louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05347563: Study on Ventilation Distribution With Electrical Impedance Tomography for Paediatric Respiratory Failure
Official title: Study on Ventilation Distribution With Electrical Impedance Tomography for Paediatric Respiratory Failure: Impact of Intervention
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Acute Respiratory Failure
Keywords: Electrical impedance tomography
Children
Pediatric intensive care unit
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2022-04-26
Enrollment: 250
Sex: ALL
Minimum age (years): 0
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 250 Childrens group A: Patient \< 18 years old admitted to a continuous monitoring unit - resuscitation for acute respiratory failure regardless of the ventilation modality and benefiting from TIE monitoring Group B (reference): Patient under general anesthesia with mechanical ventilation without respiratory pathology.

Brief summary: Electrical impedance tomography (EIT) is a non-invasive, bedside monitoring technique that provides continuous, real-time information about the regional distribution of the ventilation.

There are very few data in children admitted to the PICU (pediatric intensive care unit) and the aim of the study is to describe the distribution of the ventilation in children with acute respiratory failure and to study the impact of the interventions in the PICU (change in ventilatory settings, change in position, suction, respiratory kinesiotherapy,...)

Detailed description: Children with acute respiratory failure admitted to the PICU (pediatric intensive care unit)

Eligibility criteria: Inclusion Criteria:

Groupe A

* children \< 18 years
* Admitted to the PICU with acute respiratory failure
* Monitoring with EIT
* non opposition of parents or legal representative Groupe B
* children \< 18 years
* With general anesthesia and mechanical ventilation
* Monitoring with EIT
* non opposition of parents or legal representative

Exclusion Criteria:

* Monitor not available
* contra indication to the use of thoracic belt
* Intraoperative period with use of electrocautery
* Child not affiliated to a social security system and under protective measures legal

Primary outcomes:
measure: Distribution of Ventilation
timeFrame: up to 48 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Bron
country: France
facility: Hôpital Femme Mère Enfant Service de néonatologie et réanimation néonatale
state: Rhone
city: Bron
country: France
facility: Hôpital Femme Mère Enfant Service de réanimation et d'urgence pédiatrique
state: Rhone
city: Bron
country: France
facility: Paediatric intensive care Unit
state: Rhone
Study officials:
affiliation: Hospices Civils de Lyon
name: Florent Baudin, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00436163: A Study of Peginterferon Alfa-2a (40KD) (PEGASYS®) in Participants With Hepatitis B Envelope Antigen (HBeAg) - Positive Chronic Hepatitis B
Official title: Baltic Post-marketing Program of PEGASYS (Peg Interferon Alpha-2a 40KD) in Patients With HBeAg-positive and HBeAg-negative Chronic Hepatitis B
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hepatitis B, Chronic
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2007-02-16
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This single-arm study will evaluate the efficacy and safety of peginterferon alfa-2a in treatment-naive Baltic participants with Hepatitis B envelope antigen (HBeAg)-positive chronic Hepatitis B virus (HBV). All participants will receive peginterferon alfa-2a 180 micrograms (mcg) subcutaneously once weekly. Following 48 weeks of treatment, there will be a 24 week period of treatment-free follow-up. The anticipated time on study treatment is 3-12 months, and the target sample size is less than 100 participants.


Eligibility criteria: Inclusion Criteria:

* Adult participants, 18-70 years of age;
* HBeAg positive, Hepatitis B surface antigen (HBsAg) positive for greater than or equal to 6 months;
* anti-HBs negative;
* Hepatitis B virus deoxyribonucleic acid (HBV DNA) greater than 5,00,000 copies/milliliters.

Exclusion Criteria:

* Previous antiviral or interferon-based therapy for chronic hepatitis B;
* Evidence of decompensated liver disease;
* Chronic liver disease other than viral hepatitis;
* Co-infection with active hepatitis A, C or D virus;
* Co-infection with human immunodeficiency virus.

Primary outcomes:
measure: Number of Hepatitis B Envelope Antigen (HBeAg) Positive Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV-DNA) Less Than (<) 1,00,000 Copies Per Milliliter (Copies/mL)
timeFrame: Week 72
measure: Number of HBeAg Negative Participants With HBV-DNA < 10,000 Copies/mL
timeFrame: Week 72
Secondary outcomes:
measure: Number of Participants With HBV-DNA < 400 Copies/mL
timeFrame: Week 72
measure: Percentage of Hepatitis B Surface Antigen (HBsAg) Negative Participants
timeFrame: Week 48 and Week 72
measure: Percentage of Anti-HBs Positive Participants
timeFrame: Week 48 and Week 72
measure: Mean Alanine Aminotransferase (ALT) Concentrations
timeFrame: Week 48 and Week 72
measure: Percentage of HBeAg Negative Participants
timeFrame: Week 48 and Week 72
measure: Percentage of Anti-HBe Positive Participants
timeFrame: Week 48 and Week 72
Other outcomes:
Locations:
city: Tallinn
country: Estonia
city: Tallinn
country: Estonia
city: Tartu
country: Estonia
city: Riga
country: Latvia
city: Kaunas
country: Lithuania
city: Kaunas
country: Lithuania
city: Klaipeda
country: Lithuania
city: Vilnius
country: Lithuania
city: Vilnius
country: Lithuania
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT00614263: A Study to Examine Levels of Sedation During Outpatient Colonoscopies
Official title: A Prospective, Blinded Study Examining Sedation Levels During Outpatient Colonoscopies
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Outpatient Colonoscopy
Keywords: Colonoscopy
Sedation levels
Lead sponsor: Baylor Research Institute
Sponsor class: OTHER
First posted: 2008-02-13
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Study population: Outpatient GI clinic

Brief summary: Examine levels of sedation required for patients to comfortably undergo colonoscopy using propofol and if adjunct monitoring equipment promotes patient safety.

Detailed description: Propofol for sedation during outpatient endoscopy has become a popular technique in place of midazolam and opioid sedation. It has been associated with improved patient satisfaction and a faster recovery with less nausea and vomiting. However, there are a number of potential adverse effects associated with propofol. It has no analgesic effects; therefore, when used for moderate sedation procedures it frequently has to provide deeper levels of sedation to allow a painful procedure to be performed.

Some patients are sedated to the level of general anesthesia and may develop respiratory depression or airway obstruction requiring immediate airway support.

We examined the level of sedation required for patients to comfortably undergo routine colonoscopy using propofol and what monitoring system would best predict the patients who might need an airway intervention.

Eligibility criteria: Inclusion Criteria:

* Greater than 18 years of age
* ASA classification of I, II, or III

Exclusion Criteria:

* Anesthesiologist plans to use a combination of medications other than propofol for sedation.
* ASA classification IV or higher
* Lesions on forehead or earlobes

Primary outcomes:
measure: Examine possible relationships (correlations) between sedation using the SEDLine monitors and level of sedation using the Ramsay Sedation Scale and examine the number and type of airway interventions and clinical signs performed during the procedure.
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Baylor University Medical Center - Department of Anesthesiology
state: Texas
Study officials:
affiliation: Baylor Research Institute
name: Michael Ramsay, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04615663: Assessment of Burden Disease in Patients With Mast Cell Disorders
Official title: Assessment of Personal, Psychosocial, Work, and Economic Burden in Patients With Mast Cell Disorders,
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Mastocytosis
Cutaneous
Keywords: Burden
quality of life
mast cell disease
work impairment
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2020-11-04
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Prospective, descriptive study, both transversal and longitudinal, open, monocentric, performed in 200 patients with mast cell disease and follow-up at the CEREMAST Toulouse

Brief summary: The symptoms caused by mast cell disorders can have a significant impact on the state of health of individuals, constituting a real burden for them, and consequently altering their quality of life. It therefore seems important to clarify the impact on the quality of life, on the psycho-affective sphere, on professional life and on the direct and indirect costs caused by the disease, as well as on the "patient's remaining burden". It seems possible by a longitudinal study (patient follow-up over 1 year).

Primary objective is Assessment of quality of life in adult patient with mast cell diseases at M0.

Detailed description: Mast cell activation symptoms are due to the release of mast cell mediators after uncontrolled activation of mast cells. The release by mast cells of mast cell mediators (tryptase, histamine, prostaglandins, serotonin) results in mast cell activation symptoms, found in mast cell activation syndrome but also in mastocytosis. These symptoms interested the skin, gastrointestinal gut, pulmonary, cardiovascular and neuropsychiatric organs, etc.

In mastocytosis, along with these symptoms of mast cell activation, the infiltration of different organs by abnormal mast cells produces many clinical signs related to the excess of monoclonal mast cells present in the organs.

According to our clinical experience, the impact of mast cell disorder on various dimensions of life, including economic life, seems important, but it has never accurately evaluated.

Eligibility criteria: Inclusion Criteria:

* Adult patient (\> 18 years old) with confirmed mast cell disorder according to international criteria
* Patient affiliated to social security regime

Exclusion Criteria:

* Patient under legal protection (guardianship, curators or court order)
* Patient does not speak French

Primary outcomes:
measure: Quality of life of mast cell disorder patients
timeFrame: Baseline
Secondary outcomes:
measure: Mast cell disorder patient's life quality
timeFrame: 6 months
measure: Mast cell disorder patient's quality of life
timeFrame: 12 months
Other outcomes:
Locations:
city: Toulouse
country: France
facility: Cristina BULAI LIVIDEANU
Study officials:
affiliation: University Hospital, Toulouse
name: LIVIDEANU Cristina, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00319163: Study Comparing Two Manufacturing Processes for Levonorgestrel 90 mg/Ethinyl Estradiol 20 mg (LNG/EE) in Healthy, Cycling Women
Official title: An Open-label, Single-dose, Randomized, 2-period, Crossover, Bioequivalence Study to Compare Two Manufacturing Processes for Levonorgestrel 90 mg/Ethinyl Estradiol 20 mg (LNG/EE) in Healthy, Cycling Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: oral contraceptive
therapeutic equivalency
contraceptives, oral, combined
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2006-04-27
Enrollment: 26
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: Primary Objective: To determine the bioequivalence between the clinical batch process and the new processes for manufacturing LNG/EE.

Secondary Objective: To obtain additional safety and tolerability data concerning LNG/EE in healthy, cycling women.


Eligibility criteria: Inclusion Criteria:

* Women 18 - 35 years of age
* Non-smokers

Exclusion Criteria:

* History of thromboembolic disease
* Prior adverse experiences with oral contraceptives

Primary outcomes:
measure: Pharmacokinetic sampling over the course of 4 days following two different formulations of the same compound
Secondary outcomes:
measure: Additional safety--clinical labs
measure: electrocardiograms (ECGs)
measure: vital signs
measure: and adverse event recording over 4 days following administration of each formulation (LNG/EE)
Other outcomes:
Locations:
city: Miami
country: United States
state: Florida
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT03951363: iControl Chronic Kidney Disease
Official title: Using Digital Health to Improve Diet and Exercise Adherence for Chronic Kidney Disease Management
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Chronic Kidney Diseases
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2019-05-15
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The proposed study is responsive to the call for obtaining enhanced preliminary data for an external grant resubmission. The goal is to demonstrate a novel approach using digital health tools to help preserve kidney function. The investigators aim to adapt a previous behavioral intervention and conduct formative testing among patients with CKD. Specifically, the investigators will:

Aim 1: Modify an existing technology platform to build the iControl CKD system and adapt intervention content to reflect behavioral guidelines for patients with mild to moderate CKD.

Aim 2: Conduct qualitative interviews and user testing among patients with CKD to obtain feedback on the design of the intervention.

Aim 3: Conduct a prospective cohort feasibility trial to assess the feasibility and initial acceptability of the iControl CKD intervention.


Eligibility criteria: Inclusion criteria:

Qualitative interview:

* Age 18 or older
* Diagnosed with CKD (self-report)
* Proficient in English

Inclusion criteria:

Pilot Groups:

* Age 18 or older
* Diagnosed with mild to moderate CKD (documented eGFR ≥60 ml/min/1.73m2 plus albuminuria or eGFR 45-59 ml/min/1.73m2 )
* Diagnosed with diabetes and/or hypertension
* Proficient in English
* Access to a test-enabled mobile phone
* Willing to receive and send multiple text messages in a week

Primary outcomes:
measure: Proportion of participants responding to Interactive Voice Response (IVR) calls or text tracking prompts
timeFrame: Approximately 1 Month
Secondary outcomes:
measure: Change in CKD diet adherence as measured through consumption of CKD-specific nutrients (i.e. sodium, protein, potassium, and phosphorus)
timeFrame: Approximately 1 Month
measure: Change in physical activity minutes
timeFrame: Approximately 1 month
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke Global Digital Health Science Center
state: North Carolina
Study officials:
affiliation: Duke University
name: Dori Steinberg, PhD, RD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02196363: New Ultrasound Parameters for Predicting Birthweight
Official title: New Ultrasound Parameters for Predicting Birthweight
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fetal Development
Lead sponsor: Manchester University NHS Foundation Trust
Sponsor class: OTHER_GOV
First posted: 2014-07-22
Enrollment: 253
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants will be identified by screening booked scan appointments in regular antenatal clinics. The first approach will be by either the named local investigators

Brief summary: Babies that are either very small or very big have increased perinatal morbidity and mortality. Predicting which babies will fall into these groups is traditionally done with risk assessment and third trimester manual palpation, however neither of these techniques are sensitive and a considerable number of affected pregnancies are missed. This results in stillbirth for small babies or birth trauma for larger ones. Serial scanning in the third trimester can improve detection rates but this is expensive and cannot currently be provided to all NHS patients.

A more sensitive test that can be performed earlier in pregnancy would allow identification of at risk pregnancies allowing for increased monitoring. New three dimensional ultrasound techniques that measure volume and volumetric flow have become available that may allow this to happen. This study proposes to trial newer ultrasound techniques on a cohort of pregnant women. The findings from these scans will then be correlated with actual birth weights at the end of pregnancy to determine the ability of these parameters to act as screening tools for babies at the extremes of size.


Eligibility criteria: Inclusion Criteria:

* Pregnant women the beginning of pregnancy to term

Exclusion Criteria:

* Pregnancies in women previously affected by unclassfied fetal abnormality
* Multiple pregnancy

Primary outcomes:
measure: Kidney volume, thigh volume, placental volume, brain volume, final birthweight
timeFrame: up to 34-36 weeks pregnancy gestation
Secondary outcomes:
Other outcomes:
Locations:
city: Manchester
country: United Kingdom
facility: Central Manchester University Hospitals NHS Foundation Trust
Study officials:
affiliation: CMFT
name: Ed Johnstone, MBChB PhD MRCOG
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00715663: Observational Study to Evaluate Safety, Efficacy and Convenience of Using NovoMix® 30 FlexPen® in Type 2 Diabetes
Official title: A Multi-center, Prospective, Non-interventional Evaluation of Efficacy, Safety and Convenience of Using NovoMix® 30 FlexPen® as Monotherapy, or in Combination With OHA, in Treatment of Type 2 Diabetic Patients in Routine Clinical Practice: A Post-Marketing Surveillance Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes
Diabetes Mellitus, Type 2
Delivery Systems
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2008-07-15
Enrollment: 1584
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients with type 2 diabetes, inadequately controlled on their current therapy, who are prescribed NovoMix® 30 FlexPen® as monotherapy, or in combination with OHA, in accordance with the approved labelling.

Brief summary: This study is conducted in Asia. The aim of this observational study is to evaluate safety, efficacy and convenience in using NovoMix® 30 FlexPen® in type 2 diabetes under normal clinical practice conditions.


Eligibility criteria: Inclusion Criteria:

* All patients with type 2 diabetes, not adequately controlled on their current therapy, who were prescribed NovoMix® 30 FlexPen® as monotherapy, or in combination with OHA, in accordance with the approved labeling, are eligible for the survey.

Primary outcomes:
measure: Change in HbA1c
timeFrame: after 12 weeks of therapy
measure: Change in post-prandial glucose (PPG)
timeFrame: after 12 weeks of therapy
measure: Change in fasting plasma glucose (FPG)
timeFrame: after 12 weeks of therapy
measure: Change in prandial glucose increment (PGI)
timeFrame: after 12 weeks of therapy
measure: Incidence of hypoglycaemia and other adverse drug reaction
timeFrame: after 12 weeks of therapy
measure: Patient and doctor's convenience
timeFrame: after 12 weeks of therapy
Secondary outcomes:
measure: Response of different patient profiles to NovoMix 30 therapy and patient profiles considered eligible for insulin treatment in physicians' routine clinical practice
timeFrame: For the duration of the study
measure: Patient satisfaction on devices
timeFrame: after 12 weeks of treatment
Other outcomes:
Locations:
city: Jakarta
country: Indonesia
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
Clinical trial NCT02708563: Meconium Aspiration and Tracheal Suctioning-Feasibility Study
Official title: Meconium Aspiration Syndrome and Non-vigorous Neonates-Pilot Study
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Meconium Aspiration Syndrome
Keywords: meconium
neonatal resuscitation
Lead sponsor: St. Louis University
Sponsor class: OTHER
Collaborators: name: American Academy of Pediatrics
First posted: 2016-03-15
Enrollment: 0
Sex: ALL
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Feasibility study to randomize non-vigorous newborn infants born through meconium-stained amniotic fluid to endotracheal suctioning or immediate resuscitation.

Detailed description: This will be a pilot feasibility trial of endotracheal intubation and suctioning versus routine resuscitation for term, non-vigorous newborns born through meconium-stained amniotic fluid to compare the incidence of meconium aspiration syndrome, extracorporeal membrane oxygenation or death.

Eligibility criteria: Inclusion Criteria:

* Term newborns (\>37 weeks of gestation)
* Delivery through meconium-stained amniotic fluid
* Mothers \>18 years of age

Exclusion Criteria:

* No consent from mother
* Infant vigor at delivery (muscle tone and respiratory effort)
* Prenatally diagnosed major anomalies (excluding gastroschisis)
* Plan to not resuscitate infant
* Family does not speak English

Primary outcomes:
measure: Ability to identify, consent, enroll and randomize 70% of eligible infants into study.
timeFrame: 18 months
measure: The number of infants in the study who develop meconium aspiration syndrome, require extracorporeal membrane oxygenation or die
timeFrame: 18 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: