timeFrame: Up to day 3
measure: Adverse events on the day of catheterization
timeFrame: Up to 21 days
measure: Adverse events on the day of catheter removal
timeFrame: Up to 21 days
Other outcomes:
Locations:
city: Montpellier
country: France
facility: UH Montpellier
Study officials:
References:
Clinical trial NCT01501318: Impact of Personalized Feedback Alone on Substance Use Behaviors
Official title: Brief Education to Reduce Health Care Consumers' Risky Substance Use Behaviors: How Brief is Brief?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Substance Abuse
Keywords: SBIRT
brief intervention
alcohol
drug abuse
Lead sponsor: University of Missouri-Columbia
Sponsor class: OTHER
Collaborators: name: University of Missouri, St. Louis
name: Institute of Mental Health, Singapore
First posted: 2011-12-29
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 105
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The investigators seek to develop a more efficient and effective approach to providing brief behavioral health interventions for risky substance use behaviors by comparing a brief coach directed intervention to a tailored report only group.

Detailed description: Screening and brief intervention (SBIRT) generally involves universal screening for risky substance use behaviors in medical settings and the immediate provision of a 3-15 minute intervention to those found to be at risk. In this pilot study, the investigators seek to develop a more efficient and effective approach to providing brief behavioral health interventions in the field by comparing a brief coach directed intervention to a tailored report only group. The goal is to create a cost-effective and sustainable system that provides consumers with tailored information that will help them both initiate and sustain the lifestyle changes necessary for improving their overall health.

Hypothesis 1: In a medical setting, personalized feedback alone will be associated with a reduction in risky substance use behaviors.

Hypothesis 2: In a medical setting, personalized feedback alone will have the same impact on behavior as that information plus a brief coach education session on risky substance use behaviors..

Eligibility criteria: Inclusion Criteria:

* Low level risky substance use

Exclusion Criteria:

* high substance use risk levels
* potential alcohol or drug addiction or dependence

Primary outcomes:
measure: Substance use behaviors and consequences
timeFrame: 1 month follow-up
Secondary outcomes:
measure: Substance use behavioral intentions
timeFrame: 1 month follow-up
Other outcomes:
Locations:
city: Columbia
country: United States
facility: University of Missouri Hospital ER
state: Missouri
Study officials:
affiliation: Missouri Institute of Mental Health
name: Matthew G Hile, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01025518: DAHANCA 25A: Resistance Training and Dietary Supplements as Intervention for Regaining Muscle Mass Following Radiotherapy in Head and Neck Cancer Patients
Official title: A Randomized Trial Evaluating Resistance Training and Dietary Supplements as Intervention for Regaining Muscle Mass Following Radiotherapy in Head and Neck Cancer Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Head and Neck Neoplasms
Keywords: Head and Neck Neoplasms
Resistance training
Muscle mass
Functional capacity
Lead sponsor: Danish Head and Neck Cancer Group
Sponsor class: NETWORK
Collaborators: name: Danish Center for Interventional Research in Radiation Oncology (CIRRO)
First posted: 2009-12-03
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to investigate whether resistance training in combination with dietary supplementation is tolerable among head and neck cancer patients and to evaluate the possible effect on muscle mass, strength and functional capacity.

Detailed description: Head and neck cancer patients experience a significant loss of muscle mass following radiotherapy treatment due to cachexia and dysphagia. This negatively affects muscle strength and functional capacity.

Studies on healthy individuals and various groups of patients show that resistance training in combination with protein and creatine ingestion is an effective means of increasing muscle mass, strength and functional capacity.

Thus the aim is to investigate the following:

* is resistance training and dietary supplements tolerable among head and neck cancer patients
* the effect of the intervention on muscle mass, strength and functional capacity

Eligibility criteria: Inclusion Criteria:

* head and neck cancer patients (localized to the larynx, pharynx and oral cavity) treated with curative radiotherapy
* complete loss of tumor
* WHO performance status between 0-1 and expected ability to complete the training protocol
* No parenteral feeding
* above the age of 18
* written concent

Exclusion Criteria:

* other malignant diseases
* pregnancy
* undergoing systematic resistance training or creatin ingestion
* Alcohol abuse

Primary outcomes:
measure: Muscle mass and muscle strength
timeFrame: 13 weeks
Secondary outcomes:
measure: Functional capacity
timeFrame: 13 weeks
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Dept. of Experimental Clinical Oncology, Aarhus University Hospital
state: Region Midt
city: Aarhus
country: Denmark
facility: Dept. of Experimental Clinical Oncology
Study officials:
affiliation: DAHANCA
name: Jens Overgaard, Professor, MD
role: STUDY_CHAIR
References:
Clinical trial NCT00339118: EpSSG (European Soft Tissue Sarcoma Study Group) Protocol for Non-Metastatic Rhabdomyosarcoma in Children
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Rhabdomyosarcoma
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
First posted: 2006-06-20
Sex: ALL
Minimum age (years): 6
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The purpose of the study is achieve standardization treatment of low and intermediate risk rhabdomyosarcoma patients, with an attempt to improve treatment results in high and very high risk patients by the addition of doxorubicin as induction treatment and at the maintenance phase.


Eligibility criteria: Inclusion Criteria:

* child
* non metastatic rhabdomyosarcoma
* adequate heart, kidney, liver function

Exclusion Criteria:

* age over 21 years, under 6 months
* metastatic disease
* heart, kidney, liver disease

Primary outcomes:
measure: event free survival
measure: overall survival
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Sheba Medical Center
name: Iris Kventsel, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bisogno G, De Salvo GL, Bergeron C, Gallego Melcon S, Merks JH, Kelsey A, Martelli H, Minard-Colin V, Orbach D, Glosli H, Chisholm J, Casanova M, Zanetti I, Devalck C, Ben-Arush M, Mudry P, Ferman S, Jenney M, Ferrari A; European paediatric Soft tissue sarcoma Study Group. Vinorelbine and continuous low-dose cyclophosphamide as maintenance chemotherapy in patients with high-risk rhabdomyosarcoma (RMS 2005): a multicentre, open-label, randomised, phase 3 trial. Lancet Oncol. 2019 Nov;20(11):1566-1575. doi: 10.1016/S1470-2045(19)30617-5. Epub 2019 Sep 24.