louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03915418: Validation of a Method of Screening for Sleep Disorders in Children With Cerebral Palsy, Using Connected Tools
Official title: Validation of a Simple Method of Screening for Sleep Disorders in Children With Cerebral Palsy, Using Connected Tools
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Sleep Disorders
Keywords: Screening
sleep disorders
children
cerebral palsy
connected tools
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2019-04-16
Enrollment: 140
Sex: ALL
Minimum age (years): 6
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Cerebral palsy (CP) is the most common cause of child disability. Nearly 40% of PC children suffer from sleep disorders, which are not routinely screened. The neuro-cognitive, physical and environmental morbidity of sleep disorders should require their diagnosis and management. Limited access to the reference exam (polysomnography or PSG) delays the diagnosis and only allows screening of these disorders for a limited number of PC children. The hypothesis of our study is that connected technologies could optimize screening for sleep disorders in PC children by selecting children requiring PSG exploration and specific management.


Eligibility criteria: Inclusion Criteria:

* Boy or girl between 6 and 15 years old
* Confirmed diagnosis of cerebral palsy
* GMFCS class\> 3
* Parents and child agreement

Exclusion Criteria:

* Pharmacological treatment of sleep disorders
* Diurnal and / or nocturnal ventilatory support
* Difficulty understanding and / or participation
* Subjects under 6 and over 15
* Refusal to participate
* Not affiliated with and not a beneficiary of a health insurance plan

Primary outcomes:
measure: Sensitivity of the diagnosis of sleep disorder
timeFrame: 15 days
measure: Specificity of the diagnosis of sleep disorder
timeFrame: 15 days
Secondary outcomes:
measure: Diagnosis
timeFrame: 15 days
measure: Acceptability assessed by acceptability score for parents, and if possible children
timeFrame: 15 days
measure: Sleep Quality Questionnaire
timeFrame: 15 days
measure: Data quality outcome measures
timeFrame: 25 months
measure: A cost analysis of the sensor screening strategy will be compared to the PSG and the quality of life
timeFrame: 25 months
Other outcomes:
Locations:
city: Angers
country: France
facility: CHU Angers
city: Brest
country: France
facility: CHRU Brest
city: Brest
country: France
facility: Fondation Ildys Ty-Yann
city: Nantes
country: France
facility: ESEAN Nantes
city: Paris
country: France
facility: AP-HP Hôpital Trousseau
city: Ploemeur
country: France
facility: Kerpape
Study officials:
affiliation: Brest University Hospital in France
name: Juliette Ropars, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02935218: Parenting Skills for Mothers With Borderline Personality Disorder: A Newly Developed Group Training Program
Official title: Parenting Skills for Mothers With Borderline Personality Disorder: A Newly Developed Group Training Program
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Borderline Personality Disorder
Lead sponsor: Freie Universität Berlin
Sponsor class: OTHER
First posted: 2016-10-17
Enrollment: 15
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: N=15 mothers with Borderline Personality Disorder who had young children (aged 0-6 years) participated in a 12-week training program. To estimate the participants' impairment, parental stress and psychological distress were assessed before the training. After the training, participants and trainers were asked to provide feedback regarding the valuation of and the changes due to the training.


Eligibility criteria: Inclusion Criteria:

* Borderline diagnosis in mothers
* Infants between 6 months and 6 years
* Mothers and their children must be in regular contact with each other

Exclusion Criteria:

* Acute child endangerment
* Maternal acute suicidality

Primary outcomes:
measure: written feedback
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Renneberg B, Rosenbach C. "There is not much help for mothers like me": Parenting Skills for Mothers with Borderline Personality Disorder - a newly developed group training program. Borderline Personal Disord Emot Dysregul. 2016 Dec 1;3:16. doi: 10.1186/s40479-016-0050-4. eCollection 2016.
Clinical trial NCT03622918: Colistin-rifampin Combination and Colistin Monotherapy in Extensively Drug-resistant Acinetobacter Baumannii
Official title: Comparison of Efficacy and Safety of Colistin-rifampin Combination and Colistin Monotherapy in Extensively Drug-resistant Acinetobacter Baumannii: Utility of the Synergy Test Results (E-test) in Vitro
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colistin
Rifampin
Acinetobacter Infections
Lead sponsor: Gangnam Severance Hospital
Sponsor class: OTHER
First posted: 2018-08-09
Enrollment: 9
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The investigators aimed to confirm the utility of the synergy test results (E-tesT) in vitro to predict the efficacy and safety of colistin-rifampin combination and colistin monotherapy in extensively drug-resistant acinetobacter baumannii.

Detailed description: We will searched pneumonia patients with CoRAB in Gangnam Severance Hospital. Subjects will be enrolled and randomized in a blinded fashion using a computerized random number generator (permuted-block randomization) for treatment with colistin and rifampin combination and colistin only at a ratio of 1:1. We will perform the E-test MIC:MIC ratio method to predict in vitro synergy of colistin and rifampin combination therapy.

Eligibility criteria: Inclusion Criteria:

* Pneumonia, blood septicemia, urinary tract infection, or other infection or even colonization with evidence of extensively drug-resistant Acinetobacter baumannii infection

Exclusion Criteria:

* Hypersensitivity reaction to colistin or rifampin
* use of colistin or rifampin in 15 days prior to screening
* evidence of extensively drug-resistant Acinetobacter baumannii infection in 15 days prior to screening
* CLcr \< 15 mL/min, ALT or AST \> 3xULN, total bilirubin \> 2xULN, Hb \< 7 gm/dL, ANC \< 500/mm3, Platelet \< 50,000/mm3

Primary outcomes:
measure: microbiologic response
timeFrame: 14 days
Secondary outcomes:
measure: clinical response
timeFrame: 14 days
measure: mortality
timeFrame: 30 days
Other outcomes:
Locations:
Study officials:
References:
citation: Park HJ, Cho JH, Kim HJ, Han SH, Jeong SH, Byun MK. Colistin monotherapy versus colistin/rifampicin combination therapy in pneumonia caused by colistin-resistant Acinetobacter baumannii: A randomised controlled trial. J Glob Antimicrob Resist. 2019 Jun;17:66-71. doi: 10.1016/j.jgar.2018.11.016. Epub 2018 Nov 23.
Clinical trial NCT03284918: Lipid Lowering Effect of a Cereal Based Snack Bar With Added Plant Stanol Ester
Official title: Effect of a Cereal Based Snack Bar With Added Plant Stanol Ester on Serum Total and Lipoprotein Lipids
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypercholesterolemia
Hyperlipidemias
Dyslipidemias
Lead sponsor: Raisio Group
Sponsor class: INDUSTRY
Collaborators: name: Oy Medfiles Ltd
First posted: 2017-09-15
Enrollment: 71
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to investigate the cholesterol lowering efficacy of a cereal based snack bar with added plant stanol ester when used between meals as part of a habitual diet by subjects with mild to moderate hypercholesterolemia.


Eligibility criteria: Inclusion Criteria:

* Serum total cholesterol 5.2-8.5 mmol/l
* Serum triglycerides \< 3 mmol/l
* Signed written informed consent

Exclusion Criteria:

* Abnormal liver, kidney and thyroid function
* Use of lipid lowering medication
* Consumption of other plant sterol or plant stanol containing food products or supplements, or other foods or supplements for cholesterol lowering 1 month prior to visit 2
* History of unstable coronary artery disease (myocardial infarction, coronary artery bypass graft (CABG), percutaneous transluminal coronary angioplasty (PTCA) within the previous 6 months
* Diagnosed type 1 or type 2 diabetes requiring medical treatment
* History of recent temporal ischemic attack or malignant diseases (\< 5 yrs)
* Celiac disease, or allergy or intolerance to the ingredients of the test products
* Medically prescribed diet/medication for slimming or a special diet like very low calorie diet or obesity drug, or vegan and gluten-free diet
* Subjects with alcohol abuse (\> 4 portion per day)
* Pregnancy or planned pregnancy or lactating

Primary outcomes:
measure: Percentage change in serum LDL cholesterol
timeFrame: 4 weeks
Secondary outcomes:
measure: Absolute change in serum LDL cholesterol (mmol/l)
timeFrame: 4 weeks
measure: Absolute and percentage change in serum total, HDL- and non-HDL cholesterol and serum total triglycerides
timeFrame: 4 weeks
Other outcomes:
Locations:
Study officials:
References:
citation: Sarkkinen E, Lyyra M, Nieminen S, Kuusisto P, Wester I. Cereal-Based Snack Bar with Added Plant Stanol Ester (Benecol(R)) Consumed between Meals Lowers Serum Total and LDL Cholesterol Effectively in Mildly to Moderately Hypercholesterolemic Subjects. Cholesterol. 2018 May 2;2018:1463628. doi: 10.1155/2018/1463628. eCollection 2018.
Clinical trial NCT05021718: Strengthening Exercise and Activities of Daily Living Instructions for Patients With Lumbar Disc Herniation
Official title: Effectiveness of Strengthening Exercise Plus Activities of Daily Living Instructions in Reducing Pain in Patients With Lumbar Disc Herniation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lumbar Disc Herniation
Keywords: Low back pain
Disc herniation
Strengthening exercise
ADL instructions
Lead sponsor: Chittagong Medical College
Sponsor class: OTHER
First posted: 2021-08-25
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Lumbar disc herniation (LDH) is one of the most common causes of mechanical low back pain (LBP) associated with radiating leg pain. Conservative treatment, including exercise, analgesic, and physical therapy, is regarded as the first-line treatment of LDH.

This randomized clinical trial was conducted to evaluate the effectiveness of back and hip strengthening exercises combined with activities of daily living instructions (ADLIs) to reduce pain intensity in patients with LDH.

Detailed description: A total of 70 patients with LDH were randomly allocated to either the intervention group (IG) or the control group (CG). Patients in IG received different back and hip strengthening exercises five days a week for six weeks. The patients in CG were treated with Naproxen (500 mg) and Baclofen (10 mg) tablet twice a day for three weeks, followed by hot moist compression for the next three weeks. In addition, the patients in both groups were instructed to follow the ADLIs during the intervention and at least 3 months after the intervention.

The straight leg raising (SLR) test and the Visual Analogue Scale (VAS) score were used to evaluate the patients' pain intensity. Outcomes were measured at baseline, at three weeks, and six weeks of the intervention. Patients were followed up after 3 months of the intervention.

Eligibility criteria: Inclusion Criteria:

* Age: 18 - 59 years.
* Clinically diagnosed LDH that was confirmed by MRI.
* Duration of the pain: ≥ 3 months

Exclusion Criteria:

* Painful spinal deformity
* Cauda equina syndrome
* Progressive neurological signs and/or muscle-wasting
* History of spinal surgery, spine fracture, scoliosis, tuberculosis, and tumours.
* Treated with epidural injections.
* Pregnancy

Primary outcomes:
measure: Changes in perceived pain intensity
timeFrame: Outcomes were evaluated at baseline, at three weeks, and six weeks of the intervention. Patients were followed up after 3 months of the intervention.
Secondary outcomes:
measure: Changes in the range of hip flexion during straight leg raising test
timeFrame: Outcomes were evaluated at baseline, at three weeks, and six weeks of the intervention. Patients were followed up after 3 months of the intervention.
Other outcomes:
Locations:
city: Chittagong
country: Bangladesh
facility: Chittagong Medical College Hospital
Study officials:
References:
Clinical trial NCT00538018: Telithromycin, Treating Adult Outpatients With Mild to Moderate Community-acquired Pneumonia (CAP) in High Bacterial Resistance Areas
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pneumonia
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2007-10-02
Enrollment: 978
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: Demonstrate efficacy of telithromycin over single-agent oral antibiotics usually prescribed by local guidelines ("usual care") for treating adult outpatients with mild to moderate community-acquired pneumonia (CAP) in high bacterial resistance areas.


Eligibility criteria: Inclusion Criteria:

* Adult outpatients with mild to moderate CAP. Diagnosis of CAP was based on the presence of fever and/or hyperleucocytosis and the new and sudden onset of at least two clinical signs and symptoms of pneumonia (cough, dyspnea or tachypnea, chills, pleuritic chest pain, purulent sputum or change in sputum character, auscultatory findings). Clinical diagnosis of CAP had to be confirmed by chest X-ray findings (e.g. presence of presumably new infiltrate). Specimens for microbiological documentation had to be collected within 24 hours prior to enrollment.

Exclusion Criteria:

* Subjects requiring parenteral antibiotic treatment.
* Subjects with severe CAP requiring hospitalization. The CAP was to be considered as severe in the presence of any of the following conditions:
* chest X-ray showing a multilobar consolidation (\> 1 lobe)3 and/ or an increase in the size of the opacity by greater than or = to 50% within 48 hours of the current evaluation
* shock
* altered mental status (disorientation to person, place or time that is not known to be chronic, lethargy, stupor or coma)
* total peripheral white blood cell count \< 4,000/mm3
* requirement for mechanical ventilation
* requirement for vasopressors
* acute renal failure

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Primary outcomes:
measure: To compare the effect of telithromycin versus "usual care" on the total symptoms score of pneumonia and on health outcomes, in CAP adult outpatients at the end of therapy visit.
timeFrame: (Days 8-11)
Secondary outcomes:
measure: For health outcomes at the test of cure visit; e.g. additional LRTI-related antibiotic use, LRTI related hospitalization with length of stay and LRTI related office visit/emergency room visit.
timeFrame: (Days 17-21)
Other outcomes:
Locations:
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References:
Clinical trial NCT01080118: Effectiveness of Video System in Improving Learning of Tracheal Intubation Using Standard Laryngoscopy Among Novices
Official title: A Clinical Trial on the Effectiveness of Video System in Improving Learning of Tracheal Intubation Using Standard Laryngoscopy Among Novices
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intubation Intraesophageal
Keywords: Teaching
Video Scope
Intubation
Lead sponsor: Northwestern University
Sponsor class: OTHER
First posted: 2010-03-03
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The use of the video laryngoscope to teach laryngoscopy will improve the performance of tracheal intubation done by novices because it will allow a shared view of the airway leading to a better feedback from the trainer to the trainee.

Detailed description: A group of 30 fourth year medical students and interns rotating through the department of anesthesiology will be studied. Firstly, a standard lecture will be provided in which the description and importance of laryngoscopy and tracheal intubation will be explained. This will include descriptions of anatomy, relevant equipment and technique of tracheal intubation. Following the lecture , the students will be randomly allocated using sealed envelopes into two groups : a control group ( taught with a standard Macintosh Laryngoscope ) and a study group ( taught with the Airtraq video laryngoscope).Each group will receive a demonstration and verbal instruction on how to perform laryngoscopy and tracheal intubation by their instructor.

Eligibility criteria: Students:

Inclusion criteria for the medical student:

* Medical student or intern rotating through the anesthesiology department

Exclusion criteria for the medical student:

* Previous attempts of laryngoscopy in humans
* Subject who refuses participation

Patients:

Inclusion Criteria:

* Age 18 -75 years of age
* ASA PS I, II
* Procedure that will require General anesthesia with tracheal intubation

Exclusion Criteria:

* Age \< 18 years old or greater than 75 years of age
* Patient or student who refuses participation
* ASA Physical status class III or greater
* History of lung disease
* History of obstructive sleep apnea
* History of difficult intubation
* Evidence of possible difficult airway (Mallampati Class \>2, TMH distance \<6 cm, mouth opening \<4 cm and limited neck mobility)
* Unanticipated difficult laryngoscopy (defined by inability of the attending anesthesiology to intubate after 2 attempts)
* Patients at risk for aspiration
* Patients with BMI greater than 35
* Pregnant patients

Primary outcomes:
measure: Successful Endotracheal Intubation
timeFrame: 120 seconds
Secondary outcomes:
measure: Time to Intubation
timeFrame: 120 seconds
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern Memorial Hospital
state: Illinois
Study officials:
affiliation: Northwestern University
name: Gildasio DeOliveira, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01529918: Detecting Diabetes Sooner With a Risk Survey for the Family Doctor:Comparing Internet and Traditional Methods of Communication for Patients and Doctors
Official title: e-Diabetes:Uptake, Patient Preferences and Clinical Outcomes Regarding Self-screening and Clinical Follow-up Using Web-based Technologies in a Large Team-based Primary Care Setting
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Diabetes
Keywords: Diabetes
Self-screening
Web-based technology
follow-up clinical care
randomized control trial
Lead sponsor: McMaster University
Sponsor class: OTHER
First posted: 2012-02-09
Enrollment: 2000
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This pilot RCT study aims to develop and evaluate the uptake, feasibility, and potential value of a strategy for web-diabetes risk assessment versus paper-based methods in an undiagnosed diabetes population over 40 years of age from all listed FHT provided through an electronic medical record database. Following randomization, intervention participants will have the option to decide to use web-based self-screening and the control group will receive only a paper-based method. There will be two options for web-based screening; one involves completion of the CAN-RISK screening tool as part of a personal health record self-management program (MyOscar) versus a one off online risk-assessment. The intervention and control group will be compared with respect to risk-assessment uptake. Educational sessions and further assessment of diabetes conducted by the clinical health care team will be offered to all participants who scored a high risk of diabetes in accordance with the CAN-RISK results. Actual numbers of diabetes cases in those with a high risk score will be compared between the intervention and control groups as well as compared to the usual method of diabetes screening in a randomly chosen non-identifiable sample from the same clinical setting in the same one year period. The assessment of patient acceptability in feasibility of the implementation of the self-screening tool will be accomplished through surveys designed to be completed by patients and staff.


Eligibility criteria: Inclusion Criteria:

* Patients aged 40 and over who did not have diagnosis of diabetes and no previous use of personal health record (MyOscar)

Exclusion Criteria:

* People with diabetes, and those who are already registered as MyOSCAR (personal e-health record) users

Primary outcomes:
measure: Patient's uptake and preferences
timeFrame: 1 year
Secondary outcomes:
measure: The comparison of yield of actual diabetes detected from those who have high risk at self risk-assessment, compared to the usual diabetes detection rate in a random sample from the practice within a one year period.
timeFrame: 1 year
Other outcomes:
Locations:
Study officials:
affiliation: McMaster University, Department of Family Medicine
name: Gina Agarwal, Dr.
role: PRINCIPAL_INVESTIGATOR
References: