louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01976754: Safety Study of Dexmedetomidine in Septic Patients
Official title: The Effective Dose of Dexmedetomidine for Moderate Sedation of Adult Intubated Septic Patients in the ICU.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sepsis
Agitation
Lead sponsor: First Affiliated Hospital of Zhejiang University
Sponsor class: OTHER
First posted: 2013-11-06
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: Septic patients in Intensive Care Unit always need mechanical ventilation and conscious-sedation. But the recommended dose 0.2-0.7μg/kg/h could not run well because of wide range. The purpose of this study is to find the effective dose of dexmedetomidine adult septic patients of mechanical ventilation .

Detailed description: Inclusion Criteria:

Age: between 18 years mechanical ventilation RASS≥2 A diagnosis of sepsis within 48 hours

Exclusion Criteria:

Cardiac disease Cardiac rhythm abnormalities liver dysfunction coma severe hypotension muscle relaxant users

Primary Outcome Measures:

Dose of dexmedetomidine

Secondary Outcome Measures:

RASS score Requirement for rescue intervention, RASS will be recorded per hour.

Eligibility criteria: Inclusion Criteria:

* intubated patients RASS≥2 A diagnosis of sepsis within 48h

Exclusion Criteria:

* Cardiac disease Cardiac rhythm abnormalities liver dysfunction coma severe hypotension muscle relaxant users

Primary outcomes:
measure: Dose of dexmedetomidine
timeFrame: 12 hours
Secondary outcomes:
measure: RASS score Requirement for rescue intervention, RASS will be recorded per hour.
timeFrame: 1 hour
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Zhanqin Zhang
state: Zhejiang
Study officials:
affiliation: First Affiliated Hospital of Zhejiang University
name: xiangming fang, PHD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04659954: Feasibility and Acceptability Study of the "O'Dide" Application in People Suffering From an Addiction
Official title: Feasibility and Acceptability Study of the "O'Dide" Application in People Suffering From an Addiction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Substance-Related Disorders
Personality Disorders
Keywords: E health
Application
Substance use disorders
Personality disorders
Care observance
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
Collaborators: name: Institut de Recherche en Santé Publique, France
First posted: 2020-12-09
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Substance Use Disorders (SUD) are associated with cognitive schemas that lead to care attrition and mistrust towards care. Considering this within SUD management, it is important to establish a confident relation between the patient and the care team to favorize acre observance. However, it demands an important availability of the healthcare team, allowing for frequent interactions at all times, including at night and during days off. With the present study, the investigator postulated that an application called Ô DIDE for Digital Interaction for Detoxification Engagement, that aims to help the caregivers maintaining a link with the patient in order to facilitate confidence in the relationship, could favorize care observance especially consumption report.

Detailed description: The present research aims to assess the feasibility of the "Ô DIDE" application after 8 weeks of use by patients treated for a disorder related to substance use at the Toulouse University Hospital.

Eligibility criteria: Inclusion Criteria:

* Suffering from any type of addiction, with an active addiction requiring weekly monitoring of consumption
* Possessing an Android smartphone or having access to an Android smartphone and having access to an internet connection
* Able to read and understand French
* Affiliated or beneficiary of a social security scheme.
* Free, informed and written consent signed by the participant and the investigator (at the latest on the day of inclusion and before any examination required by the research).

Exclusion Criteria:

* Patient with cognitive or psychiatric disorders that may affect their ability to consent
* Participation in another protocol involving a modification of the treatment for addiction
* Person under legal protection, guardianship or curatorship
* Known or suspected pregnancy

Primary outcomes:
measure: Feasibility of use of the application O'DIDE during 8 weeks
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Toulouse
country: France
facility: University hospital of Toulouse
Study officials:
affiliation: University Hospital, Toulouse
name: Juliette Salles, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00180154: Tumor Metabolism of Lung Cancer in Patients Who Underwent Percutaneous Radiation Measured With F-18-FDG-PET
Official title: Tumor Metabolism of Lung Cancer Underwent Percutaneous Radiation Measured With F-18-FDG-PET
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lung Cancer
Keywords: radiation therapy
F-18-FDG
NSCLC
Lead sponsor: Technische Universität Dresden
Sponsor class: OTHER
First posted: 2005-09-16
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study includes consecutive patients from Department of Radiooncology with inoperable non-small cell lung cancer (NSCLC) intended for a curative radiotherapy.

Brief summary: The purpose of the study is to describe the regional and global FDG-kinetics in non-small-cell lung cancer (NSCLC) during percutaneous radiation therapy.


Eligibility criteria: Inclusion Criteria:

* Histologically confirmed NSCLC not curable by surgery
* Karnofsky \> 80%
* Tumor volume and localization allow curative radiotherapy
* Written consent

Exclusion Criteria:

* Metastases
* Diabetes
* Pregnancy
* Psychiatric impairment

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Dresden
country: Germany
facility: Department of Nuclear Medicine
Study officials:
affiliation: Department of Nuclear Medicine
name: Joerg Kotzerke, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02247154: A Study of the Safety and Efficacy of Vigam® Liquid in Patients With Primary or Secondary Antibody Deficiency
Official title: A Study of the Safety and Efficacy of an Intravenous Immunoglobulin (Vigam® Liquid) in Patients With Primary or Secondary Antibody Deficiency.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Primary or Secondary Antibody Deficiency
Lead sponsor: Bio Products Laboratory
Sponsor class: OTHER
First posted: 2014-09-23
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: To determine:

1. The safety of Vigam® Liquid in patients with primary or secondary antibody deficiency (PAD or SAD).
2. The efficacy of Vigam® Liquid in patients with primary or secondary antibody deficiency.
3. The half-life of Vigam® Liquid after 4 months of treatment.
4. The subclass and total gammaglobulin concentrations after each infusion of Vigam® Liquid.


Eligibility criteria: Inclusion Criteria:

* Adults (18-80 years) with PAD or SAD
* With a low serum IgG (\<6 g/l) and a history of recurrent infections
* Requiring and eligible for polyvalent intravenous immunoglobulin (IVIG) replacement therapy
* Non-reactive for HBsAg and with an alanine aminotransferase (ALT) level less than twice upper limit of normal prior to entry into the trial

Exclusion Criteria:

-

Primary outcomes:
measure: IgG half-life
timeFrame: Pre-dose, 5 min, 1, 2, 4, 7, 10, 14, 21 days post-dose
Secondary outcomes:
Other outcomes:
Locations:
city: Papworth Everard
country: United Kingdom
facility: Papworth Hospital
state: Cambridgeshire
city: Cardiff
country: United Kingdom
facility: Cardiff Royal Infirmary
city: Leicester
country: United Kingdom
facility: Leicester Royal Infirmary
city: London
country: United Kingdom
facility: Royal Brompton Hospital
city: London
country: United Kingdom
facility: Royal Free Hospital
city: Newcastle
country: United Kingdom
facility: Royal Victoria Infirmary
city: Rugby
country: United Kingdom
facility: Hospital of St Cross
city: Somerset
country: United Kingdom
facility: Taunton & Somerset Hospital
Study officials:
References:
Clinical trial NCT05784454: Prevalance of Sleep Bruxism Among a Group of Egyptian Children
Official title: Prevalence of Sleep Bruxism in a Group of Egyptian Children and Its Relation to Screen Time and Sugar Consumption
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Sleep Bruxism
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2023-03-27
Enrollment: 349
Sex: ALL
Minimum age (years): 6
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants will be selected according to the mentioned eligibility criteria

Brief summary: The goal of this observational study is to detect the prevalence of sleep bruxism in a group of Egyptian children and detect its relation to screen-time and sugar consumption. The main questions it aims to answer are:

1. In a group of Egyptian Children what is the prevalence of sleep bruxism?
2. What is the relation between sleep bruxism and screen time and sugar consumption?

Detailed description: Parents of a group of Egyptian Children aged 6-8 years old will be asked to fill

1. An informed Consent
2. Children Sleep Habit Questionnaire to detect the presence of sleep bruxism or not?
3. Food Frequency Questionnaire of Health Behaviour Sugar Consumption questionnaire
4. Leisure Time, Television Use, Computer Use Sections of the Health Behaviour Sugar Consumption Questionnaire

Eligibility criteria: Inclusion Criteria:

* Positive Subject acceptance for participation in the study
* Healthy children aged 6-8 years old
* Both genders
* The presence of mixed dentition with permnant first molar erupted

Exclusion Criteria:

* Children with mental or neurological disorders
* Children with systemic disorders
* Children who use medications that could not interfere with the central nervous system
* Children suffering from sleep disorders. e.g: Obstructive Sleep Apnea

Primary outcomes:
measure: Prevalence of Sleep Bruxism in a group of Egyptian Children aged 6-8 years old
timeFrame: 1 year
Secondary outcomes:
measure: Correlation between sleep bruxism and screen time and sugar consumption
timeFrame: 1 year
Other outcomes:
Locations:
Study officials:
affiliation: Cairo University
name: Mira A Kamal, Bachelor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Restrepo C, Santamaria A, Manrique R. Sleep bruxism in children: relationship with screen-time and sugar consumption. Sleep Med X. 2021 Apr 24;3:100035. doi: 10.1016/j.sleepx.2021.100035. eCollection 2021 Dec.
Clinical trial NCT00002454: Papilloma Virus Vaccine Therapy in Treating Young Patients With Recurrent Papilloma of the Larynx
Official title: Phase II Study of Immunotherapy With Autogenous Papilloma Vaccine in Patients With Recurrent Juvenile Papilloma of the Larynx
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Precancerous Condition
Keywords: lung papilloma
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2004-02-27
Sex: ALL
Minimum age (years): 1
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: RATIONALE: Vaccines made from papilloma virus cells may make the body build an immune response to and kill papilloma cells.

PURPOSE: Phase II trial to study the effectiveness of papilloma virus vaccine in treating young patients with recurrent papilloma of the larynx.

Detailed description: OBJECTIVES: I. Determine the immune response in patients with juvenile papilloma of the larynx treated with autogenous vaccine derived from each patient's own tumor.

OUTLINE: Patients receive autogenous papilloma vaccine intradermally and subcutaneously weekly for 20 weeks.

PROJECTED ACCRUAL: Not specified

Eligibility criteria: DISEASE CHARACTERISTICS: Diagnosis of severe recurrent juvenile papilloma of the larynx requiring surgery at least 4 times per year Condition must have existed for more than 1 year

PATIENT CHARACTERISTICS: Age: 1 and over Performance status: Not specified Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified

PRIOR CONCURRENT THERAPY: See Disease Characteristics

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Newark
country: United States
facility: New Jersey Medical School
state: New Jersey
Study officials:
affiliation: Rutgers, The State University of New Jersey
name: James M. Oleske, MD
role: STUDY_CHAIR
References:
citation: Oleske J, Fishman D, Cooper R, et al.: Autogenous vaccine in the treatment of laryngeal papilloma. In: Proceeding of the 12th International Congress of Chemotherapy, 1981. pp 1099-1101.
citation: Oleske JM, Kushnick T. Juvenile papilloma of the larynx. Am J Dis Child. 1971 May;121(5):417-9. doi: 10.1001/archpedi.1971.02100160087011. No abstract available.
Clinical trial NCT04695054: Buzzy Plus EMLA Cream for Vascular Access in Children
Official title: Combined Use of Buzzy and EMLA Cream for Vascular Access in Children. A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vascular Access
Keywords: Children
Buzzy device
EMLA cream
Peripheral vascular access
Lead sponsor: IRCCS Burlo Garofolo
Sponsor class: OTHER
First posted: 2021-01-05
Enrollment: 94
Sex: ALL
Minimum age (years): 4
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Venepuncture and peripheral intravenous cannulation are commonly performed in children and may cause substantial pain and distress. The aim of this study is to evaluate the efficacy of the combination of EMLA cream and Buzzy device in pain and distress relief during venipuncture or peripheral vascular access in hospitalized children.

The study is an open randomized controlled study. Eligible children will be randomized to receive the application of EMLA cream 60 minutes before the needle procedure or the application of EMLA 60 minutes before the procedure and the use of Buzzy device during procedure.

The primary study outcome will be the mean distress score experienced by children at the moment of the procedure, evaluated with the CEMS scale. Secondary outcomes will be the mean distress score recorded by operators; the self-reported mean pain score; the mean pain score reported by parents and operators.


Eligibility criteria: Inclusion Criteria:

* children between 4 and 12yrs of age needing venipuncture or peripheral vascular access
* children who have applied EMLA cream at least 60 minutes before the procedure

Exclusion Criteria:

* children with cognitive impairment
* children with skin lesion that does not allow the application of Buzzy device
* children diseases that cause hypersensibility to cold (i.e. Raynaud syndrome, sickle cell disease)
* children who have taken any analgesics in the 8 hours before enrollment

Primary outcomes:
measure: Mean distress evaluated by parents
timeFrame: Intraprocedural
Secondary outcomes:
measure: Mean distress evaluated by operators
timeFrame: intraprocedural
measure: Mean pain score evaluated by children
timeFrame: Immediately after the procedure
measure: Mean pain score evaluated by parents
timeFrame: Immediately after the procedure
measure: Mean pain score evaluated by operators
timeFrame: Immediately after the procedure
measure: Success at first attempt
timeFrame: Intraprocedural
Other outcomes:
Locations:
city: Trieste
country: Italy
facility: IRCCS materno infantile Burlo Garofolo
state: TS
Study officials:
affiliation: Institute for Maternal and Child Health IRCCS Burlo Garofolo
name: Tamara Strajn, Nurse
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04191954: Fasudil Eye Drop in Retinopathy Of Prematurity(ROP)
Official title: Fasudil Eye Drop in Retinopathy Of Prematurity, Retinal Vascularization Induction and Disease Progression Inhibition, a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Retinopathy of Prematurity
Lead sponsor: Shahid Beheshti University of Medical Sciences
Sponsor class: OTHER
First posted: 2019-12-10
Enrollment: 184
Sex: ALL
Maximum age (years): 45
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Eligible eyes are randomly assigned into two groups. Group A receive Fasudil eye drops (concentration 0.5 percent) twice daily. Group B, receive artificial tears drop with the same frequency. Retinal specialists who are expert in Retinopathy Of Prematurity field will perform fundus examination regularly. The examiners are blind. The progression of normal retinal vascularization and need to treatment will be documented and compared between the two study groups. The topical eye drops are used until the retinal vascularization are complete (45 week after LMP) or the patient needs to be treated.


Eligibility criteria: Inclusion Criteria:

* Premature infants who are candidate for retinopathy of prematurity (ROP) screening with ROP Type 2

Exclusion Criteria:

* Serious systemic problems
* Other ocular problems Except ROP

Primary outcomes:
measure: Stimulation of normal retinal vascularization and disease progression inhibition
timeFrame: 3 months
Secondary outcomes:
measure: Any adverse event
timeFrame: 3 months
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Ophthalmic Research Center
Study officials:
References:
Clinical trial NCT00792454: Reduction of Mortality Prior to and During the First 90 Days of Dialysis Through a Renal Rehabilitation Program
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Kidney Disease
End Stage Kidney Disease
Cardiovascular Disease
Keywords: Chronic kidney disease
End stage renal disease
Exercise
Cardiovascular disease
Lead sponsor: MaineHealth
Sponsor class: OTHER
First posted: 2008-11-18
Enrollment: 116
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The mortality rate of treated patients with end stage renal disease(ESRD)is 22 deaths patient-years at risk in 2006. Incident patients with ESRD are most vulnerable within the first 90 days of dialysis, with an annualized mortality rate of 50 deaths/100 patient years. The vast majority of these deaths are due to cardiovascular causes. As cardiac rehabilitation programs have shown a 20% reduction in one year overall mortality rate post myocardial infarction the investigator proposes that a similar type of rehabilitation program will also have a benificial effect on morbidity and mortality in patients with chronic kidney disease(CKD)and ESRD.The overall goal of this project is to study whether a renal rehabilitation program based on guided exercise implemented in patients with stage III and stage IV CKD can influence the mortality rate of these patients prior to and during the first 90 days of dialysis

Hypothesis:The application of a guided exercise program (renal rehabilitation) instituted in patients with stage III or Stage IV CKD will decrease the mortality rate prior to the initiation of renal replacement therapy.

Hypothesis:The application of renal rehabilitation during the late stages of CKD will decrease the mortality risk during the first 90 days of renal rehabilitation therapy.

Hypothesis:A guided exercise program will have an immediate and prolonged effect on activity levels, mental health and adaption to chronic illness in patients with advanced CKD.


Eligibility criteria: Inclusion Criteria:

* greater than 18 yo
* stage III CKD (GFR\<60ml/min)
* stage IV CKD (GFR\<30ml/min)

Exclusion Criteria:

* active angina pectoris
* lower extremity amputation with no prosthesis
* orthopedic disorder severly exacerbated by activity
* chronic lung disease resulting in significant shortness of breath or oxygen de-saturation at rest
* cerebro cascular disease manifested by ongoing TIAs
* malignant carcinoma

Primary outcomes:
measure: Mortality prior to and During the First 90 Days of Dialysis
timeFrame: 5 years
Secondary outcomes:
measure: Measurement of physical fitness and quality of life
timeFrame: 5 years
Other outcomes:
Locations:
city: Portland
country: United States
facility: Maine Nephrology Associates
state: Maine
Study officials:
References:
Clinical trial NCT04397354: Intracochlear Dexamethasone Application During Cochlear Implantation for Preserving Cochlear Cells
Official title: Intracochlear Dexamethasone Application During Cochlear Implantation for Preserving Cochlear Cells
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hearing Loss, Sensorineural
Keywords: cochlear implant
dexamethasone
Lead sponsor: Pamukkale University
Sponsor class: OTHER
First posted: 2020-05-21
Enrollment: 34
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective, randomized
Primary purpose: PREVENTION

Brief summary: The protection of cochlear cells is one of the main concerns of cochlear implant surgery. New electrode designs or additional molecules have been used for this purpose. The aim of the study is to test the effect of dexamethasone in two different application methods.

Detailed description: The protection of cochlear cells is one of the main concerns of cochlear implant surgery. New electrode designs or additional molecules have been used for this purpose. The aim of the study is to test the effect of dexamethasone in two different application methods. Participants who will have cochlear implant surgery will be divided into three groups. Group 1 will have intracochlear dexamethasone after the incision of the round window membrane. Group 2 will have intratympanic dexamethasone after the incision of the round window membrane. Group 3 will serve as a control group. All participants will be tested after a week, a month, 3, and 6 months. Impedance and threshold measurements will be compared.

Eligibility criteria: Inclusion Criteria:

* Patients with sensorineural hearing loss
* Patients who will have cochlear implant surgery with CI422 electrode

Exclusion Criteria:

* Patients with cochlear abnormality
* Patients with auditory neuropathy

Primary outcomes:
measure: Electrode Impedance(Ohm)
timeFrame: 1-3 months
measure: Electrode thresholds(CL)
timeFrame: 1-3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Denizli
country: Turkey
facility: Pamukkale University
Study officials:
affiliation: Pamukkale University
name: Fazil N Ardic, MD
role: PRINCIPAL_INVESTIGATOR
References: